Q3 2023 Novo Nordisk A/S Earnings Call
Operator: Good day and thank you for standing by welcome to the Q3 2023 Novo Nordisk A/S earnings conference call, at this time all participants are in a listen only mode, after the speaker's presentation there'll be a question and answer session, to ask your question during the session you will need to press star one and one on your telephone, you will then hear an automated message advising your hand is raised, to withdraw your question please press star one and one again, please be advised that today's conference is being recorded, I would now like to turn the conference over to your first speaker today, Daniel Bohsen head of Investor Relations. Please go ahead Sir.
Camilla Sylvest: Total Rare Disease sales decreased 18%, which was driven by a 22% decrease in International Operations and by a 13% decrease in North America Operations. Please turn to the next slide. With 25% sales growth in our Diabetes Care, we are now growing faster than the total market, improving our global diabetes value market share to 33.3%. The increase reflects market share gains in both North America Operations and International Operations. In International Operations, total Diabetes Care sales increased by 21% in the first nine months of 2023. This was driven by GLP-1 sales growing 60%, driven by all geographical areas. Novo Nordisk is the market leader in International Operations with a GLP-1 value market share of 69%. Ozempic continues its GLP-1 market leadership with just shy of 46% market share.
Camilla Sylvest: Total Rare Disease sales decreased 18%, which was driven by a 22% decrease in International Operations and by a 13% decrease in North America Operations. Please turn to the next slide. With 25% sales growth in our Diabetes Care, we are now growing faster than the total market, improving our global diabetes value market share to 33.3%. The increase reflects market share gains in both North America Operations and International Operations.
One one on your telephone you will then have an automated message advising Johan does raise to withdraw your question. Please press star one on one again. Please be advised that today's conference is being recorded I would now like to turn the conference over to your first you could stay on your person head of Investor Relations. Please go ahead Sir.
Daniel Bohsen: Welcome to this Novo Nordisk earnings calls for the first nine months of 2023, this calls follows the early announcement of topline results and the updated outlook for 2023 shared in October, the release was advanced due to Danish Securities regulations, my name is Daniel Bohsen and I'm the head of Investor Relations at Novo Nordisk, with me today I have CEO of Novo Nordisk last forego Johnson executive Vice President and head of commercial strategy and corporate Affairs, Cumulus serviced executive Vice President and head of North America Operation Stock Langer Executive Vice President and head of development Martin Hall, just lung and finally, Chief Financial Officer, Karsten Munk Knudsen. Speakers will be available for the Q&A session today's announcement and the slides for this call are available on our website at <unk> Com. Please note that this call is being webcast live and a recording will be made available on our web. Side as well the call is scheduled one hour please. Please turn to slide presentation. This structure is outlined on slide two please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified please turn to the next slide. As always we need to advise you that this call will contain forward looking statements. These are subject to risks and uncertainties that could cause. Actual results to differ materially from patients. For further detail on the risks. Sorry risk factors. Please see the company's announcement for the first nine months of two <unk> III and. The slides prepared for this presentation, but what's your last one update on epic aspirations.
Daniel Bohsen: Welcome to this Novo Nordisk earnings calls for the first nine months of 2023, this calls follows the early announcement of topline results and the updated outlook for 2023 shared in October, the release was advanced due to Danish Securities regulations, my name is Daniel Bohsen and I'm the head of Investor Relations at Novo Nordisk,
Camilla Sylvest: In International Operations, total Diabetes Care sales increased by 21% in the first nine months of 2023. This was driven by GLP-1 sales growing 60%, driven by all geographical areas. Novo Nordisk is the market leader in International Operations with a GLP-1 value market share of 69%. Ozempic continues its GLP-1 market leadership with just shy of 46% market share. Rybelsus has 12% value market share, driven by strong uptake across geographies. With that, I will hand over the word to Doug.
Daniel Bohsen: With me today I have CEO of Novo Nordisk Lars Fruergaard Jorgenssen, executive Vice President and head of commercial strategy and corporate Affairs Camilla Sylvest, executive Vice President and head of North America Operation Doug Langa, Executive Vice President and head of development Martin Holst Lange and finally Chief Financial Officer, Karsten Munk Knudsen, all speakers will be available for the Q&A session. Today's announcement and the slides for this call are available on our website at <unk> Com. Please note that this call is being webcast live and a recording will be made available on our web. Side as well the call is scheduled one hour please. Please turn to slide presentation. This structure is outlined on slide two please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified please turn to the next slide. As always we need to advise you that this call will contain forward looking statements. These are subject to risks and uncertainties that could cause. Actual results to differ materially from patients. For further detail on the risks. Sorry risk factors. Please see the company's announcement for the first nine months of two <unk> III and. The slides prepared for this presentation, but what's your last one update on epic aspirations.
Daniel Bohsen: With me today I have CEO of Novo Nordisk Lars Fruergaard Jorgenssen, executive Vice President and head of commercial strategy and corporate Affairs Camilla Sylvest, executive Vice President and head of North America Operation Doug Langa, Executive Vice President and head of development Martin Holst Lange and finally Chief Financial Officer, Karsten Munk Knudsen, all speakers will be available for the Q&A session.
Novo Nordisk last forego Johnson executive Vice President and head of commercial strategy and corporate Affairs, Cumulus serviced executive Vice President and head of North America Operation Stock Langer Executive Vice President and head of development Martin Hall, just lung and finally, Chief Financial Officer, Karsten Munk Knudsen.
Camilla Sylvest: Rybelsus has 12% value market share, driven by strong uptake across geographies. With that, I will hand over the word to Doug.
Daniel Bohsen: Thank you, Camilla. Please turn to the next slide. The GLP-1 class expansion continues in the US in the first 9 months of 2023. The US GLP-1 market volume grew around 50%, comparing Q3 of 2023 to Q3 of 2022. Measured on total prescriptions, Novo Nordisk continues to be the market leader with 53% market share. Please go to the next slide. Obesity care sales grew by 174% in the first 9 months of 2023. This was mainly driven by the US.
Doug Langa: Thank you, Camilla. Please turn to the next slide. The GLP-1 class expansion continues in the US in the first 9 months of 2023. The US GLP-1 market volume grew around 50%, comparing Q3 of 2023 to Q3 of 2022. Measured on total prescriptions, Novo Nordisk continues to be the market leader with 53% market share. Please go to the next slide. Obesity care sales grew by 174% in the first 9 months of 2023. This was mainly driven by the US.
Speakers will be available for the Q&A session today's announcement and the slides for this call are available on our website at <unk> Com. Please note that this call is being webcast live and a recording will be made available on our web.
Daniel Bohsen: Today's announcement and the slides for this call are available on our website at novonordisk.com, please note that this call is being webcasted live and a recording will be made available on our website as well, the call is scheduled for one hour, please turn the slide presentation. This structure is outlined on slide two please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified please turn to the next slide. As always we need to advise you that this call will contain forward looking statements. These are subject to risks and uncertainties that could cause. Actual results to differ materially from patients. For further detail on the risks. Sorry risk factors. Please see the company's announcement for the first nine months of two <unk> III and. The slides prepared for this presentation, but what's your last one update on epic aspirations.
Daniel Bohsen: Today's announcement and the slides for this call are available on our website at novonordisk.com, please note that this call is being webcasted live and a recording will be made available on our website as well, the call is scheduled for one hour, please turn the slide
Side as well the call is scheduled one hour please.
Please turn to slide presentation. This structure is outlined on slide two please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified please turn to the next slide.
Daniel Bohsen: The presentation structure is outlined on slide two, please note that all sales and operating profit growth statements will be at constant exchange rates, unless otherwise specified, please turn to the next slide, as always we need to advise you that this call will contain forward looking statements, these are subject to risks and uncertainties that could cause actual results to differ materially from (inaudible) For further info on the risks, sorry risk factors, please see the company's announcement for the first nine months of 2023 and the slides prepared for this presentation (Inaudible).
As always we need to advise you that this call will contain forward looking statements. These are subject to risks and uncertainties that could cause.
Doug Langa: The global branded anti-obesity market expansion continues with a global volume growth of 94%. In International Operations, Obesity Care sales are driven by strong Saxenda performance and the Wegovy launches in 5 International Operations countries. While eager to launch Wegovy in more IO countries, our focus remains to do this in a sustainable manner, for example, by capping volumes. In the US alone, sales of Wegovy grew by 467%. Demand for Wegovy continues to exceed supply, and to safeguard continuity of care for patients already on Wegovy, the supply of the lower Wegovy dose strengths in the US has been reduced since May 2023. Please go to the next slide. Our Rare Disease sales decreased by 18%.
Doug Langa: The global branded anti-obesity market expansion continues with a global volume growth of 94%. In International Operations, Obesity Care sales are driven by strong Saxenda performance and the Wegovy launches in 5 International Operations countries. While eager to launch Wegovy in more IO countries, our focus remains to do this in a sustainable manner, for example, by capping volumes. In the US alone, sales of Wegovy grew by 467%. Demand for Wegovy continues to exceed supply, and to safeguard continuity of care for patients already on Wegovy, the supply of the lower Wegovy dose strengths in the US has been reduced since May 2023. Please go to the next slide. Our Rare Disease sales decreased by 18%.
Actual results to differ materially from patients.
For further detail on the risks.
Sorry risk factors. Please see the company's announcement for the first nine months of two <unk> III and.
The slides prepared for this presentation, but what's your last one update on epic aspirations.
Lars Fruergaard Joergensen: Thank you Daniel, next slide please, in the first nine months of 2023, we delivered 33% sales and 37% operating profit growth at constant exchange rates, I'd like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues. Well in terms of sustainability, we continue to make progress on carbon emissions decreased by 28% compared to pre pandemic levels 92019 and. And in line with our aspiration of being a sustainable stated prior we continued to expand the number of women in senior leadership positions. This is now 41% compared to 38% last year. In R&D, an important milestone is that we will stop the flow kidney outcomes trial early estimate <unk> demonstrated a benefit in people with type two diabetes and chronic kidney disease. Within R&D, we have recently agreed to acquire <unk> for the treatment of cardiovascular disease. To support our exploration of establishing our presence in other serious chronic diseases with a high unmet medical need. The market will come back to this and all R&D milestones later. The sales growth reflect strong commercial execution with both operating units contributing to a continuous sales growth driven by increasing demand for our tier one based diabetes and obesity treatments Camilla talk will go through the details in there in the therapy area later. Within commercial execution. We are pleased to have reached our BC aspiration of 25 billion Danish kroner, and our exploration for diabetes by reaching a global value market share of one third naturally the progress is not holding us back and we continue to aim for treating more patients with our innovative treatments. Cotton will go through the financial details, but I am very pleased with our overall performance for the first nine months of 2023, which has enabled us to raise our outlook for the full year. With that I'll give the word to Camilla for an update on commercial execution.
Lars Fruergaard Joergensen: Thank you Daniel, next slide please, in the first nine months of 2023, we delivered 33% sales and 37% operating profit growth at constant exchange rates, I'd like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues.
In the first nine months of 2023, we delivered 33% sales and 37% operating profit growth at constant exchange rates I'd like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues.
Lars Fruergaard Joergensen: Well in terms of sustainability, we continue to make progress, our carbon emissions decreased by 28% compared to pre pandemic levels in 2019 and in line with our aspiration of being a sustainable employer, we continued to expand the number of women in senior leadership positions, this is now 41% compared to 38% last year. In R&D, an important milestone is that we will stop the flow kidney outcomes trial early estimate <unk> demonstrated a benefit in people with type two diabetes and chronic kidney disease. Within R&D, we have recently agreed to acquire <unk> for the treatment of cardiovascular disease. To support our exploration of establishing our presence in other serious chronic diseases with a high unmet medical need. The market will come back to this and all R&D milestones later. The sales growth reflect strong commercial execution with both operating units contributing to a continuous sales growth driven by increasing demand for our tier one based diabetes and obesity treatments Camilla talk will go through the details in there in the therapy area later. Within commercial execution. We are pleased to have reached our BC aspiration of 25 billion Danish kroner, and our exploration for diabetes by reaching a global value market share of one third naturally the progress is not holding us back and we continue to aim for treating more patients with our innovative treatments. Cotton will go through the financial details, but I am very pleased with our overall performance for the first nine months of 2023, which has enabled us to raise our outlook for the full year. With that I'll give the word to Camilla for an update on commercial execution.
Lars Fruergaard Joergensen: Well in terms of sustainability, we continue to make progress, our carbon emissions decreased by 28% compared to pre pandemic levels in 2019 and in line with our aspiration of being a sustainable employer, we continued to expand the number of women in senior leadership positions, this is now 41% compared to 38% last year.
Well in terms of sustainability, we continue to make progress on carbon emissions decreased by 28% compared to pre pandemic levels 92019 and.
And in line with our aspiration of being a sustainable stated prior we continued to expand the number of women in senior leadership positions. This is now 41% compared to 38% last year.
Doug Langa: The sales decrease was driven by a 13% decline in North America Operations and a 22% sales decline in International Operations. Sales of Rare Blood Disorders increased by 2%, driven by the launch products in hemophilia A and B, and partially countered by NovoSeven. Sales of Rare Endocrine Disorder products decreased by 54%, reflecting a temporary reduction in manufacturing output. Now over to you, Martin, for an update on R&D.
Doug Langa: The sales decrease was driven by a 13% decline in North America Operations and a 22% sales decline in International Operations. Sales of Rare Blood Disorders increased by 2%, driven by the launch products in hemophilia A and B, and partially countered by NovoSeven. Sales of Rare Endocrine Disorder products decreased by 54%, reflecting a temporary reduction in manufacturing output. Now over to you, Martin, for an update on R&D.
Lars Fruergaard Joergensen: In R&D, an important milestone is that we will stop the FLOW kidney outcomes trial early as semaglutide demonstrated a benefit in people with type 2 diabetes and chronic kidney disease, further within R&D, we have recently agreed to acquire Ocedurenone for the treatment of cardiovascular disease. To support our exploration of establishing our presence in other serious chronic diseases with a high unmet medical need. The market will come back to this and all R&D milestones later. The sales growth reflect strong commercial execution with both operating units contributing to a continuous sales growth driven by increasing demand for our tier one based diabetes and obesity treatments Camilla talk will go through the details in there in the therapy area later. Within commercial execution. We are pleased to have reached our BC aspiration of 25 billion Danish kroner, and our exploration for diabetes by reaching a global value market share of one third naturally the progress is not holding us back and we continue to aim for treating more patients with our innovative treatments. Cotton will go through the financial details, but I am very pleased with our overall performance for the first nine months of 2023, which has enabled us to raise our outlook for the full year. With that I'll give the word to Camilla for an update on commercial execution.
Lars Fruergaard Joergensen: In R&D, an important milestone is that we will stop the FLOW kidney outcomes trial early as semaglutide demonstrated a benefit in people with type 2 diabetes and chronic kidney disease, further within R&D, we have recently agreed to acquire Ocedurenone for the treatment of cardiovascular disease.
In R&D, an important milestone is that we will stop the flow kidney outcomes trial early estimate <unk> demonstrated a benefit in people with type two diabetes and chronic kidney disease.
Within R&D, we have recently agreed to acquire <unk> for the treatment of cardiovascular disease.
Lars Fruergaard Joergensen: This support our aspiration of establishing our presence in other serious chronic diseases with a high unmet medical need, Martin will come back to this and all R&D milestones later, the sales growth reflect strong commercial execution with both operating units contributing to a continuous sales growth driven by increasing demands for our GLP-1 based diabetes and obesity treatments Camilla and Doug will go through the details in there in the therapy area later. Within commercial execution. We are pleased to have reached our BC aspiration of 25 billion Danish kroner, and our exploration for diabetes by reaching a global value market share of one third naturally the progress is not holding us back and we continue to aim for treating more patients with our innovative treatments. Cotton will go through the financial details, but I am very pleased with our overall performance for the first nine months of 2023, which has enabled us to raise our outlook for the full year. With that I'll give the word to Camilla for an update on commercial execution.
Lars Fruergaard Joergensen: This support our aspiration of establishing our presence in other serious chronic diseases with a high unmet medical need, Martin will come back to this and all R&D milestones later, the sales growth reflect strong commercial execution with both operating units contributing to a continuous sales growth driven by increasing demands for our GLP-1 based diabetes and obesity treatments Camilla and Doug will go through the details in there in the therapy area later.
To support our exploration of establishing our presence in other serious chronic diseases with a high unmet medical need.
The market will come back to this and all R&D milestones later.
Martin Holst Lange: Thank you, Doc. Please turn to the next slide. Serious chronic non-communicable diseases affect millions of people globally and have emerged in recent years as a major public health issue. Given our extensive scientific and clinical knowledge within metabolic diseases, we're well-positioned to advance our understanding of semaglutide's potential benefits in associated health complications. With the current body of evidence, it is clear that the beneficial effects of semaglutide goes even further than glycemic control and weight loss. Semaglutide has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies. This includes SUSTAIN 6 and PIONEER 6 in type 2 diabetes, as well as STEP-HFpEF and SELECT in obesity. While we await data from the SELECT trial to be presented, we continue to build evidence for the semaglutide molecule in the cardiovascular space. In 2024, we expect several readouts.
Martin Holst Lange: Thank you, Doc. Please turn to the next slide. Serious chronic non-communicable diseases affect millions of people globally and have emerged in recent years as a major public health issue. Given our extensive scientific and clinical knowledge within metabolic diseases, we're well-positioned to advance our understanding of semaglutide's potential benefits in associated health complications. With the current body of evidence, it is clear that the beneficial effects of semaglutide goes even further than glycemic control and weight loss. Semaglutide has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies. This includes SUSTAIN 6 and PIONEER 6 in type 2 diabetes, as well as STEP-HFpEF and SELECT in obesity. While we await data from the SELECT trial to be presented, we continue to build evidence for the semaglutide molecule in the cardiovascular space. In 2024, we expect several readouts.
The sales growth reflect strong commercial execution with both operating units contributing to a continuous sales growth driven by increasing demand for our tier one based diabetes and obesity treatments Camilla talk will go through the details in there in the therapy area later.
Lars Fruergaard Joergensen: Within commercial execution we are pleased to have reached our obesity aspiration of 25 billion Danish Kroner, and our exploration for diabetes by reaching a global value market share of one third, naturally the progress is not holding us back and we continue to aim for treating more patients with our innovative treatments. Cotton will go through the financial details, but I am very pleased with our overall performance for the first nine months of 2023, which has enabled us to raise our outlook for the full year. With that I'll give the word to Camilla for an update on commercial execution.
Lars Fruergaard Joergensen: Within commercial execution we are pleased to have reached our obesity aspiration of 25 billion Danish Kroner, and our exploration for diabetes by reaching a global value market share of one third, naturally the progress is not holding us back and we continue to aim for treating more patients with our innovative treatments.
Within commercial execution. We are pleased to have reached our BC aspiration of 25 billion Danish kroner, and our exploration for diabetes by reaching a global value market share of one third naturally the progress is not holding us back and we continue to aim for treating more patients with our innovative treatments.
Lars Fruergaard Joergensen: Karsten will go through the financial details, but I am very pleased with our overall performance for the first nine months of 2023, which has enabled us to raise our outlook for the full year, with that I'll give the word to Camilla for an update on commercial execution.
Cotton will go through the financial details, but I am very pleased with our overall performance for the first nine months of 2023, which has enabled us to raise our outlook for the full year.
With that I'll give the word to Camilla for an update on commercial execution.
Camilla Sylvest: Thank you Lars and please turn to the next slide, in the first nine months of 2023, our total sales increased by 33%, this sales growth was driven by both operating units with North America operations growing 49% and international operations growing 17%, our GLP-1 sales increased 49% driven by North America, growing 43% and international operations growing 60%. Insulin sales decreased by 7% driven by a 1% decline in international operations and a 24% decline in North America operations. Sales decrease was driven by a decrease in sales in the U S and region China. Obesity care sales grew 174% overall in international operations sales grew 52% driven by both <unk> and <unk>. In North America operations obesity care sales grew 244%. Total <unk> sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations. Turn to the next slide. With 25% sales growth in our diabetes care, we are now growing faster than the total market improving our global diabetes value market share to 33, 3%. The increase reflects market share gains in both North America operations and international operations. And international operations total diabetes cafes increased by 21% in the first nine months of 2023. This was driven by tier one sales growing 60% driven by all geographical areas. No it is. Is the market leader in international operator, TLC, one value market share of 69%. <unk> continues its tier one market leadership with just shy of 46% market share. We've also has 12% value market share driven by strong uptake across geographies and with that I will hand over the word to Doug.
Camilla Sylvest: Thank you Lars and please turn to the next slide, in the first nine months of 2023, our total sales increased by 33%, this sales growth was driven by both operating units with North America operations growing 49% and international operations growing 17%, our GLP-1 sales increased 49% driven by North America, growing 43% and international operations growing 60%.
In the first nine months of 2023, our total sales increased by 33%. This sales growth was driven by both operating units with North America operations growing 49% and international operations growing 17%.
Martin Holst Lange: This includes type two diabetes cardiovascular outcomes study, SOUL, with oral semaglutide 14 mg, and the functional outcomes trial, STRIDE, which focuses on the high-risk population with peripheral vascular disease. As previously discussed, we also investigated the potential therapeutic effects of semaglutide on osteoarthritis and metabolic dysfunction-associated steatohepatitis, previously known as nonalcoholic steatohepatitis. In addition to this, we recently announced early closure of the FLOW trial due to efficacy. Next slide, please. This closure was based on a recommendation from the FLOW Independent Data Monitoring Committee following a pre-planned interim analysis. As you know, FLOW is an outcomes trial conducted across 28 countries and more than 400 sites. 3,534 people were enrolled and randomized in a 1:1 ratio to receive either once weekly semaglutide 1.0 mg or placebo.
Martin Holst Lange: This includes type two diabetes cardiovascular outcomes study, SOUL, with oral semaglutide 14 mg, and the functional outcomes trial, STRIDE, which focuses on the high-risk population with peripheral vascular disease. As previously discussed, we also investigated the potential therapeutic effects of semaglutide on osteoarthritis and metabolic dysfunction-associated steatohepatitis, previously known as nonalcoholic steatohepatitis. In addition to this, we recently announced early closure of the FLOW trial due to efficacy. Next slide, please. This closure was based on a recommendation from the FLOW Independent Data Monitoring Committee following a pre-planned interim analysis. As you know, FLOW is an outcomes trial conducted across 28 countries and more than 400 sites. 3,534 people were enrolled and randomized in a 1:1 ratio to receive either once weekly semaglutide 1.0 mg or placebo.
Our tier one sales increased 9% driven by North America, growing 43% and international operations growing 60%.
Camilla Sylvest: Insulin sales decreased by 7% driven by a 1% decline in international operations and a 24% sales decline in North America operations, the sales decrease was driven by a decrease in sales in the US and region China, obesity care sales grew 174% overall in international operations sales grew 52% driven by both Saxenda and Wegobi, in North America operations obesity care sales grew 244%. total rare disease sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations. Turn to the next slide. With 25% sales growth in our diabetes care, we are now growing faster than the total market improving our global diabetes value market share to 33, 3%. The increase reflects market share gains in both North America operations and international operations. And international operations total diabetes cafes increased by 21% in the first nine months of 2023. This was driven by tier one sales growing 60% driven by all geographical areas. No it is. Is the market leader in international operator, TLC, one value market share of 69%. <unk> continues its tier one market leadership with just shy of 46% market share. We've also has 12% value market share driven by strong uptake across geographies and with that I will hand over the word to Doug.
Camilla Sylvest: Insulin sales decreased by 7% driven by a 1% decline in international operations and a 24% sales decline in North America operations, the sales decrease was driven by a decrease in sales in the US and region China, obesity care sales grew 174% overall in international operations sales grew 52% driven by both Saxenda and Wegobi, in North America operations obesity care sales grew 244%.
Insulin sales decreased by 7% driven by a 1% decline in international operations and a 24% decline in North America operations.
Sales decrease was driven by a decrease in sales in the U S and region China.
Obesity care sales grew 174% overall in international operations sales grew 52% driven by both <unk> and <unk>.
In North America operations obesity care sales grew 244%.
Camilla Sylvest: Total rare disease sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations, please turn to the next slide. With 25% sales growth in our diabetes care, we are now growing faster than the total market improving our global diabetes value market share to 33.3%. The increase reflects market share gains in both North America operations and international operations. And international operations total diabetes cafes increased by 21% in the first nine months of 2023. This was driven by tier one sales growing 60% driven by all geographical areas. No it is. Is the market leader in international operator, TLC, one value market share of 69%. <unk> continues its tier one market leadership with just shy of 46% market share. We've also has 12% value market share driven by strong uptake across geographies and with that I will hand over the word to Doug.
Camilla Sylvest: Total rare disease sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations, please turn to the next slide. With 25% sales growth in our diabetes care, we are now growing faster than the total market improving our global diabetes value market share to 33.3%. The increase reflects market share gains in both North America operations and international operations.
Total <unk> sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations.
Turn to the next slide.
With 25% sales growth in our diabetes care, we are now growing faster than the total market improving our global diabetes value market share to 33, 3%.
Martin Holst Lange: The eligibility criteria were designed to include patients with type 2 diabetes and high or very high risk for progression of chronic kidney disease. The primary objective of FLOW is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of SGLT2s. The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate, major adverse cardiovascular events, and all-cause death. Today, few treatment options exist for chronic kidney disease in people living with type 2 diabetes. With a projected global increase in type 2 diabetes, there is a clear need for additional treatment options to help mitigate the residual risk in people with concomitant chronic kidney disease.
Martin Holst Lange: The eligibility criteria were designed to include patients with type 2 diabetes and high or very high risk for progression of chronic kidney disease. The primary objective of FLOW is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of SGLT2s. The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate, major adverse cardiovascular events, and all-cause death. Today, few treatment options exist for chronic kidney disease in people living with type 2 diabetes. With a projected global increase in type 2 diabetes, there is a clear need for additional treatment options to help mitigate the residual risk in people with concomitant chronic kidney disease.
The increase reflects market share gains in both North America operations and international operations.
Camilla Sylvest: In international operations total diabetes care sales increased by 21% in the first nine months of 2023, this was driven by GLP-1 sales growing 60% driven by all geographical areas. Novo Nordisk is the market leader in international operator, GLP-1 value market share of 69%. Ozempic continues its GLP-1 market leadership with just shy of 46% market share, we've also had 12% value market share driven by strong uptake across geographies and with that I will hand over the word to Doug.
And international operations total diabetes cafes increased by 21% in the first nine months of 2023.
This was driven by tier one sales growing 60% driven by all geographical areas.
No it is.
Is the market leader in international operator, TLC, one value market share of 69%.
<unk> continues its tier one market leadership with just shy of 46% market share.
We've also has 12% value market share driven by strong uptake across geographies and with that I will hand over the word to duck.
Doug Langa: Thank you Camilla please turn to the next slide, the GLP-1 class expansion continues in the US, in the first nine months of 2023, the US GLP-1 market volume grew around 50% comparing Q3 of 2023 to Q3 of 2022, measured on total prescriptions Novo Nordisk continues to be the market leader with 53% market share. Please go to the next slide. Obesity care sales grew by 174% in the first nine months of 2023. This was mainly driven by the U S. The global branded anti obesity market expansion continues with a global volume growth of 94%. In international operations obesity care sales are driven by strong <unk> performance and <unk> launches and five international operation countries. While eager to launch will go via more Io countries. Our focus remains to do this in a sustainable manner for example by capping volumes. In the U S alone sales of <unk> grew. <unk> grew by 467%. Demand for will go we continues to exceed supply and a safeguard continuity of care for patients already on <unk>. The supply of the lower we'll go with dose strengths in the U S has been reduced since may of 2023. Please go to the next slide. Our rare disease sales decreased by 18%. The sales decrease was driven by a 30% decline in North America operations, and a 22% sales decline in international operations. Sales of rare blood disorders increased by 2% driven by the launch products in hemophilia, a and B and partially countered by <unk> seven. Sales of rare endocrine disorder products decreased by 54%, reflecting a temporary reduction in manufacturing output. Now wherever you Martin for an update on R&D.
Doug Langa: Thank you Camilla please turn to the next slide, the GLP-1 class expansion continues in the US, in the first nine months of 2023, the US GLP-1 market volume grew around 50% comparing Q3 of 2023 to Q3 of 2022, measured on total prescriptions Novo Nordisk continues to be the market leader with 53% market share. Please go to the next slide.
The GOP one class expansion continues in the U S. In the first nine months of 2023.
The U S. <unk> market volume grew around 50% comparing Q3 of 2023 to Q3 of 2022.
Martin Holst Lange: The next step will be to close down the trial. Start of FLOW is expected in H1 2024. The presentation of detailed data is expected to take place at a medical conference also during 2024. Next slide, please. In line with our strategic aspiration of establishing a presence in other serious chronic diseases, we are pleased to announce the acquisition of ocedurenone for the treatment of cardiovascular disease from KBP Biosciences. There remains a significant need in treatment of hypertension, which is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease, and death. Ocedurenone is a once daily oral administered small molecule with a long half-life and a high affinity for the mineralocorticoid receptor.
Martin Holst Lange: The next step will be to close down the trial. Start of FLOW is expected in H1 2024. The presentation of detailed data is expected to take place at a medical conference also during 2024. Next slide, please. In line with our strategic aspiration of establishing a presence in other serious chronic diseases, we are pleased to announce the acquisition of ocedurenone for the treatment of cardiovascular disease from KBP Biosciences. There remains a significant need in treatment of hypertension, which is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease, and death. Ocedurenone is a once daily oral administered small molecule with a long half-life and a high affinity for the mineralocorticoid receptor.
Measured on total prescriptions Novo Nordisk continues to be the market leader with 53% market share. Please go to the next slide.
Doug Langa: Obesity care sales grew by 174% in the first nine months of 2023, this was mainly driven by the US, the global branded anti-obesity market expansion continues with a global volume growth of 94%, in international operations, obesity care sales are driven by strong Saxenda performance and the Wegovy launches in five international operation countries. While eager to launch will go via more Io countries. Our focus remains to do this in a sustainable manner for example by capping volumes. In the U S alone sales of <unk> grew. <unk> grew by 467%. Demand for will go we continues to exceed supply and a safeguard continuity of care for patients already on <unk>. The supply of the lower we'll go with dose strengths in the U S has been reduced since may of 2023. Please go to the next slide. Our rare disease sales decreased by 18%. The sales decrease was driven by a 30% decline in North America operations, and a 22% sales decline in international operations. Sales of rare blood disorders increased by 2% driven by the launch products in hemophilia, a and B and partially countered by <unk> seven. Sales of rare endocrine disorder products decreased by 54%, reflecting a temporary reduction in manufacturing output. Now wherever you Martin for an update on R&D.
Doug Langa: Obesity care sales grew by 174% in the first nine months of 2023, this was mainly driven by the US, the global branded anti-obesity market expansion continues with a global volume growth of 94%, in international operations, obesity care sales are driven by strong Saxenda performance and the Wegovy launches in five international operation countries.
Obesity care sales grew by 174% in the first nine months of 2023. This was mainly driven by the U S.
The global branded anti obesity market expansion continues with a global volume growth of 94%.
In international operations obesity care sales are driven by strong <unk> performance and <unk> launches and five international operation countries.
Doug Langa: While eager to launch Wegovy in more IO countries, our focus remains to do this in a sustainable manner, for example, by capping volumes, in the US alone sales of Wegovy grew by 467%, Demand for Wegovy continues to exceed supply and a safeguard continuity of care for patients already on Wegovy, the supply of the lower Wegovy dose strengths in the US has been reduced since may of 2023. Please go to the next slide. Our rare disease sales decreased by 18%. The sales decrease was driven by a 30% decline in North America operations, and a 22% sales decline in international operations. Sales of rare blood disorders increased by 2% driven by the launch products in hemophilia, a and B and partially countered by <unk> seven. Sales of rare endocrine disorder products decreased by 54%, reflecting a temporary reduction in manufacturing output. Now wherever you Martin for an update on R&D.
Doug Langa: While eager to launch Wegovy in more IO countries, our focus remains to do this in a sustainable manner, for example, by capping volumes, in the US alone sales of Wegovy grew by 467%, Demand for Wegovy continues to exceed supply and a safeguard continuity of care for patients already on Wegovy, the supply of the lower Wegovy dose strengths in the US has been reduced since may of 2023, please go to the next slide.
While eager to launch will go via more Io countries. Our focus remains to do this in a sustainable manner for example by capping volumes.
In the U S alone sales of <unk> grew.
<unk> grew by 467%.
Martin Holst Lange: Ocedurenone has an attractive efficacy and safety profile and is currently being examined in the phase 3 trial, CLARION-CKD, in patients with uncontrolled hypertension and advanced chronic kidney disease. We expect to initiate additional cardiovascular as well as chronic kidney disease outcomes trials during the course of 2024. Next slide, please. Turning to other R&D milestones, I would like to highlight some of the other trial readouts and initiations across our therapy areas in 2023 and in H1 2024. Within diabetes in Q3 2023, we initiated the first pivotal phase 3 trial in the REDEFINE program for CagriSema in people with type 2 diabetes. In Q4, we have submitted oral semaglutide 25 and 50 milligram in the EU.
Martin Holst Lange: Ocedurenone has an attractive efficacy and safety profile and is currently being examined in the phase 3 trial, CLARION-CKD, in patients with uncontrolled hypertension and advanced chronic kidney disease. We expect to initiate additional cardiovascular as well as chronic kidney disease outcomes trials during the course of 2024. Next slide, please. Turning to other R&D milestones, I would like to highlight some of the other trial readouts and initiations across our therapy areas in 2023 and in H1 2024. Within diabetes in Q3 2023, we initiated the first pivotal phase 3 trial in the REDEFINE program for CagriSema in people with type 2 diabetes. In Q4, we have submitted oral semaglutide 25 and 50 milligram in the EU.
Demand for will go we continues to exceed supply and a safeguard continuity of care for patients already on <unk>. The supply of the lower we'll go with dose strengths in the U S has been reduced since may of 2023. Please go to the next slide.
Doug Langa: Our rare disease sales decreased by 18%, the sales decrease was driven by a 30% decline in North America operations, and a 22% sales decline in international operations, sales of rare blood disorders increased by 2%, driven by the launch products in hemophilia, A and B and partially countered by NovoSeven, sales of rare endocrine disorder products decreased by 54%, reflecting a temporary reduction in manufacturing output, now we're over to you Martin for an update on R&D.
Our rare disease sales decreased by 18%.
The sales decrease was driven by a 30% decline in North America operations, and a 22% sales decline in international operations.
Sales of rare blood disorders increased by 2% driven by the launch products in hemophilia, a and B and partially countered by <unk> seven.
Sales of rare endocrine disorder products decreased by 54%, reflecting a temporary reduction in manufacturing output.
Now wherever you Martin for an update on R&D.
Martin Holst Lange: Thank you Doug, Please turn to the next slide, serious Chronic Noncommunicable Diseases affect millions of people globally and have emerged in recent years as a major public health issue, given our extensive scientific and clinical knowledge within metabolic diseases, we are well positioned to advance our understanding of Semaglutide potential benefits in associated with health complications. With the current body of evidence it is clear. Beneficial effects, obviously, you're making type goes even further than placebo control and weight loss <unk>. <unk> has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies. This includes sustain six and pioneer six in type two diabetes. As well as step have pet select. Yes. While we await data from this electronics should be presented we continue to build evidence for this magnetek molecule in the cardiovascular space. In 2024, we expect several readouts. This includes type two diabetes control. Type two diabetes cardiovascular outcome study sold was also <unk> 40 milligram and the functional outcome trial stride, which focuses on the high risk population with peripheral vascular disease. As previously discussed we also investigated the potential therapeutic effects of <unk> on osteoarthritis and metabolic hepatic dysfunction associated states Youll hepatitis previously known as not alcoholic stay with John hepatitis. In addition to this we recently announced early closure of the floor. Due to efficacy next slide please. Yes. This closure was based on a recommendation from the flow independent data monitoring committee following a pre planned interim analysis. As you know flow is an outcomes trial conducted across 28 countries and more than 400 sites. 3534 people were enrolled and randomized one to one ratio to receive either a once weekly <unk> 1.0 milligram or placebo. The eligibility criteria were designed to include patients with type two diabetes and high or very high risk for progression of chronic kidney disease. The primary adept objective of flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of <unk>. The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths. Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes. With the projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people. With concomitant chronic kidney disease. The next step for you to close down the trial sort of flow. As expected in the first half of 2024. Presentation of detailed data is expected to take place at a medical conference also during 2024 next slide please.
Martin Holst Lange: Thank you Doug, Please turn to the next slide, serious Chronic Noncommunicable Diseases affect millions of people globally and have emerged in recent years as a major public health issue, given our extensive scientific and clinical knowledge within metabolic diseases, we are well positioned to advance our understanding of Semaglutide potential benefits in associated health complications.
Serious chronic noncommunicable diseases affect millions of people globally and have emerged in recent years as a major public health issue.
Martin Holst Lange: We are also anticipating the results from the ongoing pivotal phase 3 trial for IcoSema COMBINE 3 in H1 2024. IcoSema has the potential to be a first-in-class, once-weekly, fixed-ratio combination of basal insulin and GLP-1 receptor agonist in patients with type 2 diabetes in need of intensification. Within obesity, we're happy to announce that we in September initiated a 32-week phase 1 trial with once-weekly subcutaneous amycretin in people with overweight obesity. While we await SELECT data going to be presented at the American Heart Association Congress, we have submitted the trial to the US FDA and the European Medicines Agency. We are pleased that the FDA has granted priority review for the supplemental new drug application.
Martin Holst Lange: We are also anticipating the results from the ongoing pivotal phase 3 trial for IcoSema COMBINE 3 in H1 2024. IcoSema has the potential to be a first-in-class, once-weekly, fixed-ratio combination of basal insulin and GLP-1 receptor agonist in patients with type 2 diabetes in need of intensification. Within obesity, we're happy to announce that we in September initiated a 32-week phase 1 trial with once-weekly subcutaneous amycretin in people with overweight obesity. While we await SELECT data going to be presented at the American Heart Association Congress, we have submitted the trial to the US FDA and the European Medicines Agency. We are pleased that the FDA has granted priority review for the supplemental new drug application.
Given our extensive scientific and clinical knowledge within metabolic diseases, we are well positioned to advance our understanding of <unk> potential benefits in associated with health complications.
With the current body of evidence it is clear.
Martin Holst Lange: With the current body of evidence, it is clear that the beneficial effects of Semaglutide goes even further than glycemia control and weight loss, Semaglutide has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies. This includes sustain six and pioneer six in type two diabetes. As well as step have pet select. Yes. While we await data from this electronics should be presented we continue to build evidence for this magnetek molecule in the cardiovascular space. In 2024, we expect several readouts. This includes type two diabetes control. Type two diabetes cardiovascular outcome study sold was also <unk> 40 milligram and the functional outcome trial stride, which focuses on the high risk population with peripheral vascular disease. As previously discussed we also investigated the potential therapeutic effects of <unk> on osteoarthritis and metabolic hepatic dysfunction associated states Youll hepatitis previously known as not alcoholic stay with John hepatitis. In addition to this we recently announced early closure of the floor. Due to efficacy next slide please. Yes. This closure was based on a recommendation from the flow independent data monitoring committee following a pre planned interim analysis. As you know flow is an outcomes trial conducted across 28 countries and more than 400 sites. 3534 people were enrolled and randomized one to one ratio to receive either a once weekly <unk> 1.0 milligram or placebo. The eligibility criteria were designed to include patients with type two diabetes and high or very high risk for progression of chronic kidney disease. The primary adept objective of flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of <unk>. The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths. Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes. With the projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people. With concomitant chronic kidney disease. The next step for you to close down the trial sort of flow. As expected in the first half of 2024. Presentation of detailed data is expected to take place at a medical conference also during 2024 next slide please.
Martin Holst Lange: With the current body of evidence, it is clear that the beneficial effects of Semaglutide goes even further than glycemia control and weight loss, Semaglutide has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies, this includes SUSTAIN 6 and PIONEER 6 in Type 2 diabetes, as well as STEP HFpEF SELECT in obesity.
Beneficial effects, obviously, you're making type goes even further than placebo control and weight loss <unk>.
<unk> has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies.
This includes sustain six and pioneer six in type two diabetes.
As well as step have pet select.
Yes.
While we await data from this electronics should be presented we continue to build evidence for this magnetek molecule in the cardiovascular space.
Martin Holst Lange: While we await data from the SELECT files to be presented, we continue to build evidence for the Semaglutide molecule in the cardiovascular space, in 2024, we expect several readouts, this includes Type 2 diabetes cardiovascular outcome study SOUL, with oral Semaglutide 40 milligram and the functional outcome trial STRIDE, which focuses on the high risk population with peripheral vascular disease. As previously discussed we also investigated the potential therapeutic effects of <unk> on osteoarthritis and metabolic hepatic dysfunction associated states Youll hepatitis previously known as not alcoholic stay with John hepatitis. In addition to this we recently announced early closure of the floor. Due to efficacy next slide please. Yes. This closure was based on a recommendation from the flow independent data monitoring committee following a pre planned interim analysis. As you know flow is an outcomes trial conducted across 28 countries and more than 400 sites. 3534 people were enrolled and randomized one to one ratio to receive either a once weekly <unk> 1.0 milligram or placebo. The eligibility criteria were designed to include patients with type two diabetes and high or very high risk for progression of chronic kidney disease. The primary adept objective of flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of <unk>. The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths. Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes. With the projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people. With concomitant chronic kidney disease. The next step for you to close down the trial sort of flow. As expected in the first half of 2024. Presentation of detailed data is expected to take place at a medical conference also during 2024 next slide please.
Martin Holst Lange: While we await data from the SELECT files to be presented, we continue to build evidence for the Semaglutide molecule in the cardiovascular space, in 2024, we expect several readouts, this includes Type 2 diabetes cardiovascular outcome study SOUL, with oral Semaglutide 40 milligram and the functional outcome trial STRIDE, which focuses on the high risk population with peripheral vascular disease.
In 2024, we expect several readouts.
This includes type two diabetes control.
Type two diabetes cardiovascular outcome study sold was also <unk> 40 milligram and the functional outcome trial stride, which focuses on the high risk population with peripheral vascular disease.
Martin Holst Lange: This marks a significant milestone in our ongoing efforts to address unmet needs in patients with overweight, obesity, and cardiovascular disease. Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients and diabetes to read out in Q4 of this year. In rare disease, nedosiran was approved by the US FDA for treatment of primary hyperoxaluria type 1. This marks the first approved siRNA treatment for Novo Nordisk. In other serious chronic diseases, we initiated a phase I trial with our angiopoietin-like 3 protein inhibitor. This is a monoclonal antibody in development for cardiovascular disease, specifically for lowering of cholesterol and triglycerides. With that, over to you, Karsten.
Martin Holst Lange: This marks a significant milestone in our ongoing efforts to address unmet needs in patients with overweight, obesity, and cardiovascular disease. Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients and diabetes to read out in Q4 of this year. In rare disease, nedosiran was approved by the US FDA for treatment of primary hyperoxaluria type 1. This marks the first approved siRNA treatment for Novo Nordisk. In other serious chronic diseases, we initiated a phase I trial with our angiopoietin-like 3 protein inhibitor. This is a monoclonal antibody in development for cardiovascular disease, specifically for lowering of cholesterol and triglycerides. With that, over to you, Karsten.
As previously discussed we also investigated the potential therapeutic effects of <unk> on osteoarthritis and metabolic hepatic dysfunction associated states Youll hepatitis previously known as not alcoholic stay with John hepatitis.
Martin Holst Lange: As previously discussed we also investigated the potential therapeutic effects of Semaglutide on osteoarthritis and metabolic dysfunction associated to Steatohepatitis previously known as Non-alcoholic Steatohepatitis, in addition to this we recently announced early closure of the FLOW trial due to efficacy, next slide please. Yes. This closure was based on a recommendation from the flow independent data monitoring committee following a pre planned interim analysis. As you know flow is an outcomes trial conducted across 28 countries and more than 400 sites. 3534 people were enrolled and randomized one to one ratio to receive either a once weekly <unk> 1.0 milligram or placebo. The eligibility criteria were designed to include patients with type two diabetes and high or very high risk for progression of chronic kidney disease. The primary adept objective of flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of <unk>. The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths. Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes. With the projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people. With concomitant chronic kidney disease. The next step for you to close down the trial sort of flow. As expected in the first half of 2024. Presentation of detailed data is expected to take place at a medical conference also during 2024 next slide please.
Martin Holst Lange: As previously discussed we also investigated the potential therapeutic effects of Semaglutide on osteoarthritis and metabolic dysfunction associated to Steatohepatitis previously known as Non-alcoholic Steatohepatitis, in addition to this we recently announced early closure of the FLOW trial due to efficacy, next slide please.
In addition to this we recently announced early closure of the floor.
Martin Holst Lange: This closure was based on a recommendation from the FLOW independent data monitoring committee following a pre-planned interim analysis, as you know FLOW is an outcomes trial conducted across 28 countries and more than 400 sites, 3,534 people were enrolled and randomized in a one to one ratio to receive either a once weekly Semaglutide 1.0 milligram or placebo. The eligibility criteria were designed to include patients with type two diabetes and high or very high risk for progression of chronic kidney disease. The primary adept objective of flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of <unk>. The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths. Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes. With the projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people. With concomitant chronic kidney disease. The next step for you to close down the trial sort of flow. As expected in the first half of 2024. Presentation of detailed data is expected to take place at a medical conference also during 2024 next slide please.
Martin Holst Lange: This closure was based on a recommendation from the FLOW independent data monitoring committee following a pre-planned interim analysis, as you know FLOW is an outcomes trial conducted across 28 countries and more than 400 sites, 3,534 people were enrolled and randomized in a one to one ratio to receive either a once weekly Semaglutide 1.0 milligram or placebo.
Due to efficacy next slide please.
Yes.
This closure was based on a recommendation from the flow independent data monitoring committee following a pre planned interim analysis.
As you know flow is an outcomes trial conducted across 28 countries and more than 400 sites.
3534 people were enrolled and randomized one to one ratio to receive either a once weekly <unk> 1.0 milligram or placebo.
Karsten Munk Knudsen: Thank you, Martin. Please turn to the next slide. In the first 9 months of 2023, our sales grew by 29% in DKK and 33% at constant exchange rates, driven by both our operating units. The gross margin increased to 84.5% compared to 84.3% in 2022. The increase in gross margin reflects a positive product mix driven by increased sales of GLP-1 based treatments. This is partially countered by costs related to ongoing capacity expansions, negative currency impact, and lower realized prices, mainly in the US and region China. Sales and distribution costs increased by 22% in DKK and by 25% at constant exchange rates. The increase is driven by both operating units. In North America, the cost increase is driven by the relaunch of Wegovy and promotional activities for Ozempic.
Karsten Munk Knudsen: Thank you, Martin. Please turn to the next slide. In the first 9 months of 2023, our sales grew by 29% in DKK and 33% at constant exchange rates, driven by both our operating units. The gross margin increased to 84.5% compared to 84.3% in 2022. The increase in gross margin reflects a positive product mix driven by increased sales of GLP-1 based treatments. This is partially countered by costs related to ongoing capacity expansions, negative currency impact, and lower realized prices, mainly in the US and region China. Sales and distribution costs increased by 22% in DKK and by 25% at constant exchange rates. The increase is driven by both operating units. In North America, the cost increase is driven by the relaunch of Wegovy and promotional activities for Ozempic.
Martin Holst Lange: The eligibility criteria were designed to include patients with Type 2 diabetes and high or very high risk for progression of chronic kidney disease, the primary adept objective of flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of <unk>. The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths. Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes. With the projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people. With concomitant chronic kidney disease. The next step for you to close down the trial sort of flow. As expected in the first half of 2024. Presentation of detailed data is expected to take place at a medical conference also during 2024 next slide please.
Martin Holst Lange: The eligibility criteria were designed to include patients with Type 2 diabetes and high or very high risk for progression of chronic kidney disease, the primary adept objective of flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint, this is on top of standard of care, including the use of SGLT2s.
The eligibility criteria were designed to include patients with type two diabetes and high or very high risk for progression of chronic kidney disease.
The primary adept objective of flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint.
Martin Holst Lange: This is on top of standard of care, including the use of SGLT2s The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths. Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes. With the projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people. With concomitant chronic kidney disease. The next step for you to close down the trial sort of flow. As expected in the first half of 2024. Presentation of detailed data is expected to take place at a medical conference also during 2024 next slide please.
Martin Holst Lange: This is on top of standard of care, including the use of SGLT2s
This is on top of standard of care, including the use of <unk>.
Martin Holst Lange: The trial is powered to detect a 20% risk reduction on the primary endpoint, key secondary endpoints include annual rate of change in estimated glomerular filtration rate, major adverse cardiovascular events and all cause deaths, today a few treatment options exist for chronic kidney disease in people living with Type 2 diabetes. With the projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people. With concomitant chronic kidney disease. The next step for you to close down the trial sort of flow. As expected in the first half of 2024. Presentation of detailed data is expected to take place at a medical conference also during 2024 next slide please.
Martin Holst Lange: The trial is powered to detect a 20% risk reduction on the primary endpoint, key secondary endpoints include annual rate of change in estimated glomerular filtration rate, major adverse cardiovascular events and all cause deaths, today a few treatment options exist for chronic kidney disease in people living with Type 2 diabetes.
The trial is powered to detect a 20% risk reduction on the primary endpoint.
Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths.
Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes.
Karsten Munk Knudsen: In international operations, the cost increase is driven by promotional activities for Rybelsus as well as obesity care market development activities. The increase in sales and distribution costs are impacted by adjustments through legal provisions. Research and development costs increased by 38% measured in Danish kroner and 39% at constant exchange rates. The increase reflects increased late-stage clinical trial activity and increased early research activities compared to the first nine months of 2022. The acquisition of Forma Therapeutics in 2022 and in Inversago Pharma also increased R&D spending. Administration costs increased by 9% measured in Danish kroner and 11% at constant exchange rates. Operating profit increased by 31% measured in Danish kroner and 37% at constant exchange rates, reflecting the sales growth.
Karsten Munk Knudsen: In international operations, the cost increase is driven by promotional activities for Rybelsus as well as obesity care market development activities. The increase in sales and distribution costs are impacted by adjustments through legal provisions. Research and development costs increased by 38% measured in Danish kroner and 39% at constant exchange rates. The increase reflects increased late-stage clinical trial activity and increased early research activities compared to the first nine months of 2022. The acquisition of Forma Therapeutics in 2022 and in Inversago Pharma also increased R&D spending. Administration costs increased by 9% measured in Danish kroner and 11% at constant exchange rates. Operating profit increased by 31% measured in Danish kroner and 37% at constant exchange rates, reflecting the sales growth.
Martin Holst Lange: With the projected global increase in Type 2 diabetes, there's a clear need for additional treatment options to help mitigate the residual risk in people with concomitant chronic kidney disease, the next step for you to close down the trial sort of flow is as expected in the first half of 2024, the presentation of detailed data is expected to take place at a medical conference also during 2024, next slide please. In line with our strategic aspiration of establishing a presence in other serious chronic diseases. We are pleased to announce the acquisition of <unk> for the treatment of cardiovascular disease from <unk> Biosciences.
Martin Holst Lange: With the projected global increase in Type 2 diabetes, there's a clear need for additional treatment options to help mitigate the residual risk in people with concomitant chronic kidney disease, the next step for you to close down the trial sort of flow is as expected in the first half of 2024, the presentation of detailed data is expected to take place at a medical conference also during 2024, next slide please.
With the projected global increase in type two diabetes.
Clear need for additional treatment options to help mitigate the residual risk and people.
With concomitant chronic kidney disease.
The next step for you to close down the trial sort of flow.
As expected in the first half of 2024.
Presentation of detailed data is expected to take place at a medical conference also during 2024 next slide please.
Martin Holst Lange: In line with our strategic aspiration of establishing a presence in other serious chronic diseases we are pleased to announce the acquisition of Ocedurenone for the treatment of cardiovascular disease from KBP Biosciences, there remains a significant need in treatment of hypertension, which is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease and death. <unk> is a once daily orally administered small molecule with a long half life and a high affinity for the mainland Cologuard receptor. <unk> has an attractive efficacy and safety profile and is currently being examined in the phase III trial <unk>. Patients with uncontrolled hypertension and at <unk>. <unk> chronic kidney disease. We expect to initiate. To initiate additional cardiovascular as well as chronic kidney disease outcomes trials. During the course of 2024 next slide please. Turning to other R&D milestones I would like to highlight some of the other trial readouts. And the initiations across all therapy areas in 2023 and in the first half of 2024. Within diabetes in the first quarter. Third quarter of 2020 free we initiated the first pivotal phase III trial in the re imagined program, Okay, Kusama and people with type two diabetes. In the fourth quarter. We have submitted also made in fab 25, and 50 milligram in the EU. We are also anticipating the results from the ongoing pivotal phase III trial for Iqos, Emma combined free. In the first half of 2024. <unk> has the potential to be first in class once weekly fixed ratio combination of basal insulin NGL receptor sorry Sheila. One receptor agonist and <unk> type two diabetes in need of intensification. Within obesity, we have. Happy to announce that we in September initiated a 32 week phase <unk> trial was once weekly subcutaneous <unk> in people with all with obesity. While we await select data. At the American. It's going to be presented at the American Heart Association Congress, we have submitted the trial to the U S FDA and the European Medicines Agency.
Martin Holst Lange: In line with our strategic aspiration of establishing a presence in other serious chronic diseases we are pleased to announce the acquisition of Ocedurenone for the treatment of cardiovascular disease from KBP Biosciences, there remains a significant need in treatment of hypertension, which is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease and death.
In line with our strategic aspiration of establishing a presence in other serious chronic diseases. We are pleased to announce the acquisition of <unk> for the treatment of cardiovascular disease from <unk> Biosciences.
There remains a significant need.
Treatment of hypertension.
Karsten Munk Knudsen: Net financials showed a net gain of DKK 1.2 billion compared to a net loss of DKK 5 billion last year. The effective tax rate was 19.9% in the first nine months of 2023, compared to 20.5% in the first nine months of 2022. Net profit increased by 47%, and diluted earnings per share increased by 49% to 13 kroner and 71 øre. Free cash flow was DKK 75.6 billion, compared with DKK 62.6 billion in the first nine months of 2022. In line with the strategic aspiration of delivering attractive capital allocation to shareholders, a total of DKK 52 billion has been paid back to shareholders through share buybacks and dividends. The cash conversion is positively impacted by timing of payment of rebates in the US.
Karsten Munk Knudsen: Net financials showed a net gain of DKK 1.2 billion compared to a net loss of DKK 5 billion last year. The effective tax rate was 19.9% in the first nine months of 2023, compared to 20.5% in the first nine months of 2022. Net profit increased by 47%, and diluted earnings per share increased by 49% to 13 kroner and 71 øre. Free cash flow was DKK 75.6 billion, compared with DKK 62.6 billion in the first nine months of 2022. In line with the strategic aspiration of delivering attractive capital allocation to shareholders, a total of DKK 52 billion has been paid back to shareholders through share buybacks and dividends. The cash conversion is positively impacted by timing of payment of rebates in the US.
Which is a leading risk factor for cardiovascular events heart failure, chronic kidney disease and death.
Martin Holst Lange: Ocedurenone is a once daily orally administered small molecule with a long half life and a high affinity for the mineralocorticoid receptor, Ocedurenone has an attractive efficacy and safety profile and is currently being examined in the Phase III trial CLARION-CKD in patients with uncontrolled hypertension and advanced chronic kidney disease. We expect to initiate. To initiate additional cardiovascular as well as chronic kidney disease outcomes trials. During the course of 2024 next slide please. Turning to other R&D milestones I would like to highlight some of the other trial readouts. And the initiations across all therapy areas in 2023 and in the first half of 2024. Within diabetes in the first quarter. Third quarter of 2020 free we initiated the first pivotal phase III trial in the re imagined program, Okay, Kusama and people with type two diabetes. In the fourth quarter. We have submitted also made in fab 25, and 50 milligram in the EU. We are also anticipating the results from the ongoing pivotal phase III trial for Iqos, Emma combined free. In the first half of 2024. <unk> has the potential to be first in class once weekly fixed ratio combination of basal insulin NGL receptor sorry Sheila. One receptor agonist and <unk> type two diabetes in need of intensification. Within obesity, we have. Happy to announce that we in September initiated a 32 week phase <unk> trial was once weekly subcutaneous <unk> in people with all with obesity. While we await select data. At the American. It's going to be presented at the American Heart Association Congress, we have submitted the trial to the U S FDA and the European Medicines Agency.
Martin Holst Lange: Ocedurenone is a once daily orally administered small molecule with a long half life and a high affinity for the mineralocorticoid receptor, Ocedurenone has an attractive efficacy and safety profile and is currently being examined in the Phase III trial CLARION-CKD in patients with uncontrolled hypertension and advanced chronic kidney disease, we expect to initiate additional cardiovascular, as well as chronic kidney disease outcomes trials during the course of 2024, next slide please.
<unk> is a once daily orally administered small molecule with a long half life and a high affinity for the mainland Cologuard receptor.
<unk> has an attractive efficacy and safety profile and is currently being examined in the phase III trial <unk>.
Patients with uncontrolled hypertension and at <unk>.
Martin Holst Lange: We expect to initiate additional cardiovascular, as well as chronic kidney disease outcomes trials during the course of 2024, next slide please. Turning to other R&D milestones I would like to highlight some of the other trial readouts. And the initiations across all therapy areas in 2023 and in the first half of 2024. Within diabetes in the first quarter. Third quarter of 2020 free we initiated the first pivotal phase III trial in the re imagined program, Okay, Kusama and people with type two diabetes. In the fourth quarter. We have submitted also made in fab 25, and 50 milligram in the EU. We are also anticipating the results from the ongoing pivotal phase III trial for Iqos, Emma combined free. In the first half of 2024. <unk> has the potential to be first in class once weekly fixed ratio combination of basal insulin NGL receptor sorry Sheila. One receptor agonist and <unk> type two diabetes in need of intensification. Within obesity, we have. Happy to announce that we in September initiated a 32 week phase <unk> trial was once weekly subcutaneous <unk> in people with all with obesity. While we await select data. At the American. It's going to be presented at the American Heart Association Congress, we have submitted the trial to the U S FDA and the European Medicines Agency.
Martin Holst Lange: We expect to initiate additional cardiovascular, as well as chronic kidney disease outcomes trials during the course of 2024, next slide please.
<unk> chronic kidney disease.
We expect to initiate.
To initiate additional cardiovascular as well as chronic kidney disease outcomes trials. During the course of 2024 next slide please.
Martin Holst Lange: Turning to other R&D milestones, I would like to highlight some of the other trial readouts and the initiations across all therapy areas in 2023 and in the first half of 2024, within diabetes in the first quarter, third quarter of 2023, we initiated the first pivotal Phase III trial in the re-imagined program Cagrisema in people with Type 2 diabetes. In the fourth quarter. We have submitted also made in fab 25, and 50 milligram in the EU. We are also anticipating the results from the ongoing pivotal phase III trial for Iqos, Emma combined free. In the first half of 2024. <unk> has the potential to be first in class once weekly fixed ratio combination of basal insulin NGL receptor sorry Sheila. One receptor agonist and <unk> type two diabetes in need of intensification. Within obesity, we have. Happy to announce that we in September initiated a 32 week phase <unk> trial was once weekly subcutaneous <unk> in people with all with obesity. While we await select data. At the American. It's going to be presented at the American Heart Association Congress, we have submitted the trial to the U S FDA and the European Medicines Agency.
Martin Holst Lange: Turning to other R&D milestones, I would like to highlight some of the other trial readouts and the initiations across all therapy areas in 2023 and in the first half of 2024, within diabetes in the first quarter, third quarter of 2023, we initiated the first pivotal Phase III trial in the re-imagined program Cagrisema in people with Type 2 diabetes.
Turning to other R&D milestones I would like to highlight some of the other trial readouts.
And the initiations across all therapy areas in 2023 and in the first half of 2024.
Karsten Munk Knudsen: Capital expenditure for property, plant and equipment was DKK 16.4 billion compared to DKK 7.2 billion in 2022. This primarily reflects investments in additional capacity for active pharmaceutical ingredient production and fill finished capacity for both current and future injectable and oral products. Please go to the next slide. Nine months into 2023, we are continuing our sales growth momentum, which has enabled us to raise the outlook for the full year. We now expect the sales growth to be between 32% and 38% at constant exchange rates. The increased sales outlook is primarily reflecting higher full year expectations for Ozempic volume sold in the US and gross to net adjustments for Ozempic and Wegovy in the US. The guidance reflects expectation for sales growth in both North America Operations and International Operations.
Karsten Munk Knudsen: Capital expenditure for property, plant and equipment was DKK 16.4 billion compared to DKK 7.2 billion in 2022. This primarily reflects investments in additional capacity for active pharmaceutical ingredient production and fill finished capacity for both current and future injectable and oral products. Please go to the next slide. Nine months into 2023, we are continuing our sales growth momentum, which has enabled us to raise the outlook for the full year. We now expect the sales growth to be between 32% and 38% at constant exchange rates. The increased sales outlook is primarily reflecting higher full year expectations for Ozempic volume sold in the US and gross to net adjustments for Ozempic and Wegovy in the US. The guidance reflects expectation for sales growth in both North America Operations and International Operations.
Within diabetes in the first quarter.
Third quarter of 2020 free we initiated the first pivotal phase III trial in the re imagined program, Okay, Kusama and people with type two diabetes.
Martin Holst Lange: In the fourth quarter, we have submitted oral Semaglutide 25, and 50 milligram in the EU, we are also anticipating the results from the ongoing pivotal Phase III trial for IcoSema combined free, in the first half of 2024, IcoSema has the potential to be a first in class, once weekly, fixed ratio combination of basal insulin NGL receptor sorry GLP-1 receptor agonist in Type 2 diabetes in need of intensification. Within obesity, we have. Happy to announce that we in September initiated a 32 week phase <unk> trial was once weekly subcutaneous <unk> in people with all with obesity. While we await select data. At the American. It's going to be presented at the American Heart Association Congress, we have submitted the trial to the U S FDA and the European Medicines Agency.
Martin Holst Lange: In the fourth quarter, we have submitted oral Semaglutide 25, and 50 milligram in the EU, we are also anticipating the results from the ongoing pivotal Phase III trial for IcoSema combined free, in the first half of 2024, IcoSema has the potential to be a first in class, once weekly, fixed ratio combination of basal insulin NGL receptor sorry GLP-1 receptor agonist in patients with Type 2 diabetes in need of intensification.
In the fourth quarter. We have submitted also made in fab 25, and 50 milligram in the EU.
We are also anticipating the results from the ongoing pivotal phase III trial for Iqos, Emma combined free.
In the first half of 2024.
<unk> has the potential to be first in class once weekly fixed ratio combination of basal insulin NGL receptor sorry Sheila.
One receptor agonist and <unk> type two diabetes in need of intensification.
Martin Holst Lange: Within obesity, we are happy to announce that we in September initiated a 32 week Phase I trial with once weekly subcutaneous Amycretin in people with overweight obesity, while we await select data at the American, It's going to be presented at the American Heart Association Congress, we have submitted the trial to the US FDA and the European Medicines Agency. We're pleased that the FDA has granted priority review for the supplemented supplemental new drug application.
Martin Holst Lange: Within obesity, we are happy to announce that we in September initiated a 32 week Phase I trial with once weekly subcutaneous Amycretin in people with overweight obesity, while we await select data at the American, It's going to be presented at the American Heart Association Congress, we have submitted the trial to the US FDA and the European Medicines Agency.
Within obesity, we have.
Happy to announce that we in September initiated a 32 week phase <unk> trial was once weekly subcutaneous <unk> in people with all with obesity.
Karsten Munk Knudsen: The guidance is mainly driven by volume growth of GLP-1 based treatments for diabetes and obesity care. This is partially countered by declining sales in rare disease due to a temporary reduction in manufacturing outputs. The guidance reflects the level of volume growth of GLP-1 based treatments. The inherent uncertainty of the pace of obesity care market expansion following the relaunch of Wegovy in the US and a limited rollout in international operations are also included in the guidance range. Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies. Novo Nordisk is investing in internal and external capacity to increase supply both short-term and long-term. While supply capacity for Wegovy is gradually being expanded, the lower dose strengths in the US will remain restricted to safeguard continuity of care.
Karsten Munk Knudsen: The guidance is mainly driven by volume growth of GLP-1 based treatments for diabetes and obesity care. This is partially countered by declining sales in rare disease due to a temporary reduction in manufacturing outputs. The guidance reflects the level of volume growth of GLP-1 based treatments. The inherent uncertainty of the pace of obesity care market expansion following the relaunch of Wegovy in the US and a limited rollout in international operations are also included in the guidance range. Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies. Novo Nordisk is investing in internal and external capacity to increase supply both short-term and long-term. While supply capacity for Wegovy is gradually being expanded, the lower dose strengths in the US will remain restricted to safeguard continuity of care.
While we await select data.
At the American.
It's going to be presented at the American Heart Association Congress, we have submitted the trial to the U S FDA and the European Medicines Agency.
Martin Holst Lange: We're pleased that the FDA has granted priority review for the supplemental new drug application, this marks a significant milestone in our ongoing efforts to address unmet needs in patients with overweight and obesity and established cardiovascular disease. Finally, we also expect the chronic heart failure trial with preserved ejection fraction patients have diabetes to read out in the last quarter of this year. In rare disease. The document was approved by the U S. FDA for treatment of primary Hyperoxaluria type one this marks the first approved. <unk> treatment for Novo Nordisk. And that's in. In North America, the cost increase is driven by the relaunch of the Kobe and promotional activities for <unk>. And his last operations the cost increase is driven by promotion activities for rebellious. As well as obesity can market development activities. The increase in citizenship distribution costs impacted by adjustments to legal provisions. Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates. The increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of 2022. The exorcist in a form of therapeutics and 22 and in Masako Farmer also increased allergy spending. Administration costs increased by 9% method, and Dennis Corona and 11% at constant exchange rates. Operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth. Net financial showed a net gain of 1.2 billion Danish kroner compared to a net loss of 5 billion Danish kroner last year. The effective tax rate was 19.9% in the first nine months of 20 tree compared to 20.5% in the first nine months of 22. Net profit increased by 47% and diluted earnings per share increased by 49% to 13 Corona in 71. Yeah. Free cash flow was 75.6 billion Danish kroner, compared with 62.6 billion kronor in the first nine months of 2002. In line with the strategic aspiration of delivering attractive capsule to shareholders. A total of 52 billion Danish kroner has been paid back to shareholders through sheer pipex and dividends. <unk> conversion is positively impacted by timing of payment of rebates in the US.
Martin Holst Lange: We're pleased that the FDA has granted priority review for the supplemental new drug application, this marks a significant milestone in our ongoing efforts to address unmet needs in patients with overweight and obesity and established cardiovascular disease, finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients and diabetes to read out in the last quarter of this year.
We're pleased that the FDA has granted priority review for the supplemented supplemental new drug application.
This marks a significant milestone in our ongoing efforts to address unmet needs in patients with overweight and obesity and established cardiovascular disease.
Finally, we also expect the chronic heart failure trial with preserved ejection fraction patients have diabetes to read out in the last quarter of this year.
Martin Holst Lange: Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients and diabetes to read out in the last quarter of this year, in rare disease, Nedosiran was approved by the U S. FDA for treatment of primary Hyperoxaluria type one this marks the first approved. <unk> treatment for Novo Nordisk. And that's in. In North America, the cost increase is driven by the relaunch of the Kobe and promotional activities for <unk>. And his last operations the cost increase is driven by promotion activities for rebellious. As well as obesity can market development activities. The increase in citizenship distribution costs impacted by adjustments to legal provisions. Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates. The increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of 2022. The exorcist in a form of therapeutics and 22 and in Masako Farmer also increased allergy spending. Administration costs increased by 9% method, and Dennis Corona and 11% at constant exchange rates. Operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth. Net financial showed a net gain of 1.2 billion Danish kroner compared to a net loss of 5 billion Danish kroner last year. The effective tax rate was 19.9% in the first nine months of 20 tree compared to 20.5% in the first nine months of 22. Net profit increased by 47% and diluted earnings per share increased by 49% to 13 Corona in 71. Yeah. Free cash flow was 75.6 billion Danish kroner, compared with 62.6 billion kronor in the first nine months of 2002. In line with the strategic aspiration of delivering attractive capsule to shareholders. A total of 52 billion Danish kroner has been paid back to shareholders through sheer pipex and dividends. <unk> conversion is positively impacted by timing of payment of rebates in the US.
Martin Holst Lange: Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients and diabetes to read out in the last quarter of this year,
In rare disease. The document was approved by the U S. FDA for treatment of primary Hyperoxaluria type one this marks the first approved.
<unk> treatment for Novo Nordisk.
Martin Holst Lange: In rare disease, Nedosiran was approved by the US FDA for treatment of primary Hyperoxaluria type one, this marks the first approved siRNA treatment for Novo Nordisk, in other serious chronic diseases, we initiated a Phase I trial with our angiopoietin-like 3 protein inhibitor, this is a monoclonal antibody in development for cardiovascular disease, specifically for lowering of cholesterol and triglycerides, with that, over to you Karsten. and that's in. In North America, the cost increase is driven by the relaunch of the Kobe and promotional activities for <unk>. And his last operations the cost increase is driven by promotion activities for rebellious. As well as obesity can market development activities. The increase in citizenship distribution costs impacted by adjustments to legal provisions. Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates. The increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of 2022. The exorcist in a form of therapeutics and 22 and in Masako Farmer also increased allergy spending. Administration costs increased by 9% method, and Dennis Corona and 11% at constant exchange rates. Operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth. Net financial showed a net gain of 1.2 billion Danish kroner compared to a net loss of 5 billion Danish kroner last year. The effective tax rate was 19.9% in the first nine months of 20 tree compared to 20.5% in the first nine months of 22. Net profit increased by 47% and diluted earnings per share increased by 49% to 13 Corona in 71. Yeah. Free cash flow was 75.6 billion Danish kroner, compared with 62.6 billion kronor in the first nine months of 2002. In line with the strategic aspiration of delivering attractive capsule to shareholders. A total of 52 billion Danish kroner has been paid back to shareholders through sheer pipex and dividends. <unk> conversion is positively impacted by timing of payment of rebates in the US.
Martin Holst Lange: In rare disease, Nedosiran was approved by the US FDA for treatment of primary Hyperoxaluria type one, this marks the first approved siRNA treatment for Novo Nordisk, in other serious chronic diseases, we initiated a Phase I trial with our Angiopoietin-like 3 protein inhibitor, this is a monoclonal antibody in development for cardiovascular disease, specifically for lowering of cholesterol and triglycerides, with that, over to you Karsten. Thank you Martin
Martin Holst Lange: In rare disease, Nedosiran was approved by the US FDA for treatment of primary Hyperoxaluria type one, this marks the first approved siRNA treatment for Novo Nordisk, in other serious chronic diseases, we initiated a Phase I trial with our Angiopoietin-like 3 protein inhibitor, this is a monoclonal antibody in development for cardiovascular disease, specifically for lowering of cholesterol and triglycerides, with that, over to you Karsten.
Karsten Munk Knudsen: We now expect operating profit to grow between 40% and 46% at constant exchange rates. This primarily reflects the sales growth outlook and continued investments in future and current growth drivers within research and development and commercial. For 2023, we expect net financial items to amount to a gain of around DKK 1.6 billion, mainly reflecting gains associated with foreign exchange hedging contracts. Capital expenditure is still expected to be around DKK 25 billion, reflecting the upscaling of the supply chain and the innovation-based growth strategy pursued by Novo Nordisk. In the coming years, the capital expenditure to sales ratio is expected to be low double digits. The free cash flow is now expected to be between DKK 65 and 73 billion, reflecting the sales growth, a favorable impact from rebates in the US, and investments and capital expenditure.
Karsten Munk Knudsen: We now expect operating profit to grow between 40% and 46% at constant exchange rates. This primarily reflects the sales growth outlook and continued investments in future and current growth drivers within research and development and commercial. For 2023, we expect net financial items to amount to a gain of around DKK 1.6 billion, mainly reflecting gains associated with foreign exchange hedging contracts. Capital expenditure is still expected to be around DKK 25 billion, reflecting the upscaling of the supply chain and the innovation-based growth strategy pursued by Novo Nordisk.
Karsten Knudsen: Thank you Martin, please turn to the next slide, In the first 9 months of 2023, our sales grew by 29% in Danis Kroner and 33% at constant exchange rate driven by both of our operating units, the gross margin increased to 84.5% compared to 84.3% in 2022, the increase in gross margin reflects a positive product mix driven by increased sales of GLP-1 based treatments, this is partially countered by costs related to ongoing capacity expansions and negative currency impact and lower realize prices mainly in the US and regent China, sales and distribution costs increased by 22% in Danish Kroner and by 25% at a constant exchange rate, the increase is driven by both operating units.
Karsten Knudsen: Thank you Martin, please turn to the next slide, In the first 9 months of 2023, our sales grew by 29% in Danis Krone and 33% at constant exchange rate driven by both of our operating units, the gross margin increased to 84.5% compared to 84.3% in 2022, the increase in gross margin reflects a positive product mix driven by increased sales of GLP-1 based treatments,
Karsten Knudsen: This is partially countered by costs related to ongoing capacity expansions and negative currency impact and lower realize prices mainly in the US and regent China, sales and distribution costs increased by 22% in Danish Krone and by 25% at a constant exchange rates, the increase is driven by both operating units.
Martin Holst Lange: In North America, the cost increase is driven by the relaunch of Wegovy and promotional activities for Ozempic, in international operations the cost increase is driven by promotion activities for Rybelsus as well as obesity care market development activities, the increase in sales and distribution costs are impacted by adjustments to legal provisions. Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates. The increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of 2022. The exorcist in a form of therapeutics and 22 and in Masako Farmer also increased allergy spending. Administration costs increased by 9% method, and Dennis Corona and 11% at constant exchange rates. Operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth. Net financial showed a net gain of 1.2 billion Danish kroner compared to a net loss of 5 billion Danish kroner last year. The effective tax rate was 19.9% in the first nine months of 20 tree compared to 20.5% in the first nine months of 22. Net profit increased by 47% and diluted earnings per share increased by 49% to 13 Corona in 71. Yeah. Free cash flow was 75.6 billion Danish kroner, compared with 62.6 billion kronor in the first nine months of 2002. In line with the strategic aspiration of delivering attractive capsule to shareholders. A total of 52 billion Danish kroner has been paid back to shareholders through sheer pipex and dividends. <unk> conversion is positively impacted by timing of payment of rebates in the US.
Karsten Knudsen: In North America, the cost increase is driven by the relaunch of Wegovy and promotional activities for Ozempic, in international operations the cost increase is driven by promotion activities for Rybelsus as well as obesity care market development activities, the increase in sales and distribution costs are impacted by adjustments to legal provisions.
Karsten Munk Knudsen: In the coming years, the capital expenditure to sales ratio is expected to be low double digits. The free cash flow is now expected to be between DKK 65 and 73 billion, reflecting the sales growth, a favorable impact from rebates in the US, and investments and capital expenditure. The updated cash flow expectation is mainly reflecting increased net profit expectations, partially countered by business development activities. That covers the outlook for 2023. Now back to you, Lars, for final remarks.
Martin Holst Lange: Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates, the increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of 2022. The exorcist in a form of therapeutics and 22 and in Masako Farmer also increased allergy spending. Administration costs increased by 9% method, and Dennis Corona and 11% at constant exchange rates. Operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth. Net financial showed a net gain of 1.2 billion Danish kroner compared to a net loss of 5 billion Danish kroner last year. The effective tax rate was 19.9% in the first nine months of 20 tree compared to 20.5% in the first nine months of 22. Net profit increased by 47% and diluted earnings per share increased by 49% to 13 Corona in 71. Yeah. Free cash flow was 75.6 billion Danish kroner, compared with 62.6 billion kronor in the first nine months of 2002. In line with the strategic aspiration of delivering attractive capsule to shareholders. A total of 52 billion Danish kroner has been paid back to shareholders through sheer pipex and dividends. <unk> conversion is positively impacted by timing of payment of rebates in the US.
Karsten Knudsen: Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates, the increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of 2022, the acquisition of Forma Therapeutics in '22 and Inversago Pharma also increased R&D spending.
Karsten Munk Knudsen: The updated cash flow expectation is mainly reflecting increased net profit expectations, partially countered by business development activities. That covers the outlook for 2023. Now back to you, Lars, for final remarks.
And that's in.
In North America, the cost increase is driven by the relaunch of the Kobe and promotional activities for <unk>.
And his last operations the cost increase is driven by promotion activities for rebellious.
Lars Fruergaard Jørgensen: Thank you, Karsten. Please turn to the final slide. Today's announcement discloses the full set of quarterly results and updated outlook for 2023, which was shared earlier in October. Overall, we are very satisfied with the sales growth in the first nine months of 2023. The growth is driven by demand for our GLP-1 based therapeutic interventions for diabetes and obesity, which is now reaching more people than ever before. The performance in the first nine months of the year has enabled us to raise the outlook for the full year. From an R&D perspective, we have reached a significant milestone with the submission of SELECT and look forward to sharing more data at American Heart Association. In addition, we are excited about the early closure of the FLOW trial and anticipate its readout in H1 2024.
Lars Fruergaard Jørgensen: Thank you, Karsten. Please turn to the final slide. Today's announcement discloses the full set of quarterly results and updated outlook for 2023, which was shared earlier in October. Overall, we are very satisfied with the sales growth in the first nine months of 2023. The growth is driven by demand for our GLP-1 based therapeutic interventions for diabetes and obesity, which is now reaching more people than ever before. The performance in the first nine months of the year has enabled us to raise the outlook for the full year.
As well as obesity can market development activities.
The increase in citizenship distribution costs impacted by adjustments to legal provisions.
Martin Holst Lange: The acquisition of Forma Therapeutics in '22 and Inversago Pharma also increased R&D spending. Administration costs increased by 9% measured in Danish Krone and 11% at constant exchange rates. Operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth. Net financial showed a net gain of 1.2 billion Danish kroner compared to a net loss of 5 billion Danish kroner last year. The effective tax rate was 19.9% in the first nine months of 20 tree compared to 20.5% in the first nine months of 22. Net profit increased by 47% and diluted earnings per share increased by 49% to 13 Corona in 71. Yeah. Free cash flow was 75.6 billion Danish kroner, compared with 62.6 billion kronor in the first nine months of 2002. In line with the strategic aspiration of delivering attractive capsule to shareholders. A total of 52 billion Danish kroner has been paid back to shareholders through sheer pipex and dividends. <unk> conversion is positively impacted by timing of payment of rebates in the US.
Martin Holst Lange: The acquisition of Forma Therapeutics in '22 and Inversago Pharma also increased R&D spending.
Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates.
Martin Holst Lange: Administration costs increased by 9% measured in Danish Krone and 11% at constant exchange rates, operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth, net financial showed a net gain of 1.2 billion Danish kroner compared to a net loss of 5 billion Danish kroner last year. The effective tax rate was 19.9% in the first nine months of 20 tree compared to 20.5% in the first nine months of 22. Net profit increased by 47% and diluted earnings per share increased by 49% to 13 Corona in 71. Yeah. Free cash flow was 75.6 billion Danish kroner, compared with 62.6 billion kronor in the first nine months of 2002. In line with the strategic aspiration of delivering attractive capsule to shareholders. A total of 52 billion Danish kroner has been paid back to shareholders through sheer pipex and dividends. <unk> conversion is positively impacted by timing of payment of rebates in the US.
Karsten Knudsen: Administration costs increased by 9% measured in Danish Krone and 11% at constant exchange rates, operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth, net financial showed a net gain of 1.2 billion Danish kroner compared to a net loss of 5 billion Danish kroner last year.
The increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of 2022.
The exorcist in a form of therapeutics and 22 and in Masako Farmer also increased allergy spending.
Lars Fruergaard Jørgensen: From an R&D perspective, we have reached a significant milestone with the submission of SELECT and look forward to sharing more data at American Heart Association. In addition, we are excited about the early closure of the FLOW trial and anticipate its readout in H1 2024. Finally, the acquisition of ocedurenone will strengthen the portfolio of cardiovascular disease and underlines the commitment to establish presence with other serious chronic diseases. With that, I'll hand over to the final word to Daniel Boesen.
Administration costs increased by 9% method, and Dennis Corona and 11% at constant exchange rates.
Operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth.
Martin Holst Lange: The effective tax rate was 19.9% in the first nine months of '23 compared to 20.5% in the first nine months of '22, net profit increased by 47% and diluted earnings per share increased by 49% to 13.71 Krone, free cash flow was 75.6 billion Danish krone, compared with 62.6 billion krone in the first nine months of 2002. In line with the strategic aspiration of delivering attractive capsule to shareholders. A total of 52 billion Danish kroner has been paid back to shareholders through sheer pipex and dividends. <unk> conversion is positively impacted by timing of payment of rebates in the US.
Karsten Knudsen: The effective tax rate was 19.9% in the first nine months of '23 compared to 20.5% in the first nine months of '22, net profit increased by 47% and diluted earnings per share increased by 49% to 13.71 Krone, free cash flow was 75.6 billion Danish krone, compared with 62.6 billion krone in the first nine months of 2022.
Lars Fruergaard Jørgensen: Finally, the acquisition of ocedurenone will strengthen the portfolio of cardiovascular disease and underlines the commitment to establish presence with other serious chronic diseases. With that, I'll hand over to the final word to Daniel Boesen.
Net financial showed a net gain of 1.2 billion Danish kroner compared to a net loss of 5 billion Danish kroner last year.
The effective tax rate was 19.9% in the first nine months of 20 tree compared to 20.5% in the first nine months of 22.
Karsten Munk Knudsen: Thank you, Lars. Next slide, please. With that, we are now ready for the Q&A session, where I kindly ask all participants to limit her or himself to one or maximum two questions, including sub-questions. Operator, we are now ready to take the first question.
Daniel Bohsen: Thank you, Lars. Next slide, please. With that, we are now ready for the Q&A session, where I kindly ask all participants to limit her or himself to one or maximum two questions, including sub-questions. Operator, we are now ready to take the first question.
Net profit increased by 47% and diluted earnings per share increased by 49% to 13 Corona in 71.
Operator: Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now go to the first question. Your first question comes from the line of Michael Nedelcovych from TD Cowen. Please go ahead.
Operator: Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now go to the first question. Your first question comes from the line of Michael Nedelcovych from TD Cowen. Please go ahead.
Yeah.
Free cash flow was 75.6 billion Danish kroner, compared with 62.6 billion kronor in the first nine months of 2002.
Karsten Knudsen: In line with the strategic aspiration of delivering attractive capital allocation to shareholders, a total of 52 billion Danish krone has been paid back to shareholders through share buybacks and dividends, the cash conversion is positively impacted by timing of payment of rebates in the US. Capital expenditure for property plant and equipment was 16.4 billion Danish krone compared to 7.2 billion in 2022. This is primarily reflects investments in additional capacity for active thumbscrew ingredient production and food finished capacity for for both current and future injectable and all products. Please pull up to the next slide. Nine months into transferring tree, we are continuing our sales growth momentum, which has enabled us to raise the outlook for the full year. We now expect <unk> to be between 32 and 38% at constant exchange rates. The increased sales outlook is primarily reflecting higher fully expectations to simply volume sold in the U S and gross or net adjustments folks and pick and gooey in the U S. The guidance reflects expectation for sales growth in both North America operates and Internet operations. The guidance is mainly driven by volume growth of tier two entrees treatments for diabetes and obesity cure. This is possibly countered by declining sales and rare disease due to a temporary. Reduction and manufacturing output. The guidance reflects the level of volume growth of one based treatments. The inherent uncertainty of the pace of <unk>. Obesity can market expansion following the relaunch of like over in the U S and a limited roll out in international operations are also included in the guidance range. Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.
Karsten Knudsen: In line with the strategic aspiration of delivering attractive capital allocation to shareholders, a total of 52 billion Danish krone has been paid back to shareholders through share buybacks and dividends, the cash conversion is positively impacted by timing of payment of rebates in the US.
In line with the strategic aspiration of delivering attractive capsule to shareholders. A total of 52 billion Danish kroner has been paid back to shareholders through sheer pipex and dividends.
Michael Nedelcovych: Thank you for the question. I have one for Martin. Martin, if you'll allow me to set up something of a straw man. Here's a potential set of expectations for the phase 3 SELECT data when we see them at AHA. One, clinically meaningful benefit across each of the individual MACE components and regardless of BMI category. Two, cardiovascular benefit that clearly emerges within one year on Wegovy therapy and does not diminish over time. Three, no noticeable imbalance in any very rare adverse events such as suicide or cancer. My question is, would you urge me to modify these expectations in any way?
Michael Nedelcovych: Thank you for the question. I have one for Martin. Martin, if you'll allow me to set up something of a straw man. Here's a potential set of expectations for the phase 3 SELECT data when we see them at AHA. One, clinically meaningful benefit across each of the individual MACE components and regardless of BMI category. Two, cardiovascular benefit that clearly emerges within one year on Wegovy therapy and does not diminish over time. Three, no noticeable imbalance in any very rare adverse events such as suicide or cancer. My question is, would you urge me to modify these expectations in any way?
Karsten Knudsen: Capital expenditure for property plant and equipment was 16.4 billion Danish krone, compared to 7.2 billion in 2022, this primarily reflects investments in additional capacity for active pharmaceutical ingredient production and fill finished capacity for both current and future injectable and all products. Please go to the next slide. Nine months into transferring tree, we are continuing our sales growth momentum, which has enabled us to raise the outlook for the full year. We now expect <unk> to be between 32 and 38% at constant exchange rates. The increased sales outlook is primarily reflecting higher fully expectations to simply volume sold in the U S and gross or net adjustments folks and pick and gooey in the U S. The guidance reflects expectation for sales growth in both North America operates and Internet operations. The guidance is mainly driven by volume growth of tier two entrees treatments for diabetes and obesity cure. This is possibly countered by declining sales and rare disease due to a temporary. Reduction and manufacturing output. The guidance reflects the level of volume growth of one based treatments. The inherent uncertainty of the pace of <unk>. Obesity can market expansion following the relaunch of like over in the U S and a limited roll out in international operations are also included in the guidance range. Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.
Karsten Knudsen: Capital expenditure for property plant and equipment was 16.4 billion Danish krone, compared to 7.2 billion in 2022, this primarily reflects investments in additional capacity for active pharmaceutical ingredient production and fill finished capacity for both current and future injectable and all products. Please go to the next slide.
<unk> conversion is positively impacted by timing of payment of rebates in the U S.
Capital expenditure for property plant and equipment was 16.4 billion Danish krone compared to 7.2 billion in 2022.
This is primarily reflects investments in additional capacity for active thumbscrew ingredient production and food finished capacity for for both current and future injectable and all products. Please pull up to the next slide.
Karsten Knudsen: Nine months into 2023, we are continuing our sales growth momentum, which has enabled us to raise the outlook for the full year, we now expect the sales growth to be between 32 and 38% at constant exchange rates, the increased sales outlook is primarily reflecting higher full year expectations to Ozempic volume sold in the US and gross or net adjustments for Ozempic and Wegovy in the US. The guidance reflects expectation for sales growth in both North America operates and Internet operations. The guidance is mainly driven by volume growth of tier two entrees treatments for diabetes and obesity cure. This is possibly countered by declining sales and rare disease due to a temporary. Reduction and manufacturing output. The guidance reflects the level of volume growth of one based treatments. The inherent uncertainty of the pace of <unk>. Obesity can market expansion following the relaunch of like over in the U S and a limited roll out in international operations are also included in the guidance range. Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.
Karsten Knudsen: Nine months into 2023, we are continuing our sales growth momentum, which has enabled us to raise the outlook for the full year, we now expect the sales growth to be between 32 and 38% at constant exchange rates, the increased sales outlook is primarily reflecting higher full year expectations to Ozempic volume sold in the US and gross or net adjustments for Ozempic and Wegovy in the US.
Nine months into transferring tree, we are continuing our sales growth momentum, which has enabled us to raise the outlook for the full year. We now expect <unk> to be between 32 and 38% at constant exchange rates.
Karsten Munk Knudsen: Martin, a straw man for you.
Daniel Bohsen: Martin, a straw man for you.
Martin Holst Lange: Thank you very much for that question. As you probably imagine, I cannot speculate to anything beyond what we've already disclosed, and that is the 20% risk reduction on the primary endpoint for MACE, which is obviously myocardial infarction, stroke, and cardiovascular death. We see attribution from all three, but we do not go into more detail. What I will commit to is obviously that we saw a very clear and positive safety profile from SELECT and with no outliers identified.
Martin Holst Lange: Thank you very much for that question. As you probably imagine, I cannot speculate to anything beyond what we've already disclosed, and that is the 20% risk reduction on the primary endpoint for MACE, which is obviously myocardial infarction, stroke, and cardiovascular death. We see attribution from all three, but we do not go into more detail. What I will commit to is obviously that we saw a very clear and positive safety profile from SELECT and with no outliers identified.
The increased sales outlook is primarily reflecting higher fully expectations to simply volume sold in the U S and gross or net adjustments folks and pick and gooey in the U S.
Karsten Knudsen: The guidance reflects expectation for sales growth in both North America operations and International operations, the guidance is mainly driven by volume growth of GLP-1 based treatments for diabetes and obesity care, this is possibly countered by declining sales and rare disease due to a temporary reduction in manufacturing outputs. The guidance reflects the level of volume growth of one based treatments. The inherent uncertainty of the pace of <unk>. Obesity can market expansion following the relaunch of like over in the U S and a limited roll out in international operations are also included in the guidance range. Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.
Karsten Knudsen: The guidance reflects expectation for sales growth in both North America operations and International operations, the guidance is mainly driven by volume growth of GLP-1 based treatments for diabetes and obesity care, this is possibly countered by declining sales and rare disease due to a temporary reduction in manufacturing outputs.
The guidance reflects expectation for sales growth in both North America operates and Internet operations. The guidance is mainly driven by volume growth of tier two entrees treatments for diabetes and obesity cure.
This is possibly countered by declining sales and rare disease due to a temporary.
Reduction and manufacturing output.
Karsten Knudsen: The guidance reflects the level of volume growth of GLP-1 based treatments, the inherent uncertainty of the pace of Ozempic, obesity care market expansion following the re-launch of Wegovy in the U S and a limited roll out in international operations are also included in the guidance range, Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.
Karsten Knudsen: The guidance reflects the level of volume growth of GLP-1 based treatments, the inherent uncertainty of the pace of Ozempic, obesity care market expansion following the re-launch of Wegovy in the U S and a limited roll out in international operations are also included in the guidance range.
The guidance reflects the level of volume growth of one based treatments.
Karsten Munk Knudsen: Thank you, Martin, and thanks, Mike, for the question. Next question, please.
Daniel Bohsen: Thank you, Martin, and thanks, Mike, for the question. Next question, please.
The inherent uncertainty of the pace of <unk>.
Operator: Thank you. We'll now take the next question. Your next question comes from the line of Richard Parkes from BNP Paribas. Please go ahead.
Operator: Thank you. We'll now take the next question. Your next question comes from the line of Richard Parkes from BNP Paribas. Please go ahead.
Obesity can market expansion following the relaunch of like over in the U S and a limited roll out in international operations are also included in the guidance range.
Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.
Richard Parkes: Thanks very much for taking my questions. I've got a couple. Firstly, when I look at Ozempic and Wegovy US Symphony prescriptions, they're both trending flat to down over the last quarter, I think due to supply constraints. Your guidance suggests an expected acceleration in top line growth in Q4. I'm just wondering if you could help me to understand that. Are you expecting to see kind of further improved supply into the end of the year? Would be I assume kind of the swing factor there. The second question is just your slide outlines the potential benefits of semaglutide beyond glycemic control and weight loss, and maybe we'll see some insight into that from the SELECT study.
Richard Parkes: Thanks very much for taking my questions. I've got a couple. Firstly, when I look at Ozempic and Wegovy US Symphony prescriptions, they're both trending flat to down over the last quarter, I think due to supply constraints. Your guidance suggests an expected acceleration in top line growth in Q4. I'm just wondering if you could help me to understand that. Are you expecting to see kind of further improved supply into the end of the year? Would be I assume kind of the swing factor there.
Karsten Knudsen: Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortages notifications across a number of products and geographies, Novo Nordisk is investing in internal and external capacity to increase supply both short and long term. While supply capacity for the Covid is gradually being expanded the Lord of strengths in the U S will remain restricted to safeguard continuity of care. We now expect operating profit rope between 40, and 46% a concert exchange rates. This primarily reflects the sales growth outlook and continued investments in future and concourse drive us within research and development and commercial. Four 2023, we expect net financial items to amount to a gain of around 1.6 billion Danish kroner, mainly reflecting gains associated with foreign exchange hitting contracts. Capital expenditure is still expected to be around. 25 billion Danish kroner, reflecting the upscaling of the supply chain and the innovation based growth strategy pursuit biting and went to work. In the coming years, the capital expenditure to sales ratio is expected to be low double digits. The free cash flow is now expect it to be. Between 65, and 73 brilliant Danish krone, reflecting the sales growth. [noise] favorable impact from rebates in the U S and investments and capital expenditure. The updated Castro expectation is mainly reflecting increased net profit expectation. Possibly counted five business development activities. That covers the outlook for 23 now back to who lost for finding remarks.
Karsten Knudsen: Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortages notifications across a number of products and geographies, Novo Nordisk is investing in internal and external capacity to increase supply both short and long term, while supply capacity for Wegovy is gradually being expanded the load of strengths in the US will remain restricted to safeguard continuity of care.
Illinois is investing in internal and external capacity to increase supply both short and long term.
While supply capacity for the Covid is gradually being expanded the Lord of strengths in the U S will remain restricted to safeguard continuity of care.
We now expect operating profit rope between 40, and 46% a concert exchange rates.
Karsten Knudsen: We now expect operating profit to grow between 40 and 46% at constant exchange rates, this primarily reflects the sales growth outlook and continued investments in future and current growth drivers within research, development and commercial. Four 2023, we expect net financial items to amount to a gain of around 1.6 billion Danish kroner, mainly reflecting gains associated with foreign exchange hitting contracts. Capital expenditure is still expected to be around. 25 billion Danish kroner, reflecting the upscaling of the supply chain and the innovation based growth strategy pursuit biting and went to work. In the coming years, the capital expenditure to sales ratio is expected to be low double digits. The free cash flow is now expect it to be. Between 65, and 73 brilliant Danish krone, reflecting the sales growth. [noise] favorable impact from rebates in the U S and investments and capital expenditure. The updated Castro expectation is mainly reflecting increased net profit expectation. Possibly counted five business development activities. That covers the outlook for 23 now back to who lost for finding remarks.
Karsten Knudsen: We now expect operating profit to grow between 40 and 46% at constant exchange rates, this primarily reflects the sales growth outlook and continued investments in future and current growth drivers within research, development and commercial.
Richard Parkes: The second question is just your slide outlines the potential benefits of semaglutide beyond glycemic control and weight loss, and maybe we'll see some insight into that from the SELECT study. Your chart suggests there's potential for patients to benefit from the CV aspects that don't have diabetes or obesity. I'm just wondering how you can capitalize on that, given that your trials currently, I think, are just recruiting patients with either obesity, diabetes, and comorbidities. Thanks very much.
This primarily reflects the sales growth outlook and continued investments in future and concourse drive us within research and development and commercial.
Karsten Knudsen: For 2023, we expect net financial items to amount to a gain of around 1.6 billion Danish krone, mainly reflecting gains associated with foreign exchange hitting contracts, capital expenditure is still expected to be around 25 billion Danish krone, reflecting the upscaling of the supply chain and the innovation-based growth strategy pursued by Novo Nordisk. In the coming years, the capital expenditure to sales ratio is expected to be low double digits. The free cash flow is now expect it to be. Between 65, and 73 brilliant Danish krone, reflecting the sales growth. [noise] favorable impact from rebates in the U S and investments and capital expenditure. The updated Castro expectation is mainly reflecting increased net profit expectation. Possibly counted five business development activities. That covers the outlook for 23 now back to who lost for finding remarks.
Karsten Knudsen: For 2023, we expect net financial items to amount to a gain of around 1.6 billion Danish krone, mainly reflecting gains associated with foreign exchange hitting contracts, capital expenditure is still expected to be around 25 billion Danish krone, reflecting the upscaling of the supply chain and the innovation-based growth strategy pursued by Novo Nordisk.
Four 2023, we expect net financial items to amount to a gain of around 1.6 billion Danish kroner, mainly reflecting gains associated with foreign exchange hitting contracts.
Richard Parkes: Your chart suggests there's potential for patients to benefit from the CV aspects that don't have diabetes or obesity. I'm just wondering how you can capitalize on that, given that your trials currently, I think, are just recruiting patients with either obesity, diabetes, and comorbidities. Thanks very much.
Capital expenditure is still expected to be around.
25 billion Danish kroner, reflecting the upscaling of the supply chain and the innovation based growth strategy pursuit biting and went to work.
Karsten Knudsen: In the coming years, the capital expenditure to sales ratio is expected to be low double digits, the free cash flow is now expected to be between 65, and 73 billion Danish krone, reflecting the sales growth, a favorable impact from rebates in the US and investments in capital expenditure, the updated cash flow expectation is mainly reflecting increased net profit expectations, partially counted by business development activities, that covers the outlook for 2023 now back to you Lars for final remarks.
In the coming years, the capital expenditure to sales ratio is expected to be low double digits.
Daniel Bohsen: I'll give the first to you, Karsten. Supply going into our guidance.
Daniel Bohsen: I'll give the first to you, Karsten. Supply going into our guidance.
Martin Holst Lange: Yeah. Thank you for that question, Richard. Clearly when we put out guidance, that's because we believe that's the most realistic forecast range that we're putting in. We don't have too many months to roll on. Of course, we see the TRx trends and bake that into our forecast. What I would give of additional flavor on top of that is, of course, the growth rate is also a function of ex-tax sales last year. We did see Ozempic having a lower base last year in Q4 than what we would normalize into this year.
Karsten Munk Knudsen: Yeah. Thank you for that question, Richard. Clearly when we put out guidance, that's because we believe that's the most realistic forecast range that we're putting in. We don't have too many months to roll on. Of course, we see the TRx trends and bake that into our forecast. What I would give of additional flavor on top of that is, of course, the growth rate is also a function of ex-tax sales last year. We did see Ozempic having a lower base last year in Q4 than what we would normalize into this year. Of course, there can be fluctuations in inventories, for instance, with wholesalers. Finally, I would say this pickup in sales growth in the Q4 cannot be read into anything, any difference in the supply situation. What we're selling in the Q4 has been produced months ago.
The free cash flow is now expect it to be.
Between 65, and 73 brilliant Danish krone, reflecting the sales growth.
[noise] favorable impact from rebates in the U S and investments and capital expenditure.
The updated Castro expectation is mainly reflecting increased net profit expectation.
Possibly counted five business development activities.
That covers the outlook for 23 now back to who lost for finding remarks.
Lars Fruergaard Joergensen: Thank you Karsten, please turn to the final slideS, Today's announcement discloses the full set of quarterly results and updated outlook for 2023, which was shared earlier in October, overall we are very satisfied with the sales growth in the first nine months of 2023. Wegovy is driven by demand forward you to one page computer interventions for diabetes, and obesity, which is now reaching more people than ever before. The performance in the first nine months of the year is naval us to raise the outlook for the full year. From the perspective, we have reached a significant milestone with the submission of select and a photo sharing more data at American Heart Association. In addition, we excited about the early closure of the float file an anticipated. It read out in the first half of twins. All finally, the <unk> will strengthen folio of cardiovascular disease and underlines the commitment to establish presence with all those huge quantities would that all handled through the final word Daniel.
Lars Fruergaard Joergensen: Thank you Karsten, please turn to the final slides, Today's announcement discloses the full set of quarterly results and updated outlook for 2023, which was shared earlier in October, overall we are very satisfied with the sales growth in the first nine months of 2023.
Today's announcement as coaches the full set of quarterly results and updated outlook for 2023, which was shared earlier in October.
Martin Holst Lange: Of course, there can be fluctuations in inventories, for instance, with wholesalers. Finally, I would say this pickup in sales growth in the Q4 cannot be read into anything, any difference in the supply situation. What we're selling in the Q4 has been produced months ago.
All we are very satisfied with a sales calls in the first nine months of 2023 the court.
Lars Fruergaard Joergensen: Wegovy is driven by demand for GLP-1 based future interventions for diabetes and obesity, which is now reaching more people than ever before, the performance in the first nine months of the year has enabled us to raise the outlook for the full year, from the R&D perspective, we have reached a significant milestone with the submission of SELECT and look forward to sharing more data at American Heart Association. In addition, we excited about the early closure of the float file an anticipated. It read out in the first half of twins. All finally, the <unk> will strengthen folio of cardiovascular disease and underlines the commitment to establish presence with all those huge quantities would that all handled through the final word Daniel.
Lars Fruergaard Joergensen: Wegovy is driven by demand for GLP-1 based future interventions for diabetes and obesity, which is now reaching more people than ever before, the performance in the first nine months of the year has enabled us to raise the outlook for the full year, from the R&D perspective, we have reached a significant milestone with the submission of SELECT and look forward to sharing more data at American Heart Association.
Is driven by demand forward you to one page computer interventions for diabetes, and obesity, which is now reaching more people than ever before.
The performance in the first nine months of the year is naval us to raise the outlook for the full year.
From the perspective, we have reached a significant milestone with the submission of select and a photo sharing more data at American Heart Association.
Daniel Bohsen: Thank you, Karsten. Martin, any comments on the benefits beyond weight loss for Sem?
Daniel Bohsen: Thank you, Karsten. Martin, any comments on the benefits beyond weight loss for Sem?
Martin Holst Lange: First of all, I think it's exactly right that our starting point is the cardiometabolic space, starting out with obesity and diabetes, and these are the patients that we investigate. I think it's important to call out that the vast majority of patients suffering from ASCVD, from heart failure, from chronic kidney disease, but also metabolic liver disease, also have an element of metabolic derangement. And there's a clear association and overlap to both diabetes and obesity. From our perspective, this actually creates some very nice synergies, and are certainly not seen as exclusive. Our starting point is patients suffering from diabetes and obesity.
Martin Holst Lange: First of all, I think it's exactly right that our starting point is the cardiometabolic space, starting out with obesity and diabetes, and these are the patients that we investigate. I think it's important to call out that the vast majority of patients suffering from ASCVD, from heart failure, from chronic kidney disease, but also metabolic liver disease, also have an element of metabolic derangement. And there's a clear association and overlap to both diabetes and obesity. From our perspective, this actually creates some very nice synergies, and are certainly not seen as exclusive. Our starting point is patients suffering from diabetes and obesity.
In addition, we excited about the early closure of the float file an anticipated.
Lars Fruergaard Joergensen: In addition, we are excited about the early closure of the FLOW trial, and anticipate read out in the first half of 2024, finally, the (inaudible) Ocedurenone will strengthen the portfolio of cardiovascular disease and underlines the commitment to establish presence with other serious chronic diseases, with that I'll hand the final word to Daniel.
It read out in the first half of twins. All finally, the <unk> will strengthen folio of cardiovascular disease and underlines the commitment to establish presence with all those huge quantities would that all handled through the final word Daniel.
Daniel Bohsen: Thank you Lars, next slide please, with that we are now ready for the Q&A session, we kindly ask all participants to limit her or himself to one or maximum two questions, including sub questions. Operator, we're now ready to take the first question. Thank you to ask a question you would need to press star one on one on your telephone I'm with your name to be announced to withdraw. Your question. Please press star one on one again. We will now go to the Fries question. And your first question comes on the line of Michael <unk> from T. D. Cowan. Please go ahead.
Daniel Bohsen: Thank you Lars, next slide please, with that we are now ready for the Q&A session, we kindly ask all participants to limit her or himself to one or maximum two questions, including sub questions. Operator, we're now ready to take the first question.
Himself to one on maximum two questions, including sub questions. Operator, we're now ready to take the first question.
Thank you to ask a question you would need to press star one on one on your telephone I'm with your name to be announced to withdraw. Your question. Please press star one on one again.
Operator: Thank you, to ask a question you will need to press star one and one on your telephone and wait for your name to be announced to withdraw your question, please press star one and one again, we will now go to the first question and your first question comes on the line of Michael Nedelcovych from T. D. Cowen. Please go ahead.
We will now go to the Fries question.
Daniel Bohsen: Thank you, Martin. Thank you, Richard, for the questions, and we are ready for the next question.
Daniel Bohsen: Thank you, Martin. Thank you, Richard, for the questions, and we are ready for the next question.
And your first question comes on the line of Michael <unk> from T. D. Cowan. Please go ahead.
Operator: Thank you. We will now take the next question. Your next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.
Operator: Thank you. We will now take the next question. Your next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.
Michael Nedelcovych: Thank you for the question I have one for Martin, Martin if you'll allow me to set up something of a straw man, here is a potential set of expectations for the Phase III select data when we see them at AHA, One, clinically meaningful benefit across each of the individual maze components and regardless of BMI category. Two cardiovascular benefit that clearly emerges within one year on we go be therapy and does not diminish over time. And three no noticeable imbalance in any very rare adverse events such as suicide or cancer. My question is would you urge me to modify these expectations in any way. Martinez strongman for Y.
Michael Nedelcovych: Thank you for the question I have one for Martin, Martin if you'll allow me to set up something of a straw man, here is a potential set of expectations for the Phase III select data when we see them at AHA, One, clinically meaningful benefit across each of the individual MACE components and regardless of BMI category.
Seamus Fernandez: Oh, thanks very much for the question. So just very quickly, as we think about the SELECT trial results in the wake, not just of the presentation but the very rapid filing. There have been a lot of questions around this being actually a cardiovascular medication and perhaps gaining access to CMS in that regard. Can you just talk about the prospects of that actually becoming reality? And then the second question is just on the oral amycretin and the initiation of the subcutaneous amycretin. Can you just help us understand, is this more of a supply chain related decision, an IRA related decision, or a decision related to some challenges with the oral formulation of amycretin? Thanks so much.
Seamus Fernandez: Oh, thanks very much for the question. So just very quickly, as we think about the SELECT trial results in the wake, not just of the presentation but the very rapid filing. There have been a lot of questions around this being actually a cardiovascular medication and perhaps gaining access to CMS in that regard. Can you just talk about the prospects of that actually becoming reality? And then the second question is just on the oral amycretin and the initiation of the subcutaneous amycretin. Can you just help us understand, is this more of a supply chain related decision, an IRA related decision, or a decision related to some challenges with the oral formulation of amycretin? Thanks so much.
One clinically meaningful benefit across each of the individual components and regardless of be in my category.
Two cardiovascular benefit that clearly emerges within one year on we go be therapy and does not diminish over time.
Michael Nedelcovych: Two, cardiovascular benefit that clearly emerges within one year on Wegovy therapy and does not diminish over time And three no noticeable imbalance in any very rare adverse events such as suicide or cancer, my question is, would you urge me to modify these expectations in any way. Martinez strongman for Y.
Michael Nedelcovych: Two, cardiovascular benefit that clearly emerges within one year on Wegovy therapy and does not diminish over time And three no noticeable imbalance in any very rare adverse events such as suicide or cancer, my question is, would you urge me to modify these expectations in any way.
And three no noticeable imbalance in any very rare adverse events such as suicide or cancer. My question is would you urge me to modify these expectations in any way.
Martinez strongman for Ya.
Daniel Bohsen: Martin a Straw Man for You
Martin Holst Lange: Hello, thank you very much for that question, as you have probably imagined I I cannot speculate to anything beyond what we've already disclosed and that is the 20% risk reduction on the primary endpoint for MACE, which is obviously myocardial infarction stroke and cardiovascular death. We see attributions from from all free, but but we do not go into more detail what I will commit to is obviously that that we saw a very clear. And and and positive safety profile from. Perhaps select and with no outliers identified thank.
Martin Holst Lange: Hello, thank you very much for that question, as you have probably imagined I I cannot speculate to anything beyond what we've already disclosed and that is the 20% risk reduction on the primary endpoint for MACE, which is obviously myocardial infarction stroke and cardiovascular death.
20% risk reduction on the primary endpoint.
Paul formation, which is obviously myocardial infarction stroke and cardiovascular death.
Daniel Bohsen: Thank you, Seamus. Doc, I'll give the first question to you.
Daniel Bohsen: Thank you, Seamus. Doc, I'll give the first question to you.
We see attributions from from all free, but but we do not go into more detail what I will commit to is obviously that that we saw a very clear.
Martin Holst Lange: We see attributions from all three, but we do not go into more detail, what I will commit to is obviously that we saw a very clear and positive safety profile from SELECT and with no outliers identified.
Richard Parkes: Yeah. Thanks, Seamus. We do believe that there's an opportunity, a potential opportunity to use the medical exception process, through the CV component, but let's wait to see.
Doug Langa: Yeah. Thanks, Seamus. We do believe that there's an opportunity, a potential opportunity to use the medical exception process, through the CV component, but let's wait to see.
And and and positive safety profile from.
Daniel Bohsen: Thanks, Doc. Martin, any thoughts on amycretin?
Daniel Bohsen: Thanks, Doc. Martin, any thoughts on amycretin?
Perhaps select and with no outliers identified thank.
Martin Holst Lange: Yeah, on amycretin our decision to go also into subcutaneous is actually caused by another of the above three reasons that you mentioned. It's actually driven by the fact that we are learning that optionality is important for patients and prescribing physicians in both diabetes and obesity. We've seen a clear potential for amycretin to become both an oral but certainly also a subcutaneous offering. Therefore in phase 1, it is prudent for us to investigate both.
Martin Holst Lange: Yeah, on amycretin our decision to go also into subcutaneous is actually caused by another of the above three reasons that you mentioned. It's actually driven by the fact that we are learning that optionality is important for patients and prescribing physicians in both diabetes and obesity. We've seen a clear potential for amycretin to become both an oral but certainly also a subcutaneous offering. Therefore in phase 1, it is prudent for us to investigate both.
Daniel Bohsen: Thank you Martin and thanks Mike for the question next question. Please.
Operator: Thank you I'll now take the next question and the next question comes from the line of Richard Parkes from BNP Paribas please go ahead.
Oh, no I'll take the next question.
Do next question comes from the line of which apart from B M. P. Probably about please go ahead.
Richard Parkes: Thank you very much for taking my questions, I've got a couple, so firstly when I look at Ozempic and Wegovy US (inaudible) prescriptions are both trending flat to down over the last quarter, assuming due to supply constraints, but your guidance suggests unexpected acceleration and top line growth in Q4 so I'm just wondering if you could help me to understand that are you expecting to see kind of further improved supply uhm into the end of the year would be R. I C <unk> to that. And then the second question Uhm is just <unk>. Yours slot outlines the potential benefits of smack retard beyond <unk> control of the White lost and maybe we'll see some insight into that from the selected today uhm, but your your child's suggest this potential for patients to benefit from the C. V aspects that done you have diabetes or <unk>. So I'm just wondering how you can <unk> given that you're trials currently I think I'll, just recreating license with either a b C and diabetes type morbidities, thanks very much.
Richard Parkes: Thank you very much for taking my questions, I've got a couple, so firstly when I look at Ozempic and Wegovy US (inaudible) prescriptions are both trending flat to down over the last quarter, assuming due to supply constraints, but your guidance suggests unexpected acceleration and top line growth in Q4, so I'm just wondering if you could help me to understand that, are you expecting to see kind of further improved supply into the end of the year would be I assume kind of a swing factor there
Daniel Bohsen: Thanks, Martin, and thanks, Seamus. We are ready for the next question.
Daniel Bohsen: Thanks, Martin, and thanks, Seamus. We are ready for the next question.
Operator: Thank you. We'll now take the next question. Your next question comes from the line of Peter Verdult from Citigroup. Please go ahead.
Operator: Thank you. We'll now take the next question. Your next question comes from the line of Peter Verdult from Citigroup. Please go ahead.
In queue for so I'm just wondering if you could help me to understand that are you expecting to see kind of further improved supply uhm into the end of the year would be R. I C <unk> to that.
Richard Parkes: So I'm just wondering if you could help me to understand that, are you expecting to see kind of further improved supply into the end of the year would be I assume kind of a swing factor here and then the second question Uhm is just <unk>. Yours slot outlines the potential benefits of smack retard beyond <unk> control of the White lost and maybe we'll see some insight into that from the selected today uhm, but your your child's suggest this potential for patients to benefit from the C. V aspects that done you have diabetes or <unk>. So I'm just wondering how you can <unk> given that you're trials currently I think I'll, just recreating license with either a b C and diabetes type morbidities, thanks very much.
Richard Parkes: So I'm just wondering if you could help me to understand that, are you expecting to see kind of further improved supply into the end of the year would be I assume kind of a swing factor here
Peter Verdult: Yeah. Thank you. Peter Verdult, Citi. Two questions, Karsten. Your favorite topics, supply and pricing. Just on supply, if we take the sort of run rate for GLP-1 volumes, your franchise in the US, and just extrapolate into 2024, if nothing changes, I mean, there's gonna be a big disconnect in terms of people's expectations for growth next year, and I think it'd be effectively flat. Now, I know it's going to improve next year, but can I just push you on, you know, when we might see, you know, the handbrake being released? I mean, logical thinking might be that at the time of the Mounjaro launch, you'll want to be in a less capacity constrained position.
Peter Verdult: Yeah. Thank you. Peter Verdult, Citi. Two questions, Karsten. Your favorite topics, supply and pricing. Just on supply, if we take the sort of run rate for GLP-1 volumes, your franchise in the US, and just extrapolate into 2024, if nothing changes, I mean, there's gonna be a big disconnect in terms of people's expectations for growth next year, and I think it'd be effectively flat. Now, I know it's going to improve next year, but can I just push you on, you know, when we might see, you know, the handbrake being released? I mean, logical thinking might be that at the time of the Mounjaro launch, you'll want to be in a less capacity constrained position.
And then the second question Uhm is just <unk>.
Richard Parkes: And then the second question is, just your slide outlines the potential benefits of Semaglutide beyond glycemic control and weight lost and maybe we'll see some insight into that from the SELECT study, but your your charts suggest there's potential for patients to benefit from the CV aspects that don't have diabetes or obesity. So I'm just wondering how you can capitalize on that, given that you're trials currently I think are just recruiting patients with either obesity and diabetes and comorbidities, thanks very much.
Yours slot outlines the potential benefits of smack retard beyond <unk> control of the White lost and maybe we'll see some insight into that from the selected today uhm, but your your child's suggest this potential for patients to benefit from the C. V aspects that done you have diabetes or <unk>.
So I'm just wondering how you can <unk> given that you're trials currently I think I'll, just recreating license with either a b C and diabetes type morbidities, thanks very much.
Peter Verdult: I know you can't go into too much detail, but just some incremental color on when we might see, you know, the handbrake being removed would be helpful. Then on pricing, if we do our value per script calculation, there's a huge jump from Q2 to Q3. I know you've called out gross to net adjustments. We know that commercial mix has improved.
Peter Verdult: I know you can't go into too much detail, but just some incremental color on when we might see, you know, the handbrake being removed would be helpful. Then on pricing, if we do our value per script calculation, there's a huge jump from Q2 to Q3. I know you've called out gross to net adjustments. We know that commercial mix has improved. Just making sure, is this a sort of high watermark, a one-off in terms of value prescription? In terms of baselining and thinking going forward, can we use the value per script in Q3 as a baseline or is it artificially high? Thank you.
Daniel Bohsen: I will give the first to you Karsten, supply going into our guidance.
Karsten Knudsen: Yeah, so thank you for that question Richard, and clearly when we put out guidance, that's because we believe that's the most. Realistic forecast range set that we're putting in and we don't have too many amounts to roll on so, of course, we see the TRx trends and bake that into our forecast, what I would give off additional flavor on top of that is of course, the growth rate of social function of I'll fix extra sales last year, and we did see a big having a lower base last year and in the fourth quarter than the than what we would normally lives in into this year and and then of course, there can be fluctuations in inventories for instance, with wholesalers. And then finally I would say this this pick up in safeco enforce the fourth quarter. It's not to be kind of red into anything any difference on the supply situation, what we're showing in the fourth quarter has been produced months ago,
Karsten Knudsen: Yeah, so thank you for that question Richard, and clearly when we put out guidance, that's because we believe that's the most. Realistic forecast range set that we're putting in and we don't have too many amounts to roll on so, of course, we see the TRx trends and bake that into our forecast, what I would give of additional flavor on top of that is
Realistic forecast rain said that we're putting in and and we don't have too many amounts to to roll on so so of course, we see that your ex trends and breaks that in into a into our forecast what I would give off additional flavor.
Lars Fruergaard Jørgensen: Just making sure, is this a sort of high watermark, a one-off in terms of value prescription? In terms of baselining and thinking going forward, can we use the value per script in Q3 as a baseline or is it artificially high? Thank you.
Karsten Knudsen: Of course, the growth rate is also function of ex-factory sales last year, and we did see also a bit, having a lower base last year in the fourth quarter than what we would normalize into this year and and then of course, there can be fluctuations in inventories for instance, with wholesalers and then finally I would say, this pick up in sales growth in the fourth quarter, this is not to be kind of read into anything, any difference on the supply situation, what we're showing in the fourth quarter has been produced months ago,
On top of that is of course, the growth rate of social function of I'll fix extra sales last year, and we did see a big having a lower base last year and in the fourth quarter than the than what we would normally lives in into this year and and then of course, there can be fluctuations in inventories for instance, with wholesalers.
Daniel Bohsen: Thanks, Pete. Karsten, supply going into 2024 and value per script.
Daniel Bohsen: Thanks, Pete. Karsten, supply going into 2024 and value per script.
Karsten Munk Knudsen: Pete, thank you for those, my favorite subjects. So I would say first of all, with the guidance that for the full year this year that has a midpoint of 35% sales growth at constant exchange rates, at least in the Novo setting, it feels like we have released the handbrake and moving at very high pace in terms of growth rates. At least it's the highest in the history of the company. That said, extrapolations into 2024, I would say first of all, we're clearly pursuing growth strategy based on the innovation.
Karsten Munk Knudsen: Pete, thank you for those, my favorite subjects. So I would say first of all, with the guidance that for the full year this year that has a midpoint of 35% sales growth at constant exchange rates, at least in the Novo setting, it feels like we have released the handbrake and moving at very high pace in terms of growth rates. At least it's the highest in the history of the company. That said, extrapolations into 2024, I would say first of all, we're clearly pursuing growth strategy based on the innovation.
And then finally I would say this this pick up in safeco enforce the fourth quarter.
It's not to be kind of red into anything any difference on the supply situation, what we're showing in the fourth quarter has been produced months ago.
Daniel Bohsen: Thank you Karsten, Martin any comments on the benefits beyond weight loss with him?
Martin Holst Lange: So first of all I think it's exactly right that our starting point is the cardio metabolic space, starting out with obesity and diabetes and these are the patients that we investigate, I think it's important to call out that the vast majority of patients suffering from ASCVD, from heart failure, from chronic kidney disease, but also metabolic liver disease. Also have add an element of metropolitan arrangement. Association and overlap both diabetes and obesity sofa from our perspective this actually creates some very nice images. And assorted Nazis. Exclusive. Our starting point is patient suffering from from diabetes and obesity.
Martin Holst Lange: So first of all I think it's exactly right that our starting point is the cardio metabolic space, starting out with obesity and diabetes and these are the patients that we investigate, I think it's important to call out that the vast majority of patients suffering from ASCVD, from heart failure, from chronic kidney disease, but also metabolic liver disease.
Karsten Munk Knudsen: We have shown that we have the innovation platforms, especially in Ozempic and Wegovy to drive growth this year and clearly also next year. Not teaching you how to extrapolate, but if you extrapolate our implied Q4 sales growth based on our guidance, then you actually get to a sales growth number next year in the double digits, which is actually not that far away from where consensus is currently. I do believe that we're scaling very fast.
Karsten Munk Knudsen: We have shown that we have the innovation platforms, especially in Ozempic and Wegovy to drive growth this year and clearly also next year. Not teaching you how to extrapolate, but if you extrapolate our implied Q4 sales growth based on our guidance, then you actually get to a sales growth number next year in the double digits, which is actually not that far away from where consensus is currently. I do believe that we're scaling very fast.
These are the patients that we investigate.
I think it's important to call out that that the best majority of patients suffering from from my activity.
From heart failure from <unk>.
Chronic kidney disease, but also.
Metabolic Newark Liberty disease.
Also have add an element of metropolitan arrangement.
Martin Holst Lange: Also have an element of metabolic derangement and there's a clear association and overlap to both diabetes and obesity, so from our perspective this actually creates some very nice synergies and certainly not seen as exclusive but starting point is patient suffering from from diabetes and obesity.
Association and overlap both diabetes and obesity sofa from our perspective this actually creates some very nice images.
Karsten Munk Knudsen: Then specifically on Wegovy and any handbrakes there, then what I'll say as to 2024 is that in 2024 we will be delivering significant step up in volumes to the US market compared to 2023, as we did from 2022 to 2023. Then to your pricing questions, as we've said on numerous occasions, the appropriate way of looking at net realized pricing in the US is to look at the year to date numbers. So most contracts are contracted on an annual basis. The tricky part is the lag effect between when a script is written and then we receive the rebate claims from the payers.
Karsten Munk Knudsen: Then specifically on Wegovy and any handbrakes there, then what I'll say as to 2024 is that in 2024 we will be delivering significant step up in volumes to the US market compared to 2023, as we did from 2022 to 2023. Then to your pricing questions, as we've said on numerous occasions, the appropriate way of looking at net realized pricing in the US is to look at the year to date numbers. So most contracts are contracted on an annual basis.
And assorted Nazis.
Exclusive.
Our starting point is patient suffering from from diabetes and obesity.
Daniel Bohsen: Thank You Martin, thank you Richard for the questions and we're ready for the next question.
Operator: Thank you, I'll now take the next question and your next question comes from the line of Seamus Fernandez, from Guggenheim Securities, please go ahead.
Mmm no I'll take the next question.
Do next question comes from the line of Seamus Fernandez, Some Guggenheim Security can you go ahead.
<unk>.
Seamus Christopher Fernandez: Oh Thank you very much for the questions, So just very quickly, as we think about the SELECT trial results in the week, not just of the presentation, but very rapid filing, there have been a lot of questions around this being actually a cardiovascular medication and perhaps gaining access to CMS in that regard, can you just talk about the prospect of that actually becoming reality and then the second question is just on the oral <unk> and the initiation of the subcutaneous Democrat and can you just help US understand is this more of a supply chain related decision. And I already related decision or a decision related to some challenges with the oil formulation of immigrants. Thanks, so much.
Seamus Christopher Fernandez: Oh Thank you very much for the questions, So just very quickly, as we think about the SELECT trial results in the week, not just of the presentation, but very rapid filing, there have been a lot of questions around this being actually a cardiovascular medication and perhaps gaining access to CMS in that regard, can you just talk about the prospect of that actually becoming reality.
Select trial resolved in the week not just of the presentation, but very rapid filing.
Having a lot of questions around this being actually a cardiovascular medication and perhaps gaining access to CMS in that regard can you just talk.
Karsten Munk Knudsen: The tricky part is the lag effect between when a script is written and then we receive the rebate claims from the payers. There's just a lag effect of several months. That's why, you know, in reality, Q3 is the first point where we see how the channel payer mix tool is falling out for 2023. I wouldn't use Q3 in isolation for anything forecasting wise. I would recommend you to use year-to-date Q3 as a starting point. Thank you.
Talk about the prospect of that actually becoming reality and then the second question is just on the oral <unk> and the initiation of the subcutaneous Democrat and can you just help US understand is this more of a supply chain related decision.
Karsten Munk Knudsen: There's just a lag effect of several months. That's why, you know, in reality, Q3 is the first point where we see how the channel payer mix tool is falling out for 2023. I wouldn't use Q3 in isolation for anything forecasting wise. I would recommend you to use year-to-date Q3 as a starting point. Thank you.
Seamus Christopher Fernandez: And then the second question is just on the oral Amycretin and the initiation of the subcutaneous Amycretin, can you just help us understand, is this more of a supply chain related decision, and IRA related decision or a decision related to some challenges with the oral formulation of Amycretin, Thanks, so much.
And I already related decision or a decision related to some challenges with the oil formulation of immigrants. Thanks, so much.
Daniel Bohsen: Thank you, Karsten. Thanks, Peter.
Daniel Bohsen: Thank you, Karsten. Thanks, Peter.
Lars Fruergaard Jørgensen: Very good. Thank you. Thank you.
Peter Verdult: Very good. Thank you. Thank you.
Daniel Bohsen: We're ready for the next question.
Daniel Bohsen: We're ready for the next question.
Daniel Bohsen: Thank you Seamus, Doug I'll give the first question to you.
Operator: Thank you. Your next question comes from the line of Mark Purcell from Morgan Stanley. Please go ahead.
Operator: Thank you. Your next question comes from the line of Mark Purcell from Morgan Stanley. Please go ahead.
Doug Langa: Thanks Seamus, we do believe there is an opportunity, a potential opportunity to use the medical exemption process through the CV component, but let's let's wait to see.
Mark Purcell: Yeah, thank you very much for taking my questions. The first one on GLP-1 and higher doses. Clearly starting higher dose trials for tirzepatide. You have 8 and 16 milligrams coming through by the end of this year. Can you help me understand your expectations there and the importance of increasing your dose where the pivotal trial at 7.2 will read out late next year? Secondly, in terms of the pen platform leverage, we estimate that about 100 million GLP-1 pen units are going to be sold by Novo in 2023, for GLP-1s that is. The majority is the FlexTouch platform with a 3 mL platform. Will you use those two platforms to launch Wegovy in the US? And if not, why not?
Mark Purcell: Yeah, thank you very much for taking my questions. The first one on GLP-1 and higher doses. Clearly starting higher dose trials for tirzepatide. You have 8 and 16 milligrams coming through by the end of this year. Can you help me understand your expectations there and the importance of increasing your dose where the pivotal trial at 7.2 will read out late next year? Secondly, in terms of the pen platform leverage, we estimate that about 100 million GLP-1 pen units are going to be sold by Novo in 2023, for GLP-1s that is. The majority is the FlexTouch platform with a 3 mL platform. Will you use those two platforms to launch Wegovy in the US? And if not, why not?
Daniel Bohsen: Thanks Doug, Martin any thoughts on Amycretin?
Martin any thoughts on it make reaching down an increase in our decision to go also into subcutaneous is actually close by neither of the above the free reasons that you mentioned it's actually.
Martin any thoughts on it make reaching
Martin Holst Lange: Yeah on Amycretin, our decision to go also into subcutaneous is actually caused by neither of the above of the three reasons that you mentioned, it's actually driven by the fact that we're learning that optionality is important for patients centered and prescribing physicians in both diabetes and obesity and we have seen a clear potential for Amycretin to become both an oral but also a subcutaneous offering and therefore in Phase I it is prudent to investigate both.
Driven by the fact that we're learning that Optionality is important for patient centered prescribing physicians in both diabetes and obesity and we have seen it clear potential for increasing to become pose an oral touch shortly also a subcutaneous offering and therefore interface. One it is prudent to investigate those.
Daniel Bohsen: Thanks Martin and thanks Seamus, we're ready for the next question.
Daniel Bohsen: Martin, the first question for you, GLP-1 higher dose considerations.
Daniel Bohsen: Martin, the first question for you, GLP-1 higher dose considerations.
<unk>.
Karsten Munk Knudsen: Yeah, absolutely. Thank you for that question. You're absolutely right. We're investigating 8 and 16 mg in diabetes, but we're also investigating 7.2 mg in obesity. The purpose is obviously to assess whether we can achieve an even higher efficacy without compromising on safety. Our models suggest, in particular in the obesity space, that a higher dose could potentially be associated with an even greater weight loss without having to compromise on safety. Being diligent, we want to assess this.
Martin Holst Lange: Yeah, absolutely. Thank you for that question. You're absolutely right. We're investigating 8 and 16 mg in diabetes, but we're also investigating 7.2 mg in obesity. The purpose is obviously to assess whether we can achieve an even higher efficacy without compromising on safety. Our models suggest, in particular in the obesity space, that a higher dose could potentially be associated with an even greater weight loss without having to compromise on safety. Being diligent, we want to assess this.
Operator: Thank You, I'll now take the next question, and your next question comes from the line of Peter Verdult, from Citigroup, Please go ahead
And your next question comes from the line of Pizza <unk> go ahead.
Peter Verdult: Yeah thank you, Peter Verdult citi, two questions Karsten on your favorite topics supply and pricing, just on supply, if we take the sort of run rate for GLP-1 volumes you'll franchise in the US and just extrapolate into '24, if nothing changes I mean, there's gonna be a big disconnect in terms of People's expectations for growth next year and I think it will be effectively flat no I know, it's going to improve next year, but can I just push you on when we might see the handbrake being released I mean. Logical thinking might be the the time with the <unk> launch you'll be willing to be the less capacity constrained position. So I know you can't go into too much detail, but just some incremental color on when we want to see the heartbreak being removed would be helpful. And then on pricing if we do value per script. Collation, there's a huge jump from Q2 Q3, <unk>, you've called Outgrows Tonight adjustments, we know the commercial mix of improved but just making sure is is this is a high water mark of one of the in terms of valuable prescription hazard based learning and thinking going forward. Can we use the value of his grip and Q3 as a baseline or or is it artificially high. Thank you.
Peter Verdult: Yeah thank you, Peter Verdult citi, two questions Karsten on your favorite topics supply and pricing, just on supply, if we take the sort of run rate for GLP-1 volumes you'll franchise in the US and just extrapolate into '24, if nothing changes I mean, there's gonna be a big disconnect in terms of People's expectations for growth next year and I think it will be effectively flat no I know, it's going to improve next year, but can I just push you on when we might see the handbrake being released.
Supply and pricing just don't supply if we take this little run rate for G. L. B one volumes you'll franchise in the U S. Just extrapolate into 24, if nothing changes I mean, there's gonna be a big disconnect in terms of People's expectations for growth next year and nothing will be effective flat no I know, it's going to improve next year.
Daniel Bohsen: Thank you, Martin. If I understood your question correct, Mark, then the question was whether we'll leverage our FlexTouch platform also to launch Wegovy in the US in the FlexTouch device. But Lars, maybe to you, any strategic considerations on our device platforms?
Daniel Bohsen: Thank you, Martin. If I understood your question correct, Mark, then the question was whether we'll leverage our FlexTouch platform also to launch Wegovy in the US in the FlexTouch device. But Lars, maybe to you, any strategic considerations on our device platforms?
What kind of just push you all need when we might see the handbrake being released I mean.
Peter Verdult: I mean. Logical thinking might be the the time with the <unk> launch you'll be willing to be the less capacity constrained position. So I know you can't go into too much detail, but just some incremental color on when we want to see the heartbreak being removed would be helpful. And then on pricing if we do value per script. Collation, there's a huge jump from Q2 Q3, <unk>, you've called Outgrows Tonight adjustments, we know the commercial mix of improved but just making sure is is this is a high water mark of one of the in terms of valuable prescription hazard based learning and thinking going forward. Can we use the value of his grip and Q3 as a baseline or or is it artificially high. Thank you.
Peter Verdult: I mean the logical thinking might be that at the time with the Mounjaro launch you'll be wanting to be the less capacity constrained position, so I know you can't go into too much detail, but just some incremental color on when we might see the heartbreak being removed would be helpful.
Logical thinking might be the the time with the <unk> launch you'll be willing to be the less capacity constrained position. So I know you can't go into too much detail, but just some incremental color on when we want to see the heartbreak being removed would be helpful. And then on pricing if we do value per script.
Lars Fruergaard Jørgensen: Yeah. Mark, thanks for the question. I'll just say that we have a situation today where we have a number of device platforms inside the company, one using outside vendor and technology. That gives us flexibility, and it's actually part of fueling the growth today that we can flex this. I'll not go into specific speculation about what we use of device per market, but we see that it's a strength that we can flex between different presentations. We see today that it's really the, you know, the efficacy of the molecule that drives that. That gives quite some flexibility in how we go to market, country by country and strategic flexibility on our side. Thank you.
Lars Fruergaard Jørgensen: Yeah. Mark, thanks for the question. I'll just say that we have a situation today where we have a number of device platforms inside the company, one using outside vendor and technology. That gives us flexibility, and it's actually part of fueling the growth today that we can flex this. I'll not go into specific speculation about what we use of device per market, but we see that it's a strength that we can flex between different presentations. We see today that it's really the, you know, the efficacy of the molecule that drives that. That gives quite some flexibility in how we go to market, country by country and strategic flexibility on our side. Thank you.
Peter Verdult: And then on pricing, if we do our value per script calculation, there's a huge jump from Q2 to Q3 although you've called out gross to net adjustments, we know the commercial mix has improved but, just making sure, is this a sort of high water mark, one of, in terms of valuable prescription hazard, in terms of based learning and thinking on going forward, can we use the value per script in Q3 as a baseline or or is it artificially high. Thank you.
Collation, there's a huge jump from Q2 Q3, <unk>, you've called Outgrows Tonight adjustments, we know the commercial mix of improved but just making sure is is this is a high water mark of one of the in terms of valuable prescription hazard based learning and thinking going forward.
Can we use the value of his grip and Q3 as a baseline or or is it artificially high. Thank you.
Daniel Bohsen: Thanks Pete, Karsten, supply going into 24 and the value per script.
Karsten Knudsen: Yeah Pete thank you for those, my favorite topics so I'd say, so first of all with the guidance for the full year, this year that has a mid point of 35% sales growth at constant change rates at least in the Novo setting it feels like we have released the handbrake and moving a at very high pace in terms of growth rates, at least it's the highest in the history of the company. But but that's it and annexed extrapolation and intertwined to 24. I would say first of all we're clearly appearance broke growth strategy based on the innovation. We have shown that we have the innovation platforms, especially in <unk> in vehicle, which were to drive growth. This year and clearly also also next year. So and so are not teaching you how to extrapolate, but if you extrapolate our impact too far sales growth based on our guidance than the than you actually get two essays growth number next year. In the double digits, which is actually not that far away from a from a consensus is currently so with us. So I I do believe that we're escaping very very fast and then specifically on on. On the Kobe and any hand breaks there than than what I would say is two extra 2024. In 2024. He will be delivering significant step up in volumes should the U S. Mark compared to 2020 tree as we did from 22 to 23. And then the Ventura pricing questions. S. We've set on numerous occasions said the appropriate way of looking at net realized pricing in in the U S has to look at it at the year to date numbers. Sir So most contracts are a contract it on an annual basis and to end the tricky part is. Lag effect between when a script is written and then we received the rebate claims from from the pay us and there's just a lack effect of several months and and that's why you know in. In reality Q3 is the first point, where we see how how the challenge pay amyx truly is falling out 442000, French tree. So so I wouldn't use Q3 in isolation for financing forecasting wise I would recommend you to use you to date Q3 as a starting point. Thank you.
Karsten Knudsen: Yeah Pete thank you for those, my favorite topics so I'd say, so first of all with the guidance for the full year, this year that has a mid point of 35% sales growth at constant change rates at least in the Novo setting it feels like we have released the handbrake and moving a at very high pace in terms of growth rates, at least it's the highest in the history of the company.
First of all with the guidance for the full year. This year that has some mid point of 35% say schools that constant change rates.
Daniel Bohsen: Thank you, Lars. Next question, please.
Daniel Bohsen: Thank you, Lars. Next question, please.
Operator: Thank you. Your next question comes from the line of Emily Field from Barclays. Please go ahead.
Operator: Thank you. Your next question comes from the line of Emily Field from Barclays. Please go ahead.
At least in the normal setting it feels like we we have released the handbrake.
Speaker 13: Hi. Thanks for taking my question. I'll ask two. One, just on the STEP 9 osteoarthritis study, I believe that this is not large enough to be added to the Wegovy label. If this were to be a positive study, what would be your next steps plans? Just, you know, on anti-obesity medications and muscle loss, we've seen competitors, you know, more explicitly, make efforts in R&D, for compounds that could preserve lean mass over fat mass and overall weight loss. I was wondering if you could just give an update on where you stand on that, within your R&D portfolio. Thank you.
Emily Field: Hi. Thanks for taking my question. I'll ask two. One, just on the STEP 9 osteoarthritis study, I believe that this is not large enough to be added to the Wegovy label. If this were to be a positive study, what would be your next steps plans? Just, you know, on anti-obesity medications and muscle loss, we've seen competitors, you know, more explicitly, make efforts in R&D, for compounds that could preserve lean mass over fat mass and overall weight loss. I was wondering if you could just give an update on where you stand on that, within your R&D portfolio. Thank you.
And moving a at very high pace in terms of growth rates at least it's the highest in in the history of the company.
But but that's it and annexed extrapolation and intertwined to 24.
Karsten Knudsen: But that said and extrapolated into 2024, I would say, first of all, we're clearly pursuing growth strategy based on the innovation, we have shown that we have the innovation platforms, especially in Ozempic and Wegovy to drive growth this year and clearly also next year so, not teaching you how to extrapolate, but if you extrapolate our implied Q4 sales growth based on our guidance then you actually get to a sales growth number next year in the double digits, which is actually not that far away from our consensus currently so with us. So I I do believe that we're escaping very very fast and then specifically on on. On the Kobe and any hand breaks there than than what I would say is two extra 2024. In 2024. He will be delivering significant step up in volumes should the U S. Mark compared to 2020 tree as we did from 22 to 23. And then the Ventura pricing questions. S. We've set on numerous occasions said the appropriate way of looking at net realized pricing in in the U S has to look at it at the year to date numbers. Sir So most contracts are a contract it on an annual basis and to end the tricky part is. Lag effect between when a script is written and then we received the rebate claims from from the pay us and there's just a lack effect of several months and and that's why you know in. In reality Q3 is the first point, where we see how how the challenge pay amyx truly is falling out 442000, French tree. So so I wouldn't use Q3 in isolation for financing forecasting wise I would recommend you to use you to date Q3 as a starting point. Thank you.
Karsten Knudsen: But that said and extrapolated into 2024, I would say, first of all, we're clearly pursuing growth strategy based on the innovation, we have shown that we have the innovation platforms, especially in Ozempic and Wegovy to drive growth this year and clearly also next year so, not teaching you how to extrapolate, but if you extrapolate our implied Q4 sales growth based on our guidance then you actually get to a sales growth number next year in the double digits, which is actually not that far away from our consensus currently, so I do believe that we're scaling very fast.
I would say first of all we're clearly appearance broke growth strategy based on the innovation. We have shown that we have the innovation platforms, especially in <unk> in vehicle, which were to drive growth. This year and clearly also also next year.
So and so are not teaching you how to extrapolate, but if you extrapolate our impact too far sales growth based on our guidance than the than you actually get two essays growth number next year.
Daniel Bohsen: Thank you, Emily. Martin, two for you.
Daniel Bohsen: Thank you, Emily. Martin, two for you.
Martin Holst Lange: Yeah. So specifically on the osteoarthritis trial, you are right, it's not the biggest trial. I think it's too early to speculate whether that will have an impact on a label. It's very clear that for us, it's also guiding for future clinical activities, specifically maybe for our GLP-1 GIP combination. So it has actually two potentials both to serve for information specifically for Wegovy, but also to guide us for future activities.
Martin Holst Lange: Yeah. So specifically on the osteoarthritis trial, you are right, it's not the biggest trial. I think it's too early to speculate whether that will have an impact on a label. It's very clear that for us, it's also guiding for future clinical activities, specifically maybe for our GLP-1 GIP combination. So it has actually two potentials both to serve for information specifically for Wegovy, but also to guide us for future activities.
In the double digits, which is actually not that far away from a from a consensus is currently so with us. So I I do believe that we're escaping very very fast and then specifically on on.
Karsten Knudsen: And then specifically on Wegovy and any hand breaks there, then what I would say as to 2024 is that in 2024 we will be delivering significant step-up in volumes to the US market compared to 2023, as we did from 22 to 23, and then to the pricing questions, as we've said on numerous occasions, the appropriate way of looking at net realize pricing in the US is to look at the year to date numbers. So most contracts are a contract it on an annual basis and to end the tricky part is. Lag effect between when a script is written and then we received the rebate claims from from the pay us and there's just a lack effect of several months and and that's why you know in. In reality Q3 is the first point, where we see how how the challenge pay amyx truly is falling out 442000, French tree. So so I wouldn't use Q3 in isolation for financing forecasting wise I would recommend you to use you to date Q3 as a starting point. Thank you.
Karsten Knudsen: And then specifically on Wegovy and any hand breaks there, then what I would say as to 2024 is that in 2024 we will be delivering significant step-up in volumes to the US market compared to 2023, as we did from 22 to 23, and then to the pricing questions, as we've said on numerous occasions, the appropriate way of looking at net realize pricing in the US is to look at the year to date numbers.
On the Kobe and any hand breaks there than than what I would say is two extra 2024.
In 2024.
He will be delivering significant step up in volumes should the U S. Mark compared to 2020 tree as we did from 22 to 23.
Daniel Bohsen: The second one, Martin, obesity and research and development focus on muscle loss versus
Daniel Bohsen: The second one, Martin, obesity and research and development focus on muscle loss versus.
Martin Holst Lange: Yeah. I think this is a relevant point. It's also a focus of ours. With current treatments, specifically Wegovy and Saxenda, we actually see a reasonable preservation of lean body mass, given the broader weight loss. It has to be a focus area, and you'll probably see also in our pipeline without going into details, maybe even quite soon, assets that could lead to a preservation of lean mass.
Martin Holst Lange: Yeah. I think this is a relevant point. It's also a focus of ours. With current treatments, specifically Wegovy and Saxenda, we actually see a reasonable preservation of lean body mass, given the broader weight loss. It has to be a focus area, and you'll probably see also in our pipeline without going into details, maybe even quite soon, assets that could lead to a preservation of lean mass.
And then the Ventura pricing questions.
S. We've set on numerous occasions said the appropriate way of looking at net realized pricing in in the U S has to look at it at the year to date numbers. Sir So most contracts are a contract it on an annual basis and to end the tricky part is.
Karsten Knudsen: So most contracts are a contracted on an annual basis and the tricky part is the lag effect between, when a script is written and then we receive the rebate claims from the payers and there's just a lag effect of several months and that's why you know in reality Q3 is the first point where we see how the chanel payer mix tool is falling out for 2023, so I wouldn't use Q3 in isolation for our financing forecasting wise, I would recommend you to use year to date Q3 as a starting point. Thank you.
Lag effect between when a script is written and then we received the rebate claims from from the pay us and there's just a lack effect of several months and and that's why you know in.
Daniel Bohsen: Thank you, Martin. Thank you, Emily. We are ready for the next question.
Daniel Bohsen: Thank you, Martin. Thank you, Emily. We are ready for the next question.
Operator: Thank you. Your next question comes from the line of Simon Baker from Redburn. Please go ahead.
Operator: Thank you. Your next question comes from the line of Simon Baker from Redburn. Please go ahead.
In reality Q3 is the first point, where we see how how the challenge pay amyx truly is falling out 442000, French tree. So so I wouldn't use Q3 in isolation for financing forecasting wise I would recommend you to use you to date Q3 as a starting point. Thank you.
Speaker 14: Thank you for taking my questions. Two if I may. Firstly, on China, growth looks pretty good over there, but I just wondered if you could give us an update on the impact of reduced access to Chinese hospitals on how that is affecting things, if indeed at all. Secondly, on semaglutide, there was an interesting journal preprint on Monday looking at its use in alcohol use disorder, which looked very impressive. Be interesting to get your thoughts on the potential of that indication in your opinion. Thanks so much.
Simon Baker: Thank you for taking my questions. Two if I may. Firstly, on China, growth looks pretty good over there, but I just wondered if you could give us an update on the impact of reduced access to Chinese hospitals on how that is affecting things, if indeed at all. Secondly, on semaglutide, there was an interesting journal preprint on Monday looking at its use in alcohol use disorder, which looked very impressive. Be interesting to get your thoughts on the potential of that indication in your opinion. Thanks so much.
Peter Verdult: Very clear, Thank You.
Daniel Bohsen: We're ready for the next question.
Operator: Thank you, your next question comes from the line of Mark Purcell for Morgan Stanley, please go ahead.
Your next question comes on the line of <unk> for Morgan Stanley. Please go ahead.
Mark Douglas Purcell: Thanks very much for taking my questions, the first one on GLP-1 on higher doses, Lilly is starting higher dose trials for Tirzepatide, you have 8 and 60 milligrams coming through by the end of this year, can you help me understand your expectations there and the importance of increasing your dose whith the pivotal trial at 7.2 read out late next year and then secondly in terms of the pen platform leverage we estimate about $100 million <unk>, it's going to be solved by Nova in 2023 joked ones that is. The majority is the flex touch platform with a three a mental pout form. So will you use that those two platforms to launch would go with me in the U S and if not why not. Latin the third question for you if you want higher dose consideration absolutely. Thank you for that question. So you're absolutely right where investigated at 815 milligram in diabetes, but we also investigated and 7.2 milligram it will be soon. The purpose is obviously true to assess whether we. We can achieve an even higher efficacy without compromising safety. A large suggest in particular new piece of space that are hired those could potentially. Be associated with an even greater weight loss without having to compromise on safety and be intelligent. We want to assist us.
Mark Douglas Purcell: Thanks very much for taking my questions, the first one on GLP-1 on higher doses, Lilly is starting higher dose trials for Tirzepatide, you have 8 and 60 milligrams coming through by the end of this year, can you help me understand your expectations there and the importance of increasing your dose whith the pivotal trial at 7.2 read out late next year
At the end by the end of this year can you help me understand your expectations, there and the importance of increasing your dose where the pivotal trial at some point to read out late next year and then secondly in terms of the pen platform leverage we estimate about $100 million <unk>, it's going to be solved by Nova in 2023 joked ones that is.
Daniel Bohsen: Thank you, Simon. Camilla, the first one to you, do we see reduced access to Chinese hospitals?
Daniel Bohsen: Thank you, Simon. Camilla, the first one to you, do we see reduced access to Chinese hospitals?
Camilla Sylvest: In general, we are working across the country and we also have access to hospitals in general. What we do see in China is an effect of the VPP, of course, that's what you mean, the insulin sales results. That is also when you look at an overall IO business point of view, that is what is actually dragging down the overall IO insulin growth. But in China, Ozempic is going really well. We have a great momentum of Ozempic that we've had since the launch and since the inclusion on the reimbursement list, and that can drive growth in China.
Camilla Sylvest: In general, we are working across the country and we also have access to hospitals in general. What we do see in China is an effect of the VPP, of course, that's what you mean, the insulin sales results. That is also when you look at an overall IO business point of view, that is what is actually dragging down the overall IO insulin growth. But in China, Ozempic is going really well. We have a great momentum of Ozempic that we've had since the launch and since the inclusion on the reimbursement list, and that can drive growth in China.
Mark Douglas Purcell: And then secondly in terms of the pen platform leverage, we estimate about $100 million GLP-1 pen units are going to be sold by Novo in 2023 for GLP-1s that is, and the majority is the FlexTouch platform with a 3ml platform, so will you use those two platforms to launch Wegovy in the US and if not why not? Latin the third question for you if you want higher dose consideration absolutely. Thank you for that question. So you're absolutely right where investigated at 815 milligram in diabetes, but we also investigated and 7.2 milligram it will be soon. The purpose is obviously true to assess whether we. We can achieve an even higher efficacy without compromising safety. A large suggest in particular new piece of space that are hired those could potentially. Be associated with an even greater weight loss without having to compromise on safety and be intelligent. We want to assist us.
Mark Douglas Purcell: And then secondly in terms of the pen platform leverage, we estimate about $100 million GLP-1 pen units are going to be sold by Novo in 2023 for GLP-1s that is, and the majority is the FlexTouch platform with a 3ml platform, so will you use those two platforms to launch Wegovy in the US and if not why not?
The majority is the flex touch platform with a three a mental pout form. So will you use that those two platforms to launch would go with me in the U S and if not why not.
Latin the third question for you if you want higher dose consideration absolutely. Thank you for that question. So you're absolutely right where investigated at 815 milligram in diabetes, but we also investigated and 7.2 milligram it will be soon.
Mark Douglas Purcell: Martin the third question for you, if you want higher dose consideration absolutely. Thank you for that question. So you're absolutely right where investigated at 815 milligram in diabetes, but we also investigated and 7.2 milligram it will be soon. The purpose is obviously true to assess whether we. We can achieve an even higher efficacy without compromising safety. A large suggest in particular new piece of space that are hired those could potentially. Be associated with an even greater weight loss without having to compromise on safety and be intelligent. We want to assist us.
Daniel Bohsen: Martin the first question for you, GLP-1 higher dose consideration
Martin Holst Lange: Absolutely, thank you for that question, so you're absolutely right, we're investigating at 8 and 60 milligram in diabetes, but we're also investigating 7.2 milligram in obesity, the purpose is obviously to assess whether we can achieve an even higher efficacy without compromising on safety, our model suggest in particular in the obesity space that a higher dose could potentially be associated with an even greater weight loss without having to compromise on safety and being dilligent, we want to assess this.
The purpose is obviously true to assess whether we.
We can achieve an even higher efficacy without compromising safety.
Daniel Bohsen: Thank you. No major issues with access. Martin, the second question.
Daniel Bohsen: Thank you. No major issues with access. Martin, the second question.
A large suggest in particular new piece of space that are hired those could potentially.
Martin Holst Lange: Yeah, thank you very much for the question. We've also seen these observational studies and being intrigued by the fact that GLP-1 may have a place in also treating alcohol abuse does actually lie within the mode of action of GLP-1. From our perspective and also considering the timing, the combination of two modes of action that could potentially also help here, namely GLP-1 and amylin, so specifically from our perspective, CagriSema is probably the more attractive and efficacious approach. If you see us going into that space, that would be with CagriSema and not with semaglutide alone.
Martin Holst Lange: Yeah, thank you very much for the question. We've also seen these observational studies and being intrigued by the fact that GLP-1 may have a place in also treating alcohol abuse does actually lie within the mode of action of GLP-1. From our perspective and also considering the timing, the combination of two modes of action that could potentially also help here, namely GLP-1 and amylin, so specifically from our perspective, CagriSema is probably the more attractive and efficacious approach. If you see us going into that space, that would be with CagriSema and not with semaglutide alone.
Be associated with an even greater weight loss without having to compromise on safety and be intelligent.
We want to assist us.
Daniel Bohsen: Thank you Martin and if I understood your question correct Mark then the question was whether we leverage our FlexTouch platform also to launch Wegovy in the US and in the FlexTouch device platform but Lars maybe to you any strategic considerations so now at the Mark platforms
You're a Christian quake Mac than the question was whether we live with a child Flex talk platform also to launch that go in the U S and.
In the flex touch device, but but last maybe to you any strategic considerations. So now the Mac platform.
Lars Fruergaard Joergensen: Thanks for the question I would just say that we have a situation today, where we have a number of device platforms beside the company one, using outside vendor and technology, so that gives us flexibility and it's actually part of fueling the growth today that we can flex this, so I'll not go into specific explanation about what the use of device per market, but we see that it's a strength that we can flex between different presentations and we see each day that it's really the efficiency of the molecule that drives this, so that gives quite some flexibility in how we go to market country by country and a strategic flexibility on our side. Thank you.
A number of device platforms.
Beside the company one.
Daniel Bohsen: Thank you, Martin.
Daniel Bohsen: Thank you, Martin.
Speaker 14: Thanks so much.
Simon Baker: Thanks so much.
Daniel Bohsen: We're ready for the next question.
Daniel Bohsen: We're ready for the next question.
Yoshi outside vendor.
Operator: Thank you. Your next question comes from the line of Naresh Chouhan from Intron Health. Please go ahead.
Operator: Thank you. Your next question comes from the line of Naresh Chouhan from Intron Health. Please go ahead.
Linda and technology, so that gives us flexibility and it's actually.
Fueling the growth today that we can we can flex. This so I'll not go into specifics speculation about what the use of device per market, but we see that it's a strength that we can flex between different presentations.
Speaker 15: Hi there. Thanks for taking my questions. First one on Wegovy US market access. We're hearing that a growing number of employers are having to opt out, having already opted in, because the demand's been too high. Can you just help us to get a sense of how big or small an issue this is? And obviously next year, that's probably potentially likely to increase when supply resumes and demand increases. And secondly, on supply, if I look back at when you you seemed to be relatively comfortable with the demand, we were around about 30,000 new patient starts a week in the US. Would that be a fair starting point for kind of the ability to supply and growth from there going into 2024? Thank you.
Naresh Chouhan: Hi there. Thanks for taking my questions. First one on Wegovy US market access. We're hearing that a growing number of employers are having to opt out, having already opted in, because the demand's been too high. Can you just help us to get a sense of how big or small an issue this is? And obviously next year, that's probably potentially likely to increase when supply resumes and demand increases. And secondly, on supply, if I look back at when you you seemed to be relatively comfortable with the demand, we were around about 30,000 new patient starts a week in the US. Would that be a fair starting point for kind of the ability to supply and growth from there going into 2024? Thank you.
And we see each day that it's treated Ah.
The molecule that drive set so that gives us quite some flexibility in how we go to market a country by country and such.
Strategic flexibility on our site. Thank you.
Daniel Bohsen: Thank you Lars, next question please.
Question. Please.
Operator: Thank you, your next question comes from the line of Emily Field from Barclays. Please go ahead.
Your next question comes from the line of Emily feel from Barclays. Please go ahead.
Emily Field: Hi, Thanks for taking my question, I'll ask two, one just on the STEP 9 osteoarthritis study, I believe that this is not large enough to be added to the Wegovy labels, so if this were to be a positive study, what would be your next steps plans? and then just on anti obesity medications and muscle loss we've seen competitors more explicitly make efforts in R&D for compounds that could preserve lean mass over fat mass in overall weight loss, I was wondering if you could just give an update on where you stand on that within your R&D portfolio? Thank you.
I'll ask you one just on the step nine osteoarthritis study I believe that this is not large enough to be added to look all the labels. So if this were to be a positive study what would be your next steps plans.
And then just an anthill D C medications and muscle loss is seen competitors more explicitly make efforts and R&D Ah for compounds I could preserve lean mass over fat Madison overall weight loss I was wondering if you could just give an update on where you stand on that within your R&D portfolio. Thank you.
Daniel Bohsen: Thank you, Naresh. Doug, any updates on US market access for Wegovy?
Daniel Bohsen: Thank you, Naresh. Doug, any updates on US market access for Wegovy?
Doug Langa: Yeah. Thanks, Naresh. Overall, we're very pleased with the broad market access that we have for Wegovy. Most major PBMs and health plans are covering it and authorize around 50 million people with obesity now being covered. Importantly, we're seeing about 80% of the patients that are paying less than $25 for Wegovy. Now, to your question specifically around employers, we do see some opt-outs, but we're seeing overall more opt-ins than opt-outs. Directionally, we're heading in the right direction. Our focus will be continuing on securing employer coverage as well as stronger access for AOMs overall.
Doug Langa: Yeah. Thanks, Naresh. Overall, we're very pleased with the broad market access that we have for Wegovy. Most major PBMs and health plans are covering it and authorize around 50 million people with obesity now being covered. Importantly, we're seeing about 80% of the patients that are paying less than $25 for Wegovy. Now, to your question specifically around employers, we do see some opt-outs, but we're seeing overall more opt-ins than opt-outs. Directionally, we're heading in the right direction. Our focus will be continuing on securing employer coverage as well as stronger access for AOMs overall.
Daniel Bohsen: Thank you Emily, Martin two for you.
Martin Holst Lange: So specifically on the osteoarthritis trial, you are right it's not the biggest trial, I think it's too early to speculate whether that will have an impact on a label, it's very very clear that for us it's also guiding for future clinical activities, specifically, maybe for Cagrisema, Amycretin or GLP-1/GIP combination, so it has actually two potentials, both to serve for information, specifically for Wegovy but also to guide us for future activities. And the second one matching obesity and the research and development focus on muscle loss. I think this is irrelevant point that it's also a focus of ours. With current treatments specifically, we go in and take said that we actually see. A reasonable presentation of. Lean body mass given the broader weight loss, but it has to be a focus area and you'll probably see you're also an oil pipeline without going into details. Maybe even glad to access that quote. The two. Preservation of Leanness. Thank you imagine thank you Emily we're ready for the next question.
Martin Holst Lange: So specifically on the osteoarthritis trial, you are right it's not the biggest trial, I think it's too early to speculate whether that will have an impact on a label, it's very very clear that for us it's also guiding for future clinical activities, specifically, maybe for Cagrisema, Amycretin or GLP-1/GIP combination, so it has actually two potentials, both to serve for information, specifically for Wegovy but also to guide us for future activities.
Right.
Right. It's not the biggest tried I think it's too early to speculate whether that will have an impact on on a label.
It's very very clear that for US. It's also guide in full.
Future clinical activities, specifically, maybe four K per cent increase in all GOP one.
TRP.
Combination so so.
It is actually two potential both to show for information.
<unk> quickly probably go away, but also to guide us for future activities.
Martin Holst Lange: And the second one matching obesity and the research and development focus on muscle loss. I think this is irrelevant point that it's also a focus of ours. With current treatments specifically, we go in and take said that we actually see. A reasonable presentation of. Lean body mass given the broader weight loss, but it has to be a focus area and you'll probably see you're also an oil pipeline without going into details. Maybe even glad to access that quote. The two. Preservation of Leanness. Thank you imagine thank you Emily we're ready for the next question.
Daniel Bohsen: And the second one matching obesity and the research and development focus on muscle loss.
Daniel Bohsen: Thank you, Doug. Karsten, any additional comments on the Wegovy supply going into next year?
Daniel Bohsen: Thank you, Doug. Karsten, any additional comments on the Wegovy supply going into next year?
And the second one matching obesity and the research and development focus on muscle loss.
Martin Holst Lange: I think this is a relevant point that's also a focus of ours, with current treatments specifically, Wegovy and Saxenda we actually see a reasonable preservation of lean body mass, given the broader weight loss, but it has to be a focus area and you'll probably see also in our pipeline without going into details, maybe even quite soon, access that could lead to the preservation of lean mass. Thank you Martin, thank you Emily we're ready for the next question.
Martin Holst Lange: I think this is a relevant point that's also a focus of ours, with current treatments specifically, Wegovy and Saxenda we actually see a reasonable preservation of lean body mass, given the broader weight loss, but it has to be a focus area and you'll probably see also in our pipeline without going into details, maybe even quite soon, access that could lead to the preservation of lean mass.
Karsten Munk Knudsen: I think the way to look at the US Wegovy supply is a starting point of currently around 100,000 TRX per week, according to IQVIA. We have the five different dose strengths and of course,
I think this is irrelevant point that it's also a focus of ours.
Karsten Munk Knudsen: I think the way to look at the US Wegovy supply is a starting point of currently around 100,000 TRX per week, according to IQVIA. We have the five different dose strengths and of course, The magic is to get that split right into the link in into manufacturing, and then we scale from there. As we've said in prior quarters, this is something we do dynamically. Don't look for a hockey stick. It's a gradual process where of course we'll be starting at the lower doses, and then increasing them as we move forward. There are different data sources in terms of new starts. I'm not really sure what your data source is. I think my data point is lower than yours in terms of the number of new starts per week.
With current treatments specifically, we go in and take said that we actually see.
A reasonable presentation of.
Lean body mass given the broader weight loss, but it has to be a focus area and you'll probably see you're also an oil pipeline without going into details.
Martin Holst Lange: The magic is to get that split right into the link in into manufacturing, and then we scale from there. As we've said in prior quarters, this is something we do dynamically. Don't look for a hockey stick. It's a gradual process where of course we'll be starting at the lower doses, and then increasing them as we move forward. There are different data sources in terms of new starts. I'm not really sure what your data source is. I think my data point is lower than yours in terms of the number of new starts per week.
Maybe even glad to access that quote.
The two.
Preservation of Leanness. Thank you imagine thank you Emily we're ready for the next question.
Daniel Bohsen: Thank you Martin, thank you Emily we're ready for the next question.
Operator: Thank you, your next question comes from the line of Simon Baker from Redburn, please go ahead.
Your next question comes from the line of finding Bacon from Redfin. Please go ahead.
Simon Baker: Thank you for taking my questions two for me, Firstly on China, growth looks pretty good over there, but I just wonder if you could give us an update on the impact of reduced access to Chinese hospitals on how that is affecting things if indeed at all, and then secondly on Semaglutide, there was an interesting journal pre-print on Monday, looking at it's use in alcohol use disorder, which looked very impressive, I'm interested to get your thoughts on the potential of that indication in your opinion. Thanks. So much.
It looks looks looks.
Pretty good over there, but I just wonder if you could give us an update on the the impact of which you should access to Chinese hospitals on.
On how how 'bout is affecting things if indeed, two and then secondly.
Daniel Bohsen: Thank you, Karsten. Thank you, Naresh. We are ready for the next question, please.
Daniel Bohsen: Thank you, Karsten. Thank you, Naresh. We are ready for the next question, please.
On on <unk>, there was a an interesting journal preprint on Monday looking at each you seen alcohol use disorder, which looked very impressive interesting to get your thoughts on the potential of that indication in your opinion. Thanks. So much.
Operator: Thank you. Your next question comes from the line of Florent Cespedes from Société Générale. Please go ahead.
Operator: Thank you. Your next question comes from the line of Florent Cespedes from Société Générale. Please go ahead.
Speaker 16: Good afternoon. Thank you very much for taking my questions too, please. First one on Wegovy in Europe. Have you started to talk to the payers in Europe as you have already submitted the data to the European authorities? Do you believe that you will need to show a statistically significant benefit on the cardiovascular test that will be presented at the AHA next week? My second question is on Ozempic. Following the FLOW results, how would you position the product on this population as we already have products available to treat these patients, notably the SGLT2? It seems that in the trial, 15% of the patients are under SGLT2 treatment. So some color on this one would be helpful. Thank you.
Florent Cespedes: Good afternoon. Thank you very much for taking my questions too, please. First one on Wegovy in Europe. Have you started to talk to the payers in Europe as you have already submitted the data to the European authorities? Do you believe that you will need to show a statistically significant benefit on the cardiovascular test that will be presented at the AHA next week? My second question is on Ozempic. Following the FLOW results, how would you position the product on this population as we already have products available to treat these patients, notably the SGLT2? It seems that in the trial, 15% of the patients are under SGLT2 treatment. So some color on this one would be helpful. Thank you.
Daniel Bohsen: Thank you Simon, so Camilla the first one to you, do we see reduced access to Chinese hospitals.
So.
<unk> the first one to you.
To receive reduced access to Chinese hospitals.
Camilla Sylvest: In general we are working across the country in, and we also have access to hospitals in general, what we do see in China is an effect of the VPP of course, that's what you mean the insulin sales results and that is also, when you look at an overall IO business point of view, that is what is actually dragging down the overall IO insulin growth, but in China Ozempic is going really well, we have a great momentum of Ozempic that we've had since the launch and since the inclusion on the reimburstment list and that kind of drives growth in China. No major issues with <unk> matching the second question, yes. Thank you very much for the question. We've also seen the these these observational studies and and and and. Been intrigued by by the fact that that one may have a place and also creating alcohol abuse. Those actually lie within the motivation of tier two one from our perspective and also considering the timing the combination of two mode of action that could potentially also help here, namely GTP, Juan and Emily and so specifically from our perspective <unk> sorry <unk>. Is probably the more attractive and efficacious approach. So if you see us going into that space that would be with eczema and not with some maintenance I dunno.
Camilla Sylvest: In general we are working across the country in, and we also have access to hospitals in general, what we do see in China is an effect of the VPP of course, that's what you mean the insulin sales results and that is also, when you look at an overall IO business point of view, that is what is actually dragging down the overall IO insulin growth, but in China Ozempic is going really well, we have a great momentum of Ozempic that we've had since the launch and since the inclusion on the reimbursement list and that kind of drives growth in China.
<unk> and <unk> and that is also when you look at an overall I owe business point of view that is why do you think any tracking it down the aisle a incident broke and but in China and authenticate sampling really well we have a great moment authentic that'd be <unk>.
<unk> <unk>, that's my list and that that kind of drive ankle from China.
Daniel Bohsen: Thank you, Florent. Camilla, maybe the first one for you in terms of Wegovy, outside the US.
Daniel Bohsen: Thank you, Florent. Camilla, maybe the first one for you in terms of Wegovy, outside the US.
Camilla Sylvest: No major issues with <unk> matching the second question, yes. Thank you very much for the question. We've also seen the these these observational studies and and and and. Been intrigued by by the fact that that one may have a place and also creating alcohol abuse. Those actually lie within the motivation of tier two one from our perspective and also considering the timing the combination of two mode of action that could potentially also help here, namely GTP, Juan and Emily and so specifically from our perspective <unk> sorry <unk>. Is probably the more attractive and efficacious approach. So if you see us going into that space that would be with eczema and not with some maintenance I dunno.
Camilla Sylvest: No major issues with acces then, Martin the second question,
Camilla Sylvest: Yeah. In terms of, I believe the question was whether we need statistical significance. I would just say, you know, now we await the presentation at the conference. In general, there is a great interest in Wegovy and of course also the benefits in SELECT. We will get back to that. We do see authorities interested in bringing up the discussion again with us already at this point for reimbursement of Wegovy. Just a reminder, we have reimbursement of Saxenda already in close to 15 countries, all around the world. Of course here we are talking a step up in treatment.
Camilla Sylvest: Yeah. In terms of, I believe the question was whether we need statistical significance. I would just say, you know, now we await the presentation at the conference. In general, there is a great interest in Wegovy and of course also the benefits in SELECT. We will get back to that. We do see authorities interested in bringing up the discussion again with us already at this point for reimbursement of Wegovy. Just a reminder, we have reimbursement of Saxenda already in close to 15 countries, all around the world. Of course here we are talking a step up in treatment.
No major issues with <unk> matching the second question, yes. Thank you very much for the question. We've also seen the these these observational studies and and and and.
Martin Holst Lange: Yes, thank you very much for the question, we've also seen these observational studies and been intrigued by the fact that GLP-1 may have a place in also treating alcohol abuse, that was actually live within the mode of action of GLP-1, from our perspective and also considering the timing, the combination of two mode of actions that could potentially also help here, namely GLP-1 and Amylin so specifically from our perspective Cagrisema, is probably the more attractive and efficacious approach, so if you see us going into that space that would be with Cagrisema and not with Semaglutide alone.
Been intrigued by by the fact that that one may have a place and also creating alcohol abuse.
Those actually lie within the motivation of tier two one from our perspective and also considering the timing the combination of two mode of action that could potentially also help here, namely GTP, Juan and Emily and so specifically from our perspective <unk> sorry <unk>.
Is probably the more attractive and efficacious approach. So if you see us going into that space that would be with eczema and not with some maintenance I dunno.
Daniel Bohsen: Thank you, Camilla. Martin, any medical perspectives on FLOW and the population that we potentially could treat?
Daniel Bohsen: Thank you, Camilla. Martin, any medical perspectives on FLOW and the population that we potentially could treat?
Martin Holst Lange: Yeah, absolutely. Maybe just also calling out on SELECT. The study was designed to have a power specifically for the primary endpoint. So assuming statistical significance or for the secondary endpoints is to be seen as an upside and not as something to be expected. I just wanna call that out. Obviously, please tune in on what we can present on 11 November in Philadelphia. Specifically on FLOW, I think there's a tremendous unmet need in the diabetes space. It's also very, very clear that not all patients today who suffer from diabetes and chronic kidney disease are on an SGLT2 or on a GLP-1.
Martin Holst Lange: Yeah, absolutely. Maybe just also calling out on SELECT. The study was designed to have a power specifically for the primary endpoint. So assuming statistical significance or for the secondary endpoints is to be seen as an upside and not as something to be expected. I just wanna call that out. Obviously, please tune in on what we can present on 11 November in Philadelphia. Specifically on FLOW, I think there's a tremendous unmet need in the diabetes space. It's also very, very clear that not all patients today who suffer from diabetes and chronic kidney disease are on an SGLT2 or on a GLP-1.
Daniel Bohsen: Thank you Martin.
Thanks, So much we are ready for the next year.
Simon Baker: Thanks, So much
Daniel Bohsen: We are ready for the next question.
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Operator: Thank you, your next question comes from the line of Naresh Chouhan from Intron Health please go ahead.
It was on the line of novice Callahan from intern how can you go ahead.
Naresh Chouhan: Hi, there thanks for taking my questions, first one on Wegovy US market access, we are hearing on a growing number of employers are having to opt out, having already opted in because of demand's being too high, can you sort of help us get a sense of how big or small an issue this is? and obviously, next year that's probably potentially likely to increase when supply resumes and demand increases and secondly on supply, if I look back at when you seemed to be relatively comfortable with the demand, we were and about 30,000, new pet a week in the US That'd be, is that a fair starting point for kind of, the ability to supply and grow from there going into 2024. Thank you.
Naresh Chouhan: Hi, there thanks for taking my questions, first one on Wegovy US market access, we are hearing on a growing number of employers are having to opt out, having already opted in because of demand's being too high, can you sort of help us get a sense of how big or small an issue this is? and obviously, next year that's probably potentially likely to increase when supply resumes and demand increases
<unk> hearing and a growing number of employees having to opt out.
Having a radio today uhm, because the demands being too high can you. Please help us to get a sense of how big or small issue. This is and what was the nature of that can be potentially like to increase when supply.
And demand increases.
And certainly [noise].
Naresh Chouhan: And secondly on supply, if I look back at when you seemed to be relatively comfortable with the demand, we were and about 30,000, new pet a week in the US That'd be, is that a fair starting point for kind of, the ability to supply and grow from there going into 2024. Thank you.
On supply.
Well it back it when you you seem to be relatively come through with the with the demand. We were we were and about 30000, new pet so weak in the U S. That'd be is that a bad starting point for what kind of.
Martin Holst Lange: Therefore, to have data to suggest that we can actually decrease, and again, we haven't seen the data, but we can potentially decrease the kidney disease deterioration by a substantial number on top of standard of care, including SGLT2, is a really attractive offering. It will allow more patients in need to get on a GLP-1.
Martin Holst Lange: Therefore, to have data to suggest that we can actually decrease, and again, we haven't seen the data, but we can potentially decrease the kidney disease deterioration by a substantial number on top of standard of care, including SGLT2, is a really attractive offering. It will allow more patients in need to get on a GLP-1.
The ability to supply them in good from that going into between 24. Thank you.
Daniel Bohsen: Thank you Naresh so Doug, any updates on the US market access for Wegovy
Daniel Bohsen: Thank you, Martin. Thanks for the question.
Daniel Bohsen: Thank you, Martin. Thanks for the question.
Doug Langa: Yep, Thanks Naresh and overall, we're very pleased with the broad market access that we have for Wegovy, most major PBMs and health plans are covering and that derives around 50 million people with obesity now have been covered and importantly, we're seeing about 80% of the patients that are paying less than $25 for Wegovy, now to your question specifically around employers, we do see some opt outs, but we're seeing overall more opt in's than opt outs so directionally, we're heading in the right direction and our focus will continuing on securing employer coverage as well as stronger access for AOMs overall.
Doug Langa: Yep, Thanks Naresh and overall, we're very pleased with the broad market access that we have for Wegovy, most major PBMs and health plans are covering and that derives around 50 million people with obesity now have been covered and importantly, we're seeing about 80% of the patients that are paying less than $25 for Wegovy,
Speaker 16: Thank you.
Florent Cespedes: Thank you.
Daniel Bohsen: We are ready for the next question.
Daniel Bohsen: We are ready for the next question.
Operator: Thank you. We will now take the next question. The question comes from the line of Richard Vosser from JP Morgan. Please go ahead.
Operator: Thank you. We will now take the next question. The question comes from the line of Richard Vosser from JP Morgan. Please go ahead.
Most major Pbms and health plans are covering it not the rise around 50 million people with obesity now I'm covered.
Speaker 17: Hi. Thanks for taking my question. Question on the European rollout of Wegovy first. Obviously we know in Denmark in May there was a substantial demand for Wegovy in about 1% of the population. I was wondering how that has developed since then, both in terms of volume and how you're seeing patients staying on the drug in Denmark, given it's an out-of-pocket market. The second question is on your KBP Biosciences product. Just wondering how that differentiates from other MR antagonists, particularly Kerendia from Bayer, but there are also others in development from AstraZeneca, etc. Just your thoughts on how this is different. Thanks very much.
Richard Vosser: Hi. Thanks for taking my question. Question on the European rollout of Wegovy first. Obviously we know in Denmark in May there was a substantial demand for Wegovy in about 1% of the population. I was wondering how that has developed since then, both in terms of volume and how you're seeing patients staying on the drug in Denmark, given it's an out-of-pocket market. The second question is on your KBP Biosciences product. Just wondering how that differentiates from other MR antagonists, particularly Kerendia from Bayer, but there are also others in development from AstraZeneca, etc. Just your thoughts on how this is different. Thanks very much.
And importantly, we're seeing about 80% of the patients that are paying less than $25 for will go with me now to your question specifically around employers, we do see some opt outs, but we're seeing overall more opt in or opt out. So directionally, we're heading in the right direction and our focus will <unk> continue on continuing on securing.
Doug Langa: Now to your question specifically around employers, we do see some opt outs, but we're seeing overall more opt in's than opt outs so directionally, we're heading in the right direction and our focus will continuing on securing employer coverage as well as stronger access for AOMs overall.
Employer coverage as well as stronger access for airlines overall.
Daniel Bohsen: Thank you, Karsten any additional comments on the Wegovy supply going into next year.
Additional comments on the go with supply going into next year.
Karsten Knudsen: Yeah so I think the way to look at the US Wegovy supply is as a starting point of currently around 100,000 TRx per week according to AQVIA and then we have the five different dose strengths and of course the magic is to get that split right into the link and into manufacturing and then we scale from there and as we've said in prior quarters than this is something we do dynamically. So so don't look for hargis tickets. It's a gradual process where of course will be starting at the lordosis. And then increasing them as we move forward. The different data sources in terms of new sites, so I'm not I'm not really sure what what your data sources, but I. I think my data point is lower than yours in terms of the number of new thoughts. Week.
Karsten Knudsen: Yeah so I think the way to look at the US Wegovy supply is as a starting point of currently around 100,000 TRx per week according to AQVIA and then we have the five different dose strengths and of course the magic is to get that split right into the link and into manufacturing and then we scale from there and as we've said in prior quarters than this is something we do dynamically.
I as a starting point of of currently around hundred thousand to your extra week. According to attract trivia and then we have five different drove strengths and of course.
Daniel Bohsen: Thank you, Richard. Camilla, the first one to you. Wegovy rollout in Denmark and impacts.
Daniel Bohsen: Thank you, Richard. Camilla, the first one to you. Wegovy rollout in Denmark and impacts.
The magic is to get that.
Camilla Sylvest: Yeah. In Denmark, we see a continued interest in Wegovy, and the Wegovy continues to perform very well. It is more than 1% of the population at this point in time. In terms of how many stay on the product, it's too early to give you exact stay time numbers, but we do have. I could say anecdotal evidence that there is a high number, a very, very high number of the people that stay on the product from the beginning of the year when the product was launched.
Camilla Sylvest: Yeah. In Denmark, we see a continued interest in Wegovy, and the Wegovy continues to perform very well. It is more than 1% of the population at this point in time. In terms of how many stay on the product, it's too early to give you exact stay time numbers, but we do have. I could say anecdotal evidence that there is a high number, a very, very high number of the people that stay on the product from the beginning of the year when the product was launched.
Right right.
The link into manufacturing and then scale from that and as we've set in prior quarters than the than this is something we do dynamically. So so don't look for hargis tickets.
Karsten Knudsen: So don't look for harvest tickets, it's a gradual process where, of course we'll be starting at the lower doses and then increasing them as we move forward, there are different data sources in terms of new starts, so I'm not really sure what your data source is, but I think my data point is lower than yours, in terms of the number of new starts per Week.
It's a gradual process where of course will be starting at the lordosis.
And then increasing them as we move forward.
The different data sources in terms of new sites, so I'm not I'm not really sure what what your data sources, but I.
Daniel Bohsen: Thank you, Camilla Sylvest. Martin Holst Lange, reflections on ocedurenone.
Daniel Bohsen: Thank you, Camilla Sylvest. Martin Holst Lange, reflections on ocedurenone.
I think my data point is lower than yours in terms of the number of new thoughts.
Martin Holst Lange: Yeah, absolutely. What we've seen with ocedurenone is a molecule with a very high affinity for the receptor, and also a very high half-life. That actually means that we expect to see differentiation not only on efficacy, but it also-
Martin Holst Lange: Yeah, absolutely. What we've seen with ocedurenone is a molecule with a very high affinity for the receptor, and also a very high half-life. That actually means that we expect to see differentiation not only on efficacy, but it also- Appears to have a potential upside on the safety side, specifically on hyperkalemia. We do expect to see a differentiated drug in this space.
Week.
Daniel Bohsen: Thank you Karsten, thank you Naresh and we're ready for the next question please.
Operator: Thank You, your next question comes from the line of Florent Cespedes from Societe Generale, please go ahead.
Your next question comes from the line of horrendous as bad as some society Generale. Please go ahead.
Karsten Munk Knudsen: Appears to have a potential upside on the safety side, specifically on hyperkalemia. We do expect to see a differentiated drug in this space.
Florent Cespedes: Good afternoon, thank you very much for taking my questions, two please, first one on Wegovy in Europe, have you started to talk to the payers in Europe as you have already submitted data to the European authorities and do you believe that you will need to show statistically significant benefit on the cardiovascular test which will be presented at the AHA next week? and my second question is was empty the flu results. Would you position the product <unk> population as we already alpha. Available <unk> <unk> <unk> and then it seems that the trial of 15% of the patients are. And she will take two of treatment. So some color on this one could be it. Thank you.
Florent Cespedes: Good afternoon, thank you very much for taking my questions, two please, first one on Wegovy in Europe, have you started to talk to the payers in Europe as you have already submitted data to the European authorities and do you believe that you will need to show statistically significant benefit on the cardiovascular test which will be presented at the AHA next week?
One on <unk> in Europe have you started to talk to the payers in Europe as you have already submitted the data to the European authorities in do you believe that you will need to shoot.
Daniel Bohsen: Thank you, Martin. Thank you, Camilla. Thanks, Richard, for the question. We are ready for the next.
Daniel Bohsen: Thank you, Martin. Thank you, Camilla. Thanks, Richard, for the question. We are ready for the next.
Operator: Thank you. Your next question comes from the line of Peter Welford from Jefferies. Please go ahead.
Operator: Thank you. Your next question comes from the line of Peter Welford from Jefferies. Please go ahead.
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Speaker 18: Hi. Hope you can hear me. I've got two questions, I think. Firstly, if I could come back on the degree of gross margin. Appreciate the commentary year to date, but in Q3 it seemed to trend down quite a bit, which I guess is somewhat unusual given the quite significant improvements we saw in the gross-to-net in your most profitable market for both Wegovy and Ozempic. Can you just talk a little bit about, in Q3, what the incremental costs were or were there perhaps any write-downs or sorting of inventory or something that could potentially depress the gross margin in what would normally be a more profitable quarter?
Peter Welford: Hi. Hope you can hear me. I've got two questions, I think. Firstly, if I could come back on the degree of gross margin. Appreciate the commentary year to date, but in Q3 it seemed to trend down quite a bit, which I guess is somewhat unusual given the quite significant improvements we saw in the gross-to-net in your most profitable market for both Wegovy and Ozempic. Can you just talk a little bit about, in Q3, what the incremental costs were or were there perhaps any write-downs or sorting of inventory or something that could potentially depress the gross margin in what would normally be a more profitable quarter?
Next week and my second question is was empty the flu results.
Florent Cespedes: And my second question is on Ozempic following the FLOW results, how would you position the product on this population as we already have products available to treat these patients, notably the SGLP2 and then it seems that in the trial 15% of the patients are under SGLP2 treatment, so some color on this one could be it. Thank you.
Would you position the product <unk> population as we already alpha.
Available <unk> <unk> <unk> and then it seems that the trial of 15% of the patients are.
And she will take two of treatment. So some color on this one could be it. Thank you.
Daniel Bohsen: Thank you Florent, Camilla maybe the first one for you in terms of Wegovy outside of the US.
Speaker 18: Secondly, just coming back to the comment that was made on stay time, but thinking about it a different way, which is in the past, you've cited for Saxenda that around 25% or more of patients are on the drug for at least a year, and most of those are treated by obesity experts. Appreciate it's still early for Wegovy to necessarily give comments on the US for stay time, but can you sort of talk about whether you're seeing different trends than those of Saxenda, both in terms of the obesity experts versus those that aren't, and also the number of patients perhaps who have reached a year at this point? Thank you.
Peter Welford: Secondly, just coming back to the comment that was made on stay time, but thinking about it a different way, which is in the past, you've cited for Saxenda that around 25% or more of patients are on the drug for at least a year, and most of those are treated by obesity experts. Appreciate it's still early for Wegovy to necessarily give comments on the US for stay time, but can you sort of talk about whether you're seeing different trends than those of Saxenda, both in terms of the obesity experts versus those that aren't, and also the number of patients perhaps who have reached a year at this point? Thank you.
Camilla maybe the first one for you in terms of the Gobi outside of the U S.
Cami: Yeah so in terms of a, I believe the question was whether we need statistical significance, I would just say you know, right now we await the presentation at the conference but in general there is a great interest in Wegovy and of course also the benefits in SELECT. So we will get back to that but we have <unk> and bringing up the discussion again with us already at this point as all the investment <unk> and just to remind that we have the investment <unk> already and Nicholas 15 countries and <unk>. 11 o'clock here, we are talking. Popping in treatment.
Camilla Sylvest: Yeah so in terms of a, I believe the question was whether we need statistical significance, I would just say you know, right now we await the presentation at the conference but in general there is a great interest in Wegovy and of course also the benefits in SELECT.
I will need statistically significant I would just say.
That presentation at the at the conference spot internal basically it interesting.
<unk> and I'll spell it out for the benefit so okay. So we will get back to that but we have <unk> and bringing up the discussion again with us already at this point as all the investment <unk> and just to remind that we have the investment <unk> already and Nicholas 15 countries and <unk>.
Camilla Sylvest: So we will get back to that but we have, we do see authorities interested in bringing up the discussion again with us already at this point for reinvestment of Wegovy and just to remind that we have reinvestment of Saxenda already in close to 15 countries all around the world and of course here we are talking a step up in treatment.
Daniel Bohsen: Thank you, Peter. First of all, to Karsten on the gross margin and then later Doc on what we see on supply time in the US for Wegovy.
Daniel Bohsen: Thank you, Peter. First of all, to Karsten on the gross margin and then later Doc on what we see on supply time in the US for Wegovy.
11 o'clock here, we are talking.
Popping in treatment.
Daniel Bohsen: Thank you can be Martin any medical perspectives on flow and and the population that we potentially portrait yeah. It's Lola maybe just those will call out on select the study was designed to to to have a power.
Daniel Bohsen: Thank you Camilla, Martin any medical perspectives on FLOW and the population that we potentially pretreat
Karsten Munk Knudsen: Yeah, Peter, well spotted, for our gross margin, Q3. Just a word of caution to begin with, looking at gross margins at a quarterly basis is always tricky due to, you know, fluctuations over the year. If I am to comment specifically on the quarter then, at constant exchange rates, the gross margin is flat compared to last year. The decline compared to last year is FX driven. You could say, why is it then not increasing compared to last year given the gross net adjustment, and the product mix? There are basically two pieces to it.
Karsten Munk Knudsen: Yeah, Peter, well spotted, for our gross margin, Q3. Just a word of caution to begin with, looking at gross margins at a quarterly basis is always tricky due to, you know, fluctuations over the year. If I am to comment specifically on the quarter then, at constant exchange rates, the gross margin is flat compared to last year. The decline compared to last year is FX driven. You could say, why is it then not increasing compared to last year given the gross net adjustment, and the product mix? There are basically two pieces to it.
Martin Holst Lange: Yeah absolutely, maybe just also calling out on SELECT, the study was designed to have a power, specifically for the primary endpoint, so assuming statistical significant or for the secondary endpoint has to be seen as an upside and not as something to be expected, I just wanted to call that out, but obviously pizza tune in on what what we can present on on November 11th. Philadelphia, specifically on flow I think there's a there's a tremendous unmet need. In the diabetes space. It's also very very clear that not all patients today, who suffer from diabetes and chronic kidney disease I own instruments at you and Oh on a trip with one and therefore to have data to suggest that we could actually decrease. And again, we haven't seen the data, but we can potentially decrease. The the the. Kidney disease deterioration. But by a substantial number on trouble standard of care, including his jokes to choose is really really attracted boyfriend and it will allow. All patients indeed true to get an order to everyone.
Martin Holst Lange: Yeah absolutely, maybe just also calling out on SELECT, the study was designed to have a power, specifically for the primary endpoint, so assuming statistical significant or for the secondary endpoint has to be seen as an upside and not as something to be expected, I just wanted to call that out,
Specifically for the primary input so assuming statistical significant.
For the secondary influence has to be seen as an upside and not as something true true true to be expected I just wanted to call that out, but obviously pizza tune in on what what we can present on on November 11th.
Martin Holst Lange: But obviously please tune in on what what we can present on on November 11th in Philadelphia, specifically on FLOW I think there's a tremendous unmet need in the diabetes space, it's also very very clear that not all patients today, who suffer from diabetes and chronic kidney disease are on SGLP2 or on a GLP-1 and therefore to have data to suggest that we could actually decrease. And again, we haven't seen the data, but we can potentially decrease. The the the. Kidney disease deterioration. But by a substantial number on trouble standard of care, including his jokes to choose is really really attracted boyfriend and it will allow. All patients indeed true to get an order to everyone.
Martin Holst Lange: But obviously please tune in on what what we can present on on November 11th in Philadelphia, specifically on FLOW I think there's a tremendous unmet need in the diabetes space, it's also very very clear that not all patients today, who suffer from diabetes and chronic kidney disease are on SGLP2 or on a GLP-1
Philadelphia, specifically on flow I think there's a there's a tremendous unmet need.
In the diabetes space.
Karsten Munk Knudsen: First of all, remember the starting point. Our gross margin is already high at 84% or so. Secondly, what is different compared to prior years is that the amount of CapEx we're running these days, and just from an accounting policy standard point of view, we are realizing more costs related to our capital expenditure projects into the P&L. It doesn't all go to the balance sheet. Some of it also hits the P&L, and that is basically what is offsetting the benefit from product mix.
Karsten Munk Knudsen: First of all, remember the starting point. Our gross margin is already high at 84% or so. Secondly, what is different compared to prior years is that the amount of CapEx we're running these days, and just from an accounting policy standard point of view, we are realizing more costs related to our capital expenditure projects into the P&L. It doesn't all go to the balance sheet. Some of it also hits the P&L, and that is basically what is offsetting the benefit from product mix.
It's also very very clear that not all patients today, who suffer from diabetes and chronic kidney disease I own instruments at you and Oh on a trip with one and therefore to have data to suggest that we could actually decrease.
Martin Holst Lange: And therefore to have data to suggest that we could actually decrease and again, we haven't seen the data, but we can potentially decrease the kidney disease deterioration by a substantial number, on top of standard of care, including SGLP2s is a really really attractive offering and it will allow more patients in need to get on a GLP-1
And again, we haven't seen the data, but we can potentially decrease.
The the the.
Kidney disease deterioration.
But by a substantial number on trouble standard of care, including his jokes to choose is really really attracted boyfriend and it will allow.
All patients indeed true to get an order to everyone.
Daniel Bohsen: Thank you, Karsten. Over to you, Doug. Any insights on stay time on Wegovy in the US so far?
Daniel Bohsen: Thank you, Karsten. Over to you, Doug. Any insights on stay time on Wegovy in the US so far?
Daniel Bohsen: Thanks for the question and we are ready for the next question, we will now take the next question and the question comes from the line of Wichita that from J P. Morgan. Please go ahead.
Daniel Bohsen: Than you martin, thanks for the question and we are ready for the next question.
Thanks for the question and we are ready for the next question.
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Operator: Thank you, we will now take the next question and the question comes from the line of Richard Vosser from JP Morgan. Please go ahead.
Doug Langa: Yeah. Peter, thank you. 'Cause generally you're right. We expect to be able to say more about stay time in 2024. Obviously, it's been difficult given the few time periods with unrestricted supply. What I can say is based on early data from multiple sources, persistency on Wegovy. It looks better than Saxenda, with fewer patients dropping off in the first 12 months. We'll have more to say in 2024.
Doug Langa: Yeah. Peter, thank you. 'Cause generally you're right. We expect to be able to say more about stay time in 2024. Obviously, it's been difficult given the few time periods with unrestricted supply. What I can say is based on early data from multiple sources, persistency on Wegovy. It looks better than Saxenda, with fewer patients dropping off in the first 12 months. We'll have more to say in 2024.
We will now take the next question and the question comes from the line of Wichita that from J P. Morgan. Please go ahead.
Richard Vosser: Hi, Thanks for taking my question, a question on the European roll-out of Wegovy first, obviously we know in Denmark, in May there was a substantial demand for Wegovy in about 1% of the population so, I was wondering how that has developed since then, both in terms of volume and how you're seeing patients staying on the drug through Denmark, giving it's an out of pocket market and then the second question is on your K P. By science product just wondering how that differentiates from all the <unk>. Particularly carinthia from by but they're all so others in development from her masters and of course that your just your thoughts on how this is different. Right.
Richard Vosser: Hi, Thanks for taking my question, a question on the European roll-out of Wegovy first, obviously we know in Denmark, in May there was a substantial demand for Wegovy in about 1% of the population so, I was wondering how that has developed since then, both in terms of volume and how you're seeing patients staying on the drug through Denmark, giving it's an out of pocket market.
First obviously, we know in Denmark Ah Ah in May there was a substantial a demand for it says like Ivy and in about.
About 1% of the <unk>.
Daniel Bohsen: Thank you, Doc. Thank you, Peter. We're ready for the next question.
Daniel Bohsen: Thank you, Doc. Thank you, Peter. We're ready for the next question.
The license. So I was wondering how that has developed since then but I think in terms of volume and how you'll seeing patients staying on the drug Ah through Denmark, huh, giving it sent out to poke at market and then the second question is on your K P. By science product just wondering how that differentiates from all the <unk>.
Operator: Thank you. Your next question comes from the line of Mattias Häggblom from Handelsbanken. Please go ahead.
Operator: Thank you. Your next question comes from the line of Mattias Häggblom from Handelsbanken. Please go ahead.
Richard Vosser: And then the second question is on your KP Bioscience product, just wondering how that differentiates from all the MR antagonist, particularly Kerendia from Bayer but there are also others in development from AstraZeneca etcetera, just your thoughts on how this is different, thanks very much.
Speaker 19: Thank you so much. R&D question. In the scenario that both high-dose sema at 7.2 milligrams as well as CagriSema works in phase 3, can you help me think about the regulatory pathway for a fixed-dose combination with CagriSema using the high-dose sema and whether that would require a new phase 3 or if a small bridging study would be enough? Thanks so much.
Mattias Häggblom: Thank you so much. R&D question. In the scenario that both high-dose sema at 7.2 milligrams as well as CagriSema works in phase 3, can you help me think about the regulatory pathway for a fixed-dose combination with CagriSema using the high-dose sema and whether that would require a new phase 3 or if a small bridging study would be enough? Thanks so much.
Particularly carinthia from by but they're all so others in development from her masters and of course that your just your thoughts on how this is different.
Right.
Daniel Bohsen: Thank you Richard, Camilla the first one to you, Wegovy roll out in Denmark.
Camilla Sylvest: Yeah so in Denmark we see a continued interest in Wegovy and Wegovy continues to perform very well and it is more than 1% of the population at this point in time, in terms of the, how many stays on the product we also have, it's too early to give you exact data numbers but we do have the I could say anecdotal evidence that there is a high number, very very high number of the people that stay on the product from the beginning of the year when the product was launched.
Daniel Bohsen: Thank you, Mattias. Martin?
Daniel Bohsen: Thank you, Mattias. Martin?
Karsten Munk Knudsen: Yeah, absolutely. Thank you for that question, Mattias. That would most likely require a reasonably, I think we can bridge some safety data, but we will still have to establish both safety and efficacy. So, we actually see that as a potential opportunity, but we see that as a life cycle management activity.
Karsten Munk Knudsen: Yeah, absolutely. Thank you for that question, Mattias. That would most likely require a reasonably, I think we can bridge some safety data, but we will still have to establish both safety and efficacy. So, we actually see that as a potential opportunity, but we see that as a life cycle management activity.
You can only continues to it if I'm very well any of the smaller than 1% of the population at this point in time in terms of the and how many states on the product. We also have it's too early to give you exact daytime number is five we do have that I could say anecdotal evidence that day said hi, known by very very high number.
Daniel Bohsen: Thank you, Martin. We have time for two more set of questions. We're ready for the next one.
Daniel Bohsen: Thank you, Martin. We have time for two more set of questions. We're ready for the next one.
The people that stay on the product and from the beginning of the human to product launched thank.
Daniel Bohsen: Thank you Camilla, Martin any visions on Ocedurin. Yeah, absolutely. So what we've seen was also going on as a molecule with a very high affinity for for the receptor and also a very high half life that actually means that we expect to see differentiation not only on the secrecy.
Daniel Bohsen: Thank you Camilla, Martin reflections on Ocedurenone.
Operator: Thank you. The next question comes from the line of Emmanuel Papadakis from DB. Please go ahead.
Operator: Thank you. The next question comes from the line of Emmanuel Papadakis from DB. Please go ahead.
Martin Holst Lange: Yeah, absolutely, so what we've with Ocedurenone is a molecule with a very high affinity for the receptor and also a very high half life, that actually means that we expect to see differentiation not only on the secrecy but it also appears to have a potential upside on the safety side, specifically on Hyperkalemia, so we do expect to see a differentiated drug in this space.
Speaker 18: Thanks for taking the question. Hopefully you can hear me okay. Maybe a follow on for Karsten on supply. Karsten, you said you're going to quote, unquote, significantly increase supply in 2024 versus 2023, as you did in 2023 versus 2022. Eyeballing data, it looks like there was approximately a fivefold increase, 2023 over 2022. So are you telling us you're gonna have another fivefold increase in 2024? And if not, can you help us with the approximate quantum? And then a follow-on also on FLOW. Martin, you were helpful enough on SELECT to give us an indication that the contribution of components had been approximately equal, well balanced in SELECT. Is that also the case in FLOW, or how should we think about the contribution of the composite endpoint components, and what should we expect in terms of labeling? Thank you.
Emmanuel Papadakis: Thanks for taking the question. Hopefully you can hear me okay. Maybe a follow on for Karsten on supply. Karsten, you said you're going to quote, unquote, significantly increase supply in 2024 versus 2023, as you did in 2023 versus 2022. Eyeballing data, it looks like there was approximately a fivefold increase, 2023 over 2022. So are you telling us you're gonna have another fivefold increase in 2024? And if not, can you help us with the approximate quantum? And then a follow-on also on FLOW. Martin, you were helpful enough on SELECT to give us an indication that the contribution of components had been approximately equal, well balanced in SELECT. Is that also the case in FLOW, or how should we think about the contribution of the composite endpoint components, and what should we expect in terms of labeling? Thank you.
But it also appears to have a potential upside on the safety side, specifically on hyperkalemia. So so we do expect to see it.
Sentient or drunkenness days.
Daniel Bohsen: Than you martin, Thank you Camilla, thanks Richard for the question, we're ready for the next.
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Operator: Thank you, your next question comes on the line of Peter Welford from Jeffries. Please go ahead.
Peter Welford: Hi, I hope you can hear me, I've got two questions for me, firstly if I could come back gross margin and appreciate the comentaries year to date each day, but in the third quarter. It seemed to turn down wanted me would you get some some other unusual given the quite significant improvements we saw.
But I want them to be gross margin and appreciate the country each day, but in the third quarter. It seemed to turn down wanted me would you get some some other unusual given the quite significant improvements we saw.
Daniel Bohsen: Thank you, Emmanuel. First, Karsten, any additional supply?
Daniel Bohsen: Thank you, Emmanuel. First, Karsten, any additional supply?
Karsten Munk Knudsen: Yeah, thanks for triangulating that way around, Emmanuel. I'd love to give you a further flavor, but as you know, we are guiding for next year, come our full year results, late January. That's where we'll be doing our financial guidance for 2024 and giving too much granularity in scaling of Wegovy gets too close to guiding for next year. I'm sorry, but I'll have to provide that at a later point in time.
Karsten Munk Knudsen: Yeah, thanks for triangulating that way around, Emmanuel. I'd love to give you a further flavor, but as you know, we are guiding for next year, come our full year results, late January. That's where we'll be doing our financial guidance for 2024 and giving too much granularity in scaling of Wegovy gets too close to guiding for next year. I'm sorry, but I'll have to provide that at a later point in time.
Daniel Bohsen: Thank you, Karsten. Martin, can you share more from FLOW?
Daniel Bohsen: Thank you, Karsten. Martin, can you share more from FLOW?
Lars Fruergaard Jørgensen: Yeah, I think it's a great question. I maybe just wanna clarify, I don't think we've seen equal contribution from the three mono components. We just said that they all contributed. Obviously, again, we have to await 11 November until we see the full data set. Specifically for FLOW, I would really love to be able to answer you, but due to the nature of an interim analysis, we've not seen the data. So for better or worse, I know absolutely no more than you do at this point. So I can't speculate.
Martin Holst Lange: Yeah, I think it's a great question. I maybe just wanna clarify, I don't think we've seen equal contribution from the three mono components. We just said that they all contributed. Obviously, again, we have to await 11 November until we see the full data set. Specifically for FLOW, I would really love to be able to answer you, but due to the nature of an interim analysis, we've not seen the data. So for better or worse, I know absolutely no more than you do at this point. So I can't speculate.
Daniel Bohsen: Thank you, Martin. Thank you, Emmanuel. We'll take the last set of questions.
Daniel Bohsen: Thank you, Martin. Thank you, Emmanuel. We'll take the last set of questions.
Operator: Thank you. Your last question for today comes from the line of Michael Novod from Nordea. Please go ahead.
Operator: Thank you. Your last question for today comes from the line of Michael Novod from Nordea. Please go ahead.
Speaker 20: Yeah. Thank you very much. Just on the cost side, can you please go through some of the dynamics here in Q4 in order to sort of make the cost go up? As I see it needs to go up at an extreme pace for Q4. Are there any specific investment that you're able to take early or anything like that, prior to going into 2024 just to understand your EBIT guidance?
Michael Novod: Yeah. Thank you very much. Just on the cost side, can you please go through some of the dynamics here in Q4 in order to sort of make the cost go up? As I see it needs to go up at an extreme pace for Q4. Are there any specific investment that you're able to take early or anything like that, prior to going into 2024 just to understand your EBIT guidance?
Lars Fruergaard Jørgensen: That's over to you, Karsten.
Daniel Bohsen: That's over to you, Karsten.
Karsten Munk Knudsen: Yeah. Michael, thanks for that question. When I look at our total operating cost growth in Q4, then it's actually not markedly different compared to year to date. What you should be expecting is a continued, what I would call high level of growth in R&D expenditure around the 40% mark and some 20% plus on S&D expenditure and a competitive gross margin also in Q4. In reality, no big swings in Q4 at constant exchange rates.
Karsten Munk Knudsen: Yeah. Michael, thanks for that question. When I look at our total operating cost growth in Q4, then it's actually not markedly different compared to year to date. What you should be expecting is a continued, what I would call high level of growth in R&D expenditure around the 40% mark and some 20% plus on S&D expenditure and a competitive gross margin also in Q4. In reality, no big swings in Q4 at constant exchange rates.
Daniel Bohsen: Thank you, Karsten. Thanks for the question, Michael. This concludes the Q&A session. Thank you for participating, and please feel free to contact investor relations in case you have any follow up questions. Before we close the call, I would like to hand over to you, Lars, for any final remarks.
Daniel Bohsen: Thank you, Karsten. Thanks for the question, Michael. This concludes the Q&A session. Thank you for participating, and please feel free to contact investor relations in case you have any follow up questions. Before we close the call, I would like to hand over to you, Lars, for any final remarks.
Lars Fruergaard Jørgensen: Yeah. Thank you, Daniel. I'd also like to thank you all for participating today. I hope it's clear from our comments that we're very pleased with the strong momentum we have in our business, also underlined with the raised guidance for 2023. Many questions on the coming years, not least the coming year. We are really focused on pursuing innovation-based growth strategy. I feel confident in our ability to scale supply to support that. We're really excited about FLOW, underlining the attractiveness of semaglutide, and we are equally excited that we soon can disclose what SELECT has to show at the upcoming conference at AHA in a matter of a few days. Thank you all. We appreciate your time today. With that, we'll close the call.
Lars Fruergaard Jørgensen: Yeah. Thank you, Daniel. I'd also like to thank you all for participating today. I hope it's clear from our comments that we're very pleased with the strong momentum we have in our business, also underlined with the raised guidance for 2023. Many questions on the coming years, not least the coming year. We are really focused on pursuing innovation-based growth strategy. I feel confident in our ability to scale supply to support that. We're really excited about FLOW, underlining the attractiveness of semaglutide, and we are equally excited that we soon can disclose what SELECT has to show at the upcoming conference at AHA in a matter of a few days. Thank you all. We appreciate your time today. With that, we'll close the call. Thank you.
Lars Fruergaard Jørgensen: Thank you.
Daniel Bohsen: To Danish Securities regulations, My name is Daniel Bohsen I'm the head of Investor Relations of Novo Nordisk, with me today I have CEO of Novo Nordisk Lars Fruergaard Jorgensen, executive Vice President and head of commercial strategy and corporate Affairs Camilla Sylvest, executive Vice President and head of North America Operation Doug Langa, Executive Vice President and head of developed Martin Holst Lang and finally, Chief Financial Officer, Karsten Munk Knudsen, all speakers will be available for the Q&A session today's announcement and the slides for this call are available on our website <unk> Com. Please note that this call is being webcast live and a recording will be made available an hour with <unk>.
Daniel Bohsen: To Danish Securities regulations, My name is Daniel Bohsen I'm the head of Investor Relations of Novo Nordisk, with me today I have CEO of Novo Nordisk Lars Fruergaard Jorgensen, executive Vice President and head of commercial strategy and corporate Affairs Camilla Sylvest, executive Vice President and head of North America Operation Doug Langa, Executive Vice President and head of developed Martin Holst Lang and finally, Chief Financial Officer, Karsten Munk Knudsen,
Martin Heart lung and finally, Chief Financial Officer, Karsten Munk Knudsen, all speakers will be available for the Q&A session today's announcement and the slides for this call are available on our website <unk> Com. Please note that this call is being webcast live and a recording will be made available an hour with <unk>.
Daniel Bohsen: All speakers will be available for the Q&A session, today's announcement and the slides for this call are available on our website novonordisk.com, please note that this call is being webcast live and a recording will be made available on our website as well, the call is sketched for one hour. Please turn to that 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 please turn to the next slide.
Daniel Bohsen: All speakers will be available for the Q&A session, today's announcement and the slides for this call are available on our website novonordisk.com, please note that this call is being webcast live and a recording will be made available on our website as well, the call is sketched for one hour.
Titusville, they call to sketch one hour.
Daniel Bohsen: Please turn to slides, 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, please turn to the next slide, as always we need to advise you that this call will contain forward looking statements, these are subject to risks and uncertainties that could cause actual results to differ materially from patients. For further infill under risk factors. Sorry risk factors. Please see the company's announcement for the first nine months of two <unk> and. The slides prepared for this presentation, but what you lost one update on epic aspirations.
Daniel Bohsen: Please turn to slides, 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, please turn to the next slide, as always we need to advise you that this call will contain forward looking statements, these are subject to risks and uncertainties that could cause actual results to differ materially from (inaudible).
Please turn to that 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 please turn to the next slide.
As always we need to advise you that this call will contain forward looking statements. These are subject to risks and uncertainties that could cause.
Actual results to differ materially from patients.
Daniel Bohsen: For further info on the risk factors, please see the company's announcement for the first nine months of 2023 and the slides prepared for this presentation, With that, over to you Lars for an update on aspirations.
For further infill under risk factors.
Sorry risk factors. Please see the company's announcement for the first nine months of two <unk> and.
The slides prepared for this presentation, but what you lost one update on epic aspirations.
Lars Fruergaard Joergensen: Thank you Daniel next slide please. In the first nine months of 2023, we delivered 33% sales and 37% operating profit growth at constant exchange rates I would like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues.
Lars Fruergaard Joergensen: Thank you Daniel next slide please.
Lars Fruergaard Joergensen: In the first nine months of 2023, we delivered 33% sales and 37% operating profit growth at constant exchange rates, I would like to start this call by going through the performance highlights across our strategic aspirations, before handing over the word to my colleagues. Well in terms of sustainability, we continue to make progress on carbon emissions decreased by 28% compared to pre pandemic levels 92019 and. And in line with our aspiration of being a strategic player. We continue to expand the number of women in senior leadership positions. This is now 41% compared to 38% last year. In R&D, an important milestone is that we will stop the flow kidney outcomes trial early estimate <unk> demonstrated a benefit in people with type two diabetes and chronic kidney disease gorilla within R&D. We have recently agreed to acquire <unk> for the treatment of cardiovascular disease. This supports our exploration of establishing a presence in all those years Qantas uses with a high unmet medical need Marty. Marcia will come back to this and are all R&D milestones later. The sales growth reflect strong commercial execution with both operating units contributing to a continuous sales growth driven by increasing demand for our tier one based diabetes and obesity treatments Camilla talk will go through the details in the in the therapy area later.
Lars Fruergaard Joergensen: In the first nine months of 2023, we delivered 33% sales and 37% operating profit growth at constant exchange rates, I would like to start this call by going through the performance highlights across our strategic aspirations, before handing over the word to my colleagues.
In the first nine months of 2023, we delivered 33% sales and 37% operating profit growth at constant exchange rates I would like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues.
Well in terms of sustainability, we continue to make progress on carbon emissions decreased by 28% compared to pre pandemic levels 92019 and.
Lars Fruergaard Joergensen: Well in terms of sustainability, we continue to make progress, our carbon emissions decreased by 28% compared to pre pandemic levels in 2019 and in line with our aspiration of being a sustainable employer we continue to expand the number of women in senior leadership positions, this is now 41% compared to 38% last year. In R&D, an important milestone is that we will stop the flow kidney outcomes trial early estimate <unk> demonstrated a benefit in people with type two diabetes and chronic kidney disease gorilla within R&D. We have recently agreed to acquire <unk> for the treatment of cardiovascular disease. This supports our exploration of establishing a presence in all those years Qantas uses with a high unmet medical need Marty. Marcia will come back to this and are all R&D milestones later. The sales growth reflect strong commercial execution with both operating units contributing to a continuous sales growth driven by increasing demand for our tier one based diabetes and obesity treatments Camilla talk will go through the details in the in the therapy area later.
Lars Fruergaard Joergensen: Well in terms of sustainability, we continue to make progress, our carbon emissions decreased by 28% compared to pre pandemic levels in 2019 and in line with our aspiration of being a sustainable employer we continue to expand the number of women in senior leadership positions, this is now 41% compared to 38% last year.
And in line with our aspiration of being a strategic player.
We continue to expand the number of women in senior leadership positions. This is now 41% compared to 38% last year.
Lars Fruergaard Joergensen: In R&D, an important milestone is that we will stop the FLOW kidney outcomes trial early, as semaglutide demonstrated a benefit in people with Type 2 Diabetes and Chronic Kidney Disease, further within R&D we have recently agreed to acquire Ocedurenone for the treatment of cardiovascular disease, this supports our aspiration of establishing a presence in other serious chronic diseases with a high unmet medical need Martin will come back to this and our all R&D milestones later. The sales growth reflect strong commercial execution with both operating units contributing to a continuous sales growth driven by increasing demand for our tier one based diabetes and obesity treatments Camilla talk will go through the details in the in the therapy area later.
Lars Fruergaard Joergensen: In R&D, an important milestone is that we will stop the FLOW kidney outcomes trial early, as semaglutide demonstrated a benefit in people with Type 2 Diabetes and Chronic Kidney Disease, further within R&D we have recently agreed to acquire Ocedurenone for the treatment of cardiovascular disease, this supports our aspiration of establishing a presence in other serious chronic diseases with a high unmet medical need Martin will come back to this and our all R&D milestones later.
In R&D, an important milestone is that we will stop the flow kidney outcomes trial early estimate <unk> demonstrated a benefit in people with type two diabetes and chronic kidney disease gorilla within R&D. We have recently agreed to acquire <unk> for the treatment of cardiovascular disease.
This supports our exploration of establishing a presence in all those years Qantas uses with a high unmet medical need Marty.
Marcia will come back to this and are all R&D milestones later.
Lars Fruergaard Joergensen: The sales growth reflects strong commercial execution, with both operating units contributing to a continuous sales growth driven by increasing demands for our GLP-1 based diabetes and obesity treatments, Camilla and Doug will go through the details in the in the therapy area later. Within commercial execution. We are pleased to have reached our aspiration of 25 billion Danish kroner, and our exploration for diabetes by reaching a global value market share of one third naturally the progress is not holding us back and we continue to aim for treating more patients with our innovative treatments. Causing them to go through with a fine. <unk> details, but I'm very pleased with our overall performance for the first nine months of 2023, which has enabled us to raise our outlook for the full year. With that I'll give the word to Camilla for an update on commercial execution.
Lars Fruergaard Joergensen: The sales growth reflects strong commercial execution, with both operating units contributing to a continuous sales growth driven by increasing demands for our GLP-1 based diabetes and obesity treatments, Camilla and Doug will go through the details in the in the therapy area later.
The sales growth reflect strong commercial execution with both operating units contributing to a continuous sales growth driven by increasing demand for our tier one based diabetes and obesity treatments Camilla talk will go through the details in the in the therapy area later.
Lars Fruergaard Joergensen: Within commercial execution we are pleased to have reached our obesity aspirations of 25 billion Danish krone, and our aspirations for diabetes are reaching a global value market share of one third, naturally the progress is not holding us back and we continue to aim for treating more patients with our innovative treatments. Causing them to go through with a fine. <unk> details, but I'm very pleased with our overall performance for the first nine months of 2023, which has enabled us to raise our outlook for the full year. With that I'll give the word to Camilla for an update on commercial execution.
Lars Fruergaard Joergensen: Within commercial execution we are pleased to have reached our obesity aspirations of 25 billion Danish krone, and our aspirations for diabetes are reaching a global value market share of one third, naturally the progress is not holding us back and we continue to aim for treating more patients with our innovative treatments.
Within commercial execution. We are pleased to have reached our aspiration of 25 billion Danish kroner, and our exploration for diabetes by reaching a global value market share of one third naturally the progress is not holding us back and we continue to aim for treating more patients with our innovative treatments.
Lars Fruergaard Joergensen: Karsten will to go through these financial details, but I'm very pleased with our overall performance for the first nine months of 2023, which has enabled us to raise our outlook for the full year, with that, I'll give the word to Camilla for an update on commercial execution.
Causing them to go through with a fine.
<unk> details, but I'm very pleased with our overall performance for the first nine months of 2023, which has enabled us to raise our outlook for the full year.
With that I'll give the word to Camilla for an update on commercial execution.
Camilla Sylvest: Thank you Lasse and please turn to the next slide. In the first nine months of 2023, our total sales increased by 33%. This sales growth was driven by both operating units North America operations growing 49% and international operations growing 17%.
Camilla Sylvest: Thank you Lasse and please turn to the next slide.
In the first nine months of 2023, our total sales increased by 33%. This sales growth was driven by both operating units North America operations growing 49% and international operations growing 17%.
Camilla Sylvest: In the first nine months of 2023, our total sales increased by 33%, this sales growth was driven by both operating units with North America operations growing 49% and international operations growing 17%, our GLP-1 sales increased 9% driven by North America growing 43% and international operations growing 60%. Insulin sales decreased by 7% driven by a 1% decline in international operations and a 24% sales decline in North America operations sales decrease was driven by a decrease in sales in the U S and region China. Obesity care sales grew 174% overall in international operations sales grew 52% driven by both <unk> and <unk>. In North America operations obesity care sales grew 244%. Total <unk> sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations. Please turn to the next slide. With 25% sales growth in our diabetes care, we are now growing faster than the total market improving our global diabetes value market share to 33, 3%. The increase reflects market share gains in both North America operations and international operations. And international operations total diabetes care sales increased by 21% in the first nine months of 2023. This was driven by tier one sales growing 60% driven by all geographical areas. Minorities. Is the market leader in international Operator T. L P one value market share of 69%.
Camilla Sylvest: In the first nine months of 2023, our total sales increased by 33%, this sales growth was driven by both operating units with North America operations growing 49% and international operations growing 17%, our GLP-1 sales increased 9% driven by North America growing 43% and international operations growing 60%.
Our tier one sales increased 9% driven by North America, growing 43% and international operations growing 60%.
Camilla Sylvest: Insulin sales decreased by 7% driven by a 1% decline in international operations and a 24% sales decline in North America operations, this sales decrease was driven by a decrease in sales in the US and region China, obesity care sales grew 174% overall, in international operations sales grew 52% driven by both Saxenda and Wegovy. In North America operations obesity care sales grew 244%. Total <unk> sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations. Please turn to the next slide. With 25% sales growth in our diabetes care, we are now growing faster than the total market improving our global diabetes value market share to 33, 3%. The increase reflects market share gains in both North America operations and international operations. And international operations total diabetes care sales increased by 21% in the first nine months of 2023. This was driven by tier one sales growing 60% driven by all geographical areas. Minorities. Is the market leader in international Operator T. L P one value market share of 69%.
Camilla Sylvest: Insulin sales decreased by 7% driven by a 1% decline in international operations and a 24% sales decline in North America operations, this sales decrease was driven by a decrease in sales in the US and region China, obesity care sales grew 174% overall, in international operations sales grew 52% driven by both Saxenda and Wegovy, in North America operations obesity care sales grew 244%. Total rare disease sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations, please turn to the next slide.
Camilla Sylvest: Insulin sales decreased by 7% driven by a 1% decline in international operations and a 24% sales decline in North America operations, this sales decrease was driven by a decrease in sales in the US and region China, obesity care sales grew 174% overall, in international operations sales grew 52% driven by both Saxenda and Wegovy. In North America operations obesity care sales grew 244%. Total rare disease sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations, please turn to the next slide.
Camilla Sylvest: Insulin sales decreased by 7% driven by a 1% decline in international operations and a 24% sales decline in North America operations, this sales decrease was driven by a decrease in sales in the US and region China, obesity care sales grew 174% overall, in international operations sales grew 52% driven by both Saxenda and Wegovy.
Insulin sales decreased by 7% driven by a 1% decline in international operations and a 24% sales decline in North America operations sales decrease was driven by a decrease in sales in the U S and region China.
Obesity care sales grew 174% overall in international operations sales grew 52% driven by both <unk> and <unk>.
Camilla Sylvest: In North America operations obesity care sales grew 244%. Total rare disease sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations, please turn to the next slide.
Camilla Sylvest: In North America operations obesity care sales grew 244%, total rare disease sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations, please turn to the next slide.
Camilla Sylvest: In North America operations obesity care sales grew 244%, total rare disease sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations. Please turn to the next slide. With 25% sales growth in our diabetes care, we are now growing faster than the total market improving our global diabetes value market share to 33, 3%. The increase reflects market share gains in both North America operations and international operations. And international operations total diabetes care sales increased by 21% in the first nine months of 2023. This was driven by tier one sales growing 60% driven by all geographical areas. Minorities. Is the market leader in international Operator T. L P one value market share of 69%.
Camilla Sylvest: In North America operations obesity care sales grew 244%,
In North America operations obesity care sales grew 244%.
Camilla Sylvest: Total rare disease sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations, please turn to the next slide. With 25% sales growth in our diabetes care, we are now growing faster than the total market improving our global diabetes value market share to 33, 3%. The increase reflects market share gains in both North America operations and international operations. And international operations total diabetes care sales increased by 21% in the first nine months of 2023. This was driven by tier one sales growing 60% driven by all geographical areas. Minorities. Is the market leader in international Operator T. L P one value market share of 69%.
Camilla Sylvest: Total rare disease sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations, please turn to the next slide.
Total <unk> sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations. Please turn to the next slide.
Camilla Sylvest: With 25% sales growth in our diabetes care, we are now growing faster than the total market improving our global diabetes value market share to 33.3%, the increase reflects market share gains in both North America operations and international operations. And international operations total diabetes care sales increased by 21% in the first nine months of 2023. This was driven by tier one sales growing 60% driven by all geographical areas. Minorities. Is the market leader in international Operator T. L P one value market share of 69%.
Camilla Sylvest: With 25% sales growth in our diabetes care, we are now growing faster than the total market improving our global diabetes value market share to 33.3%, the increase reflects market share gains in both North America operations and international operations.
With 25% sales growth in our diabetes care, we are now growing faster than the total market improving our global diabetes value market share to 33, 3%.
The increase reflects market share gains in both North America operations and international operations.
Camilla Sylvest: In international operations total diabetes care sales increased by 21% in the first nine months of 2023, this was driven by GLP-1 sales growing 60% driven by all geographical areas, Novo Nordisk is the market leader in international operator GLP-1 value market share of 69%. <unk> continues its GLP-1 market leadership with just shy of 46% market share, Rybelsus has 12% value market share driven by strong uptake across geographies and with that I will hand over the word to Doug.
And international operations total diabetes care sales increased by 21% in the first nine months of 2023.
This was driven by tier one sales growing 60% driven by all geographical areas.
Minorities.
Is the market leader in international Operator T. L P one value market share of 69%.
<unk> continues its tier one market leadership with just shy of 46% market share. We've also has 12% value market share driven by strong uptake across geographies and with that I will hand over the word to duck.
Douglas J. Langa: Thank you Camilla please turn to the next slide. The GOP one class expansion continues in the U S. In the first nine months of 2023.
Douglas J. Langa: Thank you Camilla please turn to the next slide.
Douglas J. Langa: The GLP-1 class expansion continues in the US In the first nine months of 2023, the US GLP-1 market volume grew around 50%, comparing Q3 of 2023 to Q3 of 2022, measured on total prescriptions, Novo Nordisk continues to be the market leader with 53% market share. Please go to the next slide. Obesity care sales grew by 174% in the first nine months of 2023. This was mainly driven by the U S. The global branded anti obesity market expansion continues with a global volume growth of 94%. And international operations obesity care sales are driven by strong <unk> performance and <unk> launches and five international operation countries. While eager to launch will go via more Io countries. Our focus remains to do this in a sustainable manner for example, like capping volumes. In the U S alone sales of agave. Grew by 467%. Demand for will go we continues to exceed supply and to safeguard continuity of care for patients already on <unk>. The supply of the lower we'll go with dose strengths in the U S has been reduced since may of 2023. Please go to the next slide.
Douglas J. Langa: The GLP-1 class expansion continues in the US In the first nine months of 2023, the US GLP-1 market volume grew around 50%, comparing Q3 of 2023 to Q3 of 2022, measured on total prescriptions, Novo Nordisk continues to be the market leader with 53% market share. Please go to the next slide.
The GOP one class expansion continues in the U S. In the first nine months of 2023.
The U S. <unk> market volume grew around 50% comparing Q3 of 2023 to Q3 of 2022.
Measured on total prescriptions Novo Nordisk continues to be the market leader with 53% market share. Please go to the next slide.
Douglas J. Langa: Obesity care sales grew by 174% in the first nine months of 2023, this was mainly driven by the US, the global branded anti-obesity market expansion continues with a global volume growth of 94%, in international operations obesity care sales are driven by strong Saxenda performance and the Wegovy launches in five international operation countries. While eager to launch Wegovy more Io countries. Our focus remains to do this in a sustainable manner for example, like capping volumes. In the U S alone sales of agave. Grew by 467%. Demand for will go we continues to exceed supply and to safeguard continuity of care for patients already on <unk>. The supply of the lower we'll go with dose strengths in the U S has been reduced since may of 2023. Please go to the next slide.
Douglas J. Langa: Obesity care sales grew by 174% in the first nine months of 2023, this was mainly driven by the US, the global branded anti-obesity market expansion continues with a global volume growth of 94%, in international operations obesity care sales are driven by strong Saxenda performance and the Wegovy launches in five international operation countries.
Obesity care sales grew by 174% in the first nine months of 2023. This was mainly driven by the U S.
The global branded anti obesity market expansion continues with a global volume growth of 94%.
And international operations obesity care sales are driven by strong <unk> performance and <unk> launches and five international operation countries.
Douglas J. Langa: While eager to launch Wegovy in more IO countries, our focus remains to do this in a sustainable manner, for example, like capping volumes, in the U S alone sales of Wegovy grew by 467%, demand for Wegovy continues to exceed supply and to safeguard continuity of care for patients already on Wegovy, the supply of the lower Wegovy dose strengths in the U S has been reduced since may of 2023. Please go to the next slide. Our rare disease sales decreased by 18%.
Douglas J. Langa: While eager to launch Wegovy in more IO countries, our focus remains to do this in a sustainable manner, for example, like capping volumes, in the U S alone sales of Wegovy grew by 467%, demand for Wegovy continues to exceed supply and to safeguard continuity of care for patients already on Wegovy, the supply of the lower Wegovy dose strengths in the U S has been reduced since may of 2023. Please go to the next slide.
While eager to launch will go via more Io countries. Our focus remains to do this in a sustainable manner for example, like capping volumes.
In the U S alone sales of agave.
Grew by 467%.
Demand for will go we continues to exceed supply and to safeguard continuity of care for patients already on <unk>. The supply of the lower we'll go with dose strengths in the U S has been reduced since may of 2023. Please go to the next slide.
Our rare disease sales decreased by 18%.
Douglas J. Langa: Our rare disease sales decreased by 18%, the sales decrease was driven by a 30% decline in North America operations, and a 22% sales decline in international operations, sales on rare blood disorders increased by 2% driven by the launch of products in hemophilia A and B and partially countered by NovoSeven. noncommunicable diseases affect millions of people globally and have emerged in recent years as a major public health issue. Given our extensive scientific and clinical knowledge within metabolic diseases. Well positioned to advance our understanding of <unk> potential benefits in associated with health complications. With the current body of evidence it is clear. Beneficial effects of snowmaking type goes even further than placebo control and weight loss <unk>. <unk> has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies. It includes sustained six in pioneer six in type two diabetes. As well as step have petro linked. <unk>. While we await data from the select trial to be presented we continue to build evidence for this magnetek molecule in the cardiovascular space. In 2024, we expect several readouts.
Douglas J. Langa: Our rare disease sales decreased by 18%, the sales decrease was driven by a 30% decline in North America operations, and a 22% sales decline in international operations, sales on rare blood disorders increased by 2% driven by the launch products in hemophilia A and B and partially countered by NovoSeven.
The sales decrease was driven by a 30% decline in North America operations, and a 22% sales decline in international operations. Sales of rare blood disorders increased by 2% driven by the launch products in hemophilia, a and B and partially countered by Novo seven. Sales of rare endocrine disorder products decreased by 54% rift. Reflecting a temporary reduction in manufacturing output. Now over to you Martin for an update on R&D. Thank you Doug Please turn to the next slide.
Sales of rare blood disorders increased by 2% driven by the launch products in hemophilia, a and B and partially countered by Novo seven.
Sales of rare endocrine disorder products decreased by 54% rift.
Reflecting a temporary reduction in manufacturing output.
Douglas J. Langa: Sales on rare endocrine disorders products decreased by 54%, reflecting a temporary reduction in manufacturing output, now over to you Martin for more update on our R&D. millions of people globally and have emerged in recent years as a major public health issue. Given our extensive scientific and clinical knowledge within metabolic diseases. Well positioned to advance our understanding of <unk> potential benefits in associated with health complications. With the current body of evidence it is clear. Beneficial effects of snowmaking type goes even further than placebo control and weight loss <unk>. <unk> has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies. It includes sustained six in pioneer six in type two diabetes. As well as step have petro linked. <unk>. While we await data from the select trial to be presented we continue to build evidence for this magnetek molecule in the cardiovascular space. In 2024, we expect several readouts.
Douglas J. Langa: Sales on rare endocrine disorders products decreased by 54%, reflecting a temporary reduction in manufacturing output, now over to you Martin for an update on our R&D.
Now over to you Martin for an update on R&D.
Thank you Doug Please turn to the next slide.
Martin Holst Lange: Thank you Doug, please turn to the next slide, serious chronic non-communicable diseases affects millions of people globally and have emerged in recent years as a major public health issue, given our extensive scientific and clinical knowledge within metabolic diseases, we're well positioned to advance our understanding of Semaglutide's potential benefits in associated with health complications. With the current body of evidence it is clear. Beneficial effects of snowmaking type goes even further than placebo control and weight loss <unk>. <unk> has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies. It includes sustained six in pioneer six in type two diabetes. As well as step have petro linked. <unk>. While we await data from the select trial to be presented we continue to build evidence for this magnetek molecule in the cardiovascular space. In 2024, we expect several readouts.
Martin Holst Lange: Thank you Doug, please turn to the next slide, serious chronic non-communicable diseases affects millions of people globally and have emerged in recent years as a major public health issue, given our extensive scientific and clinical knowledge within metabolic diseases, we're well positioned to advance our understanding of Semaglutide's potential benefits in associated health complications.
Serious chronic noncommunicable diseases affect millions of people globally and have emerged in recent years as a major public health issue.
Given our extensive scientific and clinical knowledge within metabolic diseases.
Well positioned to advance our understanding of <unk> potential benefits in associated with health complications.
With the current body of evidence it is clear.
Martin Holst Lange: With the current body of evidence, it is clear that the beneficial effects of Semaglutide goes even further than glycemia control and weight loss, Semaglutide has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies, this includes sustained six in pioneer six in type two diabetes. As well as step have petro linked. <unk>. While we await data from the select trial to be presented we continue to build evidence for this magnetek molecule in the cardiovascular space. In 2024, we expect several readouts.
Martin Holst Lange: With the current body of evidence, it is clear that the beneficial effects of Semaglutide goes even further than glycemia control and weight loss, Semaglutide has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies,
Beneficial effects of snowmaking type goes even further than placebo control and weight loss <unk>.
<unk> has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies.
It includes sustained six in pioneer six in type two diabetes.
Martin Holst Lange: This includes SUSTAIN 6 and PIONEER 6 in type two diabetes as well as STEP HFpEF SELECT in obesity, While we await data from the SELECT trial to be presented, we continue to build evidence for the Semaglutide molecule in the cardiovascular space. In 2024, we expect several readouts.
Martin Holst Lange: This includes SUSTAIN 6 and PIONEER 6 in type two diabetes as well as STEP HFpEF SELECT in obesity, While we await data from the SELECT trial to be presented, we continue to build evidence for the Semaglutide molecule in the cardiovascular space.
As well as step have petro linked.
<unk>.
While we await data from the select trial to be presented we continue to build evidence for this magnetek molecule in the cardiovascular space.
In 2024, we expect several readouts.
Martin Holst Lange: In 2024, we expect several readouts, this includes Type 2 diabetes cardiovascular outcome study SOUL, with oral Semaglutide 40 milligram, and the functional outcome trial STRIDE, which focuses on the high risk population with peripheral vascular disease. As previously discussed we also investigated the potential therapeutic effects of <unk> on osteoarthritis and metabolic dysfunction. Dysfunction associated states Youll hepatitis previously known as not alcoholic SEATO hepatitis. In addition to this we recently announced early closure of the flow trial due to efficacy next slide please. This closure was based on a recommendation from the flow independent data monitoring committee following a pre planned interim analysis. As you know Joe is an outcomes trial conducted across 28 countries and more than 400 sites. 3534 people were enrolled and randomized in a one one ratio to receive either a once weekly <unk> 1.0 milligram or placebo. The eligibility criteria were designed to include patients with type two diabetes and high or very high risk type of question of chronic kidney disease. The primary objective of flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of ESG altitudes. The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths. Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes. With a projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people.
Martin Holst Lange: In 2024, we expect several readouts, this includes Type 2 diabetes cardiovascular outcome study SOUL, with oral Semaglutide 40 milligram, and the functional outcome trial STRIDE, which focuses on the high risk population with peripheral vascular disease.
This includes type two diabetes control.
Type two diabetes cardiovascular outcome studies show was also <unk> 40 milligram and the functional outcome trial stride, which focuses on the high risk population with peripheral vascular disease.
Martin Holst Lange: As previously discussed we also investigated the potential therapeutic effects of Semaglutide on osteoarthritis and metabolic dysfunction associated Steatohepatitis previously known as not alcoholic Steatohepatitis, in addition to this, we recently announced early closure of the FLOW trial due to efficacy, next slide please. This closure was based on a recommendation from the flow independent data monitoring committee following a pre planned interim analysis. As you know Joe is an outcomes trial conducted across 28 countries and more than 400 sites. 3534 people were enrolled and randomized in a one one ratio to receive either a once weekly <unk> 1.0 milligram or placebo. The eligibility criteria were designed to include patients with type two diabetes and high or very high risk type of question of chronic kidney disease. The primary objective of flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of ESG altitudes. The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths. Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes. With a projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people.
Martin Holst Lange: As previously discussed we also investigated the potential therapeutic effects of Semaglutide on osteoarthritis and metabolic dysfunction associated Steatohepatitis previously known as not alcoholic Steatohepatitis, in addition to this, we recently announced early closure of the FLOW trial due to efficacy, next slide please.
As previously discussed we also investigated the potential therapeutic effects of <unk> on osteoarthritis and metabolic dysfunction.
Dysfunction associated states Youll hepatitis previously known as not alcoholic SEATO hepatitis.
In addition to this we recently announced early closure of the flow trial due to efficacy next slide please.
Martin Holst Lange: This closure was based on a recommendation from the FLOW independent data monitoring committee, following a pre-planned interim analysis, as you know FLOW is an outcomes trial conducted across 28 countries and more than 400 sites, 3,534 people were enrolled and randomized in a one to one ratio to receive either once weekly Semaglutide 1.0 milligram or placebo. The eligibility criteria were designed to include patients with type two diabetes and high or very high risk type of question of chronic kidney disease. The primary objective of flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of ESG altitudes. The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths. Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes. With a projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people.
Martin Holst Lange: This closure was based on a recommendation from the FLOW independent data monitoring committee, following a pre-planned interim analysis, as you know FLOW is an outcomes trial conducted across 28 countries and more than 400 sites, 3,534 people were enrolled and randomized in a one to one ratio to receive either once weekly Semaglutide 1.0 milligram or placebo.
This closure was based on a recommendation from the flow independent data monitoring committee following a pre planned interim analysis.
As you know Joe is an outcomes trial conducted across 28 countries and more than 400 sites.
3534 people were enrolled and randomized in a one one ratio to receive either a once weekly <unk> 1.0 milligram or placebo.
Martin Holst Lange: The eligibility criteria were designed to include patients with Type 2 diabetes and high or very high risk for progression of chronic kidney disease, the primary objective of FLOW is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of ESG altitudes. The trial is powered to detect a 20% risk reduction on the primary endpoint. Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths. Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes. With a projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people.
Martin Holst Lange: The eligibility criteria were designed to include patients with Type 2 diabetes and high or very high risk for progression of chronic kidney disease, the primary objective of FLOW is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint.
The eligibility criteria were designed to include patients with type two diabetes and high or very high risk type of question of chronic kidney disease.
The primary objective of flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint.
Martin Holst Lange: This is on top of standard of care, including the use of SGLT2s, the trial is powered to detect a 20% risk reduction on the primary endpoint, key secondary endpoints include annual rate of change in estimated glomerular filtration rate, major adverse cardiovascular events and all cause deaths. Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes. With a projected global increase in type two diabetes. Clear need for additional treatment options to help mitigate the residual risk and people.
Martin Holst Lange: This is on top of standard of care, including the use of SGLT2s, the trial is powered to detect a 20% risk reduction on the primary endpoint, key secondary endpoints include annual rate of change in estimated glomerular filtration rate, major adverse cardiovascular events and all cause deaths.
This is on top of standard of care, including the use of ESG altitudes.
The trial is powered to detect a 20% risk reduction on the primary endpoint.
Key secondary endpoints include annual rate of change in estimated glomerular filtration rate major adverse cardiovascular events and all cause deaths.
Martin Holst Lange: Today a few treatment options exist for chronic kidney disease in people living with Type 2 diabetes, with a projected global increase in Type 2 diabetes, there's a clear need for additional treatment options to help mitigate the residual risk in people with concomitant chronic kidney disease. The next step for you to close down the trial that'll flow. As expected in the first half of 2024. Presentation of detailed data is expected to take place at a medical conference also during 2024 next slide please. In line with our strategic aspiration of establishing a presence in other serious chronic diseases. We are pleased to announce the acquisition of <unk> for the treatment of cardiovascular disease from <unk> Biosciences. There remains a significant need and treatment of hypertension. Which is a leading risk factor for cardiovascular events heart failure, chronic kidney disease and death. <unk> is a once daily all administered small molecule with a long half life and a high affinity for the <unk>. <unk> receptor. <unk> has an attractive efficacy and safety profile and is currently being examined in the phase III trial Clarence you Katie. In patients with uncontrolled hypertension, and advanced chronic kidney disease. We expect to initiate. To initiate additional cardiovascular as well as chronic kidney disease outcomes trials. During the course of 2024 next slide please. Yes. Turning to other R&D milestones I would like to highlight some of the other trial readouts. And initiations across all therapy areas in 2023 and in the first half of 2024.
Martin Holst Lange: Today a few treatment options exist for chronic kidney disease in people living with Type 2 diabetes, with a projected global increase in Type 2 diabetes, there's a clear need for additional treatment options to help mitigate the residual risk in people with concomitant chronic kidney disease.
Today, a few treatment options exist for chronic kidney disease and people living with type two diabetes.
With a projected global increase in type two diabetes.
Clear need for additional treatment options to help mitigate the residual risk and people.
We welcome comments and chronic kidney disease.
Martin Holst Lange: The next step for you to close down the trial (inaudible) FLOW is expected in the first half of 2024, the presentation of detailed data is expected to take place at a medical conference also during 2024, next slide please. In line with our strategic aspiration of establishing a presence in other serious chronic diseases. We are pleased to announce the acquisition of <unk> for the treatment of cardiovascular disease from <unk> Biosciences. There remains a significant need and treatment of hypertension. Which is a leading risk factor for cardiovascular events heart failure, chronic kidney disease and death. <unk> is a once daily all administered small molecule with a long half life and a high affinity for the <unk>. <unk> receptor. <unk> has an attractive efficacy and safety profile and is currently being examined in the phase III trial Clarence you Katie. In patients with uncontrolled hypertension, and advanced chronic kidney disease. We expect to initiate. To initiate additional cardiovascular as well as chronic kidney disease outcomes trials. During the course of 2024 next slide please. Yes. Turning to other R&D milestones I would like to highlight some of the other trial readouts. And initiations across all therapy areas in 2023 and in the first half of 2024.
Martin Holst Lange: The next step for you to close down the trial (inaudible) FLOW is expected in the first half of 2024, the presentation of detailed data is expected to take place at a medical conference also during 2024, next slide please, in line with our strategic aspiration of establishing a presence in other serious chronic diseases, we are pleased to announce the acquisition of Ocedurenone for the treatment of cardiovascular disease from KBP Biosciences.
The next step for you to close down the trial that'll flow.
As expected in the first half of 2024.
Presentation of detailed data is expected to take place at a medical conference also during 2024 next slide please.
In line with our strategic aspiration of establishing a presence in other serious chronic diseases. We are pleased to announce the acquisition of <unk> for the treatment of cardiovascular disease from <unk> Biosciences.
Martin Holst Lange: In line with our strategic aspiration of establishing a presence in other serious chronic diseases, we are pleased to announce the acquisition of Ocedurenone for the treatment of cardiovascular disease from KBP Biosciences, there remains a significant need in treatment of hypertension, which is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease and death. <unk> is a once daily all administered small molecule with a long half life and a high affinity for the <unk>. <unk> receptor. <unk> has an attractive efficacy and safety profile and is currently being examined in the phase III trial Clarence you Katie. In patients with uncontrolled hypertension, and advanced chronic kidney disease. We expect to initiate. To initiate additional cardiovascular as well as chronic kidney disease outcomes trials. During the course of 2024 next slide please. Yes. Turning to other R&D milestones I would like to highlight some of the other trial readouts. And initiations across all therapy areas in 2023 and in the first half of 2024.
Martin Holst Lange: In line with our strategic aspiration of establishing a presence in other serious chronic diseases, we are pleased to announce the acquisition of Ocedurenone for the treatment of cardiovascular disease from KBP Biosciences, there remains a significant need in treatment of hypertension, which is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease and death.
Martin Holst Lange: In line with our strategic aspiration of establishing a presence in other serious chronic diseases, we are pleased to announce the acquisition of Ocedurenone for the treatment of cardiovascular disease from KBP Biosciences,
Martin Holst Lange: there remains a significant need in treatment of hypertension, which is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease and death, Ocedurenone is a once daily, oral administered small molecule with a long half life and a high affinity for the mineralocorticoid receptor,
There remains a significant need and treatment of hypertension.
Which is a leading risk factor for cardiovascular events heart failure, chronic kidney disease and death.
Martin Holst Lange: Ocedurenone is a once daily, oral administered small molecule with a long half life and a high affinity for the mineralocorticoid receptor, Ocedurenone has an attractive efficacy and safety profile and is currently being examined in the Phase III trial CLARION-CKD in patients with uncontrolled hypertension, and advanced chronic kidney disease. We expect to initiate to initiate additional cardiovascular as well as chronic kidney disease outcomes trials. During the course of 2024 next slide please. Yes. Turning to other R&D milestones I would like to highlight some of the other trial readouts. And initiations across all therapy areas in 2023 and in the first half of 2024.
Martin Holst Lange: Ocedurenone is a once daily, oral administered small molecule with a long half life and a high affinity for the mineralocorticoid receptor, Ocedurenone has an attractive efficacy and safety profile and is currently being examined in the Phase III trial CLARION-CKD in patients with uncontrolled hypertension, and advanced chronic kidney disease. We expect to initiate to initiate additional cardiovascular as well as chronic kidney disease outcomes trials. During the course of 2024 next slide please. Yes.
Martin Holst Lange: Ocedurenone is a once daily, oral administered small molecule with a long half life and a high affinity for the mineralocorticoid receptor,
<unk> is a once daily all administered small molecule with a long half life and a high affinity for the <unk>.
<unk> receptor.
Martin Holst Lange: Ocedurenone has an attractive efficacy and safety profile and is currently being examined in the Phase III trial CLARION-CKD, in patients with uncontrolled hypertension, and advanced chronic kidney disease, we expect to initiate to initiate additional cardiovascular, as well as chronic kidney disease outcomes trials during the course of 2024, next slide please.
<unk> has an attractive efficacy and safety profile and is currently being examined in the phase III trial Clarence you Katie.
In patients with uncontrolled hypertension, and advanced chronic kidney disease.
Martin Holst Lange: We expect to initiate to initiate additional cardiovascular as well as chronic kidney disease outcomes trials. During the course of 2024 next slide please. Yes. Turning to other R&D milestones I would like to highlight some of the other trial readouts. And initiations across all therapy areas in 2023 and in the first half of 2024.
Martin Holst Lange: We expect to initiate to initiate additional cardiovascular as well as chronic kidney disease outcomes trials. During the course of 2024 next slide please. Yes.
We expect to initiate.
To initiate additional cardiovascular as well as chronic kidney disease outcomes trials. During the course of 2024 next slide please.
Martin Holst Lange: Turning to other R&D milestones, I would like to highlight some of the other trial readouts and initiations across our therapy areas in 2023 and in the first half of 2024, within diabetes in the third quarter of 2023 we initiated the first pivotal phase III trial in the re-imagined program for Cagrisema in people with Type 2 diabetes. In the fourth quarter, we have submitted also aided by a 25% and 50 milligram in the EU. We are also anticipating the results from the ongoing pivotal phase III trial for Iclusig, Emma combined free. In the first half of 2024. <unk> has the potential to be first in class once weekly fixed ratio combination of basal insulin NGL receptor sorry Sheila. <unk> receptor agonist and <unk> type two diabetes in need of intensification. Within obesity, we are happy to announce that we in September initiated a 32 week phase <unk> trial was once weekly subcutaneous <unk> in people with all with obesity. While we await select data. At the American. It's going to be presented at the American Heart Association Congress, we have submitted the trial to the U S FDA and the European Medicines Agency. We're pleased that the FDA has granted priority review for supplemented supplemental new drug application. This marks a significant milestone in our ongoing effort to address unmet needs in patients with overweight and obesity and established cardiovascular disease. Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients in diabetes to read out in the last quarter of this year.
Martin Holst Lange: Turning to other R&D milestones, I would like to highlight some of the other trial readouts and initiations across our therapy areas in 2023 and in the first half of 2024, within diabetes in the third quarter of 2023 we initiated the first pivotal phase III trial in the re-imagined program for CAGRISEMA in people with Type 2 diabetes.
Yes.
Turning to other R&D milestones I would like to highlight some of the other trial readouts.
And initiations across all therapy areas in 2023 and in the first half of 2024.
Within diabetes in the first quarter.
Third quarter of 2020 free we initiated the first pivotal phase III trial in the re imagine program for <unk> in people with type two diabetes.
Martin Holst Lange: In the fourth quarter, we have submitted oral Semaglutide 25 and 50 milligram in the EU, we are also anticipating the results from the ongoing pivotal Phase III trial for IcoSema combined free in the first half of 2024, IcoSema has the potential to be a first in class, once-weekly ,fixed ratio combination of basal insulin NGL receptor, sorry GLP-1 receptor agonist in patients with Type 2 diabetes in need of intensification. Within obesity, we are happy to announce that we in September initiated a 32 week phase <unk> trial was once weekly subcutaneous <unk> in people with all with obesity. While we await select data. At the American. It's going to be presented at the American Heart Association Congress, we have submitted the trial to the U S FDA and the European Medicines Agency. We're pleased that the FDA has granted priority review for supplemented supplemental new drug application. This marks a significant milestone in our ongoing effort to address unmet needs in patients with overweight and obesity and established cardiovascular disease. Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients in diabetes to read out in the last quarter of this year.
Martin Holst Lange: In the fourth quarter, we have submitted oral SEMAGLUTIDE 25 and 50 milligram in the EU, we are also anticipating the results from the ongoing pivotal Phase III trial for IcoSema combined free in the first half of 2024, IcoSema has the potential to be a first in class, once-weekly ,fixed ratio combination of basal insulin NGL receptor, sorry GLP-1 receptor agonist in patients with Type 2 diabetes in need of intensification.
In the fourth quarter, we have submitted also aided by a 25% and 50 milligram in the EU.
We are also anticipating the results from the ongoing pivotal phase III trial for Iclusig, Emma combined free.
In the first half of 2024.
<unk> has the potential to be first in class once weekly fixed ratio combination of basal insulin NGL receptor sorry Sheila.
<unk> receptor agonist and <unk> type two diabetes in need of intensification.
Martin Holst Lange: Within obesity, we are happy to announce that we in September initiated a 32 week Phase I trial, with once weekly subcutaneous Amycretin in people with overweight obesity, while we await select data at the American, It's going to be presented at the American Heart Association Congress, we have submitted the trial to the US FDA and the European Medicines Agency. We're pleased that the FDA has granted priority review for supplemented supplemental new drug application. This marks a significant milestone in our ongoing effort to address unmet needs in patients with overweight and obesity and established cardiovascular disease. Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients in diabetes to read out in the last quarter of this year.
Martin Holst Lange: Within obesity, we are happy to announce that we in September initiated a 32 week Phase I trial, with once weekly subcutaneous AMYCRETIN in people with overweight obesity, while we await select data at the American, It's going to be presented at the American Heart Association Congress, we have submitted the trial to the US FDA and the European Medicines Agency.
Within obesity, we are happy to announce that we in September initiated a 32 week phase <unk> trial was once weekly subcutaneous <unk> in people with all with obesity.
While we await select data.
At the American.
It's going to be presented at the American Heart Association Congress, we have submitted the trial to the U S FDA and the European Medicines Agency.
Martin Holst Lange: We're pleased that the FDA has granted priority review for supplemental new drug application, this marks a significant milestone in our ongoing effort to address unmet needs in patients with overweight and obesity and established cardiovascular diseases. Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients in diabetes to read out in the last quarter of this year.
Martin Holst Lange: We're pleased that the FDA has granted priority review for supplemental new drug application, this marks a significant milestone in our ongoing effort to address unmet needs in patients with overweight and obesity and established cardiovascular diseases. Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients and diabetes to read out in the last quarter of this year.
We're pleased that the FDA has granted priority review for supplemented supplemental new drug application.
This marks a significant milestone in our ongoing effort to address unmet needs in patients with overweight and obesity and established cardiovascular disease.
Martin Holst Lange: Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients in diabetes to read out in the last quarter of this year. In rare disease. The Dodge Ram was was approved by the U S. FDA for treatment of primary Hyperoxaluria type one this marks the first approved <unk>. Treatment for Novo Nordisk. In other serious chronic diseases, we initiated a phase one trial with our angiopoietin like free protein and EBITA. This is a monoclonal antibody in development for cardiovascular disease, specifically for lowering of cholesterol and triglycerides. With that over to your customer. Thank you Martin please turn to the next slide.
Martin Holst Lange: Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients in diabetes to read out in the last quarter of this year.
Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients in diabetes to read out in the last quarter of this year.
Martin Holst Lange: In rare disease. The Dodge Ram was was approved by the U S. FDA for treatment of primary Hyperoxaluria type one this marks the first approved <unk>. Treatment for Novo Nordisk. In other serious chronic diseases, we initiated a phase one trial with our angiopoietin like free protein and EBITA. This is a monoclonal antibody in development for cardiovascular disease, specifically for lowering of cholesterol and triglycerides. With that over to your customer. Thank you Martin please turn to the next slide.
Martin Holst Lange: In rare disease, Nedosiran was approved by the US FDA for treatment of primary Hyperoxaluria type 1, this marks the first approved siRNA treatment for Novo Nordisk. In other serious chronic diseases, we initiated a Phase I trial with our angiopoietin like free protein inhibitor, this is a monoclonal antibody in development for cardiovascular disease, specifically for lowering of cholesterol and triglycerides, With that over to you Karsten.
Martin Holst Lange: In rare disease, Nedosiran was approved by the US FDA for treatment of primary Hyperoxaluria type 1, this marks the first approved siRNA treatment for Novo Nordisk.
In rare disease. The Dodge Ram was was approved by the U S. FDA for treatment of primary Hyperoxaluria type one this marks the first approved <unk>.
Treatment for Novo Nordisk.
Martin Holst Lange: In other serious chronic diseases, we initiated a Phase I trial with our angiopoietin like free protein inhibitor, this is a monoclonal antibody in development for cardiovascular disease, specifically for lowering of cholesterol and triglycerides, With that over to you Karsten.
In other serious chronic diseases, we initiated a phase one trial with our angiopoietin like free protein and EBITA.
This is a monoclonal antibody in development for cardiovascular disease, specifically for lowering of cholesterol and triglycerides.
With that over to your customer.
Karsten Knudsen: Thank you Martin, please turn to the next slide. In the first nine months of 2023, our sales grew by 29% and things Corona and 33% at constant exchange rates driven by both our operating units. The gross margin increased to 84, 5% compared to 84, 3% in 2022. The increase in gross margin reflects a positive product mix driven by increased sales of tier one based treatments. This is partially countered by costs related to ongoing capacity expansions and negative currency impact and lower realized prices, mainly in the U S and region China. Sales and distribution costs increased by 22% in Danish krone, and by 25% at constant exchange rates. The increase is driven by both operating units. In North America, the cost increase is driven by the relaunch of recovery and promotional activities for <unk> and. In international operations, the cost increase is driven by promotional activities for <unk>. Well as obesity care market development activities. The increase in sales and distribution costs are impacted by adjustments to legal provisions. Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates. The increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of 'twenty two. The existing or former therapeutics in 'twenty, two and in Massawa pharma also increased R&D spending.
Karsten Knudsen: Thank you Martin, please turn to the next slide.
Thank you Martin please turn to the next slide.
Karsten Knudsen: In the first nine months of 2023, our sales grew by 29% in Danish Krone and 33% at constant exchange rates, driven by both our operating units, the gross margin increased to 84.5% compared to 84.3% in 2022, the increase in gross margin reflects a positive product mix, driven by increased sales of GLP-1 based treatments. This is partially countered by costs related to ongoing capacity expansions and negative currency impact and lower realized prices, mainly in the U S and region China. Sales and distribution costs increased by 22% in Danish krone, and by 25% at constant exchange rates. The increase is driven by both operating units. In North America, the cost increase is driven by the relaunch of recovery and promotional activities for <unk> and. In international operations, the cost increase is driven by promotional activities for <unk>. Well as obesity care market development activities. The increase in sales and distribution costs are impacted by adjustments to legal provisions. Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates. The increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of 'twenty two. The existing or former therapeutics in 'twenty, two and in Massawa pharma also increased R&D spending.
Karsten Knudsen: In the first nine months of 2023, our sales grew by 29% in Danish Krone and 33% at constant exchange rates, driven by both our operating units, the gross margin increased to 84.5% compared to 84.3% in 2022, the increase in gross margin reflects a positive product mix, driven by increased sales of GLP-1 based treatments.
In the first nine months of 2023, our sales grew by 29% and things Corona and 33% at constant exchange rates driven by both our operating units.
The gross margin increased to 84, 5% compared to 84, 3% in 2022.
The increase in gross margin reflects a positive product mix driven by increased sales of tier one based treatments.
Karsten Knudsen: This is partially countered by costs related to ongoing capacity expansions and negative currency impact and lower realized prices, mainly in the US and region China, sales and distribution costs increased by 22% in Danish krone, and by 25% at constant exchange rates. The increase is driven by both operating units. In North America, the cost increase is driven by the relaunch of recovery and promotional activities for <unk> and. In international operations, the cost increase is driven by promotional activities for <unk>. Well as obesity care market development activities. The increase in sales and distribution costs are impacted by adjustments to legal provisions. Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates. The increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of 'twenty two. The existing or former therapeutics in 'twenty, two and in Massawa pharma also increased R&D spending.
Karsten Knudsen: This is partially countered by costs related to ongoing capacity expansions and negative currency impact and lower realized prices, mainly in the US and region China, sales and distribution costs increased by 22% in Danish krone, and by 25% at constant exchange rates, the increase is driven by both operating units.
This is partially countered by costs related to ongoing capacity expansions and negative currency impact and lower realized prices, mainly in the U S and region China.
Sales and distribution costs increased by 22% in Danish krone, and by 25% at constant exchange rates.
Karsten Knudsen: The increase is driven by both operating units, in North America, the cost increase is driven by the relaunch of recovery and promotional activities for <unk> and. In international operations, the cost increase is driven by promotional activities for <unk>. Well as obesity care market development activities. The increase in sales and distribution costs are impacted by adjustments to legal provisions. Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates. The increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of 'twenty two. The existing or former therapeutics in 'twenty, two and in Massawa pharma also increased R&D spending.
Karsten Knudsen: The increase is driven by both operating units,
The increase is driven by both operating units.
Karsten Knudsen: In North America, the cost increase is driven by the re-launch of Wegovy and promotional activities for Ozempic, in international operations, the cost increase is driven by promotional activities for Rybelsus, as well as obesity care market development activities. The increase in sales and distribution costs are impacted by adjustments to legal provisions. Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates. The increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of '2022. The existing or former therapeutics in 'twenty, two and in Massawa pharma also increased R&D spending.
Karsten Knudsen: In North America, the cost increase is driven by the re-launch of WEGOVY and promotional activities for OZEMPIC, in international operations, the cost increase is driven by promotional activities for RYBELSUS, as well as obesity care market development activities.
In North America, the cost increase is driven by the relaunch of recovery and promotional activities for <unk> and.
In international operations, the cost increase is driven by promotional activities for <unk>.
Well as obesity care market development activities.
The increase in sales and distribution costs are impacted by adjustments to legal provisions.
Karsten Knudsen: The increase in sales and distribution costs are impacted by adjustments to legal provisions. Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates, the increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of '2022. The existing or former therapeutics in 'twenty, two and in Massawa pharma also increased R&D spending.
Karsten Knudsen: The increase in sales and distribution costs are impacted by adjustments to legal provisions. Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates, the increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of '2022.
Research and development costs increased by 38% measured in Danish krone, and 39% at constant exchange rates.
The increase reflects increased late stage clinical trial activity and increased early research activities compared to the first nine months of 'twenty two.
Karsten Knudsen: The acquisition of Forma therapeutics in 2022 and Inversago Pharma also increased R&D spending. Administration costs increased by 9% measured in Danish krone, and 11% at constant exchange rates. Operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth. Net financials showed a net gain of $1.2 billion Danish krone compared to a net loss of 5 billion Danish krone last year. The effective tax rate was 19.9% in the first nine months of 2023 compared to 20.5% in the first nine months of 2022. Net profit increased by 47% and diluted earnings per share increased by 49% to 13 KRONE and 71 euro. Free cash flow was $75.6 billion Danish kroner, compared with $62.6 billion krone in the first nine months of '22. In line with the strategic aspiration of delivering attractive capital allocation to shareholders a total of 52 billion Danish krone has been paid back to shareholders through share buybacks and dividends. The cash conversion is positively impacted by timing of payment of rebates in the US. Capital expenditure for property plant and equipment was $16.4 billion Danish kroner compared to $7.2 billion in 2022.
Karsten Knudsen: The acquisition of Forma therapeutics in 2022 and Inversago Pharma also increased R&D spending. Administration costs increased by 9% measured in Danish krone, and 11% at constant exchange rates.
The existing or former therapeutics in 'twenty, two and in Massawa pharma also increased R&D spending.
Administration costs increased by 9% measured in Danish krone, and 11% at constant exchange rates.
Karsten Knudsen: Operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth. Net financials showed a net gain of $1.2 billion Danish krone compared to a net loss of 5 billion Danish krone last year. The effective tax rate was 19.9% in the first nine months of 2023 compared to 20.5% in the first nine months of 2022. Net profit increased by 47% and diluted earnings per share increased by 49% to 13 KRONE and 71 euro. Free cash flow was $75.6 billion Danish kroner, compared with $62.6 billion krone in the first nine months of '22. In line with the strategic aspiration of delivering attractive capital allocation to shareholders a total of 52 billion Danish krone has been paid back to shareholders through share buybacks and dividends. The cash conversion is positively impacted by timing of payment of rebates in the US. Capital expenditure for property plant and equipment was $16.4 billion Danish kroner compared to $7.2 billion in 2022.
Karsten Knudsen: Operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth. Net financials showed a net gain of $1.2 billion Danish krone compared to a net loss of 5 billion Danish krone last year. The effective tax rate was 19.9% in the first nine months of 2023 compared to 20.5% in the first nine months of 2022.
Operating profit increased by 31% measured in Danish krone, and 37% at constant exchange rates, reflecting the sales growth.
Net financials showed a net gain of $1 2 billion Danish kroner compared to a net loss of 5 billion Danish kroner last year.
The effective tax rate was 19, 9% in the first nine months of 'twenty three compared to 25% in the first nine months of 'twenty two.
Net profit increased by 47% and diluted earnings per share increased by 49% to 13 Corona and 71.
Karsten Knudsen: Net profit increased by 47% and diluted earnings per share increased by 49% to 13 KRONE and 71 euro. Free cash flow was $75.6 billion Danish kroner, compared with $62.6 billion krone in the first nine months of '22. In line with the strategic aspiration of delivering attractive capital allocation to shareholders a total of 52 billion Danish krone has been paid back to shareholders through share buybacks and dividends. The cash conversion is positively impacted by timing of payment of rebates in the US. Capital expenditure for property plant and equipment was $16.4 billion Danish kroner compared to $7.2 billion in 2022.
Karsten Knudsen: Net profit increased by 47% and diluted earnings per share increased by 49% to 13 KRONE and 71 euro. Free cash flow was $75.6 billion Danish kroner, compared with $62.6 billion krone in the first nine months of '22.
Free cash flow was $75 6 billion Danish kroner, compared with $62 6 billion kroner in the first nine months of 'twenty two.
Karsten Knudsen: In line with the strategic aspiration of delivering attractive capital allocation to shareholders a total of 52 billion Danish krone has been paid back to shareholders through share buybacks and dividends. The cash conversion is positively impacted by timing of payment of rebates in the US. Capital expenditure for property plant and equipment was $16.4 billion Danish kroner compared to $7.2 billion in 2022.
Karsten Knudsen: In line with the strategic aspiration of delivering attractive capital allocation to shareholders a total of 52 billion Danish krone has been paid back to shareholders through share buybacks and dividends.
In line with the strategic aspiration of delivering attractive capital to shareholders.
A 52% in Danish kroner has been paid back to shareholders through share buybacks and dividends.
Karsten Knudsen: The cash conversion is positively impacted by timing of payment of rebates in the US. Capital expenditure for property plant and equipment was $16.4 billion Danish kroner compared to $7.2 billion in 2022. This primarily reflects investments in additional capacity for active pharmaceutical ingredient production and fill finish capacity for both current and future injectable and oral products. Please go ahead over the next slide.
Karsten Knudsen: The cash conversion is positively impacted by timing of payment of rebates in the US. Capital expenditure for property plant and equipment was $16.4 billion Danish kroner compared to $7.2 billion in 2022.
The cash conversion is positively impacted by timing of payment of rebates in the U S.
Capital expenditure for property plant and equipment was $16 4 billion Danish kroner compared to $7 2 billion in 2022.
Karsten Knudsen: This primarily reflects investments in additional capacity for active pharmaceutical ingredient production and for finish capacity for both current and future injectable and oral products. Please go to the next slide. Nine months into transferring story, we're continuing our sales growth momentum, which has enabled us to raise the outlook for the full year. We now expect sales growth to be between 32% and 38% at constant exchange rates the. The increased sales outlook is primarily reflecting higher full year expectations to simply volume sold in the U S and gross to net adjustments for <unk> and <unk> in the U S. The guidance reflects expectations for sales growth in both North America operations and international operations. The guidance is mainly driven by volume growth of th, one phase <unk> treatments for diabetes and obesity care. This is partly countered by declining sales in rare disease due to a temporary. Reductions in manufacturing output. The guidance reflects the level of volume growth of direct one based treatments. The inherent uncertainty of the pace of <unk>. Obesity care market expansion following the re launch of <unk> in the U S and a limited rollout in international operations are also included in the guidance range.
Karsten Knudsen: This primarily reflects investments in additional capacity for active pharmaceutical ingredient production and for finish capacity for both current and future injectable and oral products. Please go to the next slide.
This primarily reflects investments in additional capacity for active pharmaceutical ingredient production and fill finish capacity for both current and future injectable and oral products. Please go ahead over the next slide.
Karsten Knudsen: Nine months into 2023 we're continuing our sales growth momentum, which has enabled us to raise the outlook for the full year, we now expect sales growth to be between 32% and 38% at constant exchange rates, the increased sales outlook is primarily reflecting higher full year expectations to OZEMPIC volume sold in the US and gross to net adjustments for OZEMPIC and WEGOVY in the US. The guidance reflects expectations for sales growth in both North America operations and international operations. The guidance is mainly driven by volume growth of GLP-1 based treatments for diabetes and obesity care. This is partly countered by declining sales in rare disease due to a temporary reductions in manufacturing output. The guidance reflects the level of volume growth of GLP-1 based treatments. The inherent uncertainty of the pace of OZEMPIC obesity care market expansion following the re launch of WEGOVY in the US and a limited rollout in international operations are also included in the guidance range.
Karsten Knudsen: Nine months into 2023 we're continuing our sales growth momentum, which has enabled us to raise the outlook for the full year, we now expect sales growth to be between 32% and 38% at constant exchange rates, the increased sales outlook is primarily reflecting higher full year expectations to OZEMPIC volume sold in the US and gross to net adjustments for OZEMPIC and WEGOVY in the US.
Nine months into transferring story, we're continuing our sales growth momentum, which has enabled us to raise the outlook for the full year.
We now expect sales growth to be between 32% and 38% at constant exchange rates the.
The increased sales outlook is primarily reflecting higher full year expectations to simply volume sold in the U S and gross to net adjustments for <unk> and <unk> in the U S.
Karsten Knudsen: The guidance reflects expectations for sales growth in both North America operations and international operations. The guidance is mainly driven by volume growth of GLP-1 based treatments for diabetes and obesity care. This is partly countered by declining sales in rare disease due to a temporary reductions in manufacturing output. The guidance reflects the level of volume growth of GLP-1 based treatments. The inherent uncertainty of the pace of OZEMPIC obesity care market expansion following the re.launch of WEGOVY in the US and a limited rollout in international operations are also included in the guidance range.
Karsten Knudsen: The guidance reflects expectations for sales growth in both North America operations and international operations. The guidance is mainly driven by volume growth of GLP-1 based treatments for diabetes and obesity care. This is partly countered by declining sales in rare disease due to a temporary reductions in manufacturing output. The guidance reflects the level of volume growth of GLP-1 based treatments.
Karsten Knudsen: The guidance reflects expectations for sales growth in both North America operations and international operations. The guidance is mainly driven by volume growth of GLP-1 based treatments for diabetes and obesity care.
The guidance reflects expectations for sales growth in both North America operations and international operations. The guidance is mainly driven by volume growth of th, one phase <unk> treatments for diabetes and obesity care.
This is partly countered by declining sales in rare disease due to a temporary.
Karsten Knudsen: This is partly countered by declining sales in rare disease due to a temporary reductions in manufacturing output. The guidance reflects the level of volume growth of GLP-1 based treatments.
Reductions in manufacturing output.
The guidance reflects the level of volume growth of direct one based treatments.
Karsten Knudsen: The inherent uncertainty of the pace of OZEMPIC obesity care market expansion following the re.launch of WEGOVY in the US and a limited rollout in international operations are also included in the guidance range. Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.
Karsten Knudsen: The inherent uncertainty of the pace of OZEMPIC obesity care market expansion following the re.launch of WEGOVY in the US and a limited rollout in international operations are also included in the guidance range.
The inherent uncertainty of the pace of <unk>.
Obesity care market expansion following the re launch of <unk> in the U S and a limited rollout in international operations are also included in the guidance range.
Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.
Karsten Knudsen: Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies, Novo Nordisk is investing in internal and external capacity to increase supply both short and long term. While supply capacity for WEGOVY is gradually being expanded, the lower dose strengths in the US will remain restricted to safeguard continuity of care. We now expect operating profit to grow between 40 and 46% at constant exchange rates. This primarily reflects the sales growth outlook and continued investments in future and current growth drivers within research development and commercial. For 2023 we expect net financial items to amount to a gain of around $1.6 billion Danish kroner, mainly reflecting gains associated with foreign exchange hedging contracts. Capital expenditure is still expected to be around 25 billion Danish kroner, reflecting the upscaling of the supply chain and the innovation based growth strategy pursuit by Novo Nordisk. In the coming years, the capital expenditure to sales ratio is expected to be low double digits. The free cash flow is now expected to be between 65, and 73 billion Danish krone, reflecting the sales growth, a Favorable impact from rebates in the US and investments in capital expenditure. The updated cash flow expectation is mainly reflecting increased net profit expectations, partially countered by our business development activities. That covers the outlook for 'twenty three now back to you lost for final remarks.
Karsten Knudsen: Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies, Novo Nordisk is investing in internal and external capacity to increase supply both short and long term.
<unk> is investing in internal and external capacity to increase supply both short and long term.
Karsten Knudsen: While supply capacity for WEGOVY is gradually being expanded, the lower dose strengths in the US will remain restricted to safeguard continuity of care. We now expect operating profit to grow between 40 and 46% at constant exchange rates. This primarily reflects the sales growth outlook and continued investments in future and current growth drivers within research development and commercial. For 2023 we expect net financial items to amount to a gain of around $1.6 billion Danish kroner, mainly reflecting gains associated with foreign exchange hedging contracts. Capital expenditure is still expected to be around 25 billion Danish kroner, reflecting the upscaling of the supply chain and the innovation based growth strategy pursuit by Novo Nordisk. In the coming years, the capital expenditure to sales ratio is expected to be low double digits. The free cash flow is now expected to be between 65, and 73 billion Danish krone, reflecting the sales growth, a Favorable impact from rebates in the US and investments in capital expenditure. The updated cash flow expectation is mainly reflecting increased net profit expectations, partially countered by our business development activities. That covers the outlook for 'twenty three now back to you lost for final remarks.
Karsten Knudsen: While supply capacity for WEGOVY is gradually being expanded, the lower dose strengths in the US will remain restricted to safeguard continuity of care. We now expect operating profit to grow between 40 and 46% at constant exchange rates. This primarily reflects the sales growth outlook and continued investments in future and current growth drivers within research development and commercial.
While supply capacity for recovery is gradually being expanded the lower dose strengths in the U S will remain restricted to safeguard continuity of care.
We now expect operating profit to grow between 40 and 46% at constant exchange rates.
This primarily reflects the sales growth outlook and continued investments in future and current growth drivers within research development and commercial.
Karsten Knudsen: For 2023 we expect net financial items to amount to a gain of around $1.6 billion Danish kroner, mainly reflecting gains associated with foreign exchange hedging contracts. Capital expenditure is still expected to be around 25 billion Danish kroner, reflecting the upscaling of the supply chain and the innovation based growth strategy pursuit by Novo Nordisk. In the coming years, the capital expenditure to sales ratio is expected to be low double digits. The free cash flow is now expected to be between 65, and 73 billion Danish krone, reflecting the sales growth, a Favorable impact from rebates in the US and investments in capital expenditure. The updated cash flow expectation is mainly reflecting increased net profit expectations, partially countered by our business development activities. That covers the outlook for 'twenty three now back to you lost for final remarks.
Karsten Knudsen: For 2023 we expect net financial items to amount to a gain of around $1.6 billion Danish kroner, mainly reflecting gains associated with foreign exchange hedging contracts. Capital expenditure is still expected to be around 25 billion Danish kroner, reflecting the upscaling of the supply chain and the innovation based growth strategy pursuit by Novo Nordisk.
For 2023, we expect net financial items to amount to a gain of around $1 6 billion Danish kroner, mainly reflecting gains associated with foreign exchange hedging contracts.
Capital expenditure is still expected to be around <unk>.
<unk> 25 billion Danish kroner, reflecting the upscaling of the supply chain and the innovation based growth strategy pursuit final Norsk.
Karsten Knudsen: In the coming years, the capital expenditure to sales ratio is expected to be low double digits. The free cash flow is now expected to be between 65, and 73 billion Danish krone, reflecting the sales growth, a Favorable impact from rebates in the US and investments in capital expenditure. The updated cash flow expectation is mainly reflecting increased net profit expectations, partially countered by our business development activities. That covers the outlook for 'twenty three now back to you lost for final remarks.
Karsten Knudsen: In the coming years, the capital expenditure to sales ratio is expected to be low double digits. The free cash flow is now expected to be between 65, and 73 billion Danish krone, reflecting the sales growth, a Favorable impact from rebates in the US and investments in capital expenditure.
In the coming years, the capital expenditure to sales ratio is expected to be low double digits.
The free cash flow is now expected to be.
Between 65, and 73 billion Danish krone, reflecting the sales growth.
Favorable impact from rebates in the U S and investments in capital expenditure.
Karsten Knudsen: The updated cash flow expectation is mainly reflecting increased net profit expectations, partially countered by our business development activities. That covers the outlook for 2023 now back to you Lars for final remarks.
The updated cash flow expectation is mainly reflecting increased net profit expectations, partially countered by business development activities.
That covers the outlook for 'twenty three now back to you lost for final remarks.
Lars Fruergaard Joergensen: Thank you Carsten, please turn to the final slides. Today's announcement discloses the full set of quarterly results and updated outlook for 2023, which was shared earlier in October.
Lars Fruergaard Joergensen: Thank you Carsten, please turn to the final slides.
Today's announcement discloses the full set of quarterly results and updated outlook for 2023, which was shared earlier in October.
Lars Fruergaard Joergensen: Today's announcement discloses the full set of quarterly results and updated outlook for 2023, which was shared earlier in October. Overall we are very satisfied with our sales growth in the first nine months of 2023, the growth is driven by demand for our GLP-1 base therapeutic interventions for diabetes and obesity, which is now reaching more people than ever before. The performance in the first nine months of the year has enabled us to raise the outlook for the full year. From an R&D perspective, we have reached a significant milestone with the submission of SELECT and look forward to sharing more data at American Heart Association. In addition we're excited about the early closure of the FLOW trial and anticipate it read out in the first half of 2024. Finally, the acquisition of OCEDURENONE will strenght the portfolio of cardiovascular disease, and underlines our commitment to established presence with other serious chronic diseases. With that I'll hand over the final word for Daniel. thank you Lars, Next slide please. With that we're now ready for the Q&A session, we kindly ask all participants to limit her or himself to one or maximum two questions, including sub-questions, Operator we're now ready to take the first question.
Lars Fruergaard Joergensen: Today's announcement discloses the full set of quarterly results and updated outlook for 2023, which was shared earlier in October. Overall we are very satisfied with our sales growth in the first nine months of 2023, the growth is driven by demand for our GLP-1 base therapeutic interventions for diabetes and obesity, which is now reaching more people than ever before. The performance in the first nine months of the year has enabled us to raise the outlook for the full year. From an R&D perspective, we have reached a significant milestone with the submission of SELECT and look forward to sharing more data at American Heart Association. In addition we're excited about the early closure of the FLOW trial and anticipate it read out in the first half of 2024. Finally, the acquisition of OCEDURENONE will strenght the portfolio of cardiovascular disease, and underlines our commitment to established presence with other serious chronic diseases. With that I'll hand over the final word for Daniel.
Lars Fruergaard Joergensen: Today's announcement discloses the full set of quarterly results and updated outlook for 2023, which was shared earlier in October.
Lars Fruergaard Joergensen: Overall we are very satisfied with our sales growth in the first nine months of 2023, the growth is driven by demand for our GLP-1 base therapeutic interventions for diabetes and obesity, which is now reaching more people than ever before. The performance in the first nine months of the year has enabled us to raise the outlook for the full year. From an R&D perspective, we have reached a significant milestone with the submission of SELECT and look forward to sharing more data at American Heart Association. In addition we're excited about the early closure of the FLOW trial and anticipate it read out in the first half of 2024. Finally, the acquisition of OCEDURENONE will strenght the portfolio of cardiovascular disease, and underlines our commitment to established presence with other serious chronic diseases. With that I'll hand over the final word for Daniel.
Lars Fruergaard Joergensen: Overall we are very satisfied with our sales growth in the first nine months of 2023, the growth is driven by demand for our GLP-1 base therapeutic interventions for diabetes and obesity, which is now reaching more people than ever before. The performance in the first nine months of the year has enabled us to raise the outlook for the full year.
All we are very satisfied with our sales growth in the first nine months of 2023.
This is driven by demand for <unk> base for future interventions for diabetes, and obesity, which is now reaching more people than ever before the.
Lars Fruergaard Joergensen: The performance in the first nine months of the year has enabled us to raise the outlook for the full year. From an R&D perspective, we have reached a significant milestone with the submission of SELECT and look forward to sharing more data at American Heart Association. In addition we're excited about the early closure of the FLOW trial and anticipate it read out in the first half of 2024. Finally, the acquisition of OCEDURENONE will strenght the portfolio of cardiovascular disease, and underlines our commitment to established presence with other serious chronic diseases. With that I'll hand over the final word for Daniel.
Lars Fruergaard Joergensen: The performance in the first nine months of the year has enabled us to raise the outlook for the full year.
The performance in the first nine months of the year has enabled us to raise the outlook for the full year.
From an R&D perspective, we have reached a significant milestone with the submission of select and look forward to sharing more data at American Heart Association. In addition, we're excited about the early closure of the flow trial and anticipate.
Lars Fruergaard Joergensen: From an R&D perspective, we have reached a significant milestone with the submission of SELECT and look forward to sharing more data at American Heart Association. In addition we're excited about the early closure of the FLOW trial and anticipate it read out in the first half of 2024. Finally, the acquisition of OCEDURENONE will strenght the portfolio of cardiovascular disease, and underlines our commitment to established presence with other serious chronic diseases. With that I'll hand over the final word for Daniel.
Lars Fruergaard Joergensen: From an R&D perspective, we have reached a significant milestone with the submission of SELECT and look forward to sharing more data at American Heart Association.
Lars Fruergaard Joergensen: In addition we're excited about the early closure of the FLOW trial and anticipate it read out in the first half of 2024. Finally, the acquisition of OCEDURENONE will strenght the portfolio of cardiovascular disease, and underlines our commitment to established presence with other serious chronic diseases. With that I'll hand over the final word for Daniel.
It read out in the first half of <unk> finally, the accuracy Usher turan.
Folio of cardiovascular disease, and underlines our commitment to established presence with other serious quantities with that I'll hand over to the final word for Daniel.
Lars Fruergaard Joergensen: Thank you Lars, Next slide please. With that we're now ready for the Q&A session, we kindly ask all participants to limit her or himself to one or maximum two questions, including sub-questions, Operator we're now ready to take the first question.
Next slide please with that we're now ready for the Q&A session, where can you ask all participants to limit our himself to one or maximum two questions including sub questions.
<unk>, we're now ready to take the first question.
Operator: Thank you, To ask a question you will need to press star one and one on your telephone and wait for your name to be announced, to withdraw your question please press star one and one again. We will now go to the last question. And your first question comes from the line of Michael <unk> from TD Cowen. Please go ahead.
Operator: Thank you, To ask a question you will need to press star one and one on your telephone and wait for your name to be announced, to withdraw your question please press star one and one again.
We will now go to the last question.
Operator: We will now go to the first question, and your first question comes from the line of Michael Nedelkovych from TD Cowen. Please go ahead.
And your first question comes from the line of Michael <unk> from TD Cowen. Please go ahead.
Michael Nedelcovych: Thank you for the question I have one for Martin, Martin if you'll allow me to set up something of a straw man, here's a potential set of expectations for the Phase III SELECT data when we see them at AHA. One clinically meaningful benefit across each of the individual MACE components and regardless of BMI category. Two cardiovascular benefit that clearly emerges within one year on WEGOVY therapy, and does not diminish over time. And three no noticeable imbalance in any very rare adverse events such as suicide or cancer. My question is would you urge me to modify these expectations in any way. Martinez <unk> for you.
Michael Nedelcovych: Thank you for the question I have one for Martin, Martin if you'll allow me to set up something of a straw man, here's a potential set of expectations for the Phase III SELECT data when we see them at AHA. One clinically meaningful benefit across each of the individual MACE components and regardless of BMI category. Two cardiovascular benefit that clearly emerges within one year on WEGOVY therapy, and does not diminish over time. And three no noticeable imbalance in any very rare adverse events such as suicide or cancer. My question is would you urge me to modify these expectations in any way.
Michael Nedelcovych: Thank you for the question I have one for Martin, Martin if you'll allow me to set up something of a straw man, here's a potential set of expectations for the Phase III SELECT data when we see them at AHA. One clinically meaningful benefit across each of the individual MACE components and regardless of BMI category.
One clinically meaningful benefit across each of the individual components and regardless of BMI category.
Two cardiovascular benefit that clearly emerges within one year on <unk> therapy, and does not diminish over time.
Michael Nedelcovych: Two cardiovascular benefit that clearly emerges within one year on WEGOVY therapy, and does not diminish over time. And three no noticeable imbalance in any very rare adverse events such as suicide or cancer. My question is would you urge me to modify these expectations in any way.
And three no noticeable imbalance in any very rare adverse events such as suicide or cancer. My question is would you urge me to modify these expectations in any way.
Martinez <unk> for you.
Daniel Bohsen: Martin a straw Man for you.
Martin Holst Lange: So thank you very much for that question, as you've probably imagined I cannot speculate to anything beyond what we've already disclosed and that is the 20% risk reduction on the primary endpoint for MACE, which is obviously myocardial infarction stroke and cardiovascular deaths. We see attributions from all three but we do not go into more detail, what I will commit to is obviously that we saw a very clear and positive safety profile from SELECT and with no outliers identified.
One 2% risk reduction on the primary endpoint.
For Mace, which is obviously myocardial infarction stroke and cardiovascular deaths.
We see attributions from from oil free but but.
We do not go into more detail what I will commit to is obviously that we saw a very clear.
And positive safety profile from.
Perhaps select and with no outliers identified thank.
Daniel Bohsen: Thank you Martin and thanks Mike for the question, next question please.
Operator: Thank you, we'll now take the next question. And your next question comes from the line of Richard Parkes from BNP paribas please go ahead.
Well now take the next question.
And your next question comes from the line of Richard Parkes from BNP, probably about please go ahead.
Okay.
Richard Parkes: Thanks very much for taking my questions, I've got a couple. So firstly when I look at the down peak on WEGOVY US Symphony prescriptions trending flat to down over the last quarter, I assume due to supply constraints, but your guidance suggests unexpected acceleration and top line growth in Q4. So I'm just wondering if you could help me to understand that, are you expecting to see kind of further improved supply into the end of the year, would be I assume, kind of a swing factor there. and then the second question. Is just. Your slide outlines the potential benefits of some macro Todd beyond cost control and weight loss and maybe we'll see some insight into that from the select study. Your charts suggest the potential for patients to benefit from the Cvs bags. Doug I have diabetes or basically so I'm just wondering how you can capitalize. Given that Youre trials currently I think just recruiting patients with either obesity and diabetes and type of Morbidities. Thanks very much. Well get the first are you casting supply going into our guidance.
Richard Parkes: Thanks very much for taking my questions, I've got a couple. So firstly when I look at the down peak on WEGOVY US Symphony prescriptions trending flat to down over the last quarter, I assume due to supply constraints, but your guidance suggests unexpected acceleration and top line growth in Q4. So I'm just wondering if you could help me to understand that, are you expecting to see kind of further improved supply into the end of the year, would be I assume, kind of a swing factor there.
Richard Parkes: Thanks very much for taking my questions, I've got a couple. So firstly when I look at the down peak on WEGOVY US Symphony prescriptions trending flat to down over the last quarter, I assume due to supply constraints, but your guidance suggests unexpected acceleration and top line growth in Q4.
Over the last quarter, I think due to supply constraints.
Guidance suggests unexpected acceleration in top line growth in Q4. So I'm just wondering if you could help me to understand.
Richard Parkes: So I'm just wondering if you could help me to understand that, are you expecting to see kind of further improved supply into the end of the year, would be I assume, kind of a swing factor there.
Are you expecting to see kind of further improved supply.
Into the end of the year would be I assume kind of a swing factor to that and then the second question.
Is just.
Richard Parkes: And then the second question is just. Your slide outlines the potential benefits of SEMAGLUTIDE beyond glycemic control and weight loss and maybe we'll see some insight into that from the SELECT study, but your chart suggest there's potential for patients to benefit from the CV aspects that don't have diabetes or obesity. so I'm just wondering how you can capitalize. Given that Youre trials currently I think just recruiting patients with either obesity and diabetes and type of Morbidities. Thanks very much. Well get the first are you casting supply going into our guidance.
Richard Parkes: And then the second question is just. Your slide outlines the potential benefits of SEMAGLUTIDE beyond glycemic control and weight loss and maybe we'll see some insight into that from the SELECT study, but your chart suggest there's potential for patients to benefit from the CV aspects that don't have diabetes or obesity.
Your slide outlines the potential benefits of some macro Todd beyond cost control and weight loss and maybe we'll see some insight into that from the select study.
Your charts suggest the potential for patients to benefit from the Cvs bags.
Doug I have diabetes or basically so I'm just wondering how you can capitalize.
Richard Parkes: So I'm just wondering how you can capitalize on that, given that your trials currently I think are just recruiting patients with either obesity and diabetes and comorbidities. Thanks very much. Well get the first are you casting supply going into our guidance.
Richard Parkes: So I'm just wondering how you can capitalize on that, given that your trials currently I think are just recruiting patients with either obesity and diabetes and comorbidities. Thanks very much.
Given that Youre trials currently I think just recruiting patients with either obesity and diabetes and type of Morbidities. Thanks very much.
Daniel Bohsen: I will give the first one to you Karsten on supply going into our guidance.
Well get the first are you casting supply going into our guidance.
Karsten Knudsen: Yeah so thank you for that question Richard, and clearly when we put out guidance that's because we believe that's the most realistically forecast range set that we're putting in and we don't have too many months to roll on so, of course we see the TRx trends and bake that in into our forecast. What I would give of additional flavor on top of that is, of course the growth rate is also a function of those extra sales last year, and we did see OZEMPIC having a lower base last year and in the fourth quarter than what we would normalize into this year and then of course, there can be fluctuations in inventories, for instance with wholesalers and then finally I'll say this pick up in sales growth in the fourth quarter, this is not to be kind of read into anything any difference on the supply situation. What we're selling in the fourth quarter has been produced months ago.
Karsten Knudsen: Yeah so thank you for that question Richard, and clearly when we put out guidance that's because we believe that's the most realistically forecast range set that we're putting in and we don't have too many months to roll on so, of course we see the TRx trends and bake that in into our forecast.
And clearly when we put out guidance and that's because we believe that that's the most.
Realistically forecast range that we're putting in and we don't have too many months through to roll on so so of course, we see the T Rex trends and baked that in into our into our forecast and what I would give of additional flavor.
Karsten Knudsen: What I would give of additional flavor on top of that is, of course the growth rate is also a function of those extra sales last year, and we did see OZEMPIC having a lower base last year and in the fourth quarter than what we would normalize into this year and then of course, there can be fluctuations in inventories, for instance with wholesalers and then finally I'll say this pick up in sales growth in the fourth quarter, this is not to be kind of read into anything any difference on the supply situation. What we're selling in the fourth quarter has been produced months ago.
Karsten Knudsen: What I would give of additional flavor on top of that is, of course the growth rate is also a function of those extra sales last year, and we did see OZEMPIC having a lower base last year and in the fourth quarter than what we would normalize into this year.
On top of that is of course the growth rate is also a function of.
I'll fix extra sales last year, and we did see some big having a lower base last year and in the fourth quarter than the than what we would normalize in into this year and then of course, there can be fluctuations in inventory for instance, with wholesalers and then finally I'll say this this pick up in <unk>.
Karsten Knudsen: And then of course, there can be fluctuations in inventories, for instance with wholesalers and then finally I'll say this pick up in sales growth in the fourth quarter, this is not to be kind of read into anything any difference on the supply situation. What we're selling in the fourth quarter has been produced months ago.
<unk> growth in the first fourth quarter. This is not to be kind of read into anything any difference on the supply situation. What we're selling in the fourth quarter has been produced months ago.
Daniel Bohsen: Thank you Karsten, Martin any comments on the benefits beyond weight loss with him.
Martin Holst Lange: So first of all I think it's exactly right, that our starting point is the cardio metabolic space, starting out with obesity and diabetes and these are the patients that we investigate, I think it's important to call out that the vast majority of patients suffering from ASCVD, from heart failure, from Chronic Kidney Disease, but also Metabolic Liver Disease also have an element of metabolic derangement and there is a clear association and the overlap to both diabetes and obesity. So from our perspective this actually creates some very nice synergies and is certainly not seen as exclusive. But our starting point is patients suffering from diabetes and obesity.
Martin Holst Lange: So first of all I think it's exactly right, that our starting point is the cardio metabolic space, starting out with obesity and diabetes and these are the patients that we investigate, I think it's important to call out that the vast majority of patients suffering from ASCVD, from heart failure, from Chronic Kidney Disease, but also Metabolic Liver Disease also have an element of metabolic derangement and there is a clear association and the overlap to both diabetes and obesity.
Martin Holst Lange: So first of all I think it's exactly right, that our starting point is the cardio metabolic space, starting out with obesity and diabetes and these are the patients that we investigate,
The cardio metabolic space, starting out with obesity and diabetes and these are the patients that we investigate.
I think it's important to call out there that the vast majority of patients suffering from <unk>.
Martin Holst Lange: I think it's important to call out that the vast majority of patients suffering from ASCVD, from heart failure, from Chronic Kidney Disease, but also Metabolic Liver Disease also have an element of metabolic derangement and there is a clear association and the overlap to both diabetes and obesity.
From heart failure from.
Chronic kidney disease, but also.
Metabolic liver disease.
So have add an element of metabolic arrangement.
And there is a clear association and the overlap both diabetes and obesity. So from us from our perspective. This actually creates some very nice synergies.
Martin Holst Lange: So from our perspective this actually creates some very nice synergies and is certainly not seen as exclusive. But our starting point is patients suffering from diabetes and obesity.
So it is not seen as <unk>.
Lucid.
But our starting point is patients suffering from diabetes and obesity.
Daniel Bohsen: Thank you Martin Thank you Richard for the questions and we're ready for the next question.
Operator: Thank you. We will now take the next question. And your next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.
We will now take the next question.
Your next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.
Seamus Christopher Fernandez: Oh, thanks very much for the question, so just very quickly as we think about the SELECT trial result, in the week, not just of the presentation but the very rapid filing, there had been a lot of questions around this being actually a cardiovascular medication and perhaps gaining access to CMS in that regard. Can you just talk about the prospect of that actually becoming reality, and then the second question is just on the oral AMYCRETIN and the initiation of a subcutaneous AMYCRETIN, can you just help us understand is this more of a supply chain related decision, an IRA related decision, or a decision related to some challenges with the oral formulation of AMYCRETIN. Thanks, so much.
Seamus Christopher Fernandez: Oh, thanks very much for the question, so just very quickly as we think about the SELECT trial result, in the week, not just of the presentation but the very rapid filing, there had been a lot of questions around this being actually a cardiovascular medication and perhaps gaining access to CMS in that regard. Can you just talk about the prospect of that actually becoming reality?
No.
Very quickly as we think about the.
Select trial result.
The weak not just of the presentation, but the very rapid filing there had been a lot of questions around this being actually a cardiovascular medication and perhaps <unk>.
Gaining access to CMS in that regard can you just.
Seamus Christopher Fernandez: Can you just talk about the prospect of that actually becoming reality, and then the second question is just on the oral AMYCRETIN and the initiation of a subcutaneous AMYCRETIN, can you just help us understand is this more of a supply chain related decision, an IRA related decision, or a decision related to some challenges with the oral formulation of AMYCRETIN. Thanks, so much.
Seamus Christopher Fernandez: Can you just talk about the prospect of that actually becoming reality,
Talk about the prospect of that actually becoming reality and then the second question is just on the oral and the initiation of a subcutaneous <unk>.
Seamus Christopher Fernandez: and then the second question is just on the oral AMYCRETIN and the initiation of a subcutaneous AMYCRETIN, can you just help us understand is this more of a supply chain related decision, an IRA related decision, or a decision related to some challenges with the oral formulation of AMYCRETIN? Thanks, so much.
Can you just help us understand is this more of a supply chain related decision.
<unk> related decision or.
And related to <unk>.
Challenges with the oral formulation of amacrine. Thanks, so much.
Operator: Thank you Seamus, Doug I'll give the first question to you.
Doug Langa: Yeah. Thanks Seamus, we do believe there is an opportunity, a potential opportunity to use the medical exception process through the CV component, but let's wait and see.
Operator: Thanks, Doug. Martin any thoughts on AMYCRETIN
Martin any thoughts on accretion down Ami creates and our decision to go also into subcutaneous has actually caused by by neither of the above the three reasons that you mentioned, it's actually drew.
Martin any thoughts on accretion down
Martin Holst Lange: Yeah on AMYCRETIN our decision to go also into subcutaneous in actually caused by neither of the above the three reasons that you mentioned, it's actually driven by the fact that we are learning that optionality is important for patients and their prescribing physicians in both diabetes and obesity and we have seen a clear potential for him AMYCRETIN to become both an oral but surely also a subcutaneous offering and therefore in Phase I it is prudent for us to investigate both.
Driven by the fact that we are learning that Optionality is important for patient centered prescribing physicians in both diabetes and obesity and we have seen a clear potential for him accretions will become both an oral but surely also a subcutaneous offering and therefore in phase one it is prudent for us to invest peoples.
Daniel Bohsen: Thanks, Martin and thanks, James we're ready for the next question.
Operator: Thank you. We will now take the next question. And Your next question comes from the line of Peter Verdult from Citigroup. Please go ahead.
We will now take the next question Andrew.
Your next question comes from the line of Pizza adult from Citigroup. Please go ahead.
Peter Verdult: Thank you Pete Verdult Citi, two questions Karsten on your favorite topics supply and pricing, just on supply if we take the sort of run rate for GLP-1 volumes, your franchise in the US and just extrapolate into 2024, if nothing changes I mean, there's going to be a big disconnect in terms of People's expectations for growth next year and I think it will be effectively flat, now I know it's going to improve next year, but can I just push you on when we might see the handbrake being released? I mean logical thinking might be that at the time of the Mounjaro launch, you'll be want to be in a less capacity constrained position. So I know you can't go into too much detail but, just some incremental color on when we might see the handbrake being removed would be helpful. And then on pricing if we do a value per script calculation, there's a huge jump from Q2 to Q3, I know you've called out gross to net adjustments, we know that commercial mix has improved but, just making sure, is this a sort of high watermark, a one off in terms of value per prescription how should, in terms of base lining and thinking going forward. Can we use the value per script in Q3, as a baseline or is it artificially high? Thank You.
Peter Verdult: Thank you Pete Verdult Citi, two questions Karsten on your favorite topics supply and pricing, just on supply if we take the sort of run rate for GLP-1 volumes, your franchise in the US and just extrapolate into 2024, if nothing changes I mean, there's going to be a big disconnect in terms of People's expectations for growth next year and I think it will be effectively flat,
Supply and pricing just on supply if we take sort of a run rate for <unk> won't volumes Youll franchise in the U S and just extrapolate.
In 24, if nothing changes I mean, that's going to be a big disconnect in terms of People's expectations for growth next year and I think it will be effectively flat I know, it's going to improve next year, but can I just push you on when we might see the handbrake being released I mean.
Peter Verdult: now I know it's going to improve next year, but can I just push you on when we might see the handbrake being released? I mean logical thinking might be that at the time of the Mounjaro launch, you'll be want to be in a less capacity constrained position. So I know you can't go into too much detail but, just some incremental color on when we might see the handbrake being removed would be helpful. And then on pricing if we do a value per script calculation, there's a huge jump from Q2 to Q3, I know you've called out gross to net adjustments, we know that commercial mix has improved but, just making sure, is this a sort of high watermark, a one off in terms of value per prescription how should, in terms of base lining and thinking going forward. Can we use the value per script in Q3, as a baseline or is it artificially high? Thank You.
Peter Verdult: now I know it's going to improve next year, but can I just push you on when we might see the handbrake being released? I mean logical thinking might be that at the time of the Mounjaro launch, you'll be want to be in a less capacity constrained position. So I know you can't go into too much detail but, just some incremental color on when we might see the handbrake being removed would be helpful.
Peter Verdult: now I know it's going to improve next year, but can I just push you on when we might see the handbrake being released? I mean logical thinking might be that at the time of the Mounjaro launch, you'll be want to be in a less capacity constrained position.
Logical thinking might be.
Sorry about the Montreal relaunch, you'll be want to be in the less capacity constrained position. So I know you can't go into too much detail, but just some incremental color on when we might see.
Peter Verdult: So I know you can't go into too much detail but, just some incremental color on when we might see the handbrake being removed would be helpful.
The handbrake being removed would be helpful. And then on pricing if we do a value per script calculation. There was a huge jump from Q2 to Q3, you've called out gross to net adjustments. We know the commercial mix has improved but.
Peter Verdult: And then on pricing if we do a value per script calculation, there's a huge jump from Q2 to Q3, I know you've called out gross to net adjustments, we know that commercial mix has improved but, just making sure, is this a sort of high watermark, a one off in terms of value per prescription how should, in terms of base lining and thinking going forward. Can we use the value per script in Q3, as a baseline or is it artificially high? Thank You.
Peter Verdult: And then on pricing if we do a value per script calculation, there's a huge jump from Q2 to Q3, I know you've called out gross to net adjustments, we know that commercial mix has improved but, just making sure,
Just making sure as this is sort of a high watermark of one off in terms of value per prescription housing in terms of the.
Peter Verdult: is this a sort of high watermark, a one off in terms of value per prescription how should, in terms of base lining and thinking going forward. Can we use the value per script in Q3, as a baseline or is it artificially high? Thank You.
Base lining I'm thinking going forward.
Can we use the value per script in Q3, as a baseline or is it artificially high.
Okay.
Yeah.
Daniel Bohsen: Thanks Pete. Karsten supply going into 2024 and the value per script.
Karsten Knudsen: Yeah Pete Thank you for those, my favorite subjects, so I would say. First of all with the guidance for the full year, this year that has a midpoint of 35% sales growth at constant exchange rates at least in the novo settings it feels like we have released the handbrake. And moving at very high pace in terms of growth rates, at least it's the highest in the history of the company. But that said and extrapolations into 2024. I would say first of all, we're clearly pursuing growth strategy based on the innovation. We have shown that we have the innovation platforms, especially in OZEMPIC and WEGOVY to drive growth this year and clearly also also next year. So not teaching you how to extrapolate, but if you extrapolate our implied Q4 sales growth based on our guidance then you actually get to a sales growth number next year in the double digits, which is actually not that far away from from where consensus is currently, so I do believe that we're scaling very fast. And then specifically on WEGOVY and any hand brakes there, then what I'd say as to 2024 is that in 2024 we will be delivering significant step up in volumes to the US market compared to 2023 as we did from '22 to '23. And then to your pricing questions, as we've said on numerous occasions. The appropriate way of looking at net realized pricing in the US is to look at the year to date numbers. So most contracts are contracted on an annual basis and the tricky part is the lag effect between when a script is written and then we receive the rebate claims from the payers and that's just the lag effect of several months and that's why in reality Q3 is the first point, where we see how how the channel-payer mix tool is falling out for 2023. So I wouldn't use Q3 in isolation for a financing forecasting wise I would recommend you to use year to date Q3 as a starting point.
Karsten Knudsen: Yeah Pete Thank you for those, my favorite subjects, so I would say. First of all with the guidance for the full year, this year that has a midpoint of 35% sales growth at constant exchange rates at least in the novo settings it feels like we have released the handbrake.
First of all with a guidance for the full year. This year that has a midpoint of 35% sales growth at cost exchange rates at least in the neuro settings. It feels like we have released the handbrake.
And moving.
It's very high pace in terms of growth rates at least it's the highest in the history of the company.
Karsten Knudsen: And moving at very high pace in terms of growth rates, at least it's the highest in the history of the company. But that said and extrapolations into 2024, I would say first of all, we're clearly pursuing growth strategy based on the innovation. We have shown that we have the innovation platforms, especially in OZEMPIC and WEGOVY to drive growth this year and clearly also also next year. So not teaching you how to extrapolate, but if you extrapolate our implied Q4 sales growth based on our guidance then you actually get to a sales growth number next year in the double digits, which is actually not that far away from from where consensus is currently, so I do believe that we're scaling very fast. And then specifically on WEGOVY and any hand brakes there, then what I'd say as to 2024 is that in 2024 we will be delivering significant step up in volumes to the US market compared to 2023 as we did from '22 to '23. And then to your pricing questions, as we've said on numerous occasions. The appropriate way of looking at net realized pricing in the US is to look at the year to date numbers. So most contracts are contracted on an annual basis and the tricky part is the lag effect between when a script is written and then we receive the rebate claims from the payers and that's just the lag effect of several months and that's why in reality Q3 is the first point, where we see how how the channel-payer mix tool is falling out for 2023. So I wouldn't use Q3 in isolation for a financing forecasting wise I would recommend you to use year to date Q3 as a starting point.
Karsten Knudsen: And moving at very high pace in terms of growth rates, at least it's the highest in the history of the company. But that said and extrapolations into 2024, I would say first of all, we're clearly pursuing growth strategy based on the innovation. We have shown that we have the innovation platforms, especially in OZEMPIC and WEGOVY to drive growth this year and clearly also also next year.
But that said and extrapolations and into 2024.
I would say first of all we're clearly appearance growth strategy based on the innovation. We have shown that we have the innovation platforms, especially in <unk> and veeco, which were to drive growth. This year and clearly also also next year.
So.
So not teaching you how to extrapolate, but if you extrapolate our implied Q4 sales growth based on our guidance. Then the then you actually get to a sales growth number next year.
Karsten Knudsen: So not teaching you how to extrapolate, but if you extrapolate our implied Q4 sales growth based on our guidance then you actually get to a sales growth number next year in the double digits, which is actually not that far away from from where consensus is currently, so I do believe that we're scaling very fast. And then specifically on WEGOVY and any hand brakes there, then what I'd say as to 2024 is that in 2024 we will be delivering significant step up in volumes to the US market compared to 2023 as we did from '22 to '23. And then to your pricing questions, as we've said on numerous occasions. The appropriate way of looking at net realized pricing in the US is to look at the year to date numbers. So most contracts are contracted on an annual basis and the tricky part is the lag effect between when a script is written and then we receive the rebate claims from the payers and that's just the lag effect of several months and that's why in reality Q3 is the first point, where we see how how the channel-payer mix tool is falling out for 2023. So I wouldn't use Q3 in isolation for a financing forecasting wise I would recommend you to use year to date Q3 as a starting point.
Karsten Knudsen: So not teaching you how to extrapolate, but if you extrapolate our implied Q4 sales growth based on our guidance then you actually get to a sales growth number next year in the double digits, which is actually not that far away from from where consensus is currently, so I do believe that we're scaling very fast.
In the double digits, which is actually not that far away from from a consensus is currently so.
So I do believe that we're scaling very very fast and then specifically on.
Karsten Knudsen: So I do believe that we're scaling very fast. And then specifically on WEGOVY and any hand brakes there, then what I'd say as to 2024 is that in 2024 we will be delivering significant step up in volumes to the US market compared to 2023 as we did from '22 to '23. And then to your pricing questions, as we've said on numerous occasions. The appropriate way of looking at net realized pricing in the US is to look at the year to date numbers. So most contracts are contracted on an annual basis and the tricky part is the lag effect between when a script is written and then we receive the rebate claims from the payers and that's just the lag effect of several months and that's why in reality Q3 is the first point, where we see how how the channel-payer mix tool is falling out for 2023. So I wouldn't use Q3 in isolation for a financing forecasting wise I would recommend you to use year to date Q3 as a starting point.
Karsten Knudsen: So I do believe that we're scaling very fast.
The Kobe and any hand brakes, there than than what I would say as soon as 2024.
Karsten Knudsen: And then specifically on WEGOVY and any hand brakes there, then what I'd say as to 2024 is that in 2024 we will be delivering significant step up in volumes to the US market compared to 2023 as we did from '22 to '23. And then to your pricing questions, as we've said on numerous occasions. The appropriate way of looking at net realized pricing in the US is to look at the year to date numbers. So most contracts are contracted on an annual basis and the tricky part is the lag effect between when a script is written and then we receive the rebate claims from the payers and that's just the lag effect of several months and that's why in reality Q3 is the first point, where we see how how the channel-payer mix tool is falling out for 2023. So I wouldn't use Q3 in isolation for a financing forecasting wise I would recommend you to use year to date Q3 as a starting point.
Karsten Knudsen: And then specifically on WEGOVY and any hand brakes there, then what I'd say as to 2024 is that in 2024 we will be delivering significant step up in volumes to the US market compared to 2023 as we did from '22 to '23. And then to your pricing questions, as we've said on numerous occasions.
In 2024.
We will be delivering significant step up in volumes to the U S <unk> compared to 'twenty to 'twenty three as we did from 'twenty to 'twenty three.
And then essentially a pricing questions.
Yeah.
As we've said on numerous occasions Sir.
Karsten Knudsen: The appropriate way of looking at net realized pricing in the US is to look at the year to date numbers. So most contracts are contracted on an annual basis and the tricky part is the lag effect between when a script is written and then we receive the rebate claims from the payers and that's just the lag effect of several months and that's why in reality Q3 is the first point, where we see how how the channel-payer mix tool is falling out for 2023. So I wouldn't use Q3 in isolation for a financing forecasting wise I would recommend you to use year to date Q3 as a starting point.
Karsten Knudsen: The appropriate way of looking at net realized pricing in the US is to look at the year to date numbers. So most contracts are contracted on an annual basis and the tricky part is the lag effect between when a script is written and then we receive the rebate claims from the payers
The appropriate way of looking at net realized pricing in the U S is to look at it at the year to date numbers.
So most contracts.
Our contracted on an annual basis and to end the tricky part is the.
The lag effect between when a script is written and then we received at the rebate claims from from the pay us and that's just the lag effect of several months and Thats why <unk>.
Karsten Knudsen: and that's just the lag effect of several months and that's why in reality Q3 is the first point, where we see how how the channel-payer mix tool is falling out for 2023. So I wouldn't use Q3 in isolation for a financing forecasting wise I would recommend you to use year to date Q3 as a starting point. Thank You.
<unk> royalty Q3 is the first point, where we see how how the channel and payer mix tool is falling out for.
For 2023.
So I wouldn't use Q3 in isolation for a financing forecasting wise I would recommend you to use year to date Q3 Sss.
Peter Verdult: Thank you.
Sure.
Daniel Bohsen: We're ready for the next question.
Operator: Thank you. Your next question comes from the line of Mark Purcell from Morgan Stanley. Please go ahead.
Your next question comes from the line of Mark Purcell from Morgan Stanley. Please go ahead.
Mark Douglas Purcell: Yeah. Thanks, very much for taking my questions first one on <unk>, one on higher doses really starting high dose trials for <unk>, you have 860 milligrams coming through. At the end by the end of this year can you help me understand your expectations, there and the importance of increasing your dose where the pivotal trial at some point to read out late next year and then secondly in terms of the pen platform leverage we estimate. About 100 million GOP, one Penn units can be sold by Nova in 2023 for up to one side is. The majority is the flex platform with a three ml platform. So will you use those two platforms to launch in the U S and if not why not. And the third question. <unk> higher dose considerations yeah, absolutely. Thank you for that question. So you're absolutely right. We're investigating it eight and 16 milligram in diabetes, but we're also investigating seven two milligram <unk>. The purpose is obviously to assess whether we. We can achieve an even higher efficacy without compromising on safety. Our model suggests in particular, new business space that are higher those could potentially be. The associated with an even greater weight loss without having to compromise on safety and be intelligent.
Mark Douglas Purcell: Yeah Thanks very much for taking my questions, the first one on GLP-1 on higher doses, Lilly is starting high dose trials for Tirzepatide, you have 8 and 60 milligrams coming through by the end of this year, can you help me understand your expectations, there and the importance of increasing your dose where the pivotal trial at some point to read out late next year? and then secondly in terms of the pen platform leverage we estimate. About 100 million GOP, one Penn units can be sold by Nova in 2023 for up to one side is. The majority is the flex platform with a three ml platform. So will you use those two platforms to launch in the U S and if not why not. And the third question. <unk> higher dose considerations.
Mark Douglas Purcell: Yeah Thanks very much for taking my questions, the first one on GLP-1 on higher doses, Lilly is starting high dose trials for Tirzepatide, you have 8 and 16 milligrams coming through by the end of this year, can you help me understand your expectations, there and the importance of increasing your dose where the pivotal trial at some point to read out late next year?
At the end by the end of this year can you help me understand your expectations, there and the importance of increasing your dose where the pivotal trial at some point to read out late next year and then secondly in terms of the pen platform leverage we estimate.
Mark Douglas Purcell: And then secondly in terms of the pen platform leverage, we estimate that about 100 million GLP-1 Pen units can be sold by Novo in 2023 for GLP-1s that is, and he majority is the FlexTouch platform with a 3ml platform. So will you use those two platforms to launch WEGOVY in the U S and if not why not. And the third question. <unk> higher dose considerations.
Mark Douglas Purcell: And then secondly in terms of the pen platform leverage, we estimate that about 100 million GLP-1 Pen units are gonna be sold by Novo in 2023 for GLP-1s that is, and he majority is the FlexTouch platform with a 3ml platform. So will you use those two platforms to launch WEGOVY in the U S and if not why not.
About 100 million GOP, one Penn units can be sold by Nova in 2023 for up to one side is.
The majority is the flex platform with a three ml platform. So will you use those two platforms to launch in the U S and if not why not.
And the third question.
<unk> higher dose considerations yeah, absolutely. Thank you for that question. So you're absolutely right. We're investigating it eight and 16 milligram in diabetes, but we're also investigating seven two milligram <unk>.
Daniel Bohsen: Martin first question for you, GLP-1 higher dose considerations.
Martin Holst Lange: Yeah, absolutely, thank you for that question. So you're absolutely right. We're investigating 8 and 16 milligram in diabetes, but we're also investigating 7.2 milligram in obesity, the purpose is obviously to assess whether we can achieve an even higher efficacy without compromising on safety. Our model suggests in particular in the obesity space that a higher those could potentially be associated with an even greater weight loss without having to compromise on safety and being diligent we want to assess this.
Martin Holst Lange: Yeah, absolutely, thank you for that question. So you're absolutely right. We're investigating 8 and 16 milligram in diabetes, but we're also investigating 7.2 milligram in obesity, the purpose is obviously to assess whether we can achieve an even higher efficacy without compromising on safety.
The purpose is obviously to assess whether we.
We can achieve an even higher efficacy without compromising on safety. Our model suggests in particular, new business space that are higher those could potentially be.
Martin Holst Lange: Our model suggests in particular in the obesity space that a higher those could potentially be associated with an even greater weight loss without having to compromise on safety and being diligent we want to assess this.
The associated with an even greater weight loss without having to compromise on safety and be intelligent.
We want to assess this.
Daniel Bohsen: Thank you Martin and if I understood. Your question correct Mark than the question was whether we will leverage our flex platform also to launch <unk> in the U S. In the flex touch device, but but last maybe for you any strategic considerations in our device platforms, yes, Marc. Thanks for the question I would just say that we have a situation today, where we have.
Daniel Bohsen: Thank you Martin and if I understood your question correct Mark then the question was whether we will leverage our FlexTouch platform also to launch WEGOVY in the US in the FlexTouch device, but Lars maybe to you any strategic considerations in our device platforms.
Your question correct Mark than the question was whether we will leverage our flex platform also to launch <unk> in the U S.
In the flex touch device, but but last maybe for you any strategic considerations in our device platforms, yes, Marc. Thanks for the question I would just say that we have a situation today, where we have.
Lars Fruergaard Joergensen: Yes, Mark thanks for the question, I would just say that we have a situation today where we have a number of device platforms inside the company, one using outside vendor and technology, so that gives us flexibility and is actually part of fueling the growth today that we can we can flex this, so I'll not go into specific speculation about what we use of device per market but we see that it's a strength that we can flex between different presentations and we see today that its really the figures of the molecule that drives that so that gives us quite some flexibility in how we go to market country by country and strategic strategic flexibility on our side. Thank you.
Lars Fruergaard Joergensen: Yes, Mark thanks for the question, I would just say that we have a situation today where we have a number of device platforms inside the company, one using outside vendor and technology, so that gives us flexibility and is actually part of fueling the growth today that we can we can flex this,
The number of device platforms.
Inside the company one.
Yeah.
Using outside.
Vendor and technology, so that gives us flexibility and is actually.
Lars Fruergaard Joergensen: so I'll not go into specific speculation about what we use of device per market but we see that it's a strength that we can flex between different presentations and we see today that its really the figures of the molecule that drives that so that gives quite some flexibility in how we go to market country by country and strategic flexibility on our side. Thank you.
Part of fueling the growth today that we can we can flex. This so I'll not go into specifics for inspiration about water use of device per market.
But we see that it's a strength that we can flex between different.
<unk>.
And we see today that its really the.
The figure of the molecule that drives that so that gives us quite some flexibility in how we go to market country by country and strategic.
Strategic flexibility on our side. Thank you.
Daniel Bohsen: Thank you Lars, next question please.
Operator: Thank you. Your next question comes from the line of Emily Field from Barclays. Please go ahead.
Your next question comes from the line of Emily Field from Barclays. Please go ahead.
Emily Field: Hi, Thanks for taking my question. I'll ask two, one just on the STEP 9 osteoarthritis study I believe that this is not large enough to be added to the WEGOVY label, so if this were to be a positive study what would be your next steps plans? And then just on anti obesity medications and muscle loss, we've seen competitors more explicitly make efforts in R&D. For compounds that could preserve lean mass over fat mass and overall weight loss I was wondering if you could just give an update on where you stand on that within your R&D portfolio. Thank you.
Emily Field: Hi, Thanks for taking my question. I'll ask two, one just on the STEP 9 osteoarthritis study I believe that this is not large enough to be added to the WEGOVY label, so if this were to be a positive study what would be your next STEPs plans?
I'll ask two one just on the step nine osteoarthritis study I believe that this is not large enough to be added to the Goldie label. So if this were to be a positive study what would be your next steps plans.
Emily Field: And then just on anti obesity medications and muscle loss, we've seen competitors more explicitly make efforts in R&D for compounds that could preserve lean mass over fat mass and overall weight loss I was wondering if you could just give an update on where you stand on that within your R&D portfolio. Thank you.
And then just on anti obesity medications and muscle loss, we've seen competitors more explicitly make efforts in R&D.
For compounds that could preserve lean mass over fat mass and overall weight loss I was wondering if you could just give an update on where you stand on that within your R&D portfolio. Thank you.
Daniel Bohsen: Thank you Emily Martin two for you.
Martin Holst Lange: So specifically on the. Throughout this trial Youre right its not the biggest driver I think it's too early to speculate whether that will have an impact on our label. It's very very clear that for us it's also guiding for. Future clinical activities, specifically, maybe for Kevin <unk>. GOP comb. Combination so so. It has actually two potentials both to serve for information. Typically probably go with but also to guide us for future activities. And the second one Martin obesity, and research and development focus on the muscle loss. I think this is a relevant point that it's also a focus of ours. With current treatment specifically when you go and extend that we actually see them. A reasonable preservation of. Lean body mass given the broader weight loss, but it has to be a focus area and you will probably see also in our pipeline without going into details. Maybe even gladstone assets that could. The two. Preservation of Numis. Thank you Martin. Thank you Emily we are ready for the next question.
Martin Holst Lange: So specifically on the Osteoarthritis trial, You're right its not the biggest trial I think it's too early to speculate whether that will have an impact on our label. It's very very clear that for us it's also guiding for future clinical activities, specifically, maybe for CAGRISEMA, AMYCRETIN or our GLP-1/GIP combination so it has actually two potentials both to serve for information. Typically probably go with but also to guide us for future activities. And the second one Martin obesity, and research and development focus on the muscle loss. I think this is a relevant point that it's also a focus of ours. With current treatment specifically when you go and extend that we actually see them. A reasonable preservation of. Lean body mass given the broader weight loss, but it has to be a focus area and you will probably see also in our pipeline without going into details. Maybe even gladstone assets that could. The two. Preservation of Numis.
Martin Holst Lange: So specifically on the Osteoarthritis trial, You're right its not the biggest trial I think it's too early to speculate whether that will have an impact on our label. It's very very clear that for us it's also guiding for future clinical activities, specifically, maybe for CAGRISEMA, AMYCRETIN or our GLP-1/GIP combination.
Martin Holst Lange: So specifically on the Osteoarthritis trial, You're right its not the biggest trial I think it's too early to speculate whether that will have an impact on our label.
Throughout this trial Youre right its not the biggest driver I think it's too early to speculate whether that will have an impact on our label.
It's very very clear that for us it's also guiding for.
Martin Holst Lange: It's very very clear that for us it's also guiding for future clinical activities, specifically, maybe for CAGRISEMA, AMYCRETIN or our GLP-1/GIP combination so it has actually two potentials both to serve for information specifically for WEGOVY but also to guide us for future activities.
Future clinical activities, specifically, maybe for Kevin <unk>.
GOP comb.
Martin Holst Lange: So it has actually two potentials both to serve for information specifically for WEGOVY but also to guide us for future activities. And the second one Martin obesity, and research and development focus on the muscle loss. I think this is a relevant point that it's also a focus of ours. With current treatment specifically when you go and extend that we actually see them. A reasonable preservation of. Lean body mass given the broader weight loss, but it has to be a focus area and you will probably see also in our pipeline without going into details. Maybe even gladstone assets that could. The two. Preservation of Numis.
Martin Holst Lange: So it has actually two potentials both to serve for information specifically for WEGOVY but also to guide us for future activities.
Combination so so.
It has actually two potentials both to serve for information.
Typically probably go with but also to guide us for future activities.
Martin Holst Lange: And the second one Martin obesity, and research and development focus on the muscle loss. I think this is a relevant point that it's also a focus of ours. With current treatment specifically when you go and extend that we actually see them. A reasonable preservation of. Lean body mass given the broader weight loss, but it has to be a focus area and you will probably see also in our pipeline without going into details. Maybe even gladstone assets that could. The two. Preservation of Numis.
Daniel Bohsen: And the second one Martin obesity, and research and development focus on the muscle loss.
And the second one Martin obesity, and research and development focus on the muscle loss.
Martin Holst Lange: I think this is a relevant point that it's also a focus of ours. With current treatment specifically WEGOVY and SAXENDA we actually see a reasonable preservation of lean body mass given the broader weight loss, but it has to be a focus area and you will probably see also in our pipeline without going into details, maybe even quite soon, assets that could lead to a preservation of lean mass.
I think this is a relevant point that it's also a focus of ours.
With current treatment specifically when you go and extend that we actually see them.
A reasonable preservation of.
Lean body mass given the broader weight loss, but it has to be a focus area and you will probably see also in our pipeline without going into details.
Maybe even gladstone assets that could.
The two.
Daniel Bohsen: Thank you Martin. Thank you Emily, we are ready for the next question.
Preservation of Numis. Thank you Martin. Thank you Emily we are ready for the next question.
Operator: Thank you. Your next question comes from the line of Simon Baker from Redburn. Please go ahead.
Next question comes from the line of Simon Baker from Redburn. Please go ahead.
Simon Baker: Thank you for taking my questions, two if I may, firstly on China. Growth looks pretty good over there, but I just wondering if you could give us an update on the impact of reduced access to Chinese hospitals, on how about is affecting things, if indeed at all. and then secondly. On on Sumac a charge. There was an interesting. Preprint on Monday, looking at Houston alcohol use disorder, which look very impressive. Be interesting to get your thoughts on the potential of that indication. Opinion, thanks, so much.
Simon Baker: Thank you for taking my questions, two if I may, firstly on China. Growth looks pretty good over there, but I just wondering if you could give us an update on the impact of reduced access to Chinese hospitals, on how about is affecting things, if indeed at all.
Gross looks looks looks pretty good over there, but I just wondering if you could give us an update on the impact of reduced access to Chinese hospitals.
On how on how about is affecting things if indeed true and then secondly.
On on Sumac a charge.
Simon Baker: And then secondly on SEMAGLUTIDE, there was an interesting journal pre-print on Monday, looking at it's use in alcohol use disorder, which looked very impressive, I'm interested to get your thoughts on the potential of that indication in your opinion, thanks, so much.
There was an interesting.
Preprint on Monday, looking at Houston alcohol use disorder, which look very impressive.
Be interesting to get your thoughts on the potential of that indication.
Opinion, thanks, so much.
Daniel Bohsen: Thank you Simon, so Camilla, the first one to you, do we see reduced access to Chinese hospitals?
So.
So Ken Miller, the first one to you.
Do we see reduced access to Chinese hospitals.
Camilla Sylvest: So in general we are working across the country and we also have access to hospitals in general, what we do see in China is an effect of the VPP of course, that's why do you mean the insulin sales results and that is also, when you look at an overall IO business point of view, that is what is actually dragging down the overall IO insulin growth, but in China OZEMPIC is going really well, we have a great momentum of OZEMPIC that we've had since the launch and since the inclusion on the reimbursement list and that kind of drive growth in China. No major issues with access, Martin the second question, yes. Thank you very much for the question. <unk> also seen these. These observational studies. And. Been intrigued by the fact that that one may have a place in also treating alcohol abuse. It was actually lie within the motive action of tier one from our perspective when also considering the timing the combination of two mode of action that could potentially also help here, namely GOP, one and emmeline so specifically from our perspective. Eric Hagen with <unk>. As far as the more attractive and efficacious approach. So if you see us growing into that space that would be with geico cinema in northwest Merseyside alone.
Camilla Sylvest: So in general we are working across the country and we also have access to hospitals in general, what we do see in China is an effect of the VPP of course, that's why do you mean the insulin sales results and that is also, when you look at an overall IO business point of view, that is what is actually dragging down the overall IO insulin growth, but in China OZEMPIC is going really well, we have a great momentum of OZEMPIC that we've had since the launch and since the inclusion on the reimbursement list and that kind of drive growth in China.
Camilla Sylvest: So in general we are working across the country and we also have access to hospitals in general, what we do see in China is an effect of the VPP of course, that's why do you mean the insulin sales results and that is also, when you look at an overall IO business point of view, that is what is actually dragging down the overall IO insulin growth.
So have access to.
Hospitals in general and while we do see in China is there an effect of D. A.
<unk> of course, that's why do you mean, the insulin man.
Sales and results.
And that is also when you look at an overall Io business point of view that is why do you think could be dragging down the overall IL <unk>.
Insulin growth and but in China, <unk> said going really well, we have a great momentum.
Camilla Sylvest: But in China OZEMPIC is going really well, we have a great momentum of OZEMPIC that we've had since the launch and since the inclusion on the reimbursement list and that kind of drive growth in China.
I think that we've had since it launched and since the inclusion.
On the <unk>.
That's my list and that that kind of drive growth in China.
Camilla Sylvest: No major issues with access, Martin the second question, yes. Thank you very much for the question. <unk> also seen these. These observational studies. And. Been intrigued by the fact that that one may have a place in also treating alcohol abuse. It was actually lie within the motive action of tier one from our perspective when also considering the timing the combination of two mode of action that could potentially also help here, namely GOP, one and emmeline so specifically from our perspective. Eric Hagen with <unk>. As far as the more attractive and efficacious approach. So if you see us growing into that space that would be with geico cinema in northwest Merseyside alone.
Daniel Bohsen: No major issues with access, Martin the second question,
No major issues with excess matching the second question, yes. Thank you very much for the question.
Martin Holst Lange: Yes, thank you very much for the question. We have also seen these observational studies and been intrigued by the fact that GLP-1 may have a place in also treating alcohol abuse, that was actually live within the mode of action of GLP-1. From our perspective and also considering the timing, the combination of two mode of actions that could potentially also help here, namely GLP-1 and Amylin so specifically from our perspective CAGRISEMA is probably the more attractive and efficacious approach. So if you see us growing into that space, that would be with CAGRISEMA and not with SEMAGLUTIDE alone.
Martin Holst Lange: Yes, thank you very much for the question. We have also seen these observational studies and been intrigued by the fact that GLP-1 may have a place in also treating alcohol abuse, that was actually live within the mode of action of GLP-1.
<unk> also seen these.
These observational studies.
And.
Been intrigued by the fact that that one may have a place in also treating alcohol abuse.
It was actually lie within the motive action of tier one from our perspective when also considering the timing the combination of two mode of action that could potentially also help here, namely GOP, one and emmeline so specifically from our perspective.
Martin Holst Lange: From our perspective and also considering the timing, the combination of two mode of actions that could potentially also help here, namely GLP-1 and Amylin so specifically from our perspective CAGRISEMA is probably the more attractive and efficacious approach. So if you see us growing into that space, that would be with CAGRISEMA and not with SEMAGLUTIDE alone.
Martin Holst Lange: From our perspective and also considering the timing, the combination of two mode of actions that could potentially also help here, namely GLP-1 and Amylin so specifically from our perspective CAGRISEMA is probably the more attractive and efficacious approach.
Eric Hagen with <unk>.
As far as the more attractive and efficacious approach. So if you see us growing into that space that would be with geico cinema in northwest Merseyside alone.
Martin Holst Lange: So if you see us growing into that space, that would be with CAGRISEMA and not with SEMAGLUTIDE alone.
Daniel Bohsen: Thank you Martin, we're ready for the next question.
Thanks, So much we're ready for the next year.
Operator: Thank you. Your next question comes from the line of Naresh Chouhan from Intron Health. Please go ahead.
Your next question.
It goes from the line of Morris Callahan from <unk>. Please go ahead.
Naresh Chouhan: Hi, there thanks for taking my questions. First one on WEGOVY US market access, we are hearing of a growing number of employers having to opt out, having already opted in because of demand's being too high, can you just help us get a sense of how big or small an issue this is and obviously next year, that's probably potentially likely to increase when supply resiliences and demand increases. And secondly on supply, if I look back at when you, you seemed to be relatively comfortable with the demand. You were round about 30,000, new (inaudible) starts a week in the US, that would be, is that a fair starting point for the ability to supply and grow from there going into 2024. Thank you.
Naresh Chouhan: Hi, there thanks for taking my questions.
Naresh Chouhan: First one on WEGOVY US market access, we are hearing of a growing number of employers having to opt out, having already opted in because of demand's being too high, can you just help us get a sense of how big or small an issue this is and obviously next year, that's probably potentially likely to increase when supply resiliences and demand increases. And secondly on supply, if I look back at when you, you seemed to be relatively comfortable with the demand. You were round about 30,000, new (inaudible) starts a week in the US, that would be, is that a fair starting point for the ability to supply and grow from there going into 2024. Thank you.
Naresh Chouhan: First one on WEGOVY US market access, we are hearing of a growing number of employers having to opt out, having already opted in because of demand's being too high, can you just help us get a sense of how big or small an issue this is and obviously next year, that's probably potentially likely to increase when supply resiliences and demand increases.
First one on the.
The U S market access.
We are hearing.
Growing number of employers having too.
Having already are today.
Demand has been too high can.
Can you just help us get a sense of how big or small issue. This is Ben.
Next year, that's probably potentially annualized increase when supply and.
When demand increases.
And secondly.
Naresh Chouhan: And secondly on supply, if I look back at when you, you seemed to be relatively comfortable with the demand. You were round about 30,000, new (inaudible) starts a week in the US, that would be, is that a fair starting point for the ability to supply and grow from there going into 2024. Thank you.
On supply.
If I look back at when you are you seem to be relatively comfortable with the demand.
We round about 30000, new thoughts a week in the U S.
That would be is that a fair starting point for.
The ability to supply them in growth from that going into 2024. Thank you.
Daniel Bohsen: Thank you Naresh, so Doug, any updates on the US market access for WEGOVY?
Doug Langa: Yes, thanks Naresh, and overall we're very pleased with the broad market access that we have for WEGOVY. Most major PBMs and health plans are covering and that derives around 50 million people with obesity now have been covered and importantly, we're seeing about 80% of the patients that are paying less than $25 for WEGOVY. Now to your question specifically around employers, we do see some opt-outs, but we're seeing overall, more opt-ins than opt-outs so directionally, we're heading in the right direction and our focus will be continuing on securing employer coverage as well as stronger access for AOMs overall.
Doug Langa: Yes, thanks Naresh, and overall we're very pleased with the broad market access that we have for WEGOVY. Most major PBMs and health plans are covering and that derives around 50 million people with obesity now have been covered and importantly, we're seeing about 80% of the patients that are paying less than $25 for WEGOVY.
Most major Pbms and health plans are covering it not arise around 50 million people with obesity now covered and.
And importantly, we're seeing about 80% of the patients that are paying less than $25. Four will go now.
Doug Langa: Now to your question specifically around employers, we do see some opt-outs, but we're seeing overall, more opt-ins than opt-outs so directionally, we're heading in the right direction and our focus will be continuing on securing employer coverage as well as stronger access for AOMs overall.
Now to your question specifically around employers, we do see some opt outs, but we're seeing overall more opt in opt out so directionally, we're heading in the right direction and our focus will be continue on continuing on securing employer coverage as well as stronger access for airlines overall.
Daniel Bohsen: Thank you Doug, Karsten any additional comments on the WEGOVY supply going into next year.
Any additional comments on the coal supply going into next year.
Yes, so I think the way to look at the U S. We have equal with suppliers as a starting point of of currently around 100000 to your extra week. According to track through the year and then we have five different dose strengths and then of course. The magic is to get that split right. Into the Lincoln instrument in factoring and then scale from there and as we've said in prior quarters then. And then this is something we do dynamically. So so don't look for a hockey stick. It's a gradual process where of course, we will be starting it at the lower doses and then increasing them as we move forward. <unk>. Different data sources in terms of new starts so I'm not I'm not really sure what youre data sources. I think my data point is lower than yours in terms of number of new starts per week. Thank you Pat and thank you and our risks and we're ready for the next question. Please.
Karsten Knudsen: Yes, so I think the way to look at the US WEGOVY supply is as a starting point of currently around 100,000 TRx per week according to IQVIA and then we have five different dose strengths and then of course the magic is to get that split right into the link and into manufacturing and then we scale from there and as we've said in prior quarters then this is something we do dynamically so don't look for a hockey stick, it's a gradual process where of course we'll be starting it at the lower doses and then increasing them as we move forward. There are different data sources in terms of new starts so I'm not really sure what your data source is but I think my data point is lower than yours in terms of number of new starts per week.
Karsten Knudsen: Yes, so I think the way to look at the US WEGOVY supply is as a starting point of currently around 100,000 TRx per week according to IQVIA and then we have five different dose strengths and then of course the magic is to get that split right into the link and into manufacturing and then we scale from there
The magic is to get that split right.
Into the Lincoln instrument in factoring and then scale from there and as we've said in prior quarters then.
Karsten Knudsen: And as we've said in prior quarters then this is something we do dynamically so don't look for a hockey stick, it's a gradual process where of course we'll be starting it at the lower doses and then increasing them as we move forward. There are different data sources in terms of new starts so I'm not really sure what your data source is but I think my data point is lower than yours in terms of number of new starts per week.
Karsten Knudsen: And as we've said in prior quarters then this is something we do dynamically so don't look for a hockey stick, it's a gradual process where of course we'll be starting it at the lower doses and then increasing them as we move forward.
And then this is something we do dynamically. So so don't look for a hockey stick.
It's a gradual process where of course, we will be starting it at the lower doses and then increasing them as we move forward.
Karsten Knudsen: There are different data sources in terms of new starts so I'm not really sure what your data source is but I think my data point is lower than yours in terms of number of new starts per week.
<unk>.
Different data sources in terms of new starts so I'm not I'm not really sure what youre data sources.
I think my data point is lower than yours in terms of number of new starts per week.
Daniel Bohsen: Thank you Karsten and thank you Naresh and we're ready for the next question please.
Thank you Pat and thank you and our risks and we're ready for the next question. Please.
Operator: Thank you. Your next question comes from the line of Florent Cespedes from Societe Generale. Please go ahead.
Your next question comes from the line of funds. That's part of it is from Society Generale. Please go ahead.
Florent Cespedes: Good afternoon thank you very much for taking my questions, two please. First one on WEGOVY in Europe, have you started to talk to the payers in Europe as you have already submitted data to the European authorities and do you believe that you will need to show statistically significant benefit on the cardiovascular beat will be presented at the AHA next week and my second question is on OZEMPIC following the FLOW results. How would you position the product in this population as we already have products available to treat these patients, notably de SGLT2, and then it seems that in the trial 15% of the patients are under SGLT2 treatment so some color on this one could be helpful, thank you.
Florent Cespedes: Good afternoon thank you very much for taking my questions, two please. First one on WEGOVY in Europe, have you started to talk to the payers in Europe as you have already submitted data to the European authorities and do you believe that you will need to show statistically significant benefit on the cardiovascular beat will be presented at the AHA next week.
Bruce one on <unk> in Europe have you started to talk to the payers in Europe as you have already submitted the data to the European.
<unk> do you believe that you will need to show statistically significant benefit on the <unk> will be presented.
Next week and my second question is on <unk> peak flu results.
Florent Cespedes: And my second question is on OZEMPIC following the FLOW results. How would you position the product in this population as we already have products available to treat these patients, notably de SGLT2, and then it seems that in the trial 15% of the patients are under SGLT2 treatment so some color on this one could be helpful, thank you.
How would you position the product in this population.
We already offer available.
To predict patients.
The Ngl's too and then it seems like the tri of 15% of the patients.
Under two.
Two of treatment. So some color on this one could be thank you.
Daniel Bohsen: Thank you Florent and Camilla maybe the first one for you in terms of WEGOVY outside the US.
Outside the U S.
Camilla Sylvest: Yes, so in terms of, I believe the question was whether we need statistical significance, I would just say right now we await the presentation at the conference, but in general there is a great interest in WEGOVY and of course also the benefits in SELECT, so we will get back to that but we have and we do see authorities interested in bringing up the discussion again with us already at this point for reimbursement of WEGOVY and just a reminder we have the investment of SAXENDA already in close to 15 countries all around the world and of course here we are talking a step up in treatment.
Camilla Sylvest: Yes, so in terms of, I believe the question was whether we need statistical significance, I would just say right now we await the presentation at the conference, but in general there is a great interest in WEGOVY and of course also the benefits in SELECT, so we will get back to that.
They need the question was whether we need statistical significant I would say.
Okay.
That presentation at <unk>.
At the conference, but in general the Asa great interest in it.
<unk> and of course also the benefits.
So we will get back to that but we have and we can see us allocate interested in bringing up the discussion again with us already at this point and for reimbursement of Nicola and just to remind that we have the investment of Asics and already close to 15 countries and all around the world and of course here we are talking.
Camilla Sylvest: But we have and we do see authorities interested in bringing up the discussion again with us already at this point for reimbursement of WEGOVY and just a reminder we have the investment of SAXENDA already in close to 15 countries all around the world and of course here we are talking a step up in treatment.
They are popping in treatment.
Daniel Bohsen: Thank you Camilla, Martin any medical perspectives on FLOW and the population that we potentially could treat.
Martin Holst Lange: Yeah absolutely, maybe just also calling out on SELECT, the study was designed to have a power, specifically for the primary endpoint, so assuming statistical significant for the secondary endpoints is to be seen as an upside and not as something to be expected, I just want to call that out, but obviously please tune in on what we can present on November 11th In Philadelphia. Specifically on FLOW, I think there's a tremendous unmet need in the diabetes space it's Also very very clear that not all patients today, who suffer from diabetes and chronic kidney disease are on an SGLT2 and or on a GLP-1 and therefore to have data to suggest that we can actually decrease and again, we haven't seen the data, but we can potentially decrease the Kidney disease deterioration by a substantial number, on top of standard of care, including SGLT2s is a really really attractive offering and it will allow more patients in need to get on a GLP-1.
Martin Holst Lange: Yeah absolutely, maybe just also calling out on SELECT, the study was designed to have a power, specifically for the primary endpoint, so assuming statistical significant for the secondary endpoints is to be seen as an upside and not as something to be expected, I just want to call that out,
Specifically for the primary endpoint, so assuming statistical significant.
For the secondary endpoints is to be seen as an upside.
Is something to be.
We expect that I, just want to call that out, but obviously please tune in on what we can present.
Martin Holst Lange: But obviously please tune in on what we can present on November 11th In Philadelphia. Specifically on FLOW, I think there's a tremendous unmet need in the diabetes space it's also very very clear that not all patients today, who suffer from diabetes and chronic kidney disease are on an SGLT2 and or on a GLP-1 and therefore to have data to suggest that we can actually decrease and again, we haven't seen the data, but we can potentially decrease the Kidney disease deterioration by a substantial number, on top of standard of care, including SGLT2s is a really really attractive offering and it will allow more patients in need to get on a GLP-1.
Martin Holst Lange: But obviously please tune in on what we can present on November 11th In Philadelphia. Specifically on FLOW, I think there's a tremendous unmet need in the diabetes space it's also very very clear that not all patients today, who suffer from diabetes and chronic kidney disease are on an SGLT2 and or on a GLP-1
On November 11.
In Philadelphia.
Typically on flow.
I think there's a.
There is a tremendous unmet need.
The diabetes space.
Also very very clear that not all patients today, who suffer from diabetes and chronic kidney disease are on in Israel to chew and.
On July one and therefore to have data to suggest that we can actually decrease.
Martin Holst Lange: And therefore to have data to suggest that we can actually decrease and again, we haven't seen the data, but we can potentially decrease the Kidney disease deterioration by a substantial number, on top of standard of care, including SGLT2s is a really really attractive offering and it will allow more patients in need to get on a GLP-1.
And again, we haven't seen the data, but we can potentially decrease.
The.
Kidney disease deterioration.
But by a substantial number on top of standard of care, including his jokes to choose as a really really attractive offering and it will allow more patients in need to get on a jetblue one thank.
Daniel Bohsen: Thank you Martin. Thanks for the question and we are ready for the next question.
Thanks for the question and we are ready for the next question.
Operator: Thank you. We will now take the next question and the question comes from the line of Richard Vosser from JP Morgan. Please go ahead.
Now take the next question.
Question comes from the line of Richard Vasa from Jpmorgan. Please go ahead.
Richard Vosser: Hi, Thanks for taking my questions, a question on the European rollout in WEGOVY first, obviously we know in Denmark in May there was a substantial demand for WEGOVY in about 1% of the population. So I was wondering how that has developed since then, both in terms of volume and how you're seeing patients staying on the drug through Denmark, given its an out of pocket market. And then the second question is on your KP Bioscience product, just wondering how that differentiates from other MR antagonist, particularly KERENDIA from Bayer but there are also others in development from from AstraZeneca etcetera, just your thoughts on how this is different, thanks very much.
Richard Vosser: Hi, Thanks for taking my questions, a question on the European rollout in WEGOVY first, obviously we know in Denmark in May there was a substantial demand for WEGOVY in about 1% of the population.
Question Oh.
On the European rollout is what gave me first obviously, we know in Denmark Ah in May there was a substantial.
Demand for it so it's like IV and.
Richard Vosser: So I was wondering how that has developed since then, both in terms of volume and how you're seeing patients staying on the drug through Denmark, given its an out of pocket market. And then the second question is on your KP Bioscience product, just wondering how that differentiates from other MR antagonist, particularly KERENDIA from Bayer but there are also others in development from from AstraZeneca etcetera, just your thoughts on how this is different, thanks very much.
Richard Vosser: So I was wondering how that has developed since then, both in terms of volume and how you're seeing patients staying on the drug through Denmark, given its an out of pocket market.
About 1% of the population. So I was wondering how that has developed since then both in terms of volume and how youre seeing patients staying on the drug.
Through Denmark, given its announced the pocket market.
Richard Vosser: And then the second question is on your KP Bioscience product, just wondering how that differentiates from other MR antagonist, particularly KERENDIA from Bayer but there are also others in development from from AstraZeneca etcetera, just your thoughts on how this is different, thanks very much.
And then the second question is on your K P. Bioscience product just wondering how that differentiates from Oh, the MLR antagonist, particularly Korea, India from ball out, but there are also others in development from from Astrazeneca et cetera, just your thoughts on how this is different thanks very much.
Daniel Bohsen: Thank you Richard, Camilla the first one to you, WEGOVY rollout in Denmark (inaudible).
Camilla Sylvest: In Denmark, we see a continued interest in WEGOVY and WEGOVY continues to perform very well and it is more than 1% of the population at this point in time. In terms of how many stays on the product we also have, it's too early to give you exact data and numbers, but we do have the, I could say anecdotal evidence that there is a high number, a very very high number of the people to stay on the product from the beginning of the year when the product was launched.
Continued interest in <unk>.
And.
Yes.
Dolby continues to perform very well.
And it is more than 1% of the population at this point in time in terms of.
And how many states on the product. We also have it's too early to give you exact numbers, but we do have that I could say anecdotal evidence that there is a high number of very very high number for people to stay on the.
The product and from the beginning of the yen when the product was launched thank.
Thank you Camilla Martin reflections on the ASO Jordan, Yeah, absolutely. So what we've seen with <unk> as a molecule with a very high affinity for the receptor.
Daniel Bohsen: Thank you Camilla Martin reflections on the OCEDURENONE.
Martin Holst Lange: Yeah, absolutely. So what we've seen with <unk> as a molecule with a very high affinity for the receptor. And also a very high high half life that actually means that we expect to see differentiation not only on efficacy, but it also appears to have a potential upside on the safety side, specifically on hyperkalemia. So we do expect to see a differentiated drug in this space. Thank you Martin. Thank you. Thanks, Richard for the question we are ready for the next.
Martin Holst Lange: Yeah, absolutely. So what we've seen with OCEDURENONE is a molecule with a very high affinity for the receptor and also a very high half life, that actually means that we expect to see differentiation not only on efficacy, but it also appears to have a potential upside on the safety side, specifically on hyperkalemia. So we do expect to see a differentiated drug in this space.
And also a very high high half life that actually means that we expect to see differentiation not only on efficacy, but it also appears to have a potential upside on the safety side, specifically on hyperkalemia.
So we do expect to see a differentiated drug in this space. Thank you Martin. Thank you. Thanks, Richard for the question we are ready for the next.
Martin Holst Lange: Thank you Martin, thank you Camilla, thanks Richard for the question we are ready for the next.
Operator: Thank you. Your next question comes from the line of Peter Welford from Jefferies. Please go ahead.
Your next question comes from the line of Peter Welford from Jefferies. Please go ahead.
Peter Welford: Hi, hopefully you can hear me I've got two questions please. Firstly, if I could come back to (inaudible) gross margin and I appreciate the commentary year to date, but in the third quarter it seemed to trend down quite a bit, which I guess it's somewhat unusual given the quite significant improvements we saw in the gross to nets in your most profitable market, both WEGOVY and OZEMPIC so can you just talk a little bit about in the third quarter, what the incremental cost or whether perhaps any write downs or sort of inventory or something that could potentially depress the gross margin in what would normally be a more profitable quarter. And then secondly, just coming back to the comment that was made on stay time and thinking about it in a different way, which is in the past you cited for SAXENDA that around 25% or more patients are on the drug for at least a year and most of those are treated by obesity experts, I appreciate it's still early for WEGOVY to necessarily give comments on the US and stay time but can you sort of talk about what you're seeing different trends than those of SAXENDA, both in terms of the obesity experts versus both arms and also the number of patient perhaps who are reaching a year at this point. Thank you.
Peter Welford: Hi, hopefully you can hear me I've got two questions please.
Two questions left please.
Peter Welford: Firstly, if I could come back to (inaudible) gross margin and I appreciate the commentary year to date, but in the third quarter it seemed to trend down quite a bit, which I guess it's somewhat unusual given the quite significant improvements we saw in the gross to nets in your most profitable market, both WEGOVY and OZEMPIC so can you just talk a little bit about in the third quarter, what the incremental cost or whether perhaps any write downs or sort of inventory or something that could potentially depress the gross margin in what would normally be a more profitable quarter. And then secondly, just coming back to the comment that was made on stay time and thinking about it in a different way, which is in the past you cited for SAXENDA that around 25% or more patients are on the drug for at least a year and most of those are treated by obesity experts, I appreciate it's still early for WEGOVY to necessarily give comments on the US and stay time but can you sort of talk about what you're seeing different trends than those of SAXENDA, both in terms of the obesity experts versus both arms and also the number of patient perhaps who are reaching a year at this point. Thank you.
Peter Welford: Firstly, if I could come back to (inaudible) gross margin and I appreciate the commentary year to date, but in the third quarter it seemed to trend down quite a bit, which I guess it's somewhat unusual given the quite significant improvements we saw in the gross to nets in your most profitable market, both WEGOVY and OZEMPIC
Firstly, if I could come back.
The gross margin and I appreciate the commentary year to date, but in the third quarter it seemed to trend down quite a bit which I guess, it's somewhat unusual given the quite significant improvements we saw in the gross to nets in your most profitable market.
Peter Welford: so can you just talk a little bit about in the third quarter, what the incremental cost or whether perhaps any write downs or sort of inventory or something that could potentially depress the gross margin in what would normally be a more profitable quarter. And then secondly, just coming back to the comment that was made on stay time and thinking about it in a different way, which is in the past you cited for SAXENDA that around 25% or more patients are on the drug for at least a year and most of those are treated by obesity experts, I appreciate it's still early for WEGOVY to necessarily give comments on the US and stay time but can you sort of talk about what you're seeing different trends than those of SAXENDA, both in terms of the obesity experts versus both arms and also the number of patient perhaps who are reaching a year at this point. Thank you.
Peter Welford: so can you just talk a little bit about in the third quarter, what the incremental cost or whether perhaps any write downs or sort of inventory or something that could potentially depress the gross margin in what would normally be a more profitable quarter.
So can you just talk a little bit of pause in the third quarter, what the incremental cost of whether perhaps any write downs or inventory or something that could potentially depress. The gross margin in what would normally be a more profitable quarter.
Peter Welford: And then secondly, just coming back to the comment that was made on stay time and thinking about it in a different way, which is in the past you cited for SAXENDA that around 25% or more patients are on the drug for at least a year and most of those are treated by obesity experts, I appreciate it's still early for WEGOVY to necessarily give comments on the US and stay time but can you sort of talk about what you're seeing different trends than those of SAXENDA, both in terms of the obesity experts versus both arms and also the number of patient perhaps who are reaching a year at this point. Thank you.
Peter Welford: And then secondly, just coming back to the comment that was made on stay time and thinking about it in a different way, which is in the past you cited for SAXENDA that around 25% or more patients are on the drug for at least a year and most of those are treated by obesity experts,
And then secondly, just coming back to this.
And that was made on stay time and thinking about it a different way, which is in the past you cited for that around 25% or more patients are on drug for at least the yes. Most of those treated by obesity experts I. Appreciate it's still early the wake of the two necessarily you could comment on the U S and stay time.
Peter Welford: I appreciate it's still early for WEGOVY to necessarily give comments on the US and stay time but can you sort of talk about what you're seeing different trends than those of SAXENDA, both in terms of the obesity experts versus both arms and also the number of patient perhaps who are reaching a year at this point. Thank you.
But can you sort of talk about what you're seeing different trends than those of the sector.
Both in terms of the obesity experts.
And also the number of patient Pops of reaching a year at this point. Thank you.
Daniel Bohsen: Thank you Peter So first of all to Karsten on the gross margin and then later Doug on what we see on state time in the US for WEGOVY.
Karsten Knudsen: Yeah Peter, well as part of the growing gross margin in Q3 and just a word of caution to begin with, looking at the gross margins at a quarterly basis is always tricky due to fluctuations over the year, but if I am to comment specifically on the quarter then at constant exchange rates the gross margin was flat compared to last year. So the decline compared to last year is FX driven and then you could say, why is it then not increasing compared to last year, given the gross to net adjustment and the product mix and there are basically two pieces to it. First of all it, remember the starting point, our gross margin is already high at 84% or so and then secondly. What is different compared to prior years is that the amount of Capex, we are running these days and just from an accounting policy standup point of view, we are realizing more cost related to our capital expenditure projects into the P&L. So it doesn't all go towards the balance sheet. Some of it also hits the P&L and that is basically what is offsetting the benefit from product mix.
Karsten Knudsen: Yeah Peter, well as part of the growing gross margin in Q3 and just a word of caution to begin with, looking at the gross margins at a quarterly basis is always tricky due to fluctuations over the year, but if I am to comment specifically on the quarter then at constant exchange rates the gross margin was flat compared to last year.
Well that's part of it.
Martin Q3.
And and just a word of caution to begin with looking at the gross margins at a quarterly basis as it is always tricky due to fluctuation so over the year, but but if I am to comment specifically on the quarter then.
And then at constant exchange rates gross margin was flat compared to last year. So the decline compared to last year is FX driven and then you can say.
Karsten Knudsen: So the decline compared to last year is FX driven and then you could say, why is it then not increasing compared to last year, given the gross to net adjustment and the product mix and there are basically two pieces to it. First of all it, remember the starting point, our gross margin is already high at 84% or so and then secondly. What is different compared to prior years is that the amount of Capex, we are running these days and just from an accounting policy standup point of view, we are realizing more cost related to our capital expenditure projects into the P&L. So it doesn't all go towards the balance sheet. Some of it also hits the P&L and that is basically what is offsetting the benefit from product mix.
Karsten Knudsen: So the decline compared to last year is FX driven and then you could say, why is it then not increasing compared to last year, given the gross to net adjustment and the product mix and there are basically two pieces to it. First of all it, remember the starting point, our gross margin is already high at 84% or so and then secondly.
Why is it they're not increasing compared to compared to last year, given the gross to net adjustment in the product mix.
And there are basically two pieces to it.
First of all it remember the starting point, our gross margin is already high at 84% or so and <unk> and then secondly.
Karsten Knudsen: What is different compared to prior years is that the amount of Capex, we are running these days and just from an accounting policy standup point of view, we are realizing more cost related to our capital expenditure projects into the P&L. So it doesn't all go towards the balance sheet. Some of it also hits the P&L and that is basically what is offsetting the benefit from product mix.
What is different compared to prior years is that the.
The amount of Capex, we are running these days and just from an accounting policy standup point of view, we are realizing more cost related to our capital expenditure projects into the P&L. So it doesn't all go to towards the balance sheet. Some of it also hits the P&L and that.
That is basically what is offsetting.
The benefit from product mix. Thank.
Daniel Bohsen: Thank you Karsten and over to you Doug any insights on state time on WEGOVY in the US so far.
Doug Langa: Yes Peter, Thank you because generally you are right, we expect to be able to say more about state time in 2024 obviously it's been difficult given the few time periods with unrestricted supply, but what I can say is based on early data from multiple sources, persistency on WEGOVY, it looks better than SAXENDA With fewer patients dropping off in the first 12 months, but we'll have more to say in 2024.
Doug Langa: Yes Peter, Thank you because generally you are right, we expect to be able to say more about state time in 2024 obviously it's been difficult given the few time periods with unrestricted supply.
It's been difficult given the few time periods with unrestricted supply, but what I can say is based on early data from multiple sources persistency on <unk>, it looks better than sex and.
Doug Langa: But what I can say is based on early data from multiple sources, persistency on WEGOVY, it looks better than SAXENDA With fewer patients dropping off in the first 12 months, but we'll have more to say in 2024.
With fewer patients dropping off in the first 12 months, but we will have more to say in 2024.
Daniel Bohsen: Thank you Doug and thank you Peter and we're ready for the next question.
Operator: Thank you. Your next question comes from the line of Mattias Häggblom from Handelsbanken. Please go ahead.
Your next question comes from the line of my T. As Heck Bloom from Handelsbanken. Please go ahead.
Mattias Häggblom: Thank you so much an R&D question, in the scenario that both high dose SEMA 7.2 milligram as well as CAGRISEMA works in Phase III can you help me think about the regulatory pathway for fixed dose combination with CAGRISEMA using the high dose demo and whether that would require a new Phase III or ir a small pitching study would be enough. Thanks. So much.
Mattias Häggblom: Thank you so much an R&D question,
R&D question in this scenario that both high dose that much seven milligram as well as Congress works in phase III.
Mattias Häggblom: In the scenario that both high dose SEMA 7.2 milligram as well as CAGRISEMA works in Phase III can you help me think about the regulatory pathway for fixed dose combination with CAGRISEMA using the high dose demo and whether that would require a new Phase III or ir a small pitching study would be enough. Thanks so much.
Help me think about the regulatory pathway for fixed dose combination with calculus isn't the high dose demo and whether that would require a new phase III. What are your thoughts more pitching study would be enough. Thanks. So much.
Thank you Michel Martin Yeah, absolutely. Thank you for that question, let's yes.
Daniel Bohsen: Thank you Mattias, Martin.
Martin Holst Lange: Yeah, absolutely, thank you for that question Mattias. That would most likely require a reasonably, I think we can bridge some safety data, but we will still have to establish both safety and efficacy. So we actually see that as a potential opportunity, but we see that as a lifecycle management activity.
That would most likely require.
Yes.
Reasonably I think we can bridge some safety data, but we will still have to establish both safety and efficacy.
So we actually see that as a potential opportunity, but we see that as a lifecycle management activity.
Daniel Bohsen: Thank you Martin and we have time for two more set of questions. So we're ready for the next one.
Operator: Thank you. The next question comes from the line of Emmanuel Papadakis from DB. Please go ahead.
The next question comes from the line of Emmanuel Papadakis from DB. Please go ahead.
Emmanuel Papadakis: Thanks for taking the question hopefully you can hear me okay, maybe a follow on for Karsten on supply. Karsten you said you're going to quote on quote, significantly increase supply in '24 versus '23, as you did in '23 versus '22. Eyeballing data it looks like there was approximately a five fold increase 23 out of the 22, so you're telling us you're going to have another fivefold increase in 2024, and if not, could you help us with the approximate quantum and then a follow on also on FLOW, Martin you helpful enough on SELECT to give us an indication that the contribution of components had been approximately equal well balanced in SELECT, is that also the case in FLOW or how should we think about the contribution of the composite endpoint components and what should we expect in terms of labeling. Thank You.
Emmanuel Papadakis: Thanks for taking the question hopefully you can hear me okay, maybe a follow on for Karsten on supply. Karsten you said you're going to quote on quote, significantly increase supply in '24 versus '23, as you did in '23 versus '22.
Emmanuel Papadakis: Eyeballing data it looks like there was approximately a five fold increase 23 out of the 22, so you're telling us you're going to have another fivefold increase in 2024, and if not, could you help us with the approximate quantum and then a follow on also on FLOW, Martin you helpful enough on SELECT to give us an indication that the contribution of components had been approximately equal well balanced in SELECT, is that also the case in FLOW or how should we think about the contribution of the composite endpoint components and what should we expect in terms of labeling. Thank You.
Emmanuel Papadakis: Eyeballing data it looks like there was approximately a five fold increase 23 out of the 22, so you're telling us you're going to have another fivefold increase in 2024, and if not, could you help us with the approximate quantum and then a follow on also on FLOW,
<unk> data it looks like there was approximately a five fold increase 23 out of the 22, so you're telling us you're going to have another fivefold increase in 2024, and if not could you help us with the approximate quantum and then a follow on also on flow.
Martin you helpful enough on select to give us an indication that the contribution of components had been approximately equal.
Emmanuel Papadakis: Martin you helpful enough on SELECT to give us an indication that the contribution of components had been approximately equal well balanced in SELECT, is that also the case in FLOW or how should we think about the contribution of the composite endpoint components and what should we expect in terms of labeling. Thank You.
Balance in select is that also the case at flow how should we think about the contribution of the composite endpoint components.
And what should we expect in terms of labeling.
Daniel Bohsen: Thank you Emmanuel first Karsten on any additional supply.
Additional supply.
Karsten Knudsen: Yeah and thanks for Triangulating that way around Emmanuel. I'd love to give you a further flavor but as you know we are guiding for next year come off full year results late January so that's why we'll be doing our financial guidance for 2024 and giving too much granularity in anticipating of WEGOVY gets too close to guiding for next year so, I'm, sorry, but I don't I'd have to provide that at a later point in time.
And thanks for Triangulating that way round Emmanuel.
I'd love to give you a further flavor but.
But as you know we are guiding for next year come off full year results late January so that's why we'll be doing our financial guidance for <unk>, 'twenty, four and giving giving too much granularity in anticipating of recoup it gets it gets too close to guiding for next year. So.
I'm, sorry, but I don't I'd have to price that at a later point in time. Thank.
Daniel Bohsen: Thank you Karsten, Martin can you share more control.
Can you share more control.
Martin Holst Lange: I think it's a great question and I maybe just want to clarify, I don't think we've seen equal contribution from the three model components. We would just say that they all contributed and obviously again, we have to await November 11th until we see the full dataset. Specifically for FLOW I would really love to be able to answer you but due to the nature of an interim analysis, we have not seen the data so for better or worse I know absolutely no more than you do at this point so I can't speculate.
Martin Holst Lange: I think it's a great question and I maybe just want to clarify, I don't think we've seen equal contribution from the three model components. We would just say that they all contributed and obviously again, we have to await November 11th until we see the full dataset.
Maybe just want to clarify I don't think we've seen equal contribution from the three components. We would just say that they all contributed and obviously again, we'd have to await November.
On November 11 until we see the full dataset.
Quickly for flow our drill it ought to be able to answer you but.
Martin Holst Lange: Specifically for FLOW I would really love to be able to answer you but due to the nature of an interim analysis, we have not seen the data so for better or worse I know absolutely no more than you do at this point so I can't speculate.
Due to the nature of an interim analysis, we have not seen the data so so so for better or worse.
No.
Absolutely no more than you do at this point.
I can't speculate. Thank you Martin. Thank you Emmanuel then we will take the last.
I can't speculate.
Daniel Bohsen: Thank you Martin. Thank you Emmanuel then we'll take the last set of questions.
Set of questions.
Operator: Thank you. Your last question for today comes from the line of Michael Novod from Nordea. Please go ahead.
Michael Novod: Yes. Thank you very much, just on the on the cost side, can you please go through some of the dynamics here in Q4 in order to sort of make the cost go up, as I see it, it needs to go up in extreme pace for Q4, are there any specific investment that you're able to take early or anything like that, price going into 2024 just to understand your EBIT guidance.
Michael Novod: Yes. Thank you very much, just on the on the cost side,
Please go through some of the dynamics here in Q4 in order to sort of make the cost.
Michael Novod: can you please go through some of the dynamics here in Q4 in order to sort of make the cost go up, as I see it, it needs to go up in extreme pace for Q4, are there any specific investment that you're able to take early or anything like that, price going into 2024 just to understand your EBIT guidance.
Go up.
As I see it it needs to go up.
And extreme pace for Q4 on any specific investment that youre able to take early or anything like that.
Price going into 2020 forward just to understand you.
Guidance.
Okay.
<unk>.
Yeah.
Daniel Bohsen: That's over to you Karsten.
Karsten Knudsen: Yeah Michael, thanks for that question. When I look at our total operating cost growth in the fourth quarter, then it's actually not markedly different compared to a year to date so what you should be expecting is a continued, what I call, high level of growth in R&D expenditure around the 40% Mark and some 20% plus on an S&D expenditure and the comparative gross margin also in the fourth quarter. So in reality no big swings in the fourth quarter at constant exchange rates.
Karsten Knudsen: Yeah Michael, thanks for that question.
Karsten Knudsen: When I look at our total operating cost growth in the fourth quarter, then it's actually not markedly different compared to a year to date so what you should be expecting is a continued, what I call, high level of growth in R&D expenditure around the 40% Mark and some 20% plus on an S&D expenditure and the comparative gross margin also in the fourth quarter. So in reality no big swings in the fourth quarter at constant exchange rates.
Karsten Knudsen: When I look at our total operating cost growth in the fourth quarter, then it's actually not markedly different compared to a year to date so what you should be expecting is a continued, what I call, high level of growth in R&D expenditure around the 40% Mark and some 20% plus on an S&D expenditure and the comparative gross margin also in the fourth quarter.
And some 20% plus on an SD expenditure.
And the comparative gross margin also in the fourth quarter.
Karsten Knudsen: So in reality no big swings in the fourth quarter at constant exchange rates.
So in reality no big swings in the fourth quarter at constant exchange rates.
Daniel Bohsen: Thank you Karsten, thanks for the question Michael and this concludes the Q&A session, thank you for participating and please feel free to contact Investor Relations in case you have any follow up questions. Before we close the call I would like to hand over to your Lars for any final remarks, yes. Thanks for that and I would also like to thank you all for participating today I hope it is clear from our core.
Daniel Bohsen: Thank you Karsten, thanks for the question Michael and this concludes the Q&A session, thank you for participating and please feel free to contact Investor Relations in case you have any follow up questions. Before we close the call I would like to hand over to your Lars for any final remarks,
Daniel Bohsen: Thank you Karsten, thanks for the question Michael and this concludes the Q&A session, thank you for participating and please feel free to contact Investor Relations in case you have any follow up questions.
Daniel Bohsen: Before we close the call I would like to hand over to your Lars for any final remarks,
Lars Fruergaard Joergensen: Yes, thank you Daniel and I would also like to thank you all for participating today, I hope it is clear from our comments that we are very pleased with the strong momentum we have in our business, also underlined with the raised guidance for '23 and any questions on the coming years, and not least to the coming year, but we're really focused on pursuing innovation based growth strategy and I feel confident in our ability to scale supply to support that. We are really excited about FLOW underlining the attractiveness of SEMAGLUTIDE and we are equally excited that we soon can disclose what SELECT has to show at the upcoming conference at AHA in a matter of a few days so thank you all, we appreciate your time today and with that we'll close the call. Thank you.
Lars Fruergaard Joergensen: Yes, thank you Daniel and I would also like to thank you all for participating today, I hope it is clear from our comments that we are very pleased with the strong momentum we have in our business, also underlined with the raised guidance for '23 and any questions on the coming years, and not least to the coming year, but we're really focused on pursuing innovation based growth strategy and I feel confident in our ability to scale supply to support that.
Lars Fruergaard Joergensen: Yes, thank you Daniel and I would also like to thank you all for participating today.
Lars Fruergaard Joergensen: I hope it is clear from our comments that we are very pleased with the strong momentum we have in our business, also underlined with the raised guidance for '23 and any questions on the coming years, and not least to the coming year, but we're really focused on pursuing innovation based growth strategy and I feel confident in our ability to scale supply to support that.
That'd be very pleased with the strong momentum we have in our business also underlined with the raised guidance for 'twenty three.
Many questions on the on the coming years and it leads to the coming year, but we're really focused on doing innovation based growth strategy.
Lars Fruergaard Joergensen: but we're really focused on pursuing innovation based growth strategy and I feel confident in our ability to scale supply to support that. We are really excited about FLOW underlining the attractiveness of SEMAGLUTIDE and we are equally excited that we soon can disclose what SELECT has to show at the upcoming conference at AHA in a matter of a few days so thank you all, we appreciate your time today and with that we'll close the call. Thank you.
Lars Fruergaard Joergensen: but we're really focused on pursuing innovation based growth strategy and I feel confident in our ability to scale supply to support that.
I feel confident in our ability to scale supply to support that.
We are really excited about flow Oh, underlining the attractiveness of similar size and we are equally excited that we soon can you disclose what the select has too.
Lars Fruergaard Joergensen: We are really excited about FLOW underlining the attractiveness of SEMAGLUTIDE and we are equally excited that we soon can disclose what SELECT has to show at the upcoming conference at AHA in a matter of a few days so thank you all, we appreciate your time today and with that we'll close the call. Thank you.
To show at the upcoming conference at <unk>.
In a matter of a few days ago.
Thank you all.
We appreciate your time today and with that we'll close the call. Thank you.