Half Year 2026 H Lundbeck A/S Earnings Call & Business Update

Operator: Ladies and gentlemen, welcome to the financial statements for the H1 2026 conference call. I am Moritz, your conference call operator. I would like to remind you that all participants will be in a listen-only mode, and the conference is being recorded. The presentation will be followed by a question and answer session. You can register for questions at any time by pressing star and 1 on your telephone. For operator assistance, please press star and 0. The conference must not be recorded for publication or broadcast. At this time, it is my pleasure to hand over to Charl van Zyl, President and CEO. Please go ahead, sir.

Operator: Ladies and gentlemen, welcome to the Financial Statements for the H1 2026 Conference Call. I am Moritz, your conference call operator. I would like to remind you that all participants will be in a listen-only mode, and the conference is being recorded. The presentation will be followed by a question and answer session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it is my pleasure to hand over to Charl van Zyl, President and CEO. Please go ahead, sir.

Speaker #1: Ladies and gentlemen, welcome to the financial statements for the first six months of 2026 conference call. I'm Moritz, your conference call operator. I would like to remind you that all participants will be in listen-only mode and the conference is being recorded.

Speaker #1: The presentation will be followed by a question-and-answer session. You can register for questions at any time by pressing star and 1 on your telephone.

Speaker #1: For operator assistance, please press star then 0. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Charles van Zuyl, President and CEO.

Speaker #1: Please go ahead, sir.

Speaker #2: So, welcome, everybody. Thank you for joining our call today for our first half of 2026 earnings call. I am, of course, pleased to have my executive leadership team join me today, whom I will be introducing very shortly.

Charl van Zyl: Welcome, everybody. Thank you for joining our call today for our H1 2026 earnings call. I am, of course, pleased to have my executive leadership team join me today, whom I will be introducing very shortly. Just a few opening remarks before we get into the main presentation. Again, very pleased to see the strong momentum that we see in the H1 of this year. As you recall, we upgraded in Q1, and we see now the full year guidance confirmed through this halfway point through 2026. I want to again emphasize also that these results are not by chance. They are really through strategic choice, through clear intent, and disciplined execution of our focused innovative strategy, which is predicated around growth, building a compelling innovative pipeline, and being very disciplined around our capital allocation. Before we unpack these results, let me go to the next slide.

Charl van Zyl: Welcome, everybody. Thank you for joining our call today for our H1 2026 earnings call. I am, of course, pleased to have my executive leadership team join me today, whom I will be introducing very shortly. Just a few opening remarks before we get into the main presentation. Again, very pleased to see the strong momentum that we see in the H1 of this year. As you recall, we upgraded in Q1, and we see now the full year guidance confirmed through this halfway point through 2026. I want to again emphasize also that these results are not by chance. They are really through strategic choice, through clear intent, and disciplined execution of our focused innovative strategy, which is predicated around growth, building a compelling innovative pipeline, and being very disciplined around our capital allocation. Before we unpack these results, let me go to the next slide.

Speaker #2: So, just a few opening remarks before we get into the main presentation. Again, we're very pleased to see the strong momentum in the first half of this year.

Speaker #2: As you recall, we upgraded in Q1, and we now see the full-year guidance confirmed through this halfway point of 2026. I want to again emphasize that these results are not by chance.

Speaker #2: They really, through strategic choice, clear intent, and disciplined execution of our focused innovator strategy—which is predicated on growth, building a compelling innovative pipeline, and being very disciplined around our capital allocation.

Speaker #2: Before we unpack these results, let me go to the next slide. Of course, today contains forward-looking statements, which are subject to change. So, if we can go to the next slide, here I will just provide a very short overview of our performance as things stand at the halfway point 2026.

Charl van Zyl: Of course, today contains forward-looking statements which are subject to change. If we can go to the next slide. Here I will just provide a very short overview of our performance as things stand at the halfway point to 2026. First of all, as I mentioned, our strategy is now in its third year of a focused innovator approach, which is built around growing what we have, growing our key strategic assets, building a strong innovative pipeline, and ensuring that we have disciplined funding and allocation to either invest in growth or in innovation. Just a few points to first unpack on the growth side. Again, our performance through the H1 shows very strong strategic brand growth of 17%. This is underpinned by VYEPTI at 46% and REXULTI at 17%.

Charl van Zyl: Of course, today contains forward-looking statements which are subject to change. If we can go to the next slide. Here I will just provide a very short overview of our performance as things stand at the halfway point to 2026. First of all, as I mentioned, our strategy is now in its third year of a focused innovator approach, which is built around growing what we have, growing our key strategic assets, building a strong innovative pipeline, and ensuring that we have disciplined funding and allocation to either invest in growth or in innovation. Just a few points to first unpack on the growth side. Again, our performance through the H1 shows very strong strategic brand growth of 17%. This is underpinned by VYEPTI at 46% and REXULTI at 17%.

Speaker #2: First of all, as I mentioned, our strategy is now in its third year of a focused innovator approach, which is built around growing what we have, growing our key strategic assets, building a strong, innovative pipeline, and ensuring that we have disciplined funding and allocation to either invest in growth or in innovation.

Speaker #2: And just a few points to first unpack on the growth side. Again, our performance through the first half shows very strong strategic brand growth of 17%.

Speaker #2: This is underpinned by Vyepti at 46% and Rexulti at 17%. Again, these are assets that we have consciously invested in over the last three years, and we truly see the fruits of those results with strong, sustained growth coming from both those assets.

Charl van Zyl: Again, these are assets that we have consciously invested in over the last three years, and we are truly seeing the fruits of those results with strong, sustained growth coming from both those assets. We have also transitioned to a commercial model in our key countries, 27 partner markets. Of course, we are about eight months into that partnership and continue to see strong momentum with this relationship in our commercial model. Let me then go to innovation, which is really a transformation as we have seen in Lundbeck over the last three years. There are two parts to that. Let me talk to a few highlights on the early and mid-stage pipeline. First of all, our D1/D2 agonist is advancing into phase II in Parkinson's disease. We have seen also really promising results of asedebart progressing in two indications, congenital adrenal hyperplasia and Cushing's disease.

Charl van Zyl: Again, these are assets that we have consciously invested in over the last three years, and we are truly seeing the fruits of those results with strong, sustained growth coming from both those assets. We have also transitioned to a commercial model in our key countries, 27 partner markets. Of course, we are about eight months into that partnership and continue to see strong momentum with this relationship in our commercial model. Let me then go to innovation, which is really a transformation as we have seen in Lundbeck over the last three years. There are two parts to that. Let me talk to a few highlights on the early and mid-stage pipeline. First of all, our D1/D2 agonist is advancing into phase II in Parkinson's disease. We have seen also really promising results of asedebart progressing in two indications, congenital adrenal hyperplasia and Cushing's disease.

Speaker #2: We've also transitioned to a commercial model in our key countries—27 partner markets. And, of course, we are about eight months into that partnership and continue to see strong momentum with this relationship in our commercial model.

Speaker #2: Let me then go to innovation, which is really the transformation that we've seen in Lundbeck over the last three years. And there are two parts to that.

Speaker #2: So, let me talk to a few highlights on the early and mid-stage pipeline. First of all, our D1/D2 agonist is advancing into Phase 2 in Parkinson's.

Speaker #2: We have also seen really promising results from a set of our programs progressing in two indications: congenital adrenal hyperplasia and Cushing's disease. And we also see very promising early results from our Erexon program, which has been given fast-track designation by the FDA.

Charl van Zyl: And we also see very promising early results on our orexin program, which has been given Fast Track designation by the FDA. Really compelling early to mid-stage pipeline that are really promising for the future and long-term sustainable growth of Lundbeck. When I talk a little bit about the late stage, again, here you have heard from us before, but very important and good to see the progress we are making on bexicaserin with the DEEp OCEAN study that is closed randomization ahead of time, and we expect our Q4 results or headline results from this particular study. As we also published before, amlenetug, the MASCOT randomization has completed ahead of schedule and on track for H2 2027 readout. Bocunebart continues to advance following the phase II-B, and we are preparing to enter phase III later in 2026.

Charl van Zyl: And we also see very promising early results on our orexin program, which has been given Fast Track designation by the FDA. Really compelling early to mid-stage pipeline that are really promising for the future and long-term sustainable growth of Lundbeck. When I talk a little bit about the late stage, again, here you have heard from us before, but very important and good to see the progress we are making on bexicaserin with the DEEp OCEAN study that is closed randomization ahead of time, and we expect our Q4 results or headline results from this particular study. As we also published before, amlenetug, the MASCOT randomization has completed ahead of schedule and on track for H2 2027 readout. Bocunebart continues to advance following the phase II-B, and we are preparing to enter phase III later in 2026.

Speaker #2: So, a really compelling early- to mid-stage pipeline that is really promising for the future and long-term sustainable growth of Lundbeck. When I talk a little bit about the late stage, again, here you've heard from us before, but it's very important and good to see the progress we're making on vexicastrin with the DEEP OCEAN study that has closed randomization.

Speaker #2: Ahead of time, and we expect our Q4 results or headline results from this particular study. As we also published before, enrollment in the MASCOT randomization has completed ahead of schedule, and on track for a second half 2027 readout.

Speaker #2: VacunaBart continues to advance following the Phase 2B, and we're preparing to enter Phase 3 later in 2026. Importantly, also to say, the funding part, which has been, as you have come to know from us, very disciplined.

Charl van Zyl: Importantly, also to say the funding part, which has been, as you have come to know from us, very disciplined. We have maintained a very strong investment in R&D of 20% to 25% of our revenue, but we have done that through careful allocation and reallocation of capital throughout the company, and we have seen that free cash flow very strong in H1 2026, which has also allowed us to deleverage fast following a Longboard acquisition to a ratio of 1 for net debt to adjusted EBITDA. As I mentioned in my opening remarks, we have upgraded in Q1 based on strong underlying trends, and we are therefore confirming our guidance at this halfway point to 7% to 9% constant on top line and adjusted EBITDA at 8% to 14% on a constant basis as well.

Charl van Zyl: Importantly, also to say the funding part, which has been, as you have come to know from us, very disciplined. We have maintained a very strong investment in R&D of 20% to 25% of our revenue, but we have done that through careful allocation and reallocation of capital throughout the company, and we have seen that free cash flow very strong in H1 2026, which has also allowed us to deleverage fast following a Longboard acquisition to a ratio of 1 for net debt to adjusted EBITDA. As I mentioned in my opening remarks, we have upgraded in Q1 based on strong underlying trends, and we are therefore confirming our guidance at this halfway point to 7% to 9% constant on top line and adjusted EBITDA at 8% to 14% on a constant basis as well.

Speaker #2: We have maintained a very strong investment in R&D of 20% to 25% of our revenue in 2020, but we've done that through careful allocation and reallocation of capital throughout the company.

Speaker #2: And we've seen that free cash flow was very strong in the first half of 2026, which has also allowed us to deleverage fast following the Longboard acquisition to a ratio of 1.4x net debt to adjusted EBITDA.

Speaker #2: So, as I mentioned in my opening remarks, we have upgraded in Q1 based on strong underlying trends, and we are therefore confirming our guidance at this halfway point to 7% to 9% constant on top line, and adjusted EBITDA at 8% to 14% on a constant basis as well.

Speaker #2: So before I hand it to the team again, I want to just emphasize a few things. Lundbeck is continuing on a very strong path of transformation.

Charl van Zyl: Before I hand to the team again, I want to just emphasize a few things. Lundbeck is continuing on a very strong path of transformation. We are today a much stronger commercial organization. We are financially in a much stronger position, and we have a really compelling pipeline to support the long-term sustainable growth of Lundbeck. If I can go to the next slide, and of course, my pleasure to introduce the rest of the speakers who will give you a more detailed update today. You will hear from our two Executive Vice Presidents from our geographies, Thomas and Michala. It is also my pleasure to welcome our soon-to-be-appointed Executive Vice President of Research and Development, Tarek, who will be joining Johan in this very smooth transition in our R&D organization. Of course, you will be concluded with Joerg going in more detail to the financial results.

Charl van Zyl: Before I hand to the team again, I want to just emphasize a few things. Lundbeck is continuing on a very strong path of transformation. We are today a much stronger commercial organization. We are financially in a much stronger position, and we have a really compelling pipeline to support the long-term sustainable growth of Lundbeck. If I can go to the next slide, and of course, my pleasure to introduce the rest of the speakers who will give you a more detailed update today. You will hear from our two Executive Vice Presidents from our geographies, Thomas and Michala. It is also my pleasure to welcome our soon-to-be-appointed Executive Vice President of Research and Development, Tarek, who will be joining Johan in this very smooth transition in our R&D organization. Of course, you will be concluded with Joerg going in more detail to the financial results.

Speaker #2: We are today a much stronger commercial organization. We are financially in a much stronger position, and we have a really compelling pipeline to support the long-term, sustainable growth of Lundbeck.

Speaker #2: So if I can go to the next slide, and of course, it's my pleasure to introduce the rest of the speakers who will give you a more detailed update today.

Speaker #2: You'll hear from our two Executive Vice Presidents from our geographies, Tom and Mikola, and it's also my pleasure to welcome our soon-to-be-appointed Executive Vice President of Research and Development, Tarek, who will be joining Johan in this very smooth transition in our R&D organization.

Speaker #2: Of course, you'll be concluded with Jörg going into more detail on the financial results. So with that, it's my pleasure to hand over to Tom.

Charl van Zyl: With that, it is my pleasure to hand over to Thomas.

Charl van Zyl: With that, it is my pleasure to hand over to Thomas.

Speaker #3: Great, thank you, Cheryl. And hello, everyone. Overall, we are pleased with our commercial performance during the first half of the year, and once again, the highlight was Vyepti.

Thomas Gibbs: Great. Thank you, Charles. Hello, everyone. Overall, we are pleased with our commercial performance during the H1 of the year, and once again, the highlight was VYEPTI. VYEPTI delivered strong market-leading growth during the H1 of 2026, and we expect this to continue throughout the year. This performance has been powered by continued robust underlying demand in both the US and our Europe and international markets. Global revenue reached DKK 2.865 billion in the H1 of 2026, growing at 46% at constant exchange rates. In the US, revenue grew 47%, fueled by demand growth of 41.3%. This is nearly triple the growth rate of the market at 15.3%. This sustained outperformance reflects precision execution across the marketing mix, including the impact of our sales force and DTC investments, which are increasingly being guided by internally developed AI tools and advanced analytics.

Thomas Gibbs: Great. Thank you, Charles. Hello, everyone. Overall, we are pleased with our commercial performance during the H1 of the year, and once again, the highlight was VYEPTI. VYEPTI delivered strong market-leading growth during the H1 of 2026, and we expect this to continue throughout the year. This performance has been powered by continued robust underlying demand in both the US and our Europe and international markets. Global revenue reached DKK 2.865 billion in the H1 of 2026, growing at 46% at constant exchange rates. In the US, revenue grew 47%, fueled by demand growth of 41.3%. This is nearly triple the growth rate of the market at 15.3%. This sustained outperformance reflects precision execution across the marketing mix, including the impact of our sales force and DTC investments, which are increasingly being guided by internally developed AI tools and advanced analytics.

Speaker #3: Vyepti delivered strong, market-leading growth during the first half of 2026, and we expect this to continue throughout the year. This performance has been powered by continued robust underlying demand in both the US and our Europe and international markets.

Speaker #3: Global revenue reached DKK 2.865 billion in the first half of 2026, growing 46% at constant exchange rates. In the US, revenue grew 47%, fueled by demand growth of 41.3%.

Speaker #3: This is nearly triple the growth rate of the market at 15.3%. This sustained outperformance reflects precision execution across the marketing mix, including the impact of our sales force and DTC investments, which are increasingly being guided by internally developed AI tools and advanced analytics.

Speaker #3: Our monthly market share in the US reached an all-time high of 13.01%, compared to 11% at the beginning of 2026, and surpassing Amavig for the first time.

Thomas Gibbs: Our monthly market share in the US reached an all-time high of 13.01% compared to 11% at the beginning of 2026 and surpassing Aimovig for the first time. This market share expansion is driven by continued growth in new patient starts, a high written to infusion conversion ratio, and category-leading patient persistency. We continue to allocate resources in a disciplined and data-driven way as we move through the year to continue to drive market-leading growth. In Europe and international operations, VYEPTI grew 39% at constant exchange rates with strong uptake across key markets, also outpacing anti-CGRP market growth. Market share in these prioritized markets has increased approximately 2 percentage points year over year. Importantly, we are also making good progress towards expanding into Asia and preparing for the launches in China, Japan, and South Korea. We see these as meaningful additional growth opportunities over time. Next slide, please.

Thomas Gibbs: Our monthly market share in the US reached an all-time high of 13.01% compared to 11% at the beginning of 2026 and surpassing Aimovig for the first time. This market share expansion is driven by continued growth in new patient starts, a high written to infusion conversion ratio, and category-leading patient persistency. We continue to allocate resources in a disciplined and data-driven way as we move through the year to continue to drive market-leading growth. In Europe and international operations, VYEPTI grew 39% at constant exchange rates with strong uptake across key markets, also outpacing anti-CGRP market growth.

Speaker #3: This market share expansion is driven by continued growth in new patient starts, a high written-to-infusion conversion ratio, and category-leading patient persistency. We continue to allocate resources in a disciplined and data-driven way as we move through the year to drive market-leading growth.

Speaker #3: In Europe and international markets, at constant exchange rates, we saw strong uptake across key markets. We also outpaced anti-CGRP market growth. Market share in these prioritized markets has increased approximately 2 percentage points year over year.

Thomas Gibbs: Market share in these prioritized markets has increased approximately 2 percentage points year over year. Importantly, we are also making good progress towards expanding into Asia and preparing for the launches in China, Japan, and South Korea. We see these as meaningful additional growth opportunities over time. Next slide, please.

Speaker #3: Importantly, we're also making good progress towards expanding into Asia and preparing for the launches in China, Japan, and South Korea. We see these as meaningful, additional growth opportunities over time.

Speaker #3: Next slide, please. A key part of sustaining Vyepti's momentum is continuing to invest in building the evidence base, both through clinical trials and real-world evidence.

Thomas Gibbs: A key part of sustaining VYEPTI's momentum is continuing to invest in building the evidence base, both through clinical trials and real-world evidence, with the goal of continuing to elevate the clinical and economic value proposition to further differentiate VYEPTI and drive earlier use within the treatment paradigm. Our phase III and phase IV programs created a strong clinical foundation demonstrating rapid and sustained efficacy. These data are now supported by DELIVER, which assessed patients who have failed oral preventative treatments, INFUSE, which provides real-world evidence after anti-CGRP failures, and THRIVE, which is currently evaluating VYEPTI efficacy and safety after insufficient response to one prior anti-CGRP. These data are compelling. 60% of patients reported fewer than 4 monthly headache days sustained through 104 weeks. In DELIVER, 50% of patients with 2 to 4 previous oral preventative treatment failures achieved at least a 50% reduction in monthly migraine days.

Thomas Gibbs: A key part of sustaining VYEPTI's momentum is continuing to invest in building the evidence base, both through clinical trials and real-world evidence, with the goal of continuing to elevate the clinical and economic value proposition to further differentiate VYEPTI and drive earlier use within the treatment paradigm. Our phase III and phase IV programs created a strong clinical foundation demonstrating rapid and sustained efficacy. These data are now supported by DELIVER, which assessed patients who have failed oral preventative treatments, INFUSE, which provides real-world evidence after anti-CGRP failures, and THRIVE, which is currently evaluating VYEPTI efficacy and safety after insufficient response to one prior anti-CGRP.

Speaker #3: With the goal of continuing to elevate the clinical and economic value proposition to further differentiate Vyepti and drive earlier use within the treatment paradigm.

Speaker #3: Our phase 3 and 4 programs created a strong clinical foundation, demonstrating rapid and sustained efficacy. These data are now supported by DELIVER, which assesses patients who have failed oral preventative treatments; INFUSE, which provides real-world evidence after anti-CGRP failures; and THRIVE, which is currently evaluating Vyepti efficacy and safety after insufficient response to one prior anti-CGRP.

Speaker #3: These data are compelling. Sixty percent of patients reported fewer than four monthly headache days, sustained through 104 weeks. In DELIVER, 50% of patients with two to four previous oral preventative treatment failures achieved at least a 50% reduction in monthly migraine days.

Thomas Gibbs: These data are compelling. 60% of patients reported fewer than 4 monthly headache days sustained through 104 weeks. In DELIVER, 50% of patients with 2 to 4 previous oral preventative treatment failures achieved at least a 50% reduction in monthly migraine days.

Speaker #3: And in Infuse, 44% of treated patients achieved at least a 50% reduction in monthly headache days, despite prior exposure to more than one anti-CGRP.

Thomas Gibbs: In INFUSE, 44% of treated patients achieved at least a 50% reduction in monthly headache days, despite prior exposure to more than one anti-CGRP. Importantly, in the ongoing THRIVE study, the interim analysis suggests 45% of patients reporting a PGIC response of much or very much improved after an inadequate response to one anti-CGRP targeting preventative treatment. Overall, we are continuously adding complementary evidence that supports meaningful differentiation and clinical evidence to move VYEPTI earlier in the treatment paradigm so that migraine patients have the potential to achieve the outcome that they deserve. Next slide, please. Turning to REXULTI, which continues to deliver strong double-digit growth. During the H1 of 2026, global revenue reached DKK 3.297 billion, an increase of 17% at constant exchange rates versus the same period last year.

Thomas Gibbs: In INFUSE, 44% of treated patients achieved at least a 50% reduction in monthly headache days, despite prior exposure to more than one anti-CGRP. Importantly, in the ongoing THRIVE study, the interim analysis suggests 45% of patients reporting a PGIC response of much or very much improved after an inadequate response to one anti-CGRP targeting preventative treatment. Overall, we are continuously adding complementary evidence that supports meaningful differentiation and clinical evidence to move VYEPTI earlier in the treatment paradigm so that migraine patients have the potential to achieve the outcome that they deserve. Next slide, please. Turning to REXULTI, which continues to deliver strong double-digit growth. During the H1 of 2026, global revenue reached DKK 3.297 billion, an increase of 17% at constant exchange rates versus the same period last year.

Speaker #3: And importantly, in the ongoing Thrive study, the interim analysis suggests 45% of patients reported a PGIC response of "much" or "very much improved" after an inadequate response to one anti-CGRP targeting preventative treatment.

Speaker #3: So overall, we are continuously adding complementary evidence that supports meaningful differentiation and clinical evidence to move Vyepti earlier in the treatment paradigm, so that migraine patients have the potential to achieve the outcome that they deserve.

Speaker #3: Next slide, please. Turning to Rexulti, which continues to deliver strong, double-digit growth. During the first half of 2026, global revenue reached DKK 3.297 billion, an increase of 17% at constant exchange rates versus the same period last year.

Speaker #3: In the US, TRx demand grew 16.3% on a rolling six-month basis, and ADAD is the main growth driver, with TRx up 37%. While MDD remains a solid contributor, growing 15.7%, this really demonstrates strong, underlying brand fundamentals.

Thomas Gibbs: In the US, TRX demand grew 16.3% on a rolling six-month basis, and AADAD is the main growth driver with TRXs up 37%, while MDD remains a solid contributor, growing 15.7%, really demonstrating strong underlying brand fundamentals. Rexulti AADAD volume is becoming increasingly important to the overall Rexulti brand. The 65 plus segment now contributes over 36% or more than one out of every three of Rexulti TRX claims based upon the most recently available claims data. In our latest awareness, trial, and usage market research survey, Rexulti was identified as the number one preferred brand for the treatment of AADAD and remains an important driver for future growth for the brand. We are pleased with the momentum of Rexulti, and demand is tracking to plan despite an increasingly competitive market.

Thomas Gibbs: In the US, TRX demand grew 16.3% on a rolling six-month basis, and AADAD is the main growth driver with TRXs up 37%, while MDD remains a solid contributor, growing 15.7%, really demonstrating strong underlying brand fundamentals. Rexulti AADAD volume is becoming increasingly important to the overall Rexulti brand. The 65 plus segment now contributes over 36% or more than one out of every three of Rexulti TRX claims based upon the most recently available claims data. In our latest awareness, trial, and usage market research survey, Rexulti was identified as the number one preferred brand for the treatment of AADAD and remains an important driver for future growth for the brand. We are pleased with the momentum of Rexulti, and demand is tracking to plan despite an increasingly competitive market.

Speaker #3: Rexulti AADAD volume is becoming increasingly important to the overall Rexulti brand. The 65-plus segment now contributes over 36%, or more than 1 out of every 3, according to the most recently available claims data.

Speaker #3: In our latest Awareness, Trial, and Usage market research survey, Rexulti was identified as the number one preferred brand for the treatment of AADAD and remains an important driver for future growth for the brand.

Speaker #3: We're pleased with the momentum of Rexulti, and demand is tracking to plan despite an increasingly competitive market. Precision execution across the marketing mix, including our expanded sales team and primary care, is expected to reinforce long-term growth and help address increased competition.

Thomas Gibbs: Precision execution across the marketing mix, including our expanded sales team in primary care, is expected to reinforce long-term growth and help address increased competition. In Europe and international operations, Rexulti delivered strong growth of 24% at constant exchange rates, and this reflects continued momentum across key markets. Next slide, please, and I will hand it over to you, Michala.

Thomas Gibbs: Precision execution across the marketing mix, including our expanded sales team in primary care, is expected to reinforce long-term growth and help address increased competition. In Europe and international operations, Rexulti delivered strong growth of 24% at constant exchange rates, and this reflects continued momentum across key markets. Next slide, please, and I will hand it over to you, Michala.

Speaker #3: In Europe and international operations, Rexulti delivered strong growth of 24% at constant exchange rates, and this reflects continued momentum across key markets. Next slide, please, and I'll hand it over to you, Michela.

Speaker #2: Thank you, Tom. Let's turn our attention to the Abilify LAI franchise, where we continue to see solid growth in the first half of the year, driven by the uptake of our two-monthly formulation.

Michala Fischer-Hansen: Thank you, Tom. Let's turn our attention to the Abilify LAI franchise, where we continued to see solid growth in the H1 of the year, driven by the uptake of our two monthly formulation. Globally, we saw franchise growth of 7% at constant exchange rates in the H1, delivering 1.97 billion DKK in sales, with ABILIFY ASIMTUFII growing 86%. ABILIFY MAINTENA at one monthly declined by 3%, while the continued uptake of ABILIFY ASIMTUFII more than offset this development and also supported the growth of the overall franchise. If we look to the US, the franchise continues to grow market share. We gained 1.1 percentage point year over year, with ABILIFY ASIMTUFII contributing around one percentage point of that increase. Importantly, ABILIFY ASIMTUFII total prescriptions increased by approximately 38% compared to last year.

Michala Fischer-Hansen: Thank you, Tom. Let's turn our attention to the Abilify LAI franchise, where we continued to see solid growth in the H1 of the year, driven by the uptake of our two monthly formulation. Globally, we saw franchise growth of 7% at constant exchange rates in the H1, delivering 1.97 billion DKK in sales, with ABILIFY ASIMTUFII growing 86%. ABILIFY MAINTENA at one monthly declined by 3%, while the continued uptake of ABILIFY ASIMTUFII more than offset this development and also supported the growth of the overall franchise. If we look to the US, the franchise continues to grow market share. We gained 1.1 percentage point year over year, with ABILIFY ASIMTUFII contributing around one percentage point of that increase. Importantly, ABILIFY ASIMTUFII total prescriptions increased by approximately 38% compared to last year.

Speaker #2: Globally, we saw franchise growth of 7% at constant exchange rates in the first half, delivering DKK 1.97 billion in sales, with Simplify growing 86%.

Speaker #2: Abilify Maintena 1-monthly declined by 3%, while the continued uptake of Simplify more than offset this development and also supported the growth of the overall franchise.

Speaker #2: If we look to the US, the franchise continues to grow market share. We gained 1.1 percentage points year over year, with Simplify contributing around 1 percentage point of that increase.

Speaker #2: And importantly, Simplify total prescriptions increased by approximately 38% compared to last year. If we look to Europe and international operations, we also continue to see strong uptake of the 2-monthly formulation.

Michala Fischer-Hansen: If we look to Europe and international operations, we also continue to see strong uptake of the two monthly formulation. Conversion is progressing well across key markets as you can see, which gives us further confidence in the continued growth potential of the franchise. What is particularly encouraging across the geographies is where that uptake is coming from. Globally, we see that around 50% to 60% of the ABILIFY ASIMTUFII patients are new to the Abilify franchise, coming from either oral antipsychotics, other long-acting injectables, or being new to treatment. That gives us confidence that the ABILIFY ASIMTUFII brand is not just simply about converting patients within the franchise, but also helping us expand the franchise overall. Looking ahead, we continue to expect limited impact from ABILIFY MAINTENA generic entry in our key markets during 2026, which gives us additional runway to drive franchise value. Next slide, please.

Michala Fischer-Hansen: If we look to Europe and international operations, we also continue to see strong uptake of the two monthly formulation. Conversion is progressing well across key markets as you can see, which gives us further confidence in the continued growth potential of the franchise. What is particularly encouraging across the geographies is where that uptake is coming from. Globally, we see that around 50% to 60% of the ABILIFY ASIMTUFII patients are new to the Abilify franchise, coming from either oral antipsychotics, other long-acting injectables, or being new to treatment.

Speaker #2: Conversion is progressing well across key markets, as you can see, which gives us further confidence in the continued growth potential of the franchise. What is particularly encouraging across the geographies is where that uptake is coming from.

Speaker #2: Globally, we see that around 50% to 60% of the Simplify patients are new to the Abilify franchise, coming from either oral antipsychotics, other long-acting injectables, or being new to treatment.

Speaker #2: That gives us confidence that the Simplify brand is not just simply about converting patients within the franchise, but also helping us expand the franchise overall.

Michala Fischer-Hansen: That gives us confidence that the ABILIFY ASIMTUFII brand is not just simply about converting patients within the franchise, but also helping us expand the franchise overall. Looking ahead, we continue to expect limited impact from ABILIFY MAINTENA generic entry in our key markets during 2026, which gives us additional runway to drive franchise value. Next slide, please.

Speaker #2: Looking ahead, we continue to see we continue to expect limited impact from Abilify maintained a generic entry in our key markets during 2026, which gives us additional runway to drive franchise value.

Speaker #2: Next slide, please. If we turn to the partner markets, I briefly want to put the reported H1 growth into context and take you through some of the underlying performance.

Michala Fischer-Hansen: If we turn to the partner markets, I briefly want to put the reported H1 growth into context and take you through some of the underlying performance. As you have seen at the group level, revenue grew 16% at constant exchange rates, and as we also discussed in Q1, this includes the planned one-time inventory build of DKK 470 million, as well as shipment timing and the structural impact of partner commissions. When we adjust for the inventory build, group revenue growth was approximately 13% at constant exchange rates. The transition itself is progressing according to plan across the 27 markets, and more importantly, the underlying demand signals remain strong. The partners have broader local reach and distribution capabilities, and the in-market performance continues to support our confidence in the model. I want to emphasize that the one-time inventory build occurred in Q1 and is not expected to reoccur.

Michala Fischer-Hansen: If we turn to the partner markets, I briefly want to put the reported H1 growth into context and take you through some of the underlying performance. As you have seen at the group level, revenue grew 16% at constant exchange rates, and as we also discussed in Q1, this includes the planned one-time inventory build of DKK 470 million, as well as shipment timing and the structural impact of partner commissions. When we adjust for the inventory build, group revenue growth was approximately 13% at constant exchange rates. The transition itself is progressing according to plan across the 27 markets, and more importantly, the underlying demand signals remain strong. The partners have broader local reach and distribution capabilities, and the in-market performance continues to support our confidence in the model.

Speaker #2: As you've seen at the group level, revenue grew 16% at constant exchange rates. And, as we also discussed in Q1, this includes the planned one-time inventory build of 470 million kroner, as well as shipment timing and the structural impact of partner commissions.

Speaker #2: When we adjust for the inventory build, group revenue growth was approximately 13% at constant exchange rates. The transition itself is progressing according to plan across the 27 markets.

Speaker #2: And more importantly, the underlying demand signals remain strong. The partners have broader local reach and distribution capabilities, and the in-market performance continues to support our confidence in the model.

Speaker #2: I want to emphasize that the one-time inventory build occurred in Q1 and is not expected to reoccur. We do expect inventory to normalize during the second half of the year, and the shipment patterns can continue to create quarterly variability, as we also explained in Q1.

Michala Fischer-Hansen: I want to emphasize that the one-time inventory build occurred in Q1 and is not expected to reoccur. We do expect inventory to normalize during the H2 of the year, and the shipment patterns can continue to create quarterly variability, as we also explained in Q1. That is a timing effect of the model, not a change in the underlying demand trend. The key message is therefore that the transition to partners is on track. Our underlying H1 performance is strong, and the expected inventory normalization and shipment phasing is already reflected in our full year planning. With that, I will hand over to Johan for the portfolio update.

Michala Fischer-Hansen: We do expect inventory to normalize during the H2 of the year, and the shipment patterns can continue to create quarterly variability, as we also explained in Q1. That is a timing effect of the model, not a change in the underlying demand trend. The key message is therefore that the transition to partners is on track. Our underlying H1 performance is strong, and the expected inventory normalization and shipment phasing is already reflected in our full year planning. With that, I will hand over to Johan for the portfolio update.

Speaker #2: That is a timing effect of the model, not a change in the underlying demand trend. The key message is, therefore, that the transition to partners is on track.

Speaker #2: Our underlying half-one performance is strong, and the expected inventory normalization and shipment phasing is already reflected in our full-year planning. With that, I'll hand over to Johan for the portfolio update.

Speaker #3: Yeah. Thank you very much, Michela and Tom. It's been a great pleasure working with you. Before turning to some of the more detailed progress on the portfolio, I want to recognize our leadership transition in R&D.

Johan Luthman: Yeah. Thank you very much, Michala and Thomas. It has been a great pleasure working with you. Before turning to some of the more details on the progress of the portfolio, I want to recognize our leadership transition in R&D. As announced in June, upon my retirement, Tarek Samad will step in as the Executive Vice President and Head R&D position as of 1 September. Tarek brings deep experience in neuroscience and biopharma R&D. He has worked internationally in a career spanning Europe and the US, working across academia, big pharma, and small biotech companies. I have had the great pleasure working with him for five years in Lundbeck, seeing him fundamentally transforming our research, organization, and building a highly innovative early portfolio of high-end drug candidates. He is with us on the call today, as you heard. Tarek, a few words.

Johan Luthman: Yeah. Thank you very much, Michala and Thomas. It has been a great pleasure working with you. Before turning to some of the more details on the progress of the portfolio, I want to recognize our leadership transition in R&D. As announced in June, upon my retirement, Tarek Samad will step in as the Executive Vice President and Head R&D position as of 1 September. Tarek brings deep experience in neuroscience and biopharma R&D. He has worked internationally in a career spanning Europe and the US, working across academia, big pharma, and small biotech companies. I have had the great pleasure working with him for five years in Lundbeck, seeing him fundamentally transforming our research, organization, and building a highly innovative early portfolio of high-end drug candidates. He is with us on the call today, as you heard. Tarek, a few words.

Speaker #3: As announced in June, upon my retirement, Tarek Samad will step in as the Executive Vice President and Head of R&D, effective September 1st.

Speaker #3: Tarek brings deep experience in neuroscience and biopharma R&D. He has worked internationally in a career spanning Europe and the US, working across academia, big pharma, and small biotech companies.

Speaker #3: I've had the great pleasure of working with him for 5 years at LUNDBECK, seeing him fundamentally transform our research organization and build a highly innovative early portfolio of high-end drug candidates.

Speaker #3: He's with us on the call today, as you heard. Tarek, a few words.

Speaker #4: Thank you, Johan. I'm excited to be taking on the role of Head of R&D at Lundbeck and to be joining the Executive Leadership Team.

Tarek Samad: Thank you, Johan. I am excited to be taking on the role of Head of R&D at Lundbeck and to be joining the executive leadership team. Having led Lundbeck's global research organization for the past five years, I have seen firsthand the strength of our capabilities and pipeline, as well as our ability to harness partnerships to accelerate progress. I have also seen the exceptional talent across our R&D organization. I am excited to build on these foundations to continue to advance innovation and improve the lives of people living with brain disease. I also want to take this opportunity to thank Johan and the entire R&D organization for the tremendous work over the past years to transform Lundbeck's pipeline, putting us on a strong footing for future success. Thank you. Over to you, Johan.

Tarek Samad: Thank you, Johan. I am excited to be taking on the role of Head of R&D at Lundbeck and to be joining the executive leadership team. Having led Lundbeck's global research organization for the past five years, I have seen firsthand the strength of our capabilities and pipeline, as well as our ability to harness partnerships to accelerate progress. I have also seen the exceptional talent across our R&D organization. I am excited to build on these foundations to continue to advance innovation and improve the lives of people living with brain disease. I also want to take this opportunity to thank Johan and the entire R&D organization for the tremendous work over the past years to transform Lundbeck's pipeline, putting us on a strong footing for future success. Thank you. Over to you, Johan.

Speaker #4: Having led Lundbeck's global research organization for the past five years, I have seen firsthand the strength of our capabilities and pipeline, as well as our ability to harness partnerships to accelerate progress.

Speaker #4: I have also seen the exceptional talent across our R&D organization. I'm excited to build on these foundations to continue advancing innovation and improving the lives of people living with brain diseases.

Speaker #4: I also want to take this opportunity to thank Johan and the entire R&D organization for the tremendous work over the past years to transform Lundbeck's pipeline, putting us on a strong footing for future success.

Speaker #4: Thank you. Over to you, Johan.

Speaker #3: Well, thanks, Tarek. I'm really glad you're taking over this role as head of R&D for Lundbeck. So, let me now turn to some more details on the recent pipeline developments.

Johan Luthman: Well, thanks, Tarek. I am really glad you are taking over this role as Head of R&D for Lundbeck. Let me now turn to some more details on the recent pipeline developments. Next slide, please. Yeah, we are on it. Overall, we continue progressing our broad and diversified pipeline with several Breakthrough Therapy opportunities. Let me first highlight a little bit further on some key milestones on our migraine prevention brand, VYEPTI. In South Korea, VYEPTI received marketing approval on 26 May, an important first geographic expansion in Asia. Further, the market authorization reviews are progressing very well in Japan and China, with action date in Japan within very shortly. For the innovation pipeline, first, an update on bexicaserin. As you heard, our selective 5-HT2C agonist for developmental and epileptic encephalopathies, DEE for short, has in July closed randomization in the DEEp OCEAN trial.

Johan Luthman: Well, thanks, Tarek. I am really glad you are taking over this role as Head of R&D for Lundbeck. Let me now turn to some more details on the recent pipeline developments. Next slide, please. Yeah, we are on it. Overall, we continue progressing our broad and diversified pipeline with several Breakthrough Therapy opportunities. Let me first highlight a little bit further on some key milestones on our migraine prevention brand, VYEPTI. In South Korea, VYEPTI received marketing approval on 26 May, an important first geographic expansion in Asia. Further, the market authorization reviews are progressing very well in Japan and China, with action date in Japan within very shortly. For the innovation pipeline, first, an update on bexicaserin. As you heard, our selective 5-HT2C agonist for developmental and epileptic encephalopathies, DEE for short, has in July closed randomization in the DEEp OCEAN trial.

Speaker #3: Next slide, please. Yeah, we’re on it. So, overall, we continue progressing our broad and diversified pipeline with several breakthrough therapy opportunities. But let me first highlight a little bit further some key milestones for our migraine prevention brand, VYEPTI.

Speaker #3: In South Korea, VYEPTI received marketing approval on May 26—an important first geographical expansion in Asia. Further, the market authorization reviews are progressing very well in Japan and China, with an action date in Japan expected very shortly.

Speaker #3: For the innovation pipeline, first an update on Vexicaserine. As you heard, our selective 5-HT2C agonist for developmental and epileptic encephalopathies, DE for short, has, in July, closed randomization in the Deep Ocean trial.

Speaker #3: This is the largest DE study ever conducted, with 367 patients included across many different DAE conditions. Partially thanks to strong uptake in screening before closing, we ended up very fast.

Johan Luthman: This is the largest DEE study ever conducted, with 367 patients included across many different DEE conditions. Partially thanks to strong uptake in screening before closing, we ended up very fast. With now the last patient randomized, the headline results are expected by the end of the year. In the other pivoted trial of the bexicaserin program, DEEp SEA in Dravet syndrome, we are also progressing well, having ended enrollment and target to close randomization already in mid-September. This means that the pivotal trials will read out very nicely close together in spite of covering different patient populations within the DEE spectrum. At the Q1 reporting, we already presented a very encouraging phase I-B data on our orally dosed D1/D2 agonist Lu AF28996 in Parkinson's disease. Lu AF28996 showed a strong increase in good on time alongside a substantial reduction of off time versus baseline.

Johan Luthman: This is the largest DEE study ever conducted, with 367 patients included across many different DEE conditions. Partially thanks to strong uptake in screening before closing, we ended up very fast. With now the last patient randomized, the headline results are expected by the end of the year. In the other pivoted trial of the bexicaserin program, DEEp SEA in Dravet syndrome, we are also progressing well, having ended enrollment and target to close randomization already in mid-September. This means that the pivotal trials will read out very nicely close together in spite of covering different patient populations within the DEE spectrum. At the Q1 reporting, we already presented a very encouraging phase I-B data on our orally dosed D1/D2 agonist Lu AF28996 in Parkinson's disease. Lu AF28996 showed a strong increase in good on time alongside a substantial reduction of off time versus baseline.

Speaker #3: With the last patient now randomized, the headline results are expected by the end of the year. In the other pivotal trial of the VEXICASERINE program, DEEPC in Dravet syndrome, we are also progressing well, having ended enrollment and targeting to close randomization already in mid-September.

Speaker #3: This means that the pivotal trials we read out very nicely, close together, in spite of covering different patient populations within the DE spectrum. At the Q1 reporting, you were already presented with very encouraging Phase 1b data on our orally dosed D1/D2 agonist, LU996, in Parkinson’s disease.

Speaker #3: LU996 showed a strong increase in good on-time alongside a substantial reduction of off-time versus baseline. Those results garnered major interest at the ADPD '26 meeting in the spring.

Johan Luthman: Those results garnered major interests at the AD/PD 26th meeting in the spring. We have now, as you heard from Charl, initiated our phase II program with a trial called DARE2 in patients with advanced Parkinson's disease with motor fluctuations. In our Lu AH69593 program, Lu AH69593 received Fast Track designation from FDA in July for the treatment on narcolepsy. We have several development candidates in this program and are positioning them as potential best-in-class opportunities within daytime hypersomnolence disorders. On Lu AG22515, our CD40L blocker, ligand blocker, data from the phase I-B study in Thyroid Eye Disease, TED, established proof of mechanism. Strong reductions in TSH receptor autoantibodies, confirming an interesting mechanistic effect. However, this biological activity did not translate to robust enough clinical effect on disease outcomes in TED, and consequently, we are not progressing the program further for that indication.

Johan Luthman: Those results garnered major interests at the AD/PD 26th meeting in the spring. We have now, as you heard from Charl, initiated our phase II program with a trial called DARE2 in patients with advanced Parkinson's disease with motor fluctuations. In our Lu AH69593 program, Lu AH69593 received Fast Track designation from FDA in July for the treatment on narcolepsy. We have several development candidates in this program and are positioning them as potential best-in-class opportunities within daytime hypersomnolence disorders.

Speaker #3: We have now, as you heard from Charles, initiated our Phase 2 program with the trial called DARE2 in patients with advanced Parkinson's disease with motor fluctuations.

Speaker #3: In our REXIM program, LU593 received Fast Track designation from the FDA in July for the treatment of narcolepsy. We have several development candidates in this program, and we are positioning them as potential best-in-class opportunities within daytime hypersomnolence disorders.

Speaker #3: On LU515, our CD40L ligand blocker, data from the Phase 1b study in thyroid eye disease (TED) established proof of mechanism, with strong reductions in TSH receptor autoantibodies confirming an interesting mechanistic effect.

Johan Luthman: On Lu AG22515, our CD40L blocker, ligand blocker, data from the phase I-B study in Thyroid Eye Disease, TED, established proof of mechanism. Strong reductions in TSH receptor autoantibodies, confirming an interesting mechanistic effect. However, this biological activity did not translate to robust enough clinical effect on disease outcomes in TED, and consequently, we are not progressing the program further for that indication. I also like to highlight that we currently are holding 14 special regulatory designations across several programs across our portfolio. That includes nine Orphan Drug designations, with a few more expected in the coming weeks. We have three Fast Track designations and two Breakthrough Therapy designations.

Speaker #3: However, this biological activity did not translate to a robust enough clinical effect on disease outcomes in TAD, and consequently, we are not progressing the program further for that indication.

Speaker #3: I would also like to highlight that we are currently holding 14 special regulatory designations across several programs in our portfolio. That includes 9 orphan drug designations, with a few more expected in the coming weeks.

Johan Luthman: I also like to highlight that we currently are holding 14 special regulatory designations across several programs across our portfolio. That includes nine Orphan Drug designations, with a few more expected in the coming weeks. We have three Fast Track designations and two Breakthrough Therapy designations. This illustrates the critical transformation of the portfolio we have undertaken the last six, seven years, pivoting into a broad portfolio with several first-in-class, even first-in-indication opportunities, the majority in rare diseases. With that, let us discuss some more details on the asedebart program in Cushing's disease. Next slide, please. We have now established mechanistic as well as clinical proof of concept in this indication for asedebart. This is an addition to the proof of concept we already presented last year for congenital adrenal hyperplasia. In both diseases, ACTH is a central driver of pathology. asedebart is a monoclonal antibody binding ACTH directly.

Speaker #3: We have three FAST track designations and two breakthrough therapy designations. This illustrates the critical transformation of the portfolio we have undertaken in the last six to seven years, pivoting into a broad portfolio with several first-in-class, even first-in-indication, opportunities.

Johan Luthman: This illustrates the critical transformation of the portfolio we have undertaken the last six, seven years, pivoting into a broad portfolio with several first-in-class, even first-in-indication opportunities, the majority in rare diseases. With that, let us discuss some more details on the asedebart program in Cushing's disease. Next slide, please. We have now established mechanistic as well as clinical proof of concept in this indication for asedebart. This is an addition to the proof of concept we already presented last year for congenital adrenal hyperplasia. In both diseases, ACTH is a central driver of pathology. asedebart is a monoclonal antibody binding ACTH directly.

Speaker #3: The majority in rare diseases. So with that, let us discuss some more details on the Setabart program in Cushing's disease. Next slide, please. We have now established mechanistic as well as clinical proof of concept in this indication for Setabart.

Speaker #3: This is an addition to the proof of concept we already presented last year for congenital adrenal hyperplasia. In both diseases, ACTH is a central driver of pathology.

Speaker #3: Asetabart is a monoclonal antibody binding ACTH directly. Consequently, we are targeting the upstream, main driver of pathophysiology, rather than the downstream consequences of excess ACTH on cortisol and androgen production.

Johan Luthman: Consequently, we are targeting the upstream main driver of pathophysiology rather than the downstream consequences of excess of ACTH on cortisol and androgen production. asedebart is being investigated in a Cushing's disease phase II study called BalanCeD. BalanCeD has an A part with intravenous administration, followed by a B part that evaluates subcutaneous administration, both with a titration scheme. We have now concluded the IV cohort of the study and presented the data at the end of 2026 meeting this summer. You can see the expected rather large span of baseline urinary free cortisol levels in the patients. After asedebart administration, we see a clear reduction independent on baseline values in urinary cortisol levels, with 7 of the 8 available participants achieving normalization.

Johan Luthman: Consequently, we are targeting the upstream main driver of pathophysiology rather than the downstream consequences of excess of ACTH on cortisol and androgen production. asedebart is being investigated in a Cushing's disease phase II study called BalanCeD. BalanCeD has an A part with intravenous administration, followed by a B part that evaluates subcutaneous administration, both with a titration scheme. We have now concluded the IV cohort of the study and presented the data at the end of 2026 meeting this summer. You can see the expected rather large span of baseline urinary free cortisol levels in the patients. After asedebart administration, we see a clear reduction independent on baseline values in urinary cortisol levels, with 7 of the 8 available participants achieving normalization.

Speaker #3: Asetabart is being investigated in a Cushing's disease Phase 2 study called BALANCED. BALANCED has an A part with intravenous administration, followed by a B part that evaluates subcutaneous administration.

Speaker #3: Both with the titration scheme. We have now concluded the IV cohort of the study and presented the data at the end of the 26th meeting this summer.

Speaker #3: You can see the expected, rather large span of baseline urinary free cortisol levels in the patients. After setabart administration, we see a clear reduction, dependent on baseline values, in urinary cortisol levels, with 7 out of 8 available participants achieving normalization.

Speaker #3: The eighth patient, marked here with an asterisk, did actually reach normal urinary cortisol levels with higher doses, but after that, patients were shifted to subcutaneous dosing with the up-titration scheme.

Johan Luthman: The 8th patient, marked here with asterisks, did actually reach normal urinary cortisol levels with higher doses, but after that, patients were shifted to subcu dosing with the up titration scheme. Thus, all observable patients did eventually respond with normalization. The observed hypercortisolism events were mild and transient, which is a clear differentiation from other therapeutic approaches. One participant unfortunately died during the study. However, that was assessed as not related to the drug. So the safety and tolerability profile of this compound remains supportive, a particularly important feature for a possible new therapeutic in this field. Naturally, since this is an antibody, we do not expect any drug-drug interaction liabilities. We have now started the process of finalizing the ongoing part B, the subcu cohort.

Johan Luthman: The 8th patient, marked here with asterisks, did actually reach normal urinary cortisol levels with higher doses, but after that, patients were shifted to subcu dosing with the up titration scheme. Thus, all observable patients did eventually respond with normalization. The observed hypercortisolism events were mild and transient, which is a clear differentiation from other therapeutic approaches. One participant unfortunately died during the study. However, that was assessed as not related to the drug. So the safety and tolerability profile of this compound remains supportive, a particularly important feature for a possible new therapeutic in this field. Naturally, since this is an antibody, we do not expect any drug-drug interaction liabilities. We have now started the process of finalizing the ongoing part B, the subcu cohort.

Speaker #3: Thus, in all observable patients, normalization did eventually occur. The observed hypercortisolism events were mild and transient, which is a clear differentiation from other therapeutic approaches.

Speaker #3: One participant, unfortunately, died during the study. However, that was assessed as not related to the drug. So the safety and tolerability profile of this compound remains supportive—a particularly important feature for a possible new therapeutic in this field.

Speaker #3: Naturally, since this is an antibody, we do not expect any drug-drug interaction liabilities. We have now started the process of finalizing the ongoing Part B, the subcu cohort.

Speaker #3: Therefore, with the new proof of concept established in both congenital adrenal hyperplasia and now Cushing's disease, we are finishing up the ongoing Phase 2 studies and preparing for late-stage development, with a start within the coming year.

Johan Luthman: Therefore, with a new proof of concept established in both congenital adrenal hyperplasia and now Cushing's disease, we are finishing up the ongoing phase II studies and preparing for late-stage development, which starts within the coming year. Next slide, please. As I mentioned initially, R&D is providing some critical brand support, primarily for Rayaldee. But let me dive further into our innovation development pipeline, how it evolves. Lexscafine, as I already described, is now progressing to headline results for the 2 ongoing phase III trials as next key events, concluding the pivotal trial program by beginning next year. Therefore, if all goes well with the data readouts, we have set the path for an NDA submission during next year. In our other ongoing pivotal program, amlenetug, we have completed the randomization in its pivotal MASCOT trial already early this year.

Johan Luthman: Therefore, with a new proof of concept established in both congenital adrenal hyperplasia and now Cushing's disease, we are finishing up the ongoing phase II studies and preparing for late-stage development, which starts within the coming year. Next slide, please. As I mentioned initially, R&D is providing some critical brand support, primarily for Rayaldee. But let me dive further into our innovation development pipeline, how it evolves. Lexscafine, as I already described, is now progressing to headline results for the 2 ongoing phase III trials as next key events, concluding the pivotal trial program by beginning next year. Therefore, if all goes well with the data readouts, we have set the path for an NDA submission during next year. In our other ongoing pivotal program, amlenetug, we have completed the randomization in its pivotal MASCOT trial already early this year.

Speaker #3: Next slide, please. As I mentioned initially, R&D is providing some critical brand support, primarily for YFD. But let me dive further into our innovation development pipeline, and how it evolves.

Speaker #3: Pexacatrin, as I already described, is now progressing to headline results for the two ongoing Phase 3 trials as the next key events, concluding the pivotal trial program by beginning next year.

Speaker #3: Therefore, if all goes well with the data readouts, we have set the path for an NDA submission during next year. In our other ongoing pivotal program, I'm in Linnetug.

Speaker #3: We have completed the randomization in this pivotal master trial already early this year. Since this master trial has a 72-week double-blind treatment period with placebo, it will take until late '27 until headline results can be expected.

Johan Luthman: Since this MASCOT trial has a 72-week double-blind treatment period with placebo, it will take until late 2027 until headline results can be expected. As you recall, this is a pioneering trial, both in design and in its indication. In the bocunebart, our PACAP antibody program for migraine prevention, the preparations for phase III initiations are progressing well. As you recall, we reported headline results from the comprehensive Phase IIb PROCEED trial in February this year. It is statistically significant reduction in monthly migraine days versus placebo in patients with 2 to 4 prior preventive treatment failures. Some of the PROCEED data have now been presented at key scientific meetings, such as the American Headache Society Congress in early June. We have also showed that bocunebart is well-tolerated with concomitant use of gepants.

Johan Luthman: Since this MASCOT trial has a 72-week double-blind treatment period with placebo, it will take until late 2027 until headline results can be expected. As you recall, this is a pioneering trial, both in design and in its indication. In the bocunebart, our PACAP antibody program for migraine prevention, the preparations for phase III initiations are progressing well. As you recall, we reported headline results from the comprehensive Phase IIb PROCEED trial in February this year. It is statistically significant reduction in monthly migraine days versus placebo in patients with 2 to 4 prior preventive treatment failures. Some of the PROCEED data have now been presented at key scientific meetings, such as the American Headache Society Congress in early June. We have also showed that bocunebart is well-tolerated with concomitant use of gepants.

Speaker #3: As you recall, this is a pioneering trial both in design and in its indication. In the core market, our pick-up antibody program for migraine prevention—the preparations for Phase 3 initiations are progressing well.

Speaker #3: As you recall, we reported headline results from the comprehensive Phase 2b PROCEED trial in February this year. We did see a statistically significant reduction in monthly migraine days versus placebo in patients with two to four prior preventive treatment failures.

Speaker #3: Some of the PROCEED data have now been presented at key scientific meetings, such as the American Headache Society Congress in early June. We have also shown that the compound is well tolerated with concomitant use of triptans.

Speaker #3: The Cornerbart program data have been very well received by clinical migraine experts. They see the program as an exciting opportunity to establish anti-PCAP therapy as a novel option, particularly in the treatment of resistant chronic migraine patients.

Johan Luthman: The bocunebart program data have been very well received by clinical migraine experts that see the program as an exciting opportunity to establish anti-PACAP therapy as a novel option, in particular in the treatment of resistant chronic migraine patients. In the recent month, we have also conducted fruitful regulatory interactions that guide further our phase III program design. As already mentioned, our orexin agonist platform, although very still early in development, presents opportunities for a set of strong contenders in this very recognized drug class. We think there are opportunities for best-in-class or possibly even first in the indication across the field on many different daytime hypersomnolence disorders. Overall, we have rapidly expanding and diversified innovation pipeline that is increasingly maturing. Several assets have already shown strong scientific and clinical validation as well as supportive regulatory special designations.

Johan Luthman: The bocunebart program data have been very well received by clinical migraine experts that see the program as an exciting opportunity to establish anti-PACAP therapy as a novel option, in particular in the treatment of resistant chronic migraine patients. In the recent month, we have also conducted fruitful regulatory interactions that guide further our phase III program design. As already mentioned, our orexin agonist platform, although very still early in development, presents opportunities for a set of strong contenders in this very recognized drug class. We think there are opportunities for best-in-class or possibly even first in the indication across the field on many different daytime hypersomnolence disorders.

Speaker #3: In the recent month, we have also conducted fruitful regulatory interactions that further guide our phase 3 program design. As already mentioned, our excellent agonist platform, although still very early in development, presents opportunities for a set of strong contenders in this highly recognized drug class.

Speaker #3: We think we have opportunities for best-in-class, or possibly even first-in-indication, across the field of many different daytime hypersomnolence disorders. Overall, we have a rapidly expanding and diversified innovation pipeline that is increasingly maturing.

Johan Luthman: Overall, we have rapidly expanding and diversified innovation pipeline that is increasingly maturing. Several assets have already shown strong scientific and clinical validation as well as supportive regulatory special designations. As this overview also shows, we have delivered on our ambitious target by having five to six indications in mid to late development. We are indeed looking at the prospect of having enabled multiple programs entering pivotal stage by beginning next year. Our transformed pipeline therefore combines seven near-term catalysts matched with longer-term innovation, with multiple major value inflection points coming in the next one to two years. With that, I am concluding my last quarterly earnings call for Lundbeck. I would like to thank analysts for great interactions over the years and hand over to Joerg for financial updates.

Speaker #3: Several assets have already shown strong scientific and clinical validation, as well as supportive regulatory special designations. As this overview also shows, we had delivered on our ambitious target by having five to six indications in mid- to late-stage development.

Johan Luthman: As this overview also shows, we have delivered on our ambitious target by having five to six indications in mid to late development. We are indeed looking at the prospect of having enabled multiple programs entering pivotal stage by beginning next year. Our transformed pipeline therefore combines seven near-term catalysts matched with longer-term innovation, with multiple major value inflection points coming in the next one to two years. With that, I am concluding my last quarterly earnings call for Lundbeck. I would like to thank analysts for great interactions over the years and hand over to Joerg for financial updates.

Speaker #3: We are indeed looking at the prospect of having enabled multiple programs entering the pivotal stage by the beginning of next year. Our transform pipeline, therefore, combines several near-term catalysts matched with longer-term innovation.

Speaker #3: With multiple major value inflection points coming in the next one to two years. So with that, I'm concluding my last quarterly earnings call for Lundbeck.

Speaker #3: I'd like to thank the analysts for great interactions over the years, and hand over to Jörg for financial updates.

Speaker #1: Thank you, Jörn. Before I take you through the numbers, let me briefly put the H1 performance into a broader financial perspective. We continue to see strong underlying growth, which is supporting our strategic ambition to reallocate resources toward our highest-value opportunities.

Joerg Hornstein: Thank you, Johan. Before I take you through the numbers, let me briefly put the H1 performance into a broader financial perspective. We continue to see strong underlying growth, which is supporting our strategic ambition to reallocate resources towards our highest value opportunities. Importantly, we are also stepping up investment in R&D as the pipeline matures, while strong cash generation and continued deleveraging are further strengthening our financial flexibility. Overall, H1 shows a business that is growing, becoming more efficient, while continuing to invest for the future. With that, let me take you through the financial performance in more detail. Next slide, please. Revenue reached DKK 13.6 billion, up 16% at constant exchange rate with underlying growth of around 13%. This reflects continued strong commercial momentum set by VYEPTI and REXULTI, with additional contribution from inventory build and phasing dynamics in our partnership model in 27 markets.

Joerg Hornstein: Thank you, Johan. Before I take you through the numbers, let me briefly put the H1 performance into a broader financial perspective. We continue to see strong underlying growth, which is supporting our strategic ambition to reallocate resources towards our highest value opportunities. Importantly, we are also stepping up investment in R&D as the pipeline matures, while strong cash generation and continued deleveraging are further strengthening our financial flexibility.

Speaker #1: Importantly, we are also stepping up investment in R&D as the pipeline matures, while strong cash generation and continued deleveraging are further strengthening our financial flexibility.

Speaker #1: So overall, H1 shows a business that is growing, becoming more efficient, while continuing to invest for the future. With that, let me take you through the financial performance in more detail.

Joerg Hornstein: Overall, H1 shows a business that is growing, becoming more efficient, while continuing to invest for the future. With that, let me take you through the financial performance in more detail. Next slide, please. Revenue reached DKK 13.6 billion, up 16% at constant exchange rate with underlying growth of around 13%. This reflects continued strong commercial momentum set by VYEPTI and REXULTI, with additional contribution from inventory build and phasing dynamics in our partnership model in 27 markets. The adjusted gross margin was 86.7%, reflecting the impact of commission costs associated with the partnership model in 27 markets, as well as unfavorable product and geographic mix. Sales and distribution costs increased 2% at constant exchange rates.

Speaker #1: Next slide, please. Revenue reached $13.6 billion, up 16% at constant exchange rates, with underlying growth of around 13%. This reflects continued strong commercial momentum, led by YFD and Rexalti, with additional contribution from inventory build and phasing dynamics in our partnership model.

Speaker #1: In 27 markets, the adjusted gross margin was 86.7%, reflecting the impact of commission costs associated with the partnership model in 27 markets, as well as unfavorable product and geographic mix.

Joerg Hornstein: The adjusted gross margin was 86.7%, reflecting the impact of commission costs associated with the partnership model in 27 markets, as well as unfavorable product and geographic mix. Sales and distribution costs increased 2% at constant exchange rates. The savings from the new commercial model have continued to be reinvested mainly into our strong growth of VYEPTI in the US, as well as the launch preparations for VYEPTI in Asia. Administrative expenses reached DKK 760 million, corresponding to a slight increase of 3% at constant exchange rates, which is in line with expectations. R&D costs increased according to plan by 24% at constant exchange rates, reaching DKK 2.8 billion, driven by the progression of our phase III programs for bexicaserin and amlenetug, and a maturing mid-stage pipeline. Other operating expenses reached DKK 141 million, primarily reflecting a one-off restructuring provision in Q1.

Speaker #1: Sales and distribution costs increased 2% at constant exchange rates. The savings from the new commercial model have continued to be reinvested, mainly into our strong growth of YFD in the US, as well as the launch preparations for YFD in Asia.

Joerg Hornstein: The savings from the new commercial model have continued to be reinvested mainly into our strong growth of VYEPTI in the US, as well as the launch preparations for VYEPTI in Asia. Administrative expenses reached DKK 760 million, corresponding to a slight increase of 3% at constant exchange rates, which is in line with expectations. R&D costs increased according to plan by 24% at constant exchange rates, reaching DKK 2.8 billion, driven by the progression of our phase III programs for bexicaserin and amlenetug, and a maturing mid-stage pipeline. Other operating expenses reached DKK 141 million, primarily reflecting a one-off restructuring provision in Q1.

Speaker #1: Administrative expenses reached 716 million, corresponding to a slight increase of 3% at constant exchange rates, which is in line with expectations. R&D costs increased according to plan by 24% at constant exchange rates, reaching 2.8 billion, driven by the progression of our Phase 3 programs for Pexacatrin and Amlenetug.

Speaker #1: And the maturing mid-stage pipeline. Other operating expenses reached $141 million, primarily reflecting a one-off restructuring provision in Q1. Adjusted EBITDA grew by 19% at constant exchange rates, primarily driven by the strong performance of YFD and Rexulti, as well as the gross profit benefit from the one-time inventory build supporting the transition to a partnership model.

Joerg Hornstein: Adjusted EBITDA grew by 19% at constant exchange rates, primarily driven by the strong performance of VYEPTI and REXULTI, as well as the gross profit benefit from the one-time inventory build, supporting the transition to a partnership model. This was partially offset by higher cost of sales and continued investments in R&D. Next slide, please. EBIT increased 14% to DKK 3.7 billion, driven by higher gross profit from strong sales, including the one-time impact from the inventory build, as well as a lower sales and distribution costs ratio. This was partially offset, again, by increased investments in R&D. Net financials were an expense of DKK 56 million, benefiting from favorable currency movements and lower interest costs following continued deleveraging. Our effective tax rate was 22%, in line with full-year expectation. Net profit increased by 36% to DKK 2.8 billion, and adjusted net profit grew 28% to DKK 3.7 billion.

Joerg Hornstein: Adjusted EBITDA grew by 19% at constant exchange rates, primarily driven by the strong performance of VYEPTI and REXULTI, as well as the gross profit benefit from the one-time inventory build, supporting the transition to a partnership model. This was partially offset by higher cost of sales and continued investments in R&D. Next slide, please. EBIT increased 14% to DKK 3.7 billion, driven by higher gross profit from strong sales, including the one-time impact from the inventory build, as well as a lower sales and distribution costs ratio. This was partially offset, again, by increased investments in R&D. Net financials were an expense of DKK 56 million, benefiting from favorable currency movements and lower interest costs following continued deleveraging. Our effective tax rate was 22%, in line with full-year expectation.

Speaker #1: This was partially offset by higher cost of sales and continued investments in R&D. Next slide, please. EBIT increased 14% to $3.7 billion, driven by higher gross profit from strong sales, including the one-time impact from the inventory build, as well as a lower sales and distribution cost ratio.

Speaker #1: This was partially offset again by increased investments in R&D. Net financials were an expense of $56 million, benefiting from favorable currency movements and lower interest costs following continued deleveraging.

Speaker #1: Our effective tax rate was 22%, in line with full-year expectations. Net profit increased by 36% to DKK 2.8 billion, and adjusted net profit grew 28% to DKK 3.7 billion.

Joerg Hornstein: Net profit increased by 36% to DKK 2.8 billion, and adjusted net profit grew 28% to DKK 3.7 billion. This translates into an adjusted EPS growth of 28%, consistent with the underlying performance of the business. Overall, profitability development reflects both strong execution and a disciplined financial framework. Next slide, please. Cash flow from operating activities was mainly driven by the higher EBIT performance, reaching DKK 2.6 billion, partially offset by higher working capital outflows and tax payments. Cash flow from investing activities was an outflow of DKK 261 million, mainly reflecting investments in property, plant, and equipment. Cash flow from financing activities was an outflow of DKK 3.6 billion, reflecting net loan repayments related to the revolving credit facility and a higher dividend payment.

Speaker #1: This translates into an adjusted EPS growth of 28%, consistent with the underlying performance of the business. So overall, profitability development reflects both strong execution and a disciplined financial framework.

Joerg Hornstein: This translates into an adjusted EPS growth of 28%, consistent with the underlying performance of the business. Overall, profitability development reflects both strong execution and a disciplined financial framework. Next slide, please. Cash flow from operating activities was mainly driven by the higher EBIT performance, reaching DKK 2.6 billion, partially offset by higher working capital outflows and tax payments. Cash flow from investing activities was an outflow of DKK 261 million, mainly reflecting investments in property, plant, and equipment. Cash flow from financing activities was an outflow of DKK 3.6 billion, reflecting net loan repayments related to the revolving credit facility and a higher dividend payment. As a result, net debt reduced to DKK 7.4 billion, again, reflecting strong cash generation and continued progress on deleveraging following the Longboard acquisition. Overall, our financial position remains solid, providing flexibility to continue investing into both growth and innovation. Next slide, please.

Speaker #1: Next slide, please. Cash flow from operating activities was mainly driven by the higher EBIT performance, reaching $2.6 billion, partially offset by higher working capital outflows and tax payments.

Speaker #1: Cash flow from investing activities was an outflow of $261 million, mainly reflecting investments in property, plant, and equipment. And cash flow from financing activities was an outflow of $3.6 billion, reflecting net loan repayments related to the revolving credit facility and a higher dividend payment.

Speaker #1: As a result, net debt reduced to $7.4 billion, again reflecting strong cash generation and continued progress on deleveraging following the Longboard acquisition. Overall, our financial position remains solid, providing flexibility to continue investing into both.

Joerg Hornstein: As a result, net debt reduced to DKK 7.4 billion, again, reflecting strong cash generation and continued progress on deleveraging following the Longboard acquisition. Overall, our financial position remains solid, providing flexibility to continue investing into both growth and innovation. Next slide, please.

Speaker #1: Growth and innovation. Next slide, please. We've had a very strong first half, and importantly, we continue to see strong underlying commercial momentum. As you will recall, with our Q1 results, we increased and narrowed our full-year guidance.

Joerg Hornstein: We have had a very strong H1, and importantly, we continue to see strong underlying commercial momentum. As you will recall with our Q1 results, we increased and narrowed our full-year guidance. Following the strong H1 performance, we are maintaining those upgraded ranges at constant exchange rates. The H1 performance gives us confidence that we are tracking well within these ranges, and at this stage, perhaps towards the upper end of the guidance. At the same time, we remain mindful that some of the H1 strength reflects inventory and shipment phasing. We expect some normalization in the H2. Against that backdrop, we believe it is appropriate to maintain the guidance at this point rather than make a further adjustment. Cost-wise, we continue to invest in the pipeline and still expect R&D costs in the range of DKK 5.6 to DKK 5.9 billion for the full year.

Joerg Hornstein: We have had a very strong H1, and importantly, we continue to see strong underlying commercial momentum. As you will recall with our Q1 results, we increased and narrowed our full-year guidance. Following the strong H1 performance, we are maintaining those upgraded ranges at constant exchange rates. The H1 performance gives us confidence that we are tracking well within these ranges, and at this stage, perhaps towards the upper end of the guidance. At the same time, we remain mindful that some of the H1 strength reflects inventory and shipment phasing. We expect some normalization in the H2. Against that backdrop, we believe it is appropriate to maintain the guidance at this point rather than make a further adjustment. Cost-wise, we continue to invest in the pipeline and still expect R&D costs in the range of DKK 5.6 to DKK 5.9 billion for the full year.

Speaker #1: Following the strong H1 performance, we are maintaining those upgraded ranges at constant exchange rates. The first-half performance gives us confidence that we're tracking well within these ranges and, at this stage, perhaps towards the upper end of the guidance.

Speaker #1: At the same time, we remain mindful that some of the H1 strength reflects inventory and shipment phasing, and we expect some normalization in the second half.

Speaker #1: Against that backdrop, we believe it is appropriate to maintain the guidance at this point rather than make a further adjustment. Cost-wise, we continue to invest in the pipeline and still expect R&D costs in the range of $5.6 to $5.9 billion for the full year.

Speaker #1: We've also updated some of our other financial assumptions or financial modeling considerations, with several of these changes reflecting developments in exchange rates. At current rates, revenue growth is expected to be around 4 percentage points lower than at constant exchange rates, and adjusted EBITDA growth around 8 percentage points lower than at constant exchange rates.

Joerg Hornstein: We have also updated some of our other financial assumptions or financial modeling considerations with several of these changes reflecting the development in exchange rates. At current rates, revenue growth is expected to be around 4 percentage points lower than constant exchange rates, and adjusted EBITDA growth around 8 percentage points lower than constant exchange rates. We now expect a negative hedging effect of around DKK 150 million and net financial expenses of around DKK 200 million. Adjusted gross margin is expected around 87%, and depreciation and amortization at DKK 1.8 to DKK 1.9 billion. Our tax rate and year-end net debt expectations remain unchanged. Overall, the strong H1 supports the guidance increase and narrowing we made at Q1 and gives us confidence that we are currently tracking towards the upper end of our full-year ranges.

Joerg Hornstein: We have also updated some of our other financial assumptions or financial modeling considerations with several of these changes reflecting the development in exchange rates. At current rates, revenue growth is expected to be around 4 percentage points lower than constant exchange rates, and adjusted EBITDA growth around 8 percentage points lower than constant exchange rates. We now expect a negative hedging effect of around DKK 150 million and net financial expenses of around DKK 200 million. Adjusted gross margin is expected around 87%, and depreciation and amortization at DKK 1.8 to DKK 1.9 billion. Our tax rate and year-end net debt expectations remain unchanged. Overall, the strong H1 supports the guidance increase and narrowing we made at Q1 and gives us confidence that we are currently tracking towards the upper end of our full-year ranges.

Speaker #1: We now expect a negative hedging effect of around €150 million, and net financial expenses of around €200 million. Adjusted gross margin is expected to be around 87%, and depreciation and amortization at €1.8 to €1.9 billion.

Speaker #1: Our tax rate and year-end net debt expectations remain unchanged. So overall, the strong first half supports the guidance increase and narrowing we made at Q1, and gives us confidence that we're currently tracking towards the upper end of our full-year ranges.

Speaker #1: However, given the expected normalization and lower pace of growth in H2, we believe maintaining those ranges is appropriate at this stage. And with that, I would like to hand back to Charles.

Joerg Hornstein: However, given the expected normalization lower pace of growth in H2, we believe maintaining those ranges is appropriate at this stage. I would like to hand back to Charl.

Joerg Hornstein: However, given the expected normalization lower pace of growth in H2, we believe maintaining those ranges is appropriate at this stage. I would like to hand back to Charl.

Speaker #2: Yep. Thank you, Jörg. And so let me make some concluding remarks before we go to questions. So if we can have the first slide there.

Charl van Zyl: Yep. Thank you, Joerg. Let me make some concluding remarks before we go to questions. If we can have the first slide there. Thank you. First of all, I think what I want to take a moment here is just to depict a bit what has really evolved at Lundbeck over the last 3 years. The first half results confirm that our ability to really deliver on what we have set as priorities, and often exceeding those expectations. If you think about the focus on growth, on innovation, and on funding, we have truly set up a very strong commercial model led by VYEPTI with strong momentum across all the key markets and also for the future launches that we will have.

Charl van Zyl: Yep. Thank you, Joerg. Let me make some concluding remarks before we go to questions. If we can have the first slide there. Thank you. First of all, I think what I want to take a moment here is just to depict a bit what has really evolved at Lundbeck over the last 3 years. The first half results confirm that our ability to really deliver on what we have set as priorities, and often exceeding those expectations. If you think about the focus on growth, on innovation, and on funding, we have truly set up a very strong commercial model led by VYEPTI with strong momentum across all the key markets and also for the future launches that we will have.

Speaker #2: So thank you. So first of all, I think what I want to take a moment here is just to depict a bit what has really evolved at LUNDBECK over the last three years.

Speaker #2: And the first half results confirm our ability to really deliver on what we have set as priorities, and often exceed those expectations.

Speaker #2: And if you think about the focus on growth, on innovation, and on funding, we have truly set up a very strong commercial model led by YFD, with strong momentum across all the key markets and also for the future launches that we will have.

Speaker #2: We have truly seen a transformation in the pipeline, both in breadth and in stage, from mid-stage to late stage. And through our disciplined capital allocation, we've been able to strengthen the balance sheet with a strong cash position as we go into the next phase of our journey, 2027 to 2029, which is the scale phase, where we will see really a platform of a company that's able to expand in the space of severe preventative migraine, with launches of YFD in the future, but also VacunaBart as a new mechanism in this space.

Charl van Zyl: We have truly seen a transformation in the pipeline, both in breadth and in stage, from mid-stage to late stage, and through our disciplined capital allocation, we've been able to strengthen the balance sheet with a strong cash position as we go into the next phase of our journey, 2027 to 2029, which is the scale phase. We will see really a platform of a company that's able to expand in the space of severe preventative migraine with launches of VYEPTI in the future, but also bocunebart as a new mechanism in this space. You'll see a company that has really a different pipeline, more in rare diseases but also in neurospecialty, and that breadth of the pipeline will continue to expand as we go into the scale phase.

Charl van Zyl: We have truly seen a transformation in the pipeline, both in breadth and in stage, from mid-stage to late stage, and through our disciplined capital allocation, we've been able to strengthen the balance sheet with a strong cash position as we go into the next phase of our journey, 2027 to 2029, which is the scale phase. We will see really a platform of a company that's able to expand in the space of severe preventative migraine with launches of VYEPTI in the future, but also bocunebart as a new mechanism in this space. You'll see a company that has really a different pipeline, more in rare diseases but also in neurospecialty, and that breadth of the pipeline will continue to expand as we go into the scale phase.

Speaker #2: You'll see a company that really has a different pipeline, more in rare diseases but also in neuro specialty. That breadth of the pipeline will continue to expand as we go into the scale phase.

Speaker #2: And we will also see a certain expansion of our AI capabilities to truly become a bionic company as we enter into this next phase of our journey.

Charl van Zyl: We will also see a certain expansion of our AI capabilities to truly become a bionic company as we enter into this next phase of our journey. What you will expect from us in the second half is really strong momentum on the strategic brands as we continue that focused execution journey, but also strong execution in the pipeline with our next important readout of the bexicaserin DEEp OCEAN study in Q4 of 2026. When we think a little bit about Lundbeck and where we stand at this stage of our 3-year journey into our focused innovator strategy as a company that's stronger commercially, that has a much stronger pipeline and stronger financial position as we enter into the next phase. Which gives us a lot of confidence as we embark on the next phase of our journey.

Charl van Zyl: We will also see a certain expansion of our AI capabilities to truly become a bionic company as we enter into this next phase of our journey. What you will expect from us in the second half is really strong momentum on the strategic brands as we continue that focused execution journey, but also strong execution in the pipeline with our next important readout of the bexicaserin DEEp OCEAN study in Q4 of 2026. When we think a little bit about Lundbeck and where we stand at this stage of our 3-year journey into our focused innovator strategy as a company that's stronger commercially, that has a much stronger pipeline and stronger financial position as we enter into the next phase. Which gives us a lot of confidence as we embark on the next phase of our journey.

Speaker #2: What you will expect from us in the second half is really strong momentum on the strategic brands, as we continue that focused execution journey, but also strong execution in the pipeline with our next important readout of the BEXI-CASHRUN-OSIN study in the fourth quarter of 2026.

Speaker #2: So, when we think a little bit about Lundbeck and where we stand at this stage of our three-year journey into our focused innovator strategy, we are a company that's stronger commercially, with a much stronger pipeline and a stronger financial position as we enter into the next phase. This gives us a lot of confidence as we embark on the next phase of our journey.

Speaker #2: Before I open again for questions, I also want to take this moment to thank you, Johan, for your contribution and impact in truly transforming our pipeline. I also want to take this opportunity to welcome Tarek to our executive leadership team.

Charl van Zyl: Before I open again for questions, I want to also take this moment to thank you, Johan, for your contribution and impact to really transforming our pipeline and take this moment also to welcome Tarek to our executive leadership team. With that, I would open the line for questions, please.

Charl van Zyl: Before I open again for questions, I want to also take this moment to thank you, Johan, for your contribution and impact to really transforming our pipeline and take this moment also to welcome Tarek to our executive leadership team. With that, I would open the line for questions, please.

Speaker #2: With that, I would like to open the line for questions, please.

Operator: Ladies and gentlemen, we will now begin the question and answer session.

Operator: Ladies and gentlemen, we will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode when asking a question. Anyone who has a question may press star and one at this time. One moment for the first question, please. The first question comes from Thomas Bowers from SEB. Please go ahead.

Speaker #3: Ladies and gentlemen, we will now begin the question-and-answer session. Anyone who wishes to ask a question may press star and one on their telephone.

Operator: Anyone who wishes to ask a question may press star and one on their telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode when asking a question. Anyone who has a question may press star and one at this time. One moment for the first question, please. The first question comes from Thomas Bowers from SEB. Please go ahead.

Speaker #3: You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two.

Speaker #3: Questions asked on the phone are requested to disable the loudspeaker mode while asking a question. Anyone who has a question may press star and one at this time.

Speaker #3: One moment for the first question, please. And the first question comes from Thomas Bowers from SEB. Please go ahead.

Speaker #1: Yes, thank you very much. Two pipeline questions from my table here. So, just to start with the BEXI Cash Run and the OSIN trial readout here.

Thomas Bowers: Yes. Thank you very much. Two pipeline questions from my table here. Just kicking off with the bexicaserin and the DEEp OCEAN trial readout here. Can you maybe just comment a bit on patient demographics, anything on the disease severity, baseline seizure frequency, background therapies, stuff like that, anything that could mean that there are some meaningful differences between what you saw in the PACIFIC trial, anything that could affect the efficacy or placebo response here would be appreciated. Then last one on amlenetug. As I understand it, futility analysis is coming up here near term. Can you maybe clarify what exactly will be assessed here? Will this primarily be probability on primary endpoint?

Thomas Bowers: Yes. Thank you very much. Two pipeline questions from my table here. Just kicking off with the bexicaserin and the DEEp OCEAN trial readout here. Can you maybe just comment a bit on patient demographics, anything on the disease severity, baseline seizure frequency, background therapies, stuff like that, anything that could mean that there are some meaningful differences between what you saw in the PACIFIC trial, anything that could affect the efficacy or placebo response here would be appreciated. Then last one on amlenetug. As I understand it, futility analysis is coming up here near term. Can you maybe clarify what exactly will be assessed here? Will this primarily be probability on primary endpoint?

Speaker #1: Can you maybe just comment a bit on patient demographics? So anything on the disease severity, baseline seizure frequency, background therapies, stuff like that? Anything that could mean that there are some meaningful differences between what you saw in the Pacific trial?

Speaker #1: Anything that could sort of affect the efficacy or placebo response here would be appreciated. And then last one on Amilintoc, so as I understand it, futility analysis is coming up here near term.

Speaker #1: So, can you maybe clarify what exactly will be assessed here? Will this primarily be probability on the primary endpoint? Is there anything in this analysis that could change your view on sample size—increase sample size, trial design—or is this just a strict stop-and-go decision that this is based on?

Thomas Bowers: Is there anything in this analysis that could change your view on sample size, increased sample size, trial design, or is this just a strict stop-and-go decision that this is based on? Thank you.

Thomas Bowers: Is there anything in this analysis that could change your view on sample size, increased sample size, trial design, or is this just a strict stop-and-go decision that this is based on? Thank you.

Speaker #1: Thank you.

Speaker #2: Yeah, I guess that's for me. Thanks a lot. Let's start with BEXI Cash Run. So, just to make it a little simple for you, if we look at the Pacific trial, we're not fundamentally different in the general baseline criteria.

Johan Luthman: Yeah, I guess that's for me. Thanks a lot. Let's start with bexicaserin. Just to make it a little simple for you, if we look at the PACIFIC trial, we're not fundamentally different in the general baseline criteria and demographics. Of course, it's much broader because it's a very broad DE. When we announced the DEEp OCEAN enclosure, we said it was well over 60 different DEs, and that is important. We like to really cover a wide span. In the DEEp OCEAN trial, a good balance between people that travel all the way to Lennox-Gastaut diagnosis and those that remain with different DE diagnosis. It's a good balance. We are very confident in terms of fulfilling what we would need to show in terms of the DE label. Background therapies, it's the usual. It's not a big difference.

Johan Luthman: Yeah, I guess that's for me. Thanks a lot. Let's start with bexicaserin. Just to make it a little simple for you, if we look at the PACIFIC trial, we're not fundamentally different in the general baseline criteria and demographics. Of course, it's much broader because it's a very broad DE. When we announced the DEEp OCEAN enclosure, we said it was well over 60 different DEs, and that is important. We like to really cover a wide span. In the DEEp OCEAN trial, a good balance between people that travel all the way to Lennox-Gastaut diagnosis and those that remain with different DE diagnosis. It's a good balance. We are very confident in terms of fulfilling what we would need to show in terms of the DE label. Background therapies, it's the usual. It's not a big difference.

Speaker #2: And demographics, of course, is much broader because it's a very broad DE. Actually, when we announced the Deep Ocean closure, we said it was well over 60 different DEs.

Speaker #2: And that is important. We like to really cover a wide span. In the Deep Ocean trial, there is a good balance between people who progress all the way to Lennox-Gastaut diagnosis and those who remain with different DE diagnoses.

Speaker #2: So it's a good balance. We're very confident in terms of fulfilling what we would need to show in terms of the DE label.

Speaker #2: Background therapies—it's the usual. It's not a big difference. Of course, this is a trial that traveled around the world, so it differs a little bit depending on the geographies, but they're traditional.

Johan Luthman: Of course, this is a trial that travel around the world, so it differs a little bit depending on the geographies, but they're traditional, the migrant therapies you would expect. Same thing with the number of baseline seizures. There's really no major thing in difference from the PACIFIC trial. We don't expect any surprises there. The Dravet trial, of course, is Dravet, and we have enrolled very well, as I said, so it's going to be a well-powered trial, that one as well as DEEp OCEAN. For the amlenetug question, of course, every big trial, you may have different interims and look at that. We're never commenting on anything that we may or may not have in those pivotal trials. The trial is progressing well, and that is where we are at this stage.

Johan Luthman: Of course, this is a trial that travel around the world, so it differs a little bit depending on the geographies, but they're traditional, the migrant therapies you would expect. Same thing with the number of baseline seizures. There's really no major thing in difference from the PACIFIC trial. We don't expect any surprises there. The Dravet trial, of course, is Dravet, and we have enrolled very well, as I said, so it's going to be a well-powered trial, that one as well as DEEp OCEAN. For the amlenetug question, of course, every big trial, you may have different interims and look at that. We're never commenting on anything that we may or may not have in those pivotal trials. The trial is progressing well, and that is where we are at this stage.

Speaker #2: The migrant therapies you would expect. Same thing with the number of baseline seizures. So there is really no major difference from the Pacific trial.

Speaker #2: So we don't expect any surprises there. The Dravet trial, of course, is Dravet. And we have enrolled very well, as I said, so it's going to be a well-powered trial.

Speaker #2: That one as well at Deep Ocean. For the Amelina2 question, yeah, we, of course, every big trial you may have different interims and look at that.

Speaker #2: We never comment on anything that we may or may not have. In those pivotal trials, the trial is progressing well, and that is where we are at this stage.

Speaker #1: Okay, very clear. Thank you.

Thomas Bowers: Okay. Very clear. Thank you.

Thomas Bowers: Okay. Very clear. Thank you.

Speaker #3: And the next question comes from Kirsty Ross Stewart from BNP Paribas. Please go ahead.

Operator: Then the next question comes from Kirsty Ross-Stewart from BNP Paribas. Please go ahead.

Operator: Then the next question comes from Kirsty Ross-Stewart from BNP Paribas. Please go ahead.

Speaker #4: Hi there. Yeah, thank you for taking my question. So maybe just one more on Bexi Cash Run to start. With the Deep Ocean trial now anticipated to read out by year-end, can I just come back to the filing strategy for the asset?

Kirsty Ross-Stewart: Hi there. Thank you for taking my questions. Maybe just one more on bexicaserin to start. With the DEEp OCEAN trial now anticipated to read out before year-end, can I just come back on the filing strategy for the asset? Is it still your intention to have data from both trials before filing for approval with regulators, or is there a possibility to file with the DEEp OCEAN data and follow up with the additional data as part of a rolling submission? Then perhaps one for Joerg on just looking ahead to 2027. You have your midterm guidance framework, but consensus already high single digit above the implied 2027 revenue and EBITDA from that midterm guidance. Just wondering if we should treat that framework as effectively superseded by your current trajectory, or do those targets still represent a ceiling that you are working to?

Kirsty Ross-Stewart: Hi there. Thank you for taking my questions. Maybe just one more on bexicaserin to start. With the DEEp OCEAN trial now anticipated to read out before year-end, can I just come back on the filing strategy for the asset? Is it still your intention to have data from both trials before filing for approval with regulators, or is there a possibility to file with the DEEp OCEAN data and follow up with the additional data as part of a rolling submission? Then perhaps one for Joerg on just looking ahead to 2027. You have your midterm guidance framework, but consensus already high single digit above the implied 2027 revenue and EBITDA from that midterm guidance. Just wondering if we should treat that framework as effectively superseded by your current trajectory, or do those targets still represent a ceiling that you are working to?

Speaker #4: Is it still your intention to have data from both trials before filing for approval with regulators? Or is there a possibility to file with the Deep Ocean data and follow up with the additional data as part of a rolling submission?

Speaker #4: And then perhaps one for Jörg. Just looking ahead to 2027, you've got your midterm guidance framework, but consensus is already high single-digit above the implied 2027 revenue and EBITDA from that midterm guidance.

Speaker #4: So, just wondering if we should treat that framework as kind of effectively superseded by your current trajectory, or do those targets still represent a ceiling that you're working to?

Speaker #4: And just lastly, thanks to Johan for your help over the years. Wishing you a very happy retirement. Thanks very much.

Kirsty Ross-Stewart: Lastly, thanks to Johan for your help over the years. Wishing you a very happy retirement. Thanks very much.

Kirsty Ross-Stewart: Lastly, thanks to Johan for your help over the years. Wishing you a very happy retirement. Thanks very much.

Speaker #2: Yep. Thank you, Kirsty, for that. Let's take the question on the BEXI Cash Run filing strategy. We have Johan to take that.

Charl van Zyl: Yep. Thank you, Kirsty, for that. Let's take the question on bexicaserin filing strategy. We have Johan to take that.

Charl van Zyl: Yep. Thank you, Kirsty, for that. Let's take the question on bexicaserin filing strategy. We have Johan to take that.

Johan Luthman: Yeah. I like to have help with Maria here, so I want to comment on this. First, thank you for congratulating me on retirement. I even commented on this in my talking notes here. It is a big challenge when you have two very different populations as this is to have it lined up very nicely, and we do have it lined up very nicely. So that is already kind of an answer to you. If you have a year or half a year between, you may think about alternative strategies, but here we are looking forward to have the totality of the pivotal program delivering in one go, and it is just a few months between the two, so that is actually very good. In terms of other strategic considerations, I think Maria should comment on that.

Johan Luthman: Yeah. I like to have help with Maria here, so I want to comment on this. First, thank you for congratulating me on retirement. I even commented on this in my talking notes here. It is a big challenge when you have two very different populations as this is to have it lined up very nicely, and we do have it lined up very nicely. So that is already kind of an answer to you. If you have a year or half a year between, you may think about alternative strategies, but here we are looking forward to have the totality of the pivotal program delivering in one go, and it is just a few months between the two, so that is actually very good. In terms of other strategic considerations, I think Maria should comment on that.

Speaker #5: Yeah. And I'd like to have help with Maria. I'll take it here. So I'm going to comment on this. But first, thank you for congratulating me on retirement.

Speaker #5: Yeah, I even commented on this in my talking notes here. It's a big challenge, when you have two very different populations, as this is, to have it all lined up very nicely.

Speaker #5: And we do have it lined up very nicely. So that's already kind of an answer to you. If you have a year or half a year between, you may think about alternative strategies, but here we're looking forward to having the totality of the pivotal program delivering in one go.

Speaker #5: And it's just a few months between the two, so that's actually very good. In terms of other strategic considerations, I think Maria should comment on that.

Speaker #4: Yeah, thank you very much, Johan. And thank you for the question. As you know, we got a breakthrough designation for the US and also for China, and also orphan disease designation for the US.

Maria Alfaiate: Thank you very much, Johan, and thank you for the question. As you know, we got Breakthrough Therapy designation for the US and also for China and also Orphan Drug designation for the US. So we follow the global development strategy for this program because we see the unmet need across different geographies, and the intention is indeed to file and make the drug available to as many patients as possible.

Maria Alfaiate: Thank you very much, Johan, and thank you for the question. As you know, we got Breakthrough Therapy designation for the US and also for China and also Orphan Drug designation for the US. So we follow the global development strategy for this program because we see the unmet need across different geographies, and the intention is indeed to file and make the drug available to as many patients as possible.

Speaker #4: So, we follow the global development strategy for this program because we see the unmet need across different geographies, and the intention is indeed to file and make the drug available to as many patients as possible.

Speaker #5: I'm happy to take questions on the guidance. The current full-year, or basically midterm, guidance targets remain in place, and that's of course what we are, in principle, aiming for.

Joerg Hornstein: I am happy to take the questions on the guidance. The current full year or basically midterm guidance targets remain in place, and that is of course what we are in principle aiming for. At the same time, we said we

Joerg Hornstein: I am happy to take the questions on the guidance. The current full year or basically midterm guidance targets remain in place, and that is of course what we are in principle aiming for. At the same time, we said we, will provide an update on how we will look for midterm targets in the future, but that is probably something more towards the end of the year, beginning of next year.

Speaker #5: At the same time, we said we will provide an update on how we will look for midterm targets in the future. But that's probably something more towards the end of the year, or the beginning of next year.

Joerg Hornstein: will provide an update on how we will look for midterm targets in the future, but that is probably something more towards the end of the year, beginning of next year.

Speaker #3: Ladies and gentlemen, as a reminder, please limit yourself to two questions. The next question comes from Xiang Deng at UBS. Please go ahead.

Operator: Ladies and gentlemen, as a reminder, please limit yourself to two questions. The next question comes from Xian Deng from UBS. Please go ahead.

Operator: Ladies and gentlemen, as a reminder, please limit yourself to two questions. The next question comes from Xian Deng from UBS. Please go ahead.

Speaker #4: Hi, Xiang from UBS. Thank you for taking my question. So, I guess first of all, Johan, I wish you all the best with your retirement.

Xian Deng: Hi, Xian from UBS. Thank you for taking my question. First of all, to you, Johan, wish you all the best with your retirement, and it was really, really nice working with you, and thank you very much for all your help. Then in front of the questions, the first one to Joerg, please. In terms of your full year 2026 guidance, you had a nice beat in Q2, but understand you are mentioning some of the inventory, but the underlying is still very strong. Just wondering, given you are not raising the guidance as you say, just wondering, could you maybe elaborate a bit more with the push and pulls, and for the consideration and what type of scenarios would drive the full year top line to go above your guidance versus let this stay within this range? That is the first question.

Xian Deng: Hi, Xian from UBS. Thank you for taking my question. First of all, to you, Johan, wish you all the best with your retirement, and it was really, really nice working with you, and thank you very much for all your help. Then in front of the questions, the first one to Joerg, please. In terms of your full year 2026 guidance, you had a nice beat in Q2, but understand you are mentioning some of the inventory, but the underlying is still very strong. Just wondering, given you are not raising the guidance as you say, just wondering, could you maybe elaborate a bit more with the push and pulls, and for the consideration and what type of scenarios would drive the full year top line to go above your guidance versus let this stay within this range? That is the first question.

Speaker #4: It was really, really nice working with you, and thank you very much for all your help. In terms of questions, I guess the first one is to Jörg, please.

Speaker #4: So in terms of your full-year '26 guidance, you had a nice beat in Q2, but I understand you're mentioning some of the inventory. The underlying business is still very strong.

Speaker #4: So, just wondering, given you're not raising the guidance at this stage, could you maybe elaborate a bit more on the pushes and pulls in your considerations, and what types of scenarios would drive the full-year top line to go above your guidance versus staying within this range at this stage?

Speaker #4: So that's the first question. And the second one, to Johan, please. Maybe just on the orexin program. So, just wondering, with Takeda's drug that's recently got approval in narcolepsy 1, how is your program differentiated from the Takeda one?

Xian Deng: The second one to Johan, please. Maybe just on the orexin program. Just wondering, with the Takeda's drug that recently got approval in narcolepsy 1, just wondering, how is your program differentiated from the Takeda one and just wondering, are you after better side effects or better efficacy or potentially even targeting narcolepsy 2? Thank you very much.

Xian Deng: The second one to Johan, please. Maybe just on the orexin program. Just wondering, with the Takeda's drug that recently got approval in narcolepsy 1, just wondering, how is your program differentiated from the Takeda one and just wondering, are you after better side effects or better efficacy or potentially even targeting narcolepsy 2? Thank you very much.

Speaker #4: And just wondering, after better side effects or better efficacy, or potentially even targeting narcolepsy 2. Thank you very much.

Speaker #5: Well, let me take the first question, of course. We haven't upgraded our guidance, but I'll also try to state that we are trending towards the upper end of the guidance to start with.

Joerg Hornstein: Well, let me take the first question, of course. We have not upgraded our guidance, but I also try to state that we are trending towards the upper end of the guidance to start with. I think what keeps us a bit of cautious for the H2, part of it is clearly the transparency we have on the partner markets to really be absolutely clear what can be traced to underlying demand versus timing effects. That can be a bit of a put and take at one and the same time. I think VYEPTI is performing strong and there are currently no concerns and that was also one of the reasons why we have stepped up our Q1 guidance in the first place. I think when we look at REXULTI, we are pretty much in line with our expectations for the year.

Joerg Hornstein: Well, let me take the first question, of course. We have not upgraded our guidance, but I also try to state that we are trending towards the upper end of the guidance to start with. I think what keeps us a bit of cautious for the H2, part of it is clearly the transparency we have on the partner markets to really be absolutely clear what can be traced to underlying demand versus timing effects. That can be a bit of a put and take at one and the same time. I think VYEPTI is performing strong and there are currently no concerns and that was also one of the reasons why we have stepped up our Q1 guidance in the first place. I think when we look at REXULTI, we are pretty much in line with our expectations for the year.

Speaker #5: I think what keeps us a bit cautious for the second half—part of it is clearly the transparency we have on the partner markets, to really be absolutely clear on what we can trace to underlying demand versus timing effects that can be a bit of a put and take at one and the same time.

Speaker #5: I think Viatpi is performing strongly, and there are currently no concerns. That was also one of the reasons why we have stepped up our Q1 guidance in the first place.

Speaker #5: I think when we look at Rexulti, we're pretty much in line with our expectations for the year. But at the same time, we're a bit cautious because we haven't seen enough data yet about competition coming in, especially around Ovality.

Joerg Hornstein: But at the same time, a bit cautious about we haven't seen enough data yet about competition coming in, especially around AUVELITY. Last but not least, I would also say we are sure that there's no generics entry on ABILIFY MAINTENA in Europe this year. But in principle, there's still a bit of a question mark around Australia and Canada. So you can take that in principle either way and see it as an upside if it doesn't materialize, but a downside if it does.

Joerg Hornstein: But at the same time, a bit cautious about we haven't seen enough data yet about competition coming in, especially around AUVELITY. Last but not least, I would also say we are sure that there's no generics entry on ABILIFY MAINTENA in Europe this year. But in principle, there's still a bit of a question mark around Australia and Canada. So you can take that in principle either way and see it as an upside if it doesn't materialize, but a downside if it does.

Speaker #5: And last but not least, I would also say we're sure that there's no generics entry on Abilify Maintena in Europe this year. But in principle, there's still a bit of a question mark around Australia and Canada.

Speaker #5: So, you can take that, in principle, either way and see it as an upside if it doesn't materialize, but a downside if it does.

Speaker #2: Yeah, thanks, Xiang, for the comment. And when it comes to Rexin program differentiation here, obviously, we shouldn't comment too much on other companies' assets or Cephale.

Johan Luthman: Yeah, thanks, Xian, for the comment. When it comes to the REXULTI program differentiation here, obviously we shouldn't comment too much on other companies' assets or resembling. Good brand name is now approved in China and FDA, and of course, they publish some of the data. We know very well what they have. We also know very well what other programs have, and there are some key ingredients everyone talk about public in the field. So I will comment on that, what you like to see in a good orexin drug. First of all sleep drugs, they need to be squeaky clean. You cannot have much side effects, tolerability issues, et cetera. So there is very, very little tolerability for any issues like liver signals, et cetera. So that's the main one. So make sure that you have a clean drug.

Johan Luthman: Yeah, thanks, Xian, for the comment. When it comes to the REXULTI program differentiation here, obviously we shouldn't comment too much on other companies' assets or resembling. Good brand name is now approved in China and FDA, and of course, they publish some of the data. We know very well what they have. We also know very well what other programs have, and there are some key ingredients everyone talk about public in the field. So I will comment on that, what you like to see in a good orexin drug. First of all sleep drugs, they need to be squeaky clean. You cannot have much side effects, tolerability issues, et cetera. So there is very, very little tolerability for any issues like liver signals, et cetera. So that's the main one. So make sure that you have a clean drug.

Speaker #2: It's a good brand name. It's now approved in China and by the FDA. And, of course, they've published some of the data. We know very well what they have.

Speaker #2: We also know very well what other programs have. And there are some key ingredients everyone talks about, talked about publicly in the field. So I will comment on that—what you like to see in a good orexin drug.

Speaker #2: First of all, all sleep drugs need to be squeaky clean. You cannot have many side effects, tolerability issues, et cetera. So there is very, very little tolerance for any issues like liver signals, et cetera.

Speaker #2: So that's the main one. So make sure that you have a clean drug. As you may recall, this is a heavyweight chemistry. This is breakthrough chemistry.

Johan Luthman: As you may recall, this is a heavyweight chemistry. This is a Breakthrough Therapy chemistry, and it's very rarely done that you get an allosteric agonist for a peptide receptor. So it's been very challenging, and many of the companies are on the second or third compound. So that's really to get the right profile. When it comes to the more important ones you're after, half-life is fundamental, and the field is very well aware that you don't like to have a long half-life because this is daily dosing, maybe two or one time a day if you can, and you don't want to run into insomnia problems in the nighttime. So that's a tricky, finicky one to balance strong effect, lasting efficacy with the day, and then get rid of the effect when you go to bed.

Johan Luthman: As you may recall, this is a heavyweight chemistry. This is a Breakthrough Therapy chemistry, and it's very rarely done that you get an allosteric agonist for a peptide receptor. So it's been very challenging, and many of the companies are on the second or third compound. So that's really to get the right profile. When it comes to the more important ones you're after, half-life is fundamental, and the field is very well aware that you don't like to have a long half-life because this is daily dosing, maybe two or one time a day if you can, and you don't want to run into insomnia problems in the nighttime. So that's a tricky, finicky one to balance strong effect, lasting efficacy with the day, and then get rid of the effect when you go to bed.

Speaker #2: And it's very rarely done that you get an orthostatic agonist for a peptide receptor, so it's been very challenging. And many of the companies are on their second or third compound.

Speaker #2: So that's really to get the right profile. When it comes to the more important ones you're after, half-life is fundamental. And the field is very well aware that you don't like to have a long half-life.

Speaker #2: Because this is daily dosing, maybe two or one time a day if you can. And you don't want to run into insomnia problems in the nighttime.

Speaker #2: So that's a tricky, finicky one to balance: strong effect, lasting efficacy over the day, and then getting rid of the effect when you go to bed.

Johan Luthman: I touch upon this a little bit when it comes to liver toxicity and safety. You also like to drive the doses down because you really like very potent drugs, particularly when you go beyond NT1, when you have loss of nerve cells, because you like to hit the system now that is essentially intact. And you need a very potent drug to be able to dose enough to get an effect also in the non-degenerative conditions. And the field is talking about a three to fourfold more potent effect is needed. So that's what we're after. Potent drugs, right half-life, low doses, and then we hope we can balance this out.

Johan Luthman: I touch upon this a little bit when it comes to liver toxicity and safety. You also like to drive the doses down because you really like very potent drugs, particularly when you go beyond NT1, when you have loss of nerve cells, because you like to hit the system now that is essentially intact. And you need a very potent drug to be able to dose enough to get an effect also in the non-degenerative conditions. And the field is talking about a three to fourfold more potent effect is needed. So that's what we're after. Potent drugs, right half-life, low doses, and then we hope we can balance this out.

Speaker #2: I touched upon this a little bit when it comes to liver toxicity and safety. You also like to drive the doses down because you really like very potent drugs.

Speaker #2: Particularly when you go beyond NT1, when you have loss of nerve cells. Because you like to hit the system now that is essentially intact.

Speaker #2: And you need a very potent drug to be able to dose enough to get an effect also in the non-degenerative conditions. And the field is talking about a three- to four-fold more potent effect being needed.

Speaker #2: So that's what we're after: potent drugs, right half-life, low doses, and then we hope we can balance this out.

Speaker #4: Thank you very much.

Xian Deng: Thank you very much.

Xian Deng: Thank you very much.

Speaker #3: The next question comes from Peter Hughcraff Ankersen from Nordea. Please go ahead.

Operator: The next question comes from Peter Hugreffe Ankersen from Nordea. Please go ahead.

Operator: The next question comes from Peter Hugreffe Ankersen from Nordea. Please go ahead.

Speaker #6: Yeah, hi. Peter Hughcraff from Nordea. Thank you for taking my two questions. I’d like to continue the conversation around 2026, and particularly the second half.

Peter Hugreffe Ankersen: Yeah. Hi, Peter Hugreffe from Nordea. Thank you for taking my two questions. I need to continue the conversation around 2026 and particularly H2. I know, Joerg, you said that you are trending towards the high end, but when I look at the so-called low end, then essentially you are implicitly guiding for -5% sales and -15% EBIT and an EBITDA margin of 26%. Just in my book, it comes across as overly conservative. I heard the four or five arguments you had, but is there anything else that we are kind of overlooking on that part, or is it just full leverage? Secondly, I am intrigued by your orexin program, you know that, Johan. I noticed that you are enrolling patients in a phase I with Lu AH69593. Is there anything I am kind of particularly looking for?

Peter Hugreffe Ankersen: Yeah. Hi, Peter Hugreffe from Nordea. Thank you for taking my two questions. I need to continue the conversation around 2026 and particularly H2. I know, Joerg, you said that you are trending towards the high end, but when I look at the so-called low end, then essentially you are implicitly guiding for -5% sales and -15% EBIT and an EBITDA margin of 26%. Just in my book, it comes across as overly conservative. I heard the four or five arguments you had, but is there anything else that we are kind of overlooking on that part, or is it just full leverage? Secondly, I am intrigued by your orexin program, you know that, Johan. I noticed that you are enrolling patients in a phase I with Lu AH69593. Is there anything I am kind of particularly looking for?

Speaker #6: I know, Jörg, you said that you're trending towards the high end. But when I look at the so-called low end, then essentially you're implicitly guiding for minus 5% sales.

Speaker #6: And minus 15% EBIT, and EBITDA margin of 26%. And just in my book, it comes across as overly conservative. And I heard the four or five arguments you had.

Speaker #6: But is there anything else that we're kind of overlooking on that part, or is it just poor leverage? And then secondly, I'm intrigued by your Rexin program.

Speaker #6: You know, Johan, I noticed that you are enrolling in phase one, which, in my mind, is March. So is there anything I should be particularly looking for?

Speaker #6: And, of course, I know your question is to ask whether there is any kind of dose finding in it. But.

Peter Hugreffe Ankersen: Of course, I know a good question to ask whether there is any kind of dose finding in it.

Peter Hugreffe Ankersen: Of course, I know a good question to ask whether there is any kind of dose finding in it.

Speaker #2: Peter, we didn't get your second question on Rexin. There was a bit of a commitment. Could you—yeah, that's better.

Joerg Hornstein: Peter, we didn't get your second question on orexin. There was a bit of a-

Joerg Hornstein: Peter, we didn't get your second question on orexin. There was a bit of a-

Peter Hugreffe Ankersen: Oh, sorry.

Peter Hugreffe Ankersen: Oh, sorry.

Peter Hugreffe Ankersen: Could you Yep, that's better.

Joerg Hornstein: Could you Yep, that's better.

Speaker #6: OK. Yeah, so on rexin, I just noted that there are more than 100 patients claimed to be enrolled. And that's, of course, quite intriguing, as normally that's a fairly large portion for phase one.

Peter Hugreffe Ankersen: Okay. Yeah. On orexin, I just noted that there is more than 100 patients planned to be enrolled, and that's of course quite intriguing as normally it's a fairly large portion for a phase I. So is there any reasons for that? Anything you can share in terms of why you have decided to have such a large completion? I'll stop there.

Peter Hugreffe Ankersen: Okay. Yeah. On orexin, I just noted that there is more than 100 patients planned to be enrolled, and that's of course quite intriguing as normally it's a fairly large portion for a phase I. So is there any reasons for that? Anything you can share in terms of why you have decided to have such a large completion? I'll stop there.

Speaker #6: So, is there any reason for that? Anything you can share in terms of why you have decided to have such a large population? I'll stop there.

Speaker #5: Well, I'm happy to take the first question. To build upon the reasons I gave to the earlier question, I think you have to look a little bit at the cost position.

Joerg Hornstein: Well, I am happy to take the first question. To build upon the reasons I gave to the earlier question is, I think you have to look a little bit at the cost position. Our sales and distribution cost investments are geared towards the H2, and probably center also a little bit around specific investments targeting VYEPTI, as well as some, you can say, geographic investments we have held back in H1. The second one is clearly the step up in R&D because in principle, we have reconfirmed the range, but I would also say here that we are probably trending a bit more towards the higher end of it. The last piece is plain and simply what we have seen as the impact on the gross margin, where you really have to differentiate between two things.

Joerg Hornstein: Well, I am happy to take the first question. To build upon the reasons I gave to the earlier question is, I think you have to look a little bit at the cost position. Our sales and distribution cost investments are geared towards the H2, and probably center also a little bit around specific investments targeting VYEPTI, as well as some, you can say, geographic investments we have held back in H1. The second one is clearly the step up in R&D because in principle, we have reconfirmed the range, but I would also say here that we are probably trending a bit more towards the higher end of it. The last piece is plain and simply what we have seen as the impact on the gross margin, where you really have to differentiate between two things.

Speaker #5: Our sales and distribution cost investments are geared towards the second half, and probably center also a little bit around specific investments targeting in Bi-Epti, as well as some, you can say, geographic investments we have held back in H1.

Speaker #5: The second one is clearly the step-up in R&D, because in principle, we've reconfirmed the range. But I would also say here that we're probably trending a bit more towards the higher end of it.

Speaker #5: And the last piece is, plain and simply, what we have seen as the impact on the gross margin, where you really have to differentiate between two things.

Speaker #5: One is a structural impact that you, plain and simply, have because of the partnership model—that accounts for, let's say, 1%. But there is also, you can say, a bit of impact from contract work and Bi-Epti dynamics, which we get from a full gross profit contribution.

Joerg Hornstein: One is the structural impact that you plain and simply have because of the partnership model that accounts for, let us say, 1%. But there is also a bit of a, you can say, impact from contract work and VYEPTI dynamics, which we get from a full gross profit contribution, but that is still currently a bit below the overall group margin. So I would say the second part of that gross margin implication also plays into these dynamics.

Joerg Hornstein: One is the structural impact that you plain and simply have because of the partnership model that accounts for, let us say, 1%. But there is also a bit of a, you can say, impact from contract work and VYEPTI dynamics, which we get from a full gross profit contribution, but that is still currently a bit below the overall group margin. So I would say the second part of that gross margin implication also plays into these dynamics.

Speaker #5: But that is still currently a bit below the overall group margin, so I would say the second part of that gross margin implication also plays into these dynamics.

Speaker #2: Yeah, and thanks, Peter, for the Rexin question. Risking going into a one-hour lecture about what I think is important in early drug development, but to nail it down, we're really big fans of Phase 1b studies.

Johan Luthman: Yeah. Thanks, Peter, for the orexin question. Risking going into a one-hour lecture about what I think is important in early drug development. But to nail it down, we are really big fans of the phase I-B studies. You really like to have the "let the molecule speak," as we call it, right? You like to see what is happening. So you will need to have a lot of flexibility built in there. As you know, orexin field is some core indications where we have seen effect, and you like to broaden out in different hypersomnolence indications. This is open label, most of the things you do, and you can have very early readouts if you want. Sleep is particularly permissive for this. So this is an umbrella sort of number that we like to have. Quite frankly, we will also have other molecules progressing.

Johan Luthman: Yeah. Thanks, Peter, for the orexin question. Risking going into a one-hour lecture about what I think is important in early drug development. But to nail it down, we are really big fans of the phase I-B studies. You really like to have the "let the molecule speak," as we call it, right? You like to see what is happening. So you will need to have a lot of flexibility built in there. As you know, orexin field is some core indications where we have seen effect, and you like to broaden out in different hypersomnolence indications. This is open label, most of the things you do, and you can have very early readouts if you want. Sleep is particularly permissive for this. So this is an umbrella sort of number that we like to have. Quite frankly, we will also have other molecules progressing.

Speaker #2: You really like to 'let the molecule speak,' as we call it, right? You like to see what's happening, so you'll need to have a lot of flexibility built in there.

Speaker #2: As you know, Rexin field is some core indications where we have seen effect. And you’d like to broaden out into different hypersomnolence indications. This is open label.

Speaker #2: Most other things you do, and you can have very early readouts if you want. Sleep is particularly permissive for this. So, this is an umbrella sort of number that we like to have.

Speaker #2: And, quite frankly, we will also have other molecules progressing. We have two molecules already in clinical development, so this is a placeholder for activities that are going to happen.

Johan Luthman: We have two molecules already in clinical development. So this is a placeholder of activities that are going to happen. Once you have that signal, you can go fast wherever you like.

Johan Luthman: We have two molecules already in clinical development. So this is a placeholder of activities that are going to happen. Once you have that signal, you can go fast wherever you like.

Speaker #2: Once you have that signal, you can go fast wherever you like.

Speaker #6: OK, thank you. And best of luck, Johan.

Peter Hugreffe Ankersen: Okay. Thank you, and best of luck going.

Peter Hugreffe Ankersen: Okay. Thank you, and best of luck going.

Speaker #3: The next question comes from Charles Bittman King from Barclays. Please go ahead.

Operator: The next question comes from Charles Pitman-King from Barclays. Please go ahead.

Operator: The next question comes from Charles Pitman-King from Barclays. Please go ahead.

Speaker #7: Hi, guys. Thanks very much for taking my questions, and I also want to extend my congratulations to Johan on his retirement. Thank you for your help.

Charles Pitman-King: Hi, guys. Thanks very much for taking my questions. Also I want to wish my congratulations to Johan for his retirement, and thanks for all your help. Firstly for me, can we talk a little more about the dynamics with REXULTI? I think you mentioned that the questions around availability competition risk could be one reason not to raise guidance in 2026. Also noting that AAD is now over a third of prescriptions. This is quite a rapid acceleration, at least versus my expectations, and yet REXULTI was in line with where consensus expected. How should we think about how MDD is progressing? Are there any phasing elements between the indications that we need to take into account? Secondly, a question on BD. All leverage is now down to 1x again.

Charles Pitman-King: Hi, guys. Thanks very much for taking my questions. Also I want to wish my congratulations to Johan for his retirement, and thanks for all your help. Firstly for me, can we talk a little more about the dynamics with REXULTI? I think you mentioned that the questions around availability competition risk could be one reason not to raise guidance in 2026. Also noting that AAD is now over a third of prescriptions. This is quite a rapid acceleration, at least versus my expectations, and yet REXULTI was in line with where consensus expected. How should we think about how MDD is progressing? Are there any phasing elements between the indications that we need to take into account? Secondly, a question on BD. All leverage is now down to 1x again.

Speaker #7: Firstly, for me, can we talk a little bit more about the dynamics with Rexalty? I mean, I think you mentioned that the questions around availability, competition, and risk could be one reason not to raise guidance in FY26.

Speaker #7: But also noting that AAD is now over a third of prescriptions. This is quite a rapid acceleration, but at least, firstly, my expectations, and yet Rexalty was in line with where consensus expected.

Speaker #7: So, how should we think about how MDD is progressing? And are there any phasing elements between the indications that we need to take into account?

Speaker #7: And then secondly, a question on BD. So, obviously, our leverage is now down to one times again. You're getting to the point where Bexie can launch, hopefully next year, with positive data.

Charles Pitman-King: You are getting to the point where bexicaserin can launch hopefully next year with positive data, or at least before next year rather. When we are thinking about further optionality, one area that has seen increasing favor is the psychedelic space. I know we have spoken about it before. Johan, specifically, any interest in your thoughts on whether or not Eli Lilly and Company and AbbVie moving into the space and the newly announced FDA commissioner who has possibly been quite active in psychedelic discussions via office, whether or not that is making the area more of interest to you guys? Thank you.

Charles Pitman-King: You are getting to the point where bexicaserin can launch hopefully next year with positive data, or at least before next year rather. When we are thinking about further optionality, one area that has seen increasing favor is the psychedelic space. I know we have spoken about it before. Johan, specifically, any interest in your thoughts on whether or not Eli Lilly and Company and AbbVie moving into the space and the newly announced FDA commissioner who has possibly been quite active in psychedelic discussions via office, whether or not that is making the area more of interest to you guys? Thank you.

Speaker #7: Or at least before next year, rather. So, when we're thinking about further optionality, one area that has seen increasing favor is the psychedelic space.

Speaker #7: I know we've spoken about it before. So Johan, specifically, any interest in your thoughts on whether or not Lilly and AbbVie moving into this space and the newly announced FDA commissioner who's reportedly been quite active in psychedelic discussions in the Oval Office, whether or not that's making the area more of interest to you guys?

Speaker #7: Thank you.

Speaker #2: Thank you, Charles. So, let's take Rexalty. Tom, if you would like.

Charl van Zyl: Thank you, Charles. Let's take Rexulti. Tom, if you would like.

Charl van Zyl: Thank you, Charles. Let's take Rexulti. Tom, if you would like.

Speaker #4: So, Charles, thanks for the question. I think, most importantly, it's important to indicate that Rexalty's performance is in line with our expectations, given the competitive environment.

Thomas Gibbs: Charles, thanks for the question. I think most importantly, it's important to indicate that Rexulti performance is in line with our expectations given the competitive environment. I'll first talk a little bit about AAD/AD. As I've said before, new competitors in the marketplace can be friend or foe. In AAD/AD only, about one-third of patients are accurately diagnosed and treated. The unmet need in AAD/AD is massive, and an increase in resources to educate HCPs and caregivers on the disease burden of AAD/AD to accelerate diagnosis and treatment rates is welcome. Although very early, we are beginning to see some incremental market growth in new patient starts with the entrance of AUVELITY into the market. I do think it's important to note, though, that over the past three years, Lundbeck and Otsuka have firmly established Rexulti as the preferred treatment for AADAD.

Thomas Gibbs: Charles, thanks for the question. I think most importantly, it's important to indicate that Rexulti performance is in line with our expectations given the competitive environment. I'll first talk a little bit about AAD/AD. As I've said before, new competitors in the marketplace can be friend or foe. In AAD/AD only, about one-third of patients are accurately diagnosed and treated. The unmet need in AAD/AD is massive, and an increase in resources to educate HCPs and caregivers on the disease burden of AAD/AD to accelerate diagnosis and treatment rates is welcome. Although very early, we are beginning to see some incremental market growth in new patient starts with the entrance of AUVELITY into the market. I do think it's important to note, though, that over the past three years, Lundbeck and Otsuka have firmly established Rexulti as the preferred treatment for AADAD.

Speaker #4: And I'll first talk a little bit about AAD/AD. As I've said before, new competitors in the marketplace can be friend or foe. In AAD/AD only, about one-third of patients are accurately diagnosed and treated.

Speaker #4: So the unmet need in AAD/AD is massive. An increase in resources to educate HCPs and caregivers on the disease burden of AAD/AD to accelerate diagnosis and treatment rates is welcome.

Speaker #4: Now, although it is very early, we are beginning to see some incremental market growth in new patient starts with the entrance of Ovality into the market.

Speaker #4: I do think it's important to note, though, that over the past three years, Lundbeck and Otsuka have firmly established Rexulti as the preferred treatment for AAD/AD.

Speaker #4: In our latest awareness, trial, and usage market research survey, 47% of HCPs identified Rexalty as their preferred treatment option, which is nearly twice the number of the nearest competitor.

Thomas Gibbs: In our latest awareness trial and usage market research survey, 47% of HCPs identified Rexulti as their preferred treatment option, which is nearly twice the number of the nearest competitor. In the same survey, 75% of respondents expected an increase in prescribing of Rexulti for AADAD, and 70% of HCPs are very satisfied with the results they have seen with Rexulti in AADAD. If we look at prescription volume, based upon the most recent monthly data, Rexulti TRXs are about 11 times the volume over AUVELITY at this point in time. Although there are some benefits of the AUVELITY label, including no black box warning, we do continue to believe the clinical profile of Rexulti offers meaningful advantages that are very important in this AADAD population. Turning to MDD.

Thomas Gibbs: In our latest awareness trial and usage market research survey, 47% of HCPs identified Rexulti as their preferred treatment option, which is nearly twice the number of the nearest competitor. In the same survey, 75% of respondents expected an increase in prescribing of Rexulti for AADAD, and 70% of HCPs are very satisfied with the results they have seen with Rexulti in AADAD. If we look at prescription volume, based upon the most recent monthly data, Rexulti TRXs are about 11 times the volume over AUVELITY at this point in time. Although there are some benefits of the AUVELITY label, including no black box warning, we do continue to believe the clinical profile of Rexulti offers meaningful advantages that are very important in this AADAD population. Turning to MDD.

Speaker #4: And in the same survey, 75% of respondents expected an increase in prescribing of Rexalty for AAD/AD, and 70% of HCPs are very satisfied with the results they have seen with Rexalty and AAD/AD.

Speaker #4: And then, if we look at prescription volume, based upon the most recent monthly data, Rexalty TRXs are about 11 times the volume of Ovality at this point in time.

Speaker #4: Now, although there are some benefits of the Ovality label, including no black box warning, we do continue to believe the clinical profile of Rexalty offers meaningful advantages that are very important in this AAD/AD population.

Speaker #4: Now, turning to MDD, I think within this competitive marketplace, Rexalty has demonstrated significant resilience in MDD, continuing to drive double-digit growth. As I said, Rexalty MDD growth rates were 15.7% during the first six months of the year versus the prior year.

Thomas Gibbs: I think within this competitive marketplace, Rexulti has demonstrated significant resilience in MDD, continuing to drive double-digit growth. As I said, Rexulti MDD growth rates were 15.7% during the first six months of the year versus prior year. I think as you think about the competitive marketplace for MDD, we did see significant investment of Johnson & Johnson as it relates to introducing CAPLYTA for MDD, both from a sales force expansion standpoint, also from a DTC standpoint. But as I said, Rexulti's clinical profile continues to distinguish itself in the marketplace, and for the first time, based upon the most recent data, Rexulti NBRx growth in the month of June was higher than what we saw for CAPLYTA.

Thomas Gibbs: I think within this competitive marketplace, Rexulti has demonstrated significant resilience in MDD, continuing to drive double-digit growth. As I said, Rexulti MDD growth rates were 15.7% during the first six months of the year versus prior year. I think as you think about the competitive marketplace for MDD, we did see significant investment of Johnson & Johnson as it relates to introducing CAPLYTA for MDD, both from a sales force expansion standpoint, also from a DTC standpoint. But as I said, Rexulti's clinical profile continues to distinguish itself in the marketplace, and for the first time, based upon the most recent data, Rexulti NBRx growth in the month of June was higher than what we saw for CAPLYTA.

Speaker #4: And I think, as you think about the competitive marketplace for MDD, we did see significant investment by J&J as it relates to introducing Caplyta for MDD, both from a Salesforce expansion standpoint and also from a DTC standpoint.

Speaker #4: But as I said, Rexalty's clinical profile continues to distinguish itself in the marketplace. And for the first time, based on the most recent data, Rexalty NBRx growth in the month of June was higher than what we saw for Caplyta.

Speaker #2: Thank you, Tom. And just quickly, Charles, on the business development strategy—we remain acquisitive. I mean, we certainly think that we have, of course, a much stronger pipeline.

Charl van Zyl: Thank you, Tom. Just quickly, Charles, on the business development strategy, we remain acquisitive. I mean, we think certainly that we have, of course, a much stronger pipeline, but business development is part of our strategy and continues to be one where we keep scouting for new opportunities. If you want to have a quick word on psychedelics, Johan, just how we see that.

Charl van Zyl: Thank you, Tom. Just quickly, Charles, on the business development strategy, we remain acquisitive. I mean, we think certainly that we have, of course, a much stronger pipeline, but business development is part of our strategy and continues to be one where we keep scouting for new opportunities. If you want to have a quick word on psychedelics, Johan, just how we see that.

Speaker #2: But business development is part of our strategy, and continues to be one where we keep scouting for new opportunities. If you want to have a quick word on psychedelics, Johan, just how we see that.

Speaker #7: Yes, just a very quick word. We are not active in this field right now, but of course, we are extremely well aware of what's going on in that field.

Johan Luthman: Yeah, very quick word. We are not active in this field right now, but of course, we are extremely well aware what is going on in that field. Now bigger companies are stepping in the more well-established, I would say 5-HT2A agonist space. So it is an interesting space. Proof of concept validation is there and programs are progressing. On the regulatory side, there is definitely feasibility and there are guidance developed by FDA and other regulators in Europe and other places are open-minded about this. There is a very good consensus in the regulatory environment that you still follow the more conventional pathway. You need to show what you need to show, two trials, et cetera, in phase III. We are following this path and will see what opportunity that may surface in that space.

Johan Luthman: Yeah, very quick word. We are not active in this field right now, but of course, we are extremely well aware what is going on in that field. Now bigger companies are stepping in the more well-established, I would say 5-HT2A agonist space. So it is an interesting space. Proof of concept validation is there and programs are progressing. On the regulatory side, there is definitely feasibility and there are guidance developed by FDA and other regulators in Europe and other places are open-minded about this. There is a very good consensus in the regulatory environment that you still follow the more conventional pathway. You need to show what you need to show, two trials, et cetera, in phase III. We are following this path and will see what opportunity that may surface in that space.

Speaker #7: And our bigger companies are stepping in, and the more sort of well-established, I would say, privacy-to-A agonist space. So it's an interesting space.

Speaker #7: Proof of concept and validation are there, and programs are progressing. On the regulatory side, there is definitely feasibility, and there is guidance developed by the FDA and other regulators in Europe and other places who are open-minded about this.

Speaker #7: There is a very good consensus in the regulatory environment that you still follow the more conventional pathway. You need to show what you need to show.

Speaker #7: Two trials, et cetera, in phase three. We are following this path, and we'll see what opportunity may surface in that space.

Speaker #5: Thank you so much.

Charl van Zyl: Thank you so much.

Charles Pitman-King: Thank you so much.

Speaker #1: And the next question comes from Sean Hammer from Jefferies. Please go ahead.

Operator: The next question comes from Sean Hammer from Jefferies. Please go ahead.

Operator: The next question comes from Sean Hammer from Jefferies. Please go ahead.

Speaker #6: Hey there. Thanks for taking my question. Just so that I may. Just to follow up on the midterm guidance, is there anything further you can share about how many years perhaps the midterm will encompass, given several LOEs upcoming?

Sean Hammer: Hey there. Thanks for taking my questions. Just two if I may. Just to follow up on the midterm guidance, is there anything further you can share about how many years perhaps the midterm will encompass given several LOEs upcoming, but then also several readouts? Secondly, as VYEPTI continues to account for a larger proportion of group sales, should we expect further pressure on gross margins from the product mix, or do you see this normalizing over time? Thank you.

Shan Hama: Hey there. Thanks for taking my questions. Just two if I may. Just to follow up on the midterm guidance, is there anything further you can share about how many years perhaps the midterm will encompass given several LOEs upcoming, but then also several readouts? Secondly, as VYEPTI continues to account for a larger proportion of group sales, should we expect further pressure on gross margins from the product mix, or do you see this normalizing over time? Thank you.

Speaker #6: But then also several readouts. And then secondly, as YMC continues to account for a larger proportion of group sales, should we expect further pressure on gross margins from the product mix, or do you see this normalizing over time?

Speaker #6: Thank you.

Speaker #2: Let me take both questions. I think the first one is, again, we'll provide an update on how we think about midterm guidance around Q4 and Q1.

Joerg Hornstein: Let me take both questions. I think the first one is, again, we will provide an update on how we think about midterm guidance around Q4 and Q1. I do not want to jump ahead of that and already give an answer on how long it will run out. The second one was a question on gross margin. I think, like I said, look at the first impact as a structural impact, because in principle, you take SG&A costs out of the partnership model, but you bring them into gross to net sales. You still have your cost of goods sold sitting in there. That is in principle, the 1% step down. For me, it is the consequence of a right strategic choice.

Joerg Hornstein: Let me take both questions. I think the first one is, again, we will provide an update on how we think about midterm guidance around Q4 and Q1. I do not want to jump ahead of that and already give an answer on how long it will run out. The second one was a question on gross margin. I think, like I said, look at the first impact as a structural impact, because in principle, you take SG&A costs out of the partnership model, but you bring them into gross to net sales. You still have your cost of goods sold sitting in there. That is in principle, the 1% step down. For me, it is the consequence of a right strategic choice.

Speaker #2: So I don't want to jump ahead of that and already give an answer on how long it will run out. The second one was a question on gross margin.

Speaker #2: I think, like I said, look at the first impact as a structural impact, because, in principle, you take SG&A costs out of the partnership model.

Speaker #2: But you bring them into gross-to-net sales, so you still have your cost of goods sold sitting in there. And that is, in principle, the 1% step-down.

Speaker #2: So for me, it is the consequence of a right strategic choice where personally, I take that one percentage point decrease any day of the week, because ultimately, we have a much larger potential of really developing that into a growth business.

Joerg Hornstein: Where personally I take that one percentage point decrease any day of the week, because ultimately we have a much larger potential of really developing that into a growth business. In terms of outlook, I would say we have given the indication of the 87% right now for this year, and I think that is the best starting point.

Joerg Hornstein: Where personally I take that one percentage point decrease any day of the week, because ultimately we have a much larger potential of really developing that into a growth business. In terms of outlook, I would say we have given the indication of the 87% right now for this year, and I think that is the best starting point.

Speaker #2: In terms of outlook, I would say we've given the indication of the 87% right now for this year, and I think that's the best starting point.

Speaker #6: Thank you.

Sean Hammer: Thank you.

Shan Hama: Thank you.

Speaker #1: And the next question comes from Alex Moore from Bank of America. Please go ahead.

Operator: And the next question comes from Alex Moore from Bank of America. Please go ahead.

Operator: And the next question comes from Alex Moore from Bank of America. Please go ahead.

Speaker #5: Hi there. Thanks for taking my questions, and just echoing congratulations to Johan and noting some interesting discussions over the past couple of years. So, I was just wondering if I could push a bit more on Rexalty.

Alex Moore: Hi there. Thanks for taking my questions and just echoing congratulations to Johan on some interesting discussions over the past couple of years. I was just wondering if I could push a bit more on Rexulti. I mean, your comment to potential new competition expanding diagnosis and treatment rates in what remains a somewhat underpenetrated market. But TRX growth seems to moderate in Q2 relative to Q1 slightly. And your competitor recently commented to strong early NBRx trends for its Alzheimer's agitation launch.

Alex Moore: Hi there. Thanks for taking my questions and just echoing congratulations to Johan on some interesting discussions over the past couple of years. I was just wondering if I could push a bit more on Rexulti. I mean, your comment to potential new competition expanding diagnosis and treatment rates in what remains a somewhat underpenetrated market. But TRX growth seems to moderate in Q2 relative to Q1 slightly. And your competitor recently commented to strong early NBRx trends for its Alzheimer's agitation launch.

Speaker #5: I mean, you comment on potential new competition expanding diagnosis and treatment rates in what remains a somewhat underpenetrated market. But TRx growth seems to moderate in two key periods relative to one key period slightly.

Speaker #5: And your competitor recently commented on strong early MBRX trends for its outside agitation launch. So, I mean, is this broadly due to increasing competitive pressures in the space, or were there any other dynamics we should be aware of?

Alex Moore: I assume this is broadly due to increasing competitive pressures in the space, or were there any other dynamics we should be aware of? Then more broadly, I think consensus expectations for Rexulti growth have sort of moved from low teens to high single-digit percent for the full year. With that in mind, how should we think about the balance between competitive pressures and opportunity for further market expansion when thinking about Rexulti's growth outlook from here?

Alex Moore: I assume this is broadly due to increasing competitive pressures in the space, or were there any other dynamics we should be aware of? Then more broadly, I think consensus expectations for Rexulti growth have sort of moved from low teens to high single-digit percent for the full year. With that in mind, how should we think about the balance between competitive pressures and opportunity for further market expansion when thinking about Rexulti's growth outlook from here?

Speaker #5: And then more broadly, I think consensus expectations for resulting growth have sort of moved from low teens to high single digits percent for the full year.

Speaker #5: So, with that in mind, how should we think about the balance between competitive pressures and the opportunity for further market expansion when considering Rexalty's growth outlook from here?

Speaker #4: Yeah, so thank you for the question, Alex. I think, as I suggested before, with the increasingly competitive marketplace as it relates to both MDD as well as AADAD, Rexalty is performing to expectations.

Thomas Gibbs: Yeah. So thank you for the question, Alex. I think as I suggested before, with the increasingly competitive marketplace as it relates to both MDD as well as AAD/AD, Rexulti is performing to expectations and the penetration of the new competitors is consistent with how we envision the marketplace. I believe at least from an AAD/AD standpoint, this will continue to be a strong growth driver for the brand. All indications based upon the feedback that we're receiving from physicians is that Rexulti continues to play an important role as it relates to the increasing aware, the diagnosis and treatment rates of AAD/AD, as well as the clinical profile to help address the significant unmet needs. From an MDD standpoint, as I said, this brand continues to be very resilient.

Thomas Gibbs: Yeah. So thank you for the question, Alex. I think as I suggested before, with the increasingly competitive marketplace as it relates to both MDD as well as AAD/AD, Rexulti is performing to expectations and the penetration of the new competitors is consistent with how we envision the marketplace. I believe at least from an AAD/AD standpoint, this will continue to be a strong growth driver for the brand. All indications based upon the feedback that we're receiving from physicians is that Rexulti continues to play an important role as it relates to the increasing aware, the diagnosis and treatment rates of AAD/AD, as well as the clinical profile to help address the significant unmet needs. From an MDD standpoint, as I said, this brand continues to be very resilient.

Speaker #4: And the penetration of the new competitors is consistent with how we envision the marketplace. I believe, at least from an AADAD standpoint, this will continue to be a strong growth driver for the brand.

Speaker #4: All indications, based upon the feedback we're receiving from physicians, are that Rexalty continues to play an important role as it relates to increasing the diagnosis and treatment rates of AADAD, as well as its clinical profile to help address the significant unmet needs.

Speaker #4: From an MDD standpoint, as I said, this brand has continued to be very resilient. We look at double-digit growth for MDD within the marketplace.

Thomas Gibbs: We look at double-digit growth for MDD within the marketplace, and we believe that the competitive dynamics are beginning to start to plateau based upon when we look at NBRx rates for MDD. As I said, in the most recent monthly data that we have, the NBRx growth rate month-over-month for REXULTI exceeded CAPLYTA for the first time since their launch.

Thomas Gibbs: We look at double-digit growth for MDD within the marketplace, and we believe that the competitive dynamics are beginning to start to plateau based upon when we look at NBRx rates for MDD. As I said, in the most recent monthly data that we have, the NBRx growth rate month-over-month for REXULTI exceeded CAPLYTA for the first time since their launch.

Speaker #4: And we believe that the competitive dynamics are beginning to plateau based on when we look at NBRx rates for MDD. And as I said, in the most recent monthly data that we have, the NBRx growth rate month over month for Rexulti exceeded Compelled for the first time since their launch.

Operator: Ladies and gentlemen, this was the last question for today. I would now like to turn the conference back over to Charl van Zyl for any closing remarks.

Operator: Ladies and gentlemen, this was the last question for today. I would now like to turn the conference back over to Charl van Zyl for any closing remarks.

Speaker #1: Ladies and gentlemen, this was the last question for today. I would now like to turn the conference back over to Charles Van Zuyl for any closing remarks.

Speaker #2: Yeah, thank you, everybody, for joining, of course, today. And as I conclude here, I want to again say that we are very confident as we go through the first half of the year.

Charl van Zyl: Yeah. Thank you everybody for joining, of course, today. As I conclude here, I want to again say that we are very confident as we go through the H1 of the year and our full year guidance that we will have another strong year, and of course underpinned by strong growth and a very compelling pipeline with some near-term catalysts coming up very soon with bexicaserin. So thank you again for joining today.

Charl van Zyl: Yeah. Thank you everybody for joining, of course, today. As I conclude here, I want to again say that we are very confident as we go through the H1 of the year and our full year guidance that we will have another strong year, and of course underpinned by strong growth and a very compelling pipeline with some near-term catalysts coming up very soon with bexicaserin. So thank you again for joining today.

Speaker #2: And our full-year guidance is that we will have another strong year, of course underpinned by strong growth and a very compelling pipeline, with some near-term catalysts coming up very soon with Bexley and Catherine.

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Half Year 2026 H Lundbeck A/S Earnings Call & Business Update

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HLUN B

H Lundbeck

Earnings

Half Year 2026 H Lundbeck A/S Earnings Call & Business Update

HLUN B

Wednesday, August 19th, 2026 at 11:00 AM

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