Q1 2024 Novo Nordisk AS Earnings Call

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Speaker Change: Good day and thank you for standing by welcome to the Q1 'twenty 'twenty for Novo Nordisk <unk> 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 task a question. During the session you will need to press star one.

Operator: Good day, and thank you for standing by. Welcome to the Q1 2024 Novo Nordisk AS Earnings Conference Call. At this time, all participants are in a listen-only mode.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising that your hand is raised.

And one on your telephone you didn't hear 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 speak of today that new person C V. P of Investor Relations. Please go.

Operator: To withdraw your question, please press star 1 and 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Daniel Bohsen, CBP Investor Relations. Please go ahead, sir.

Speaker Change: Heads up.

Thank you welcome to listen we noticed earnings call for the first three months of 2020 full my name is Damian, which meant bullshit and I'm the head of Investor Relations at Novo Nordisk with me today I have CEO of Novo Nordisk basketball Johnson Executive Vice President and head of commercial strategy and corporate Affairs, Cumulus serviced executive Vice President and head up North.

Daniel Bohsen: Thank you. Welcome to this Novo Nordisk earnings call for the first three months of 2024. My name is Daniel Moosman Bohsen, and I'm the Head of Investor Relations at Novo Nordisk. With me today I have the CEO of Novo Nordisk, Lars Forgaard Jrgensen, Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camilla Sylvest, Executive Vice President and Head of North America Operations, Doug Lange, Executive Vice President and Head of Development, Martin Holz Lange, and finally, Chief Financial Officer, Karsten. All speakers will be available for the Q&A session.

Speaker Change: Matter of collaborations to Atlanta, Executive Vice President and head of development marching hard Schlanger, and finally, Chief Financial Officer, Kathryn Munk Knudsen, all speakers will be available for the Q&A session.

Daniel Bohsen: 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 scheduled to last one hour; please turn to the next slide.

Speaker Change: 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 on our website as well the call is scheduled to last one hour.

Speaker Change: Please turn to the next slide the presentation is struck just as outlined on slide two. Please note that all sales and operating profit growth statement will be at constant exchange rates unless otherwise specified please turn to the next slide.

Daniel Bohsen: The presentation is structured as outlined on slide two. Please note that all sales and operating profit growth statements will be at a constant exchange rate unless otherwise specified; returns to the next We need to advise you that this call will contain forward-looking statements, which are subject to risk and uncertainty that could cause actual results to differ materially from expectations.

Speaker Change: We need to advise you that this call will contain forward looking statements. These are subject to risks and uncertainties that could cause actual results to differ materially from expectations for further information on the risk factors. Please see the company announcement for the first three months of 2024 and the slides prepared for this presentation with that over to you last one update on <unk>.

Daniel Bohsen: For further information on the risk factors, please see the company announcement for the first three months of 2024 and the slides prepared for this presentation. With that, I turn to you Lars for an update on our strategic aspirations. Thank you, Daniel.

Speaker Change: Strategic aspirations.

Speaker Change: Thank you Daniel Please turn to next slide.

Daniel: And the first three months, we have delivered 24% sales growth and 30% operating profit growth. Furthermore, we have raised the outlook for the full year.

Lars Fruergaard Jorgensen: Please turn to the next slide. In the first three months, we delivered 24% sales growth and 30% operating profit growth. Furthermore, we have raised the outlook for the full year. 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. Starting with our focus on purpose and sustainability, we are now serving almost 42 million patients with our diabetes and obesity treatment

Daniel: 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.

Daniel: Starting with our focus on purpose and sustainability, we're now serving almost 42 million patients without diabetes and obesity treatments.

Lars Fruergaard Jorgensen: Our total carbon emissions rose by 32% as compared to the first quarter of 2023. This was primarily driven by our increased investments in capital expenditure to meet the high demand for our product. Compared to the first quarter of 2019, carbon emissions from operations and transportation decreased by 31%.

Daniel: Our total copper carbon emission rose by 42, 32% as compared to the first quarter of 2023.

Daniel: This was primarily driven by our increased investments in capital expenditure to meet the high demand for our products.

To the first quarter of 2019 carbon emissions from operations and transportation decreased by 31%.

Daniel: To uphold our commitment to being a sustainable employer, we expanded the number of women in senior leadership positions to 41% compared with 39% in the first quarter of 2023.

Lars Fruergaard Jorgensen: To uphold our commitment to being a sustainable employer, we expanded the number of women in senior leadership positions to 41%, compared with 39% in the first quarter of 2023. In R&D, we are pleased with the successful completion of the Flow Kidney Outcomes Trial and the approval of the Rigobit Label Expansion in the U.S. based on the Select Cardiovascular Outcomes Trial. Martin will come back to this and our overall R&D milestones later.

Daniel: Then Andy we are pleased with the successful completion of the flow kidney outcomes trial and approval of the recovered label expansion in the U S based on the select cardiovascular outcomes trial.

Daniel: Martin will come back to this and our or R&D milestones later.

Daniel: We also announced the agreement to acquire three feel finish sites from Noah Holdings in connection with the transaction when Noah Holdings has agreed to acquire <unk>.

Lars Fruergaard Jorgensen: We also announced the agreement to acquire three FILFINI sites from Novo Holdings in connection with a transaction where Novo Holdings has agreed to acquire Catalan. This is expected to enable us to reach many more people living with serious chronic diseases. The quarter sales growth reflects solid commercial execution across operating units.

This is expected to enable us to reach many more people living with serious chronic diseases.

Daniel: The quarter sales growth reflects solid commercial execution across our operating units.

Lars Fruergaard Jorgensen: Both operating units contributed to sales growth driven by demand for AlgaeBorne treatments for both diabetes and obesity. Camilla and Doug will go through the details per therapy area later. The cast will go through the financials, but I'm very pleased with the performance so far this year.

Daniel: Operating units contributed sales growth driven by demand for our tier one treatments for both diabetes and obesity.

Daniel: Camilla and talk will go through the details per therapy area later.

Daniel: Customer goes through the financials, but I am very pleased with the performance. So far this year now I'd like to hand, the word ultra Camilla will give us an update on our commercial execution.

Camilla Sylvest: Now I would like to hand the word over to Camilla, who will give us an update on commercial execution. Thank you, Lars, and please turn to the next slide. In the first three months of 2024, our total sales increased by 24%. The sales growth was driven by both operating units, with North America operations growing 35% and international operations growing 11%.

Camilla: Thank you Lasse and please turn to the next slide.

Camilla: In the first three months of 2024 hour total sales increased by 24%. This sales growth was driven by both operating units with North America operations growing 35% and international operations growing 11% in the U S sales growth was positively impacted by close to net sales adjustments related to prior years.

Camilla Sylvest: In the U.S., sales growth was positively impacted by gross-to-net sales adjustments related to prior. Our GLP-1 sales in diabetes increased 32%, driven by North America operations growing 37% and international operations growing 22%. Incident sales increased by 9% driven by North America operations growing 23% and international operations growing 5%. Obesity care sales increased 42% driven by North America operations growing 44% and international operations growing 35%. In both geographies, growth was driven by Vigovy, partly offset by the declining sex industry.

GSE one phase in diabetes increased 32% driven by North America operations, growing 37% and international operations growing 22%.

Insulin sales increased by 9% driven by North America operations, growing 23% and international operations growing 5%.

Camilla: Obesity care sales increased 42% driven by North America operations, growing 44% and international operations growing 35%.

Camilla: In both geographies close with Steven <unk>, partly offset by declining six industries Dr.

Doug Langa: Doug will talk more about North America obesity performance, but in I.O., Gobi sales exceeded 1 billion Danish kroner in the quarter. We continue to roll out Vigovi in a sustainable manner with volume-capped launches to balance supply and demand. Rare disease sales decreased by 3%, which Doug will also speak more about later.

Camilla: Jeff will talk more about North America obesity performance, but in Io the gold sales exceeded 1 billion Danish kroner in the quarter.

Camilla: We continue to rollout <unk> in a sustainable manner with volume cap launches to balance supply and demand.

Camilla: Where do you see sales decreased by 3% with stock would also speed module data. Please.

Please turn to the next slide.

Camilla Sylvest: Please turn to the next slide. With 24% sales growth in diabetes care, we are growing faster than the total diabetes market. As a result, our global diabetes value market share increased to 34%, which is above our strategic aspiration of reaching one third of the global diabetes value market in 2025. The increase reflects market share gains in both North America operations and international operations.

Camilla: With 24% sales growth in diabetes care, we are growing faster than the total diabetes market as a result of alcohol with diabetes value market share increased to 34%, which is above our strategic aspiration of reaching one third of the global diabetes value market in 2025.

Camilla: The increase reflect market share gains in both North America operations and international operations.

Camilla Sylvest: In international operations, please turn to the next slide. In international operations, diabetes care sales increased by 12% in the first three months of 2024, which was primarily driven by GLP-1 sales growing 22%. Novo Nordisk is the market leader in international operations with a GLP-1 value market share of around 70%. Assembly continues its CFP1 market leadership with 47.2% market share.

In International operations, Please turn to the next slide.

Camilla: International operations diabetes care sales increased by 12% in the first three months of 2024.

Camilla: Was primarily driven by tier two one sales growing 22%.

Camilla: <unk> is the market leader in international operations with a tier one value market share of about 70%.

Camilla: <unk> continues its <unk>, one market leadership with 47, 2% market share.

Duck: We are also pleased to see with Valassis, increasing its market share to around 15% driven by solid uptake across geographies and with that I will hand over the word to duck.

Doug Langa: We are also pleased to see Rebelsus increasing its market share to around 15%, driven by solid uptake across geographies. And with that, I will hand over the word to Doug. Thank you, Camilla. Please turn to the next slide. Sales in North America are driven by healthy prescription volume growth of the GLP-1 class of around 15% in the first quarter of 2024 compared to the first quarter of 2023. Novo Nordisk is taking market share, meaning we are growing faster than the market, fueled by our strategic GLP-1 brands of Ozempic and Rebels. Measured on total prescriptions, Novo Nordisk continues to be the market leader with around 56% of the market share. However, sales growth of Ozempic was negatively impacted by periodic supply constraints in the beginning of the first quarter.

Duck: Thank you Camilla please turn to the next slide.

Duck: Sales in North America is driven by healthy prescription volume growth of the GOP one class of around 15% in the first quarter of 2024 compared to the first quarter of 2023.

Speaker Change: Youll notice is taking market share, meaning we're growing more than the market.

Speaker Change: <unk> by our strategic GOP, one brands of Olympic and rebel Sis.

Speaker Change: Measured on total prescriptions Novo Nordisk continues to be the market leader with around 56% market share.

Speaker Change: Sales growth of <unk> was negatively impacted by periodic supply constraints in the beginning of the first quarter. Please go to the next slide.

Speaker Change: The safeguard continuity of care for <unk>, we reduced the release of lower dose strengths in may of 2023, which continued throughout the remainder of last year.

Doug Langa: Please go to the next slide. To safeguard continuity of care for WGOBI, we reduced the release of lower dose strengths in May of 2023, which continued throughout the remainder of last year. In the beginning of this year, we gradually started increasing the supply of the lower dose string. I am pleased to see that this has been reflected in prescriptions, and we are now seeing more than 27,000 new to brand prescriptions and approaching the peak total prescriptions seen last year. Mugovie still has broad market access, with more than 50 million covered lives, and importantly, around 10 million vulnerable patients have access to Mugovie via Medicaid in more than 15 states.

Speaker Change: In the beginning of this year, we gradually started increasing to supply the lower dose strengths.

Speaker Change: I am pleased to see that this has been reflected in prescriptions and we are now seeing more than 27000, new to brand prescriptions and approaching the peak total prescriptions seen last year.

Speaker Change: <unk> still has broad market access with more than 50 million covered lives and importantly around 10 million vulnerable patients have access to will go the Medicaid and more than 15 states.

Speaker Change: Following an expanding market access and our focus on reaching more patients will go in that prices declined in the first quarter.

Doug Langa: Following expanding market access and our focus on reaching more patients, We'll go net prices declined in the first quarter. While we continue to gradually increase the overall supply throughout the rest of 2024, our primary focus remains on ensuring continuity of care for patients who have already initiated treatment. Next slide, please. Our rare disease sales decreased by 3%. Sales and international operations declined by 18%.

Speaker Change: While we continue to gradually increase the overall supply throughout the rest of 2024, our primary focus remains on ensuring continuity of care for patients who have already initiated treatment next slide please.

Speaker Change: Our rare disease sales decreased by 3%.

Speaker Change: Sales in international operations declined by 18%.

Martin Holst Lange: This was partly offset by a 20% sales increase in North America operations reflecting the launch of Segroja and positive gross net adjustments related to prior years in the U.S. Sales of rare blood disorders decreased by 4% driven by Novo7 and hemophilia A products, partly countered by increased hemophilia B-cell. Sales of rare endocrine disorder products increased by 1%. We are working on reestablishing full supply of rare endocrine disorder products following a reduction of manufacturing output in 2022 and 2023. Now, with that over to you Martin for an update on R&D. Thank you, Doug.

Speaker Change: This was partly offset by a 20% sales increase in North America operations.

Speaker Change: Reflecting the launch of <unk> and positive gross to net adjustments related to prior years in the U S.

Speaker Change: Sales of rare blood disorders decreased by 4% driven by Novo seven in hemophilia a products.

Speaker Change: We countered by increased hemophilia B sales.

Speaker Change: Sales of rare endocrine disorder products increased by 1%.

Speaker Change: We are working on reestablishing full supply of rare endocrine.

Speaker Change: Endocrine disorder products following the reduction of manufacturing output in 2022 and 2023.

Speaker Change: Now with that overview Martin for an update on R&D.

Martin: Thank you Doug Please turn to the next slide.

Martin Holst Lange: Please turn to the next slide. In March, we announced that the FDA has approved a label expansion for Wegoe with the indication of reducing risk of major adverse cardiovascular events, abbreviated, This includes cardiovascular death, not fatal heart attack, and not fatal stroke in adults with either Overweight or Obesity and Established Cardiovascular Disorder. The approval is based on the Select Cardiovascular Outcomes Trial, which demonstrated for the primary endpoint that somatotype 2.4 mg reduced the risk of MACE by 20% compared to placebo when added to standard of care.

Martin: In March we announced that the FDA has approved a label expansion until we go live with the indication of reducing risk of major adverse cardiovascular events abbreviated mace.

Martin: This includes cardiovascular death, non fatal heart attack nonfatal stroke.

Martin: With either PUC.

Martin: Sorry, overweight or obese and established cardiovascular disease.

Martin: The approval is based on the select cardiovascular outcomes.

Martin: Construct which demonstrated for the primary endpoint the tomato side, two four milligram reduce the risk of mace by 20% compared to placebo when added to standard of care.

Martin: In addition to the cardiovascular indication. The label also is updated to include that risk reduction in mace was achieved regardless of baseline H six race ethnicity body mass index and level of renal function impairment.

Martin Holst Lange: In addition to the cardiovascular indication, the label also is updated to include that risk reduction in MACE was achieved regardless of baseline age, sex, race, ethnicity, Body Mass Index, and Level of renal function. However, cardiovascular death superiority was not confirmed, and thus the testing hierarchy was stopped. However, the label update does include data on the numerical risk reduction in cardiovascular death by 50% and a statistically significant risk reduction of death from any cause by 19%, both compared to in the Clinical Pharmacological Circuit.

Martin: Cardiovascular death superiority was not confirmed and those statistics clarity was stopped however, the label update does include data on the numerical risk reduction in cardiovascular death by 15%.

Martin: And a statistically significant risk reduction of death from any cause by 19% both compared to placebo.

Martin: And the clinical pharmacological correction.

Martin Holst Lange: The label now also describes that the exact mechanism of cardiovascular risk reduction has not been established, reflecting that the beneficial CV effects of semaglutide are not associated with weight loss. The approval of the RegoE label expansion for the indication of reducing maize in the U.S. is an important milestone for people living with obesity and cardiovascular disease. The selected data demonstrate that Magnetite 2.4 mg has the potential, Thank you.

Martin: The label now also describes that the exact mechanism of cardiovascular risk reduction has not been established reflecting the beneficial beneficial CV effects of some appetite is not associated with weight loss alone.

Martin: The approval of the <unk> label expansion for the indication of reducing base in the U S.

Martin: An important milestone for people living with obesity and cardiovascular disease.

Martin: The selected data demonstrate that magnetite, two four milligram healthy potential to prolong lives by addressing some of the leading causes of preventable deaths LIFO chamber, reducing the risk of cardiovascular events.

Martin: Next slide please.

Martin: In March of 2020 for Novo Nordisk acquired.

Martin Holst Lange: In March of 2024, Novo Nordisk acquired a majority stake in Kaja Pharmaceuticals, and the agreement includes Kaja's lead compound CDR-132L, currently in phase two clinical development for the treatment of heart failure. CDR-132L is a synthetic antisense oligonucleotide and is a disease-modifying therapy designed to halt or partially reverse cellular pathology in the heart by targeting microRNA132, with its

Martin: Concho Pharmaceuticals. The agreement includes conscious deep compound <unk> 130, <unk> currently in phase two clinical development for treatment of heart failure.

Martin: CGI 132 will is a synthetic antisense oligonucleotide and theres a disease modifying therapy designed to hold or partially reverse cellular pathology and the heart by targeting Micron a 132.

Martin: With its distinct mode of action <unk> 180, <unk> as the potential to become a first in class therapy for long lasting improvements of.

Martin Holst Lange: GDR 132L has the potential to become a first-in-class therapy for long-lasting improvements in heart function. The second Phase II trial is planned and will investigate CDR132L in a broader chronic heart failure population with left ventricular hypothalamic. This acquisition is in line with our strategic aspiration of establishing a presence in cardiovascular disease and emerging therapies. Next slide, please. As we shift our focus to the upcoming R&D milestones, there are many exciting approvals, trial initiations, and trial completions to watch out for.

Martin: Of heart function.

Martin: A second phase II trial as planned and will investigate <unk> hundred 30, <unk> in a broader chronic heart failure population with lyft.

Martin: <unk>.

Martin: This acquisition is in line with our strategic aspiration of establishing a presence in cardiovascular disease and emerging therapy areas.

Martin: Next slide please.

Martin: As we shift our focus to the upcoming coming R&D milestones. There are many exciting approvals trial initiations and trial completions to watch out for it.

Martin Holst Lange: Allow me to go through a few key milestones from the first quarter of 2024 and touch upon a few upcoming highlights later in 2024. Within diabetes, insulin IcoDig, under the brand name of Weakly, was recommended for approval for the treatment of diabetes by the European Regulatory Authority.

Martin: Allow me to go through a few key milestones from the first quarter of 'twenty fall and touch upon a few upcoming highlights later in 'twenty four.

Martin: Within diabetes insulin <unk> under the brand name of our weekly recommend.

Martin: Recommended for approval for the treatment of diabetes by the European regulatory authorities.

Martin Holst Lange: We anticipate a final decision from the European Commission within a couple of months, making an exciting milestone for the world's first once-weekly baseline. Of note, an FDA Advisory Committee meeting for Intolenicodec has been announced to discuss the new drug application. The meeting will focus on the risk-benefit profile of IQTEC in the treatment of type 1 diabetes and is scheduled for May 24, in due time prior to the action date in July.

Martin: We anticipate a final decision from the European Commission within a couple of months, making an exciting milestone for the world's first once weekly basal instruments.

Martin: Of note.

Martin: FDA Advisory Committee meeting for <unk> has been announced to disclose the new drug application.

Martin: The meeting will focus on the risk benefit profile of <unk> in the treatment of type one diabetes and is scheduled for May 24 in due time prior to the action date in July.

Martin: At weekly is currently approved in both Canada and Switzerland.

Martin Holst Lange: A weekly is currently approved in both Canada and, further on diabetes, combined to a phase 3 trial for Icocema was successful. The primary endpoint was met with Icosemma demonstrating superior reduction in A1c compared to once weekly semaglutide 1.0 mg in people with type 2 diabetes inadequately controlled on GLP-1 treatment and in need of treatment intensification from an overall A1C baseline of 8%.

Martin: Further in diabetes combined to a phase III trial <unk> was successfully completed.

Martin: The primary endpoint was met with Iqos, demonstrating superior reduction in <unk> compared to once weekly submitted was at 1.7 milligram in people with type two diabetes in adequately controlled on tier one treatment and in need of treatment intensification.

Martin: From an overall ANC baseline of eight.

Martin: Once weekly <unk> achieved an estimated reduction in <unk> of 135 percentage points.

Martin Holst Lange: Once weakly, IQOSEMA achieved an estimated reduction in A1c of 1.35% compared to 0.9% is 0.4% at 1.0 million. Icosemma appeared to have a safe and well-tolerated profile and shows the potential to set a new benchmark for once-weekly treatment of type 2 diabetes. We expect results from Combine 1 in the second quarter of 2020. We have successfully completed the Flow Kidney Outcomes Trial with once weekly injectable semaglutide 1.0 milligrams. Flow achieved its primary endpoint by demonstrating a statistically significant and superior reduction in the number of urinary tract infections. In March, the flow data was submitted as a label expansion application to the U.S. Federal, and submission to the European Regulatory Authorities

<unk> two <unk>, 9% of sponge for some maintenance at one milligram.

Martin: I Echo semi appear to have a safe and well tolerated profile and shows the potential to set a new benchmark for once weekly treatment of type two diabetes.

Martin: We expect results from a combined one in the second quarter of 'twenty four.

Martin: Also on diabetes.

Martin: We have successfully completed the flow kidney outcomes trial with <unk>.

Martin: Once weekly injectable smack inside one procurement events.

Martin: <unk> achieved its primary endpoint by demonstrating a statistically significant and superior reduction in <unk>.

Keeping the disease progression as well as cardiovascular and kidney death.

Martin: By 24% for people treated with 1.0 milligram compared to placebo.

Martin: In March the flow data was submitted as a label expansion application to the U S. FDA.

Martin: Submission to the European regulatory regulatory authorities is expected in the second half of 'twenty four.

Martin: The full results will be shared at the European Renal Association Congress later this month.

Martin Holst Lange: The full results will be shared at the European Renal Association Congress later this month. We have also successfully completed an exploratory Phase II trial with higher doses of once-weekly subcutaneous semantics. The trial investigated the efficacy and tolerability of 8 and 16 mg magnesite in people with type 2 diabetes. In the trial, dose response to weight loss was observed, and the high doses of semaglutide appeared to have a safe and well-tolerated profile in line with previous semaglutide trials.

Martin: We've also successfully completed an exploratory phase II trial with higher doses, a once weekly subcutaneous American side.

Martin: The trial investigated efficacy and Tolerability of eight at 16 milligrams magnetite in people with type two diabetes.

In the trial.

Martin: Social response on weight loss was observed at the higher doses of magnetite appear to have a safe and well tolerated profile in line with previous Magnetek class.

Martin Holst Lange: Tumoricide in higher doses in diabetes is now being evaluated for further clinical development. Moving to obesity care in the first quarter, we've already covered that we go in for label expansion for approval for Cardiovascular Risk Reduction in the U.S. In the first quarter, the step-hef-pef.

Martin: So maybe with that in higher doses of diabetes are now being evaluated for further clinical development.

Martin: Moving to a PC to cure in the first quarter, we've already covered that we go with label expansion for approval.

Martin: For cardiovascular risk reduction in the U S.

Martin: In the first quarter the step.

Martin: Slides were submitted to the U S FDA and granted priority review.

Martin Holst Lange: Transcripts provided by Transcription Outsourcing, LLC. The FDA also announced that an advisory committee is to be convened in the second half of 2024 to discuss the application. We are excited about the expected readout of My Mate Phase 3 in the second quarter of 2021. MyMed is a novel, next-generation, factor VIII bi-specific antibody with potential for improved patient outcomes and reduced patient burden in the treatment of people with hemophilia A.

Martin: The FDA also announced that an advisory committee is to be convened in the second half of 2024 to discuss the application.

Martin: In rare disease, we're excited about the expected readout of Miami Phase III in the second quarter of 'twenty four.

Martin: I made this a novel next generation factor eight my medic bi specific antibody with potential for improved patient outcomes and reduce patient burden.

Martin: And treatment of people with hemophilia a.

Martin: Yeah.

Martin: Looking ahead to the second half of 'twenty fall at several events of note within diabetes.

Karsten Munk Knudsen: Looking ahead to the second half of 2014, there are several events of note. These include the readouts of STRIDE and the SOL trials, as well as Phase II for monolunar band, and the initiation of Phase II trials for amicres. With obesity, we look forward to the readout of the first pivotal trial in calcusemin. Lastly, within cardiovascular and emerging therapy areas, we look forward to the readout of the phase 3 essence trial within MESH.

Martin: This includes the Readouts of stride in the short run as well as phase II from Luna and.

Martin: And the initiation of phase II class for him accretive.

Martin: Within obesity, we look forward to the readout of the first pivotal trial in <unk>.

Martin: Lastly, within cardiovascular and merchant therapy areas.

Martin: Look forward to the readout of the phase III essence trial within mesh, but thats overseas lessons.

Karsten Munk Knudsen: With that, over to you. Thank you, Martin. Please turn to the next slide. In Q1 2024, our sales grew by 22% in Danish kroner and 24% at counter exchange rates, driven by both operating units. In the US, sales growth was positively impacted by growth to net sales adjustments related to the prior year.

Martin: Thank you Martin please turn to the next slide.

Martin: In Q1 towards 24 hour sales grew by 22% in Danish krone, and 24% at constant exchange rates driven by both operating units.

Martin: In the U S sales growth was positively impacted by gross to net sales adjustments related to prior year.

Martin: The gross margin increased to 84, 8% compared to 84, 7% in Q1 2023, reflecting a positive price impact due to gross to net sales adjustments in the U S.

Karsten Munk Knudsen: The gross margin increased to 84.8% compared to 84.7% in Q1 2023, reflecting a positive price impact due to gross-to-net sales adjustments in the US and a positive product mix due to increased sales of GLP-1 based products. However, this is partially countered by costs related to ongoing capacity expansions and a negative currency impact. Sales and distribution costs increased by 7% in Danish kroner and by 8% at a constant exchange rate, around 20% as a percentage of sales.

Martin: Positive product mix due to increased sales of <unk> based products.

Martin: This is partially countered by costs related to ongoing capacity expansions and a negative currency impact.

Martin: Sales and distribution costs increased by 7% in Danish kroner and by 8% at constant exchange rates around 20%.

Martin: Percentage of sales.

Karsten Munk Knudsen: In North America, operations costs are driven by promotional activities related to EGOVI, and in international operations, the increase is related to promotional activities for rebels, as well as Obisticaire Market Development Activity. Research and development costs increased by 28%, measured both in Danish kroner and at constant exchange rates, amounting to around 13% of sales. Cost increases reflect late-stage clinical trial activity and increased early research activities compared to Q1 2023. Administration costs increased by 8% measured in Danish kroner and by 9% at constant exchange rates.

North America operations costs are driven by promotional activities as it relates to recovery and international operations. The increase is related to promotional activities for <unk> as.

Martin: Our market development activities.

Research and development costs increased by 28% measured both in Danish kroner and at constant exchange rates amounting to around 13% of sales.

Cost increases reflect late stage clinical trial activity and increased early research activities.

Martin: For Q1 2023.

Martin: Administration costs increased by 8% measured in Danish krone, and by 9% at constant exchange rates.

Karsten Munk Knudsen: Operating profit increased by 27% measured in Danish kroner and by 30% at constant exchange rates, reflecting the sex growth. Net financial items showed a net gain of 72 million Danish kroner compared to a net loss of 270 million Danish kroner last year.

Martin: Operating profit increased by 27% measured in Danish krone, and by 30% at constant exchange rates, reflecting the sales growth.

Martin: Net financial items showed a net gain of 72 million Danish kroner compared to a net loss of 270 million tons coming on next year.

Karsten Munk Knudsen: The effective tax rate was 20.4% in the first three months of 2024 compared to 19.9% in the first three months of 2023. Net profit increased by 28%, and diluted earnings per share increased by 29% to 5 Danish Kroner and 68 re. Free cash flow realized in the first quarter of 2024 was 5 billion Danish Kroner compared with 24.8 billion in the first three months of 2023.

Martin: The effective tax rate was 24% in the first three months of 2024 compared to 19, 9% in the first three months of 2023.

Martin: Net profit increased by 28% and diluted earnings per share increased by 29% to five Danish kroner 68.

Martin: Free cash flow realized in the first quarter of trying to stretch for was 5 billion Danish kroner compared with $24 8 billion in the first three months of trains trencher tree.

Karsten Munk Knudsen: The lower free cash flow reflects phasing of rebates related to lower U.S. gross sales in the first quarter of 2024 compared to the fourth quarter of 2023. This is combined with reduced insulin list prices, higher taxes paid, and increasing capital expenditure towards additional manufacturing capacity. This is partially countered by increased net profit. Capital expenditure for property, plant, and equipment was 8.5 billion Danish Kroner compared with 4.7 billion in 2023.

Martin: The lower free cash flow reflects phasing of rebates related to lower U S gross sales.

Martin: In the first quarter of 2024 compared to the fourth quarter of two towards the tree.

Martin: This is combined with reduced insulin list prices higher taxes paid and increasing capital expenditure towards additional manufacturing capacity.

Martin: This is partially countered by increased net profits.

Martin: Capital expenditures for property plant and equipment was $8 5 billion Danish kroner, compared with $4 7 billion in 2023.

Karsten Munk Knudsen: Primarily reflecting investments in additional capacity for API production and finished capacity for both current and future injectable and oil products. In February 2024, we announced an agreement to acquire three Felfini sites from Novo Holdings in connection with a transaction where Novo Holdings has agreed to acquire Catalan, a global contract development and manufacturing organization. The fulfillment of various customary closing conditions is progressing, and Novo Nordisk still expects that the acquisition will be completed towards the end of 2021.

Martin: Primarily reflecting investments in additional capacity for API production and fill finish capacity for both current and future injectable and for our products.

Martin: In February 24, we announced an agreement to acquire <unk> III finished size from Noah holdings in connection with the transaction. We're number holdings has agreed to acquire catchments global contract development and manufacturing organization.

Martin: Fulfillment of various customary closing conditions is progressing and none were still expects that the acquisition will be completed towards the end of choice.

Martin: Please go to the next slide.

Karsten Munk Knudsen: Please go to the next slide. We continued the growth momentum in 2024 and increased our sales growth to between 19 and 27% at constant exchange rates. This is based on several assumptions as described in the company announcement. Of note, the updated sales outlook at constant exchange rates reflects growth to net sales adjustment related to prior years in the US in the first quarter. The guidance reflects expectations for sales growth in both North American operations and international operations, mainly driven by volume growth of GLP-1-based treatments for obesity and diabetes care, with the expectation of continued volume growth and capacity limitations.

Martin: We continued the growth momentum insurance tranche, four and has increased our sales growth to between 19 and 27% at constant exchange rates. This is based on several assumptions as described in the company's announcements.

Martin: Of note the updated sales outlook at constant exchange rates reflect gross to net sales adjustment related to prior years in the U S. In the first quarter.

Martin: The guidance reflects expectations for sales growth in both North America operations and international operations, mainly driven by volume growth of tier one based treatments for obesity and diabetes care.

With the expectation of continued volume growth in capacity limitations.

Karsten Munk Knudsen: The outlook also 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 for both short and long term. Operating profit growth is now expected to be between 22 and 30% at constant exchange rates.

Martin: Also reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.

No Norsk is investing in internal and external capacity to increase supply for both short and long term.

Martin: Operating profit growth is now expected to be between 20% to 30% at constant exchange rates.

Karsten Munk Knudsen: The increased expectation for operating profit growth is reflecting the increased sales outlook partially countered by an expected loss on other operating income and expenses. Capital expenditure is still expected to be around 45 billion Danish Kroner in 2024, reflecting the expansion of the supply chain, including the previously communicated expansions of manufacturing facilities in Denmark and France. The free cash flow is now expected to be between 57 and 67 billion Danish Kroner.

Martin: The increased expectation for operating profit growth is reflecting the increased sales outlook, partially countered by an expected loss on other operating income and expenses.

Martin: Capital expenditure is still expected to be around 45 billion Danish kroner in 2024, reflecting the expansion of the supply chain, including the previously communicated expansions of manufacturing facilities in Denmark in France.

Martin: The free cash flow is now expected to be between 57, and $6 7 billion Danish kroner.

Karsten Munk Knudsen: The updated cash flow... expectation reflects changes to growth in net sales estimates and related cash flow impacts as well as business development activities, including the planned acquisition of Cardio. That covers the outlook for 2024. Now back to you, Lars. Thank you, Karsten. Please turn to the final slide.

Martin: <unk> cash flow.

Martin: Expectation reflects changes to gross to nets.

Martin: <unk> estimates and related cash flow impacts as well as business development activities, including the planned acquisition of cardio.

Martin: That covers the outlook for 2024 and Opex for your loss.

Speaker Change: Thank you <unk>, please turn to the final slide.

Lars Fruergaard Jorgensen: We are pleased with the sales growth in the first three months of 2024, driven by increased demand for our GF01-based diabetes and obesity treatment. More patients benefit from our innovative treatments, and the agreement to acquire the three cattle and manufacturing sites will enable us to serve significantly more people living with diabetes and obesity in the future. Then R&D will be pleased with the positive results from the kidney outcomes trial with SELECT and the label expansion for cardiovascular disease risk reduction for WGOI in the U.S. With that, back to Daniel. Thank you, Lars.

Speaker Change: We are pleased with our sales growth in the first three months of 2024, driven by increased demand for whichever one based diabetes and obesity treatments more patients benefit from our innovative treatments and the agreement to acquire three catchment manufacturing sites will enable us to serve significantly more people living with diabetes and obesity in the future.

Speaker Change: We are pleased with the positive results from the kidney outcomes trial with select and the label expansion for cardiovascular disease risk reduction in the U S.

Speaker Change: With that back to Daniel.

Daniel Bohsen: Next slide, please. With that, we are now ready for the Q&A session. I kindly ask all participants to limit themselves to one or a maximum of two questions, including any sub-questions. Operator, we are now ready to take the first. Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced.

Daniel: Thank you Lasse next slide please.

Speaker Change: With that we're now ready for the Q&A session I kindly ask all participants to limit himself to one or maximum two questions, including any sub questions.

Operator: To withdraw your question, please press star 1 and 1 again. We will now go to your first question. And your first question. One moment, please. And your first question comes from the line of Michael Nedelcovych from TD Cowan. Please go ahead. Thank you for your questions. I have two.

Speaker Change: Operator, we are now ready to take the first question.

Speaker Change: Thank you to ask a question you will need to press star one on one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one on one.

Sure.

Speaker Change: We will now go to your first question.

Speaker Change: And your first question.

Speaker Change: One moment please.

Speaker Change: And your first question comes from the line of Michael made a call. It from TD Colin. Please go ahead.

Michael: Thank you for the questions I had two the first is on the guidance range.

Michael Thomas Nedelcovych: The first is on the guidance range. In every year going back to 2017, the guidance range has been between 3% and 6% and often narrowed in the first quarter. The fact that this year's guidance range spans 8% is understandable given supply uncertainties, but one might have imagined that management might have some additional clarity by now and possibly have narrowed the range. Of course, this implies risk both to the downside and to the upside, but it's hard to interpret persistent uncertainty as a good thing.

Michael: And every year going back to Q2 2017, the guidance range has been between three and 6% and often narrowed in the first quarter. The fact that this year's guidance range, 8% is understandable given supply uncertainties, but one might have imagined that management might have some additional clarity by now and possibly have narrowed the range of core system.

Michael: <unk> risk close to the downside and to the upside, but it's hard to interpret persistent uncertainty as a good thing so to what specifically do you attribute that uncertainty.

Michael Thomas Nedelcovych: So specifically, what do you attribute that uncertainty? And then my second question has to do with high-dose injectable semaglutide. As you noted, the Phase 2 trial incorporated a 16-milligram dose, which we understood to be a dose intended to find a weight loss plateau in order to make sure no efficacy was being left on the table. You note that the weight loss was dose-responsive, but did you find that plateau, and can you give us any sense of how much additional weight loss was gained at 8 and 16 milligrams of semaglutide?

Michael: And then my second question has to do with high dose injectable Mergui tide.

Michael: You noted the phase II trial incorporated a 16 milligram dose, which we understood to be a dose intended defined a weight loss plateau in order to make sure no efficacy was being left on the table.

Michael: Note that the weight loss was dose responses, but did you find that plateau and can you give us any sense how much additional weight loss was deemed at 16 milligrams of <unk> tied.

Michael Thomas Nedelcovych: And you also noted that higher doses are now being evaluated for further clinical development, but of course, Phase 3 trials at a 7.2-milligram dose are already nearing completion, so are you contemplating additional trials at even higher doses? Thank you for the questions, Mike, and thanks for being up early in the morning. Karsten, the first one, guidance range for you, and afterwards you, Martin, on the Semimax trial. Yeah, good morning,

Michael: And you also noted that higher doses are now being evaluated for further clinical development, but of course phase III trials at seven two milligram dose are already nearing completion. So are you contemplating additional trials at even higher doses.

Speaker Change: Thank you for the questions, Mike and thanks for being up early in the morning gas in the first one guidance range for you and after what you Martin on the <unk> trial.

Karsten Munk Knudsen: So, thank you for looking up our historic ranges. And of course, we do that also when we are assessing. I think it's important to note that, as we've seen over the past year or two, the run rate we have in terms of very high growth and volatility has caused us to be a little bit more cautious in terms of guidance ranges, also linked to the very strict regulations we have here as a listed company in Denmark around how to navigate that.

Speaker Change: Yeah, Good morning, Michael.

Speaker Change: So.

Speaker Change: Thank you for looking up all historic ranges and of course, we do that also.

Speaker Change: When we are assessing I think it is important to note that.

Speaker Change: As we've seen over the past.

Speaker Change: Yes, sure than the than the run rate, we have in terms of very high growth level and volatility.

Speaker Change: It has caused us to be a little bit more cautious in terms of guidance ranges also linked linked to the very strict regulations. We have here as a listed company in Denmark around how to navigate that so I would say that said no additional signals.

Karsten Munk Knudsen: So I would say there are no additional signals to the guidance range for the first quarter. We are on our base plan in terms of running our business, and there are no major changes to risks, either favorably or negatively.

Speaker Change: Two the guidance range for the first quarter, we are on our base plan in terms of running our business and there are no major changes to risks either favorably or <unk>.

Speaker Change: <unk>, we are on track and we like what we see.

Speaker Change: Thank you Catherine Latin <unk>, yes. Thank you very much for the question so.

Karsten Munk Knudsen: We are on track, and we like what we see. Thank you, Karsten. Martin, over to you.

Martin Holst Lange: Yeah, thank you very much for the question. I will not comment on the actual data, so we'll disclose them at a later time point. These are the actual weight loss observed that will be disclosed later on. I specifically talked about diabetes when we talked about evaluating further development. You are absolutely right.

Catherine: So I will.

Catherine: Ill comment on the actual data.

Catherine: We'll disclose them at a later time point.

Catherine: These are we the actual weight loss observed.

Catherine: Will be disclosed later on.

Catherine: I, specifically talked about diabetes, when we talked about evaluating.

Catherine: Further development, you're absolutely right in obesity, we're currently conducting a phase III trial and what we can say at this point is that the data that we've seen for diabetes.

Martin Holst Lange: In obesity, we're currently conducting a phase three trial, and what we can say at this point is that the data that we've seen from diabetes are reassuring us that we remain confident also on higher doses in the obesity space. Thank you, Martin. And thank you, Mike, for the questions. We are ready for the next question, please. Thank you.

Catherine: Securing that we remained confident also on higher doses and UPC space. Thank.

Speaker Change: Thank you Martin and thanks, Mike for the questions. We're ready for the next question. Please.

Speaker Change: Thank you.

Operator: I will now go to the next question. And your next question... That comes from the line from Richard Foster from J.P. Morgan, please go ahead. Hi, thanks for taking my questions. Two, please.

Speaker Change: I will now go to the next question.

Speaker Change: And your next question comes.

Speaker Change: From the line of.

Speaker Change: Foster.

J P. Morgan. Please go ahead.

Richard Vosser: First one, just on supply progression in the U.S. and ex-U.S. for Agave and Azempic. I mean, we've seen very good uptake of the starter doses in the U.S. with a substantial ramp. Should we anticipate a continued gradual ramp-up of those doses throughout this year? Is that how we should think about it? Just some more color there on supply, and particularly U.S. I think it was quite weak this quarter.

Foster: Hi, Thanks for taking my questions. Two please first one just on supply progression in the U S and.

<unk>.

Speaker Change: I mean, we've seen very good uptake of the sell today is in the U S.

Foster: With a substantial ramp should we anticipate a continued gradual ramp of those stages throughout the throughout this year is that how we should think about it to some more color there on supply and particularly I would say U S. I think it was quite weak this quarter can that be turned around.

Richard Vosser: Can that be turned around, particularly in China and some other areas? And then just a second question on My Mate. Lots of discussion on this, including some of your competitors going into new administration profiles for their products. Perhaps you could remind us a little bit more detail, Martin, of the target product profile so we can put that into perspective with the tweaks that Himalaya are making when we see them? Thanks very much.

Typically in China, and some other areas and then just second question on <unk>.

Foster: My mate lots of discussion by this including some of your competitors going into the new administration profiles.

Foster: Are there products, perhaps you could remind us a little bit more detail Martin at the target product profile. So we can put those are is that into perspective with the tweaks that.

Foster: Isn't that human labor, making when we see them thanks very much.

Foster: Thank you Richard So Catherine you start with the supply and we'll then go to Matson again like before.

Richard Vosser: Thank you, Richard. So, Karsten, you start with the supply, and we'll then go to Martin again like before. Yeah, so on supply and specifically on Vigovi, then it's a pleasure to report that from a starting point of around 5,000 NBRX weekly in the US for Vigovi entering this year, now we're in excess of 25,000. So more than 5X compared to where we started this year.

Karsten Munk Knudsen: And clearly, that is a sign of the supply chain operating and running and building inventories and supplying the market because our strategy is to supply starter doses to patients who should then be able to titrate up through the dose regime. So on that front, you should see that as confidence in scaling. We're not guiding for the full year specifically on NBRX.

Catherine: So so on the on supply and specifically on <unk> then.

Speaker Change: And then it's a pleasure to report that from a starting point of around 5000 <unk> weekly in the U S on the Kobe entering.

Speaker Change: Entering this year not now now we are in excess of 25000 so.

More than five X compared to where we started this year.

Speaker Change: And clearly that is a sign of a supply chain operating and running and building inventories and supply in the market because our strategy is to supply started doses.

Speaker Change: Two patients who are who.

Speaker Change: Who should then be able to titrate up through the dose regime. So on on that front.

Speaker Change: You should see that as confidence in scaling.

Speaker Change: We're not guiding for the full year, specifically on the <unk> I think generally speaking guiding on <unk> is a tricky discipline.

Karsten Munk Knudsen: I think, generally speaking, guiding on NBRX is a tricky discipline. But I would say that implicitly in our guidance for the full year, when you look at the midpoint compared to the first quarter performance, then that uptick or that acceleration in growth is driven by continued Vigovi expansion in the U.S. And there you should look at the TRX ramp over the year but also continued volume cap launches in IO. So Vigovi is key to growth acceleration for the remainder of the year.

Speaker Change: I would say that that implicitly in our guidance for the full year. When you look at the midpoint compared to first quarter performance than the than that uptick or that acceleration in growth is driven by continued to be colby expansion in the U S and that you should see look at the <unk>.

Speaker Change: Ramp over the year, but also continued launches in volume cap launches in Nio. So it will be Colby is key.

Speaker Change: Key to our growth exploration for the remainder of the year.

Speaker Change: Thank you Martin on <unk>, yes, thanks, very much Richard and you're absolutely right. We are only a few weeks away from the readout on <unk>, So that's going to be exciting.

Karsten Munk Knudsen: Thank you very much Richard, and you are absolutely right; we are only a few weeks away from the readout of MiMate, so that's going to be exciting. What our target profile is reflecting is, obviously, as we discussed and also about efficacy, the primary end point is annual bleeding rate, and looking at the median, if you expect more than 50% of people to have no bleeds, the APR will be zero.

Speaker Change: But what our target profile is reflecting is obviously.

Speaker Change: As we discussed an unsurpassed efficacy primary endpoint is annual bleeding rate.

Speaker Change: Looking at the median if you expect more than 50% of people having.

Speaker Change: No. Please.

Speaker Change: <unk> will be zero, so we had to look at the proportion of patients.

Martin Holst Lange: So we have to look at the proportion of patients with no bleeds throughout a year, and that's where we will see MiMate potentially having a very competitive profile. We expect to see an attractive safety profile, and then we expect to be able to demonstrate that MiMate, regardless of dose, will have a true monthly profile, which obviously gives a great convenience benefit for patients. At the same time, MiMid will be delivered in an easy to use, very intuitive device, and with an injection volume that is painless.

Speaker Change: With no bleeds, Florida yet.

Speaker Change: And Thats, where we will see myeloid potentially having a very competitive profile, we expect to see.

Speaker Change: So active safety profile.

Speaker Change: And then we expect to be able to demonstrate my made regardless of dose will have a true monthly profile, which obviously gives a great convenience benefit for patients at the same time <unk> will be delivered in an easy to use very intuitive device and with an injection volume that.

Martin Holst Lange: So potential upsides on efficacy, a good safety profile, and a clear convenience and injection pain benefit. Thank you, Martin. Thank you, Richard, for the questions. We are ready to take the next question. Thank you.

Speaker Change: That is pain free so so so potential upsides.

Speaker Change: On an efficacy good safety profile.

Speaker Change: And a clear convenience and injection pain oxide.

Speaker Change: Thank you Martin Thank you Richard for the question.

Speaker Change: We are ready to take the next question. Please.

Speaker Change: Thank you.

Speaker Change: We will now go to our next question.

Speaker Change: One moment please.

Speaker Change: Your next question.

It comes from the line of Louise Chen.

Operator: Your next question comes from the line of Louise Chen from Cantor. Please go ahead. Okay, thank you for taking my question. I just wanted to ask you about SELECT, has the approval actually helped you gain better coverage of some of butyde with your payers? And then secondly, on your ethos NASH data, we've received a lot of questions on that, and curious what you feel would be a good outcome to give you confidence that you have a commercially competitive drug. Prior, you had said it was end of the year for RETA, but now it read I didn't know if there was an acceleration in the timeline.

Louise Alesandra Chen: From Cantor. Please go ahead.

Louise Alesandra Chen: Okay. Thank you for taking my question I just wanted to ask you for select has he approval actually helps you gain better Congress.

Speaker Change: Have a good time with your payers.

Louise Alesandra Chen: Then secondly on your at the Nash data, we've received a lot of questions on that I'm curious what you feel would be a good outcome.

Louise Alesandra Chen: Ill give you confidence that you have a commercially competitive dragon. Prior you had said it was ended the year for readout, but now that it's coming out in second half 'twenty I didn't know if there was an acceleration of the timeline. Thank you.

Speaker Change: Thank you Luis Duck select and the implications for the U S market.

Louise Alesandra Chen: Thank you, Thank you, Louise. Doc, select and the implications for the U.S. market. Yep, thank you, Louise. And maybe, as a starting point, it's probably good to remind you that currently, we have over 50 million people that we cover living with obesity.

Yes, Thank you Louis and maybe as a starting point, it's probably good to remind you that.

Speaker Change: Currently we have over 50 million people that we're covering living with obesity now theres still room to grow and certainly that's our ambition, but we're pleased with the level of access today and again I think it's also important that as you know in March we will go with you was the label was expanded based on select data trial and to become the only I repeat the only.

Doug Langa: Now, there's still room to grow, and certainly that's our ambition, but we're pleased with the level of access today. And again, I think it's also important that, as you know, in March, we'll go see how the label was expanded based on select data trials and become the only, I repeat, the only AOM with proven CV benefit. And so, you know, we've already seen an impact of the label update with CMS allowing for reimbursement in Medicare Part D for AOMs with a CV indication. So, we're pleased with that. Now, there's still some work to do with plan sponsors on the exact criteria for reimbursement.

Speaker Change: AUM with proven CV benefit and so we've already seen an impact of the label update with CMS, allowing for reimbursement in Medicare part D for <unk> with the CV indication. So we're pleased with that now theres still some work to do with plan sponsors on the exact criteria of reimbursement and so we think the uptake will be gradual couple million today.

Doug Langa: And so, we think the uptake will be gradual, a couple million today. But overall, we're pleased with the level of access, and we think we're going to take advantage of selective access moving forward. Thank you, Doug. Martin on NASH.

Speaker Change: But overall, we're pleased with the level of access and we think we're going to take advantage of select moving forward.

Speaker Change: Thank you Doug Martin.

Martin Holst Lange: Yeah, thank you very much. So as a reminder, the essence trial is in two parts. First, 800 patients treated for 72 weeks, which will be the regulatory trial. Here, the primary endpoint is liver biopsy assessment of steatosis and fibrosis.

Doug Langa: Thank you very much so as a reminder, the essence trial is in two parts first 800 patients treated for 72.

Speaker Change: Weeks will be which will be the regulatory trends here. The primary endpoint is liver biopsy assessment of Steatosis and fibrosis and what we hope to see is basically what we saw in our pretty large phase II trial.

Martin Holst Lange: And what we hope to see is basically what we saw in our pretty large phase 2 trial, where we saw a significant and clinically relevant improvement in spirituosis and also clinically relevant improvement in fibrosis. If we see the same level of improvement in phase 3, we would be looking at a very attractive profile. This is also what allowed the FDA to grant us breakthrough designation based on the phase 2 data. And then, in addition, we are extending the study to an additional couple of hundred patients where we will continue treatment to look for heart outcomes. So basically, both liver-related and also cardiovascular heart outcomes.

Speaker Change: Where we saw a significant.

Speaker Change: Clinically relevant improvement in Steatosis and also clinically relevant improvement in fibrosis, if we see the same level in phase III.

Speaker Change: We would be looking at a very attractive profile. This is also what allows the FDA to go.

Speaker Change: <unk> has breakthrough designation based on the phase II data.

Speaker Change: And then in addition, we are extending the story through an additional.

A couple of hundred patients, where we will continue treatment to look for heart outcomes. So basically both liver related and also cardiovascular outcomes also Takeda too.

Martin Holst Lange: Also, to cater to the broader, both clinical, but also peer discussion. Thank you, Matt. We are now ready for the next question. Thank you. We will now go to the next question, and your next question comes from the line of Evan Zeigermann from BMO Capital Markets. Please go ahead. Hi all, thank you so much for taking my question and congratulations on all the progress. Maybe walk me through some of the expected pricing dynamics for Wigobi in the United States. And I'm asking this in the context of, you know, why are you necessarily giving prices given that, you know, supply is constrained and the demand is so high?

Speaker Change: On the broader both clinical as well as payer discussions.

Speaker Change: Thank you Martin.

Speaker Change: We are now ready for the next question.

Speaker Change: Thank you.

Speaker Change: We will now go to the next question.

Speaker Change: And your next question.

Speaker Change: Comes from the line of.

Evan Zeigermann: Maybe walk me through how you're thinking about how this will hold over the next few quarters. Thank you so much. Thank you, Evan. So Lars, will you give that a go?

Speaker Change: And then <unk> them on.

Speaker Change: From BMO capital markets. Please go ahead.

Speaker Change: Hi, all thank you so much for taking my question and congrats on all the progress maybe walk me through some of the pricing dynamics for <unk> in the United States and I'm asking this in the context.

Why are you necessarily giving price given that.

Speaker Change: Supply is constrained and the demand is so high maybe walk me through how youre thinking about how this will evolve over the next few quarters. Thank you so much.

Speaker Change: Okay.

Speaker Change: Thank you Evan.

Speaker Change: So last will you give that a go yes. So thank you for that question. So we strongly believe in the value of <unk>.

Lars Fruergaard Jorgensen: Yeah, so thank you for that question. We strongly believe in the value of our GF1 products. And we just spoke about some of the very nice outcomes data we have achieved. So we have a situation where we are gradually increasing access to more and more, say, channels of the market, which brings some of those with a lower price. So it's really a sign of us reaching more and more patients and also some of the more vulnerable patients that's impacting the pricing dynamics. We see an all-stable, competitive environment.

Speaker Change: Our overall Q1 products and we just spoke about some of the <unk>.

Speaker Change: <unk> outcomes data that we have achieved so.

Speaker Change: We have a situation, where we are gradually increasing access to more and more channels of the market, which comes some of those with a lower price. So it's really a sign of us reaching more and more patients and also some of the more vulnerable patients. That's that's impacting the pricing dynamics, we see in all stable.

Speaker Change: Competitive environment.

Lars Fruergaard Jorgensen: And with the volume opportunity we have at hand, that significantly outweighs what we see in terms of lower price points in some of these additional channels. So, strong belief in the value of our products, but also a wish to treat more and more patients, and some of those come at a slightly lower price point than what we launched at, so to say. Thank you. You're last.

Speaker Change: And with the volume opportunity we have at hand.

Speaker Change: You know significantly outweighed.

Speaker Change: What we see in terms of the lower price points in some of these additional channels. So.

Speaker Change: Strong believers in the value of our products.

Speaker Change: Also wish to treat multiple patients.

Speaker Change: And some of those come at a slightly lower price point than what.

Speaker Change: What we launched at Shaw.

Thank you.

Lars Fruergaard Jorgensen: Thank you, Evan, for the question. We're ready for the next question. Thank you. We will now go to the next question. And your next question... who's from the line of?

Speaker Change: Thank you Evan for the question, we're ready for the next question.

Speaker Change: Thank you.

Speaker Change: We will now go to the next question.

And your next question.

Comes from the line of.

Speaker Change: <unk>.

Speaker Change: So it didn't Jain from Bank of America. Please go ahead.

Sachin Jain: Sajid Jain from Bank of America, please go ahead. Hi there, Sachin Jain, Bank of America. Two for Martin, if I may.

Sachin Jain: Firstly, back on MIM-8 and the zero bleed rate you referenced, Martin. I think at the CMD you referenced the 70% zero bleed rate post hoc analysis. I think Hemlibra's got about 50% zero bleeds on the label, but Roche quotes 80 to 90% in real life.

Jain: Hi, guys. Thanks, Jamie Thanks, Mark Chief Martin If I may firstly, Amit on the zero bleed rate you referenced Martin.

Speaker Change: The CMV you referenced the 70%.

Speaker Change: They bleed rate post hoc 96 I think.

Amit: <unk> got about 50% as you are at least on the label, but rush towards 8%, 9% in real life. So given the sort of various benchmark just want zero bleed rates for you as an absolute number confirms superior profile versus a mirror with a camera of cross trial comparisons the second question.

Sachin Jain: So given the sort of various benchmarks, just what zero bleed rate for you as an absolute number confirms a superior profile versus Hemlibra with the caveat of cross-trial comparisons? The second question is on amphetamine, and maybe I misunderstood, and perhaps I didn't hear your commentary correctly. You've referenced a phase two start towards the end of this year. From the CMD, I thought you were awaiting the subcut data early next year and the diabetes data next year before a potential phase three start. Did I misunderstand that the CMD or something changed since then?

Speaker Change: Question is on <unk>, and maybe I misunderstood and perhaps I didnt hear commentary correctly, you've referenced the phase III starts.

Speaker Change: Towards the end of this year from the <unk> weighting.

Speaker Change: Early next year in diabetes data next year before potential phase III did I misunderstand that the CMT or has something changed since then.

Speaker Change: So thank you setting two for you Martin first on my right and then on the accretion timeline yep. Thank you very much.

Martin Holst Lange: Thank you. So, thank you, Sachin. Two for you, Martin. First on MyMate, and then on Emigration Timeline. Yeah, thank you very much, Sachin. So, first of all, on MyMate, obviously, I can only compare the regulatory data and what is in the label. And I think you're right. What we've seen so far in our clinical trials is slightly in excess of 70% of patients with no bleeds, which obviously if that is also confirmed in phase three will be a very competitive profile. So this is what we're looking for. And then again, you have to compare likes to likes.

Speaker Change: First of all on my made obviously I can only compare the regulatory.

Martin: The data and what is in the label.

Speaker Change: And I think you're right what we've seen so far in our.

Martin: Clinical trials is.

Martin: Yeah.

Martin: Is slightly in excess of 70% of patients with <unk>.

Martin: Which obviously if that.

Martin: As.

Martin: Also confirmed in phase III will be a very competitive profile.

Martin: So this is what we're looking for in.

Martin: And then again you have to compare like to like so the regulatory studies.

Martin Holst Lange: So the regulatory started, On amicretin, I don't think you misunderstood anything. We, for better or worse, have to focus from a regulatory perspective on obesity and diabetes as two distinct entities. And for obesity, we are currently in the process of finalizing phase one, and then we'll look at how to further progress amicretin in obesity. For type 2 diabetes, we are currently in the process of conducting a phase two study to understand the potential of amicretin in type 2 diabetes.

Martin: And I don't think misunderstood anything we feel better or worse have to focus.

Martin: From a regulatory perspective on obesity and diabetes as two distinct entities.

Martin: So obesity, we are currently in the process of finalizing the subcutaneous phase one and then we'll look at how to further progress <unk> for type two diabetes. We are currently in the process of conducting a phase III study to understand the potential of <unk> in type two diabetes.

Speaker Change: Thank you Martin Thank you Sachin we're ready for the next question.

Martin Holst Lange: Thank you, Martin. Thank you, Sachin. We're ready for the next question. Thank you. And your next question, and that comes from the line of Peter Feddle from City, please go ahead. Beat Vidal here from Citi.

Speaker Change: Thank you.

Speaker Change: We will now go to the next question.

Speaker Change: And your next question.

Speaker Change: Comes from the line.

Speaker Change: Peter <unk> from Citi. Please go ahead.

Peter Verdult: Just two questions, favorite topics for you both, supply and pricing, sorry, to test your patients. But starting with Karsten, you've consistently stated that scaling supply is management's number one priority. With that in mind, can we peek a little bit more beyond 2024?

Peter: You will hear from Citi just two questions.

Peter: Favorite topic for you, both the supply and pricing sorry to test your patients patients with starting with Thompson.

Peter: You've consistently stated that's going to play this management is number one priority with that in mind.

Peter: Can we pick a little bit more beyond 2020 full when we think about you opening the taps and quadrupling started doses, where we go is that a no too.

Peter Verdult: When we think about you opening the taps and quadrupling starter doses for WeCovi, is that a nod to supply capacity in 2025 being a multiple of 2024? I realize I'm pushing my luck here, but some sense would be helpful, and then just for Lars or Camilla, I mean, we're seeing with flow and select and have powerful, The data to support increasing use of STEMA continues to grow, but we are also now seeing a backlash politically in the US. Danish authorities want to step out of Zempik after SGLT2, lowering the price of Zempik to 30% in Denmark.

Peter: Apply capacity from 25 being a multiple of <unk>.

Speaker Change: 24, I realize I'm pushing my luck here, but some sense would be helpful.

Speaker Change: And then just allows a camilla.

Speaker Change: Seeing with Sloan select.

Speaker Change: Perhaps.

Speaker Change: Thanks to <unk>, who will increasingly sistema continues to grow but we're also now seeing the backlash.

Speaker Change: In the U S.

Speaker Change: She's willing to step out as <unk>.

Speaker Change: S GLC to.

Speaker Change: Barring the prices <unk>, Denmark. So the question is just to sort of follow up on the previous one I'm more interested in pricing for the next few quarters, but yes.

Peter Verdult: So the question is just to follow on from the previous one; I'm not interested in pricing for the next few quarters, but how do you think about just the dynamics going forward as people try and manage their budgets? I mean, the demand is clearly there. It's a case where you should expect a step up in pricing erosion, but put simply, the volume opportunity is so great that any pricing concerns get fully offset.

Speaker Change: How do you think about.

Speaker Change: Just the dynamics going forward as people try and manage their budgets.

Speaker Change: The demand is clearly there is a case, where you we should expect.

Speaker Change: A step up in pricing erosion, but put simply the volume opportunity is so great.

Peter Verdult: I just want to understand how you are thinking about that dynamic. Thank you. Thanks Pete. So first, Karsten, Pete's pushing his luck on supply in the coming years. Yeah, so, guiding for supply in 2025 at the Q1 call 2024, I think is stretching it a bit. So, so let me give you a couple of boundaries.

Speaker Change: This concerns get fully offset just wanted to understand how you are thinking about that dynamic.

Speaker Change: Thanks, Pete So first casting pits pushing his luck on supply in the coming years.

Karsten Munk Knudsen: So, from a finished point of view, then we continue to scale the single dose platform that we have launched in the US. So that is ongoing and something we're driving each and every day. And so of course, we'll continue to scale that. And, and then on top of that, which we're also out saying today, that as of now, we have launched in nine countries beyond the US because we so the ramp up outside the US will also be taking a pace this year but also into next year.

Pete: Yeah. So so guiding for supply in 2025 at the Q1 call in 2024, I think is stretching it a bit. So so let me give you a couple of foundries.

Speaker Change: So so from a fill finish point of view and then we continue to scale. The single dose platform that we have launched in the U S. So that is ongoing and something we're driving each and everyday.

Speaker Change: So of course, we will continue to scale that.

Karsten Munk Knudsen: So, net net, yes, there will be a good ramp into 2025. The exact amount and, and factors know that we'll have to get back to you on that one at a later point in time. Thank you, Karsten. Lars?

Speaker Change: And then on top of that.

Speaker Change: We're also saying today that.

Speaker Change: S.

Speaker Change: Now we have launched.

Speaker Change: In nine countries beyond the U S.

The Kobe so so the ramp up ex U S will also be taking a pace or this year, but also into next year. So net net yes, there will be a good ramp into 2025.

Speaker Change: Exact amount and in fact us and all of that will have to get back to you on that one at a later point in time.

Speaker Change: Thank you Lasse.

Lars Fruergaard Jorgensen: Yeah, thanks, Pete, for the for the question on, On how we see the pricing dynamics, I would say when we launched [inaudible] and we launched at similar pricing as prior generations despite the fact of a significantly better clinical profile and obviously that was an attractive value proposition and that has led to significant volume growth because of the benefits and right now we have a situation where you can say both that volume is to some degree putting strains on healthcare systems but at the same time we are just starting to unfold the full value of patients being on this treatment and these same healthcare systems are significantly burdened by chronic diseases and many of them linked to the exact diseases we are treating here. So I think I'm optimistic about how we can communicate the value to healthcare systems a willingness among both patients and physicians to use these medicines, and then of course we see very different markets. In the US we see typically year over year a slight erosion in net price.

Speaker Change: Thanks.

Speaker Change: For the for the question on.

Speaker Change: On how we see the pricing dynamics I would say when we launched.

Speaker Change: Similar type both in type two diabetes and obesity was into and stepped up price points in the market.

Speaker Change: And we launched at similar pricing.

Prior generations.

Speaker Change: Despite the effect of significantly better clinical profile.

Speaker Change: And obviously that wasn't attractive value proposition and that has led to a significant volume growth.

Speaker Change: Because of the benefits and right now we have a situation where you can say both that volume is.

Speaker Change: Some degree putting.

Speaker Change: Strange on health care systems, but at the same time, we are just starting to unfold.

Speaker Change: Full value of.

Speaker Change: Ah patients being on treatment and these same health care systems significantly burdened by chronic diseases. Many of them linked to the expect diseases, where triangle with Richard treating here. So so I think I'm a.

Speaker Change: Optimistic about how we can.

Speaker Change: Communicate the regulatory health care systems.

Speaker Change: Interventions I'm very optimistic about the underlying say willingness among both patients and physicians to use these medicines.

Lars Fruergaard Jorgensen: In other markets, it's more of a stable nature, and you sometimes have one-offs. So in that overall equation, I'm actually very confident that we can manage to articulate the value of medicines at a price point that's also understood by the healthcare system, and with the continued volume opportunity, this turns into a very attractive commercial model. Thank you. Thank you Lars and thanks Pete for the questions. We are ready for the next question. Thank you. We will now go to your next question. One moment, please.

Speaker Change: And then of course, we see.

Speaker Change: See very different markets in the U S. We see typically year over year, a slight erosion in net price.

Speaker Change: In other markets.

Speaker Change: It's more of a staple.

Speaker Change: In nature, and you have sometimes one or so.

Speaker Change: Equation I'm actually very confident that we can manage.

Speaker Change: To articulate the value of our medicines at a price point, that's also understood ecosystems.

Speaker Change: With the continued volume returned to this turns into a very attractive commercial model.

Speaker Change: Thank you Lasse and thanks, Peter for the questions. We are ready for the next.

Speaker Change: Thank you.

Speaker Change: Yeah.

Speaker Change: We will now go to your next question.

Speaker Change: One moment please.

Speaker Change: And your next question comes from the line of Simon Baker from Redburn. Please go ahead.

Simon Baker: And your next question comes from the line of Simon Baker from Redburn Atlantic. Please go ahead. Thank you for taking my questions. Firstly, another one on pricing, if I may. Lars, you indicated that the pricing impact that you've seen in Q1 is effectively channel mix. I just wonder if you could confirm that and apportion the amount of pricing that is down to channel mix and how much is down to pricing reductions within specific channels.

Simon Baker: Thank you for taking my questions.

Simon Baker: Firstly.

Simon Baker: Another one on pricing if I may.

Simon Baker: Lance you indicated that the <unk>.

Simon Baker: <unk> impact that you've seen in Q1 is effectively channel mix I just wondered if you could confirm that.

Simon Baker: A portion of the amounts of pricing that is down to channel mix and how much is down to.

Simon Baker: Two pricing reductions within specific channels.

Speaker Change: And then the second question on a completely different subject.

Simon Baker: And then the second question on a completely different subject. I just wonder if you could give us any commentary on the FTC's recent challenge to the Orange Book patent listing, of which you were one of the named companies. Any idea on the timeline over which this will play out?

Speaker Change: Just wanted to if you could give us any.

Speaker Change: Commentary on the FTC's recent challenge two Orange book.

Speaker Change: The listing of which you won't have the named companies any any idea on the timeline over which this will play out thanks so much.

Good. Thank you Simon so customer I think it will get both of them to you the first.

Simon Baker: Thanks so much. Good, thank you, Simon. So, Karsten, I think I'll give both of them to you.

Speaker Change: Pricing in Q1, and then the second half to see challenges of patents.

Karsten Munk Knudsen: The first, pricing in Q1, and then the second, the FTC challenge to patents. Yeah, Simon, thanks for these questions. So, as we've been saying earlier on, then one should always be careful of over-interpreting pricing in individual quarters. So, to be more specific, then on OCEANPIC, like for like, we do see a continued reduction in price. And then, yes, we have some growth to net benefit in the first quarter, but over the full year, you should, like for like, see a net price reduction for OCEANPIC in the US. And the same goes for Vigovi, back to the volume opportunity.

Speaker Change: Yes, Simon Thanks for these questions. So so.

Speaker Change: And then one should always be careful of.

Speaker Change: Or interpreting pricing in individual quarters. So.

Simon Baker: So to be more specific than the than on <unk>.

Simon Baker: Like for like we do see continued reduction in price and then yes, we have some gross to net.

Simon Baker: Benefit in the first quarter clarified, but but over the full year you should like for like see a.

Karsten Munk Knudsen: But net net, given increasing volume and competition, net pricing, like for like, will be down in the US. And then, as to the FTC letter on patents, I believe that was the question. That was the question, yes. So the FTC question on patents: it's important to note, first of all. The patents in question are related to SINPIC, Victoza, and Saxenda, but we're talking about device patents, first of all, and we're talking about patents that are valid and granted by the U.S. Patent Office.

Simon Baker: Net price reduction for example in the U S and and the same goes for the Kobe back to the volume opportunity, but net net given the increasing volume and competition net pricing like for like will be down.

Simon Baker: In the U S.

Simon Baker: And then there's two.

Simon Baker: The FTC.

Simon Baker: Later on.

Simon Baker: On patents.

Simon Baker: I believe there is of course that was the question. Yes. So the FTC gave great question on the patents.

Simon Baker: It's important to note first of all the <unk>.

Say in question are related to <unk>.

Simon Baker: Victor <unk>, but we're talking about device patents patents first of all and we're talking about patents that are valid and granted by the U S. Patent office. The question. It's all about whether they should be listed in the Orange book are not and of course.

Karsten Munk Knudsen: The question is all about whether they should be listed in the Orange Book or not. And, of course, when we listed the patents, we carefully assessed whether we were following the appropriate protocol per FDA and sought guidance and feedback on that. So, we believe that what we have done is appropriate, but, of course, we'll follow the regulations as issued by the FDA. Thank you, Karsten. Thank you, Simon, and we are ready for the next question. Thank you. We will now go to the next question. One moment, please.

Simon Baker: We listed the patents, we carefully assess whether we are following the appropriate.

Protocol per FTE, and and salt guidance and feedback on that so so all we believe that that what we have done is appropriate but of course.

Simon Baker: We'll follow the regulations issued by the FDA.

Alright, thank you.

Speaker Change: Thank you Simon and we're ready for the next question. Please.

Thank you.

Speaker Change: We will now go to the next question.

Speaker Change: One moment please.

Speaker Change: And your next question comes from the line of Florent Cespedes from Bernstein. Please go ahead.

Florent Cespedes: And your next question comes from the line by Florence Cesperides from Bernstein. Please go ahead. Good afternoon, thank you very much for taking my questions. Two quick ones. First, on obesity in Europe. Could you give us an update on the situation in Europe for Vigovi and the discussions with the payers if they are waiting for a select data pool on the label? So some color on this front would be great. My second question for Karsten, on sales and distribution, could you give us some color on how you see this line going forward as it was much lower than expected this quarter, but at least related to the fact that you have less promotion efforts. So some colors would be great.

Good afternoon. Thank you very much hope taking my questions two quick ones first.

Florent Cespedes: Thank you. Thank you, Florent. Camilla, the first question for you, Vigovi, outside the US. Yeah, and you also asked specifically about whether they're waiting for Select.

Florent Cespedes: On obesity in Europe could you give us an update on the situation in Europe.

Florent Cespedes: <unk> and the discussions with the payers.

Florent Cespedes: Our waiting for us.

Florent Cespedes: That's a pool under on the label. So some color on this front would be great. My second question for caisson.

Florent Cespedes: Sales and distribution.

Florent Cespedes: Could you give us some color on how you see this line going forward us towards much slower.

Florent Cespedes: Unexpected this quarter relates to the fact that you have less.

Florent Cespedes: From airports.

Florent Cespedes: Some costs are would be great. Thank you.

Florent Cespedes: Thank you Florent give me the first question to <unk> outside the U S. Yes.

Camilla Sylvest: Of course, we are initially waiting for the regulatory decision on Select, which we expect in the second half of this year. Having said that, there is, of course, a keen interest in this set of data. But already, we do have reimbursement in a number of countries outside the US. So, UK, Scotland, Canada, Japan, and also Switzerland.

Florent Cespedes: Yeah, and you also asked specifically about whether they are waiting for select of course, we are initially waiting for the regulatory decision on select which we expect in the second half of this year, having said that there is of course, a keen interest in this set of data.

Florent Cespedes: But already now we do have reimbursement in a number of countries outside the U S.

Florent Cespedes: So UK, Scotland, Canada and.

Florent Cespedes: Japan and also Switzerland. So we are seeing a very positive interest in <unk> and of course also in the select data that shows the strong classes.

Camilla Sylvest: So we are seeing very positive interest in Vigovi and, of course, also in the Select data that shows a strong cost effect. Camilla Karpman, S.N.D. Commercial Investments?

Florent Cespedes: Yeah.

Camilla Sylvest: Thank you Camilla Castanon.

Speaker Change: <unk> development.

Karsten Munk Knudsen: Yes, so coming back to our recent Capital Markets Day and our strategic resource allocation, then what I was discussing there was our intent to allocate substantial resources towards innovation, i.e. R&D, so having an increasing R&D ratio, i.e. investments there are growing faster than sales, and our commercial investments are growing at a slower pace than sales, and that is exactly what you're seeing this quarter and also what you should expect to be seeing this year, that commercial investments are growing slower than sales.

Speaker Change: Commercial investments, yes, so so coming back to to our recent capital markets day in our strategic resource allocation than the than what what.

Speaker Change: I was discussing there was.

Speaker Change: It was our intent.

Speaker Change: To allocate substantial resources towards.

Speaker Change: Innovation.

Speaker Change: So having an increasing R&D ratio.

Speaker Change: Investments grew.

Speaker Change: Faster than sales and our commercial investments growing at a slower pace.

Speaker Change: Sales and Thats exactly what Youre seeing this this quarter and also what you should expect to be seeing this year that commercial investments are growing slower than sales.

Karsten Munk Knudsen: We have the majority of our commercial infrastructure in place across our therapeutic categories, so what we're pursuing are really targeted investments. I'd say a lot of focus on obesity market development and building the obesity market, and then we also have some early investments in some of our newer therapy areas. So building some infrastructure on the cardiovascular side. So that is really the main focus area for commercial investment. Thank you very much for the key.

Speaker Change: We have the majority of our commercial infrastructure in place.

Speaker Change: Across our therapeutic categories. So so what we are pursuing.

Speaker Change: A really targeted investments I would say a lot of focus on obesity market development and <unk>.

Speaker Change: Building the obesity market and then we also have some early investments in some of our newer therapy areas. So we're building some infrastructure on the cardiovascular side. So that is really the main focus areas on commercial investments.

Speaker Change: Okay. Thank you very much very clear.

Speaker Change: And we are ready for the next question. Please.

Karsten Munk Knudsen: And we are ready for the next question, please. Thank you. Your next question comes from the line of Mark Purcell from Morgan Stanley. Please go ahead. Yeah, thank you very much for taking my questions. I have two.

Speaker Change: Thank you.

Speaker Change: Your next question.

Speaker Change: Comes from the line of Mark Purcell from Morgan Stanley. Please go ahead.

Mark Purcell: Yes. Thank you very much for taking my questions I have two the first one is just going back to Stuart gave you a starting dose the pace of growth at the moment it seems to be increasing a bit it's about 10% week over week now up to 33000.

Mark Purcell: The first one is just going back to the Wagovi US starting dose. The pace of growth at the moment seems to be increasing a bit. It's about 10% week over week now up to 33,000.25 milligram doses per week.

Mark Purcell: 0.25 milligram doses per week should we assume that this sort of increase will continue to be steady or is there going to be a slowdown in that 10% growth week over week annual conference and converting to the high doses would be helpful. And then the second question is on the <unk> dual chamber device I Wonder if you could help us understand some of the properties of this size in terms of weather.

Mark Purcell: Should we assume that this sort of increase will continue to be steady? Or is there going to be a slowdown in that 10% growth week over week, and your confidence in converting to high doses would be helpful? And then the second question is about the Cagliosoma dual chamber device. I wonder if you could help us understand some of the properties of this device in terms of whether it's connected and the importance in terms of patient compliance, potentially from it being a connected device, the launch preparedness, and any implications of the co-formulation of Cagliosoma. What does that mean for the dual chamber device?

Mark Purcell: It's connected and importance in terms of patient compliance potentially from it being a connected device the launch preparedness and any medications of the co formulation of <unk>, what does that mean for the dual chamber device. Thank you.

Mark Purcell: Yeah.

Good so the first question over to you talk for the commercial dynamics right now with <unk> in the U S.

Doug Langa: Thank you. Good. So the first question over to you, Doug, about the commercial dynamics right now with Vigovi in the US. Yeah, thanks, Mark. I mean, we're certainly pleased with the last couple weeks of MBRX. As I stated in the beginning, over 27,000 and reaching an all-time high with TRX.

Talk: Yeah. Thanks, Mark I mean, we're certainly pleased with the last couple of weeks.

Martin Holst Lange: But remember, as I've talked about quarter over quarter, our key focus remains the safeguarding of patient continuity of care, and we manage that supply dynamically to do that. So we're going to continue to gradually scale up efforts, and we're going to we're going to do that throughout the remainder of this year. And certainly, we're happy and pleased with what we're seeing now. And we're very pleased with select and what we're going to be what we're going to be able to do moving forward.

Speaker Change #101: <unk> as I stated in the beginning over 27000, and reaching all time high with Trs, but remember as I've talked about quarter over quarter. Our key focus remains the safeguarding of patient continuity.

Speaker Change #102: Sure and we manage that supply dynamically to do that so we're going to continue to gradually scale efforts and.

Speaker Change #102: We're going to we're going to do that throughout the remainder of this year.

Speaker Change #102: And certainly we're we're happy and pleased with what we're seeing now and we're very pleased with with select and where we're going but we're going to be able to do moving forward.

Speaker Change #103: Good Thank you Doc Marten, <unk> device and connectivity.

Martin Holst Lange: Good. Thank you, Doug. Martin, Cagri-Semme device and connectivity? Yep. So very briefly, the Cagri-Semme device, as you say, it is a dual chamber device, as the two drugs can currently not be co-formulated, and and and it's a single-dose device very simple to use so basically you should compare that to the device we currently know connectivity embedded in that device, On the question on cope formulation, obviously, with a dual chamber device, that's not our normal platform, the cope formulation will allow us more flexibility in that we can then deliver CAG with SEMA in more versions, one could potentially be in text touch, thereby from a supply perspective, allowing us more flexibility.

Speaker Change #103: Very briefly the calculus similar device.

Doc Marten: It is a dual chamber device.

Doc Marten: As the two drugs can currently not be co formulated.

Doc Marten: And it's a single dose device very simple to use so basically you should compare that to the device of weaker currently no connectivity.

Doc Marten: Headed in that device.

Doc Marten: On the question on co formulation.

Doc Marten: Obviously.

The dual chamber device.

Doc Marten: Our normal platform the cultural integration will allow us more flexibility.

We can then deliver calculus.

Doc Marten: In more versions, one could potentially be an index touch thereby from ESI.

Doc Marten: Active allowing us flexibility.

Speaker Change #105: Thank you Martin Thanks for the question, we're ready for the next.

Martin Holst Lange: Thank you, Martin. Thanks for the question. We're ready for the next one.

Speaker Change #106: Thank you.

Operator: Thank you. We will now take your next question. And your next question comes from the line of Harry Sephton from UBS. Please go ahead. Brilliant. Thank you very much for taking my questions. Two, please.

Speaker Change #107: We will now take our next question.

UBS: And your next question comes from the line of how is <unk> from UBS. Please go ahead.

Harry Thomas d'Alton Sephton: So my first question is whether you saw any material impact to your first quarter volumes in the US from the cyber attack on UnitedHealth's Change Payments platform that may have restricted some patients' access to co-pay support and, as a result, could have contributed to some weakness on volumes beyond just the supply constraints. And then my second question is you've talked about the fact that the ex-US, Thank you. Thank you, Harry.

Howie: Brendan Thank you very much for taking my questions. Two please say on the first question is whether you saw any material impacts to your first quarter volumes in the U S from the cyber attack on Unitedhealth change payments platform that may have restricted some patients access to co pay support.

Brendan: And as a result could have contributed to some weakness on volumes beyond just the supply constraints.

Brendan: And then my second question is you've talked about the fact that the ex U S obesity market could be predominantly self pay in the future.

Brendan: How do you view the potential opportunity for the U S market to meet more towards self pay and what are your ambitions. There. Thank you.

Speaker Change #111: Thank you Harry Duck two for you first on cyber attack impact potential impact in the first quarter and then second do you see the self pay market in the U S.

Harry Thomas d'Alton Sephton: Doug, two for you. First, on cyber attack impact, potential impact in the first quarter, and then second, do we see a self-pay market in the US? Yeah, thanks, Mark. Or excuse me. Thanks, Harry. Nothing material. It doesn't explain the volumes.

Speaker Change #112: Yeah, Thanks, Mark or excuse me, thanks, Harry Yes, nothing material it doesn't explain the volumes just maybe give you a little context there.

Doug Langa: Just maybe give me a little context there. Again, remember, speaking to Zempik, you know, we saw a 50% over a 50% growth rate in the quarter. We continue to gain market share, which is important, and we're clearly the market share leader. But we did see some impacts in the quarter, periodic supply constraints, and they were primarily in the early part of the year. But remember, we have a larger base. Last year, volume growth was 50%.

Speaker Change #112: Again remember speaking to <unk>, we saw.

Harry Duck: 50% over a 50% growth rate in the quarter, we continued to gain market share, which is important and we're clearly the market share leader.

Harry Duck: But we did see some impacts in the quarter periodic supply constraints and they were primarily in the early part of the year remember we have a larger base last year. The volume growth was was 50% and we do see some continuation of utilization management. So those would be more in line with what impacted some of the volumes.

Doug Langa: And we do see some continuation of utilization management, so that would be more in line with what impacted some of the volumes. In terms of self-pay, the way I would categorize that is we're always looking for opportunities to bring more patients to our products, and that could be an option. So we will evaluate everything moving forward. Thank you, Doug. And specifically also the cyber attack. Did you see any impact from that in the first quarter?

Harry Duck: In terms of self pay the way I would categorize that as we're always looking at opportunities to bring more patients to our products and that could be an option. So we evaluate everything moving forward.

Speaker Change #114: Thank you Tom.

Tom: And specifically also the cyber attack did you see any impact from that in the first quarter.

Tom: Yes, nothing material and that wouldn't explain the volumes.

Speaker Change #116: Thank you Doug and thank you.

Doug Langa: Yet not anything material, and that wouldn't explain the bond. Thank you, Doug, and thank you, Harry. Thank you. We're ready for the next question. Thank you. We'll now take your next question. And your next question is from Richard Parkes. Please go ahead. Thanks for taking my questions. So yeah, just two questions. Firstly, on melunobant, the phase two data. I'm just wondering if there's going to be anything you can generate from that phase two trial to give some comfort about the risk of psychiatric side effects, given the class, i.e.

Speaker Change #117: Sure Anthony we are ready for the next question.

Speaker Change #118: Thank you.

Speaker Change #119: We will now take your next question.

Speaker Change #119: Yes.

Richard Parkes: any data on confirmation that the drug doesn't cross the blood-brain barrier to a material degree or, And then secondly, just sort of playing devil's advocate on the commentary around value to healthcare systems from WigoV, obviously some of the arguments for that are based on stay time in the select study of three and a half years, but what we're seeing in the real world at the moment is less than 12 months in terms of median duration. So from the payer's perspective, there's a risk that they get all of the upfront costs without generating savings if they can't keep patients on drugs.

Speaker Change #119: Tim It's Richard PA, but he's going to advocate K formulation.

Tim: Thanks for taking my question.

Richard: Yes, just two questions firstly on.

Richard: Melinda bonds the phase II data. So I'm just wondering if this is going to be anything you can generate from that phase II trial to give some comfort on the risk of Catholic side effects.

Richard: Given the cost side.

Richard: The data on consummation Ctrip doesn't cross the blood brain barrier to two degree or should we just expect standard phase II readout and then secondly, just playing Devil's advocate on the commentary around value to healthcare systems from what guys.

Richard: Obviously some of the arguments based on state time in the select study three and a half years, but what we're seeing in the real world at the moment is less than 12 months in terms of median duration.

Payers perspective as a risk.

Richard: All of the upfront cost without generating savings if they cant keep patients on drug.

Speaker Change #122: Wondering if not a pushback that you often gotten how you addressed that in your discussions with payers. Thank you.

Richard Parkes: So I'm just wondering, is that a pushback that you often get and how you address that in your discussions with payers? Thank you. Thank you, Richard. So, Martin, first, the first one to you, and Lars, I'll give the second one to you.

Speaker Change #123: Thank you Richard so much interest the first one to you and lastly give the second one yes. Thank you very much. So so so I think youre right. We are quite excited about la Luna abandon the potential because we've seen potential for substantial weight loss with a scalable oil and that is of course very exciting. However, we had to.

Martin Holst Lange: Yeah, thank you very much. So, so, I think you're right. We're quite excited about Montluna Band and the potential because we've seen potential for substantial weight loss with a scalable aural.

Speaker Change #124: Rule out potential safety issues, the ongoing phase II trial will give us a good readout on the efficacy and it will also give us a reasonable readout of <unk>.

Speaker Change #124: All of the safety profile of Laguna.

Speaker Change #124: However to fully de risk this.

Speaker Change #126: We intend to investigate this as we already announced.

Speaker Change #125: And then somewhat larger.

Speaker Change #125: Sorry to secure that both obviously our efficacy, but also safety assessment of this is Ryan So youll get a good first readout from the ongoing phase II trial, but you'll see even more for from the next.

Martin Holst Lange: And that is, of course, very exciting. However, we have to, is right. So you'll get a good first readout from the ongoing phase two trial. But but but but you'll see even more from the next, Thank you. So a fair challenge on the stay time.

Lars Fruergaard Jorgensen: It's still early days, but we are pleased with the stay time we see. But I think it's also fair to say that we have not had a sustainable market presence to really be able to tell what the stay time be. I think it's also a dynamic situation in terms of understanding what obesity is and what the value of treating obesity is. So we believe over time that we'll be able to see, say, enough patients getting to durable weight loss that will also translate into real health benefits. But, of course, it takes time to establish those data.

Speaker Change #127: Thank you so first tenants on the stay time.

Speaker Change #125: It's still early days.

Speaker Change #125: We are pleased with the state time, we see.

Speaker Change #125: I think it's also fair to say that we have not had let's say a sustainable market presence to really be able to tell what will stay time.

I think it's also.

Speaker Change #125: NAMIC.

Speaker Change #125: Situation in terms of understanding what his decency and what's the value of treating obesity.

Speaker Change #125: So we believe over time that we will see.

Lars Fruergaard Jorgensen: And we have simply not been in the market long enough to document that. But I think it will be possible to do that. Thank you. Thank you, Lars and Richard, for the questions. We have time for one final brief question. Thank you. We will now take your final question. One moment, please.

Speaker Change #125: Say enough patients getting through.

Speaker Change #125: That drove in weight loss that will also translate into.

Speaker Change #125: The health benefits.

Speaker Change #125: But of course, it takes time to establish dose data.

Speaker Change #125: And we have certainly not been in the market long enough to document that.

Speaker Change #128: So, but I think it would be possible to do that thank you.

Speaker Change #129: And thank you to Richard further we have we have time for one final brief question.

Thank you.

Speaker Change #130: We'll now take your final question.

Speaker Change #131: One moment please.

Speaker Change #131: Okay.

Speaker Change #132: And your final question.

Operator: And your final question... comes from the line of Michael Novo from Nordea. Please go ahead. Thank you very much. Michael from Nadia.

Speaker Change #132: It comes from the line of Michael <unk>.

Michael: From Nordea. Please go ahead.

Thank you very much Michael from Nordea.

Michael Novod: So going back to the CMS guidance and some of the access you are getting, can you comment on... How many of the insurance companies are following CMS guidance? And also, in that connection, how do you see the potential progress for the TROA Act in the US? Could something happen in 2024 or 2025?

Michael: So going back to the CMS guidance and some of the excess youre getting can you comment on <unk>.

Speaker Change #133: How many of.

Speaker Change #134: The insurance companies are following CMS guidance and also in that connection.

Speaker Change #134: How do you see then the potential progress for the Trop Act in the U S could something happen in 'twenty 'twenty four 'twenty 'twenty five.

Michael: Thank you Michael Duck over to you for the for the last answer.

Doug Langa: Thank you, Michael. Doug, over to you for the last answer. Thank you, Michael. So, we're seeing a couple million, you could say around 4 million lives today that we're seeing as a result of the impact of the label update with CMS allowing for reimbursement and Medicare Part D. And again, this is going to be gradual, right? There's still some work to do, as I mentioned earlier, with plan sponsors on the exact criteria of reimbursement.

Speaker Change #135: Thank you Michael so we.

Michael Duck: We're seeing a couple of million dollars you could say around 4 million lives today that we're seeing as a result of the impact of the label update with CMS alone reimbursement in Medicare part D. And again this is going to be gradual right. There's still some work to do as I've mentioned earlier with planned sponsors to the exact criteria reimbursement. So it's going to be gradual, but we certainly see this as a very.

Doug Langa: So it's going to be gradual, but we certainly see this as a very positive step in the right direction. And, you know, it's certainly encouraging. Now, as far as TROA is concerned, again, as I've said many times, we're not going to, I'm not going to get into the predicting game. But again, we think it's just a matter of time. Certainly, there's support on both sides, so we still think it's just a matter of time.

Michael Duck: Positive step in the right direction and.

Michael Duck: It's certainly encouraging as far as trailer again as I've said, many quarters, we're not going to I'm not going get into the predicting game.

Michael Duck: But again, we think it's just a matter of time certainly their support on both sides. So we still think it's just a matter of time. So we're positive I just I can't give you indication as to when but we're hard at work there as well.

Speaker Change #137: Thank you Dr. Thank you Michael.

Doug Langa: So we're positive. I just can't give an indication as to when, but we're hard at work there as well. Thank you, Doug. Thank you, Michael. And this concludes the Q&A session for this earnings call. Thank you for participating, and please feel free to contact Investor Relations, as always, regarding any follow-up questions you might have. Before we close the call, I would like to hand over to you Lars for his final remarks.

And this concludes the Q&A session for this earnings call. Thank you for participating and please feel free to contact Investor relations as always regarding any follow up questions. You might have before we close the call I would like to hand over to <unk> for the final remarks, yes. Thank you Daniel and thank you all for joining US today. So I hope it comes across that we are very pleased with the momentum of our business right now.

Doug Langa: Yeah, thank you, Daniel. And thank you all for joining us today. So I hope it comes across that we're very pleased with the momentum of our business right now, as evidenced by the sales performance in the first three months, and not least the development of scripts for both ASEMBIC and WeGoWe in the US, really proving that we are on track of scaling supplies here during the year, but also our commitment to scale supplies significantly for the coming years to treat even more patients.

Speaker Change #138: As evidenced by the solid performance in the first three months.

Speaker Change #139: The development in script for both are simply can we go in the U S really proving that we are on track of scaling suppliers.

Speaker Change #139: Here.

Speaker Change #140: During the year, but also our commitment to scale supply significantly for the coming years to treat even more patients. We're also excited about our pipeline progress and what we have coming up in terms of my maiden Caicos, Emma and I will.

Doug Langa: We're all excited about our pipeline progress and what we have coming up in terms of MyMate and Kaggle Seminar. And on a final note, I'd like to thank you, Daniel. This was the last quarter with you at Helmuth as IR head.

Speaker Change #140: Finally, I'd like to thank you Daniel this was the last quarter would you have.

Lars Fruergaard Jorgensen: Thank you for your leadership and best of luck with your continued career in New Nordisk. With this, we close the call. Thank you all. Thank you. This concludes today's conference call. Thanks for participating. You may now disconnect. [inaudible] , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? , , , , , , , , , , , , , , , , ,

Daniel: Thank you for your leadership and the best of luck with your continued Korea invoice. This will close the call. Thank you all.

Speaker Change #141: Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.

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