Novo Nordisk Full Year 2025 Novo Nordisk AS Earnings Call and Business Update | AllMind AI Earnings | AllMind AI
Full Year 2025 Novo Nordisk AS Earnings Call and Business Update
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Speaker #1: I would now like to hand the conference over to your first speaker today, Michael Novot, Head of Investor Relations. Please go ahead.
Speaker #1: ahead. Thank you
Speaker #2: very much, and welcome to this NOVO NORDISK earnings call for the full year of 2025. My name is Michael Novot. I'm the head of Investor Relations at NOVO NORDISK.
Michael Novart: I'm the Head of Investor Relations at Novo Nordisk. With me today, I have CEO of Novo Nordisk, Mike Doustdar; EVP Product and Portfolio Strategy, Ludovic Helfgott; EVP US Operations, Dave Moore; EVP Research and Development and Chief Scientific Officer, Martin Lange, and Chief Financial Officer, Karsten Knudsen. All speakers will be available for the Q&A session. Today's call is being webcasted live, and a recording will be made available on our website. The call is scheduled to last 1 hour. Next slide, please. The presentation is structured as outlined on slide 2. 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 call will contain forward-looking statements. These are subject to risk and uncertainty that could cause actual results to differ materially from expectations.
Michael Novod: I'm the Head of Investor Relations at Novo Nordisk. With me today, I have CEO of Novo Nordisk, Mike Doustdar; EVP Product and Portfolio Strategy, Ludovic Helfgott; EVP US Operations, Dave Moore; EVP Research and Development and Chief Scientific Officer, Martin Lange, and Chief Financial Officer, Karsten Knudsen. All speakers will be available for the Q&A session. Today's call is being webcasted live, and a recording will be made available on our website. The call is scheduled to last 1 hour. Next slide, please. The presentation is structured as outlined on slide 2. 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 call will contain forward-looking statements. These are subject to risk and uncertainty that could cause actual results to differ materially from expectations.
Speaker #2: With me today, I have CEO of Novo Nordisk, Maziar Doustdar; EVP, Product and Portfolio Strategy, Ludovic Helfgott; EVP, US Operations, David Moore; EVP, Research and Development and Chief Scientific Officer, Martin Lange; and Chief Financial Officer, Karsten Munk Knudsen.
Full Year 2025 Novo Nordisk AS Earnings Call and Business Update
Speaker #2: All speakers will be available for the Q&A session. Today's call is being webcast live, and a recording will be made available on our website.
Speaker #2: The call is scheduled to last one hour. Next slide, please. 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.
Speaker #2: Next slide, please. We need to advise you that this call will contain forward-looking statements. These are subject to risk and uncertainty that could cause actual results to differ materially from expectations.
Speaker #2: For further information on the risk factors, please see the company announcement for the full year 2025 and the slides prepared for this presentation. With that, over to you, Mike, for an update on our strategic
Michael Novart: For further information on the risk factors, please see the company announcement for the full year 2025 and the slides prepared for this presentation. With that, over to you, Mike, for an update on our strategic aspirations. Thank you, Michael. Next slide, please. In 2025, Novo Nordisk delivered 10% sales growth and operating profit growth of 6%. We sharpened our strategic focus in 2025, doubling down in our core therapeutic areas of obesity and diabetes. This year marks the conclusion of the 2025 strategic aspirations that were established back in 2019. Since then, we have more than doubled our sales and operating profit, and our obesity care sales have increased from DKK 6 billion in 2019 to DKK 82 billion in 2025. Rare disease is now positioned for sustained growth with the late-stage pipeline assets Mim8, now called Dysanimic, and Etavopivat.
Michael Novod: For further information on the risk factors, please see the company announcement for the full year 2025 and the slides prepared for this presentation. With that, over to you, Mike, for an update on our strategic aspirations.
Speaker #2: aspirations. Thank you,
Mike Doustdar: Thank you, Michael. Next slide, please. In 2025, Novo Nordisk delivered 10% sales growth and operating profit growth of 6%. We sharpened our strategic focus in 2025, doubling down in our core therapeutic areas of obesity and diabetes. This year marks the conclusion of the 2025 strategic aspirations that were established back in 2019. Since then, we have more than doubled our sales and operating profit, and our obesity care sales have increased from DKK 6 billion in 2019 to DKK 82 billion in 2025. Rare disease is now positioned for sustained growth with the late-stage pipeline assets Mim8, now called Dysanimic, and Etavopivat.
Speaker #3: Michael. Next slide, please. In 2025, Novo Nordisk delivered 10% sales growth and operating profit growth of 6%. We sharpened our strategic focus in 2025, doubling down in our core therapeutic areas of obesity and diabetes.
Speaker #3: This year marked the conclusion of the 2025 strategic aspirations that were established back in 2019. Since then, we have more than doubled our sales and operating profit, and our revenue has increased from 6 billion DKK in 2019 to 82 billion DKK in 2025.
Speaker #3: Rare disease is now positioned for sustained growth with the late-stage pipeline assets MiMate, now called Decinimic, and Etavo PVAD. Furthermore, over 300 billion Danish kroner have been returned to our shareholders since 2019.
Michael Novart: Furthermore, over DKK 300 billion has been returned to our shareholders since 2019. Most importantly, we have increased our reach by an additional 16 million people with our obesity and diabetes treatments. This quarter, we saw several exciting readouts, including the next-generation treatment for type 2 diabetes with the phase 2 readout of Amycretin and phase 3 readout for CagriSema. Novo Nordisk also continued to build upon its pipeline across therapy areas. Martin will discuss this in more detail later in the call. By late 2025, we received FDA approval for the Wegovy pill, the first oral GLP-1 for obesity, and submitted CagriSema in the US. Dave will speak more to the Wegovy pill later, but we are encouraged by the early uptake of the pill and what we see these milestones would mean for people living with obesity.
Mike Doustdar: Furthermore, over DKK 300 billion has been returned to our shareholders since 2019. Most importantly, we have increased our reach by an additional 16 million people with our obesity and diabetes treatments. This quarter, we saw several exciting readouts, including the next-generation treatment for type 2 diabetes with the phase 2 readout of Amycretin and phase 3 readout for CagriSema. Novo Nordisk also continued to build upon its pipeline across therapy areas. Martin will discuss this in more detail later in the call. By late 2025, we received FDA approval for the Wegovy pill, the first oral GLP-1 for obesity, and submitted CagriSema in the US. Dave will speak more to the Wegovy pill later, but we are encouraged by the early uptake of the pill and what we see these milestones would mean for people living with obesity.
Speaker #3: Most importantly, we have increased our reach by an additional 16 million people with our obesity and diabetes treatments. This quarter, we saw several exciting readouts, including the next-generation treatment for type 2 diabetes, with the phase two readout of Zenegematide and phase three readout for Cagrissema.
Speaker #3: Novo Nordisk also continued to build upon its pipeline across therapy areas. Martin will discuss this in more detail later in the call. By late 2025, we received FDA approval for the Wegovy pill.
Speaker #3: The first oral GLP-1 for obesity and submitted Cagrissema in the US. Dave will speak more to the Wegovy pill later. But we are encouraged by the early uptake of the pill and what we see these milestones meaning would mean for people living with obesity.
Speaker #3: We are treating nearly 46 million people with our innovative medicines, reflecting Novo Nordisk's commitment to innovation and the ongoing efforts to expand access to our therapies worldwide.
Michael Novart: We are treating nearly 46 million people with our innovative medicines, reflecting Novo Nordisk's commitment to innovation and the ongoing efforts to expand access to our therapies worldwide. Finally, Karsten will come back to it, but we have released our 2026 guidance, which reflects a year of pricing headwinds. We do not take this lightly, and we will do all we can to pursue the volume opportunities in obesity and diabetes. Next slide, please. Yesterday, we also announced changes to the executive management team. Dave Moore has decided to leave Novo Nordisk for personal reasons after more than eight years with the company. Dave began his Novo journey in 2017 and returned to Novo in 2022 after a time outside of the company to lead our global business development area before returning to the US as the Executive Vice President of the US Operations in January of 2025.
Mike Doustdar: We are treating nearly 46 million people with our innovative medicines, reflecting Novo Nordisk's commitment to innovation and the ongoing efforts to expand access to our therapies worldwide. Finally, Karsten will come back to it, but we have released our 2026 guidance, which reflects a year of pricing headwinds. We do not take this lightly, and we will do all we can to pursue the volume opportunities in obesity and diabetes. Next slide, please. Yesterday, we also announced changes to the executive management team. Dave Moore has decided to leave Novo Nordisk for personal reasons after more than eight years with the company. Dave began his Novo journey in 2017 and returned to Novo in 2022 after a time outside of the company to lead our global business development area before returning to the US as the Executive Vice President of the US Operations in January of 2025.
Speaker #3: Finally, Karsten will come back to it, but we have released our 2026 guidance, which reflects a year of pricing headwinds. We do not take this lightly, and we will do all we can to pursue the volume opportunities in obesity and diabetes.
Speaker #3: Next slide, please. Yesterday, we also announced changes to the executive management team. David Moore has decided to leave Novo Nordisk for personal reasons after more than eight years with the company.
Speaker #3: Dave began his NOVO journey in 2017 and returned to NOVO in 2022 after a time outside of the company, to lead our global business development as the executive vice president of the US Operations in January of 2025.
Speaker #3: Dave has moved the needle throughout his time at NOVO. From driving the blockbuster launch of Ozempic to leading the acquisition of three Catalan manufacturing sites, to overseeing the launch of the Wegovy pill in the US.
Michael Novart: Dave has moved the needle throughout his time at Novo Nordisk, from driving the blockbuster launch of Ozempic to leading the acquisition of three Catalent manufacturing sites to overseeing the launch of the Wegovy pill in the US. In addition, Ludovic Helfgott has decided to leave Novo Nordisk to pursue new opportunities. Ludo joined Novo Nordisk back in 2019 to lead what was back then called BioPharm business and eventually became our rare disease therapy area. Ludovic's patient-first leadership is reflected in Novo Nordisk's strong presence in rare blood and endocrine disorders today. Ludovic was able to translate this passion across all of our therapy areas over the last 10 months as the Head of Product and Portfolio Strategy. On behalf of Novo Nordisk and myself, I would like to thank Dave and Ludovic for their bold and steady leadership.
Mike Doustdar: Dave has moved the needle throughout his time at Novo Nordisk, from driving the blockbuster launch of Ozempic to leading the acquisition of three Catalent manufacturing sites to overseeing the launch of the Wegovy pill in the US. In addition, Ludovic Helfgott has decided to leave Novo Nordisk to pursue new opportunities. Ludo joined Novo Nordisk back in 2019 to lead what was back then called BioPharm business and eventually became our rare disease therapy area. Ludovic's patient-first leadership is reflected in Novo Nordisk's strong presence in rare blood and endocrine disorders today. Ludovic was able to translate this passion across all of our therapy areas over the last 10 months as the Head of Product and Portfolio Strategy. On behalf of Novo Nordisk and myself, I would like to thank Dave and Ludovic for their bold and steady leadership.
Speaker #3: In addition, Ludovic Helfgott has decided to leave Novo Nordisk to pursue new opportunities. Ludo joined Novo Nordisk back in 2019 to lead what was back then called the Biopharm business and eventually became our Rare Disease therapy area.
Speaker #3: Ludovic's patient-first leadership is reflected in Novo Nordisk's strong presence in rare blood and endocrine disorders today. Ludovic was able to translate this passion across all of our therapy areas over the last 10 months as the Head of Product and Portfolio Strategy.
Speaker #3: On behalf of Novo Nordisk and myself, I would like to thank Dave and Ludovic for their bold and steady leadership. After a thoughtful selection process over the last few months, I'm very pleased to announce the addition of Jamie Miller and Anne Hongchao to Novo Nordisk and the executive management team.
Michael Novart: After a thoughtful selection process over the last few months, I'm very pleased to announce the addition of Jamie Miller and Hong Chow to Novo Nordisk and the executive management team. Next slide, please. Starting 5 February, Jamie Miller joins Novo Nordisk as an Executive Vice President of US Operations. Jamie brings more than 30 years of extensive leadership experience in the pharmaceutical industry with proven track record in launching major therapies and shaping commercial strategy. He joins us from UnitedHealth Group, where he served as the CEO of Optum Specialty Holdings and brings deep expertise in US market access and product lifecycle management. Beginning 15 February, Hong Chow will join Novo Nordisk as an Executive Vice President of Product and Portfolio Strategy.
Mike Doustdar: After a thoughtful selection process over the last few months, I'm very pleased to announce the addition of Jamie Miller and Hong Chow to Novo Nordisk and the executive management team. Next slide, please. Starting 5 February, Jamie Miller joins Novo Nordisk as an Executive Vice President of US Operations. Jamie brings more than 30 years of extensive leadership experience in the pharmaceutical industry with proven track record in launching major therapies and shaping commercial strategy. He joins us from UnitedHealth Group, where he served as the CEO of Optum Specialty Holdings and brings deep expertise in US market access and product lifecycle management. Beginning 15 February, Hong Chow will join Novo Nordisk as an Executive Vice President of Product and Portfolio Strategy.
Speaker #3: Next slide, please. Starting February 5, Jamie Miller joins Novo Nordisk as an executive vice president of US Operations. Jamie brings more than 30 years of extensive leadership experience in the pharmaceutical industry, with a proven track record in launching major therapies and shaping commercial strategy.
Speaker #3: He joins us from UnitedHealth Group, where he served as the CEO of Optum Specialty Holding and brings deep expertise in US market access and product lifecycle management.
Speaker #3: Beginning February 15th, Hongchao will join Novo Nordisk as an executive vice president of Product and Portfolio Strategy. Hong brings deep global leadership experience to Novo Nordisk, serving as the executive vice president and head of China and International at Merck Healthcare.
Michael Novart: Hong brings deep global leadership experience to Novo Nordisk, serving as the Executive Vice President and Head of China and International at Merck Healthcare and leading their global cardiovascular, metabolism, and endocrine portfolio. Her leadership in advancing innovation, health equity, and large-scale product strategies at companies such as Merck, Roche, and Bayer demonstrates her outstanding capability to drive our vision forward. We look forward to welcoming Jamie and Hong to Novo Nordisk this month, and both Dave and Ludo will help to ensure a successful transition to their successors throughout the end of this quarter. I will now hand over to Ludo for an update on our commercial execution in 2025. Thank you, Mike, and please turn to next slide. The global GLP-1 market grew over 30% in 2025. Novo Nordisk's total sales increased by 10% as US operations grew 8% and international operations grew 14%.
Mike Doustdar: Hong brings deep global leadership experience to Novo Nordisk, serving as the Executive Vice President and Head of China and International at Merck Healthcare and leading their global cardiovascular, metabolism, and endocrine portfolio. Her leadership in advancing innovation, health equity, and large-scale product strategies at companies such as Merck, Roche, and Bayer demonstrates her outstanding capability to drive our vision forward. We look forward to welcoming Jamie and Hong to Novo Nordisk this month, and both Dave and Ludo will help to ensure a successful transition to their successors throughout the end of this quarter. I will now hand over to Ludo for an update on our commercial execution in 2025.
Speaker #3: And leading their global cardiovascular, metabolism, and endocrine portfolio. Her leadership in advancing innovation, health equity, and large-scale product strategies at companies such as Merck, Roche, and Bayer demonstrates her outstanding capability to drive our vision forward.
Speaker #3: We look forward to welcoming Jamie and Hong to Novo Nordisk this month. Both Dave and Ludo will help to ensure a successful transition to their successors throughout the end of this quarter.
Speaker #3: I will now hand over to Ludo for an update on our commercial execution.
Speaker #3: 2025.
Ludovic Helfgott: Thank you, Mike, and please turn to next slide. The global GLP-1 market grew over 30% in 2025. Novo Nordisk's total sales increased by 10% as US operations grew 8% and international operations grew 14%. Sales growth was positively impacted by one-offs in the US. Our GLP-1 sales in diabetes increased by 6%, driven by US operations +5% and international operations growing 7%. Insulin sales decreased by 1%. US operations increased by 2%, positively impacted by positive channel and payer mix, and partially countered by a decline in volume. International operations decreased by 2%, impacted by market share losses. Obesity care sales increased 31% in 2025, driven by both operating units. US operations grew 15% and IO grew 73%. In both geographies, growth was driven by Wegovy.
Speaker #2: Thank you. Mike, and
Speaker #2: Please turn to the next slide. Grew over 30%. The global GLP-1 market 2025. Novo Nordisk's total sales increased by 10% as US operations grew 8% and international operations grew 14%.
Speaker #2: Sales growth was positively impacted by one-offs in the US. Our GLP-1 sales in diabetes increased by 6%, driven by US operations, up 5%, and international operations growing 7%.
Michael Novart: Sales growth was positively impacted by one-offs in the US. Our GLP-1 sales in diabetes increased by 6%, driven by US operations +5% and international operations growing 7%. Insulin sales decreased by 1%. US operations increased by 2%, positively impacted by positive channel and payer mix, and partially countered by a decline in volume. International operations decreased by 2%, impacted by market share losses. Obesity care sales increased 31% in 2025, driven by both operating units. US operations grew 15% and IO grew 73%. In both geographies, growth was driven by Wegovy. Rare disease sales increased by 9%. This was driven by sales increase in the US operations of 7% and in international operations of 10%. In both operating units, the sales increase was primarily driven by the rare endocrine disorder products, mainly due to Sogroya launch uptake. Next slide, please.
Speaker #2: Insulin sales decreased by 1%. U.S. operations increased by 2%, positively impacted by a positive channel in payer mix, and partially countered by a decline in volume.
Speaker #2: International Operations decreased by 2%, impacted by market share losses. Obesity care sales increased 31% in 2025, driven by both operating units. US Operations grew 15%, and IO grew 73%.
Speaker #2: In both geographies, growth was driven by Wegovy. Our rare disease sales increased by 9%. This was driven by a sales increase in the US operations of 7% and in international operations of 10%.
Ludovic Helfgott: Rare disease sales increased by 9%. This was driven by sales increase in the US operations of 7% and in international operations of 10%. In both operating units, the sales increase was primarily driven by the rare endocrine disorder products, mainly due to Sogroya launch uptake. Next slide, please. Sales in international operations were driven by GLP-1 products in obesity and diabetes care. The GLP-1 volume growth in international operations was 44% in 2025, and Novo Nordisk remains the overall GLP-1 market leader with a 62% volume market share. GLP-1 diabetes sales increased by 7%, driven by the sales growth of Ozempic. In region China, GLP-1 diabetes sales decreased by 5%, which was negatively impacted by wholesaler inventory movements.
Speaker #2: In both operating units, the sales increase was primarily driven by the rare endocrine disorder products, mainly due to Sugaria launch uptake. Next slide, operations were driven by GLP-1, please.
Speaker #2: Sales in international products in obesity and diabetes care. The GLP-1 volume growth in international operations was 44% in 2025, and Novo Nordisk remains the overall GLP-1 market leader with a 62% volume market share.
Michael Novart: Sales in international operations were driven by GLP-1 products in obesity and diabetes care. The GLP-1 volume growth in international operations was 44% in 2025, and Novo Nordisk remains the overall GLP-1 market leader with a 62% volume market share. GLP-1 diabetes sales increased by 7%, driven by the sales growth of Ozempic. In region China, GLP-1 diabetes sales decreased by 5%, which was negatively impacted by wholesaler inventory movements. Total obesity care sales grew up to DKK 31 billion in 2025. Wegovy was launched in 35 new countries in 2025, more than tripling the number of launches back in 2024. Sales of Wegovy reached DKK 28 billion in 2025, growing 134%. We continue to see GLP-1 market growth in international operations. A large unmet need remains, and penetration rates are low.
Speaker #2: GLP-1 diabetes sales increased by 7%, driven by the sales growth of Ozempic. In the China region, GLP-1 diabetes sales decreased by 5%, which was negatively impacted by wholesaler inventory movements.
Ludovic Helfgott: Total obesity care sales grew up to DKK 31 billion in 2025. Wegovy was launched in 35 new countries in 2025, more than tripling the number of launches back in 2024. Sales of Wegovy reached DKK 28 billion in 2025, growing 134%. We continue to see GLP-1 market growth in international operations. A large unmet need remains, and penetration rates are low. Looking into 2026, we plan to further expand the obesity and diabetes markets in IO through new online channels, partnerships, and by bringing new products to patients with the ongoing rollout of semaglutide 7.2 mg for weight loss and Ozempic 2 mg for diabetes in certain markets.
Speaker #2: Total obesity care sales grew to DKK 31 billion in 2025. Wegovy was launched in 35 new countries in 2025, more than tripling the number of launches back in 2024.
Speaker #2: Sales of Wegovy reached DKK 28 billion in '25, growing 134%. We continue to see GLP-1 market growth in International Operations. A large unmet need remains, and penetration rates are low.
Speaker #2: Looking into '26, we plan to further expand the obesity and diabetes markets in IO through new online channels and partnerships, and by bringing new products to patients with the ongoing rollout of semaglutide 7.2 milligrams for weight loss and Ozempic 2 milligrams for diabetes in certain markets.
Michael Novart: Looking into 2026, we plan to further expand the obesity and diabetes markets in IO through new online channels, partnerships, and by bringing new products to patients with the ongoing rollout of semaglutide 7.2 mg for weight loss and Ozempic 2 mg for diabetes in certain markets. With that, I would like to thank my colleagues and the entire Novo Nordisk organization for a tremendous seven years. It has been a privilege to work on impactful medicines that have already and hopefully soon will make it to the hands of patients. Now I will hand it over for Dave for an update on US operations. Thank you, Ludo. Next slide, please. Sales of GLP-1 diabetes care products in the US increased by 5% in 2025. The sales increase was driven by continued uptake of Ozempic, partially countered by Victoza and Rybelsus.
Ludovic Helfgott: With that, I would like to thank my colleagues and the entire Novo Nordisk organization for a tremendous seven years. It has been a privilege to work on impactful medicines that have already and hopefully soon will make it to the hands of patients. Now I will hand it over for Dave for an update on US operations.
Speaker #2: And with that, I would like to thank my colleagues and the entire Novo Nordisk organization for a tremendous seven years. It has been a privilege to work on impactful medicines that have already, and hopefully soon will, make it to the hands of patients.
Speaker #2: And now, I will hand it over to Dave for an update on US operations.
Dave Moore: Thank you, Ludo. Next slide, please. Sales of GLP-1 diabetes care products in the US increased by 5% in 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 GLP-1 diabetes market growth, partially countered by market share losses and lower realized prices. Weekly Ozempic prescriptions are currently around 610,000. The GLP-1 diabetes market grew just over 10% in Q4 2025 compared to Q4 2024. In the US, we continue to meet people with type 2 diabetes where they are, including through our self-pay offering for Ozempic that is currently now around 8,000 prescriptions per week. We also received FDA approval for the updated formulation of the Ozempic pill, formerly known as Rybelsus, and that happened last week.
Speaker #3: Thank you, Ludo. Next slide, please. Sales of GLP-1 diabetes care products in the US increased by 5% in 2025. The sales increase was driven by continued uptake of Ozempic, partially countered by Victoza and Rybelsus.
Speaker #3: Ozempic sales in the U.S. were positively impacted by growth-to-net sales adjustments and GLP-1 diabetes market growth, partially countered by market share losses and lower realized prices.
Michael Novart: Ozempic sales in the US were positively impacted by gross-to-net sales adjustments and GLP-1 diabetes market growth, partially countered by market share losses and lower realized prices. Weekly Ozempic prescriptions are currently around 610,000. The GLP-1 diabetes market grew just over 10% in Q4 2025 compared to Q4 2024. In the US, we continue to meet people with type 2 diabetes where they are, including through our self-pay offering for Ozempic that is currently now around 8,000 prescriptions per week. We also received FDA approval for the updated formulation of the Ozempic pill, formerly known as Rybelsus, and that happened last week. Next slide, please. As Mike noted earlier, 2025 ended with an exciting milestone for Novo Nordisk and, importantly, people living with obesity in the US. The Wegovy pill was approved by FDA on 22 December 2025.
Speaker #3: Weekly, Ozempic prescriptions are currently around 610,000. The GLP-1 diabetes market grew just over 10% in the fourth quarter of 2025 compared to the fourth quarter of 2024.
Speaker #3: In the with type 2 diabetes where they US, we continue to meet people are including through our self-pay offering for Ozempic that is currently now around 8,000 prescriptions per week.
Speaker #3: We also received FDA approval for the updated formulation of the Ozempic pill, formerly known as Rybelsus, and that happened last week. Next slide, please.
Dave Moore: Next slide, please. As Mike noted earlier, 2025 ended with an exciting milestone for Novo Nordisk and, importantly, people living with obesity in the US. The Wegovy pill was approved by FDA on 22 December 2025. Thanks to outstanding efforts across our entire organization, we were able to bring the first and best-in-class oral GLP-1 for weight management to the US market on 5 January. The Wegovy pill is the only GLP-1 peptide formulated into a pill, delivering the weight loss efficacy of injectable Wegovy in a once-daily oral tablet. When looking separately at the phase 3 trial data in obesity for the Wegovy pill and for Orfoglipron, the Wegovy pill shows around 35% greater reported weight loss. We have seen encouraging early uptake of the Wegovy pill.
Speaker #3: As Mike noted earlier, 2025 ended with an exciting milestone for Novo Nordisk and, importantly, people living with obesity in the US. The Wegovy pill was approved by the FDA on December 22nd.
Speaker #3: And thanks to outstanding efforts across our entire organization, we were able to bring the first and best-in-class oral GLP-1 for weight management to the U.S. market on January 5th.
Michael Novart: Thanks to outstanding efforts across our entire organization, we were able to bring the first and best-in-class oral GLP-1 for weight management to the US market on 5 January. The Wegovy pill is the only GLP-1 peptide formulated into a pill, delivering the weight loss efficacy of injectable Wegovy in a once-daily oral tablet. When looking separately at the phase 3 trial data in obesity for the Wegovy pill and for Orfoglipron, the Wegovy pill shows around 35% greater reported weight loss. We have seen encouraging early uptake of the Wegovy pill. Our compiled data shows that total prescriptions are around 50,000 for the week ending 23 January, with around 45,000 of these prescriptions coming through self-pay. The uptake is over twice that of any prior anti-obesity drug launches in the United States.
Speaker #3: The Wegovy pill is the only GLP-1 peptide formulated into a pill, delivering the weight loss efficacy of injectable Wegovy in a once-daily oral tablet.
Speaker #3: When looking separately at the phase 3 trial data in obesity for the Wegovy pill and for Orforglipron, the Wegovy pill shows around 35% greater reported weight loss.
Speaker #3: We have seen encouraging early uptake of the Wegovy pill. Our compiled data shows that total prescriptions are around 50,000 for the week ending January 23.
Dave Moore: Our compiled data shows that total prescriptions are around 50,000 for the week ending 23 January, with around 45,000 of these prescriptions coming through self-pay. The uptake is over twice that of any prior anti-obesity drug launches in the United States. Though it is still early in the launch, most prescriptions appear to be for patients new to these medications, suggesting the market is expanding. The Wegovy pill is offered at over 70,000 retail pharmacies and through NovoCare Pharmacy and numerous telehealth partners. Commercial access for the Wegovy pill is progressing, with coverage currently via CVS, Prime, Optum, and Anthem, amounting to just below half the covered lives we have for injectable Wegovy.
Speaker #3: With around 45,000 of these prescriptions coming through self-pay, the uptake is over twice that of any prior anti-obesity drug launches in the United States.
Speaker #3: Though it is still early in the launch, most prescriptions appear to be for patients new to these medications, suggesting the market is expanding. The Wegovy pill is offered at over 70,000 retail pharmacies, through NOVOCARE Pharmacy, and numerous telehealth partners.
Michael Novart: Though it is still early in the launch, most prescriptions appear to be for patients new to these medications, suggesting the market is expanding. The Wegovy pill is offered at over 70,000 retail pharmacies and through NovoCare Pharmacy and numerous telehealth partners. Commercial access for the Wegovy pill is progressing, with coverage currently via CVS, Prime, Optum, and Anthem, amounting to just below half the covered lives we have for injectable Wegovy. We continue working to develop reimbursed access and broaden reach through more partnerships in order to provide people with obesity an oral therapeutic option with a competitive label of Wegovy and best-in-class weight loss. Next slide, please. Wegovy sales increased by 16% in US operations in 2025. The Wegovy sales growth was driven by increased volumes, partially countered by lower realized prices. In the holiday week ending 23 January 2025, Wegovy had around 230,000 weekly prescriptions.
Speaker #3: Commercial access for the Wegovy pill is progressing, with coverage currently via CVS, Prime, Optum, and Anthem. That amounts to just below half the covered lives we have for injectable Wegovy.
Dave Moore: We continue working to develop reimbursed access and broaden reach through more partnerships in order to provide people with obesity an oral therapeutic option with a competitive label of Wegovy and best-in-class weight loss. Next slide, please. Wegovy sales increased by 16% in US operations in 2025. The Wegovy sales growth was driven by increased volumes, partially countered by lower realized prices. In the holiday week ending 23 January 2025, Wegovy had around 230,000 weekly prescriptions. The recent decline in injectable Wegovy prescriptions at the start of 2026 is largely attributed to benefit changes at the turn of the year, including several states that have dropping Medicaid coverage of anti-obesity medicines.
Speaker #3: We continue working to develop reimbursed access and broaden reach through more partnerships in order to provide people with obesity an oral therapeutic option with a competitive label to Wegovy and best-in-class weight loss.
Speaker #3: Next slide, please. Wegovy sales increased by 16% in U.S. operations in 2025. The Wegovy sales growth was driven by increased volumes, partially countered by lower realized prices.
Speaker #3: In the holiday week ending January 23rd, Wegovy had around 230,000 weekly prescriptions. The recent decline in injectable Wegovy prescriptions at the start of 2026 is largely attributed to benefit changes at the turn of the year.
Michael Novart: The recent decline in injectable Wegovy prescriptions at the start of 2026 is largely attributed to benefit changes at the turn of the year, including several states that have dropping Medicaid coverage of anti-obesity medicines. The combined injectable and pill Wegovy brand is currently now more than 75,000 weekly NBRx, and that makes it the leading anti-obesity medication franchise measured by NBRx in the US. In the last year, the branded anti-obesity market has more than doubled in size. US operations have prioritized making our anti-obesity medications available to more people through multiple avenues to meet the outstanding unmet need. Novo Nordisk launched NovoCare Pharmacy in March 2025, and together with retail and telehealth, total self-pay now makes up around 30% of total injectable Wegovy prescriptions.
Speaker #3: Including several states that are dropping Medicaid coverage of anti-obesity medicines. The combined injectable and pill Wegovy brand is currently now at more than 75,000 weekly NBRXs.
Dave Moore: The combined injectable and pill Wegovy brand is currently now more than 75,000 weekly NBRx, and that makes it the leading anti-obesity medication franchise measured by NBRx in the US. In the last year, the branded anti-obesity market has more than doubled in size. US operations have prioritized making our anti-obesity medications available to more people through multiple avenues to meet the outstanding unmet need. Novo Nordisk launched NovoCare Pharmacy in March 2025, and together with retail and telehealth, total self-pay now makes up around 30% of total injectable Wegovy prescriptions.
Speaker #3: And that makes it the leading anti-obesity medication franchise measured by NBRx in the US. In the last year, the branded anti-obesity market size—US operations have prioritized making our anti-obesity medications available to more people through multiple avenues.
Speaker #3: To meet the outstanding unmet need, Novo Nordisk launched NovoCare Pharmacy in March 2025. And together with retail and telehealth, total self-pay now makes up around 30% of total injectable Wegovy prescriptions.
Speaker #3: In under one year, our increased efforts in the self-pay channel have resulted in close to 120,000 current weekly TRXs across Wegovy and Ozempic brands.
Michael Novart: In under one year, our increased efforts in the self-pay channel have resulted in close to 120,000 current weekly TRx across Wegovy and Ozempic brands, and we continue to add more patients daily. Novo Nordisk will continue to invest in the expansion of the direct-to-patient initiatives, like the recently announced collaboration with Amazon Pharmacy. In November, we announced that Novo Nordisk entered an agreement with the US administration, including coverage for obesity medicines in US Medicare Part D via the CMMI pilot program. We are encouraged that more patients will have affordable access to our medicines, and we anticipate that coverage will begin around the middle of the year. In addition to access, we remain focused on bringing innovation to the market. Novo Nordisk submitted the high-dose semaglutide 7.2 mg to FDA in November.
Dave Moore: In under one year, our increased efforts in the self-pay channel have resulted in close to 120,000 current weekly TRx across Wegovy and Ozempic brands, and we continue to add more patients daily. Novo Nordisk will continue to invest in the expansion of the direct-to-patient initiatives, like the recently announced collaboration with Amazon Pharmacy. In November, we announced that Novo Nordisk entered an agreement with the US administration, including coverage for obesity medicines in US Medicare Part D via the CMMI pilot program. We are encouraged that more patients will have affordable access to our medicines, and we anticipate that coverage will begin around the middle of the year. In addition to access, we remain focused on bringing innovation to the market. Novo Nordisk submitted the high-dose semaglutide 7.2 mg to FDA in November.
Speaker #3: And we continue to add more patients daily. Novo Nordisk will continue to invest in the expansion of the direct-to-patient initiatives, like the recently announced collaboration with Amazon Pharmacy.
Speaker #3: In November, we announced that Novo Nordisk entered an agreement with the US administration, including coverage for obesity medicines in US Medicare Part D via the CMMI pilot program.
Speaker #3: We are encouraged that more patients will have affordable access to our medicines, and we anticipate that coverage will begin around the middle of the year.
Speaker #3: In addition to access, we remain focused on bringing innovation to the market. Novo Nordisk submitted the high-dose semaglutide, 7.2 milligrams, to the FDA in November.
Speaker #3: It's under the CNPV pilot program, and we anticipate a decision during the first quarter of 2026. Furthermore, KAGRA SEMA has been submitted to the FDA in December.
Michael Novart: It's under the CNPV pilot program, and we anticipate a decision during Q1 2026. Furthermore, CagriSema has been submitted to the FDA in December, and we expect a decision towards the turn of the year. As my time at Novo Nordisk comes to an end, I am excited about its future and proud of the positive impact I've witnessed on patients worldwide, and I look forward to seeing Novo Nordisk continue with this mission. And now I'll turn it over to Martin for an update on R&D. Thank you, Dave. Please turn to the next slide. This week, we announced the top-line readout from Reimagine2, a phase 3 trial for CagriSema and type 2 diabetes. The trial included around 2,700 people with type 2 diabetes inadequately controlled with metformin, with or without an SGLT2 inhibitor.
Dave Moore: It's under the CNPV pilot program, and we anticipate a decision during Q1 2026. Furthermore, CagriSema has been submitted to the FDA in December, and we expect a decision towards the turn of the year. As my time at Novo Nordisk comes to an end, I am excited about its future and proud of the positive impact I've witnessed on patients worldwide, and I look forward to seeing Novo Nordisk continue with this mission. And now I'll turn it over to Martin for an update on R&D.
Speaker #3: And we expect a decision towards the turn of the year. As my time at Novo Nordisk comes to an end, I am excited about its future.
Speaker #3: And proud of the positive impact I've witnessed on patients worldwide. And I look forward to seeing Novo Nordisk continue with this mission. And now I'll turn it over to Martin for an update on
Speaker #3: R&D. Thank you, Dave.
Martin Lange: Thank you, Dave. Please turn to the next slide. This week, we announced the top-line readout from Reimagine2, a phase 3 trial for CagriSema and type 2 diabetes. The trial included around 2,700 people with type 2 diabetes inadequately controlled with metformin, with or without an SGLT2 inhibitor. People were randomly assigned to receive either CagriSema 2.4mg or 1mg, semaglutide 2.4mg or 1mg, or cagrilintide 2.4mg or placebo. The study assessed superiority of CagriSema versus semaglutide on A1C as the primary endpoint, with change in body weight as one of the secondary endpoints. Approximately 40% of all participants were using an SGLT2 inhibitor before initiating the trial. Please go to the next slide. In Reimagine2, CagriSema 2.4mg demonstrated superior A1C reduction and weight loss versus semaglutide 2.4mg.
Speaker #2: Please turn to the next slide. This week, we announced the top-line readout from Reimagine 2, a Phase 3 trial for KAGRA SEMA in type 2 diabetes.
Speaker #2: The trial included around 2,700 people with type 2 diabetes inadequately controlled with metformin, with or without an SGLT2 inhibitor. People were randomly assigned to receive either KAGRA SEMA 2.4 milligrams or 1 milligram, semaglutide 2.4 milligrams or 1 milligram, Kadrylantide 2.4 milligrams, or placebo.
Michael Novart: People were randomly assigned to receive either CagriSema 2.4mg or 1mg, semaglutide 2.4mg or 1mg, or cagrilintide 2.4mg or placebo. The study assessed superiority of CagriSema versus semaglutide on A1C as the primary endpoint, with change in body weight as one of the secondary endpoints. Approximately 40% of all participants were using an SGLT2 inhibitor before initiating the trial. Please go to the next slide. In Reimagine2, CagriSema 2.4mg demonstrated superior A1C reduction and weight loss versus semaglutide 2.4mg. Assuming all people adhered to treatment and from a mean A1C baseline of 8.2%, CagriSema 2.4mg achieved a superior A1C reduction of 1.91 percentage points. This is compared to 1.76 percentage points with semaglutide 2.4mg. In addition, CagriSema 2.4mg achieved a superior weight loss reduction of 14.2%.
Speaker #2: The study assessed superiority of KAGRA SEMA versus semaglutide on A1c as the primary endpoint, with changes in body weight as one of the secondary endpoints.
Speaker #2: Approximately 40% of all participants were using an SGLT2 inhibitor before initiating the trial. This goes to the next slide. In Reimagine 2, KAGRA SEMA semaglutide sorry, KAGRA SEMA 2.4 milligram demonstrated superior A1c reduction and weight loss versus semaglutide 2.4 milligram.
Martin Lange: Assuming all people adhered to treatment and from a mean A1C baseline of 8.2%, CagriSema 2.4mg achieved a superior A1C reduction of 1.91 percentage points. This is compared to 1.76 percentage points with semaglutide 2.4mg. In addition, CagriSema 2.4mg achieved a superior weight loss reduction of 14.2%. More than 40% of the participants treated with CagriSema 2.4 mg achieved over 15% weight loss, and around 1 in 4 achieved over 20% weight loss. In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal, with the vast majority being mild to moderate and decreasing over time. This data is in line with the recent top-line readout of Reimagine3 with CagriSema as an add-on to basal insulin.
Speaker #2: Assuming all people adhere to treatment, and from a mean A1c baseline of 8.2%, KAGRA SEMA 2.4 milligram achieved a superior A1c reduction of 1.91 percentage points.
Speaker #2: This is compared to 1.76 percentage points with semaglutide 2.4 milligrams. In addition, KAGRA SEMA 2.4 milligrams achieved a superior weight loss reduction of 14.2%.
Speaker #2: More than 40% of the participants treated with KAGRA SEMA 2.4 milligrams achieved over 15% weight loss, and around 1 in 4 achieved over 20% weight loss.
Michael Novart: More than 40% of the participants treated with CagriSema 2.4 mg achieved over 15% weight loss, and around 1 in 4 achieved over 20% weight loss. In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal, with the vast majority being mild to moderate and decreasing over time. This data is in line with the recent top-line readout of Reimagine3 with CagriSema as an add-on to basal insulin. In that study, people treated with CagriSema 2.4 mg achieved an A1C reduction of 2.33 percentage points and a weight loss of 12% at 40 weeks, all superior to placebo. Results from the pivotal Reimagine1 trial are anticipated in Q1 2026. In addition, we await the long-term safety and efficacy cardiovascular outcomes trial, Redefine3.
Speaker #2: In the trial, KAGRA SEMA appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal, with the vast majority being mild to moderate and decreasing over time.
Speaker #2: This data is in line with the recent top-line readout of Reimagine 3 with TO basal insulin. In that study, people treated with KAGRA SEMA 2.4 milligram achieved an A1c reduction of 2.33 percentage points and a weight loss of 12% at 40 weeks, all superior to placebo.
Martin Lange: In that study, people treated with CagriSema 2.4 mg achieved an A1C reduction of 2.33 percentage points and a weight loss of 12% at 40 weeks, all superior to placebo. Results from the pivotal Reimagine1 trial are anticipated in Q1 2026. In addition, we await the long-term safety and efficacy cardiovascular outcomes trial, Redefine3. Following these results, Novo Nordisk will approach authorities to discuss the regulatory pathway for CagriSema and type 2 diabetes. In summary, CagriSema has demonstrated superior results in both glycemic control and weight reduction. These results represent a highly effective treatment option for individuals with type 2 diabetes seeking weight management solutions in addition to glycemic control. Next slide, please.
Speaker #2: Results from the pivotal REIMAGINE 1 trial are anticipated in the first quarter of 2026. In addition, we await the long-term safety and efficacy cardiovascular outcomes trial, REDEFINED 3.
Speaker #2: Following these results, Novo Nordisk will approach authorities to discuss the regulatory pathway for KAGRA SEMA in type 2 diabetes. In summary, KAGRA SEMA has demonstrated superior results in both glycemic control and weight reduction.
Michael Novart: Following these results, Novo Nordisk will approach authorities to discuss the regulatory pathway for CagriSema and type 2 diabetes. In summary, CagriSema has demonstrated superior results in both glycemic control and weight reduction. These results represent a highly effective treatment option for individuals with type 2 diabetes seeking weight management solutions in addition to glycemic control. Next slide, please. In November, we announced positive headline results from the first evaluation of amycretin, formerly called amitriptyline, in people with type 2 diabetes. The trial investigated the efficacy, safety, and pharmacokinetics of once-weekly subcutaneous and once-daily oral amycretin compared to placebo. The trial included around 450 people with type 2 diabetes inadequately controlled on metformin, with or without an SGLT2 inhibitor as standard of care. About 40% of participants were using an SGLT2 inhibitor at baseline.
Speaker #2: These results represent a highly effective treatment option for individuals with type 2 diabetes seeking weight management solutions in addition to glycemic control. Next slide, please.
Martin Lange: In November, we announced positive headline results from the first evaluation of amycretin, formerly called amitriptyline, in people with type 2 diabetes. The trial investigated the efficacy, safety, and pharmacokinetics of once-weekly subcutaneous and once-daily oral amycretin compared to placebo. The trial included around 450 people with type 2 diabetes inadequately controlled on metformin, with or without an SGLT2 inhibitor as standard of care. About 40% of participants were using an SGLT2 inhibitor at baseline. The trial was a combined multi-ascending dose study investigating six subcutaneous doses ranging from 0.4mg to 40mg and three oral doses ranging from 6mg, 25mg, to 50mg. From a mean baseline HbA1c of 7.8%, once-weekly Amycretin lowered HbA1c by up to 1.8 percentage points at week 36 in a dose-dependent manner, assuming all people adhered to treatment.
Speaker #2: In November, we announced positive headline results from the first evaluation of senogemtide, formerly called amitriptyline, in people with type 2 diabetes. The trial investigated the efficacy, safety, and pharmacokinetics of once-weekly subcutaneous senogemtide compared to once-daily oral senogemtide placebo.
Speaker #2: The trial included around 450 people with type 2 diabetes inadequately controlled on metformin, with or without an SGLT2 inhibitor, as standard of care. About 40% of participants were using an SGLT2 inhibitor at baseline.
Speaker #2: The trial was a combined multi-ascending dose study investigating six subcutaneous doses ranging from 0.4 milligrams to 40 milligrams, and three oral doses of 6 milligrams, 25 milligrams, and 50 milligrams.
Michael Novart: The trial was a combined multi-ascending dose study investigating six subcutaneous doses ranging from 0.4mg to 40mg and three oral doses ranging from 6mg, 25mg, to 50mg. From a mean baseline HbA1c of 7.8%, once-weekly Amycretin lowered HbA1c by up to 1.8 percentage points at week 36 in a dose-dependent manner, assuming all people adhered to treatment. The proportion of people achieving HbA1c below 7% was up to 89.1%. Furthermore, people treated with oral Amycretin achieved dose-dependent reductions of HbA1c of up to 1.5 percentage points by week 36 from a baseline of 8%. Almost 78% of people achieved an HbA1c level below 7%. The estimated improvements in HbA1c were all statistically significant versus placebo, confirming the primary endpoint on the trial. Both subcutaneous and oral Amycretin appeared to have a safe and well-tolerated profile consistent with other GLP-1 and amylin-based therapies.
Speaker #2: From a mean baseline HbA1c of 7.8%, once-weekly senogemtide lowered A1c by up to 1.8 percentage points at week 36 in a dose-dependent manner, assuming all people adhere to treatment.
Speaker #2: The proportion of people achieving A1c below 7% was up to 89.1%. Furthermore, people treated with oral senogemtide achieved dose-dependent reductions of A1c of up to 1.5 percentage points, by week 36, from a baseline of 8%.
Martin Lange: The proportion of people achieving HbA1c below 7% was up to 89.1%. Furthermore, people treated with oral Amycretin achieved dose-dependent reductions of HbA1c of up to 1.5 percentage points by week 36 from a baseline of 8%. Almost 78% of people achieved an HbA1c level below 7%. The estimated improvements in HbA1c were all statistically significant versus placebo, confirming the primary endpoint on the trial. Both subcutaneous and oral Amycretin appeared to have a safe and well-tolerated profile consistent with other GLP-1 and amylin-based therapies. The data further support the potential of amycretin as a next-generation treatment for type 2 diabetes, and we look forward to bringing it into an extensive phase 3 program called Ambition in type 2 diabetes and other indications in the second half of 2026.
Speaker #2: Almost 78% of people achieved an A1c level below 7%. The estimated improvements in A1c were all statistically significant versus placebo, confirming the primary endpoint of the trial.
Speaker #2: Both subcutaneous and oral senogemtide appeared to have a safe and well-tolerated profile, consistent with other ingredients and ambient-based therapies. The data further support the potential of senogemtide as a next-generation treatment for type 2 diabetes, and we look forward to bringing it into an extensive phase 3 program called AMBITION in type 2 diabetes and other indications in the second half of 2026.
Michael Novart: The data further support the potential of amycretin as a next-generation treatment for type 2 diabetes, and we look forward to bringing it into an extensive phase 3 program called Ambition in type 2 diabetes and other indications in the second half of 2026. In addition, the phase 3 obesity program called AMACE will start in Q1 2026. As a reminder, the phase 1B/2A clinical trial with amycretin in people with obesity or overweight demonstrated a 22% weight loss with a 20mg dose after 36 weeks of treatment. The Ambition and the AMACE programs will both investigate the subcutaneous maintenance dose up to 40mg. Next slide, please. We have an exciting year ahead across therapy areas here at Novo Nordisk, beginning with diabetes. You just heard about the advances that we made with our late-stage internal assets, CagriSema and amycretin.
Martin Lange: In addition, the phase 3 obesity program called AMACE will start in Q1 2026. As a reminder, the phase 1B/2A clinical trial with amycretin in people with obesity or overweight demonstrated a 22% weight loss with a 20mg dose after 36 weeks of treatment. The Ambition and the AMACE programs will both investigate the subcutaneous maintenance dose up to 40mg. Next slide, please. We have an exciting year ahead across therapy areas here at Novo Nordisk, beginning with diabetes. You just heard about the advances that we made with our late-stage internal assets, CagriSema and amycretin. We've also achieved progress through external innovation that we have done throughout the last few years.
Speaker #2: In addition, the Phase 3 obesity program called AMACE will start in the first quarter of 2026. As a reminder, the Phase 1b/2a clinical trial with amitriptyline in people with obesity or overweight demonstrated a 22% weight loss with a 20 milligram dose after 36 weeks of treatment.
Speaker #2: The AMBITION and the AMACE programs will both investigate the subcutaneous maintenance dose up to 40 milligrams. Next slide, please. We have an exciting year ahead across therapeutic areas here at Novo Nordisk.
Speaker #2: Beginning with diabetes, you just heard about the advances that we made with our late-stage internal ACEs, such as KAGRA SEMA and senogemtide. We've also achieved progress through external innovation, which we have done throughout the last few years.
Michael Novart: We've also achieved progress through external innovation that we have done throughout the last few years. We expect phase 2 data from our in-licensed UBT251 asset, a GLP-1 GIP glucagon triagonist, in a Chinese type 2 diabetes population in the first half of this year, with plans to initiate our own phase 2 study in type 2 diabetes in the second half of this year. Within the diabetes-associated comorbidities, the first readout of ziltivekimab from the SUSE phase 3 trial is anticipated in the second half of this year. The trial is assessing free-point MACE relative risk reduction on top of standard of care. Ziltivekimab holds the potential to be a first-in-class treatment targeting systemic inflammation in people living with atherosclerotic cardiovascular disease and chronic kidney disease. In obesity, we expect results from the Redefine4 trial in the first quarter of this year, assessing weight loss efficacy compared to tirzepatide.
Martin Lange: We expect phase 2 data from our in-licensed UBT251 asset, a GLP-1 GIP glucagon triagonist, in a Chinese type 2 diabetes population in the first half of this year, with plans to initiate our own phase 2 study in type 2 diabetes in the second half of this year. Within the diabetes-associated comorbidities, the first readout of ziltivekimab from the SUSE phase 3 trial is anticipated in the second half of this year. The trial is assessing free-point MACE relative risk reduction on top of standard of care. Ziltivekimab holds the potential to be a first-in-class treatment targeting systemic inflammation in people living with atherosclerotic cardiovascular disease and chronic kidney disease. In obesity, we expect results from the Redefine4 trial in the first quarter of this year, assessing weight loss efficacy compared to tirzepatide.
Speaker #2: We expect Phase 2 data from our in-licensed UBT251 asset at GLP-1, GIP, and glucagon triagonist, in a Chinese type 2 diabetes population in the first half of this year, with plans to initiate our own Phase 2 study in type 2 diabetes in the second half of this year.
Speaker #2: Within the diabetes-associated comorbidities, the first readout of siltivecumab from the SUS phase 3 trial is anticipated in the second half of this year. The trial is assessing 3-point MACE relative risk reduction on top of standard of care.
Speaker #2: Siltivecumab holds the potential to be a first-in-class treatment targeting systemic inflammation in people living with atherosclerotic cardiovascular disease and chronic kidney disease. In obesity, we expect results from the redefined 4 trial in the first quarter of this year, assessing weight loss efficacy compared to cepatite.
Speaker #2: The study's primary change in body weight assessed for endpoint is percent non-inferiority. We are assessing further KAGRA SEMA weight loss potential in the ongoing REDEFINED 11 trial, with results expected early in 2027.
Michael Novart: The study's primary endpoint is percent change in body weight assessed for non-inferiority. We are assessing further CagriSema weight loss potential in the ongoing Redefine11 trial, with results expected early in 2027. A new phase 3 trial with CagriSema high dose is also planned to initiate later this year. For our triple agonist, we expect phase 2 data from our in-licensed UBT251 asset in a Chinese obese and overweight population in the first half of this year, and we have already initiated our own phase 1B2 study in obesity. We would also like to highlight the first human dose trial with our internal triagonist, a GLP-1, GIP, amylin-targeted agonist that was completed in Q3 2025. Single doses up to 1.5mg and multiple weekly subcutaneous doses up to 1.24mg were tested. The primary endpoint was treatment emergent adverse events.
Martin Lange: The study's primary endpoint is percent change in body weight assessed for non-inferiority. We are assessing further CagriSema weight loss potential in the ongoing Redefine11 trial, with results expected early in 2027. A new phase 3 trial with CagriSema high dose is also planned to initiate later this year. For our triple agonist, we expect phase 2 data from our in-licensed UBT251 asset in a Chinese obese and overweight population in the first half of this year, and we have already initiated our own phase 1B2 study in obesity. We would also like to highlight the first human dose trial with our internal triagonist, a GLP-1, GIP, amylin-targeted agonist that was completed in Q3 2025. Single doses up to 1.5mg and multiple weekly subcutaneous doses up to 1.24mg were tested. The primary endpoint was treatment emergent adverse events.
Speaker #2: And a new phase 3 trial with KAGRA SEMA high dose is also planned to initiate later this year. For our triple agonist, we expect phase 2 data from our in-licensed UBT251 asset in a Chinese obese and overweight population in the first half of this year, and we've already initiated our own phase 1b/2 study in obesity.
Speaker #2: We would also like to highlight the first human dose trial without internal triagonist at GLP-1, GIP, amyloid-targeted agonist that was completed in the third quarter of 2025.
Speaker #2: Single doses up to 1.5 milligrams and multiple weekly subcutaneous doses up to 1.24 milligrams were tested. The primary endpoint was treatment-emerging adverse events.
Speaker #2: The safety profile of the triagonist was consistent with increased attempt-based therapies. The percentage change in body weight from baseline ranged from minus 3.6% to 5.3% for the triagonist versus 0.5% for placebo at four weeks.
Michael Novart: The safety profile of the triagonist was consistent with GLP-1-based therapies. The percentage change in body weight from baseline ranged from -3.6% to -5.3% for the triagonist versus -0.5% for placebo at four weeks. The four-week data confirm our belief in the potential for high weight loss efficacy with the triagonist. We recently initiated a phase 1b/2 trial in obesity with expected readout during the first half of 2027. In addition, we have several ongoing submissions in obesity in the US and globally. We anticipate the EU's decision on oral semaglutide 25 mg and injectable semaglutide 7.2 mg during the second half of this year. We also anticipate forthcoming decisions regarding semaglutide 7.2 mg, and later in the year, CagriSema in the US. 2026 is an exciting year in rare disease as well.
Martin Lange: The safety profile of the triagonist was consistent with GLP-1-based therapies. The percentage change in body weight from baseline ranged from -3.6% to -5.3% for the triagonist versus -0.5% for placebo at four weeks. The four-week data confirm our belief in the potential for high weight loss efficacy with the triagonist. We recently initiated a phase 1b/2 trial in obesity with expected readout during the first half of 2027. In addition, we have several ongoing submissions in obesity in the US and globally. We anticipate the EU's decision on oral semaglutide 25 mg and injectable semaglutide 7.2 mg during the second half of this year. We also anticipate forthcoming decisions regarding semaglutide 7.2 mg, and later in the year, CagriSema in the US. 2026 is an exciting year in rare disease as well.
Speaker #2: The four-week data confirm our belief in the potential for high weight loss efficacy with the triagonist. We recently initiated a phase 1b/2 trial in obesity, with expected readout during the first half of 2027.
Speaker #2: In addition, we have several ongoing submissions in obesity in the US and globally. We anticipate the EU's decision on oral semaglutide 25 milligram and injectable semaglutide 7.2 milligram during the second half of this year.
Speaker #2: We also anticipate forthcoming decisions regarding semaglutide 7.2 milligrams, and later in the year, KAGRA SEMA in the US. 2026 is an exciting year in rare disease as well.
Speaker #2: The Phase 3 HIBISCUS readout for etabopivet and sickle cell disease is expected in the second quarter of this year. Etabopivet has a novel mechanism of action with the potential to improve both hemoglobin health and vaso-occlusive crisis event rates in people living with sickle cell disease.
Michael Novart: The Phase 3 Hibiscus readout for its Etavopivat in sickle cell disease is expected in Q2 of this year. Its Etavopivat has a novel mechanism of action with the potential to improve both hemoglobin health and vaso-occlusive crisis event rates in people living with sickle cell disease. Finally, we are awaiting regulatory decision for Dysanimic, previously known as Mim8. Dysanimic is a once-monthly, once every two weeks, or once-weekly prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in people with hemophilia A with or without inhibitors. Regulatory decisions in the US and the EU are expected in the second half of 2026. With that, over to you, Karsten. Thank you, Martin. Please turn to the next slide. In 2025, our sales grew by 10% at constant exchange rates driven by both operating units. In the US, sales growth was positively impacted by gross-to-net sales adjustments.
Martin Lange: The Phase 3 Hibiscus readout for its Etavopivat in sickle cell disease is expected in Q2 of this year. Its Etavopivat has a novel mechanism of action with the potential to improve both hemoglobin health and vaso-occlusive crisis event rates in people living with sickle cell disease. Finally, we are awaiting regulatory decision for Dysanimic, previously known as Mim8. Dysanimic is a once-monthly, once every two weeks, or once-weekly prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in people with hemophilia A with or without inhibitors. Regulatory decisions in the US and the EU are expected in the second half of 2026. With that, over to you, Karsten.
Speaker #2: Finally, we are awaiting a regulatory decision for denizumic, previously known as mymete. Denizumic is a once-monthly, once-every-two-weeks, or once-weekly prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in people with hemophilia A, with or without inhibitors.
Speaker #2: Regulatory decisions in the US and the EU are expected in the second half of 2026. With that, over to you, Karsten. Thank you, Martin.
Karsten Knudsen: Thank you, Martin. Please turn to the next slide. In 2025, our sales grew by 10% at constant exchange rates driven by both operating units. In the US, sales growth was positively impacted by gross-to-net sales adjustments. The gross margin decreased to 81% compared to 84.7% in 2024. The decrease in gross margin is impacted by amortizations and depreciation related to the acquisition of the three Catalent manufacturing sites, as well as one-off restructuring costs related to the company-wide transformation we announced in the third quarter. Operating profit decreased by 1% in Danish kroner and increased by 6% at constant exchange rates, reflecting higher sales and distribution costs tied to Wegovy promotional activities and launches, as well as increased early research and development stage investments.
Speaker #2: Please turn to the next slide. In 2025, our sales grew by 10% at constant exchange rates, driven by both operating units. In the US, sales growth was positively impacted by gross-to-net sales adjustments.
Speaker #2: The gross margin decreased to 81% compared to 84.7% in 2024. The decrease in gross margin is impacted by amortization and depreciation related to the acquisition of the three Catalent manufacturing sites.
Michael Novart: The gross margin decreased to 81% compared to 84.7% in 2024. The decrease in gross margin is impacted by amortizations and depreciation related to the acquisition of the three Catalent manufacturing sites, as well as one-off restructuring costs related to the company-wide transformation we announced in the third quarter. Operating profit decreased by 1% in Danish kroner and increased by 6% at constant exchange rates, reflecting higher sales and distribution costs tied to Wegovy promotional activities and launches, as well as increased early research and development stage investments. The main impact on operating profits was, however, the company-wide restructuring cost of around DKK 8 billion. Excluding this, operating profit would have increased by 6% in Danish kroner and 13% at constant exchange rates. Please go to the next slide.
Speaker #2: As well as one-off restructuring costs related to the company-wide transformation we announced in the third quarter. Operating profit decreased by 1% in Danish kroner and increased by 6% at constant exchange rates.
Speaker #2: Reflecting higher sales and distribution costs tied to Wegovy promotional activities and launches, as well as increased early and early research and development stage investments.
Speaker #2: The main impact on operating profits was, however, the company-wide restructuring cost of around DKK 8 billion. Excluding this, operating profit would have increased by 6% in Danish kroner and 13% at constant exchange rates.
Karsten Knudsen: The main impact on operating profits was, however, the company-wide restructuring cost of around DKK 8 billion. Excluding this, operating profit would have increased by 6% in Danish kroner and 13% at constant exchange rates. Please go to the next slide. In 2025, from a net profit of DKK 102 billion, we generated close to DKK 120 billion in cash from operating activities. Our deployment of capital followed our allocation principles. Investing in the business with around DKK 60 billion going towards manufacturing capacity expansion through capital expenditure and around DKK 30 billion to expand the R&D pipeline through business development activities. We also returned around DKK 52 billion to shareholders in the form of dividends.
Speaker #2: Please go to the next slide. In 2025, from a net profit of DKK 102 billion, we generated close to DKK 120 billion in cash from operating activities.
Michael Novart: In 2025, from a net profit of DKK 102 billion, we generated close to DKK 120 billion in cash from operating activities. Our deployment of capital followed our allocation principles. Investing in the business with around DKK 60 billion going towards manufacturing capacity expansion through capital expenditure and around DKK 30 billion to expand the R&D pipeline through business development activities. We also returned around DKK 52 billion to shareholders in the form of dividends. At the annual general meeting on 26 March 2026, the board of directors will propose a final dividend of DKK 7.95 for an expected total 2025 dividend of DKK 11.70, including the interim dividend paid out in 25 August 2025. This is a 2.6% increase compared to last year, making it the 30th consecutive year with increasing dividend per share.
Speaker #2: Our deployment of capital followed our allocation principles, investing in the business with around DKK 60 billion going towards manufacturing capacity expansion through capital expenditure, and around DKK 30 billion to expand the R&D pipeline through business development activities.
Speaker #2: We also returned around DKK 52 billion to shareholders in the form of dividends. At the annual general meeting on March 26, 2026, the Board of Directors will propose a final dividend of DKK 7.95 and EUR 0.95, for an expected total 2025 dividend of DKK 11.70 and EUR 1.40.
Karsten Knudsen: At the annual general meeting on 26 March 2026, the board of directors will propose a final dividend of DKK 7.95 for an expected total 2025 dividend of DKK 11.70, including the interim dividend paid out in 25 August 2025. This is a 2.6% increase compared to last year, making it the 30th consecutive year with increasing dividend per share. Novo Nordisk will continue to deliver returns to shareholders in 2026, with total cash returns anticipated to be over DKK 60 billion. In addition, the board of directors has approved a new share repurchase program of up to DKK 15 billion to be executed during the next 12 months. Please turn to the next slide. In 2026, sales and operating profit will be positively impacted by a reversal of sales rebate provisions of $4.2 billion related to the 340B drug pricing program in the US.
Speaker #2: Including the interim dividend paid out in August '25, this is a 2.6% increase compared to last year, making it the 30th consecutive year with increasing dividend per share.
Speaker #2: Novo Nordisk will continue to deliver returns to shareholders in 2026, with total cash returns anticipated to be over DKK 60 billion. In addition, the Board of Directors has approved a new share repurchase program of up to DKK 15 billion to be executed during the next 12 months.
Michael Novart: Novo Nordisk will continue to deliver returns to shareholders in 2026, with total cash returns anticipated to be over DKK 60 billion. In addition, the board of directors has approved a new share repurchase program of up to DKK 15 billion to be executed during the next 12 months. Please turn to the next slide. In 2026, sales and operating profit will be positively impacted by a reversal of sales rebate provisions of $4.2 billion related to the 340B drug pricing program in the US. In order to enhance transparency and comparability of underlying operating performance, Novo Nordisk will present outlook and expectations on adjusted sales and adjusted operating profit growth basis at constant exchange rates going forward. This is introduced to exclude certain exceptional and non-recurring effects, primarily of non-cash nature, including the provision reversal.
Speaker #2: Please turn to the next slide. In 2026, sales and operating profit will be positively impacted by a reversal of sales rebate provisions of $4.2 billion, US 340B drug pricing program, in the dollars related to the US.
Speaker #2: In order to enhance transparency and comparability of underlying operating performance, Novo Nordisk will present outlook and expectations on adjusted sales and adjusted operating profit growth basis at constant exchange rates going forward.
Karsten Knudsen: In order to enhance transparency and comparability of underlying operating performance, Novo Nordisk will present outlook and expectations on adjusted sales and adjusted operating profit growth basis at constant exchange rates going forward. This is introduced to exclude certain exceptional and non-recurring effects, primarily of non-cash nature, including the provision reversal. Adjusted operating profits will likewise exclude the impact of the 340B provision reversal, as well as other exceptional and non-recurring effects related to effects such as major impairment losses and major legal matters. For 2026, adjusted sales growth is expected to be -5% to -13% at constant exchange rates. Given the current exchange rate versus Danish kroner, growth reported in Danish kroner is expected to be 3 percentage points lower than at constant exchange rates.
Speaker #2: This is introduced to exclude certain exceptional and non-recurring effects, primarily of a non-cash nature, including the provision reversal. Adjusted operating profits will likewise exclude the impact of the 340B provision reversal.
Michael Novart: Adjusted operating profits will likewise exclude the impact of the 340B provision reversal, as well as other exceptional and non-recurring effects related to effects such as major impairment losses and major legal matters. For 2026, adjusted sales growth is expected to be -5% to -13% at constant exchange rates. Given the current exchange rate versus Danish kroner, growth reported in Danish kroner is expected to be 3 percentage points lower than at constant exchange rates. The outlook reflects expectations for sales growth within international operations and expectations for sales decline within US operations. The global GLP-1 market expansion is assumed to continue in 2026, enabling Novo Nordisk to increase patient reach and expand volumes. However, this is countered by lower realized prices, including impacts from the Most Favored Nations agreements in the US and loss of exclusivity for the semaglutide molecule in certain markets in international operations.
Speaker #2: As well as other exceptional and non-recurring effects, related to effects such as major impairment losses and major legal matters. For 2026, adjusted sales growth is expected to be minus 5% to minus 13% at constant exchange rates. Given the current exchange rate versus Danish kroner, growth reported in Danish kroner is expected to be 3 percentage points lower than at constant exchange rates.
Karsten Knudsen: The outlook reflects expectations for sales growth within international operations and expectations for sales decline within US operations. The global GLP-1 market expansion is assumed to continue in 2026, enabling Novo Nordisk to increase patient reach and expand volumes. However, this is countered by lower realized prices, including impacts from the Most Favored Nations agreements in the US and loss of exclusivity for the semaglutide molecule in certain markets in international operations.
Speaker #2: The outlook reflects expectations for sales growth within international operations and expectations for sales decline within US operations. The global deal-to-run market expansion is assumed to continue in 2026, enabling Novo Nordisk to increase patient reach and expand volumes.
Speaker #2: However, this is countered by lower realized prices, including impacts from most-favored-nations agreements in the US, and loss of exclusivity for the semaglutide molecule in certain markets in International Operations.
Speaker #2: Lastly, positive impacts related to US gross-to-net sales adjustments during 2025 are not anticipated to reoccur. In international operations, the outlook is based on current growth trends, including continued volume penetration from GLP-1 treatments and market expansion, mainly within obesity, as well as intensifying competition and negative impacts from the patent expiry of semaglutide in certain markets.
Michael Novart: Lastly, positive impacts related to US growth-to-net sales adjustments during 2025 are not anticipated to reoccur. In international operations, the outlook is based on current growth trends, including continued volume penetration from GLP-1 treatments and market expansion, mainly within obesity, as well as intensifying competition and negative impacts from the patent expiry of semaglutide in certain markets. In US operations, the outlook is based on current prescription trends for the injectable GLP-1 portfolio, intensifying competition, as well as negative impact from reduced anti-obesity medication coverage in Medicaid. Furthermore, lower realized prices linked to investments in market access are amplified by the MFN agreement with the US administration. Uptake related to the launch of the Wegovy pill is reflected based on a range of assumptions related to market penetration, potential negative impact on the growth of the injectable anti-obesity medication category, as well as Ozempic.
Karsten Knudsen: Lastly, positive impacts related to US growth-to-net sales adjustments during 2025 are not anticipated to reoccur. In international operations, the outlook is based on current growth trends, including continued volume penetration from GLP-1 treatments and market expansion, mainly within obesity, as well as intensifying competition and negative impacts from the patent expiry of semaglutide in certain markets. In US operations, the outlook is based on current prescription trends for the injectable GLP-1 portfolio, intensifying competition, as well as negative impact from reduced anti-obesity medication coverage in Medicaid.
Speaker #2: For US operations, the outlook is based on current prescription trends for the injectable GLP-1 portfolio, intensifying competition, as well as the negative impact from reduced anti-obesity medication coverage in Medicaid.
Karsten Knudsen: Furthermore, lower realized prices linked to investments in market access are amplified by the MFN agreement with the US administration. Uptake related to the launch of the Wegovy pill is reflected based on a range of assumptions related to market penetration, potential negative impact on the growth of the injectable anti-obesity medication category, as well as Ozempic. Adjusted operating profit growth is expected to be -5% to -13% at constant exchange rates. Given the current exchange rates versus the Danish kroner, reported operating profit growth in Danish kroner is expected to be around 5 percentage points lower than at constant exchange rates. The expectation for adjusted operating profit growth primarily reflects the sales growth outlook combined with targeted investments in current and future growth opportunities within R&D and commercial.
Speaker #2: Furthermore, lower realized prices linked to investments in market access are amplified by the MFN agreement with the US administration. Uptake related to the launch of the Wegovy pill is reflected based on a range of assumptions related to market penetration, potential negative impact on the growth of the injectable anti-obesity medication category, as well as generics.
Speaker #2: Adjusted operating profit growth is expected to be minus 5% to minus 13% at constant exchange rates. Given the current exchange rates versus the Danish kroner, reported operating profit growth in Danish kroner is expected to be around 5 percentage points lower than at constant exchange rates.
Michael Novart: Adjusted operating profit growth is expected to be -5% to -13% at constant exchange rates. Given the current exchange rates versus the Danish kroner, reported operating profit growth in Danish kroner is expected to be around 5 percentage points lower than at constant exchange rates. The expectation for adjusted operating profit growth primarily reflects the sales growth outlook combined with targeted investments in current and future growth opportunities within R&D and commercial. Other key modeling considerations for 2026 are shown on the slides. Of note, as of 2026, Novo Nordisk defines free cash flow as net cash generated from operating activities, less purchase of property, plant, and equipment, and is expected to be DKK 35 to 45 billion. Capital expenditure is expected to be around DKK 55 billion in 2026. In the coming years, the capital expenditure investments are expected to decline following expansion project finalizations.
Speaker #2: The expectation for adjusted operating profit growth primarily reflects the sales growth outlook, combined with targeted investments in current and future growth opportunities within R&D and commercial.
Karsten Knudsen: Other key modeling considerations for 2026 are shown on the slides. Of note, as of 2026, Novo Nordisk defines free cash flow as net cash generated from operating activities, less purchase of property, plant, and equipment, and is expected to be DKK 35 to 45 billion. Capital expenditure is expected to be around DKK 55 billion in 2026. In the coming years, the capital expenditure investments are expected to decline following expansion project finalizations. That covers the outlook for 2026. Now back to you, Mike.
Speaker #2: Other key modeling considerations for 2026 are shown on the slides. Of note, as of 2026, Novo Nordisk defines free cash flow as net cash generated from operating activities less purchases of property, plant, and equipment, and it is expected to be DKK 35 to 45 billion.
Speaker #2: Capital expenditure is expected to be around DKK 55 billion in 2026. In the coming years, capital expenditure investments are expected to decline following expansion project finalizations.
Michael Novart: That covers the outlook for 2026. Now back to you, Mike. Thank you, Karsten. Please turn to the next slide. Our 2025 strategic aspirations have run their course, and while the challenging 2025 presented significant challenges affecting our performance and share price, those adversities have also made us more resilient. We have plenty of work left to do in order to meet the vast unmet needs for people living with diabetes, obesity, and their related comorbidities, as well as those with rare diseases which we aim to treat in the future. We expect to introduce new strategic aspirations as part of Capital Markets Day, which will be held on 21 September in London. Until then, we will, of course, continue to report and track progress across key dimensions of the business. With that, I will turn it back to you, Michael. Thank you, Mike. Next slide, please.
Speaker #2: That covers the outlook for 2026. Now back to you, Mike. Thank you, Karsten. Please turn to the next slide. Our 2025 strategic aspirations have run their course.
Mike Doustdar: Thank you, Karsten. Please turn to the next slide. Our 2025 strategic aspirations have run their course, and while the challenging 2025 presented significant challenges affecting our performance and share price, those adversities have also made us more resilient. We have plenty of work left to do in order to meet the vast unmet needs for people living with diabetes, obesity, and their related comorbidities, as well as those with rare diseases which we aim to treat in the future. We expect to introduce new strategic aspirations as part of Capital Markets Day, which will be held on 21 September in London. Until then, we will, of course, continue to report and track progress across key dimensions of the business. With that, I will turn it back to you, Michael.
Speaker #2: And while we acknowledge 2025 presented significant challenges affecting our performance and share price, those adversities have also made us more resilient. We have plenty of work left to do in order to meet the vast unmet needs for people living with diabetes, obesity, and their related comorbidities.
Speaker #2: As well as those we aim to treat in the future. We expect to introduce new strategic aspirations as part of Capital Markets Day, which will be held on September 21st in London.
Speaker #2: Until then, we will, of course, continue to report and track progress across key dimensions of the business. With that, I will turn it back to you, Michael.
Michael Novod: Thank you, Mike. Next slide, please. With that, we're now ready for the Q&A. We'll kindly ask all participants to limit her or himself to 1 or maximum 2 questions, including sub-questions. Operator, we're now ready to take the first question.
Speaker #1: Thank you, Mike. Next slide, please. With that, we're now ready for the Q&A. We kindly ask all participants to limit himself or herself to one or a maximum of two questions, including sub-questions.
Michael Novart: With that, we're now ready for the Q&A. We'll kindly ask all participants to limit her or himself to 1 or maximum 2 questions, including sub-questions. Operator, we're now ready to take the first question. Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. We will now take the first question. And your first question today comes from the line of James Quigley from Goldman Sachs. Please go ahead. Great. Thanks for taking my question. I've got 2, please. So firstly, just to try to triangulate your guidance. You're suggesting low single-digit growth in international operations. And again, that would suggest -20 also in the US.
Speaker #1: Operator, we're now ready to take the first question.
Operator: Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. We will now take the first question. And your first question today comes from the line of James Quigley from Goldman Sachs. Please go ahead. Great.
Speaker #3: 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.
Speaker #3: Please press star, one, and one again. We will now take the first question. Today, it comes from the line of James Quigley from Goldman Sachs. Please go ahead.
Speaker #4: Great, thanks for taking my question. I've got two, please. So firstly, just to try to triangulate your guidance: you're suggesting low single-digit growth in International Operations and, again, that would suggest minus 20—and also in the US.
James Quigley: Thanks for taking my question. I've got 2, please. So firstly, just to try to triangulate your guidance. You're suggesting low single-digit growth in international operations. And again, that would suggest -20 also in the US. So could you give us a sense of how this breaks down between volumes and price at a high level, please, particularly given that your key competitor suggested low to mid-teens pricing on a global basis this morning? And the second question, on the Medicaid unlock, how are you thinking about the potential speed here? Again, your competitor suggests the unlock could be pretty fast starting from 1 July, but the guidance suggests slower uptake here. So what are the basis of your assumptions around the speed of unlock? Thank you.
Speaker #4: So, could you give us a sense of how this breaks down between volumes and price at a high level, please? Particularly given that your key competitor has suggested low- to mid-teens pricing on a global basis.
Michael Novart: So could you give us a sense of how this breaks down between volumes and price at a high level, please, particularly given that your key competitor suggested low to mid-teens pricing on a global basis this morning? And the second question, on the Medicaid unlock, how are you thinking about the potential speed here? Again, your competitor suggests the unlock could be pretty fast starting from 1 July, but the guidance suggests slower uptake here. So what are the basis of your assumptions around the speed of unlock? Thank you. Thank you, James. Two questions, both for Karsten. Yeah. Thank you, James. And thank you for listening in and posing your question. As to the guidance first, with international operations delivering 8% growth in the Q4 of last year and around 10% in the second half, that's the run rate we're entering 2026.
Speaker #4: This morning, the second question on the Medicare unlock—how are you thinking about the potential speed here? Again, your competitors suggest the unlock could be pretty fast, starting from July 1st.
Speaker #4: But you're both the guidance and the suggest slower uptake here. So what are the basis of your assumptions around the speed of unlock? Thank you.
Speaker #4: you. Thank you,
Michael Novod: Thank you, James. Two questions, both for Karsten.
Speaker #1: James. Two questions both for
Karsten Knudsen: Yeah. Thank you, James. And thank you for listening in and posing your question. As to the guidance first, with international operations delivering 8% growth in the Q4 of last year and around 10% in the second half, that's the run rate we're entering 2026. Then adjust for LOE in specific markets on CIMA, then you get to mid-single-digit growth for international. And consequently, based on our guidance, then the residual leaves the US growth to be in the teens in terms of sales decline. So that's the key factors. I would say the US decline is driven by price declines, and it's driven by both investments in market access being a key driver, build of the cash channel in the US at a different price point, so channel mix, and then the MFN impacts where we, a few quarters ago or one quarter ago, announced that it will have a low single-digit impact on group sales, meaning roughly double on US.
Speaker #2: Yeah.
Speaker #2: Thank you, James. Karsten, and thank you for posting your question. And thank you for listening in to the guidance. First, with the international operations delivering 8% growth in the fourth quarter of last year, and around 10% in the second half, that's a run rate we're entering 2026.
Speaker #2: Then adjust for LOE in specific markets on SIMA, then you get to mid-single-digit growth for International. And consequently, based on our guidance, then the residual leaves the US growth to be in the teens in terms of sales decline.
Michael Novart: Then adjust for LOE in specific markets on CIMA, then you get to mid-single-digit growth for international. And consequently, based on our guidance, then the residual leaves the US growth to be in the teens in terms of sales decline. So that's the key factors. I would say the US decline is driven by price declines, and it's driven by both investments in market access being a key driver, build of the cash channel in the US at a different price point, so channel mix, and then the MFN impacts where we, a few quarters ago or one quarter ago, announced that it will have a low single-digit impact on group sales, meaning roughly double on US. So the key notion is, of course, with these price reductions, to what extent are we then able to convert that into expanding volume reach and volumes in the marketplace? It's early days.
Speaker #2: So that's a key factor. I would say the US decline is driven by price declines, and it's driven by both investments in market access being a key driver, and the build of the cash channel in the US at a different price point.
Speaker #2: So, channel mix and then the MFN impacts, where we a few quarters ago, or one quarter ago, announced that it will have a low single-digit impact on group sales.
Speaker #2: So, meaning roughly double on US. So the key notion is, of course, with these price reductions, to what extent are we then able to convert that into expanding—and volumes in the volume reach?
Karsten Knudsen: So the key notion is, of course, with these price reductions, to what extent are we then able to convert that into expanding volume reach and volumes in the marketplace? It's early days. We have built assumptions in. Clearly, we've looked at the first four weeks of the Wegovy pill launch, where we're very encouraged, as Dave showed just before. The same on Wegovy injectable. We're actually looking to the tune of 30% of Wegovy injectable scripts now being cash-driven, so also building that. We are seeing a volume response to the lower prices. Exactly how the year pans out remains to be seen because we have a number of variables at play. Net-net, it is price declines that drive US down.
Speaker #2: Marketplace? It's early days. We have built assumptions in. Clearly, we've looked at the first four weeks of the Google Pill launch, where we're very encouraged, as Dave showed just before.
Michael Novart: We have built assumptions in. Clearly, we've looked at the first four weeks of the Wegovy pill launch, where we're very encouraged, as Dave showed just before. The same on Wegovy injectable. We're actually looking to the tune of 30% of Wegovy injectable scripts now being cash-driven, so also building that. We are seeing a volume response to the lower prices. Exactly how the year pans out remains to be seen because we have a number of variables at play. Net-net, it is price declines that drive US down. On Medicare and impact from Medicare Part D and the MFN deal, we do expect that we'll have benefits starting around mid this year, having Wegovy reimbursed in Medicare Part D and hence being available for seniors under a reimbursed setting. We have included that in our guidance.
Speaker #2: And the same on the Google Injectable, where we're actually looking at—to the tune of 30%—of the Google Injectable scripts now being cash-driven.
Speaker #2: So also building that. So we are seeing a volume response to the lower prices. Exactly how the year pans out remains to be seen.
Speaker #1: Because we have a number of variables at play . But net it is . It is . Price declines that that drives that drive us down on on Medicare and and that that drives that drives us down on on Medicare and and impact from Medicare Part D and the MFN deal .
Karsten Knudsen: On Medicare and impact from Medicare Part D and the MFN deal, we do expect that we'll have benefits starting around mid this year, having Wegovy reimbursed in Medicare Part D and hence being available for seniors under a reimbursed setting. We have included that in our guidance. But at this point, given the lag times of educating physicians and admin staff, understanding how it works, and for patients to access that benefit, it will be a gradual ramp with limited benefit this year and a bigger benefit into 2027.
Speaker #1: We we expect that that do a have benefit starting around mid , mid this year . Having wegovy reimbursed in Medicare Part D hence and being available for seniors under reimbursed .
Michael Novart: But at this point, given the lag times of educating physicians and admin staff, understanding how it works, and for patients to access that benefit, it will be a gradual ramp with limited benefit this year and a bigger benefit into 2027. Great. Thank you. Thank you. Your next question today comes from the line of Sachin Jain from Bank of America. Please go ahead. Hi there. Thanks for taking my questions. I've got two more on guidance, if I may, Karsten. Apologies. So maybe framing James's question slightly differently. I asked a pushes and pulls question at Q3, and not that I'm misspeaking, but I think you roughly phrased it as underlying growth, less three sets of headwinds, are roughly low single-digit each.
Speaker #1: We have included that in our guidance. But at this point, given the time lag of educating physicians and physicians' admin and staff, understanding settings, how it works, and for patients to access that benefit, it will be a gradual ramp with limited benefit this year and a bigger benefit as we get into 2027.
James Quigley: Great. Thank you.
Operator: Thank you. Your next question today comes from the line of Sachin Jain from Bank of America. Please go ahead.
Speaker #2: Great . Thank you
Speaker #2: .
Sachin Jain: Hi there. Thanks for taking my questions. I've got two more on guidance, if I may, Karsten. Apologies. So maybe framing James's question slightly differently. I asked a pushes and pulls question at Q3, and not that I'm misspeaking, but I think you roughly phrased it as underlying growth, less three sets of headwinds, are roughly low single-digit each.
Speaker #3: Thank you. You're into the next question from the line of Sachin Bank of Jain from America. Please go ahead.
Speaker #4: taking my there . Thanks for . Hi If I guidance . may . I've Cast an apology . So framing maybe James's question slightly differently , I asked pushes and pulls got two more on at third quarter and not when that think you misspeaking .
Speaker #4: questions .
Michael Novart: So I'm just trying to understand between Q3 and the guidance today, what shifted you from that sort of low single digit to now minus 5 to 13? So the mid to high single-digit delta versus consensus, how much that is volume and price. And within price, what's the new component? It seems to be cash channel. And then second, more specifically, a question I've had frequently overnight is, what needs to happen for you to achieve the bottom end of your guidance? Multiple investors trying to work out how conservative that is, particularly around your oral assumptions being driven by injectable switch. Thank you. Thanks, Sachin. Also two questions for Karsten on guidance and also on the sort of pushes and pulls between high and low. Yeah. Thanks for these questions, Sachin. And as you recall, I didn't guide for 2026 at our Q3 call.
Sachin Jain: So I'm just trying to understand between Q3 and the guidance today, what shifted you from that sort of low single digit to now minus 5 to 13? So the mid to high single-digit delta versus consensus, how much that is volume and price. And within price, what's the new component? It seems to be cash channel. And then second, more specifically, a question I've had frequently overnight is, what needs to happen for you to achieve the bottom end of your guidance? Multiple investors trying to work out how conservative that is, particularly around your oral assumptions being driven by injectable switch. Thank you.
Speaker #4: roughly phrased it as But I underlying growth . Less three sets of headwinds roughly , a low single digit each . So I'm just trying to understand between three Q and the guidance today , what shifted you from that sort of low single digit to now minus 5 to 13 .
Speaker #4: So, delta versus consensus, how much of that is mid to volume and digit is price? And within price, what's the new component?
Speaker #4: It seems to be cash channel. And then second, more specifically, a question I've had frequently overnight is: what needs to happen to achieve the bottom end of your, for you, guidance.
Speaker #4: Multiple investors trying to work out how conservative that is, particularly around your oral assumptions, being driven by injectable switch. Thank you.
Michael Novod: Thanks, Sachin. Also two questions for Karsten on guidance and also on the sort of pushes and pulls between high and low.
Karsten Knudsen: Yeah. Thanks for these questions, Sachin. And as you recall, I didn't guide for 2026 at our Q3 call. So that's the starting point. As we also note in our current release, we base our guidance based on the latest trends we see in the market. So the guidance we put out now is based on, of course, the run rate we left 2025 with, so Q4 performance, as I alluded to before, and then whatever triggering events and expectations and assumptions around the future we are building in. So those are really the key points that we build in. What have we known more? What do we know more today compared to Q3? We have some more nuances on the run rate in international operations.
Speaker #5: Thanks also for the questions for Carsten on guidance, and also on the sort of push and pulls between high and low.
Speaker #1: Yeah , thanks questions , for these Sachin . And and as you recall , I didn't guide for 2026 at our Q3 call .
Michael Novart: So that's the starting point. As we also note in our current release, we base our guidance based on the latest trends we see in the market. So the guidance we put out now is based on, of course, the run rate we left 2025 with, so Q4 performance, as I alluded to before, and then whatever triggering events and expectations and assumptions around the future we are building in. So those are really the key points that we build in. What have we known more? What do we know more today compared to Q3? We have some more nuances on the run rate in international operations. You see the 8% growth in Q4. Of course, some more market intel on more specific and detailed pricing and reimbursement choices in some of the markets there.
Speaker #1: So, so, so that's the point. Starting, and as, as, as in our—we currently also note we base our guidance based on, on, on the latest trends in the market.
Speaker #1: So so we see the guidance put out we now is of course , based on , the run rate we left 2025 with so , so Q4 performance , as I alluded to before .
Speaker #1: And whatever triggering events and expectations and around the future , we we are building in so , so those are really , really the the key points that that we build in known .
Speaker #1: More? What do we know? What have we—what do we have more compared to Q3 today? We have some more nuances on the run rate in international operations.
Karsten Knudsen: You see the 8% growth in Q4. Of course, some more market intel on more specific and detailed pricing and reimbursement choices in some of the markets there. Then in the US, what we know there beyond the Q4 closeout was really about, I would say, the Wegovy pill uptake in the first month, as Dave alluded to, which we're very happy with, and then the Wegovy injectable cash business and the response to the lowering of the initiation prices to $199. So that's really kind of the key fundamental changes since three months ago.
Speaker #1: You see the 8% growth in the fourth quarter and , and and of course , some more market Intel on specific on more and pricing and detailed reimbursement reimbursement choices in in some of markets , the there and then then in the US , what we know there beyond the Q4 close was is really about I would say the the pill uptake in in the first month .
Michael Novart: Then in the US, what we know there beyond the Q4 closeout was really about, I would say, the Wegovy pill uptake in the first month, as Dave alluded to, which we're very happy with, and then the Wegovy injectable cash business and the response to the lowering of the initiation prices to $199. So that's really kind of the key fundamental changes since three months ago. Hi there. Hi there. Yeah. Thanks, Michael, for reminding me on that one. It's important to remember, and we've been experiencing this for some years now, the obesity market is just significantly more dynamic than most other markets where it's much more stable prescription trends through normal GPs. So the macro variable that can both be positive and negative is the dynamics in the obesity market. We're not concerned about the expansion of the markets.
Speaker #1: As Dave alluded to , which we're very happy with . And then the Govi injectable cash business and the response to to the lowering of the of the initiation prices to to 199 .
Karsten Knudsen: Hi there. Hi there. Yeah. Thanks, Michael, for reminding me on that one. It's important to remember, and we've been experiencing this for some years now, the obesity market is just significantly more dynamic than most other markets where it's much more stable prescription trends through normal GPs. So the macro variable that can both be positive and negative is the dynamics in the obesity market. We're not concerned about the expansion of the markets. We saw it more than double in 2025. So we're very confident in continued expansion of the market space. But the variables I'm alluding to is really, of course, as always, competitive dynamics, as always, growth-to-net dynamics that are being forecasted with a lag.
Speaker #1: So , so that's that's really kind of the , the the key fundamental changes since , since three months ago
Speaker #1: Hello. Yeah. Thanks, Michael, for
Speaker #1: reminding me on . High that one . It's to , to remember and we've been experiencing this for , for you know , some some years now .
Speaker #1: The obesity market is just significantly more dynamic than, than most other markets, where it's much more stable prescription trends through the GPs.
Speaker #1: The obesity market is just significantly more dynamic than, than most other markets where it's, it's much more stable prescription trends through, through the GPs. Normal, so variable, that can both is be positive and negative, is the dynamics in the obesity market.
Michael Novart: We saw it more than double in 2025. So we're very confident in continued expansion of the market space. But the variables I'm alluding to is really, of course, as always, competitive dynamics, as always, growth-to-net dynamics that are being forecasted with a lag. And then also the sourcing dynamics and channel dynamics impacting pricing and volume of Wegovy pill and how that is impacting both Wegovy injectable but also how a competitive launch plays into all of this. So I'd say it's classic variables, but it's in a very dynamic market segment. Thanks, Karsten. Thanks, Sachin. Next question, please. Thank you. Your next question comes from the line of Richard Vosser from J.P. Morgan. Please go ahead. Hi. Thanks for taking my question. Just one follow-up thinking about formulary access for Wegovy.
Speaker #1: It's we're not concerned about the expansion of the markets . We saw it more than double in 2025 . So so we're very confident in continued expansion of of the market space .
Speaker #1: but the But alluding variables I'm to is is really of course , as always competitive dynamics as always gross to nets dynamics that are being forecasted with with a lack and and then also the sourcing dynamics and channel dynamics impacting impacting pricing and volume of of the Covid pill and and how that is impacting impacting both wegovy injectable but but also how plays into all of So this .
Karsten Knudsen: And then also the sourcing dynamics and channel dynamics impacting pricing and volume of Wegovy pill and how that is impacting both Wegovy injectable but also how a competitive launch plays into all of this. So I'd say it's classic variables, but it's in a very dynamic market segment.
Michael Novod: Thanks, Karsten. Thanks, Sachin. Next question, please.
Speaker #1: I'd say it's classic variables, but it's in a very dynamic market segment.
Operator: Thank you. Your next question comes from the line of Richard Vosser from J.P. Morgan. Please go ahead.
Speaker #5: Thanks. Thanks, Sachin. Next question, please.
Richard Vosser: Hi. Thanks for taking my question. Just one follow-up thinking about formulary access for Wegovy. You highlighted the access for oral Wegovy in a pill, but are you seeing and how are you thinking about that access in the commercial channel this year? Seems like maybe employers would be incentivized to maybe reduce access given the availability of products in the cash channel at lower prices. So just thoughts on that and how that might affect the mix and volumes in that channel. And maybe a second question, just compounder volume. Obviously, a very strong oral launch, and you're saying new patients. But any evidence that those lower prices are stymieing the compounder volume and any idea that you're taking share using the oral from compounders? Thanks very much.
Speaker #3: Thank you. Your next question comes from the line of Richard Fossa from J.P. Morgan. Please go ahead.
Michael Novart: You highlighted the access for oral Wegovy in a pill, but are you seeing and how are you thinking about that access in the commercial channel this year? Seems like maybe employers would be incentivized to maybe reduce access given the availability of products in the cash channel at lower prices. So just thoughts on that and how that might affect the mix and volumes in that channel. And maybe a second question, just compounder volume. Obviously, a very strong oral launch, and you're saying new patients. But any evidence that those lower prices are stymieing the compounder volume and any idea that you're taking share using the oral from compounders? Thanks very much. Great. Thanks, Richard. So two questions for Dave, one on the formulary access and also the other one on compounder. Yeah. Thanks very much, Richard. On the injectable side, we see relatively stable access.
Speaker #6: Hi . Thanks for taking my question . Just one follow up . Thinking about formulary Wegovy . access for You highlighted the access for for oral wegovy in a pill , but are you seeing and how you're thinking about that access in the channel this commercial seems seems like maybe year would be incentivized to to to to maybe reduce access given the availability of products in the cash channel at lower prices .
Speaker #6: So just thoughts on that, and how that might affect the mix. And volumes in that, in that channel. And maybe a second question, just compound the volume.
Speaker #6: Obviously a very strong oral launch. And you're saying new patients. Any evidence that those lower prices are stymieing the compounder volume, and any idea that you're taking share using the oral form from compounders?
Michael Novod: Great. Thanks, Richard. So two questions for Dave, one on the formulary access and also the other one on compounder.
Speaker #6: Thanks very much .
Speaker #5: Great . Thanks , Richard . So two questions for for Dave . One on the formulary access . And also the other one on compounder .
Dave Moore: Yeah. Thanks very much, Richard. On the injectable side, we see relatively stable access. And of course, we have discussions every year to maintain that level of access. And you've heard us talk about before, we're very interested in reducing that friction and making the experience easier for patients. We did have some states that have decided to not cover AOMs. For example, California is a big one. But I will say that with the lower prices that are available today, we will continue to re-engage with those states with the hopes that we can increase access in Medicaid as well. On the pill side, what you heard me mention is we've actually seen some positive progress in just the first month. We started out the month of January having CVS covering it right out of the gate. And then we quickly were able to add Prime, Optum, and Anthem.
Michael Novart: And of course, we have discussions every year to maintain that level of access. And you've heard us talk about before, we're very interested in reducing that friction and making the experience easier for patients. We did have some states that have decided to not cover AOMs. For example, California is a big one. But I will say that with the lower prices that are available today, we will continue to re-engage with those states with the hopes that we can increase access in Medicaid as well. On the pill side, what you heard me mention is we've actually seen some positive progress in just the first month. We started out the month of January having CVS covering it right out of the gate. And then we quickly were able to add Prime, Optum, and Anthem.
Speaker #7: Yeah , thanks very much , Richard . On the on the injectable side , we see relatively stable access . And of course have discussions every we year to maintain that level of access .
Speaker #7: And as you've heard us talk about before, we're very interested in reducing that friction and making the experience easier for patients. We did have some states that have decided to not cover AOMs.
Speaker #7: For example , California is a big one , but I will say that with the the lower prices that are available today , we will continue to re-engage with those states with the hopes that we can increase Medicaid access in as well .
Speaker #7: On the pill side, what you hear, you heard me mention, is we've actually seen some positive progress in just the first month.
Speaker #7: We started out , the month of January , having CVS covering it right out of the gate , and then we quickly were able to add prime , Optum and Anthem , and we will continue to build that over the course of the year .
Michael Novart: And we will continue to build that over the course of the year, expecting that there will be both plans as well as employers that will be interested in covering the pill. On your second question about compounding, we haven't seen a change yet. It's early days. The compounding market, what we're seeing right now is what we would consider relatively stable. I can tell you, as of this week, we have over 170,000 people that are on the Wegovy pill. And most of that is self-pay. And we get daily feeds because of the way that we went to market. And so we certainly expect that there could be some switching that's coming from compounding. But it's a little bit early to tell, and we don't get any of that longitudinal data, but we'll certainly be researching that as more data comes in. Thank you very much, Dave.
Dave Moore: And we will continue to build that over the course of the year, expecting that there will be both plans as well as employers that will be interested in covering the pill. On your second question about compounding, we haven't seen a change yet. It's early days. The compounding market, what we're seeing right now is what we would consider relatively stable. I can tell you, as of this week, we have over 170,000 people that are on the Wegovy pill. And most of that is self-pay. And we get daily feeds because of the way that we went to market. And so we certainly expect that there could be some switching that's coming from compounding. But it's a little bit early to tell, and we don't get any of that longitudinal data, but we'll certainly be researching that as more data comes in.
Speaker #7: You know, expecting that— that there will be both plans as well as employers that will be interested in covering the pill.
Speaker #7: On your second question about compounding , we haven't seen a change yet . It's early days . The compounding market , what we're seeing right now is what we would consider relatively stable .
Speaker #7: I can tell you, you know, as of this week, we have over 170,000 people that are on the Wegovy pill.
Speaker #7: And most of that is self-pay. And we get daily feeds because of the way that we went to market. And so we certainly expect that there could be some switching that's coming from compounding, but it's a little bit early to tell.
Michael Novod: Thank you very much, Dave. Thank you, Richard. Next question, please.
Speaker #7: And we don't get any of that longitudinal data. But we'll certainly be researching that as more data comes in.
Michael Novart: Thank you, Richard. Next question, please. Thank you. Your next question comes from the line of Peter Verdult from BNP Paribas. Please go ahead. Yeah. Thank you, Peter Verdult from BNP. Two questions. Just firstly, on Martin, realize you're not going to change the messaging on Redefine 4 at this juncture, but can you at least remind us on trial design, was flexible dosing allowed as we saw in Redefine 1, or was it more fixed in nature for CagriSema's appetite in Redefine 4? Basically, any major trial differences we need to be aware of when we compare Redefine 4 to 1. And then, Karsten and Mike, forgive me going back to guidance, but I'm not going to ask you to go line by line every assumption, but just the spirit of the guidance you've provided.
Operator: Thank you. Your next question comes from the line of Peter Verdult from BNP Paribas. Please go ahead.
Speaker #5: Thank you very much, Dave. Thank you, Richard. Next question, please.
Peter Verdult: Yeah. Thank you, Peter Verdult from BNP. Two questions. Just firstly, on Martin, realize you're not going to change the messaging on Redefine 4 at this juncture, but can you at least remind us on trial design, was flexible dosing allowed as we saw in Redefine 1, or was it more fixed in nature for CagriSema's appetite in Redefine 4? Basically, any major trial differences we need to be aware of when we compare Redefine 4 to 1. And then, Karsten and Mike, forgive me going back to guidance, but I'm not going to ask you to go line by line every assumption, but just the spirit of the guidance you've provided.
Speaker #3: Thank you. Your next question comes from the line of Peter from BNP Paribas. Please go ahead.
Speaker #8: Yeah . Thank you . . Peter BNP two questions . Just firstly on Martin . Realize you're not going to change the messaging on redefined for at this juncture .
Speaker #8: But can you at least remind us: on trial design, was flexible dosing allowed, as we saw in REDEFINE One, or was it more fixed in nature?
Speaker #8: For category Sammarinese, appetite is redefined for basically any major trial differences. We need to be aware of when we compare Redefine 4 to 1, and then fast.
Michael Novart: I mean, is this reflecting sort of genuine concerns on cannibalization and competition, or are you simply starting the year as conservatively as you can to finally prevent this persistent Owens downgrade story from continuing through 2026? Thank you. Thank you, Pete. So two questions. First to Martin on Redefine 4, and then second to Mike on high-level guidance dynamics. Absolutely. So Redefine 1, you're absolutely right. We basically have no new news, so we're not going to change the story. Redefine 4 is comparing CagriSema to Tirzepatide in an obese population on weight loss testing for non-inferiority first, followed by superiority testing. The dosing was similar to Redefine 1. As you recall, we took some learnings from Redefine 1, including that we needed to do longer studies.
Peter Verdult: I mean, is this reflecting sort of genuine concerns on cannibalization and competition, or are you simply starting the year as conservatively as you can to finally prevent this persistent Owens downgrade story from continuing through 2026? Thank you.
Speaker #8: And Mike, forgive me, going back to guidance, I'm not going to ask you to go line by line on every assumption.
Speaker #8: But just the spirit of the guidance you provided, I mean, is this reflecting sort of genuine concerns on panelization and competition, or are you simply starting the year as conservatively as you can to finally prevent this persistent earnings downgrade story from continuing through 2026?
Michael Novod: Thank you, Pete. So two questions. First to Martin on Redefine 4, and then second to Mike on high-level guidance dynamics.
Speaker #8: Thank you .
Speaker #5: Thank you, Pete. So, two questions. First to Martin on redefined 'for,' and then second to Mike on high-level guidance dynamics.
Martin Lange: Absolutely. So Redefine 1, you're absolutely right. We basically have no new news, so we're not going to change the story. Redefine 4 is comparing CagriSema to Tirzepatide in an obese population on weight loss testing for non-inferiority first, followed by superiority testing. The dosing was similar to Redefine 1. As you recall, we took some learnings from Redefine 1, including that we needed to do longer studies. And I think we maintain what we've always said for Redefine 4, but we also are looking forward to Redefine 11, where we'll see the full weight loss potential of CagriSema.
Speaker #5: Absolutely . So so redefine one . You're absolutely right . We we we basically have no new news . So we're not going to change the story .
Speaker #5: REDEFINE Forward is comparing CagriSema and tirzepatide in an obese population on weight loss, testing first for non-inferiority followed by superiority testing. The dosing was similar to REDEFINE 1.
Speaker #5: As you recall , we took some learnings from redefine one , including that we needed to do longer studies , and I think we we we maintain what we've always said for for redefine four , but we also are looking forward to redefine 11 , where we'll see the full weight loss potential of of Kagoshima .
Michael Novart: And I think we maintain what we've always said for Redefine 4, but we also are looking forward to Redefine 11, where we'll see the full weight loss potential of CagriSema. Very good. So Peter, I think I'll start by saying we have all acknowledged how volatile and dynamic the obesity market is with a lot of and lots of moving parts. The way we guide is we discuss and talk, of course, to our operating units. We take a look at the macro trends, and we put the latest information we have in place. We start by looking at last year's finish and the run rate to that, especially Q4, but even more so granularly looking at the three months within the Q4 data that we have available. So that's kind of a starting point.
Mike Doustdar: Very good. So Peter, I think I'll start by saying we have all acknowledged how volatile and dynamic the obesity market is with a lot of and lots of moving parts. The way we guide is we discuss and talk, of course, to our operating units. We take a look at the macro trends, and we put the latest information we have in place. We start by looking at last year's finish and the run rate to that, especially Q4, but even more so granularly looking at the three months within the Q4 data that we have available. So that's kind of a starting point.
Speaker #5: .
Speaker #9: Good, very. So, Peter, I think I'll start by saying we have all acknowledged how volatile and dynamic the obesity market is, with a lot of, and lots of, moving parts.
Speaker #9: The way we guide is we discuss and talk . Of course , to our operating units . look at We take a the macro trends and and we put the latest information we have in place .
Speaker #9: We start by looking at the last year's finish and and the run rate to that , especially Q4 . But even so more looking gradually at the within the Q4 data that that that we have available .
Michael Novart: Then we basically go ahead and try to see the new data we have available. Karsten alluded to it. We have 4 weeks of pill data. It's incredibly encouraging, and we consider that. It's in the guidance, basically. Of course, not fully knowing what's going to happen the next 11 months, but we make some good assumptions around that. Then there are things that we have actually previously discussed with all of you. Think about the LOE in international operations. That hasn't really changed. It was there before. It is now. We have not seen the impact of that yet. It will come into place starting from Q2. So will some of the other things on the upside that will come in in Q2. We just touched upon it, Medicare.
Mike Doustdar: Then we basically go ahead and try to see the new data we have available. Karsten alluded to it. We have 4 weeks of pill data. It's incredibly encouraging, and we consider that. It's in the guidance, basically. Of course, not fully knowing what's going to happen the next 11 months, but we make some good assumptions around that. Then there are things that we have actually previously discussed with all of you. Think about the LOE in international operations. That hasn't really changed. It was there before. It is now. We have not seen the impact of that yet. It will come into place starting from Q2. So will some of the other things on the upside that will come in in Q2. We just touched upon it, Medicare.
Speaker #9: So that's kind of a starting point. Then we basically go ahead and try to see the new data we have available. Karsten alluded to it.
Speaker #9: We have four weeks of pill data . It's incredibly encouraging . And we consider that . And it's in the guidance basically . Of course , not fully no knowing what's going to happen the next 11 months .
Speaker #9: But we make some good assumptions around that. Then there are things that we have actually previously discussed with all of you. Think about the low in international operations.
Speaker #9: That hasn't really changed . It was there before . It is now . We have not seen the impact of that yet . It will come into place starting from Q2 and so will some of the other things .
Michael Novart: Medicare is a group of people that we would love to provide GLP-1 products to, but we haven't started yet, and it's going to basically get going in the second part of the year. So we make again assumptions around that. We put the midpoint and our own targets, and then we give it the plus and minus the four points on each side. And that's how we've done it in the past. That's how we've done it this year. Great. Thanks, Mike. Thanks, Martin. And thanks, Pete. Next question, please. Thank you. Your next question comes from the line of Mike Nedelcovic from TD Cowen. Please go ahead. Hi. Thanks so much. I have two questions. My first is on Wegovy pill supply. Given the strong launch of Wegovy pill, is there any risk of supply outages in 2026?
Mike Doustdar: Medicare is a group of people that we would love to provide GLP-1 products to, but we haven't started yet, and it's going to basically get going in the second part of the year. So we make again assumptions around that. We put the midpoint and our own targets, and then we give it the plus and minus the four points on each side. And that's how we've done it in the past. That's how we've done it this year.
Speaker #9: On the that will come in in Q2, we just touched upon it. Medicare, Medicare is a group of that we people love.
Speaker #9: We provide to would GLP-1 products to, but we haven't started yet. And it's going to basically get going in the second part of the year.
Speaker #9: So so we make assumptions around that . We put the midpoint and our own targets , and then we give it the plus and minus the four points on each side .
Michael Novod: Great. Thanks, Mike. Thanks, Martin. And thanks, Pete. Next question, please.
Speaker #9: And that's how we've done it in the past. That's how we've done it this year.
Operator: Thank you. Your next question comes from the line of Mike Nedelcovic from TD Cowen. Please go ahead.
Speaker #10: Great . Thanks , Mike . Thanks , Martin . And thanks , Pete . Next question please .
Mike Nedelcovych: Hi. Thanks so much. I have two questions. My first is on Wegovy pill supply. Given the strong launch of Wegovy pill, is there any risk of supply outages in 2026? For example, if adoption persists at this current high level, could Novo service that demand through the end of the year with its current capacity? And then my second question is on CagriSema and Redefine 4. Martin, I have to admit your response to the earlier question struck me as somewhat ominous. Why do you think we will have to wait for Redefine 11 readout to see the full weight loss potential of CagriSema? Why could it not be revealed by Redefine 4 given the changes that were made to the trial? Thank you.
Speaker #3: Thank you. Your next question comes from the line of Mike Nedeljkovic from TD Cowen. Please go ahead.
Speaker #11: Hi, thanks so much. I have two questions. My first is on Wegovy pill supply, given the strong launch of the Wegovy pill.
Michael Novart: For example, if adoption persists at this current high level, could Novo service that demand through the end of the year with its current capacity? And then my second question is on CagriSema and Redefine 4. Martin, I have to admit your response to the earlier question struck me as somewhat ominous. Why do you think we will have to wait for Redefine 11 readout to see the full weight loss potential of CagriSema? Why could it not be revealed by Redefine 4 given the changes that were made to the trial? Thank you. Thank you very much. Two questions. First to Mike on Wegovy pill supply, and the second one to Martin on both Redefine 4 and Redefine 11. Yeah. Thanks very much, Mike.
Speaker #11: Is there any risk of supply outages in 2026? For example, if adoption persists at this current high level, could Novo service that demand through the end of the year with its current capacity?
Speaker #11: And then my second question is on Cagrisema and ReDefine for Martin. I have to admit, your answer to the earlier question struck me as somewhat ominous.
Speaker #11: Why do you think we will have to wait for the REDEFINE 11 readout to see the full weight loss potential of CagriSema? Why could it not be revealed by REDEFINE 4 given the changes that were made to the trial?
Michael Novod: Thank you very much. Two questions. First to Mike on Wegovy pill supply, and the second one to Martin on both Redefine 4 and Redefine 11.
Speaker #11: Thank you .
Speaker #10: Thank you very much . Two questions . First , to Mike on the Gobi supply or Gobi pill supply . And the second one to Martin on both redefined for and redefine 11 .
Mike Doustdar: Yeah. Thanks very much, Mike. Over the last period, on a number of occasions, I have spoken to how confident we are with regards to the Wegovy pill supply. We basically have said that we launched the pill in the US at a time where we will be confident enough to know we will not run into a supply situation anymore. We have seen an incredible uptake, I would say, in the first month. And today, I will reaffirm to you that we feel incredibly confident that we will be able to supply the US market.
Michael Novart: Over the last period, on a number of occasions, I have spoken to how confident we are with regards to the Wegovy pill supply. We basically have said that we launched the pill in the US at a time where we will be confident enough to know we will not run into a supply situation anymore. We have seen an incredible uptake, I would say, in the first month. And today, I will reaffirm to you that we feel incredibly confident that we will be able to supply the US market. Very clear. Yeah. On Redefine 4, we always have to think about when we do amendments to ongoing trials. We cannot fully guide what will happen. We can extend the study. But we also had to acknowledge that the learnings that we took from Redefine 1 was, in part, we needed to do longer treatment duration.
Speaker #9: Yeah. Thank you very much, Mike. Over the last period, on a number of occasions, I have spoken to how confident we are with regards to the Wegovy pill supply.
Speaker #9: We basically have said that we launched the pill in the US at a time where we were confident enough to know we will not run into a supply situation anymore.
Speaker #9: We have seen an incredible uptake, I would say, in the first month, and today I will reaffirm to you that we feel incredibly confident that we will be able to supply the US market.
Mike Nedelcovych: Very clear.
Martin Lange: Yeah. On Redefine 4, we always have to think about when we do amendments to ongoing trials. We cannot fully guide what will happen. We can extend the study. But we also had to acknowledge that the learnings that we took from Redefine 1 was, in part, we needed to do longer treatment duration. But it was actually also paradoxically, in part, to drive even more flexible dosing, securing that we actually get more patients to the highest target but using longer time. That we cannot change in Redefine 4. We have optimized that in Redefine 11. So the trial duration, we've tried to optimize in Redefine 4.
Speaker #10: Very clear .
Speaker #5: Yeah . On redefined for we we we always have to think about when when we do amendments to to to ongoing trials . We we cannot fully guide what what what will happen .
Speaker #5: We can extend the study , but we also had to acknowledge that the learnings that we took from Redefine one was in part , we needed to do longer treatment duration , but it was actually also a paradoxically , in part to drive even more flexible dosing , securing that we actually get more patients to , to , to the higher target by using longer time that we cannot change and redefine .
Michael Novart: But it was actually also paradoxically, in part, to drive even more flexible dosing, securing that we actually get more patients to the highest target but using longer time. That we cannot change in Redefine 4. We have optimized that in Redefine 11. So the trial duration, we've tried to optimize in Redefine 4. But in Redefine 11, we've taken all the learnings on titration, what we call flexible titration. I'm not sure I still like the word, but what we call flexible titration, and put that to use in Redefine 11. And we can already now see that that does really make a difference to the patients and how they act in the trial.
Martin Lange: But in Redefine 11, we've taken all the learnings on titration, what we call flexible titration. I'm not sure I still like the word, but what we call flexible titration, and put that to use in Redefine 11. And we can already now see that that does really make a difference to the patients and how they act in the trial. So I still have a lot of optimism on Redefine 4, but I think the full weight loss potential we'll only learn when we do the full trial duration and the flexible dosing that really will drive patients to use CagriSema in the optimized way.
Speaker #5: For we have optimized that in redefine 11 . So so the trial duration we tried to optimize , optimize and redefine for . But in redefine 11 we've taken all the learnings on titration , what we call flexible titration .
Speaker #5: I'm not sure I still like the word but but but what we call flexible titration . And put that to use in redefine 11 .
Michael Novart: So I still have a lot of optimism on Redefine 4, but I think the full weight loss potential we'll only learn when we do the full trial duration and the flexible dosing that really will drive patients to use CagriSema in the optimized way. Great. Thank you, Martin. Thanks, Mike. Over to the next question, please. Thank you. Your next question comes from the line of Harry Sephton from UBS. Please go ahead. Brilliant. Thanks very much for taking my questions. I have two on the Wegovy pill, please. Just want to start with what your expectations are for the sustainability of the Wegovy pill demand.
Speaker #5: And we can already now see that that that does really make a difference to the patients and how they act in the trial. So, so I still have a lot of optimism on redefined four, but I think the full weight loss potential will only be learned when we do the full trial duration.
Michael Novod: Great. Thank you, Martin. Thanks, Mike. Over to the next question, please.
Speaker #5: And the flexible dosing—that really will drive patients to use CagriSema in the optimized way.
Operator: Thank you. Your next question comes from the line of Harry Sephton from UBS. Please go ahead.
Speaker #10: Great . Thank you Martin . Thanks , Mike . Over to the next question , please .
Harry Sephton: Brilliant. Thanks very much for taking my questions. I have two on the Wegovy pill, please. Just want to start with what your expectations are for the sustainability of the Wegovy pill demand. If you wouldn't mind, is there any evidence from Novo's Rybelsus experience that points to any variation in the stay time on therapy versus the injectable, and how do you think about also the demand for the pill through the competitor or for Orfoglipron launch? And then my second question is on the economics of the Wegovy pill. So given the much lower price point and the much higher API demand, how does the gross margin contribution of the Wegovy pill compare to the injectable? Thank you very much.
Speaker #3: Thank you. Your next question comes from the line of Harry Sefton from UBS. Please go ahead.
Speaker #12: Brilliant . Thanks very much for taking my questions . I have two on the Wegovy pill . Please want to . Just start with what your expectations are for the sustainability of Wegovy pill the demand .
Michael Novart: If you wouldn't mind, is there any evidence from Novo's Rybelsus experience that points to any variation in the stay time on therapy versus the injectable, and how do you think about also the demand for the pill through the competitor or for Orfoglipron launch? And then my second question is on the economics of the Wegovy pill. So given the much lower price point and the much higher API demand, how does the gross margin contribution of the Wegovy pill compare to the injectable? Thank you very much. Thank you very much, Harry. Two questions. The first on Wegovy pill demand and dosing to Mike, and then the second one around economics to Karsten. Thanks very much. When you think about the sustainability of growth and demand, then two things come to my mind.
Speaker #12: If you wouldn't mind, is there any evidence from Novo's Rybelsus experience that points to any variation in the stay time on therapy versus the injectable, and how?
Speaker #12: Think about also the demand for the pill through the competitor or for on launch. And then my second question is on the economics of the Wegovy pill.
Speaker #12: So given the much lower price point and the much higher API demand, how does the gross margin contribution of the Wegovy pill compare to the injectable?
Michael Novod: Thank you very much, Harry. Two questions. The first on Wegovy pill demand and dosing to Mike, and then the second one around economics to Karsten.
Speaker #12: Thank much you very .
Speaker #10: very much . Harry . Thank you Two questions . The first , on the Gobi pill demand and dosing to to Mike . And then the one around second economics to cost .
Mike Doustdar: Thanks very much. When you think about the sustainability of growth and demand, then two things come to my mind. 1, of course, competitive and competitive pressure, as well as how much you push yourself into doing something despite the competitors. Let me start with the first one. We have gone all in. This has been the best launch, partially also because we have really put in all the activities and the promotions that we could think of, not least, of course, what it was alluded to earlier on, the partnership with all of our e-health players being available in 70,000 retail pharmacies today has been partially due to that has been partially the reason behind that incredible uptake. But then, of course, the question comes, what happens after competition arrives? Can you uphold this? Is it sustainable?
Speaker #9: Thanks much . very When you think about the sustainability of a growth and demand , then then two things comes to my mind .
Michael Novart: 1, of course, competitive and competitive pressure, as well as how much you push yourself into doing something despite the competitors. Let me start with the first one. We have gone all in. This has been the best launch, partially also because we have really put in all the activities and the promotions that we could think of, not least, of course, what it was alluded to earlier on, the partnership with all of our e-health players being available in 70,000 retail pharmacies today has been partially due to that has been partially the reason behind that incredible uptake. But then, of course, the question comes, what happens after competition arrives? Can you uphold this? Is it sustainable? I would say that the last 2 years has taught us something very specific with the obesity market.
Speaker #9: One, of course, competitive and competitive pressure, as well as how much you push yourself into doing something despite the competitors.
Speaker #9: Let me start with the first one . We have gone all in . This has been the best launch , partially also because we have really put in all activities and the promotions that that they could think of , not least of course , what was alluded to earlier on the partnership with all of our eHealth players being available in 70,000 retail pharmacies today has been partially due to that has been partially the reason behind that incredible uptake .
Mike Doustdar: I would say that the last 2 years has taught us something very specific with the obesity market. It has taught us that the number one criterion for a patient picking up anti-obesity medication is the magnitude of weight loss. When you take a look at this, then you realize, based on our latest trial, we have shown that when you take the drug, then Wegovy pill gives you 16.6% weight loss in addition to all the CV benefits and the great stuff that it has. But 16.6% weight loss. We've also read the data from our competing product, and we have seen that they are at 12.4%. If you round those things up, then you get to 17% and 12%. If you ask pretty much any patient, and certainly ask me, which one would you rather take, losing 17% weight loss or 12%? I know my answer.
Speaker #9: But then , of course , the question comes what happens after competition arrives ? Can you uphold this ? Is it sustainable ? I would say that the last two years taught very something the has obesity us with specific market .
Michael Novart: It has taught us that the number one criterion for a patient picking up anti-obesity medication is the magnitude of weight loss. When you take a look at this, then you realize, based on our latest trial, we have shown that when you take the drug, then Wegovy pill gives you 16.6% weight loss in addition to all the CV benefits and the great stuff that it has. But 16.6% weight loss. We've also read the data from our competing product, and we have seen that they are at 12.4%. If you round those things up, then you get to 17% and 12%. If you ask pretty much any patient, and certainly ask me, which one would you rather take, losing 17% weight loss or 12%? I know my answer.
Speaker #9: It has taught us that the number one criteria for a patient picking up an anti-obesity medication is the magnitude of weight loss . And and when you take a look at this , then you realize , based on our latest trial , we have shown that when you take the drug , then Wegovy pill gives you 16.6% weight loss .
Speaker #9: In addition to all the CV benefits and the great stuff that it has, with 16.6% weight loss, we've also read the data from our competing product, and we have seen that they are at 12.4%.
Speaker #9: If you round those things up, then you get to 17% and 12%. If you ask pretty much any patients, and certainly ask me, which one would you rather take?
Michael Novart: And we have seen the answer from 170,000 employees coming on very quickly, recognizing that this is not just a pill. It's a peptide. It's a large protein inside a pill that gives you that incredible efficacy. And that has been giving us a lot of optimism. And we will continue, of course, pushing this through and promoting it. Don't be surprised if you see in the big game on Sunday, you see us visible. And we will basically make sure that we'll do our utmost to make this pill a success. Thanks, Mike. And Karsten? Yeah. Thanks, Harry, for the manufacturing economics question. On gross margin, the short version is that the gross margin on Wegovy pill is below that of Wegovy injectable, but it's important to know that it's lower on gross margin level, but it's still an attractive gross margin.
Mike Doustdar: And we have seen the answer from 170,000 employees coming on very quickly, recognizing that this is not just a pill. It's a peptide. It's a large protein inside a pill that gives you that incredible efficacy. And that has been giving us a lot of optimism. And we will continue, of course, pushing this through and promoting it. Don't be surprised if you see in the big game on Sunday, you see us visible. And we will basically make sure that we'll do our utmost to make this pill a success.
Speaker #9: Losing 17% weight loss or 12? I know my answer, and we have seen the answer from 170,000 employees coming on very quickly, recognizing that this is not just a pill, it's a peptide.
Speaker #9: It's a large protein inside a pill that gives you that incredible efficacy, and that has been giving us a lot of optimism. And we will continue, of course, pushing this through.
Speaker #9: promoting And it . Don't be surprised if you see in the big game on Sunday , see you visible and we will . Basically make sure that we'll do our utmost to make this pill a success .
Michael Novod: Thanks, Mike. And Karsten?
Karsten Knudsen: Yeah. Thanks, Harry, for the manufacturing economics question. On gross margin, the short version is that the gross margin on Wegovy pill is below that of Wegovy injectable, but it's important to know that it's lower on gross margin level, but it's still an attractive gross margin. So we are all in pushing the pill. And of course, the overarching intention is to expand the markets and not cannibalize from our own products.
Speaker #10: Thanks, Mike and Carsten. Yeah.
Speaker #1: Thanks for for for the manufacturing economics question . The on on on gross margin . The the short version is that the gross margin on the pill is below that of the injectable .
Michael Novart: So we are all in pushing the pill. And of course, the overarching intention is to expand the markets and not cannibalize from our own products. Thank you very much, Karsten. Thanks, Harry. And the next question, please. Thank you. Your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead. Thank you very much. First question, just on Ozempic and the timing of implementation of the MFN price. When does the MFN negotiated price kick in for Medicare and Medicaid this year? And is there any associated volume uplift given it's already covered, or should we expect market share loss to sort of erase the benefit? And then just the second question, I guess, for Martin on the profile of Wegovy pill.
Speaker #1: But it's important to know that it's lower on gross margin level , but it's still an attractive gross margin . So are all are we pill .
Speaker #1: in course pushing , pushing the of And so we the the overarching intention is to expand the market and not cannibalize from from our own products .
Michael Novod: Thank you very much, Karsten. Thanks, Harry. And the next question, please.
Operator: Thank you. Your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead.
Speaker #10: Thank you very much . Carsten . Thanks , Harry . And the question , next please .
Thibault Boutherin [Equity Research: Thank you very much. First question, just on Ozempic and the timing of implementation of the MFN price. When does the MFN negotiated price kick in for Medicare and Medicaid this year? And is there any associated volume uplift given it's already covered, or should we expect market share loss to sort of erase the benefit? And then just the second question, I guess, for Martin on the profile of Wegovy pill. Just in order to understand the adherence, could you help us with what happens to a patient if they miss the pill for a day or a couple of days? How does that impact efficacy in terms of weight loss? And then similarly, on tolerability, if a patient is in the highest dose and for some reason misses a few days of pill, can they go back and resume on 25 mg? And how do side effects look like? Thank you.
Speaker #3: Thank you. Next, your question comes from the line of Thibault at Morgan Stanley. Go ahead, please.
Speaker #13: Thank you very
Speaker #13: Much... First question, just on Ozempic and the timing of implementation of the MFN price. When does—when does the negotiated price kick in for Medicare and Medicaid this year?
Speaker #13: And is there any associated volume uplift given it's already covered, or should we expect market share loss to sort of erase the benefit? And then—
Michael Novart: Just in order to understand the adherence, could you help us with what happens to a patient if they miss the pill for a day or a couple of days? How does that impact efficacy in terms of weight loss? And then similarly, on tolerability, if a patient is in the highest dose and for some reason misses a few days of pill, can they go back and resume on 25 mg? And how do side effects look like? Thank you. Okay. Two questions. First on Ozempic and MFN for you, Dave. And then the second question for you, Martin. Yeah. Thank you, Thibault. With respect to Ozempic, as you know, we have Medicare coverage right now in the diabetes. And so with respect to MFN as well as MFP, that's more of a 2027 event. Of course, we did make Ozempic available in self-pay.
Speaker #13: just the second question , I guess , profile of Wegovy Martin , on the , just to understand the , could you help us in order adherence patient if they miss the happened to a pill for of days , or a couple how does that impact a day in terms of loss efficacy ?
Speaker #13: And then , you know , on similarly tolerability , if a patient is on the highest and for some reason missed few days dose a of pill , can they go back and resume on 25mg or and what how the how do side effects look like ?
Michael Novod: Okay. Two questions. First on Ozempic and MFN for you, Dave. And then the second question for you, Martin.
Speaker #13: Thank you .
Dave Moore: Yeah. Thank you, Thibault. With respect to Ozempic, as you know, we have Medicare coverage right now in the diabetes. And so with respect to MFN as well as MFP, that's more of a 2027 event. Of course, we did make Ozempic available in self-pay. As I mentioned, we're seeing about 8,000 scripts a week now in self-pay for those patients that don't have coverage. But the MFN and MFP is more of a 2027 event.
Speaker #10: two Okay , questions . Ozempic and MFN First on for you , Dave . And then the for you , Martin second question .
Speaker #7: Yeah , thank you . TiVo Ozempic , as respect to you know , we have coverage right now in the diabetes Medicare so .
Speaker #7: Yeah , thank you . TiVo Ozempic , as respect to you know , we have coverage right now in the diabetes Medicare so .
Speaker #7: respect to with And MFN , as well as With MFP , that's more of a 2027 event course , you know , . Of we did make available in Ozempic self-pay .
Michael Novart: As I mentioned, we're seeing about 8,000 scripts a week now in self-pay for those patients that don't have coverage. But the MFN and MFP is more of a 2027 event. Thanks, Dave. Yeah. Absolutely. On the Wegovy pill, we do know that in general, when patients are on chronic treatment, sometimes they skip a dose. It is important to remind ourselves that semaglutide is semaglutide, and the half-life of semaglutide, once in steady state, is very long, basically, as you know, also in the subcutaneous state, allowing for once-weekly doses. That basically means that when you are on a stable dose on the Wegovy pill and then you skip a dose, it doesn't have a huge impact on your blood exposure in that period of time. And you can also then reinitiate at the 25 mg dose without experiencing any adverse effects.
Speaker #7: As I mentioned , we're seeing about now 8000 scripts a week in self-pay for those those patients that that don't have coverage . But MFN the MFP is a more of 2027 event .
Michael Novod: Thanks, Dave.
Martin Lange: Yeah. Absolutely. On the Wegovy pill, we do know that in general, when patients are on chronic treatment, sometimes they skip a dose. It is important to remind ourselves that semaglutide is semaglutide, and the half-life of semaglutide, once in steady state, is very long, basically, as you know, also in the subcutaneous state, allowing for once-weekly doses. That basically means that when you are on a stable dose on the Wegovy pill and then you skip a dose, it doesn't have a huge impact on your blood exposure in that period of time. And you can also then reinitiate at the 25 mg dose without experiencing any adverse effects.
Speaker #7: and
Speaker #10: .
Speaker #5: On Absolutely . on on the Wegovy on the pill . do that know We general , when in patients are on chronic treatment , sometimes they skip a dose .
Speaker #5: It is important to to to ourselves that semaglutide is magnetite a and the half of semaglutide . life steady state , is Once in very long .
Speaker #5: Basically , as you know , also in the subcutaneous state , for once allowing weekly doses that basically means that when you stable pill we go and then dose and a dose , it doesn't have a huge impact on your blood exposure that period of in time .
Speaker #5: And you can also then reinitiate at , at at the 25 milligram dose without experiencing any untoward effects . So from that perspective , semaglutide is a magnetite .
Michael Novart: So from that perspective, semaglutide is semaglutide, and we are benefiting from the long half-life of semaglutide also in the oral delivery. Other orals would have, with shorter half-life, a much different profile because that would both impact the potential efficacy but also the potential tolerability if you skip one or two doses. Great. Thank you very much, Martin. Over to the next question. We'll do two more questions. Thank you. Your next question comes from the line of Karsten Lønborg Madsen from Danske Bank. Please go ahead. Thank you very much. In terms of CapEx, again, this year, a guide for relatively high CapEx level in terms of billions being spent. Can you confirm that the API buildout is on track because it feels like this entire program is taking longer and is being much more expensive than what we expected some years ago?
Martin Lange: So from that perspective, semaglutide is semaglutide, and we are benefiting from the long half-life of semaglutide also in the oral delivery. Other orals would have, with shorter half-life, a much different profile because that would both impact the potential efficacy but also the potential tolerability if you skip one or two doses.
Speaker #5: And we have benefiting from the long half life of also the oral delivery would shorter half , other life with in have a much different profile that would both because potential efficacy , but also the potential impact the .
Michael Novod: Great. Thank you very much, Martin. Over to the next question. We'll do two more questions.
Speaker #5: If you skip 1 or 2 doses .
Operator: Thank you. Your next question comes from the line of Karsten Lønborg Madsen from Danske Bank. Please go ahead.
Speaker #10: Great . Thank you very much , Martin . Operator . Next question will do two more questions .
Carsten Lønborg Madsen: Thank you very much. In terms of CapEx, again, this year, a guide for relatively high CapEx level in terms of billions being spent. Can you confirm that the API buildout is on track because it feels like this entire program is taking longer and is being much more expensive than what we expected some years ago? And secondly, on the high-doses Wegovy approval, which we hopefully will see soon, also, will you be launching immediately? Can you confirm that? And in which type of pen will you be launching?
Speaker #3: Thank you. Your next question is from Carsten Lomberg Madsen from Danske Bank. Please go ahead.
Speaker #14: Thank you very much. In terms of CapEx, again this year, you guide for a relatively high CapEx level, in terms of billions being spent.
Speaker #14: Can you confirm that the API buildout is on track because it feels like this entire program is taking longer and is being much more expensive , expensive than what we Some expected ?
Michael Novart: And secondly, on the high-doses Wegovy approval, which we hopefully will see soon, also, will you be launching immediately? Can you confirm that? And in which type of pen will you be launching? Great. Thank you, Karsten. And the first on CapEx to Karsten, and then the second question on 7.2 to Mike. Yes. Thank you for that question, Karsten. And as I said earlier on, then we are moving downwards in terms of CapEx. This is the first step down, and then we expect to see a steeper slope in the coming years. And it really links to finalization of projects approved in prior years. As it is with projects, some are ahead, some are behind. But in the broad scheme, we are on track.
Speaker #14: years ago ? And secondly , on the high doses , wegovy . Approval , which we hopefully see soon . Also , will you launching immediately ?
Michael Novod: Great. Thank you, Karsten. And the first on CapEx to Karsten, and then the second question on 7.2 to Mike.
Speaker #14: be Can you confirm that ? And in which type of will you pen launching be ?
Speaker #10: Thank you . Great . Carsten . And the first on CapEx to Carsten . And then the second question on 7.2 to Mike .
Karsten Knudsen: Yes. Thank you for that question, Karsten. And as I said earlier on, then we are moving downwards in terms of CapEx. This is the first step down, and then we expect to see a steeper slope in the coming years. And it really links to finalization of projects approved in prior years. As it is with projects, some are ahead, some are behind. But in the broad scheme, we are on track. Specifically for API, we do expect to have some of the new major API facilities online already this year and more to come in the coming years.
Speaker #1: you for that Yes . question , Thank Carsten . And as I said earlier on , then , we are we are moving downwards in terms of , of of CapEx .
Speaker #1: This And first step down . is the to then we steeper slope in coming the years . And it really links to finalization of of projects approved in prior years , as it is with projects .
Michael Novart: Specifically for API, we do expect to have some of the new major API facilities online already this year and more to come in the coming years. Thank you, Karsten. Karsten, with regards to the 7.2 mg Wegovy high dose, then, as you know, we have filed in December last year under the CNPV voucher program, and we have announced that we should expect the approval, hopefully, in this quarter. As soon as we get the approval, we are ready to launch. So we will not sit on that regulatory approval. And we will go all in again because I think this is really, really important that the world a little bit understands that medicine is dosed differently, and depending on how you dose things, you get different effect of it. And right now, semaglutide at 2.4 mg is giving us 15-16% weight loss.
Speaker #1: Some are ahead , some are behind , but but in in in broad in the broad scheme we are on track specifically for for API we do expect to to you know , some of the major API facilities online have , already this year .
Michael Novod: Thank you, Karsten.
Mike Doustdar: Karsten, with regards to the 7.2 mg Wegovy high dose, then, as you know, we have filed in December last year under the CNPV voucher program, and we have announced that we should expect the approval, hopefully, in this quarter. As soon as we get the approval, we are ready to launch. So we will not sit on that regulatory approval. And we will go all in again because I think this is really, really important that the world a little bit understands that medicine is dosed differently, and depending on how you dose things, you get different effect of it. And right now, semaglutide at 2.4 mg is giving us 15-16% weight loss.
Speaker #1: And and more to come in in the coming years .
Speaker #9: Carsten, with regards to that, thank you. The 7.2 will be a high dose. Then, as you know, we have filed in December last year under the NPV voucher program.
Speaker #9: And and we have announced that we should expect the approval . Hopefully in this quarter , as soon as we get the approval , we are ready to launch .
Speaker #9: So we will not sit on that regulatory approval and we will go all in again because I think this is really , really important that the understands that medicine is world differently and depending on how you things , you get dose different effect of it .
Michael Novart: Tirzepatide at 15mg dosing gives you 20-21%. We have shown in a step up that when you increase the dose of SEMA to 7.2, you get very close, on par with tirzepatide. And I think it's actually very important that the world gets to know this, and then they can judge that on top of on par weight loss, you have also CV benefits, kidney benefits, and liver benefits, and then people can pick and choose which option they want. So it's very important that we go all in with that, and we're planning to do so. And we will actually. I think there was a question. And we will launch it in the same type of devices that we currently have available to start with. Great. Thank you, Mike. Thanks, Karsten. And the last question, operator, please. Thank you.
Mike Doustdar: Tirzepatide at 15mg dosing gives you 20-21%. We have shown in a step up that when you increase the dose of SEMA to 7.2, you get very close, on par with tirzepatide. And I think it's actually very important that the world gets to know this, and then they can judge that on top of on par weight loss, you have also CV benefits, kidney benefits, and liver benefits, and then people can pick and choose which option they want. So it's very important that we go all in with that, and we're planning to do so. And we will actually. I think there was a question. And we will launch it in the same type of devices that we currently have available to start with.
Speaker #9: And now , semaglutide at 2.4mg is giving us 15 , 16% weight loss at 15mg . Dosing gives you 20 , 21% . We shown have in a step that when you increase the dose of Sema to 7.2 , you get very on close par with .
Speaker #9: And I think it's actually very important world gets that the to know this . And then they can judge that on top of on par weight you have also loss , CV benefit , kidney benefits and and liver benefits .
Speaker #9: And and then people can pick and choose option they which So so it's want . very important that we go all in with that .
Speaker #9: And we're planning to do so . And we will actually I think there was a question and launch it in the same type of devices that we currently have available to start with we will .
Michael Novod: Great. Thank you, Mike. Thanks, Karsten. And the last question, operator, please.
Operator: Thank you. Your final question for today comes from the line of Simon Baker from Rothschild & Co. Please go ahead.
Michael Novart: Your final question for today comes from the line of Simon Baker from Rothschild & Co. Please go ahead. Thank you for squeezing me in two quick questions, if I may. The first one really is just going back to the guidance question that's been repeatedly asked. Conceptually, would it be fair to say that because you have high visibility on price impact and low visibility on volume uplift, that is one of the key things that is reflected in your guidance? And there's sort of a second part that's related to that. I just wonder if you could update us on your assumptions for generic competition in IO, specifically Canada. The reason I ask is we understand that all of these semaglutide generics have had notices of deficiency slapped on them by Health Canada, and the expectation is they will not resolve until the mid-year.
Speaker #10: Great . Thank you . Mike . Carsten . the last please And question , operator , .
Speaker #10: Thanks ,
Simon Baker: Thank you for squeezing me in two quick questions, if I may. The first one really is just going back to the guidance question that's been repeatedly asked. Conceptually, would it be fair to say that because you have high visibility on price impact and low visibility on volume uplift, that is one of the key things that is reflected in your guidance? And there's sort of a second part that's related to that. I just wonder if you could update us on your assumptions for generic competition in IO, specifically Canada. The reason I ask is we understand that all of these semaglutide generics have had notices of deficiency slapped on them by Health Canada, and the expectation is they will not resolve until the mid-year.
Speaker #3: you . Your final today comes question for line of from the Simon Baker from Rothschild and Co . Please go ahead .
Speaker #15: Thank you for squeezing me in . quick Two questions , if I may . The first one really is just the guidance question that's been repeatedly asked conceptually , would it be going back to say that you have high visibility on because price impact and low visibility on volume uplift , that is one of the things , key things that is reflected in your guidance and as sort of second part that's related to that .
Speaker #15: I just wonder if you could update us on your assumptions for competition in generic I o specifically Canada . The reason I ask is we understand that all of the semaglutide generics notices of have had slapped on them by Health Canada , the and expectation is they will not resolve until the mid-year .
Michael Novart: So generic semaglutide in Canada is a 2H rather than a 1H phenomenon. I'd be interested to get your thoughts on that and the extent, if any, to which that's reflected in the guidance. Thanks so much. Great. Thank you very much. Two questions, more or less, boiled down to one on the guidance dynamics again, Karsten. Yeah. So Simon, thanks for these questions. How we detailed build it, I would say, for mature reimbursed brands, I think they have very mature established trend lines for volume trends measured as TRx, and we have a good feeling for the prices being contracted, etc. So for our mature reimbursed brands, I would say that's reasonably straightforward. Where we see the uncertainty is how can I put it in the self-pay type channel because the price elasticity in the self-pay channel is something that we're still exploring.
Simon Baker: So generic semaglutide in Canada is a 2H rather than a 1H phenomenon. I'd be interested to get your thoughts on that and the extent, if any, to which that's reflected in the guidance. Thanks so much.
Speaker #15: So generic semaglutide in Canada is A2H rather phenomenon , I'd be interested than A1H to get your thoughts on that . And the extent , if any , to which that's reflected guidance .
Speaker #15: So generic semaglutide in Canada is A2H rather phenomenon , I'd be interested than A1H to get your thoughts on that . And the extent , if any , to which that's reflected in the Thanks so much .
Michael Novod: Great. Thank you very much. Two questions, more or less, boiled down to one on the guidance dynamics again, Karsten.
Karsten Knudsen: Yeah. So Simon, thanks for these questions. How we detailed build it, I would say, for mature reimbursed brands, I think they have very mature established trend lines for volume trends measured as TRx, and we have a good feeling for the prices being contracted, etc. So for our mature reimbursed brands, I would say that's reasonably straightforward. Where we see the uncertainty is how can I put it in the self-pay type channel because the price elasticity in the self-pay channel is something that we're still exploring.
Speaker #10: Thank you very much . Two questions , more or less boiled down one on the on on guidance dynamics . Again .
Speaker #1: Yeah . So Simon , thanks for these questions . Whether how we detail build it , I would say for for mature brands .
Speaker #1: reimbursed I think they're very mature trend lines established for for volume trends measured as T-Rex we have a . And and for the prices feeling being contracted , etc.
Speaker #1: . So , so for our mature reimbursed brands , that's say that's I'd reasonably straightforward for where , where where we see uncertainty the is how can I put it in in , the self-pay type channel because the price elasticity in the channel is self-pay something that that that we're still exploring .
Michael Novart: As Dave was covering before, then we've seen a fantastic uptake of the Wegovy pill here the first 4 weeks. But we also know that obesity self-pay is a super dynamic segment. So exactly how that works across the year, to what extent there are seasonalities, etc., daytime, sourcing, cannibalization, competition, clearly, there are uncertainties there. And we put our best assumptions in. And it can go both ways. We can both have an upside and a downside. And that's why we work with a range. For Canada specifically and in our guidance, as we said in prior quarters, that SEMA LOE in international markets will impact group sales by low single digits. Canada is the biggest contributor. And of course, we put in assumptions around the timing of generic approvals and launches.
Karsten Knudsen: As Dave was covering before, then we've seen a fantastic uptake of the Wegovy pill here the first 4 weeks. But we also know that obesity self-pay is a super dynamic segment. So exactly how that works across the year, to what extent there are seasonalities, etc., daytime, sourcing, cannibalization, competition, clearly, there are uncertainties there. And we put our best assumptions in. And it can go both ways. We can both have an upside and a downside. And that's why we work with a range. For Canada specifically and in our guidance, as we said in prior quarters, that SEMA LOE in international markets will impact group sales by low single digits. Canada is the biggest contributor. And of course, we put in assumptions around the timing of generic approvals and launches.
Speaker #1: And as Dave was covering before then , we've seen then a fantastic uptake of of the Wegovy pill here . The first , first four weeks .
Speaker #1: But we obesity that also know self-pay is is a super dynamic segment . So exactly how that works across the year , you know , to what extent does seasonality etc.
Speaker #1: . And stay time sourcing cannibalization , competition ? there are Clearly there . And we uncertainties put our best assumptions there in and and you know , it can go both ways .
Speaker #1: they , You know , we we can both have upside an and a downside . that's that's And why we work with the with the with a range for Canada specifically and .
Speaker #1: in our guidance , as we said And in quarters , that that similarly in international markets will impact group sales by by low single digits .
Speaker #1: Canada is the biggest contributor . And course , we put in and of assumptions around timing of of generic of approvals and . We don't launches have detailed insights into the those files and status of remediation of of these notices of deficiencies .
Michael Novart: We don't have detailed insights into the status of those files and remediation of these notices of deficiencies. But obviously, time is a key variable in terms of impact. I think the direction of travel is the same, but there could be both an upside and a downside to our guidance depending on the pace of approval of generics in Canada. Remains to be seen. Great. Thank you, Karsten. Thank you, Simon. This also concludes the Q&A session. Thank you for participating, and please feel free to contact investor relations regarding any follow-up questions you might have. Before we close the call, I would like to hand over to you, Mike, again for the final remarks. Thank you very much, Michael. I want to start by thanking Ludovic and Dave for all you have done for Novo Nordisk over the many, many years.
Karsten Knudsen: We don't have detailed insights into the status of those files and remediation of these notices of deficiencies. But obviously, time is a key variable in terms of impact. I think the direction of travel is the same, but there could be both an upside and a downside to our guidance depending on the pace of approval of generics in Canada. Remains to be seen.
Speaker #1: But but obviously know , the , you time is the key variable in terms impacts . of I think the direction of travel same .
Speaker #1: is the But , but but there could be both an upside and a downside to , to our guidance depending on on on the pace of approval of of of generics in Canada .
Michael Novod: Great. Thank you, Karsten. Thank you, Simon. This also concludes the Q&A session. Thank you for participating, and please feel free to contact investor relations regarding any follow-up questions you might have. Before we close the call, I would like to hand over to you, Mike, again for the final remarks.
Speaker #1: So it remains seen to be .
Speaker #10: Great . Thank you . Thank you Simon This also concludes the . Q&A session . Thank you for participating , and please feel free to Investor Relations regarding contact any follow up questions you might have before we close the call , I would like to hand you , Mike , again for the final remarks .
Mike Doustdar: Thank you very much, Michael. I want to start by thanking Ludovic and Dave for all you have done for Novo Nordisk over the many, many years. I also want, once again, to welcome Jamie and Hong and stress that I'm looking very much forward to working with both of you. 2026 will be basically a year where we will face some headwinds, especially on the back of the price declines. And we have shown that in our guidance today. But I also like to say that price reduction, in some ways, is our investment for the future and for capturing more patients. Perhaps no other company better than Novo Nordisk is geared in improving health at scale within the field of diabetes and obesity. And we're ready to do that. And I believe much stronger that with affordable prices, we can get to those higher volumes faster.
Speaker #9: Thank you very much , Michael . I want to start by thanking Ludwig and Dave for all you have done for Novo Nordisk over the many , many years .
Michael Novart: I also want, once again, to welcome Jamie and Hong and stress that I'm looking very much forward to working with both of you. 2026 will be basically a year where we will face some headwinds, especially on the back of the price declines. And we have shown that in our guidance today. But I also like to say that price reduction, in some ways, is our investment for the future and for capturing more patients. Perhaps no other company better than Novo Nordisk is geared in improving health at scale within the field of diabetes and obesity. And we're ready to do that. And I believe much stronger that with affordable prices, we can get to those higher volumes faster.
Speaker #9: I also want once again to welcome Jamie and Hung and that I'm looking very much forward to working with both of you . 2026 will be basically a will where we face some year headwinds , especially back price of the on the declines , and we have shown that in our guidance today .
Speaker #9: also But I like to say that price reduction in some ways is our investment for the future and for capturing more patients . Perhaps no other company better than Novo Nordisk is geared in improving health at scale the field within of diabetes and obesity , and we're ready to that .
Michael Novart: We are looking very much forward, of course, as we go forward, to share more information with you, not least about the continuous uptake of the phenomenal Wegovy pill success that we have seen, but maybe also much more exciting readouts and regulatory milestones throughout the year across all of our therapy areas. With that, I'd like to thank all of you guys for joining us today. Thank you. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
Mike Doustdar: We are looking very much forward, of course, as we go forward, to share more information with you, not least about the continuous uptake of the phenomenal Wegovy pill success that we have seen, but maybe also much more exciting readouts and regulatory milestones throughout the year across all of our therapy areas. With that, I'd like to thank all of you guys for joining us today. Thank you.
Speaker #9: And I do much stronger than with affordable prices . We can get to those higher volumes faster . We are looking very much forward , of course , as we go forward to share more information with you , not least about the continuous uptake of the phenomenal Wegovy pill success .
Speaker #9: We have seen, but maybe much more also, exciting readouts and regulatory milestones throughout the year across all of our therapy areas.
Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
Speaker #9: With that, I'd like to thank all of you guys for joining us today. Thank you.
