Q3 2025 Novo Nordisk AS Earnings Call
Speaker #2: Good day and thank you for standing by . Welcome to the Q3 2025 Novo Nordisk Earnings Conference Call . At this time , all participants are in a listen only mode .
Speaker #2: After the speaker's presentation , there will be a question and answer session . To ask a question during the session , you will need to press star one and one on your telephone .
Speaker #2: You will then hear an automated message advising your hand is raised. To withdraw your question, please press *1 and *1 again.
Speaker #2: Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Jacob Warder, Head of Investor Relations.
Speaker #2: Please go ahead .
Jacob Martin Wiborg Rode: Thank you. Welcome to this Novo Nordisk earnings call for the first nine months of 2025. My name is Jacob Rode, I'm the Head of Investor Relations. With me today, I have CEO of Novo Nordisk, Mike Duust, Executive Vice President, Product and Portfolio Strategy, Ludovic Helfgott, Executive Vice President, US Operations, David Moore, Executive Vice President, Research and Development, and Chief Scientific Officer, Martin Holst Lange, and Chief Financial Officer, Karsten Munk Knudsen. All speakers will be available for the Q&A session. Please note that the call is being webcasted live and a recording will be made available on our website as well. The call is scheduled to last a little more than one hour. Please turn to the next slide. The presentation is structured as outlined on slide two.
Jacob Martin Wiborg Rode: Thank you. Welcome to this Novo Nordisk earnings call for the first nine months of 2025. My name is Jacob Rode, I'm the Head of Investor Relations. With me today, I have CEO of Novo Nordisk, Mike Duust, Executive Vice President, Product and Portfolio Strategy, Ludovic Helfgott, Executive Vice President, US Operations, David Moore, Executive Vice President, Research and Development, and Chief Scientific Officer, Martin Holst Lange, and Chief Financial Officer, Karsten Munk Knudsen. All speakers will be available for the Q&A session. Please note that the call is being webcasted live and a recording will be made available on our website as well. The call is scheduled to last a little more than one hour. Please turn to the next slide. The presentation is structured as outlined on slide two.
Speaker #3: Thank you . Welcome to this Novo Nordisk earnings call . For the first nine months of 2025 . My name is Jacob , and I'm the head of Investor Relations .
Speaker #3: With me today are CEO of Novo Nordisk , Mike Costa , executive vice president , product and portfolio strategy , Ludovic Helfgott executive vice president , US operations Dave Moore .
Speaker #3: Executive vice president , research and development and chief scientific officer Martin Hotaling and chief financial officer Carsten Mogensen . All speakers will be available for Q&A session .
Speaker #3: Please note that the call is being webcast live, and a recording will be made available on our website as well. The call is scheduled to last a little more than one hour.
Speaker #3: Please turn to the next slide. The presentation is structured as outlined on slide two. Please note that all sales and operating profit growth statements will be at constant exchange rates, unless otherwise specified.
Jacob Martin Wiborg Rode: Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified. Next slide, please. We need to advise you that this all will contain forward-looking statements. These are subject to risks and uncertainty that could cause actual results to differ materially from expectations. For further information on risk factors, please see the company announcement for the first nine months of 2025, as well as the slides prepared for this presentation. With that, over to you, Mike, for an update on our strategic aspirations.
Jacob Martin Wiborg Rode: Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified. Next slide, please. We need to advise you that this all will contain forward-looking statements. These are subject to risks and uncertainty that could cause actual results to differ materially from expectations. For further information on risk factors, please see the company announcement for the first nine months of 2025, as well as the slides prepared for this presentation. With that, over to you, Mike, for an update on our strategic aspirations.
Speaker #3: Next slide . Next slide please . We need to advise you that this call will contain forward looking statements . These are subject to risks and uncertainties that could cause actual results to differ materially from expectations .
Speaker #3: For further information on risk factors, please see the company announcement for the first nine months of 2025, as well as the slides prepared for this presentation.
Speaker #3: And with that, over to you, Mike, for an update on our strategic aspirations.
Maziar Mike Doustdar: Thank you, Jacob. Next slide, please. In the 1st nine months of 2025, we delivered 15% sales growth and 10% operating profit growth. We've also narrowed our guidance range to 8% to 11% on sales and 4% to 7% for operating profit. This is because we expect lower growth for our GLP-1 treatments in diabetes and obesity. Karsten will get back to the guidance update later in the call. Looking into the R&D in diabetes, Rybelsus is now approved in the US and EU with CV indications based on the SOUL trial. Within obesity and business development, we have progress on a number of projects that Martin will come back to later. In rare disease, we have now submitted Mim8 for regulatory approval in both US and EU. We're now serving around 46 million people living with diabetes and obesity.
Mads Krogsgaard Thomsen: Thank you, Jacob. Next slide, please. In the 1st nine months of 2025, we delivered 15% sales growth and 10% operating profit growth. We've also narrowed our guidance range to 8% to 11% on sales and 4% to 7% for operating profit. This is because we expect lower growth for our GLP-1 treatments in diabetes and obesity. Karsten will get back to the guidance update later in the call. Looking into the R&D in diabetes, Rybelsus is now approved in the US and EU with CV indications based on the SOUL trial. Within obesity and business development, we have progress on a number of projects that Martin will come back to later. In rare disease, we have now submitted Mim8 for regulatory approval in both US and EU. We're now serving around 46 million people living with diabetes and obesity.
Speaker #4: Thank you . Jakob . Next slide please . In the first nine months of 2025 , we delivered 15% sales growth and 10% operating profit growth .
Speaker #4: We've also narrowed our guidance range to 8% to 11% on sales and 4% to 7% for operating profit. This is because we expect lower growth for our GLP-1 treatments in diabetes and obesity.
Speaker #4: Carsten will get back to the guidance update later in the call. Looking into the R&D in diabetes, Rybelsus is now approved in the US and EU with CV indications based on the SOUL trial. In addition, we have progressed on a number of projects in obesity and business development, which Martin will come back to later in rare disease.
Speaker #4: You have now submitted my mate for regulatory approval in both the US and EU. We are now serving around 46 million people living with diabetes and obesity.
Maziar Mike Doustdar: This is around 3 million more people with our GLP-1 treatment compared to just 12 months ago. Furthermore, I would like to note that 2025 strategic aspirations is our current framework for reporting, and we look forward to updating this next year as the current strategic aspiration rounds out. Next slide, please. Since I became CEO, I have said several times that Novo Nordisk will sharpen its focus on core areas, specifically diabetes and obesity. I want to take a moment to explain how we have refined our strategy. For more than 100 years, we have been guided by a simple purpose: to identify and solve major unmet medical needs. This commitment is unchanged. There are many people who can benefit from expertise in diabetes and obesity, and we believe we can serve them better than anyone else.
Mads Krogsgaard Thomsen: This is around 3 million more people with our GLP-1 treatment compared to just 12 months ago. Furthermore, I would like to note that 2025 strategic aspirations is our current framework for reporting, and we look forward to updating this next year as the current strategic aspiration rounds out. Next slide, please. Since I became CEO, I have said several times that Novo Nordisk will sharpen its focus on core areas, specifically diabetes and obesity. I want to take a moment to explain how we have refined our strategy. For more than 100 years, we have been guided by a simple purpose: to identify and solve major unmet medical needs. This commitment is unchanged. There are many people who can benefit from expertise in diabetes and obesity, and we believe we can serve them better than anyone else.
Speaker #4: This is around 3 million more people with our GLP-1 treatment compared to just 12 months ago. Furthermore, I would like to note that the 2025 strategic aspirations is our current framework for reporting, and we look forward to updating this next year as the current strategic aspiration runs out.
Speaker #4: Next slide, please. Since I became CEO, I have stated several times that Novo Nordisk will sharpen its focus on core areas, specifically diabetes and obesity.
Speaker #4: I want to take a moment to explain how we have refined our strategy. For more than 100 years, we have been guided by a simple purpose: to identify and solve major unmet medical needs.
Speaker #4: This commitment is unchanged. There are many people who can benefit from expertise in diabetes and obesity, and we believe we can serve them better than anyone else.
Maziar Mike Doustdar: Going forward, we will concentrate on these areas where we can make the greatest difference. Our strategy begins with patients at the center of everything we will do. Way more than 1 billion people are affected by diabetes or obesity. We will work tirelessly to develop products that help them live healthier, fuller lives. Some of these products will be developed internally, others will be added to our portfolio through partnerships and acquisitions. Many of these assets can address multiple unmet needs. We will explore those opportunities and expand indications where appropriate to serve our patients. Speaking of patients, it is a known fact that obesity and diabetes vary by individual and often comes with comorbidities that lack effective treatments.
Mads Krogsgaard Thomsen: Going forward, we will concentrate on these areas where we can make the greatest difference. Our strategy begins with patients at the center of everything we will do. Way more than 1 billion people are affected by diabetes or obesity. We will work tirelessly to develop products that help them live healthier, fuller lives. Some of these products will be developed internally, others will be added to our portfolio through partnerships and acquisitions. Many of these assets can address multiple unmet needs. We will explore those opportunities and expand indications where appropriate to serve our patients. Speaking of patients, it is a known fact that obesity and diabetes vary by individual and often comes with comorbidities that lack effective treatments.
Speaker #4: Going forward, we will concentrate on these areas where we can make the greatest difference. Our strategy begins with patients at the center of everything.
Speaker #4: We will do way more than 1 billion people are affected by diabetes or obesity. We will work tirelessly to develop products that help them live healthier, fuller lives.
Speaker #4: Some of these products will be developed internally. Others will be added to our portfolio through partnerships and acquisitions. Many of these assets can address multiple unmet needs.
Speaker #4: We will explore those opportunities and expand indications where appropriate to serve our patients. Speaking of patients, it is a known fact that obesity and diabetes vary by individual and often come with comorbidities.
Speaker #4: That lack effective treatments. As with the Acura acquisition, Novo Nordisk will keep pursuing innovation with identification within research and then advancing those to development to address comorbidities within our core and the overlaps with those causes.
Maziar Mike Doustdar: As with the Akero acquisition, Novo Nordisk will keep pursuing innovation with identification within research and then advancing those to development to address comorbidities within our core and the overlaps with those cores. We are now sharpening our focus. In the past, we spread our resources into areas a bit further away from our core. Think about stem cell research for Parkinson's disease. Therefore, during this last quarter, we have discontinued several non-core assets and redirected resources to areas aligned with our strength. We will intensify our commercial efforts to strengthen competitiveness. To meet evolving market dynamics and increasingly consumer-like behavior, we will, for example, expand telehealth capabilities across markets. In short, we remain disciplined about where we will compete within diabetes, obesity, and related comorbidities in the years ahead. We will also continue our targeted research and commercial work in rare disease.
Mads Krogsgaard Thomsen: As with the Akero acquisition, Novo Nordisk will keep pursuing innovation with identification within research and then advancing those to development to address comorbidities within our core and the overlaps with those cores. We are now sharpening our focus. In the past, we spread our resources into areas a bit further away from our core. Think about stem cell research for Parkinson's disease. Therefore, during this last quarter, we have discontinued several non-core assets and redirected resources to areas aligned with our strength. We will intensify our commercial efforts to strengthen competitiveness. To meet evolving market dynamics and increasingly consumer-like behavior, we will, for example, expand telehealth capabilities across markets. In short, we remain disciplined about where we will compete within diabetes, obesity, and related comorbidities in the years ahead. We will also continue our targeted research and commercial work in rare disease.
Speaker #4: We are now refining our focus. In the past, we spread our resources into areas that were a bit further away from our core.
Speaker #4: Think about stem cell research for Parkinson's disease. Therefore, during this last quarter, we have discontinued several non-core assets and redirected resources to areas aligned with our strength.
Speaker #4: We will intensify our commercial efforts to strengthen competitiveness , to meet evolving market dynamics and increasingly , consumer like behavior . We will , for example , expand telehealth capabilities across markets .
Speaker #4: In short , we remain disciplined about where we will compete within diabetes , obesity and related comorbidities in the years ahead . We will also continue our targeted research and commercial work in rare disease and to support this strategy , we have launched a company wide transformation , which I would like to give you an update on its progress right now .
Maziar Mike Doustdar: To support this strategy, we have launched a company-wide transformation, which I would like to give you an update on its progress right now. Please go to the next slide. We previously announced a company-wide transformation designed to simplify our operating model, accelerate decision-making, and reallocate capital and resource towards the highest growth opportunities in diabetes and obesity. This program supports our strategy to capture rising global demand and strengthening our competitive position in the increasingly consumer-like obesity market. As part of the plan, we expect a reduction of approximately 9,000 positions globally. While this decision was not taken lightly, it is expected to drive approximately 8 billion DKK in annual savings by the end of 2026. Those savings will be redeployed to expand our diabetes and obesity franchises and fund strategic priorities.
Mads Krogsgaard Thomsen: To support this strategy, we have launched a company-wide transformation, which I would like to give you an update on its progress right now. Please go to the next slide. We previously announced a company-wide transformation designed to simplify our operating model, accelerate decision-making, and reallocate capital and resource towards the highest growth opportunities in diabetes and obesity. This program supports our strategy to capture rising global demand and strengthening our competitive position in the increasingly consumer-like obesity market. As part of the plan, we expect a reduction of approximately 9,000 positions globally. While this decision was not taken lightly, it is expected to drive approximately 8 billion DKK in annual savings by the end of 2026. Those savings will be redeployed to expand our diabetes and obesity franchises and fund strategic priorities.
Speaker #4: Please go to the next slide. We have previously announced a company-wide transformation designed to simplify our operating model, accelerate decision-making, and reallocate capital and resources toward the highest growth opportunities in diabetes and obesity.
Speaker #4: This program supports our strategy to capture rising global demand and strengthen our competitive position in the increasingly consumer-like obesity market. As part of the plan, we expect a reduction of approximately 9,000 positions globally.
Speaker #4: While this decision was not taken lightly, it is expected to drive approximately DKK 8 billion in annual savings by the end of 2026.
Speaker #4: Those savings will be redeployed to expand our diabetes and obesity franchises and fund strategic priorities. We recognize the human impact of these changes and remain committed to a responsible transition for affected colleagues.
Maziar Mike Doustdar: We recognize the human impact of these changes and remain committed to responsible transition for affected colleagues. At the same time, we're confident this transformation will increase operational efficiency and strengthen our long-term future and enhance return for our shareholders. I will now hand over to Ludovic for an update on our commercial execution for the first nine months of 2025.
Mads Krogsgaard Thomsen: We recognize the human impact of these changes and remain committed to responsible transition for affected colleagues. At the same time, we're confident this transformation will increase operational efficiency and strengthen our long-term future and enhance return for our shareholders. I will now hand over to Ludovic for an update on our commercial execution for the first nine months of 2025.
Speaker #4: At the same time, we're confident this transformation will increase operational efficiency and strengthen our long-term future, providing enhanced returns for our shareholders.
Speaker #4: I will now hand over to Ludvig for an update on our commercial execution for the first nine months of 2025.
Ludovic Helfgott: Thank you very much, Mike, and please turn to the next slide. In the first 9 months of 2025, our total sales increased by 15%. The sales growth was driven by both operating units. US operations grew 15%, and international operations grew 16%. Sales growth in the first 9 months of 2025 was positively impacted by one-offs in the US of around DKK 6 billion. Our GLP-1 sales in diabetes increased by 10%, driven by both operating units growing at the same rate. Insulin sales increased by 3%, driven by US operations growing 18%. The sales increase was positively impacted by gross net adjustments related to prior years, as well as channel and payer mix. This was partially countered by a decline in volume.
Ludovic Helfgott: Thank you very much, Mike, and please turn to the next slide. In the first 9 months of 2025, our total sales increased by 15%. The sales growth was driven by both operating units. US operations grew 15%, and international operations grew 16%. Sales growth in the first 9 months of 2025 was positively impacted by one-offs in the US of around DKK 6 billion. Our GLP-1 sales in diabetes increased by 10%, driven by both operating units growing at the same rate. Insulin sales increased by 3%, driven by US operations growing 18%. The sales increase was positively impacted by gross net adjustments related to prior years, as well as channel and payer mix. This was partially countered by a decline in volume.
Speaker #5: Thank you very much , Mike , and please turn to the next slide . In the first nine months of 2025 , our total sales increased by 15% .
Speaker #5: The sales growth was driven by both operating units. U.S. operations grew 15%, and international operations grew 16%. Sales growth in the first nine months of 2025 was positively impacted by one-offs in the U.S. of around 6 billion Danish kroner.
Speaker #5: Our GLP one sales in diabetes increased by 10% , driven by both operating units growing at the same rate . Insulin sales increased by 3% , driven by US operations growing 18% .
Speaker #5: The sales increase was positively impacted by growth in net adjustments related to prior years, as well as channel and payer mix. This was partially countered by a decline in volume.
Ludovic Helfgott: International operations sales decreased 2%. Obesity care sales increased 41%, driven by US operations growing 24% and international operations growing 83%. Our rare disease sales increased by 13%. This was driven by sales increase in the US of 14% and in international operations of 13%. Next slide, please. Sales in international operations grew by 16% in the first nine months of 2025, driven by GLP-1 products. GLP-1 diabetes sales increased by 10%, driven by sales growth of Ozempic and Rybelsus. In region China, GLP-1 diabetes sales decreased by 4%, which was negatively impacted by wholesaler inventory movements. Obesity care grew by 83% to DKK 22.4 billion. Sales of Wegovy reached approximately DKK 20 billion, growing at 168%, driven by sales growth across all regions. Please go to next slide.
Ludovic Helfgott: International operations sales decreased 2%. Obesity care sales increased 41%, driven by US operations growing 24% and international operations growing 83%. Our rare disease sales increased by 13%. This was driven by sales increase in the US of 14% and in international operations of 13%. Next slide, please. Sales in international operations grew by 16% in the first nine months of 2025, driven by GLP-1 products. GLP-1 diabetes sales increased by 10%, driven by sales growth of Ozempic and Rybelsus. In region China, GLP-1 diabetes sales decreased by 4%, which was negatively impacted by wholesaler inventory movements. Obesity care grew by 83% to DKK 22.4 billion. Sales of Wegovy reached approximately DKK 20 billion, growing at 168%, driven by sales growth across all regions. Please go to next slide.
Speaker #5: International operations . Sales decreased 2% . Obesity care sales increased 41% , driven by US operations growing 24% , and international operations growing 83% .
Speaker #5: Rare disease sales increased by 13%. This was driven by a sales increase in the U.S. of 14% and in international operations of 13%.
Speaker #5: Next slide, please. Sales in international operations grew by 16% in the first nine months of 2025, driven by GLP products. GLP-1 diabetes sales increased by 10%, driven by sales growth of Ozempic and Rybelsus in the region.
Speaker #5: China GLP and diabetes sales decreased by 4%, which was negatively impacted by wholesaler inventory movements. Obesity care grew by 83% to 22.4 billion Danish kroner.
Speaker #5: Sales of Wegovy reached approximately 20 billion Danish kroner , growing at 168% , driven by sales growth across all regions . Please go to next slide in the combined diabetes and Obesity GLP one markets , Novo Nordisk remains the market leader in international operations .
Ludovic Helfgott: In the combined diabetes and obesity GLP-1 market, Novo Nordisk remains the market leader in international operations with a volume market share of 68%. Rybelsus is now available in more than 40 countries, and Ozempic continues to be the leading GLP-1 diabetes product within international operations, having launched in around 80 countries. In obesity, Wegovy is now launched in more than 45 countries with more to come. Oral semaglutide 25 mg or Wegovy pill has been submitted in the EU for potential launch in selected EU markets. The GLP-1 class growth of 35% in international operations is encouraging. While competition in diabetes and obesity across international operations is intensifying, the unmet needs remain substantial. With that, I would like to hand it over to Dave for an update on our US operations.
Ludovic Helfgott: In the combined diabetes and obesity GLP-1 market, Novo Nordisk remains the market leader in international operations with a volume market share of 68%. Rybelsus is now available in more than 40 countries, and Ozempic continues to be the leading GLP-1 diabetes product within international operations, having launched in around 80 countries. In obesity, Wegovy is now launched in more than 45 countries with more to come. Oral semaglutide 25 mg or Wegovy pill has been submitted in the EU for potential launch in selected EU markets. The GLP-1 class growth of 35% in international operations is encouraging. While competition in diabetes and obesity across international operations is intensifying, the unmet needs remain substantial. With that, I would like to hand it over to Dave for an update on our US operations.
Speaker #5: The volume market share of 68% for Rybelsus is now available in more than 40 countries, and Ozempic continues to be the leading GLP-1 diabetes product within international operations, having launched in around 80 countries for obesity.
Speaker #5: Wegovy is now launched in more than 45 countries, with more to come. Oral semaglutide 25 mg, or Wegovy in a pill, has been submitted in the EU for potential launch in selected EU markets.
Speaker #5: The GLP one class growth of 35% in international operations is encouraging , and while competition in diabetes and obesity across international operations is intensifying , the unmet needs remain substantial .
Speaker #5: And with that, I would like to hand it over to Dave for an update on our U.S. operations.
David Moore: Thank you, Ludovic. Please go to the next slide. Sales of GLP-1 diabetes care products in the US increased by 10% in the first nine months of 2025. The sales increase was driven by continued uptake of Ozempic, partially countered by Victoza and Rybelsus. Ozempic sales in the US were positively impacted by gross to net sales adjustments and wholesaler stocking. Weekly Ozempic prescriptions are currently around 670,000 in standard units, compared to 690,000 standard units in Q2 2025. The GLP-1 diabetes market grew around 10% in Q3 2025 compared to Q3 2024. In the US, we continue to invest in commercial activities and have recently launched Ozempic in our direct-to-patient cash offering. Please go to the next slide.
David Moore: Thank you, Ludovic. Please go to the next slide. Sales of GLP-1 diabetes care products in the US increased by 10% in the first nine months of 2025. The sales increase was driven by continued uptake of Ozempic, partially countered by Victoza and Rybelsus. Ozempic sales in the US were positively impacted by gross to net sales adjustments and wholesaler stocking. Weekly Ozempic prescriptions are currently around 670,000 in standard units, compared to 690,000 standard units in Q2 2025. The GLP-1 diabetes market grew around 10% in Q3 2025 compared to Q3 2024. In the US, we continue to invest in commercial activities and have recently launched Ozempic in our direct-to-patient cash offering. Please go to the next slide.
Speaker #6: Thank you . Ludvig , please go to the next slide . Sales of GLP one Diabetes care products in the US increased by 10% in the first nine months of 2025 .
Speaker #6: The sales increase was driven by continued uptake of Ozempic, partially countered by Victoza and Rybelsus. Ozempic sales in the U.S. were positively impacted by gross-to-net sales adjustments and wholesaler stocking.
Speaker #6: Weekly Ozempic prescriptions are currently around 670,000 . In standard units , compared to 690,000 standard units in the second quarter of 2025 . The GLP one diabetes market grew around 10% in the third quarter of 2025 , compared to the third quarter of 2024 .
Speaker #6: In the US , we continue to invest in commercial activities and have recently launched Ozempic in our direct to patient cash offering . Please go to the next slide .
David Moore: Wegovy sales increased by 25% in the US operations in the first nine months of 2025. The Wegovy sales growth was driven by increased volumes, partially countered by lower realized prices. Wegovy has around 270,000 weekly prescriptions, compared to 280,000 weekly prescriptions at the end of last quarter. In August, we announced that the US FDA approved Wegovy for the treatment of MASH. In US operations, we have established a sales force targeting US hepatologists and gastroenterologists while we work to build access in this segment. Generally, we also continue to work on expanding access to safe and authentic Wegovy. Around 55 million people with obesity have Wegovy coverage in the US, with more than 10 million people estimated to be covered with Medicaid.
David Moore: Wegovy sales increased by 25% in the US operations in the first nine months of 2025. The Wegovy sales growth was driven by increased volumes, partially countered by lower realized prices. Wegovy has around 270,000 weekly prescriptions, compared to 280,000 weekly prescriptions at the end of last quarter. In August, we announced that the US FDA approved Wegovy for the treatment of MASH. In US operations, we have established a sales force targeting US hepatologists and gastroenterologists while we work to build access in this segment. Generally, we also continue to work on expanding access to safe and authentic Wegovy. Around 55 million people with obesity have Wegovy coverage in the US, with more than 10 million people estimated to be covered with Medicaid.
Speaker #6: Wegovy sales increased by 25% in the U.S. operations in the first nine months of 2025. The Wegovy sales growth was driven by increased volumes, partially countered by lower realized prices.
Speaker #6: Wegovy has around 270,000 weekly prescriptions , compared to 280,000 weekly prescriptions at the end of last quarter . In August , we announced that the US , FDA approved wegovy for the treatment of Mash in US operations .
Speaker #6: We have established a sales force targeting us Hepatologists and gastroenterologists while we work to build access . In this segment generally , we also continue to work on expanding access to safe and authentic wegovy around 55 million people with obesity have wegovy coverage in the US , with more than 10 million people estimated to be covered with Medicaid .
David Moore: However, looking into 2026, several states have already announced changes to coverage for obesity medicines in response to budgetary concerns, which will affect Medicaid access to Wegovy. Regrettably, Novo Nordisk market research shows that compounding has continued to increase. Multiple entities continue to market and sell compounded GLP-1s, and it is now estimated to be well above 1 million patients in the US that are currently on compounded GLP-1. Novo Nordisk launched NovoCare Pharmacy in March 2025, and together with retail channel, total cash market is up around 10% of total Wegovy prescriptions. Novo Nordisk will continue to invest in the expansion of direct-to-patient initiatives like the recently announced collaborations with GoodRx and Costco. We continue to anticipate a regulatory decision regarding Wegovy in a pill later this year, which then we will be ready to launch in early 2026.
David Moore: However, looking into 2026, several states have already announced changes to coverage for obesity medicines in response to budgetary concerns, which will affect Medicaid access to Wegovy. Regrettably, Novo Nordisk market research shows that compounding has continued to increase. Multiple entities continue to market and sell compounded GLP-1s, and it is now estimated to be well above 1 million patients in the US that are currently on compounded GLP-1. Novo Nordisk launched NovoCare Pharmacy in March 2025, and together with retail channel, total cash market is up around 10% of total Wegovy prescriptions. Novo Nordisk will continue to invest in the expansion of direct-to-patient initiatives like the recently announced collaborations with GoodRx and Costco. We continue to anticipate a regulatory decision regarding Wegovy in a pill later this year, which then we will be ready to launch in early 2026.
Speaker #6: However, looking into 2026, several states have already announced changes to coverage for obesity medicines in response to budgetary concerns, which will affect Medicaid access to Adobe.
Speaker #6: Regrettably , Novo Nordisk market research shows that compounding has continued to increase multiple entities continue to market and sell compounded GLP one , and it is now estimated to be well above 1 million patients in the US that are currently on compounded GLP one .
Speaker #6: Novo Nordisk launched Novo Care Pharmacy in March 2025, and together with the retail channel Total Cash Market, is up around 10% of total Wegovy prescriptions.
Speaker #6: Novo Nordisk will continue to invest in the expansion of direct to patient initiatives like the recently announced collaborations with Goodrx and Costco . We continue to anticipate a regulatory decision regarding Wegovy , an appeal later this year , which then we will be ready to launch in early 2026 .
David Moore: Now back to you, Ludovic.
David Moore: Now back to you, Ludovic.
Speaker #6: Now back to you, Ludvig.
Ludovic Helfgott: Thanks, Dave. Please turn to the next slide. Yesterday, we confirmed that we submitted an updated proposal to acquire Metsera to further strengthen our research and development portfolio in diabetes and obesity. As we said before, unlocking the full potential of the obesity market will require a broad and deep portfolio with different treatment options, formats, serving different patient groups and their very different preferences. Obesity treatment is still in its early stage, and in Novo Nordisk, we foresee future patient segments that, for example, could be categorized based on BMI, age, gender, lifestyle, behaviors, and comorbidities. We believe that Metsera's innovative pipeline would further enhance our opportunity to meet all these very different needs of all these very different groups. MET-97 is a potential best-in-class once monthly GLP-1 treatment, and MET-233 is a next-generation amylin asset.
Ludovic Helfgott: Thanks, Dave. Please turn to the next slide. Yesterday, we confirmed that we submitted an updated proposal to acquire Metsera to further strengthen our research and development portfolio in diabetes and obesity. As we said before, unlocking the full potential of the obesity market will require a broad and deep portfolio with different treatment options, formats, serving different patient groups and their very different preferences. Obesity treatment is still in its early stage, and in Novo Nordisk, we foresee future patient segments that, for example, could be categorized based on BMI, age, gender, lifestyle, behaviors, and comorbidities. We believe that Metsera's innovative pipeline would further enhance our opportunity to meet all these very different needs of all these very different groups. MET-97 is a potential best-in-class once monthly GLP-1 treatment, and MET-233 is a next-generation amylin asset.
Speaker #5: Thanks, Dave. Please turn to the next slide. Yesterday, we confirmed that we submitted an updated proposal to acquire Meztira to further strengthen our research and development portfolio in diabetes and obesity.
Speaker #5: As we said before, unlocking the full potential of the obesity market will require a broad and deep portfolio with different treatment options, formats, and serving different patient groups.
Speaker #5: And they're very different preferences . Obesity treatment is still in its early stage , and Novo Nordisk . We foresee future patient segments that , for example , could be categorized based on BMI , age , gender , lifestyle behaviors and comorbidities .
Speaker #5: We believe that Meztira is innovative . Pipeline would further enhance our opportunity to meet all these very different needs . Of all these very different groups , Mets 97 is a potential best in class once monthly GLP one treatment and Met 233 is a next generation amylin asset .
Ludovic Helfgott: The pipeline of Metsera also includes a combination of the two mentioned above, as well as innovative oral and injectable preclinical assets. Furthermore, Metsera's institutional knowledge and capabilities around peptide engineering and synthesis, half-life extension technologies, and oral peptide delivery nicely complements Novo Nordisk's core strengths in research. The proposed deal structure includes an upfront payment of $62.2 per share in cash, equal to an approximate enterprise value of $6.7 billion. The cash consideration is paid at signing in exchange for non-voting preferred stock, representing 50% of Metsera's share capital. Up to $2.8 billion in contingent value rights, CVRs, will be issued upon the closing of the acquisition in exchange for the remaining shares. The CVRs are based on the achievement of certain clinical and regulatory milestones.
Ludovic Helfgott: The pipeline of Metsera also includes a combination of the two mentioned above, as well as innovative oral and injectable preclinical assets. Furthermore, Metsera's institutional knowledge and capabilities around peptide engineering and synthesis, half-life extension technologies, and oral peptide delivery nicely complements Novo Nordisk's core strengths in research. The proposed deal structure includes an upfront payment of $62.2 per share in cash, equal to an approximate enterprise value of $6.7 billion. The cash consideration is paid at signing in exchange for non-voting preferred stock, representing 50% of Metsera's share capital. Up to $2.8 billion in contingent value rights, CVRs, will be issued upon the closing of the acquisition in exchange for the remaining shares. The CVRs are based on the achievement of certain clinical and regulatory milestones.
Speaker #5: The pipeline of Meztira also includes a combination of the two mentioned above , as well as innovative oral and injectable preclinical assets . Furthermore , Meztira institutional knowledge and capabilities around peptide engineering and synthesis , half life extension technologies , and oral peptide delivery nicely complements Novo Nordisk's core strength in research .
Speaker #5: The proposed deal structure includes an upfront payment of $62.20 per share in cash, equal to an approximate enterprise value of $6.7 billion.
Speaker #5: The cash consideration is paid at signing in exchange for non-voting preferred stock , representing 50% of share capital . In addition , up to 2.8 billion USD in contingent value , right Cvrs will be issued upon the closing of the acquisition in exchange for the remaining shares .
Speaker #5: The Cvrs are based on the achievement of certain clinical and regulatory milestones . In total , Meztira is eligible to receive up to 10 billion USD , or 86.2 USD per share .
Ludovic Helfgott: In total, Metsera is eligible to receive up to $10 billion or $86.2 per share. Novo Nordisk believes that the proposal, including the structure of the transaction, complies with all applicable laws and is in the best interest of patients who will benefit from our commitment to innovation, as well as Metsera's shareholder. The offer highlights Novo Nordisk's commitment to investing in the US and interest in continuing to grow the scale of its US investment. Now, over to you, Martin.
Ludovic Helfgott: In total, Metsera is eligible to receive up to $10 billion or $86.2 per share. Novo Nordisk believes that the proposal, including the structure of the transaction, complies with all applicable laws and is in the best interest of patients who will benefit from our commitment to innovation, as well as Metsera's shareholder. The offer highlights Novo Nordisk's commitment to investing in the US and interest in continuing to grow the scale of its US investment. Now, over to you, Martin.
Speaker #5: Novo Nordisk believes that the proposal, including the structure of the transaction, complies with all applicable laws and is in the best interest of patients who will benefit from our commitment to innovation, as well as our shareholders.
Speaker #5: The offer highlights Novo Nordisk's commitment to investing in the U.S. and interest in continuing to grow the scale of its U.S. investment. Now over to you, Martin.
Martin Holst Lange: Thank you, Ludovic. Please turn to the next slide. As Mike described, we are intensifying our focus on key therapeutic areas such as diabetes and obesity, while continuing our commitment to related comorbidities as well as rare disease. The strategy aligns with our recent acquisition agreements of Akero and Omeros zaltenibart assets. In early October, we announced the agreement to acquire Akero and efruxifermin, a once-weekly subcutaneous long-acting FGF21 analog with potential to be first to market in F4 and best in class. efruxifermin complements a strategic position in Novo Nordisk MASH pipeline. Current treatment options, such as Wegovy, primarily target patients with F2 and F3 disease stages. There remains a significant unmet need in the F4 cirrhosis population, for which no approved therapies are currently available. The Phase 2 data for efruxifermin are encouraging across F2 to F4.
Martin Holst Lange: Thank you, Ludovic. Please turn to the next slide. As Mike described, we are intensifying our focus on key therapeutic areas such as diabetes and obesity, while continuing our commitment to related comorbidities as well as rare disease. The strategy aligns with our recent acquisition agreements of Akero and Omeros zaltenibart assets. In early October, we announced the agreement to acquire Akero and efruxifermin, a once-weekly subcutaneous long-acting FGF21 analog with potential to be first to market in F4 and best in class. efruxifermin complements a strategic position in Novo Nordisk MASH pipeline. Current treatment options, such as Wegovy, primarily target patients with F2 and F3 disease stages. There remains a significant unmet need in the F4 cirrhosis population, for which no approved therapies are currently available. The Phase 2 data for efruxifermin are encouraging across F2 to F4.
Speaker #7: Thank you . Ludwig , please turn to the next slide as Mike described , we in our focus on key therapeutic areas such as diabetes and obesity , while continuing our commitment to related comorbidities as well as rare disease .
Speaker #7: The strategy aligns with our recent acquisition agreements of Acura and numerous cells in Zanzibar . As in early October , we announced the agreement to acquire care and efruxifermin , a once weekly subcutaneous long acting FGF 21 analog with potential to be first to market in a fall and best in class proxy firm and complements a strategic position in Novo Nordisk , mesh pipeline .
Speaker #7: Current treatment options such as Wegovy primarily target patients with F2 and F3 disease . Disease stages . Consequently , there remains a significant unmet need in the .
Speaker #7: F4 cirrhosis population, for which no approved therapies are currently available. The Phase Two data for Efruxifermin are encouraging across F2 to F4.
Martin Holst Lange: Specifically, the SYMMETRY Phase 2b trial demonstrates that after 96 weeks of treatment, 29% of F4 patients show improvement of at least 1 fibrosis stage with no worsening of MASH, and 42% achieved MASH resolution without fibrosis worsening. This is the first Phase 2 trial to show statistically significant fibrosis regression in F4 patients for an FGF21 analog. efruxifermin is currently in the Phase 3 SYNCHRONY program with pivotal readouts in the coming years and expected launch by the end of this decade. As a result, efruxifermin has the potential to be first in class FGF21 analog, targeting the F1, F4 population, as well as playing a role in F2 and F3 patients, including people who are not responsive to existing treatments.
Martin Holst Lange: Specifically, the SYMMETRY Phase 2b trial demonstrates that after 96 weeks of treatment, 29% of F4 patients show improvement of at least 1 fibrosis stage with no worsening of MASH, and 42% achieved MASH resolution without fibrosis worsening. This is the first Phase 2 trial to show statistically significant fibrosis regression in F4 patients for an FGF21 analog. efruxifermin is currently in the Phase 3 SYNCHRONY program with pivotal readouts in the coming years and expected launch by the end of this decade. As a result, efruxifermin has the potential to be first in class FGF21 analog, targeting the F1, F4 population, as well as playing a role in F2 and F3 patients, including people who are not responsive to existing treatments.
Speaker #7: Specifically , the Symmetry Phase two trial demonstrates that after 96 weeks of treatment . 29% of patients of at least one fibrosis stage with no worsening of mesh and 42% achieved mesh resolution with fibrosis without fibrosis worsening .
Speaker #7: This is the first Phase 2 trial to show statistically significant fibrosis regression in F4 patients. For an FGF21 analog, F Roxy, Furman is currently in the Phase 3 Synchrony program, with readouts in the coming years and an expected launch by the end of this decade.
Speaker #7: As a result , if Roxy Furman has the potential to be first in class FGF , FGF 21 analog targeting the F1 , F4 population , as well as playing a role in F2 and F3 patients , including people who are not responsive to existing treatments .
Martin Holst Lange: We look forward to leveraging our capabilities to further optimize the SYNCHRONY program trials, assess the potential combinations with our current FGF1-based portfolio, and explore opportunities for additional indications such as Alcohol-associated liver disease. Also in October, we announced the agreement to acquire the clinical stage MASH FXR inhibitor zaltenibart from Omeros for rare blood and kidney disorders. This action aligns with the rare disease strategy with a key focus on rare blood disorders. zaltenibart is currently in phase 2 for the acquired rare blood disease, paroxysmal nocturnal hemoglobinuria, or PNH. Plans are in place to begin a global phase 3 program for zaltenibart in PNH. The molecule holds big potential in a number of additional indications within rare disease and kidney disorders, which will be evaluated at a later point in time.
Martin Holst Lange: We look forward to leveraging our capabilities to further optimize the SYNCHRONY program trials, assess the potential combinations with our current FGF1-based portfolio, and explore opportunities for additional indications such as Alcohol-associated liver disease. Also in October, we announced the agreement to acquire the clinical stage MASH FXR inhibitor zaltenibart from Omeros for rare blood and kidney disorders. This action aligns with the rare disease strategy with a key focus on rare blood disorders. zaltenibart is currently in phase 2 for the acquired rare blood disease, paroxysmal nocturnal hemoglobinuria, or PNH. Plans are in place to begin a global phase 3 program for zaltenibart in PNH. The molecule holds big potential in a number of additional indications within rare disease and kidney disorders, which will be evaluated at a later point in time.
Speaker #7: We look forward to leveraging our capabilities to further optimize the synchrony program . Trials , assess the potential combinations with our current drug based portfolio , and explore opportunities for additional indications such as alcohol , liver disease .
Speaker #7: Also in October, we announced the agreement to acquire the clinical-stage mass-free inhibitor Cel Sultanabad from Amarus for rare blood and kidney disorders.
Speaker #7: This action aligns with the rare disease strategy, with a key focus on rare blood disorders. Sultanabad is currently in Phase Two for the acquired rare blood disease paroxysmal nocturnal hemoglobinuria, or PNH.
Speaker #7: Lands are in place to begin a global phase three program for sultanabad in PNH . The molecule holds big potential in a number of additional indications within Radisys and kidney disorders , which will be evaluated in an at a later point in time .
Martin Holst Lange: We believe our extensive expertise in the development, manufacturing, and commercialization of medicines within these fields makes us well-positioned to advance these assets, optimize the value of their innovation, and ensure they reach the patients in need of these treatments in a very timely fashion. Please turn to the next slide. Looking towards our internal pipeline, we recently published a sub-analysis of REDEFINE 1 focusing on cagrilintide. In the trial, cagrilintide achieved 11.8% weight loss at 68 weeks, assuming full treatment adherence. About one in three patients on cagrilintide lost at least 15% of their body weight. Overall, cagrilintide was very well tolerated. The most common side effects were gastrointestinal of nature. The discontinuation rate due to gastrointestinal adverse events was 1.3%. Obesity is a global change that requires continued scientific innovation.
Martin Holst Lange: We believe our extensive expertise in the development, manufacturing, and commercialization of medicines within these fields makes us well-positioned to advance these assets, optimize the value of their innovation, and ensure they reach the patients in need of these treatments in a very timely fashion. Please turn to the next slide. Looking towards our internal pipeline, we recently published a sub-analysis of REDEFINE 1 focusing on cagrilintide. In the trial, cagrilintide achieved 11.8% weight loss at 68 weeks, assuming full treatment adherence. About one in three patients on cagrilintide lost at least 15% of their body weight. Overall, cagrilintide was very well tolerated. The most common side effects were gastrointestinal of nature. The discontinuation rate due to gastrointestinal adverse events was 1.3%. Obesity is a global change that requires continued scientific innovation.
Speaker #7: We believe our extension , our extensive expertise in the development , manufacturing and commercialization of medicines within these fields makes us well positioned to advance these assets , optimize the value of their innovation and ensure they reach the patients in need of these treatments in a very timely fashion .
Speaker #7: Let's turn to the next slide. Looking towards our internal pipeline, we recently published a sharp analysis of Redefine One, focusing on Cagrilintide.
Speaker #7: In the trial, we achieved an 11.8% weight loss at 68 weeks. Assuming full treatment adherence, about 1 in 3 patients on Cagrilintide lost at least 15% of their body weight.
Speaker #7: Overall, Cagrilintide was very well tolerated. The most common side effects were gastrointestinal in nature, and the discontinuation rate due to gastrointestinal adverse events was 1.3%.
Speaker #7: Obesity is a global challenge that requires continued scientific innovation and more treatment options. Also, focusing on tolerability is needed to meet the diverse individual needs and preferences.
Martin Holst Lange: More treatment options, also focusing on tolerability, are needed to meet the diverse individual needs and preferences. We are very encouraged by the first Phase 3 data for cagrilintide from REDEFINE 1, and we look forward to studying it further in Phase 3, the so-called reNEW program. reNEW 1 and reNEW 2 will assess the 2.4 mg dose in people with obesity with and without type 2 diabetes, respectively. Both trials have already been initiated, and additional studies evaluating higher doses of cagrilintide are anticipated in the beginning of first half of 2026. Let's head to the next slide. Turning to the upcoming R&D milestones, we're looking forward to the remainder of 2025 with a number of readouts and milestones.
Martin Holst Lange: More treatment options, also focusing on tolerability, are needed to meet the diverse individual needs and preferences. We are very encouraged by the first Phase 3 data for cagrilintide from REDEFINE 1, and we look forward to studying it further in Phase 3, the so-called reNEW program. reNEW 1 and reNEW 2 will assess the 2.4 mg dose in people with obesity with and without type 2 diabetes, respectively. Both trials have already been initiated, and additional studies evaluating higher doses of cagrilintide are anticipated in the beginning of first half of 2026. Let's head to the next slide. Turning to the upcoming R&D milestones, we're looking forward to the remainder of 2025 with a number of readouts and milestones.
Speaker #7: We are very encouraged by the first phase 3 data for Cagrilintide from Redefine One, and we look forward to studying it further in phase 3.
Speaker #7: The so-called Renew program, Renew One and Renew Two, will assess the 2.4 mg dose in people with obesity, with and without type 2 diabetes, respectively.
Speaker #7: Both trials have already been initiated, and additional studies evaluating higher doses of Cagrilintide are anticipated in the first half of 2026.
Speaker #7: Turning to the next slide, let's focus on the upcoming R&D milestones. We're looking forward to the remainder of 2025, as we have a number of readouts and milestones in the first half of 2026. We anticipate the readout of Reimagine Three, which is the first of three pivotal trials for Cagrisema and people with type 2 diabetes.
Martin Holst Lange: In the first half of 2026, we anticipate the readout of the REIMAGINE 3, which is the 1st of 3 pivotal trials for CagriSema in people with type 2 diabetes. REIMAGINE 3 is a smaller study with CagriSema as an add-on to basal insulin. REIMAGINE 2 is the larger study, which will provide comparison to semaglutide and will read out in Q1 2026. We also look forward to the phase 2 results of the subcutaneous and oral amycretin in type 2 diabetes in Q4 this year. Within obesity, we completed the phase 1 trial with our internal GLP-1 GIP amylin tri-agonist. The study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of the tri-agonist. In the trial, all multiple doses tested appeared to have a safe and well tolerated profile.
Martin Holst Lange: In the first half of 2026, we anticipate the readout of the REIMAGINE 3, which is the 1st of 3 pivotal trials for CagriSema in people with type 2 diabetes. REIMAGINE 3 is a smaller study with CagriSema as an add-on to basal insulin. REIMAGINE 2 is the larger study, which will provide comparison to semaglutide and will read out in Q1 2026. We also look forward to the phase 2 results of the subcutaneous and oral amycretin in type 2 diabetes in Q4 this year. Within obesity, we completed the phase 1 trial with our internal GLP-1 GIP amylin tri-agonist. The study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of the tri-agonist. In the trial, all multiple doses tested appeared to have a safe and well tolerated profile.
Speaker #7: Reimagine Three is a smaller study, as an add-on to basal insulin. Reimagine Two is the largest study, which will provide comparison to semaglutide and will read out in the first quarter of 2026.
Speaker #7: We also look forward to the phase two results of the shock and oral amycretin in type 2 diabetes in Q4 this year. Within obesity, we completed the phase one trial with our internal GLP-1 GIP amylin agonist.
Speaker #7: The study assessed the safety , tolerability , pharmacokinetics , and pharmacodynamics of the agonist in the trial . All multiple doses tested appeared to have a safe and well tolerated , tolerated profile .
Martin Holst Lange: The results of this study allow progression to a phase 1b/2 trial in individuals with overweight or obesity, which was initiated in October 2025. Looking forward, we expect the FDA decision regarding the new drug application for the Wegovy pill by the end of this year. The submission of CagriSema, as well as the readout of the REDEFINE 4 trial, remains on track for Q1 2026. Within rare disease, we have filed Mim8 as a once-monthly, once-every-two-weeks, and once-weekly prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in people with hemophilia A, with and without inhibitors, for regulatory approval in the US and in EU. We anticipate the results of the EVOKE trials in patients with early Alzheimer's disease later this year.
Martin Holst Lange: The results of this study allow progression to a phase 1b/2 trial in individuals with overweight or obesity, which was initiated in October 2025. Looking forward, we expect the FDA decision regarding the new drug application for the Wegovy pill by the end of this year. The submission of CagriSema, as well as the readout of the REDEFINE 4 trial, remains on track for Q1 2026. Within rare disease, we have filed Mim8 as a once-monthly, once-every-two-weeks, and once-weekly prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in people with hemophilia A, with and without inhibitors, for regulatory approval in the US and in EU. We anticipate the results of the EVOKE trials in patients with early Alzheimer's disease later this year.
Speaker #7: The results of this study allowed progression to a Phase 1/2 trial in individuals with overweight or obesity, which was initiated in October 2025.
Speaker #7: Looking forward , we expect the FDA decision regarding the new drug application for the Wegovy pill by the end of this year . Further , the submission of Cagrisema as well as the readout of the redefine four trial , remains on track for the first quarter of 2026 , within rare disease , we have filed my maid as a once monthly , once every two weeks , and once weekly prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in people with hemophilia A , with and without inhibitors .
Speaker #7: For regulatory approval in the US and in the EU, we anticipate the results of the trials in patients with early Alzheimer's disease later this year.
Martin Holst Lange: While there are a number of high unmet need for the treatment of Alzheimer's disease, it is important to remind you that this represents a high-risk opportunity. As the very final remark, while it is not on the slide, I would be remiss if I don't mention that the first readout of ziltivekimab is anticipated to read out in the second half of 2026. With that, over to you, Carsten.
Martin Holst Lange: While there are a number of high unmet need for the treatment of Alzheimer's disease, it is important to remind you that this represents a high-risk opportunity. As the very final remark, while it is not on the slide, I would be remiss if I don't mention that the first readout of ziltivekimab is anticipated to read out in the second half of 2026. With that, over to you, Carsten.
Speaker #7: While there are a number of high unmet need for the treatment of all , all Alzheimer's disease , it is important to remind you that this represents a high risk opportunity .
Speaker #7: And as the very final remark , while it is not on the slide , I would be remiss if I don't mention that the first readout of Cilgavimab is anticipated to readout in the second half of 2026 , with that , over to you , Carsten .
Karsten Munk Knudsen: Thank you, Martin. Please turn to the next slide. In the first nine months of 2025, our sales grew by 12% in Danish kroner and by 15% at constant exchange rates, driven by both operating units. In Q3, DKK 9 billion in costs related to the restructuring was booked. The gross margin decreased to 81.0% compared to 84.6% in 2024. The decline in gross margin mainly reflects impacts of around DKK 3 billion from the one-off restructuring costs and impairments related to a few production assets. Further costs of goods sold are impacted by amortization and depreciations related to Catalent, as well as costs related to ongoing capacity expansions. Sales and distribution costs increased by 12% in Danish kroner and by 15% at constant exchange rates.
Karsten Munk Knudsen: Thank you, Martin. Please turn to the next slide. In the first nine months of 2025, our sales grew by 12% in Danish kroner and by 15% at constant exchange rates, driven by both operating units. In Q3, DKK 9 billion in costs related to the restructuring was booked. The gross margin decreased to 81.0% compared to 84.6% in 2024. The decline in gross margin mainly reflects impacts of around DKK 3 billion from the one-off restructuring costs and impairments related to a few production assets. Further costs of goods sold are impacted by amortization and depreciations related to Catalent, as well as costs related to ongoing capacity expansions. Sales and distribution costs increased by 12% in Danish kroner and by 15% at constant exchange rates.
Speaker #5: Thank you .
Speaker #6: Martin .
Speaker #4: Please turn to the next .
Speaker #7: Slide . .
Speaker #8: In the first nine months of 2025, our sales grew by 12% in Danish kroner and by 15% at constant exchange rates, driven by both operating units.
Speaker #8: In the third quarter, DKK 9 billion in costs related to the restructuring was booked. The gross margin decreased to 81.0%, compared to 84.6% in 2024.
Speaker #8: The decline in gross margin mainly reflects impacts of around DKK 3 billion from the one-off restructuring costs and impairments related to a few production assets.
Speaker #8: Further , cost of goods sold are impacted by amortization and depreciation related to catalant , as well as costs related to ongoing capacity expansions , sales and distribution costs increased by 12% in Danish kroner and by 15% at constant exchange rates .
Karsten Munk Knudsen: The increase in co-in costs is driven by both US operations and international operations and is primarily related to Wegovy. S&D costs are impacted by one-off restructuring costs of around 2 billion DKK. Research and development costs increased by 9% in Danish kroner and by 10% at constant exchange rates. This reflects increased R&D activity across the early and late-stage portfolio, particularly within obesity care. R&D costs are impacted by one-off restructuring costs of around 4 billion DKK and impairments related to the closure of early non-core projects to free up resources for projects in core therapy areas. This is partially countered by the impairment loss related to ocedurenone of 5.7 billion DKK and other impairments of intangible assets in 2024. Operating profit increased by 5% measured in Danish kroner and by 10% at constant exchange rates.
Karsten Munk Knudsen: The increase in co-in costs is driven by both US operations and international operations and is primarily related to Wegovy. S&D costs are impacted by one-off restructuring costs of around 2 billion DKK. Research and development costs increased by 9% in Danish kroner and by 10% at constant exchange rates. This reflects increased R&D activity across the early and late-stage portfolio, particularly within obesity care. R&D costs are impacted by one-off restructuring costs of around 4 billion DKK and impairments related to the closure of early non-core projects to free up resources for projects in core therapy areas. This is partially countered by the impairment loss related to ocedurenone of 5.7 billion DKK and other impairments of intangible assets in 2024. Operating profit increased by 5% measured in Danish kroner and by 10% at constant exchange rates.
Speaker #8: The increase in costs is driven by both US operations and international operations , and is primarily related to wegovy SSD costs are impacted by one off restructuring costs of around 2 billion DKK .
Speaker #8: Research and development costs increased by 9% . Danish kroner and by 10% at constant exchange rates . This reflects the increased R&D activity across the early and late stage portfolio , particularly within obesity care .
Speaker #8: R&D costs are impacted by one off restructuring costs of around 4 billion Danish kroner and impairments related to the closure of early non-core projects to free up resources for projects in core therapy areas .
Speaker #8: This is partially accounted by the impairment loss related to our of 5.7 billion Danish kroner and other impairments of intangible assets in 2024 , operating profit increased by 5% , measured in Danish kroner , and by 10% at constant exchange rates .
Karsten Munk Knudsen: Operating profit adjusted for costs related to the restructuring increased by 16% measured in Danish kroner and 21% at constant exchange rates. Net profit increased by 4% and diluted earnings per share increased by 4% to DKK 16.99. Free cash flow in the first nine months of 2025 was DKK 63.9 billion, compared to DKK 71.8 billion in the first nine months of 2024, driven by increased CapEx. Finally, in the first nine months of 2025, we have returned DKK 53 billion to shareholders, mainly through dividend payments. Please go to the next slide. For 2025, sales growth is now expected to be 8% to 11% at constant exchange rates. The new range reflects lower expectations for sales growth of our GLP-1 treatments in diabetes and obesity.
Karsten Munk Knudsen: Operating profit adjusted for costs related to the restructuring increased by 16% measured in Danish kroner and 21% at constant exchange rates. Net profit increased by 4% and diluted earnings per share increased by 4% to DKK 16.99. Free cash flow in the first nine months of 2025 was DKK 63.9 billion, compared to DKK 71.8 billion in the first nine months of 2024, driven by increased CapEx. Finally, in the first nine months of 2025, we have returned DKK 53 billion to shareholders, mainly through dividend payments. Please go to the next slide. For 2025, sales growth is now expected to be 8% to 11% at constant exchange rates. The new range reflects lower expectations for sales growth of our GLP-1 treatments in diabetes and obesity.
Speaker #8: Operating profit , adjusted for costs related to the restructuring , increased by 16% , measured in Danish kroner and 21% at constant exchange rates .
Speaker #8: Net profit increased by 4% and diluted earnings per share increased by 4% to 16 kroner , and 99 error free cash flow in the first nine months of 2025 was 63.9 billion Danish kroner , compared to 71.8 billion in the first nine months of 2024 , driven by increased capital expenditures and finally , in the first nine months of 2025 , we have returned 53 billion Danish kroner to shareholders , mainly through dividend payments .
Speaker #8: Please go to the next slide for 2025 . Sales growth is now expected to be 8 to 11% at constant exchange rate . The new range reflects lower expectations for sales growth of our GLP one treatments in diabetes and obesity .
Karsten Munk Knudsen: Given the current exchange rate versus the Danish kroner, sales growth reported in Danish kroner is expected to be around 4 percentage points lower than constant exchange rate growth. In international operations, the updated outlook reflects current growth trends driven by GLP-1 penetration in diabetes and obesity, partially offset by intensifying competition within both diabetes and obesity. In US operations, the outlook is based on current prescription trends for Wegovy and Ozempic, as well as intensifying competition and pricing pressure within both diabetes and obesity. Operating profit is now expected to be 4% to 7% at constant exchange rates, negatively impacted by DKK 8 billion in restructuring costs. Given the current exchange rate versus Danish kroner, growth reported in Danish kroner is expected to be around 6 percentage points lower than at constant exchange rates.
Karsten Munk Knudsen: Given the current exchange rate versus the Danish kroner, sales growth reported in Danish kroner is expected to be around 4 percentage points lower than constant exchange rate growth. In international operations, the updated outlook reflects current growth trends driven by GLP-1 penetration in diabetes and obesity, partially offset by intensifying competition within both diabetes and obesity. In US operations, the outlook is based on current prescription trends for Wegovy and Ozempic, as well as intensifying competition and pricing pressure within both diabetes and obesity. Operating profit is now expected to be 4% to 7% at constant exchange rates, negatively impacted by DKK 8 billion in restructuring costs. Given the current exchange rate versus Danish kroner, growth reported in Danish kroner is expected to be around 6 percentage points lower than at constant exchange rates.
Speaker #8: Given the current exchange rate versus the Danish kroner sales growth reported in Danish , kroner is expected to be around four percentage points lower than constant exchange rate growth in international operations .
Speaker #8: The updated outlook reflects current growth trends driven by GLP one penetration in diabetes and obesity , partially offset by intensifying competition within both diabetes and obesity in US operations .
Speaker #8: The outlook is based on current prescription trends for Wegovy and Ozempic , as well as intensifying competition and pricing pressure within both diabetes and obesity .
Speaker #8: Operating profit is now expected to be 4 to 7% at constant exchange rates , negatively impacted by 8 billion Danish kroner in restructuring costs .
Speaker #8: Given the current exchange rate versus Danish kroner , growth reported in Danish kroner is expected to be around six percentage points lower than at constant exchange rates .
Karsten Munk Knudsen: The narrowing of the guidance range mainly reflects the lower sales growth outlook and costs related to the agreed acquisitions of Akero and Omeros, partially countered by reduced spending. Novo Nordisk expects net financial items to show a gain of around DKK 2.6 billion, driven by gains on hedged currencies, whereas capital expenditure is now expected to be around DKK 60 billion, driven by adjustments to expansion plans. Free cash flow is now expected to be DKK 20 to 30 billion, reflecting lower than expected trade receivables in the US and reduction in capital expenditure. Furthermore, the free cash flow guidance assume an impact from the acquisition of Akero, contingent on final timing of closing. Potential financial impacts related to the potential acquisition of Metsera has not been included.
Karsten Munk Knudsen: The narrowing of the guidance range mainly reflects the lower sales growth outlook and costs related to the agreed acquisitions of Akero and Omeros, partially countered by reduced spending. Novo Nordisk expects net financial items to show a gain of around DKK 2.6 billion, driven by gains on hedged currencies, whereas capital expenditure is now expected to be around DKK 60 billion, driven by adjustments to expansion plans. Free cash flow is now expected to be DKK 20 to 30 billion, reflecting lower than expected trade receivables in the US and reduction in capital expenditure. Furthermore, the free cash flow guidance assume an impact from the acquisition of Akero, contingent on final timing of closing. Potential financial impacts related to the potential acquisition of Metsera has not been included.
Speaker #8: The narrowing of the guidance range mainly reflects the lower sales growth outlook and costs related to the agreed acquisitions of Akiro and Omura's , partially countered by reduced spending .
Speaker #8: Expects net financial items to show a gain of around 2.6 billion Danish kroner , driven by gains on hedge currencies , whereas capital expenditure is now expected to be around 60 billion Danish kroner , driven by adjustments to expansion plans .
Speaker #8: Free cash flow is now expected to be 20 to 30 billion Danish kroner , reflecting lower than expected trade receivables in the US and reduction in capital expenditure .
Speaker #8: Furthermore , the free cash flow guidance assumes an impact from the acquisition of Akiro contingent on final timing of closing potential financial impacts .
Speaker #8: Related to the potential acquisition of Matsura has not been included for the coming years . NOVO NORDISK A S previously informed that the compound patent expiry of semaglutide molecule in certain countries in international operations is expected to have an estimated negative low single digit impact on global sales growth in 2026 .
Karsten Munk Knudsen: For the coming years, Novo Nordisk has previously informed that the compound patent expiry of semaglutide molecule in certain countries in international operations is expected to have an estimated negative low single-digit impact on global sales growth in 2026. In 2026, the agreed acquisition of Akero is expected to lead to increased R&D costs with an estimated negative impact on full year operating profit growth of around 3 percentage points, depending on the timing of closing. Lastly, Novo Nordisk accepted the Inflation Reduction Act maximum fair price, MFP, for Ozempic, Rybelsus, and Wegovy in Medicare Part D for 2027. The estimated direct impact of semaglutide MFP in Medicare Part D, had it been introduced 1 January 2025, would have been a negative low single-digit impact on global sales growth for the full year of 2025.
Karsten Munk Knudsen: For the coming years, Novo Nordisk has previously informed that the compound patent expiry of semaglutide molecule in certain countries in international operations is expected to have an estimated negative low single-digit impact on global sales growth in 2026. In 2026, the agreed acquisition of Akero is expected to lead to increased R&D costs with an estimated negative impact on full year operating profit growth of around 3 percentage points, depending on the timing of closing. Lastly, Novo Nordisk accepted the Inflation Reduction Act maximum fair price, MFP, for Ozempic, Rybelsus, and Wegovy in Medicare Part D for 2027. The estimated direct impact of semaglutide MFP in Medicare Part D, had it been introduced 1 January 2025, would have been a negative low single-digit impact on global sales growth for the full year of 2025.
Speaker #8: In 2026 , the agreed acquisition of Akiro is expected to lead to increased R&D costs , with an estimated negative impact on full year operating profit growth of around three percentage point , depending on the timing of closing .
Speaker #8: Lastly , Novo Nordisk accepted the Inflation Reduction Act maximum fair price MFP for Ozempic , Rybelsus and Wegovy in Medicare Part D for 2027 .
Speaker #8: The estimated direct impact of semaglutide MFP in Medicare Part D , had it been introduced 1st of January 2025 , would have been a negative low single digit impact on global sales growth .
Speaker #8: For the full year of 2025 . The MFP for semaglutide will be effective as of January 2027 . In Medicare Part D in the US , that covers the remaining details on the outlook for 2025 .
Karsten Munk Knudsen: The MFPs for semaglutide will be effective as of 1st January 2027 in Medicare Part D in the US. That covers the remaining details on the outlook for 2025. Now back to you, Mike.
Karsten Munk Knudsen: The MFPs for semaglutide will be effective as of 1st January 2027 in Medicare Part D in the US. That covers the remaining details on the outlook for 2025. Now back to you, Mike.
Speaker #8: Now back to you , Mark .
Maziar Mike Doustdar: Thank you, Carsten. Please turn to the next slide. It's been a busy and productive quarter. Throughout the first nine months of 2025, we delivered 15% sales growth and nearly 46 million people are now benefiting from our treatments. We have also advanced our R&D pipeline, launched a company-wide transformation program, and announced a few strategically aligned R&D acquisitions and agreements. With that, back to you, Jacob.
Mads Krogsgaard Thomsen: Thank you, Carsten. Please turn to the next slide. It's been a busy and productive quarter. Throughout the first nine months of 2025, we delivered 15% sales growth and nearly 46 million people are now benefiting from our treatments. We have also advanced our R&D pipeline, launched a company-wide transformation program, and announced a few strategically aligned R&D acquisitions and agreements. With that, back to you, Jacob.
Speaker #4: Thank you . Carson , please turn to the next slide . It's been a busy and productive quarter throughout the first nine months of 2025 .
Speaker #4: We delivered 15% sales growth and nearly 46 million people are now benefiting from our treatments . We have also advanced our R&D pipeline , launched a company wide transformation program , and announced a few strategically aligned R&D acquisitions and agreements .
Speaker #4: With that , back to you , Jakob .
Jacob Martin Wiborg Rode: Thank you, Mike. Next slide, please. With that, we're now ready for the Q&A, please. We kindly ask all participants to limit her or himself to one or maximum two questions, including the sub-questions. With that, operator, let's take the first question, please.
Jacob Martin Wiborg Rode: Thank you, Mike. Next slide, please. With that, we're now ready for the Q&A, please. We kindly ask all participants to limit her or himself to one or maximum two questions, including the sub-questions. With that, operator, let's take the first question, please.
Speaker #3: Thank you . Mike . Next slide please . And with that , we're now ready for Q&A . Please . We're kindly ask all participants to limit her or himself to one or maximum two questions , including the subquestions .
Speaker #3: So with that operator , let's take the first question , please .
Operator: Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now go to your first question. Your first question comes from the line of Carsten Lønborg Madsen from Danske Bank. Please go ahead.
Operator: Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now go to your first question. Your first question comes from the line of Carsten Lønborg Madsen from Danske Bank. Please go ahead.
Speaker #2: Thank you . To ask a question , you will need to press star one and one on your telephone and wait for your name to be announced .
Speaker #2: To withdraw your question , please press star one and one again . We will now go to your first question and your first question comes from the line of Carson Lundberg Madsen from Danske Bank .
Speaker #2: Please go ahead .
Carsten Lønborg Madsen: Yes. Thank you very much for taking my question here. I think I'll start out with a sort of a relatively basic question for Mike now that it's the first time we have you on a sort of a real quarterly conference call here. If we look at your roadshow presentation, we can see that in the combined obesity and diabetes market, the GLP-1 market, you lost 9 percentage points global market share over the last 12 months. That's quite a massive loss of share. We obviously knew about this trend, but still when you look at what you can actually do in terms of strategic initiatives to turn this around, what is it, the intangible initiatives that you are thinking about implementing? You tried pricing in US in Q3.
Carsten Lønborg Madsen: Yes. Thank you very much for taking my question here. I think I'll start out with a sort of a relatively basic question for Mike now that it's the first time we have you on a sort of a real quarterly conference call here. If we look at your roadshow presentation, we can see that in the combined obesity and diabetes market, the GLP-1 market, you lost 9 percentage points global market share over the last 12 months. That's quite a massive loss of share. We obviously knew about this trend, but still when you look at what you can actually do in terms of strategic initiatives to turn this around, what is it, the intangible initiatives that you are thinking about implementing? You tried pricing in US in Q3.
Speaker #9: Yes, thank you very much for taking my question here. I think I'll start. I have two; I'll start out with a sort of a relatively basic question for Mike.
Speaker #9: First time we have you on a sort of a real quarterly conference call here . If we look at your your roadshow presentation , you can see that in the combined obesity and diabetes market , driven market , you lost nine percentage points .
Speaker #9: Global market share over the last 12 months . That's quite a massive loss of share . We obviously knew about this trend but but still when you look at what you can actually do in terms of strategic initiatives to turn this around , what is it that intangible initiatives that you are thinking about implementing , you tried pricing in US and Q3 it doesn't really seem to have a sort of a big delta effect on your momentum in the US market .
Carsten Lønborg Madsen: It doesn't really seem to have a sort of a big delta effect on your momentum in the US market.
Carsten Lønborg Madsen: It doesn't really seem to have a sort of a big delta effect on your momentum in the US market.
Peter Verdult ): Maybe if you could give some examples. Question 2 is for Carsten. The acquisitions you have done or are planning to do will lead to a sort of a quite significant cash outflow, especially if you get them Metsera. If you have Akero, Metsera, you have CapEx, you also need to pay dividends next year, I assume. Is there anything you can talk about the capital planning, capital allocation, and also, how high in the hierarchy is the dividend payout ratio in terms of being extremely important for our investors, of course?
Carsten Lønborg Madsen: Maybe if you could give some examples. Question 2 is for Carsten. The acquisitions you have done or are planning to do will lead to a sort of a quite significant cash outflow, especially if you get them Metsera. If you have Akero, Metsera, you have CapEx, you also need to pay dividends next year, I assume. Is there anything you can talk about the capital planning, capital allocation, and also, how high in the hierarchy is the dividend payout ratio in terms of being extremely important for our investors, of course?
Speaker #9: So maybe if you could give some examples , then question two is for Carsten , the acquisitions you have done are planning to do will lead to sort of a quite significant cash outflow , especially if you get them , etc.
Speaker #9: . So if you have a carer meztira , you have CapEx , you also need to pay dividends next year . I assume .
Speaker #9: Is there anything you can talk about the capital planning, capital allocation, and also how high in the hierarchy the dividend payout ratio is in terms of being extremely important for investors?
Speaker #9: Of course .
Jacob Martin Wiborg Rode: Very good. Thanks for those two questions. On the first one, on market share development and perhaps market growth also, we'll turn to you, Mike.
Jacob Martin Wiborg Rode: Very good. Thanks for those two questions. On the first one, on market share development and perhaps market growth also, we'll turn to you, Mike.
Speaker #3: Very good . Thanks for those two questions . On the first one , on market share development and perhaps market growth . Also , we'll turn to you , Mike .
Maziar Mike Doustdar: Thank you very much, Carsten. As someone who has been part of the commercial organization for so long, then I would not lie and say I don't like losing market share. Our job right now is to focus the company's strategy around diabetes and obesity predominantly because we see a huge expansion potential as we go forward. We are expanding our pipeline through our own activities as well as, of course, acquisitions. We are getting our costs under control to invest and really make sure that no stones is unturned. We're really putting most of our efforts at this point in expanding the markets. There are millions and millions of diabetes and obesity patients out there, including in the US, that are not getting their treatments.
Mads Krogsgaard Thomsen: Thank you very much, Carsten. As someone who has been part of the commercial organization for so long, then I would not lie and say I don't like losing market share. Our job right now is to focus the company's strategy around diabetes and obesity predominantly because we see a huge expansion potential as we go forward. We are expanding our pipeline through our own activities as well as, of course, acquisitions. We are getting our costs under control to invest and really make sure that no stones is unturned. We're really putting most of our efforts at this point in expanding the markets. There are millions and millions of diabetes and obesity patients out there, including in the US, that are not getting their treatments.
Speaker #4: Thank you very much , Carsten . So as someone who has been part of the commercial organization for so long , then I would not lie and say I don't like losing market share , but our job right now is to focus the company's strategy around diabetes and obesity , predominantly because we see a huge expansion potential as we go forward .
Speaker #4: We are expanding our pipeline through our own activities as well as , of course , acquisitions . We are getting our costs under control to to invest and really make sure that no stones is unturned and we're really putting most of our efforts at this point in expanding the markets .
Speaker #4: There are millions and millions of diabetes and obesity patients out there, including in the U.S., who are not getting their treatment. Launching new products like our Wegovy pill is one way to get there.
Maziar Mike Doustdar: Launching new products like our Wegovy pill is one way to get there. Other ways is through increasing our commercial partnerships. You have seen Costco, Walmart, GoodRx, LifeMD, Ro. All of those are ways for us to expand the market and really make sure that through that, we succeed and have a successful future. It does take time for those measures to take effect. It's a marathon, as I have said a number of times now, not a sprint.
Mads Krogsgaard Thomsen: Launching new products like our Wegovy pill is one way to get there. Other ways is through increasing our commercial partnerships. You have seen Costco, Walmart, GoodRx, LifeMD, Ro. All of those are ways for us to expand the market and really make sure that through that, we succeed and have a successful future. It does take time for those measures to take effect. It's a marathon, as I have said a number of times now, not a sprint.
Speaker #4: Other ways is through increasing our commercial partnerships . You have seen Costco , Walmart , Goodrx , Lifemd Rowe , all of those are ways for us to expand the market and really make sure that through that , we succeed and have a successful future .
Speaker #4: But it does take time for those measures to take effect . It's a marathon , as I have said , a number of times now , not a sprint .
Jacob Martin Wiborg Rode: Thank you, Mike. For the second question on capital allocation, we'll turn to you, Carsten.
Jacob Martin Wiborg Rode: Thank you, Mike. For the second question on capital allocation, we'll turn to you, Carsten.
Speaker #3: Thank you, Mike. And for the second question on capital allocation, we'll talk to you, Carsten.
Karsten Munk Knudsen: Yeah. Thank you for the capital allocation question. We have a clearly articulated capital allocation framework, which says, invest in the business, provided the attractive return, pay out dividend in a consistent manner, do pipeline additions through BD and M&A, finally, if excess cash, do share buyback. So that's our framework, which has remained unchanged for quite a while. With that, I'm saying that we do have a consistent approach on dividend and have no intention of changing that. The starting point is clearly to convert our earnings into cash flow, which we focus on each and every day, and then looking at value-generating opportunities, both organically and inorganically, as in the case with the Akero, as an example.
Karsten Munk Knudsen: Yeah. Thank you for the capital allocation question. We have a clearly articulated capital allocation framework, which says, invest in the business, provided the attractive return, pay out dividend in a consistent manner, do pipeline additions through BD and M&A, finally, if excess cash, do share buyback. So that's our framework, which has remained unchanged for quite a while. With that, I'm saying that we do have a consistent approach on dividend and have no intention of changing that. The starting point is clearly to convert our earnings into cash flow, which we focus on each and every day, and then looking at value-generating opportunities, both organically and inorganically, as in the case with the Akero, as an example.
Speaker #8: Yeah . Thank you for for the capital allocation question , we have a clearly articulated capital allocation framework which says invest in the business provided attractive return pay out dividend in a consistent manner to pipeline additions through M&A and finally , if excess cash do do share buyback .
Speaker #8: So so that's our framework which is remained unchanged for for quite quite a while . And with that I'm saying that we we do have a consistent approach approach on dividend and have no incentive intention of of changing that .
Speaker #8: The starting point is clearly to convert our earnings into cash flow , which , which we focus on each and every day . And and then looking at at value generating opportunities , both organically and inorganically , as in the case with the with the Akiro as an example .
Karsten Munk Knudsen: I hope that's clear. Back to you, Jacob Rode.
Karsten Munk Knudsen: I hope that's clear. Back to you, Jacob Rode.
Speaker #8: So I hope that's clear. Back to.
Jacob Martin Wiborg Rode: Very much so. Thank you, Carsten, and also thanks to you, Carsten, and for the two questions. With that, operator, let's turn to the next set of questions, please.
Jacob Martin Wiborg Rode: Very much so. Thank you, Carsten, and also thanks to you, Carsten, and for the two questions. With that, operator, let's turn to the next set of questions, please.
Speaker #3: Very much . Thank you , and also thanks to you for for the two questions with that , operator , let's turn to the next set of questions , please .
Operator: Thank you. Your next question comes from the line of Peter Verdult from BNP Paribas. Please go ahead.
Operator: Thank you. Your next question comes from the line of Peter Verdult from BNP Paribas. Please go ahead.
Speaker #2: Thank you. Your next question comes from the line of Peter Fedora from BNP Paribas. Please go ahead.
Peter Verdult ): Yeah, thanks. Peter Verdult, BNP Paribas. Two questions, please, for Mike and Martin. Mike, don't shoot the messenger, but there are many people that view your pursuit of Metsera as an implicit signal that your confidence in the internal pipeline has waned over the past 12 months. My question is, where do you see the clinical differentiation between the assets you're looking to acquire versus the CagriSema and amycretin? Is it just the monthly dosing angle or are there other factors at play? Secondly, this is a very simple question. We've heard overnight from our network that Novo Nordisk has been contacted by FTC for information relating to Metsera. I know you're not gonna go into any details. Can you at least confirm if this is factually the case? Thank you.
Peter Verdult: Yeah, thanks. Peter Verdult, BNP Paribas. Two questions, please, for Mike and Martin. Mike, don't shoot the messenger, but there are many people that view your pursuit of Metsera as an implicit signal that your confidence in the internal pipeline has waned over the past 12 months. My question is, where do you see the clinical differentiation between the assets you're looking to acquire versus the CagriSema and amycretin? Is it just the monthly dosing angle or are there other factors at play? Secondly, this is a very simple question. We've heard overnight from our network that Novo Nordisk has been contacted by FTC for information relating to Metsera. I know you're not gonna go into any details. Can you at least confirm if this is factually the case? Thank you.
Speaker #10: Yeah . Thanks , Peter . Being but two questions , please , for Mike and Martin and Mike . Don't shoot the messenger .
Speaker #10: But there are many people who view your pursuit of meztira as an implicit signal that your confidence in the internal pipeline has waned over the past 12 months.
Speaker #10: My question is: where do you see the clinical differentiation between the assets you're looking to acquire versus a category? Calgary, Soma, and Amycretin.
Speaker #10: Is it just the monthly dosing angle, or are there other factors at play? And then, secondly, this is a very simple question that we've heard overnight from our network: that Novo has been contacted by the FTC for information relating to Meztira.
Speaker #10: I know you're not going to go into any details, but can you at least confirm if this is factually the case? Thank you.
Jacob Martin Wiborg Rode: Thank you, Pete. On the first question on Metsera, we'll turn to you first, Mike, and then Martin, you can add on on the different assets.
Jacob Martin Wiborg Rode: Thank you, Pete. On the first question on Metsera, we'll turn to you first, Mike, and then Martin, you can add on on the different assets.
Speaker #3: Thank you Pete . And on the first question on , we'll turn to you first , Mike and then Martin . You can add on on the different assets .
Maziar Mike Doustdar: Thanks very much, Pete. I would say, Pete, that I am very excited about our own pipeline. I think we have a fantastic pipeline. When you have an ambition to go to hundreds of millions of people and treat them, then no pipeline is broad enough. We have been looking at Metsera for a long time. We are very excited about these assets. The proposal to acquire Metsera really supports our long-term strategy and it's mainly because these assets are differentiated and complemented to our products and portfolio. That's why we're doing it. I'll pass it on to Martin, who can more easily explain you the differentiation to our own assets. I would say it works very complementary to what we have.
Mads Krogsgaard Thomsen: Thanks very much, Pete. I would say, Pete, that I am very excited about our own pipeline. I think we have a fantastic pipeline. When you have an ambition to go to hundreds of millions of people and treat them, then no pipeline is broad enough. We have been looking at Metsera for a long time. We are very excited about these assets. The proposal to acquire Metsera really supports our long-term strategy and it's mainly because these assets are differentiated and complemented to our products and portfolio. That's why we're doing it. I'll pass it on to Martin, who can more easily explain you the differentiation to our own assets. I would say it works very complementary to what we have.
Speaker #4: Thanks very much , Pete . I would say , Pete , that I am very excited about our own pipeline . I think we have a fantastic pipeline .
Speaker #4: But when you have an ambition to go to hundreds of millions of people and treat them, then no pipeline is broad enough.
Speaker #4: So we have been looking at Matsura for a long time . We are very excited about these assets . The proposal to acquire Matsura really supports our long term strategy and and it's mainly because these assets are differentiated and complemented to our products and portfolio .
Speaker #4: That's why we're doing it . I'll pass it on to to Martin , who can more easily explain you the differentiation to our own assets .
Speaker #4: But, I would say it works very complementary to what we have.
Karsten Munk Knudsen: I can only echo that. What we are looking for is complementarity to our pipeline. You've heard us speak to many times, obesity is not just one disease, it's many different diseases with many different presentations, different patients coming in with different age, different BMI, different behaviors, different needs, different body composition, and different comorbidities. They have different focus areas. For us to really serve the full palette of patients suffering from obesity and their comorbidities, we need a diversified pipeline. What we've seen is differentiation and complementarity. When we see that, then, if we can progress that with diligence and an assignment, then obviously we're interested.
Martin Holst Lange: I can only echo that. What we are looking for is complementarity to our pipeline. You've heard us speak to many times, obesity is not just one disease, it's many different diseases with many different presentations, different patients coming in with different age, different BMI, different behaviors, different needs, different body composition, and different comorbidities. They have different focus areas. For us to really serve the full palette of patients suffering from obesity and their comorbidities, we need a diversified pipeline. What we've seen is differentiation and complementarity. When we see that, then, if we can progress that with diligence and an assignment, then obviously we're interested.
Speaker #7: I can only echo that what we are looking for is complementarity to our pipeline. You've heard us speak to that many, many times.
Speaker #7: Obesity is not just one disease . It's many different diseases with many different presentations , different patients coming in with different age , different BMI , different behaviors , different needs , different body composition , and different comorbidities .
Speaker #7: They have different focus areas. For us to really serve the full palette of patients suffering from obesity and their comorbidities, we need a diversified pipeline.
Speaker #7: But we've seen is differentiation and complementarity . And when we see that , then we can progress that with diligence . And in addition , then obviously we're interested .
Jacob Martin Wiborg Rode: Thank you, Mike. Thank you, Martin. On the second question on the FTC, we'll turn to you, Carsten.
Jacob Martin Wiborg Rode: Thank you, Mike. Thank you, Martin. On the second question on the FTC, we'll turn to you, Carsten.
Speaker #3: Thank you , Mike , and thank you , Martin . And then on the second question on the FTC , we'll turn to you , Carson .
Karsten Munk Knudsen: Yeah.
Karsten Munk Knudsen: Yeah.
Speaker #8: Yeah. So, the short answer is that at this point, we don't want to get into any details around the process.
Karsten Munk Knudsen: The short answer is that at this point we don't want to get into any details around the process. It's still to TBD where everything lands out. We know that the Metsera board assessed our to be superior, and that's what we can relate to. I can say as part of this due diligence, as with any other due diligence, we do comprehensive homework in terms of living up to all laws and regulations in order for the deal to close. We always do that, and we did that here also with the assistance and challenge of external experts. We are confident that this deal can close according to regulations.
Karsten Munk Knudsen: The short answer is that at this point we don't want to get into any details around the process. It's still to TBD where everything lands out. We know that the Metsera board assessed our to be superior, and that's what we can relate to. I can say as part of this due diligence, as with any other due diligence, we do comprehensive homework in terms of living up to all laws and regulations in order for the deal to close. We always do that, and we did that here also with the assistance and challenge of external experts. We are confident that this deal can close according to regulations.
Speaker #8: It's still TBD where everything lands out . We know that Mazzara bought assessed our B to be superior . And and that's what we can relate to .
Speaker #8: And then I can say as part of this due diligence, as with any other due diligence, we do comprehensive homework in terms of living up to all laws and regulations in order for the deal to close.
Speaker #8: We always do that . And we did that here . Also with the assistance and challenges of external experts . So , so we are confident that this deal can can close according to the regulations .
David Moore: Thank you.
Peter Verdult: Thank you.
Jacob Martin Wiborg Rode: Thank you, Pete, for those two deal questions. Let's turn to the next set of questions, please.
Jacob Martin Wiborg Rode: Thank you, Pete, for those two deal questions. Let's turn to the next set of questions, please.
Speaker #3: Thank you. And thank you for those two questions. Let's turn to the next set of questions, please.
David Moore: Thank you. Your next questions come from the line of François-Xavier Béchon from Bernstein. Please go ahead.
David Moore: Thank you. Your next questions come from the line of François-Xavier Béchon from Bernstein. Please go ahead.
Speaker #2: Thank you. Your next question comes from the line of Florence Pérez from Bernstein. Please go ahead.
François-Xavier Béchon: Good afternoon. Thank you for taking my questions. One question I followed about Medicare. Maybe could you share with us your view on Medicare on one end, the opportunity, if there is a broader coverage of people with obesity on this channel? The second, about the potential risk or the IRA, the next step on IRA, you gave some color on the press release about that. Any comments about this opportunity and risk on Medicare would be great. Thank you.
François-Xavier Béchon: Good afternoon. Thank you for taking my questions. One question I followed about Medicare. Maybe could you share with us your view on Medicare on one end, the opportunity, if there is a broader coverage of people with obesity on this channel? The second, about the potential risk or the IRA, the next step on IRA, you gave some color on the press release about that. Any comments about this opportunity and risk on Medicare would be great. Thank you.
Speaker #11: Good afternoon. Thank you for taking my questions. One question I have is a follow-up about Medicare. Could you share with us your view on Medicare?
Speaker #11: On one hand, there is the opportunity if there is broader coverage of people with obesity on this channel, and on the other hand, there is the potential risk regarding the IRA. You provided some color on the next steps about the IRA in the press release.
Speaker #11: So any comments about this opportunity and risk on Medicare would be great. Thank you.
Jacob Martin Wiborg Rode: Thank you, François, for those two questions. For both of those, we'll turn to you, Dave, on Medicare potential and then on IRA.
Jacob Martin Wiborg Rode: Thank you, François, for those two questions. For both of those, we'll turn to you, Dave, on Medicare potential and then on IRA.
Speaker #3: Thank you . For for those two questions , for both of those will turn to to to you , Dave . On on Medicare potential and then on IRA .
David Moore: Thanks for the question, François. The Medicare opportunity is very important to us and something we've been pursuing since we launched into obesity over a decade ago. We know that there's roughly 30 million people of Medicare age that are suffering from obesity, and that is something that we feel is really important that those individuals have access to anti-obesity medicines. We can't speculate on what the potential is and how many of those patients we'll be able to reach, but we do see this as a very important development for us. Regarding your second question about IRA, as Karsten mentioned, gave an understanding of the expected impact in the company announcement as well. It's not something that we are able to comment on.
David Moore: Thanks for the question, François. The Medicare opportunity is very important to us and something we've been pursuing since we launched into obesity over a decade ago. We know that there's roughly 30 million people of Medicare age that are suffering from obesity, and that is something that we feel is really important that those individuals have access to anti-obesity medicines. We can't speculate on what the potential is and how many of those patients we'll be able to reach, but we do see this as a very important development for us. Regarding your second question about IRA, as Karsten mentioned, gave an understanding of the expected impact in the company announcement as well. It's not something that we are able to comment on.
Speaker #6: Thank you for the question on the Medicare opportunity. It is very important to us and something we've been pursuing since we launched into obesity over a decade ago.
Speaker #6: And we know that there are roughly 30 million people of Medicare age who are suffering from obesity. That is something that we feel is really important: those individuals should have access to anti-obesity medicines.
Speaker #6: We can't speculate on what the potential is and how many of those patients will be able to reach. But we do see this as a very important development for us.
Speaker #6: Regarding your second question about the IRA, we, as Karsten mentioned, provided an understanding of the expected impact in the company announcement as well.
Speaker #6: And it's not something that we are able to comment on. We are under strict confidentiality with CMS, and CMS will be making the announcement of what those prices are at some point in the near future.
David Moore: We are under strict confidentiality with CMS, and CMS will be making the announcement of what those prices are at some point in the near future.
David Moore: We are under strict confidentiality with CMS, and CMS will be making the announcement of what those prices are at some point in the near future.
Jacob Martin Wiborg Rode: Thank you, Dave. Also thanks.
Jacob Martin Wiborg Rode: Thank you, Dave. Also thanks.
Speaker #3: Thank you Dave , and also thanks to you for an . Thank you . And let's move to to the next set of questions in line , please .
François-Xavier Béchon: Thank you.
François-Xavier Béchon: Thank you.
Jacob Martin Wiborg Rode: to you, François. Thank you. Let's move to the next set of questions in line, please.
Jacob Martin Wiborg Rode: to you, François. Thank you. Let's move to the next set of questions in line, please.
David Moore: Thank you. Your next question comes from the line of Martin Parkhøi from SEB. Please go ahead.
David Moore: Thank you. Your next question comes from the line of Martin Parkhøi from SEB. Please go ahead.
Speaker #2: Thank you. Your next question comes from the line of Martin Pourquoi from Seb. Please go ahead.
Martin Parkhøi: Yes, good afternoon, Martin Parkhøi, SEB. Two questions. I have to come a little bit back to the question at beginning from Carsten, because I think he was a little bit kind to you, Mike, with respect to market share loss. If you look at your old area IO and look at reported sales, then Eli Lilly have actually done a sprint. 2 years ago, you had a market share of 80% on all Q1 sales on reported numbers, and today, you are at 50%. Can you talk a little bit about, you know, what has gone not wrong for you, but what have they done right in IO to basically capture so much more share than you?
Martin Parkhøi: Yes, good afternoon, Martin Parkhøi, SEB. Two questions. I have to come a little bit back to the question at beginning from Carsten, because I think he was a little bit kind to you, Mike, with respect to market share loss. If you look at your old area IO and look at reported sales, then Eli Lilly have actually done a sprint. 2 years ago, you had a market share of 80% on all Q1 sales on reported numbers, and today, you are at 50%. Can you talk a little bit about, you know, what has gone not wrong for you, but what have they done right in IO to basically capture so much more share than you?
Speaker #12: Yes . Good afternoon , Martin Pichai took two questions . I have to come a little bit back to the question of getting from from Carsten , because I think he was a little kind to you , Mike .
Speaker #12: Respect to to to market share loss . Because if we look at the your old area , I o and look at reported sales , then then Lilly have actually done a sprint .
Speaker #12: They two two years ago you had a market share of 80% on all sales on reported numbers . And today a you are at 50% .
Speaker #12: So can you talk a little bit about , you know , what , what has gone not wrong for you , but what have they done right in I o to basically capture so much more share than than you .
Martin Parkhøi: Is it commercial execution in IO across the countries, or is just due to product superiority? Why can they sprint and you cannot? Second question is just on device strategy. A bit of a setback for Wegovy FlexTouch in US. You had argued for that to be an important part of flexibility in the consumer channel. One, are you going to 26? Are your device strategy overall also with respect to launch of products in vials and in which market would that be relevant?
Martin Parkhøi: Is it commercial execution in IO across the countries, or is just due to product superiority? Why can they sprint and you cannot? Second question is just on device strategy. A bit of a setback for Wegovy FlexTouch in US. You had argued for that to be an important part of flexibility in the consumer channel. One, are you going to 26? Are your device strategy overall also with respect to launch of products in vials and in which market would that be relevant?
Speaker #12: Is it commercial execution in IO across the countries, or is it just due to product superiority? Why can they sprint and you cannot?
Speaker #12: And then the second question is just on the on-device strategy. A bit of a setback for Wegovy Flextouch in the U.S.; you had argued for that to be an important part of flexibility in the consumer channel.
Speaker #12: What are you going to 26 are your device strategy overall also with respect to launch of products in vials and in which market would that be relevant ?
Jacob Martin Wiborg Rode: Thank you, Martin. On the first question on IO, I'll turn it over to you, Mike.
Jacob Martin Wiborg Rode: Thank you, Martin. On the first question on IO, I'll turn it over to you, Mike.
Speaker #3: Thank you . Martin , on the first question on IO , I'll turn it over to to you , Mike .
David Moore: Yes. Thanks very much. A couple of different ways to answer your question, Martin. There are markets that we are clearly competing well and gaining market share within IO, and there are markets that we are losing. It is market dynamics that dictates IO and averages sometimes cloud the picture. In certain markets, take China as an example, the market is not growing as much as we had anticipated. We have said it in the past, it's predominantly because we had never launched a previous version of obesity drugs in that market.
Mads Krogsgaard Thomsen: Yes. Thanks very much. A couple of different ways to answer your question, Martin. There are markets that we are clearly competing well and gaining market share within IO, and there are markets that we are losing. It is market dynamics that dictates IO and averages sometimes cloud the picture. In certain markets, take China as an example, the market is not growing as much as we had anticipated. We have said it in the past, it's predominantly because we had never launched a previous version of obesity drugs in that market.
Speaker #4: Yes, thanks very much. So, there are a couple of different ways to answer your question, Martin. There are markets that we are clearly competing well in and gaining market share within, and there are markets that we are losing.
Speaker #4: So, so, so it is market dynamics that dictate IO and averages, sometimes clouding the picture in certain markets. Take China as an example.
Speaker #4: The market is not growing as much as we had anticipated. We have said it in the past. It's predominantly because we had never launched a previous version of obesity drugs in that market.
David Moore: At the same time, we have seen in the same market that we're losing in the online battle to our competitor, predominantly because obesity drugs, so Wegovy is not allowed to be sold online, while if you have a mega brand, then it's a very different picture. That's, I would say, for China. If you take a look at some of the European markets, take UK as an example, we have seen how our share of growth over a period of one quarter has now bypassed on initiation our competitors numbers. This is a dynamic
Mads Krogsgaard Thomsen: At the same time, we have seen in the same market that we're losing in the online battle to our competitor, predominantly because obesity drugs, so Wegovy is not allowed to be sold online, while if you have a mega brand, then it's a very different picture. That's, I would say, for China. If you take a look at some of the European markets, take UK as an example, we have seen how our share of growth over a period of one quarter has now bypassed on initiation our competitors numbers. This is a dynamic
Speaker #4: At the same time , we have seen in the same market that we're losing in the online battle to to , to , to our competitor predominantly because obesity drugs .
Speaker #4: So Wegovy is not allowed to be sold online, while if you have a mega brand, then it's a very different picture.
Speaker #4: So so that's I would say for , for for China , if you take a look at some of the European markets , take UK as an example .
Speaker #4: We have seen how our share of growth over a period of one quarter has now bypassed on initiation . Our competitors numbers so , so , so this is a dynamic market that changes and and it is really to be seen on a longer horizon and not quarter by quarter .
Karsten Munk Knudsen: Market that changes, and it is really to be seen on a longer horizon and not quarter by quarter. We still have a patient base more than 2 times more than our competitor in international operations. The volume strategy and the future potential of international is still incredibly attractive for us. We came to this market with a very high level of market share, 100% on our own. Losing market share is something that we had anticipated, and as our competitor comes and as we go also into next year, it will not just be, you know, Eli Lilly, but also in some of the markets, other players as we lose LOE.
Karsten Munk Knudsen: Market that changes, and it is really to be seen on a longer horizon and not quarter by quarter. We still have a patient base more than 2 times more than our competitor in international operations. The volume strategy and the future potential of international is still incredibly attractive for us. We came to this market with a very high level of market share, 100% on our own. Losing market share is something that we had anticipated, and as our competitor comes and as we go also into next year, it will not just be, you know, Eli Lilly, but also in some of the markets, other players as we lose LOE.
Speaker #4: We still have a patient base more than two times larger than our competitor in international operations. The volume strategy and the future potential of international are still incredibly attractive for us.
Speaker #4: But we came to this market with a very high level of market share, 100% on our own. So, losing market share is something that we had anticipated.
Speaker #4: And as our competitor comes and as we go also into next year , it will not just be , you know , Eli Lilly , but also in some of the markets , other players , as we lose low .
Karsten Munk Knudsen: We have to look at this longer term, and when we do look at it longer term, I am incredibly optimistic for the volumes and the level of unmet need that exists in international operations.
Karsten Munk Knudsen: We have to look at this longer term, and when we do look at it longer term, I am incredibly optimistic for the volumes and the level of unmet need that exists in international operations.
Speaker #4: So, we have to look at this longer term. And when we do look at it longer term, I am incredibly optimistic for the volumes and the level of unmet need that exists in international operations.
Jacob Martin Wiborg Rode: Thank you, Mike, and let's move to Dave for the device question, please.
Jacob Martin Wiborg Rode: Thank you, Mike, and let's move to Dave for the device question, please.
Speaker #3: Thank you , Mike , and let's move to to Dave for , for for the device question , please .
David Moore: Thank you, Martin. Yes, as you mentioned, it's a setback to receive the CRL on Wegovy FlexTouch. Looking into 2026, we are looking at other presentations. This includes vials, it includes other devices that we're thinking about entering into the market, which would lead to more optionality, especially as we continue to grow in the cash channel as well. On the FlexTouch specifically, we are in active dialogue with FDA and working through the CRL, but can't comment on any specific timelines yet at this point.
David Moore: Thank you, Martin. Yes, as you mentioned, it's a setback to receive the CRL on Wegovy FlexTouch. Looking into 2026, we are looking at other presentations. This includes vials, it includes other devices that we're thinking about entering into the market, which would lead to more optionality, especially as we continue to grow in the cash channel as well. On the FlexTouch specifically, we are in active dialogue with FDA and working through the CRL, but can't comment on any specific timelines yet at this point.
Speaker #6: Thank you . Martin . Yes , as you mentioned , as a setback to receive the CRL and Wegovy Flextouch looking into 2026 , we are looking at other presentations .
Speaker #6: This includes vials. It includes other devices that we're thinking about entering into the market, which would lead to more optionality, especially as we continue to grow in the cash channel as well.
Speaker #6: On the FlexTouch specifically, we are in active dialogue with the FDA and are working through the CRL, but we can't comment on any specific timelines yet at this point.
Jacob Martin Wiborg Rode: Thank you, Dave. Thank you, Martin, for the set of two questions. Let's move to the next question, please.
Jacob Martin Wiborg Rode: Thank you, Dave. Thank you, Martin, for the set of two questions. Let's move to the next question, please.
Speaker #3: Thank you . Dave . Thank you Martin , for for the two questions and let's move to to the next question , please .
Operator: Thank you. Your next questions come from Sachin Jain, Bank of America. Please go ahead.
Operator: Thank you. Your next questions come from Sachin Jain, Bank of America. Please go ahead.
Speaker #2: Thank you. Your next question comes from Sachin Jain, Bank of America. Please go ahead.
Sachin Jain: Hi there. I have two questions please, one commercial, one financial. Commercial on Wegovy pill. Just wondering if you could talk about how your scenario planning around orforglipron on pricing, given some news overnight, given your API restriction ability, your ability to compete on price, and any further color you can give on launch cadence as we think about that launch. The second one for Karsten. I'm sure you're expecting the question, the last couple of years, you've given some high-level color on year forward. Just wonder if you'd be willing to just share moving parts as we think about 2026. A lot of factors there, growth in the bay, semi IO patterns, Akero, consensus sitting at roughly 7% sales, low teens EBIT, just any high-level thoughts. Thank you.
Sachin Jain: Hi there. I have two questions please, one commercial, one financial. Commercial on Wegovy pill. Just wondering if you could talk about how your scenario planning around orforglipron on pricing, given some news overnight, given your API restriction ability, your ability to compete on price, and any further color you can give on launch cadence as we think about that launch. The second one for Karsten. I'm sure you're expecting the question, the last couple of years, you've given some high-level color on year forward. Just wonder if you'd be willing to just share moving parts as we think about 2026. A lot of factors there, growth in the bay, semi IO patterns, Akero, consensus sitting at roughly 7% sales, low teens EBIT, just any high-level thoughts. Thank you.
Speaker #13: Hi . There . Two questions please . One commercial , one financial commercial on Wegovy pill . Just wondered if you could talk about how your scenario planning around orforglipron pricing given some news overnight and giving you an API restriction ability , your ability to compete on price and any further color you can give on launch cadence .
Speaker #13: As we think about that launch and the second one for Carsten, I'm sure you're expecting a question. However, the last couple of years you've given some high-level color on the year forward.
Speaker #13: Some, if you'd be willing to just share moving parts. As we think about Q3 2025, a lot of factors there in the base semi-open patents, Akira consensus sitting at roughly 7% sales, low teens EBIT.
Speaker #13: So just any high-level thoughts. Thank you.
Jacob Martin Wiborg Rode: Thank you, Sachin. The first question on oral semaglutide, let's go to you, Dave, in terms of preparedness. Of course, for competitive reasons, we cannot go into any details, but the high level picture, Dave.
Jacob Martin Wiborg Rode: Thank you, Sachin. The first question on oral semaglutide, let's go to you, Dave, in terms of preparedness. Of course, for competitive reasons, we cannot go into any details, but the high level picture, Dave.
Speaker #3: Thank you . Session . The first question on oral semi . Let's go to you . To you David . Preparedness of course for competitive reasons we cannot go into any details .
Speaker #3: But the high-level picture, Dave.
David Moore: Yeah. Thanks a lot, Sachin. We're incredibly excited as we move closer to the approval date of the Wegovy pill. I think this is a big step forward in terms of expanding the market and for those individuals that align better with taking a pill for their obesity. We can't comment on specific pricing, of course, but what I would say is we are going to have the Wegovy pill available in all channels. This is different from previous launches because we will have the ability to focus on Medicaid, Medicare, and commercial, but also have a cash offering available through all of our different telehealth partnerships, as well as our own NovoCare Pharmacy and the retail partnerships that we've aligned as well. This is a new way to launch for us. We're also thinking about the competitiveness.
David Moore: Yeah. Thanks a lot, Sachin. We're incredibly excited as we move closer to the approval date of the Wegovy pill. I think this is a big step forward in terms of expanding the market and for those individuals that align better with taking a pill for their obesity. We can't comment on specific pricing, of course, but what I would say is we are going to have the Wegovy pill available in all channels. This is different from previous launches because we will have the ability to focus on Medicaid, Medicare, and commercial, but also have a cash offering available through all of our different telehealth partnerships, as well as our own NovoCare Pharmacy and the retail partnerships that we've aligned as well. This is a new way to launch for us. We're also thinking about the competitiveness.
Speaker #6: Yeah, thanks a lot, Sachin. We're incredibly excited as we move closer to the approval date of the Wegovy pill. I think this is a big step forward in terms of expanding the market.
Speaker #6: And for those individuals that that align better with , with taking a pill for their obesity , we can't comment on specific pricing , of course , but what I would say is we are going to have the wegovy pill available in all channels .
Speaker #6: And this is different from previous launches because we will have the ability to focus on Medicaid, Medicare, and commercial. But we will also have a cash offering available through all of our different telehealth partnerships.
Speaker #6: As well as our own Novacare pharmacy and the retail partnerships that we've aligned as well. This is a new way to launch for us, and we're also thinking about the competitiveness.
David Moore: This is a competitive profile with respect to efficacy and tolerability, and we're really looking forward to bringing this to people living with obesity in the US.
David Moore: This is a competitive profile with respect to efficacy and tolerability, and we're really looking forward to bringing this to people living with obesity in the US.
Speaker #6: This is a competitive profile with respect to efficacy and tolerability, and we're really looking forward to bringing this to people living with obesity in the U.S.
Jacob Martin Wiborg Rode: Thank you, Dave. That's very clear. On the second question, we'll turn it to you, Carsten.
Jacob Martin Wiborg Rode: Thank you, Dave. That's very clear. On the second question, we'll turn it to you, Carsten.
Speaker #3: Thank you, Dave. That's very clear. Then on the second question, we'll turn it to you, Carsten.
Karsten Munk Knudsen: Thank you for that question, Sachin. I think you actually already captured some of the key elements going into your own question. The starting point is, we do not guide for next year today. We'll come back to guidance for next year at a later point in time as we normally do. What I can say is, as always, current momentum is the foundation for future trends in the business. Not saying everything continues, but current momentum is where we start. We have a few specific items worth calling out in relations to next year, next year's growth rates. One is, this year we have some growth to net variability.
Karsten Munk Knudsen: Thank you for that question, Sachin. I think you actually already captured some of the key elements going into your own question. The starting point is, we do not guide for next year today. We'll come back to guidance for next year at a later point in time as we normally do. What I can say is, as always, current momentum is the foundation for future trends in the business. Not saying everything continues, but current momentum is where we start. We have a few specific items worth calling out in relations to next year, next year's growth rates. One is, this year we have some growth to net variability.
Speaker #8: Yeah , thank you for that question , Sachin . And and I think you actually already captured some of the key elements going into your own question .
Speaker #8: So the starting point is we do not guide for next year. Today we'll come back to guidance for next year at a later point in time, as we normally do.
Speaker #8: What I can say is as always , current momentum is the foundation for for future trends in in the business . Not saying everything continues , but for current momentum is , is where we start .
Speaker #8: Then we have a few specific items worth calling out in relation to next year , next year's growth rates . One is this year we have some growth to net favourability .
Karsten Munk Knudsen: I would estimate it to around 2 percentage point on group sales growth this year that will not repeat into next year. That needs to be factored into growth rate. Loss of exclusivity in certain IO markets. We've been calling that out for quite some time, including in our release, that will have an estimated negative impact of low single digits on next year's sales growth on group sales. On sales, Dave was covering the Wegovy pill, which of course is our main launch into next year and upon regulatory approval by the FDA. The final discretionary factor to call out is Akero and the step up in R&D costs associated with that transaction pending closing, expected late this year.
Karsten Munk Knudsen: I would estimate it to around 2 percentage point on group sales growth this year that will not repeat into next year. That needs to be factored into growth rate. Loss of exclusivity in certain IO markets. We've been calling that out for quite some time, including in our release, that will have an estimated negative impact of low single digits on next year's sales growth on group sales. On sales, Dave was covering the Wegovy pill, which of course is our main launch into next year and upon regulatory approval by the FDA. The final discretionary factor to call out is Akero and the step up in R&D costs associated with that transaction pending closing, expected late this year.
Speaker #8: I would estimate it to be around two percentage points on group sales growth this year. That will not repeat into next year.
Speaker #8: So so that needs to be factored into growth rate . Then a loss of exclusivity in certain I markets . We've been calling that out for quite some time , including in our in our release that will have a estimated negative impact of low single digits on on next year's sales growth on group sales , then on sales .
Speaker #8: Dave was covering the Wegovy pill , which of course is is our main launch into next year . And upon regulatory approval by by the FDA and then the final discretionary factor to call out is , is a Cairo and and the step up in R&D costs associated with that transaction pending closing expected late this year that will have a 3% negative impact on operating profit growth in 2026 .
Karsten Munk Knudsen: That will have a 3% negative impact on operating profit growth in 2026.
Karsten Munk Knudsen: That will have a 3% negative impact on operating profit growth in 2026.
Jacob Martin Wiborg Rode: Thank you, Carsten, thank you to you, Sachin, for those two questions. Now let's move to the next one in line and those set of questions, please.
Jacob Martin Wiborg Rode: Thank you, Carsten, thank you to you, Sachin, for those two questions. Now let's move to the next one in line and those set of questions, please.
Speaker #3: Thank you , Carsten , and thank you to you , Sachin , for for those two questions . Now let's move to to the next one in line .
Speaker #3: And those are the questions. Please.
Operator: Thank you. Your next question comes from the line of Michael Nedelcovych from TD Cowen. Please go ahead.
Operator: Thank you. Your next question comes from the line of Michael Nedelcovych from TD Cowen. Please go ahead.
Speaker #2: Thank you. Your next question is from the line of Mike Nedeljkovic from TD Cowen. Please go ahead.
Michael Nedelcovych: Hi. Thank you for the questions. I have 2. My first is actually a follow-up on Metsera. Martin, can you articulate what specifically about the Metsera agent is differentiated from Novo's own pipeline candidates other than the potential for once monthly dosing? In response to the previous question, you restated that Metsera is differentiated and complementary, but I'm wondering what public data lead you to that conclusion, or if those data are not public, can you confirm that? That's my first question. My second question is on the EVOKE trials. We are now less than 1 month away from the CTAD presentation, so I'm assuming that Novo has the data in-house and is simply cleaning them up before top line release ahead of the presentation. My question is, if it is an unequivocally negative result, would Novo cancel its CTAD presentation? Thank you.
Michael Nedelcovych: Hi. Thank you for the questions. I have 2. My first is actually a follow-up on Metsera. Martin, can you articulate what specifically about the Metsera agent is differentiated from Novo's own pipeline candidates other than the potential for once monthly dosing? In response to the previous question, you restated that Metsera is differentiated and complementary, but I'm wondering what public data lead you to that conclusion, or if those data are not public, can you confirm that? That's my first question. My second question is on the EVOKE trials. We are now less than 1 month away from the CTAD presentation, so I'm assuming that Novo has the data in-house and is simply cleaning them up before top line release ahead of the presentation. My question is, if it is an unequivocally negative result, would Novo cancel its CTAD presentation? Thank you.
Speaker #14: Hi . Thank you for the questions . I have two . My first is actually a follow up on Meztira Martin can you articulate what specifically about the Meztira agents is differentiated from Novo's own pipeline candidates ?
Speaker #14: Other than the potential for once monthly dosing in response to the previous question , you restated that Meztira is differentiated and complementary , but I'm wondering what public data lead you to that conclusion , or if those data are not public , could you confirm that ?
Speaker #14: So that's my first question. And then my second question is on the EVOKE trials. We are now less than a month away from the CTAD presentation.
Speaker #14: So I'm assuming that Novo has the data in-house and is simply cleaning them up before the release ahead of the presentation. So my question is, if it is an unequivocally negative result, would Novo cancel its CTAD presentation?
Speaker #14: Thank you .
Jacob Martin Wiborg Rode: Thank you, Mike, for those two questions. Let's start with the first one on revisiting the Metsera and the view and differentiation from your side, Martin.
Jacob Martin Wiborg Rode: Thank you, Mike, for those two questions. Let's start with the first one on revisiting the Metsera and the view and differentiation from your side, Martin.
Speaker #3: Thank you Mike , for those two questions . Now let's start with the first one on revisiting the Matsuura interview on differentiation from your from your side , Martin .
Martin Holst Lange: Yeah. Thank you very much for the question. I don't wanna go into specifics, but maybe just iterate what we're looking at when we look for complementarity to our pipeline. It's data on efficacy, and those can be differentiated at many levels. It's data on safety and tolerability, a little bit of the same consideration. It's scalability, and then obviously in this case, the dosing frequency. We on more than one parameter see complementarity to our pipeline, and therefore this is an attractive proposition for us. On EVOKE, I do wanna iterate, we do not know the data in-house, and in this room. If we did, we would actually have to issue a corporate announcement immediately. no knowledge amongst any of us in this room.
Martin Holst Lange: Yeah. Thank you very much for the question. I don't wanna go into specifics, but maybe just iterate what we're looking at when we look for complementarity to our pipeline. It's data on efficacy, and those can be differentiated at many levels. It's data on safety and tolerability, a little bit of the same consideration. It's scalability, and then obviously in this case, the dosing frequency. We on more than one parameter see complementarity to our pipeline, and therefore this is an attractive proposition for us. On EVOKE, I do wanna iterate, we do not know the data in-house, and in this room. If we did, we would actually have to issue a corporate announcement immediately. no knowledge amongst any of us in this room.
Speaker #7: Yeah, thank you very much for the question. I don't want to go into specifics, but maybe just iterate what we're looking at when we look for complementarity to our pipeline.
Speaker #7: It's data on efficacy . And those can be differentiated . And at many levels it's data on safety and tolerability . A little bit of the same consideration .
Speaker #7: It's scalability. And then, obviously in this case, the dose and frequency, we see complementarity to our pipeline in more than one parameter.
Speaker #7: And therefore this is an executive proposition for us on evoke . I do want to iterate . We do not know the data in-house and in this room , if we did , we would actually have to issue a corporate announcement immediately .
Speaker #7: So so no knowledge amongst any of us in this room . Our starting point is to disclose data , good or bad . So so so we currently aim to present whatever data that we will have at at the in the beginning of December .
Martin Holst Lange: Our starting point is to disclose data, good or bad. We currently aim to present whatever data that we will have at CTAD in the beginning of December.
Martin Holst Lange: Our starting point is to disclose data, good or bad. We currently aim to present whatever data that we will have at CTAD in the beginning of December.
Jacob Martin Wiborg Rode: Thanks, Martin. That's very clear. Also thank you to you, Mike, for, yeah, for both of those questions. Now let's move to next question, please.
Jacob Martin Wiborg Rode: Thanks, Martin. That's very clear. Also thank you to you, Mike, for, yeah, for both of those questions. Now let's move to next question, please.
Speaker #3: Thanks , Martin . That's very clear . And also thank you to you , Mike , for for both of those questions . Now let's move to to next question please .
Operator: Thank you. Your next question comes from Harry Sephton from UBS. Please go ahead.
Operator: Thank you. Your next question comes from Harry Sephton from UBS. Please go ahead.
Speaker #2: Thank you. Your next question comes from Harry Sefton from UBS. Please go ahead.
Harry Sephton: Brilliant. Thank you very much for taking my questions. Two on the US please. Just in light of the agreed IRA direct negotiation discounts on semaglutide, and also some of the press reports yesterday on potential obesity Medicare coverage, I don't want you to comment directly, but it appears you'll end up with significantly different prices for your products across different channels. I wanted to get your thoughts of how you expect that you're able to maintain this segmented pricing by channel, or should we assume that all prices gradually trend towards the lowest level? The second one on the US, just on the current US market trends, can you discuss how you're currently thinking about the levers to improve access and commercial insurance coverage on Wegovy and Ozempic, going into next year?
Harry Sephton: Brilliant. Thank you very much for taking my questions. Two on the US please. Just in light of the agreed IRA direct negotiation discounts on semaglutide, and also some of the press reports yesterday on potential obesity Medicare coverage, I don't want you to comment directly, but it appears you'll end up with significantly different prices for your products across different channels. I wanted to get your thoughts of how you expect that you're able to maintain this segmented pricing by channel, or should we assume that all prices gradually trend towards the lowest level? The second one on the US, just on the current US market trends, can you discuss how you're currently thinking about the levers to improve access and commercial insurance coverage on Wegovy and Ozempic, going into next year?
Speaker #15: Brilliant . Thank you very much for taking my questions . Two on the US , please . So just in light of the agreed IRA direct negotiation discounts on semaglutide and also some of the press reports yesterday on potential obesity , Medicare coverage , I don't want you to comment directly , but it appears you'll end up with significantly different prices for your products across different channels .
Speaker #15: So, I wanted to get your thoughts on how you expect that you're able to maintain this segmented pricing by channel, or should we assume that all prices gradually trend towards the lowest level?
Speaker #15: And then the second one on the U.S., just on the current U.S. market trends, can you discuss how you're currently thinking about the levers to improve access and commercial insurance coverage on Wegovy and Ozempic?
Speaker #15: Going into next year, do you expect that the majority of 2026 U.S. growth is really going to come from the launch of the pill?
Harry Sephton: Do you expect that the majority of 2026 US growth is really gonna come from the launch of the Wegovy pill? Thank you.
Harry Sephton: Do you expect that the majority of 2026 US growth is really gonna come from the launch of the Wegovy pill? Thank you.
Speaker #15: Thank you .
Jacob Martin Wiborg Rode: Thank you, Harry. No, the two questions here, I'll send both to you, Dave. The first one on the pricing dynamics then subsequently on the current access picture. Over to you, Dave.
Jacob Martin Wiborg Rode: Thank you, Harry. No, the two questions here, I'll send both to you, Dave. The first one on the pricing dynamics then subsequently on the current access picture. Over to you, Dave.
Speaker #3: Thank you . Harry . Know the two questions here ? I'll send both to you . Dave . The first one on the on the pricing dynamics .
Speaker #3: And then subsequently on the current access picture. Over to you, Dave.
David Moore: Yeah. Thank you much. As we mentioned, we can't discuss any of the specifics around IRA or MFN. We do appreciate the question and the fact that historically we have been able to maintain different prices in different channels. Given that be Medicaid, Medicare, or commercial. Now, you know, our increasingly expanding cash channel. Of course, we can't speculate, you know, what that will mean in the future. Historically we have been able to maintain the differentiation between those markets and the access that comes with it. To your second question, around the trends in terms of the quality of access, it's something that continues to be really important for us, as sometimes receiving an obesity medication can be a challenge because of the friction that exists in the marketplace.
David Moore: Yeah. Thank you much. As we mentioned, we can't discuss any of the specifics around IRA or MFN. We do appreciate the question and the fact that historically we have been able to maintain different prices in different channels. Given that be Medicaid, Medicare, or commercial. Now, you know, our increasingly expanding cash channel. Of course, we can't speculate, you know, what that will mean in the future. Historically we have been able to maintain the differentiation between those markets and the access that comes with it. To your second question, around the trends in terms of the quality of access, it's something that continues to be really important for us, as sometimes receiving an obesity medication can be a challenge because of the friction that exists in the marketplace.
Speaker #6: Yeah , thank you much . As we mentioned , we can't discuss any of the specifics around IRA or MFN , but we do appreciate the question and the fact that historically , we have been able to maintain different prices in different channels , give it given that B Medicaid , Medicare or commercial .
Speaker #6: And now , you know , our increasingly expanding cash channel , of course , we can't speculate . You know what that will mean in the future .
Speaker #6: But historically , we have been able to maintain a differentiation between those markets and the access that comes with it . Your second question around the trends in terms of the quality of access , it's something that continues to be really important for us as sometimes receiving an obesity medication can be a challenge because of the friction that exists in the marketplace .
David Moore: We are continuing to push for and invest in improved access. It's a clear priority for us. This includes both our cash offerings. It's also what we do with payers. You know, we haven't seen a large uptake yet in terms of that opportunity, but it's something that we're gonna continue to push for in 2026, access. We don't really expect the access to be largely changed in 2026, but we do know that each of the payers or Medicaid, as we mentioned earlier, you know, have budget constraints, and there could potentially be some loss of coverage as well.
David Moore: We are continuing to push for and invest in improved access. It's a clear priority for us. This includes both our cash offerings. It's also what we do with payers. You know, we haven't seen a large uptake yet in terms of that opportunity, but it's something that we're gonna continue to push for in 2026, access. We don't really expect the access to be largely changed in 2026, but we do know that each of the payers or Medicaid, as we mentioned earlier, you know, have budget constraints, and there could potentially be some loss of coverage as well.
Speaker #6: So we are continuing to push for and and invest in improved access . It's a clear priority for us . This includes both our cash offerings .
Speaker #6: It's also what we do with with payers . But you know , we haven't seen a large uptake yet in terms of that opportunity .
Speaker #6: But it's something that we're going to continue to push for in 2026 . Access . We don't really expect the access to be largely changed in 2026 , but we do know that each of the payers or Medicaid , as we mentioned earlier , you know , have budget constraints and there could potentially be some some loss of coverage as well .
Jacob Martin Wiborg Rode: Thank you, James. Thank you, Dave, for those two, and also thanks to you, Harry. Let's move to the next question, please.
Jacob Martin Wiborg Rode: Thank you, James. Thank you, Dave, for those two, and also thanks to you, Harry. Let's move to the next question, please.
Speaker #3: Thank you . James . Thank you , Dave , for those two . And also thanks to you to you Harry . Let's move to the next question , please .
Operator: Thank you. Your next question comes from Emmanuel Papadakis from Deutsche Bank. Please go ahead.
Operator: Thank you. Your next question comes from Emmanuel Papadakis from Deutsche Bank. Please go ahead.
Speaker #2: Thank you . Your next question comes from Emmanuel Papadakis from Deutsche Bank . Please go ahead .
Martin Holst Lange: Yeah, thanks. A few follow-ups, perhaps. Maybe taking a step back on US commercial channel trends in obesity. Excuse the background noise. Wegovy scripts are pretty much flat since July, despite the MASH launch. Even Zepbound has seen most of the growth coming from the cash channel. Talk us through what you think the obstacles actually are to better penetration in that commercial channel. Is it on the demand side due to product profile?
Emmanuel Papadakis: Yeah, thanks. A few follow-ups, perhaps. Maybe taking a step back on US commercial channel trends in obesity. Excuse the background noise. Wegovy scripts are pretty much flat since July, despite the MASH launch. Even Zepbound has seen most of the growth coming from the cash channel. Talk us through what you think the obstacles actually are to better penetration in that commercial channel. Is it on the demand side due to product profile?
Speaker #16: Yeah . Thanks . You follow ups . Perhaps maybe taking a step back on us commercial channel trends in obesity . Excuse the background noise .
Speaker #16: With scripts are pretty much flat since July . Despite the mass launch , even Zepbound has seen most of the growth coming from the cash channel .
Speaker #16: So talk us through what you think the obstacles actually are to better penetration in that commercial channel . Is it on the demand side due to product profile , lack of demand beyond a motivated minority , or is the barrier really on the access side ?
Emmanuel Papadakis: Lack of demand beyond the motivated minority, or is the barrier really on the access side? For example, as you referenced, potential insurance companies making it difficult for patients to actually get on or remain on therapy. Maybe a follow-up on Metsera, the deal structure and the risk associated with that. Can you just help us understand your comfort with the risk around the way you are structuring your offer? Seems there's a reasonable chance you could end up with 50% of company you don't control, to little ultimate benefit except preventing someone else from owning them. Why are you comfortable with that possibility, or how do you expect to avoid it? Then just a quick clarification on the Medicare access discussions. What would the upper limited discount you're contemplating be?
Emmanuel Papadakis: Lack of demand beyond the motivated minority, or is the barrier really on the access side? For example, as you referenced, potential insurance companies making it difficult for patients to actually get on or remain on therapy. Maybe a follow-up on Metsera, the deal structure and the risk associated with that. Can you just help us understand your comfort with the risk around the way you are structuring your offer? Seems there's a reasonable chance you could end up with 50% of company you don't control, to little ultimate benefit except preventing someone else from owning them. Why are you comfortable with that possibility, or how do you expect to avoid it? Then just a quick clarification on the Medicare access discussions. What would the upper limited discount you're contemplating be?
Speaker #16: For example , as you referenced , potential insurance companies making it difficult for patients to actually get on or remain on therapy ? Maybe a follow up on Meztira the deal structure and the risk associated with that .
Speaker #16: Can you just help us understand your comfort with the risk around the way you are structuring your offer ? Seems as a reasonable chance you could end up with 50% of the company .
Speaker #16: You don't control . The little ultimate benefit preventing someone else from owning them . So why are you comfortable with that possibility ? Or how do you expect to avoid it ?
Speaker #16: And then just a quick clarification on Medicare access discussions . What what would the upper limit of discount your contemplating be ? Would that be in line with the MFP , or this would be something in addition to that ?
Emmanuel Papadakis: Would that be in line with the MSP or this would be something in addition to that? Thank you.
Emmanuel Papadakis: Would that be in line with the MSP or this would be something in addition to that? Thank you.
Speaker #16: Thank you .
Jacob Martin Wiborg Rode: Thank you, Emmanuel. I noted two questions there. On the first one on the go prescriptions, I'll turn it to you, Dave. On the second one afterwards, on the deal structure, I'll turn to you, Ludovic. First, over to you, Dave.
Jacob Martin Wiborg Rode: Thank you, Emmanuel. I noted two questions there. On the first one on the go prescriptions, I'll turn it to you, Dave. On the second one afterwards, on the deal structure, I'll turn to you, Ludovic. First, over to you, Dave.
Speaker #3: Thank you Emmanuel . I noted I noted two questions there . On the first one on the prescriptions . I'll turn it to to you , Dave .
Speaker #3: And on the second one afterwards on the deal structure , I'll turn to you , Ludovic . But first , over to you , David .
David Moore: Yeah. Thank you, Emmanuel. As we mentioned earlier, the quality of access remains a focus point and certainly a challenge in the reverse and the reimbursed channel. Of course, we've got that combined with intense competition. We also mentioned that the compounding is continuing to increase as well. That focus and investment in the quality of access, we do think is an important factor with respect to expanding the market. In addition, you'll continue to see our efforts in expanding the cash channel through more partnerships and certainly having our product offerings available in that channel as well.
David Moore: Yeah. Thank you, Emmanuel. As we mentioned earlier, the quality of access remains a focus point and certainly a challenge in the reverse and the reimbursed channel. Of course, we've got that combined with intense competition. We also mentioned that the compounding is continuing to increase as well. That focus and investment in the quality of access, we do think is an important factor with respect to expanding the market. In addition, you'll continue to see our efforts in expanding the cash channel through more partnerships and certainly having our product offerings available in that channel as well.
Speaker #6: Yeah . Thank you . Manuel . As we as we mentioned earlier , the quality of access remains a focus point . And certainly a challenge in the reverse in the reimburse channel .
Speaker #6: Of course , we've got that combined with intense competition , and we also mentioned that that compounding is continuing to increase as well .
Speaker #6: So that that focus and investment in the quality of access , we do think is an important factor with respect to expanding the market .
Speaker #6: And in addition , you'll continue to see our efforts in expanding the cash channel through more partnerships . And and certainly having our product offerings available in that channel as well .
Jacob Martin Wiborg Rode: Thank you. Now I hand over to you, Ludovic.
Jacob Martin Wiborg Rode: Thank you. Now I hand over to you, Ludovic.
Speaker #3: Thank you . And now I'll hand over to you .
Ludovic Helfgott: Yep. Thanks. Thanks for the question, Emmanuel. Well, I think everything stems from, I guess, what you feel as an excitement for the portfolio of Metsera. We really believe in the assets, we believe in the team, and we believe that the deal structure that we have now, which by the way, as Karsten said, has been vetted and discussed with external counsels and experts and believe that it's in line with all legal standards, boils down to the quality of the asset and the confidence we have in the data that we have.
Ludovic Helfgott: Yep. Thanks. Thanks for the question, Emmanuel. Well, I think everything stems from, I guess, what you feel as an excitement for the portfolio of Metsera. We really believe in the assets, we believe in the team, and we believe that the deal structure that we have now, which by the way, as Karsten said, has been vetted and discussed with external counsels and experts and believe that it's in line with all legal standards, boils down to the quality of the asset and the confidence we have in the data that we have.
Speaker #5: Yep . Thanks . Thanks . Thanks for the question , Emmanuel . Well , I think everything's stems from , I guess , what you feel as an excitement for the portfolio of , of of Meztira .
Speaker #5: We've really believe in the assets . We believe in the team and we believe that the deal structure that we have now , which , by the way , as Carson said , has been vetted and discussed with with external councils and experts and believe that it's in line with all legal standards boils down to the quality of the asset and the data that we and the confidence we have in the data that we that we have .
Ludovic Helfgott: Of course, we know when you get into such acquisition that this deal will be reviewed, but we're comfortable that even the 50% of the shares that we would have in our pocket would be actually worth a lot if the product pans out to be the way we think it is. Products with an S, by the way, because as you said, Martin, it's a combination of products. In all cases, as it boils down to science, we believe that we have a good value proposition. Of course, we'd prefer at the end to have that in our portfolio from an operational perspective, but the value there, we believe, is really, really high in all scenarios.
Ludovic Helfgott: Of course, we know when you get into such acquisition that this deal will be reviewed, but we're comfortable that even the 50% of the shares that we would have in our pocket would be actually worth a lot if the product pans out to be the way we think it is. Products with an S, by the way, because as you said, Martin, it's a combination of products. In all cases, as it boils down to science, we believe that we have a good value proposition. Of course, we'd prefer at the end to have that in our portfolio from an operational perspective, but the value there, we believe, is really, really high in all scenarios.
Speaker #5: So of course , we know when you get into such acquisition that this deal will be reviewed , but we're comfortable that even the 50% of the shares that we would have in our pocket would be actually worth a lot if the product pans out to be the way we think it is , products with an S , by the way , because as you said , Martin , it's a combination of products .
Speaker #5: So in all cases , and it boils down to science , we believe that we have a good value proposition . Of course , we would prefer at the end to have that in our portfolio .
Speaker #5: From an operational perspective . But the value there , we believe is really , really high in all scenarios .
Jacob Martin Wiborg Rode: Thank you, Ludovic. Now let's turn to the last two questions. For the second last question, please go ahead, operator.
Jacob Martin Wiborg Rode: Thank you, Ludovic. Now let's turn to the last two questions. For the second last question, please go ahead, operator.
Speaker #3: Thank you . Ludovic . And now let's turn to the last two questions for the second last question . Please go ahead . Operator .
Operator: Thank you. The question comes from the line of Richard Vosser from JP Morgan.
Operator: Thank you. The question comes from the line of Richard Vosser from JP Morgan.
Speaker #2: Thank you . The question comes from the line of Richard Fossa from JP Morgan .
Richard Vosser: Hi. Thanks for taking my questions. First question, Mike, you alluded to more telehealth involvement, particularly in the US. I think prior arrangements, particularly with HIMSS, have faced challenges, given they continued to bulk compound. There's been some discussion around continuing or new agreements with HIMSS, but also the wider involvement of the telehealth. I wondered what was different this time and whether there's any evidence of any increased pressure around from the FDA or legal pressure to remove the compounders and what could change on that front. The second question, you mentioned a couple of times about coverage, maybe even getting a little bit worse in Medicaid, and maybe even the commercial payers, the barriers staying high.
Richard Vosser: Hi. Thanks for taking my questions. First question, Mike, you alluded to more telehealth involvement, particularly in the US. I think prior arrangements, particularly with HIMSS, have faced challenges, given they continued to bulk compound. There's been some discussion around continuing or new agreements with HIMSS, but also the wider involvement of the telehealth. I wondered what was different this time and whether there's any evidence of any increased pressure around from the FDA or legal pressure to remove the compounders and what could change on that front. The second question, you mentioned a couple of times about coverage, maybe even getting a little bit worse in Medicaid, and maybe even the commercial payers, the barriers staying high.
Speaker #17: Hi . Thanks for taking my questions . First question , might you alluded to more telehealth involvement , particularly in the US ? I think prior arrangements , particularly with Hims , of face challenges , given they continued to bulk compound .
Speaker #17: So there's been some discussion around continuing or new agreements with Hims , but also the wider involvement of the telehealth . So I wondered what was different this time and whether there's any evidence of any increased pressure from the FDA or legal pressure to remove the compound as and and what could change on that front ?
Speaker #17: And then the second question , just you mentioned a couple of times about coverage , maybe even getting a little bit worse in Medicaid and maybe even the the commercial payers , the barriers staying high .
Richard Vosser: Well, in that case, you know, how should we think about the pricing? Normally, we think about increased, you know, rebate levels and increased pricing should remove barriers to get more reimbursement. How should we think about that going into 2026? Thanks very much.
Richard Vosser: Well, in that case, you know, how should we think about the pricing? Normally, we think about increased, you know, rebate levels and increased pricing should remove barriers to get more reimbursement. How should we think about that going into 2026? Thanks very much.
Speaker #17: Well , in that case , you know , how should we think about the pricing ? Normally we we think about increased , you know , rebate levels and increased pricing .
Speaker #17: Should remove barriers to get more reimbursement . So , so . So how how should we think about that going into 2026 . Thanks very much .
Jacob Martin Wiborg Rode: Thanks a lot, Richard. On the first one, I'll turn to you, Mike, on the sales.
Jacob Martin Wiborg Rode: Thanks a lot, Richard. On the first one, I'll turn to you, Mike, on the sales.
Speaker #3: Thanks a lot Richard . On the first one I'll turn to to you , Mike . And telehealth .
David Moore: Yes. A couple of comments on that, Richard. There's been no increased pressure to answer your question directly. What we have been quite consistent with regards to the illicit API that is coming from China and being used by compounders, we find since these are not FDA approved, their safety is questionable. As a pharma company, we don't basically like that. That hasn't changed at all. We also have been saying that we need to increase our access, and we need to find ways to get to many more patients. The cash channel and eHealth is definitely an attractive way to go about it.
Mads Krogsgaard Thomsen: Yes. A couple of comments on that, Richard. There's been no increased pressure to answer your question directly. What we have been quite consistent with regards to the illicit API that is coming from China and being used by compounders, we find since these are not FDA approved, their safety is questionable. As a pharma company, we don't basically like that. That hasn't changed at all. We also have been saying that we need to increase our access, and we need to find ways to get to many more patients. The cash channel and eHealth is definitely an attractive way to go about it.
Speaker #4: Yes .
Speaker #7: .
Speaker #4: A couple of comments on that . Richard , have been no increased pressure to answer your question directly , but what we have been quite consistent with regards to the illicit API , that is coming from China and being used by Compounders , we find , since these are not FDA approved , their safety is questionable .
Speaker #4: And as a pharma company , we don't basically like that . That hasn't changed at all . We also have been saying that we need to increase our access , and we need to find ways to get to many more patients .
Speaker #4: The cash channel and e-health is definitely an attractive way to , to , to , to to go about it in that context , we're having dialogue and discussions with multiple players on how we could actually increase our our access .
David Moore: In that context, we're having dialogue and discussions with multiple players on how we could actually increase our access, and then we will see with who we should go into partnership. We've made a number of those partnerships available. We talked about Costco, we have talked about eMed, we have talked about Walmart, and ongoing dialogues with many more are ongoing in pursue of our market expansion that I spoke to earlier on.
Mads Krogsgaard Thomsen: In that context, we're having dialogue and discussions with multiple players on how we could actually increase our access, and then we will see with who we should go into partnership. We've made a number of those partnerships available. We talked about Costco, we have talked about eMed, we have talked about Walmart, and ongoing dialogues with many more are ongoing in pursue of our market expansion that I spoke to earlier on.
Speaker #4: And then we will see with who we should go into partnership . We've made a number of those partnerships available , so we talked about Costco .
Speaker #4: We have talked about Imet . We have talked about Walmart and and ongoing dialogues with many , many more are ongoing in pursuit of our market expansion that I spoke to earlier on .
Jacob Martin Wiborg Rode: Thank you, Mike. That's clear. For the second one, let's move to you again, Dave, please.
Jacob Martin Wiborg Rode: Thank you, Mike. That's clear. For the second one, let's move to you again, Dave, please.
Speaker #3: Thank you . Mike . That's clear . And for the second one , let's move to to you again , Dave , please .
Ludovic Helfgott: Yeah. Thanks very much, Richard. We continue to have dynamics that we've discussed in the past, continued pressure both in GLP-1 as well as in obesity, with respect to price as we look to unlock more volumes. I do wanna reiterate that the quality of access is a clear priority for us. We are working with payers to make sure that the experience is one that patients are able to receive their medicine more seamlessly. You know, that means lower utilization management, right? That means less of a prior authorization criteria. When we say we're investing in quality of access, that's really what we mean, and that's the focus conversation that we're having with payers. In 2026, we don't really expect a large difference in terms of access in the commercial channel.
David Moore: Yeah. Thanks very much, Richard. We continue to have dynamics that we've discussed in the past, continued pressure both in GLP-1 as well as in obesity, with respect to price as we look to unlock more volumes. I do wanna reiterate that the quality of access is a clear priority for us. We are working with payers to make sure that the experience is one that patients are able to receive their medicine more seamlessly. You know, that means lower utilization management, right? That means less of a prior authorization criteria. When we say we're investing in quality of access, that's really what we mean, and that's the focus conversation that we're having with payers. In 2026, we don't really expect a large difference in terms of access in the commercial channel.
Speaker #6: Yeah . Thank thanks very much , Richard . We continue to have dynamics that we've discussed in the past , continued pressure , both in GLP one as well as in obesity with respect to price .
Speaker #6: As we look to unlock more volumes . But I think it's I do want to reiterate that the quality of access is a clear priority for us .
Speaker #6: We're working with payers to to make sure that the experience is one that patients are able to receive their medicine more seamlessly . You know , that means lower utilization management , right ?
Speaker #6: That means less of a prior authorization criteria . When we say we're investing in quality of access , that's really what we mean .
Speaker #6: And that's the focus conversation that we're having with payers in 2026 . We we don't really expect a large difference in terms of access in the commercial channel .
Ludovic Helfgott: As we mentioned, there may be some in Medicaid. When we look at the commercial opportunity, you know, I think it is important to note that we have been making progress in terms of the access. We continue to believe that the CVS opportunity remains there, and that will, we will see Wegovy as the exclusive branded AOM at CVS in 2026 as well.
Ludovic Helfgott: As we mentioned, there may be some in Medicaid. When we look at the commercial opportunity, you know, I think it is important to note that we have been making progress in terms of the access. We continue to believe that the CVS opportunity remains there, and that will, we will see Wegovy as the exclusive branded AOM at CVS in 2026 as well.
Speaker #6: As we mentioned , there may be some in Medicaid , but when we when we look at the commercial opportunity , you know , I think it is important to note that we have been making progress in terms of the access we continue to believe that the CVS opportunity remains there , and that will we will see Wegovy as the exclusive branded A.o.m at CVS in 2026 as well .
Jacob Martin Wiborg Rode: Thanks a lot, Dave. That's clear. Let's move to the final question before I hand over to you, Mike, for closing. Final question, please.
Jacob Martin Wiborg Rode: Thanks a lot, Dave. That's clear. Let's move to the final question before I hand over to you, Mike, for closing. Final question, please.
Speaker #3: Thanks a lot , Dave . That's clear . And let's move to the to the final question before I hand over to you , Mike , for closing .
Speaker #3: So final question , please .
Operator: Thank you. Your final question today comes from the line of James Quigley from Goldman Sachs. Please go ahead.
Operator: Thank you. Your final question today comes from the line of James Quigley from Goldman Sachs. Please go ahead.
Speaker #2: Thank you . Your final question today comes from the line of James Quigley from Goldman Sachs . Please go ahead .
James Quigley: Great. Thank you for taking my questions. I've got two left, please. Firstly, on REDEFINE 4, how important is this into demonstrating differentiation from a physician and a marketing perspective versus Zepbound? Have you thought any more about how that Zepbound could behave in a flexible dosing scenario versus other trials and real world data? Can you confirm that you still look to launch
James Quigley: Great. Thank you for taking my questions. I've got two left, please. Firstly, on REDEFINE 4, how important is this into demonstrating differentiation from a physician and a marketing perspective versus Zepbound? Have you thought any more about how that Zepbound could behave in a flexible dosing scenario versus other trials and real world data? Can you confirm that you still look to launch
Speaker #18: Great . Thanks for taking my questions . I've got two left , please . So firstly , on redefined for how important is this in terms of demonstrating differentiation from a physician and a marketing perspective of Zepbound .
Speaker #18: Have you thought any more about how Zepbound could behave in a flexible dosing scenario versus other trials and real world data , and can you confirm that you still look to launch Cagrisema if redefined for shows ?
Ludovic Helfgott: Thanks, James. That's 2, 1 on REDEFINE 4 and 1 on the oral sema in IO. On the REDEFINE 1, I'll turn to you first, Martin.
Ludovic Helfgott: Thanks, James. That's 2, 1 on REDEFINE 4 and 1 on the oral sema in IO. On the REDEFINE 1, I'll turn to you first, Martin.
Speaker #18: No statistically significant difference . And second of all , can you talk through the launch preparations for oral wegovy in US ? You highlighted in the release and in the comments that you might you could look to launch in select .
Speaker #18: IO countries versus previously when it was likely to be mainly or focused on the US . So what's happened such that you consider also launching in in the US ?
Speaker #18: And how do you balance this with the US launch processes and pricing , etc. as we head into an MFN world ? Thank you .
Speaker #3: Thanks , James . That's two one and redefine four and one on the oral in in IO . But on the redefined one , I'll turn to you first , Martin .
Martin Holst Lange: Yeah. REDEFINE 4. As you well know, we've taken some learnings from REDEFINE 1, more specifically that we needed to do a number study. We amended the REDEFINE 4 study. That being said, our base case has always been non-inferiority with an upside of superiority. In the case of non-inferiority on weight loss, we still see a potential for upside on gastrointestinal side effects and tolerability. Also, we do believe that the CV benefits that we know from semaglutide could also potentially pan out and will read out from REDEFINE 3, thus clearly differentiate CagriSema vis-à-vis potential competitors. I do wanna iterate there is still the potential for a superiority upside, obviously in an amended study that should be taken with a little bit of a risk.
Martin Holst Lange: Yeah. REDEFINE 4. As you well know, we've taken some learnings from REDEFINE 1, more specifically that we needed to do a number study. We amended the REDEFINE 4 study. That being said, our base case has always been non-inferiority with an upside of superiority. In the case of non-inferiority on weight loss, we still see a potential for upside on gastrointestinal side effects and tolerability. Also, we do believe that the CV benefits that we know from semaglutide could also potentially pan out and will read out from REDEFINE 3, thus clearly differentiate CagriSema vis-à-vis potential competitors. I do wanna iterate there is still the potential for a superiority upside, obviously in an amended study that should be taken with a little bit of a risk.
Speaker #7: Yeah . Redefine for as you well know , we've taken some learnings from redefine one more specifically that we needed to do a longer study .
Speaker #7: So we amended the redefine four study . That being said , our base case has always been non-inferiority with an upside of superiority in the case of non-inferiority on weight loss , we still see a potential for upside on gastrointestinal side effects .
Speaker #7: And tolerability . But also we do believe that the CV benefits that we know from semaglutide could also potentially pan out and will read out from redefine three thus clearly differentiate .
Speaker #7: Cagrisema vis a vis potential competitors . But I do want to iterate . There is still the potential for for for for a superiority upside , but obviously in an amended study that that that should be taken with a little bit of a risk .
Jacob Martin Wiborg Rode: Thank you, Martin. Let's turn to you Ludovic for the second one, please.
Jacob Martin Wiborg Rode: Thank you, Martin. Let's turn to you Ludovic for the second one, please.
Speaker #3: Thank you , Martin . And let's turn to you . Ludwig , for the second one , please .
Ludovic Helfgott: Absolutely. Let's take a step back. The real focus and the priority of our Wegovy appeal launch is the US and will remain the US in 2026. As you rightly read, we've filed and we are opening the option to launch in selected markets in the course of 2026, depending on how, of course, on how things are ramping up. We are definitely ready in this market to be able to make the best and the most of the Wegovy appeal. By the way, we're also very quickly transferring some knowledge from the telehealth channels, for instance, in the US into some IO markets.
Ludovic Helfgott: Absolutely. Let's take a step back. The real focus and the priority of our Wegovy appeal launch is the US and will remain the US in 2026. As you rightly read, we've filed and we are opening the option to launch in selected markets in the course of 2026, depending on how, of course, on how things are ramping up. We are definitely ready in this market to be able to make the best and the most of the Wegovy appeal. By the way, we're also very quickly transferring some knowledge from the telehealth channels, for instance, in the US into some IO markets.
Speaker #5: Absolutely . So let's take a step back . The real focus and the priority of our Wegovy launch is the US , and will remain the US in 2026 .
Speaker #5: As you rightly read , we are indeed opening with reverse filed . And and we are opening the option to launch in selected markets in the course of 2026 , depending on , of course , on how things are ramping up .
Speaker #5: And we are definitely ready to in these markets to be able to make the the boast , the mess . Sorry , the best and the most of of the wegovy pill and by the way , we also very quickly transferring some knowledge from the health channel .
Speaker #5: For instance , in the US into some markets . We are very active right now as we speak in many markets across the world , not just in Europe , but also in Australia .
Ludovic Helfgott: We are very active right now as we speak in many markets across the world, not just in Europe but also in Australia, for instance, or in other parts of the world where we believe that we really are gaining progress on the telehealth side. Again, we're accelerating our overall experience curve on the telehealth, and that will be, we believe, will be proven very helpful at the time we launch the Wegovy appeal. It's also noteworthy to say that the IO markets are also markets where we have some of the nicest experience on Rybelsus in Europe and elsewhere, which means that we can also leverage our experience on the oral markets that have been successful Rybelsus to build even quicker position with the Wegovy appeal.
Ludovic Helfgott: We are very active right now as we speak in many markets across the world, not just in Europe but also in Australia, for instance, or in other parts of the world where we believe that we really are gaining progress on the telehealth side. Again, we're accelerating our overall experience curve on the telehealth, and that will be, we believe, will be proven very helpful at the time we launch the Wegovy appeal. It's also noteworthy to say that the IO markets are also markets where we have some of the nicest experience on Rybelsus in Europe and elsewhere, which means that we can also leverage our experience on the oral markets that have been successful Rybelsus to build even quicker position with the Wegovy appeal.
Speaker #5: For instance , or in other parts of the world where we believe that we we really are gaining progress on the telehealth side .
Speaker #5: So again , we accelerating our overall experience curve on the telehealth , and that will be , we believe will be proven very helpful at the time we launch the Wegovy pill .
Speaker #5: It's also not worth it to say that the I o market are also markets where we have some of the nicest experience on Rybelsus in Europe and elsewhere , which means that we can also leverage our experience on the oral markets that have been successfully able to to build even even quicker position with a with the Wegovy .
Ludovic Helfgott: Priority to the US, but fully ready to take on some selected markets in IO, when time comes.
Ludovic Helfgott: Priority to the US, but fully ready to take on some selected markets in IO, when time comes.
Speaker #5: So priority to the US , but fully ready to take on some selected markets in IO when time comes .
Jacob Martin Wiborg Rode: Thanks a lot, Ludovic. With that, let's conclude the Q&A session. Thank you for participating and please feel free to ask in the administrations for any follow-up questions if that's the case. Before we finally round off, I'll just turn it over to you, Mike, for some final remarks.
Jacob Martin Wiborg Rode: Thanks a lot, Ludovic. With that, let's conclude the Q&A session. Thank you for participating and please feel free to ask in the administrations for any follow-up questions if that's the case. Before we finally round off, I'll just turn it over to you, Mike, for some final remarks.
Speaker #3: Thanks a lot , Ludwig . And with that , let's conclude the Q&A session . Thank you for participating and please feel free to ask in the reservations for for any follow up questions .
Speaker #3: If that's the case , before we finally round off , I'll just turn it over to you , Mike , for some final remarks .
Ludovic Helfgott: Thank you, Jacob. Thank you to everyone for calling in. Before closing, I did wanna make a few remarks. Although we have narrowed the full year outlook for this year and see currently competitive headwind, the unmet need is huge. The volume opportunity longer term in our core area is enormous. We are sharpening our focus on diabetes, obesity, and associated comorbidities in order to address this unmet need. This is our home turf, and this is for us to drive the commercial execution and raise the innovation bar to treat many more patients and treat them better than ever before. We will not stop till we do that. Thank you.
Mads Krogsgaard Thomsen: Thank you, Jacob. Thank you to everyone for calling in. Before closing, I did wanna make a few remarks. Although we have narrowed the full year outlook for this year and see currently competitive headwind, the unmet need is huge. The volume opportunity longer term in our core area is enormous. We are sharpening our focus on diabetes, obesity, and associated comorbidities in order to address this unmet need. This is our home turf, and this is for us to drive the commercial execution and raise the innovation bar to treat many more patients and treat them better than ever before. We will not stop till we do that. Thank you.
Speaker #4: Thank you . Jakob , thank you to everyone for calling in before closing , I did want to make a few remarks , although we have narrowed the full year outlook for this year and see currently competitive headwind , the unmet need is huge .
Speaker #4: The volume opportunity longer term in our core area is enormous . We are sharpening our focus on diabetes , obesity and associated comorbidities in order to address this unmet need .
Speaker #4: This is our home turf and this is for us to drive the commercial execution and raise the innovation bar to treat many more patients and treat them better than ever before .
Speaker #4: And we will not stop until we do that . Thank you .
Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.