Q2 2024 Novo Nordisk AS Earnings Call
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Operator: Welcome to the first six months of the 2024 Novo Nordisk AS Earnings conference call. At this time, all participants are in a listen-only mode. 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 your hand is raised. 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 our first speaker today, Jakob Gorder, Head of Investor Relations. Please go ahead, sir.
Speaker Change: Good day and thank you for standing by. Welcome to the first six months of 2024 Novo Nordisk AS Earnings Conference Call.
Operator: At this time, all participants are in a listen-only mode.
Operator: After the speaker's presentation, there'll be a question-and-answer session. To ask you a question during the session, you will need to press star, one, and one on your telephone. You will then hear an automated message advising your hand is raised.
Speaker Change: At this time all participants are in a listen-only mode. 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 your hand is raised.
Operator: To destroy your question, please press star one and one again.
Operator: Please be advised that today's conference has been recorded.
Speaker Change: 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 first speaker today, Jakob Gorder, Head of Investor Relations. Please go ahead, sir.
Operator: I would now like to have the conference over to your first. Thank you.
Jakob Gorder: Thank you. Welcome to this Novo Nordisk earnings call for the first six months of 2024. My name is Jakob Martin Viborg Rde, and I'm the Head of Investor Relations at Novo Nordisk. With me today, I have the CEO of Novo Nordisk, Lars Rdgaard 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 Holt All speakers will be available for the Q&A session.
Jacob Martin: Welcome to this Novo Nordisk earnings call for the first six months of 2024. My name is Jacob Martin. We parole, and I'm the head of investor relations at Novo Nordisk.
Jakob Gorder: Thank you.
Speaker Change: Welcome to this Novo Nordisk earnings call for the first six months of 2024. My name is Jakob Martin Viborg Røde, and I'm the Head of Investor Relations at Novo Nordisk.
Jacob Martin: With me today, I have CEO of Novo Nordisk, Lars Joergensen, Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camila Street West, Executive Vice President and Head of North America Operations, Doug Langa, Executive Vice President and Head of Development, Martin Holtz Langa, and finally, Chief Financial Officer, Karsten Womknusen. All speakers will be available for the Q&A session. Today's announcement and the slides for this call are available on our website, novonordisk.com. Please note that this call is being broadcasted live, and a recording will be made available on our website as well. The call is scheduled to last one hour.
Speaker Change: With me today, I have CEO of Novo Nordisk, Lars Froger Jørgensen, 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 Holtz-Lange, and finally, Chief Financial Officer, Karsten Bunk-Knudsen.
Lars Rødgaard Jørgensen: Today's announcement and the slides for this call are available on our website, novo-nordisk.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 for one hour, and the presentation is structured as outlined on slide 2. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified. We need to advise you that this call will contain forward-looking statements.
Speaker Change: All speakers will be available for the Q&A session.
Speaker Change: Today's announcement and the slides for this call are available on our website, novonordisk.com. Please note that this call is being webcasted live and a recording will be made available on our website as well. The call is scheduled to last one hour. Please turn to the next slide.
Unknown Executive: Please turn to the next slide. The presentation is structured as outlined on slide two. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified.
Speaker Change: The presentation is structured as outlined on slide 2. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified.
Unknown Executive: Please turn to the next slide. We need to advise you that this call will contain forward-looking statements. These are subject to risk and uncertainty that could cause actual results to differ materially from expectations.
Speaker Change: Please turn to the next slide.
Lars Rødgaard Jørgensen: These are subject to risk and uncertainty 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 six months of 2024, as well as the slides prepared for this presentation. With that, I turn to you, Lars, for an update on our strategic aspirations.
Speaker Change: We need to advise you that this call will contain forward-looking statements.
Unknown Executive: For further information on the risk factors, please see the company announcement for the first six months of 2024, as well as the slides prepared for this presentation.
Speaker Change: These are subject to risk and uncertainty 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 six months of 2024, as well as the slides prepared for this presentation. With that, over to you Lars for an update on our strategic aspirations.
Lars Joergensen: With that, we would use Lars for an update on our strategic aspirations. Thank you, Yarob.
Lars Joergensen: Please turn to the next slide. In the first six months, we delivered 25% sales growth and 19% operating profit growth, both at constant exchange rates. The operating profit growth was impacted by the impairment loss related to oxygenation.
Lars: Thank you, Jaap. Please turn to next slide.
Lars: In the first six months, we deliver 25% sales growth and 19% operating profit growth, both at constant exchange rates.
Speaker Change: The operating profit growth was impacted by the impairment loss related to osadurinone.
Lars Joergensen: We 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 sustainability, we are now serving more than 42 million patients with our diabetes and obesity treatments. Our total carbon emissions rose by 31% as compared to the first six months of 2023. This was primarily driven by our increased investments in capital expenditure to meet the high demand for our products. To uphold our commitment to being a sustainable employer, we expanded the number of women in senior leadership positions to 41% compared to 40% in the first six months of 2023.
Lars Rødgaard Jørgensen: In the first six months, we delivered 25% sales growth and 19% operating profit growth, both at constant exchange rates. I would like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues. Starting with our focus on purpose and sustainability, we are now serving more than 42 million patients without diabetes and obesity treatment.
Lars: We would like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues.
Lars: Starting with our focus on purpose and sustainability, we are now serving more than 42 million patients with our diabetes and obesity treatments.
Lars Rødgaard Jørgensen: Our total carbon emissions rose by 31% as compared to the first six months of 2023. This was primarily driven by our increased investments in capital expenditure to meet the high demand for our products. To uphold our commitment to being a sustainable employer, we expanded the number of women in senior leadership positions to 41%, compared to 40% in the first six months of 2023. Across all leadership positions, 46% are held by women.
Lars: Our total carbon emissions rose by 31% as compared to the first six months of 2023. This was primarily driven by our increased investments in capital expenditure to meet the high demand for our products.
Lars: To uphold our commitment to being a sustainable employer, we expanded the number of women in senior leadership positions to 41%, compared to 40% in the first six months of 2023. Across all leadership positions, 46% are held by women.
Lars Joergensen: Across all leadership positions, 46% are held by women.
Lars Joergensen: Within R&D, we had a number of exciting readouts this quarter, including the positive Maymaid Phase III results. Martin will come back to this and our overall R&D milestones later. The quarterly sales growth reflects solid commercial execution across both operating units.
Lars Rødgaard Jørgensen: Within R&D, we had a number of exciting readouts this quarter, including the positive MyMate Phase 3 results. Martin will come back to this and our overall R&D milestones later. The quarterly sales growth reflects solid commercial execution across both operating units. The performance in the first six months has enabled us to raise our outlook for the full year. Camilla and Doug will go through the details later.
Martin: Within R&D we had a number of exciting readouts this quarter, including the positive MyMate Phase 3 results. Martin will come back to this and our overall R&D milestones later.
Speaker Change: The quarterly sales growth reflects solid commercial execution across both operating units. The performance in the first six months has enabled us to raise our outlook for the full year. Camilla and Doug will go through the details later.
Lars Joergensen: The performance in the first six months has enabled us to raise our outlook for the full year. Camilla and Doug will go through the details later. Cartham will go through the financials, but I'm pleased with our performance in the first six months of 2024.
Karsten: Karsten will go through the financials, but I'm very pleased with our performance in the first six months of 2024. With that, I'll give the word to Camilla for an update on commercial execution.
Camilla Street West: With that, I'll give the word to Camilla for an update on commercial execution. We'll ask, and please turn to the next slide. In the first six months of 2024, our total sales increased by 25% at constant exchange rates. The sales growth was driven by both operating units, with North America operations growing 36% and international operations growing 11%.
Lars Rødgaard Jørgensen: to last, and please turn to the next slide. Sales growth was driven by both operating units, with North America operations growing 36% and international operations growing 11%. In the U.S., sales growth was positively impacted by gross to net sales adjustments related to prior years. Our DLP1 sales increased in diabetes by 32%, driven by North America operations growing 39% and international operations growing 20%. In international operations, we continue to roll out Vigovi gradually with volume cap launches to balance supply and demand, where deceased sales decreased by 3%. Please turn to the next slide. The increase reflects market share gains in both North America operations and international operations.
Speaker Change: to last and please turn to the next slide.
Karsten: In the first six months of 2024, our total sales increased by 25% at constant exchange rates.
Speaker Change: The sales growth was driven by both operating units, with North America operations growing 36% and international operations growing 11%. In the US, sales growth was positively impacted by gross-to-net sales adjustments related to prior years.
Camilla Street West: In the U.S. Sales growth was positively impacted by growth to net sales adjustments related to prior years. Our DLP1 sales increased in diabetes by 32%, driven by North America operations growing 39% and international operations growing 20%. Insulin sales increased by 10%, driven by North America operations growing 36% and international operations growing 3%. Obesity care sales increased 37%, driven by North America growing 35% and international operations growing 47%. In international operations, we continue to roll out the GOV gradually with volume care launches to balance supply and demand. In both geographies, growth was driven by the GOV, partly offset by declining sales as the market is moving towards once-weekly treatments.
Speaker Change: Our GLP-1 sales increased in diabetes by 32%, driven by North America operations growing 39% and international operations growing 20%.
Speaker Change: Insulin sales increased by 10% driven by North America operations growing 36% and international operations growing 3%.
Speaker Change: Obesity care sales increased 37% driven by North America growing 35% and international operations growing 47%.
Camilla Street West: Where the sales increased by 3%.
Camilla Street West: Please turn to the next slide. With 25% 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 34.1%.
Operator: Please turn to the next slide.
Camilla Street West: This is above our strategic aspiration of reaching 1.3 of the global diabetes value market in 2025. The increase reflects market share gains in both North America operations and international operations.
Speaker Change: This is above our strategic escalation of reaching one third of the global diabetes value market in 2025.
Speaker Change: The increase reflects market share gains in both North America operations and international operations.
Camilla Street West: Please turn to the next slide. In international operations, diabetes care sales increased by 11% in the first 6 months of 2024, which was primarily driven by TLP1 sales growing 20%.
Please turn to the next slide.
Speaker Change: In international operations diabetes care sales increased by 11% in the first six months of 2020 fall, which was primarily driven by TLC one sales growing 20%.
Camilla Street West: No, we notice, is the market leader in international operations with a GLP1 value market share of 69%. Ossemic continues its GLP1 market leadership with 46.6% market share. We also pleased to see we both is increasing its market share to more than 16%, driven by solid uptake across geographies.
Novo Nordisk: Novo Nordisk is the market leader in international operations, where the tier one value market share of 69% or.
Novo Nordisk: <unk> continues to be a tier one market leadership with 46.6% market share.
Doug: Please proceed with balances increasing its market share to more than 16% driven by solid uptake of cost across geographies and with that I will hand over to Doug.
Doug Langa: And with that, I will hand over to Doug. Thank you, Camilla.
Doug Langa: Please turn to the next slide. Sales in North America is driven by market share gains and healthy prescription volume growth of the GLP1 class above 10% in the second quarter this year compared to the second quarter last year. Sales of GLP1 diabetes care products in the US increased by 42% at constant exchange rates. The sales increase was mainly driven by a continued uptake of Ozempic measured on total prescriptions.
Doug: Thank you Camilla Please turn to the next slide sales in North America is driven by market share gains and healthy prescription volume growth of the <unk>, one class above 10% in the second quarter this year compared to the second quarter last year sale.
Speaker Change: Sales of <unk> diabetes care products in the U S increased by 42% at constant exchange rates. The sales increase was mainly driven by continued uptake of <unk>.
Lars Rødgaard Jørgensen: Measured on total prescriptions, Novo Nordisk expands its market leadership, now with around 56% market share. Note that the sales growth of Ozempic was negatively impacted by periodic supply constraints at the beginning of the year. Please go to the next slide.
Doug Langa: No, but notice expand its market leadership now with around 56% market share. Note that the sales growth of Ozempic was negatively impacted by periodic supply constraints in the beginning of the year.
Speaker Change: On total prescriptions Novo Nordisk expand its market leadership now with around 56% market share.
Speaker Change: Note that the sales growth of Jose epic was negatively impacted by periodic supply constraints in the beginning of the year. Please go to the next slide.
Doug Langa: Please go to the next slide. To safeguard continuity of care for Wagovi, we reduced the supply of the 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 strengths. And I am pleased to see that this has been reflected in prescriptions, and we are now seeing more than double the number of prescriptions in the market compared to the beginning of the year. Further, while demand is still expected to exceed supply, we grow more confident in our ability to supply.
Lars Rødgaard Jørgensen: To safeguard continuity of care for WGOVI, we reduced the supply of the lower dose drinks in May of 2020. Ultimately, our focus is to reach more patients living with obesity. And as volumes go up, prices will come down. In the first six months of 2024, sales growth was driven by increased volumes, partially countered by lower realized prices. Our rare disease sales decreased by 3%, and sales and international operations declined by 14%. This was partly offset by a 13% sales increase in North America operations, reflecting the Segroia launch and positive gross net adjustments related to prior years in the US.
Speaker Change: To safeguard continuity of care for <unk>, we reduced the supply of the lower dose strengths in may of 2023, which continued throughout the remainder of last year.
Speaker Change: In the beginning of this year, we gradually started increasing the supply of the lower dose strengths and I am pleased to see that this has been reflected in prescriptions and we are now seeing more than double the number of prescriptions in the market compared to the beginning of the year further while demand is still expected to exceed supply we grow more confident.
Doug Langa: Hi, we will continue to dynamically manage supply, but only the initiation dose strength of 0.25 milligrams. We'll go be still has broad market access with coverage for more than 50 million people with obesity. And importantly, around 10 million vulnerable people with obesity now have access to we'll go be through channels such as Medicaid, which is now available in more than 20 states. Ultimately, our focus is to reach more patients living with obesity. And as volumes go up, prices will come down. In the first six months of 2024, sales growth was driven by increased volumes, partially countered by lower realized prices.
Speaker Change: And our ability to supply.
We will continue to dynamically manage supply, but only the initiation dose strength of two five milligrams.
Speaker Change: We will go we still has broad market access with coverage for more than 50 million people with obesity and importantly around $10 million vulnerable people with obesity now have access to adobe through channels, such as Medicaid, which is now available in more than 20 states.
Speaker Change: Ultimately our focus is to reach more patients living with obesity and as volumes go up prices will come down.
Speaker Change: And the first six months of 2024 sales growth was driven by increased volumes, partially countered by lower realized prices next slide please.
Doug Langa: Next slide, please. Our rare disease sales decreased by 3%. Sales in international operations declined by 14%.
Speaker Change: Our rare disease sales decreased by 3% sale.
Speaker Change: Sales in international operations declined by 14%.
Doug Langa: This was partly offset by a 13% sales increase in North America operations, reflecting the Segroya launch and positive growth and adjustments related to prior years in the US. Rare blood disorder sales decreased by 2%, driven by lower Novo 7 and hemophilia A sales. This was partially countered by increased hemophilia B sales.
Speaker Change: This was partly offset by a 13% sales increase in North America operations, reflecting the <unk> launch and positive gross to net adjustments related to prior years in the U S.
Lars Rødgaard Jørgensen: Rare blood disorder cells decreased by 2%, driven by lower NOVA7 and hemophilia A cells. This was partially countered by increased hemophilia B cells. Rare Endocrine Disorder Cells Decreased by 8% We are working on reestablishing full supply capacity of rare endocrine disorder products, following a reduction of manufacturing. Now over to you, Martin, for an update on R&D.
Speaker Change: Rare blood disorder sales decreased by 2% driven by lower Nova <unk> in hemophilia a sales. This was partially countered by increase hemophilia b sales.
Doug Langa: Rare and accruing disorder sales decreased by 8%.
Speaker Change: Rare endocrine disorder sales decreased by 8%.
Doug Langa: We are working on reestablishing full supply capacity of rare endocrine disorder products following a reduction of manufacturing output.
Speaker Change: We are working on reestablishing full supply capacity of rare endocrine disorder products. Following a reduction of manufacturing output now over to you Martin for an update on R&D.
Martin Holtz Langa: Now, over to you, Martin, for an update on R&D. Thank you, Doc.
Speaker Change: Okay.
Martin Holtz Langa: Please turn to the next slide. I'm very pleased to share the results of the Frontier II Phase V trial with my mate, which we provided headline results for back in May. The full data set was also disclosed at the ISTH in June.
Martin: Thank you Doug Please turn to the next slide.
Martin: I am very pleased to share the results of the frontier to phase III trial with my mate.
Martin Holtz-Lange: which we provided headline results for back in May. The full dataset was also disclosed at the ISTH in June. Frontier II was a pivotal, phase-free, 26-week, open-label, randomized, controlled, and multi-armed trial versus prior coagulation factor prophylaxis. 254 people aged 12 years and older with hemophilia A with or without inhibitors were included in the trial. Please turn to the next slide.
Martin: Should we provided headline results were back in May.
Martin: The full dataset was also disclosed at <unk>.
Martin: <unk> in June.
Martin Holtz Langa: Before I walk you through the results, I would like to briefly remind you of the innovative clinical trial design. Frontier II was a pivotal Phase III, 26-week open-label, randomized controlled, and multi-arm trial. The trial investigated the efficacy and safety of once-weekly and once-monthly subcutaneous bymate versus no previous profile access treatment or on-demand treatment, and versus prior co-operation factor profile access treatment. 254 people aged 12 years and older with hemophilia A without inhibitors were included in the trial. The co-primary endpoint was mean annualized bleeding rate for treated leads for both once-weekly and once-monthly bymate versus on-demand treatment and versus prior co-operation factor profile access treatment.
Martin: Before I walk you through the results I would like to briefly remind you of the innovative clinical trial designs.
Martin: Frontier was a pivotal phase III 26 week open label randomized controlled and multi arm trial.
Martin: The trial investigated the efficacy and safety of once weekly and once monthly subcutaneous <unk> versus no previous prophylaxis treatment.
Martin: All on demand treatment and versus prior coagulation factor prophylaxis treatment.
Martin: 254 people, aged 12 years and older with hemophilia, a with or without inhibitors were included in the trial.
Martin: The co primary endpoint was mean annualized bleeding rate for <unk> for both once weekly and once monthly by mid versus on demand treatment and versus prior calculation.
Martin Holtz Langa: Please turn to the next slide. Overall, in Frontier II, my mate demonstrated superiority of mymate profile access with both weekly and monthly dose. In the on-demand treatment population, my mate demonstrated superior reductions of 97 and 99 percent in estimated mean annualized bleeding rate for once-weekly and once-monthly treatment, respectively. This was compared to those receiving continued on-demand treatment.
Martin: In fact, the prophylaxis treatment.
Martin: Turn to the next slide.
Martin: Overall in frontier too.
Martin: <unk> demonstrated superiority of Miami prophylaxis, with both weekly and monthly dose.
Martin: In the on demand treatment population.
Martin Holtz-Lange: My men demonstrated superior reductions of 97 and 99 percent. This was compared to those receiving continued on-demand... My men demonstrated superior reductions of 48 and 43 percent in estimated mean annual bleeding rates for once-weekly and once-monthly treatment, respectively. In the population with prior coagulation factor prophylaxis, In the trial, MIMADE appeared to have a safe and well-tolerated profile with no thromboembolic events observed and no evidence of neutralizing anti-MIMADE antibodies. Further, only 5 to 10, sorry, 5 to 12% of patients experienced injection site reactions across all five treatment arms.
Martin: <unk> demonstrated superior reductions of 97.
Martin: At 19, 9% and estimated mean annualized bleeding rate for once weekly and once monthly treatment respectively.
Martin: This was compared to those receiving continued on demand treatment.
Martin Holtz Langa: In the interpatient comparison, a people will prior co-oculation factor profile access treatment. Jensen, Simon demonstrated superior reductions of 48 and 43% in estimated mean annual bleeding rates for once weekly and once monthly treatment, respectively. Of note, in the population with prior on-demand treatment, 86% and 95% of people receiving once weekly and once monthly my made treatment, respectively, experienced zero treated peace. In the population with prior correlation factor prophylaxis, 66% and 65% of people receiving once weekly and once monthly, my made respectively at zero needs.
Martin: In the inter patient comparison.
Martin: Even with prior coagulation factor prophylaxis.
Martin: <unk> demonstrated superior reductions of 48, and 43% and estimated mean annual bleeding rates.
For once weekly and once months with treatment respectively.
Martin: Of note in the population with cryo on demand treatment 80, 695% of people receiving once weekly and once monthly Miami treatment, respectively experienced zero treated please.
Martin: And the population will cryo coagulation factor prophylaxis, 6% to 6% and 65% of cheaper received once weekly and once monthly mind made respect respectively at zero bleeds.
Martin Holtz Langa: In the trial, my made appeared to have a safe and well tolerated profile, with no thromboembolic events observed and no evidence of neutralizing anti-my made antibodies. Further, only 5 to 10, sorry, 5 to 12% of patients experience injection side reactions across all five treatment arms. In conclusion, we're very excited about the Frontier to results given the differing needs of people living with hemophilia at once weekly or once monthly dose and provides optionality and flexibility for people living with hemophilia with and without inhibitors.
Martin: In the drive by made appear to have a safe and well tolerated profile with no drug related embolic events observed and no evidence of neutralizing antibody made antibodies.
Martin: The only 5% sorry, 5% to 12% of patients experience.
Martin: Side reactions across all treatment arms.
Martin Holtz-Lange: In conclusion, we're very excited about the Frontier, given the differing needs of people living with hemophilia A. Once weekly or once monthly dosing provides optionality and flexibility for people living with hemophilia A with and without inhibitors.
Martin: In conclusion, we are very excited about the frontier to results.
Speaker Change: Given the different different needs of people living with hemophilia, a once weekly or once monthly dose and provides optionality and flexibility for people living with hemophilia, a with and without inhibitors.
Martin Holtz Langa: We now expect to file for first regulatory approval of my made during the first half of 2025. Next slide, please.
Speaker Change: We now expect to file for first regulatory approval of <unk> made during the first half of 2025.
Speaker Change: Next slide please.
Martin Holtz Langa: Turning to diabetes, I would also like to share the results from the combined one trial, which investigated the use of once weekly icosema, a combination of once weekly insulin iotech and once and once weekly semacletac and people will talk to diabetes. The objective of the 52-week trial was to assess the efficacy and safety of switching to once weekly icosema compared to once weekly insulin iotech alone, and people will have two diabetes inadequately controlled on a daily basal insulin with or without oral antidiabetic drugs. The trial achieves its primary endpoint with icosema demonstrating superiority in reducing A1C and weight 52 with once weekly icosema compared with insulin iotech.
Speaker Change: Turning to diabetes I would also like to share the results from the combined one trial, which investigated the use of once <unk> Iqos Emma.
Speaker Change: A combination of once weekly insulin <unk> that's one.
Speaker Change: And once once weekly <unk> in people with type two diabetes.
Martin Holtz-Lange: The objective of the 52-week trial was to assess the efficacy and safety of switching to once-weekly IQOSEMA compared to once-weekly insulin IQODEC alone in people with type 2 diabetes inadequately controlled on a daily basal insulin with or without oral anti-diabetic drops. The trial achieved its primary end point, with icosema demonstrating superiority in reducing A1c at week 52 with once weekly icosema compared with insulin icosema, from an overall HbA1c baseline of 8.2%.
Speaker Change: Yes.
Speaker Change: Of the 52 week trial was to assess the efficacy and safety of switching to once weekly Iqos, Emma compared to once weekly insulin I could take the law and people with type two diabetes inadequately controlled on a daily basal insulin with or without oral anti diabetic drugs.
Speaker Change: The trial achieved its primary endpoint with Iqos, similar demonstrating superiority and reducing agency at week 52, with once weekly <unk> kusama compared with insulin I predict.
Martin Holtz Langa: From an overall HbA1c baseline of 8.2%, icosema achieved an estimated reduction in A1C of 1.6% compared to 0.9% for insulin iotech. People in the trial had a baseline body weight of 48, sorry, 84.5 kilograms. Treatment with icosema achieved a superior change in body weight, with a weight loss of 3.7 kilograms compared with a 1.9 kilograms weight gain with insulin iotech. The estimated treatment difference was 5.6 kilograms. In the trial, the rate of clinically significant or severe hypoglycemia was statistically significantly lower with Icosema at 0.14% per patient years of exposure versus 0.63% per patient year of exposure with once weekly insulin Iotech.
Speaker Change: From an overall HBA when see baseline of eight 2% Iqos.
<unk> achieved an estimated reduction in <unk> of one six percentage points compared to 0.9 percentage points for insulin <unk>.
Speaker Change: People in the trial had a baseline body weight of 48.
Speaker Change: Im sorry, $84 five kilograms.
Speaker Change: Treatment with <unk> achieved a superior change in body weight with a weight loss of $3 seven kilograms, compared with a one nine kilograms weight gain with haynesville and iconic.
Martin Holtz-Lange: The estimated treatment difference was 5.6 kilograms. In the trial, the rate of clinically significant or severe hypoglycemia was statistically significantly lower with icosema, at 0.14 events per patient year of exposure versus 0.63 events per patient year of exposure with 1-3-Gly into linacrotec. Next slide, please.
Speaker Change: Estimated treatment difference was five six kilograms.
Speaker Change: In the trial the rate of clinically significant or severe hypoglycemia was statistically significantly lower with iclusig.
Speaker Change: At 0.14 events per patient years of exposure versus <unk> 63 events for patient years of exposure with once weekly insulin iridic.
Martin Holtz Langa: In the trial, once weekly, icosema appeared to have a safe and well-tolerated profile.
Speaker Change: In the trial once weekly IP semi appear to have a safe and well tolerated profile.
Martin Holtz Langa: Now that the third and last pivotal phase three trial is completed, we expect to file for regulatory approval of icosema during the second half of 2024. Next slide, please.
Speaker Change: Now that the third and last pivotal phase III trial is completed we expect to file for regulatory approval all microsemi during the second half of 2024.
Speaker Change: Next slide please.
Martin Holtz Langa: Now I would like to highlight some of the additional exciting R&D news, including trial readouts and initiations anticipated for the rest of the year. Within diabetes, insulin icodec under the brand name of a weekly has been approved in multiple countries. In the US, however, we are disappointed to have received a complete response letter from the FDA for insulin icodec. The letter outline request related to the manufacturing process, and these are two, sorry, these are one diabetes indication before the application review could be completed. We are evaluating the content of this year and will work closely with the FDA to fulfill the requests.
Speaker Change: Now I would like to highlight some of the additional exciting R&D news, including trial, Readouts and initiations anticipated for the rest of the year.
Martin Holtz-Lange: Diabetes Insulin IcoDec, under the brand name Aviki, has been approved in multiple countries. In the US, however, we are disappointed to have received a complete response letter from the FDA for insulin IV. We do not expect to be able to fulfill the request during 2020.
Speaker Change: Within diabetes insulin <unk> under the brand name of our weekly has been approved in multiple countries.
Speaker Change: In the U S. However, we are disappointed to have received a complete response letter from the FDA for <unk>.
Speaker Change: Data outlined request related to the manufacturing process and this had to sorry, the type one diabetes indication before the application revenue could be completed.
Speaker Change: We are evaluating the content of the Sierra and will work closely with the FDA to fulfill the requests we do not expect to be able to fulfill that request during 2024.
Martin Holtz Langa: We do not expect to be able to fulfill the requests during 2024. In the first half of this year, the flow data was submitted as a label expansion application to the FDA in the US and to the European regulatory authorities. Submissions to regulatory authorities in Japan and China are expected in the second half of 2024. Additionally, in the second half of this year, we are expected to see the readout of the STRIDE ARC trial with a Sempec 1.0 milligram in peripheral artery disease. Further, we also expect readout of the sole cardiovascular arc of trial with the ribels whose 14 milligram.
Martin Holtz-Lange: In the first half of this year, the flow data was submitted as a label expansion application to the FDA in the U.S. Submissions to regulatory authorities in Japan and China are expected in the second half of 2025; additionally, in the second half of this year, we are expected to see the readout of the STRIDE outcome trial with SEMPEG 1.0 mg in peripheral artery disease. Further, we also expect readout of the sole cardiovascular outcomes trial with the Rebelsus-14. Both trials are expected to further strengthen the comprehensive cardiometabolic evidence that we have for semantics.
In the first half of this year the flow data were submitted as a label.
Speaker Change: Expansion application to the FDA in the U S and.
Speaker Change: And to the European regulatory authorities submissions to regulatory authorities in Japan, and China are expected in the second half of 2024.
Speaker Change: Additionally, in the second half of this year.
Speaker Change: We expected to see the readout of the scribe arcos client with a simple one <unk> milligram and peripheral artery disease.
Speaker Change: Further we also expect readout of the sole cardiovascular outcomes trial was the rebels was 14 milligram.
Martin Holtz Langa: Both trials are expected to further strengthen the comprehensive cardiometabolic evidence that we have for semacroncline.
Speaker Change: Both trials are expected to further strengthen the comprehensive cardio metabolic evidenced that we have for making side.
Martin Holtz Langa: Also, in the second half of the year, we look forward to initiate a Phase 2.5 metretin, demonstrating our commitment to continuously raising the innovation behind diabetes. Moving to obesity care, in the second quarter, we successfully completed the OASIS Fault file. OASIS Fault investigated once daily semaglutide at 25 milligram for weight management in add-ons with obesity or overweight with one or more commodity. The trial achieved its primary endpoint, with all semacroncline 25 milligram demonstrating superiority compared to placebo with respect to change in body weight. From a baseline body weight of 105.9 kilograms, all semaglutide 25 milligram achieved a 13.6% reduction compared to 2.2% reduction with placebo.
Martin Holtz-Lange: Also, in the second half of the year, we look forward to initiating a phase two study for imitritin, demonstrating our commitment to continuously raising the innovation behind diabetes. Moving to obesity care, in the second quarter, we successfully completed the OASIS-4 training. OASIS-IV investigated once-daily semaglutide 25 mg for weight management in adults with obesity or overweight with one or more comorbidities. The trial achieved its primary endpoint, with oral semaglutide 25 mg demonstrating superiority compared to placebo with respect to change in body weight.
Speaker Change: Also in the second half of the year, we look forward to initiate a phase II study for him or treating demonstrating our commitment to continuously raising the innovation behind diabetes.
Speaker Change: Moving to a piece, which occur in the second quarter, we successfully completed the Oasis full trial.
Speaker Change: Oasis <unk> investigated once a week once daily 25 milligram for weight management in adults with obesity or we'll wait with one or more comorbidities.
Speaker Change: The trial achieved its primary endpoint with all <unk> 25 milligram, demonstrating superiority compared to placebo with respect to change in body weight.
Speaker Change: From a baseline body weight of $105 nine kilograms, all to make the 25 milligram achieved a 13, 6% reduction compared to two 2% reduction with placebo.
Martin Holtz Langa: The global launch of all semacroncline 25 milligram is contingent on portfolio prioritization and manufacturing capacity. Before we go, we received regulatory approval for the treatment of obesity or overweight in China, and in the EU, the EMA adopted a positive opinion on an update of the we-go-relabel to reflect data from the select file. The select cardiovascular outcome trial demonstrated that we significantly reduced the risk of major adverse cardiovascular events by 20% compared to... Plessibok, the label update will also include select data showing a numerical risk reduction in cardiovascular death by 15%, a significant risk reduction of death from any cause by 19%, as well as a significant risk reduction of 18% in heart failure composite endpoints.
Martin Holtz-Lange: The global launch of oral semaglutide 25mg is contingent on portfolio prioritization and manufacturing capacity. For a week going, we received regulatory approval for the treatment of obesity or overweight in China. Looking ahead, we are in the second half, expecting Phase 2 results for Mond Luna Band. Within cardiovascular and emerging therapy areas, we announced in June 2024 that the Clarion CKD Phase III trial involving osadurone was terminated.
Speaker Change: The global launch of also magnitude 25 milligram is contingent on portfolio prioritization and manufacturing capacity.
Speaker Change: While we go we received regulatory approval for the treatment of obesity.
Speaker Change: <unk> in China and in the EU <unk> adopted a positive opinion for an update of the we go with labor to reflect data from this Elektra.
Speaker Change: The select cardiovascular outcome trial demonstrated that we can always statistically significant.
Speaker Change: Significantly reduced the risk of major adverse cardiovascular events by 20% compared to placebo.
Speaker Change: The label update will also include select data showing a numerical risk reduction in cardiovascular death by 15% a significant risk reduction of death from any cause by 19% as well as a significant risk reduction of 18% and heart failure composite endpoints.
Martin Holtz Langa: That further go we, based on injections with the FDA, we decided to withdraw the results from the step HEPF trials for regulatory review in the US and EU, to further substantiate the likelihood of getting heart endpoints into the label update. We now expect to resubmit the file in the beginning of 2025 with additional relevant data. We remain excited about the potential of semeditary 2.4 mg in this population, given the data that we've seen from the two completed STEP HEPF trials. Looking ahead, we are in the results for Moderna band, as well as phase 3 results for the step HEPF trial with semeditary 2.7.2 mg around the turn of the year.
Gui: That's perfect Gui based on interactions with the FDA, we have decided to withdraw the result from the step have Pip Trust for regulatory review in the U S and EU to further substantiate the likelihood of getting hot inputs into the label update.
Gui: We now expect to resubmit the file in the beginning of 2025 with additional relevant data.
Gui: We remain excited about the potential of <unk> two four milligram. This population given the data that we've seen from the two completed trials.
Gui: Looking ahead, we are in the second half expecting phase III.
Gui: Results for <unk>.
Gui: As well as phase III results for the step up trial with some evidence at two seven.
Gui: Seven two milligram <unk>.
Martin Holtz Langa: Lastly, we anticipate first phase 3 results for Redefine 1 with a cacrystema in obesity. With all of this activity, we are confident with the progress, progress we are making towards developing superior treatment solutions for people with obesity.
Gui: The turn of the year.
Gui: Lastly, we anticipate first phase III results for.
Gui: <unk> redefined one.
Gui: <unk> in obesity.
Gui: With all of this activity, we are confident with the progress progress, we're making towards developing superior treatment solutions for people with obesity.
Martin Holtz Langa: With regard to cardiovascular and emerging therapy areas, we in June 2024 announced that the Clareum-CKD-Face-3 trial involving Ocidurlan was terminated. This was based on an entry analysis performed by an independent monitoring committee that concluded that the trial met the pre-specified futility criteria, meaning that the trial, unfortunately, did not meet its primary end point. We've initiated a randomized and placebo-controlled Phase 3 cardiovascular outcomes trial called the Artemis. The trial will assess the efficacy and safety of sylcevacumate 15 mg in a acute microtal enthastic. Lastly, we look much forward to the phase 3 doubt of the Asian stride in investigating sylcevacumate 2.4 mg in mesh.
Within cardiovascular and emerging therapy areas. We in June 2024 announced that the Clariant <unk> phase III trial involving <unk> was terminated.
Gui: This was based on an interim analysis.
Gui: Formed by an independent monitoring committee that concluded that the trial met the pre specified futility criteria.
Meaning that the trial Unfortunately did not.
Gui: It meets its primary endpoint.
Gui: We have initiated a randomized and placebo controlled phase III cardiovascular outcomes trial called the Artemis trial.
Gui: I will assess the efficacy and safety of <unk> 15 milligram in acute myocardial infarction.
Gui: Lastly, we look much forward to the phase III readout of the issuance trial investigating <unk> two four milligram in mesh with that over to you.
Karsten Womknusen: With that, over to you, Karth. Thank you, Martin.
Karsten Munch: Thank you, Martin. Please turn to the next slide. In the first six months of 2024, our sales grew by 24% in Danish kroner and 25% at constant exchange rates, driven by both operating units. However, the gross margin decreased to 84.9% compared to 85.1% in 2023. The decline is mainly driven by increased costs related to ongoing capacity expansion. Sales and distribution costs increased by 5% in Danish kroner and by 6% at constant exchange rates.
Karsten Womknusen: Please turn to the next slide. In the first six months of 2024, our sales group by 24% in Danish kroner and 25% at constable exchange rates driven by both operating units. In the US, sales growth was positively impacted by growth-to-net sales adjustments related to prior years.
Gui: Thank you Martin please turn to the next slide.
Speaker Change: In the first six months of 2024 hour sales grew by 24% in Danish krone, and 25% at constant exchange rates driven by both operating units in.
Speaker Change: In the U S sales growth was positively impacted by gross to net sales adjustments related to prior years.
Karsten Womknusen: The growth margin decreased to 84.9% compared to 85.1% in 2023. The decline is mainly driven by increased costs related to ongoing capacity expansions. This is partially countered by a positive price impact from growth-to-net adjustments related to prior years in the US, in addition to positive product makes reflecting increased sales of TL21 based treatments. Sales and distribution costs increased by 5% in Danish kroner and by 6% at constable exchange rates. The increase in sales and distribution costs is impacted by adjustments to legal provisions in the second quarter of 2023. In North America operations, the cost increases are mainly driven by promotion activities related to Wigowy, while in a Snaffler operation, the increase is mainly related to promotional activities for repulsors as well as obesity care market development activities.
Speaker Change: The gross margin.
Speaker Change: Decreased to 84, 9% compared to 85, 1% and <unk> tried to treat.
Speaker Change: The decline is mainly driven by increased costs related to ongoing capacity expansions.
Speaker Change: This is partially countered by a positive price impact from gross to net adjustments related to prior years in the U S. In addition to positive product mix, reflecting increased sales of tier one phase treatments.
Speaker Change: Sales and distribution costs increased by 5% in Danish kroner and by 6% at constant exchange rates the increase in sales and distribution cost is impacted by adjustments to legal provisions in the second quarter of 2023.
Karsten Munch: The increase in sales and distribution costs is impacted by adjustments to legal provisions in the second quarter of 2023. The increase in costs is mainly driven by increased late-stage clinical trial activity and increased early research activities, as well as the impairment related to osaduronon of 5.7 billion Danish kroner and other impairments of entanglable acids. Administration costs increased by 8% measured both in Danish kroner and at the consular exchange rate. Operating profit is impacted by the impairment loss related to osadurinone of 5.7 billion Danish kroner.
Speaker Change: In North America operations, the cost increase is mainly driven by promotional activities related to recovery.
Speaker Change: While in international operations, the increase is mainly related to promotional activities for <unk>.
Speaker Change: Well.
Speaker Change: We'll be seeking market development activities.
Karsten Womknusen: Research and development costs increased by 79% measured in Danish Corona and by 78% constant exchange rates. The increase in cost is mainly driven by increased late-states clinical fire activity and increased early research activities, as well as the impairment related to Ocedora 9 of 5.7 billion Danish Corona and other impairments of intangible assets. Administration costs increased by 8% measured both in Danish corona and constant exchange rates.
Speaker Change: Research and development costs increased by 17, 9% measured in Danish kroner and by 78% at constant exchange rates.
Speaker Change: The increase in costs is mainly driven by increased late stage clinical trial activity and increased early research activities as well as the impairment related to our secured on a $5 7 billion Danish kroner and other impairments of intangible assets.
Speaker Change: Administration costs increased by 8% measured both in Danish krone and constant exchange rates.
Karsten Womknusen: Operating profit increased by 80% measured in Danish corona and by 90% constant exchange rates. Operating profit is impacted by the impairment loss related to Ocedora 9 of 5.7 billion Danish corona.
Speaker Change: Operating profit increased by 18% measured in Danish krone, and by 90% at constant exchange rates.
Speaker Change: Operating profit is impacted by the impairment loss related to our <unk> on a $5 7 billion Danish kroner.
Karsten Womknusen: Net financial items showed a net loss of 530 million Danish Corona compared to a net gain of 96 million Danish Corona last year, mainly reflecting hedging losses on the US dollar. Effective tax rate was 20.6% in the first 6 months of 2024 compared to 19.9% in the first 6 months of 2023. Net profit increased by 16% and diluted earnings per share increased by 17% to 10 Corona and 17.0. Net profit is negatively impacted by the 5.7 billion Danish corona impairment of Ocedora 9.
Karsten Munch: Net financial items showed a net loss of 530 million Danish kroner compared to a net gain of 96 million Danish kroner last year, mainly reflecting hedging losses on the US dollar. The effective tax rate was 20.6% in the first six months of 2024 compared to 19.9% in the first six months of 2023. Net profit is negatively impacted by the 5.7 billion Danish kroner impairment of osteoederma. Free cash flow realized in the first half of 2024 was 41.3 billion Danish kroner compared to 45.5 billion in the first six months of 2023.
Speaker Change: Net financial items showed in a net loss of 530 million Danish kroner compared to a net gain of 96 million Danish kroner on next year.
Speaker Change: Mainly reflecting hedging losses on the U S R.
Speaker Change: The effective tax rate was 26% in the first six months of trying to 'twenty four compared to 19, 9% in the first six months of 2023.
Speaker Change: Net profit increased by 16% and diluted earnings per share increased by 17% to 10, kroner and 17 or <unk>.
Speaker Change: Net profit is negatively impacted by the $5 7 billion Danish kroner impairment also drawing on.
Karsten Womknusen: Free cash flow realized in the first half of 2024 was 41.3 billion Danish Corona compared to 45.5 billion in the first 6 months of 2023. The lower free cash flow reflects increasing capital expenditure as well as the acquisition of intangible assets. This is partially counted by net cash generated from operating X. The impairment of the intangible asset of Ocedora 9 of 5.7 billion Danish Corona has no impact on free cash flow.
Speaker Change: Free cash flow realized in first half of 'twenty 'twenty four was 41.3 billion Danish kroner compared to $45 5 billion in the first six months of trying to trying to treat.
Speaker Change: Lower free cash flow reflects increasing capital expenditure as well as acquisition of intangible assets.
Speaker Change: This is partially countered by net cash generated from operating <unk>.
Speaker Change: The impairment of the intangible asset.
Speaker Change: $5 7 billion Danish kroner has no impact on free cash flow.
Karsten Womknusen: Capital expenditure for province planning equipment was 18.9 billion Danish kroner compared to 10.6 billion Danish kroner in 2023. This was primarily driven by investments in additional capacity for API production and filthiness capacity for both current and future intangible and all products.
Speaker Change: Capital expenditure for property plant and equipment was $18 9 billion Danish kroner compared to $10 6 billion Danish kroner in transparency tree.
Speaker Change: This was primarily driven by investments in additional capacity for API production and fill finish capacity for both current and future injectable and oral products. Please go ahead on the next slide.
Karsten Womknusen: Please go to the next line. A key priority for Namaskh is to ensure attractive allocation of capital to shareholders. For 2023, the total dividend per share increased 51.6% to 9 corona and 40 year. For 2024, the board of directors has decided to pay out an interim dividend of 3 Corona and 50 Year per share, which will be paid out in August of this year. We have returned more than 38 billion Danish corona to shareholders through dividends and share buybacks in the first 6 months of 2024. Our ongoing repurchase program for the full year amounts to up to 20 billion Danish Corona and reduction from 30 billion Danish Corona allocated last year.
Karsten Munch: A key priority for Novo Nordisk is to ensure an attractive allocation of capital to shareholders. Finally, we look towards a share buyback program as a flexible measure contingent on the first three priorities to distribute excess cash. We continued the growth momentum in 2024 and have raised our sales growth outlook to between 22% and 28% at constant exchange rates. The updated sales outlook at constant exchange rates reflects higher full-year expectations for both operating units, with the expectation of continued volume growth and capacity limitations at some manufacturing sites. Thank you very much. Precast flow is now expected to be between 59 and 69 billion Danish kroner, reflecting sales growth. Income under the 340B program has been partially recognized.
Speaker Change: A key priority for <unk> is to ensure attractive allocation of capital to shareholders for transparent story, the total dividend per share increased.
Speaker Change: 51, 6% to nine chroma and <unk>.
Speaker Change: For 2024.
Speaker Change: Board of directors has decided to pay out an interim dividend of treat corona and <unk> per share, which will be paid out in August of this year.
Speaker Change: We have returned more than 38 billion Danish kroner to shareholders through dividends and share buybacks in the first six months of 'twenty 'twenty four.
Speaker Change: Our ongoing repurchase program for the full year amounts to up to 20 billion Danish kroner, a reduction from 30% in Danish kroner allocated last year.
Karsten Womknusen: This location aligns with our strategic capture location strategy for Novo Nordisk. We prioritize investing in internal growth opportunities, returning capture to shareholders through dividends and business development activities.
Speaker Change: This allocation aligns with our strategic capsule location strategy funnel Norsk, we prioritize investing in internal growth opportunities returning capital to shareholders through dividends and business development activities. Finally, if we look towards share buyback program as effects from Asia contingent on the first three branches to.
Karsten Womknusen: Finally, we look towards Shia Pieback program as a flexible measure, contingent on the first three priorities to distribute excess cash. We continue the growth momentum in 2024 and have raised our sales growth outlook to between 22 and 28% at constant exchange rates. The updated sales outlook at constant exchange rates reflects higher fully expectations for both operating units. The guidance reflects expectations for sales growth in both North America, operations to end international operations, mainly driven by volume growth of DL-1-based treatments for obesity and diabetes care. With the expectation of continued volume growth and capacity limitations at some manufacturing sites, the outlook also reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.
Speaker Change: Distribute excess cash.
Speaker Change: We continued the growth momentum in trying to trying to fall and have raised our sales growth outlook to between 22 and try to 8% at constant exchange rates.
Speaker Change: <unk> sales outlook at constant exchange rates reflects higher for your expectations for both operating units the.
Speaker Change: 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 BT in diabetes care.
Speaker Change: With the expectation of continued volume growth in capacity limitations at some manufacturing sites.
Speaker Change: The outlook also reflects expected continued periodic supply constraints and related drug shortage notifications, a number across a number of products and geographies.
Karsten Womknusen: Novo Nordisk is investing in internal and external capacity to increase supply both short and long-term. Operating profit growth outlook is now expected to be between 20 and 28% at constant exchange rates. The updated expectation reflects the impairment loss reflected to us drawn on, communicated in June of negative six percentage points. Excluding this impact, we now expect a positive four-percentage-point increase on operating profit growth expectations for the full year. This is driven by the updated increased sales outlook compared to previous expectations. Capsule expenditure is still expected to be around 45 billion dollars crore in 2024, reflected expansion of the global supply chain.
Speaker Change: <unk> is investing in internal and external capacity to increase supply both short and long term.
Speaker Change: Operating profit growth outlook is now expected to be between 20 and 28% at constant exchange rates.
The updated expectation reflects the impairment loss reflected two Australian communicated in June of negative six percentage points. Excluding this impact we now expect our posture.
Speaker Change: Percentage point.
Speaker Change: Increase on operating profit growth expectations for the full year. This is driven by the updated increased sales outlook compared to previous expectations.
Speaker Change: Absolutely.
Still expect it to be around 45 billion. Thanks Cross training for reflecting expansion of the global supply chain.
Karsten Womknusen: Precastelo is now expected to be between 59 and 69 billion dollars crore, reflecting the sales growth, a favorable impact from rebates in the U.S. counted by investments in capsule expenditure. The updated Capsule expectation mainly reflects the increased sales growth outlook.
Speaker Change: Free cash flow is now expected to be between $59 69 billion Danish kroner, reflecting the sales growth.
Speaker Change: A favorable impact from rebates in the U S countered by investments in capital expenditure.
Speaker Change: The updated cash flow expectation, mainly reflects the increased sales growth outlook.
Karsten Womknusen: Income under the 340P program has been partially recognized; one ruling from the U.S. Court of Appeals for the 7th Circuit remains pending, and along with the DC Circuit ruling, may be subject to further discretionary appellate review before the U.S. Supreme Court, depending on the outcome of any subsequent rulings and appeals in these matters, there may be a material impact on normal financial position that sells and cash flow.
Speaker Change: Income under the 340 <unk> program has been partially recognized one ruling from the U S Court of Appeals for the seventh circuit remains pending and along with the DC circuit ruling may be subject to further just curious discretionary review before the U S. Supreme Court, depending on the outcome of any subsequent.
Speaker Change: Rulings and appeals and this matters that may be a material impact on normalized financial position net sales and cash flow.
Karsten Womknusen: Financial impacts related to and following the expected closing of the Catalan transaction have not been included in the financial guidance.
Speaker Change: Financial impacts related to and following the expected closing of the Catlin transaction have not been included in the financial guidance.
Lars Joergensen: That covers the outlook for 2024. Now back to you last. Thank you, Carsten.
Speaker Change: That covers the outlook for transplant for now back to your loss.
Lars Joergensen: Please turn to the final slides. We are very pleased with the sales growth in the first six months of 2024. The growth is driven by increasing demand for our G1 based diabetes and obesity treatments, and we are serving more patients than ever before.
Speaker Change: Thank you Carsten please turn to the final slides, we are very pleased with our sales growth in the first six months of trying to finish all the growth is driven by increasing demand for our <unk>, one based diabetes and obesity treatments and we're serving more patients than ever before.
Lars Rødgaard Jørgensen: Within R&D, we're very pleased with the first phase three trial results with MyMate and its potential for people living with hemophilia, as well as the recommendation for a label extension for cardiovascular risk reduction for WGOVI in the EU. With that, I'd like to hand over the word.
Lars Joergensen: Within R&D, we are very pleased with the first phase 3 trial results with my mate and his potential for people living with hemophilia, as well as the recommendation for a legal extension for cardiovascular risk reduction, for we go within the EU. Would that like to help the world to yak?
Speaker Change: In R&D, we are very pleased with the first phase III trial results with my mates and its potential for people living with hemophilia.
Speaker Change: Well as to a recommendation for a label extension for cardiovascular risk reduction for recovery in the EU.
Speaker Change: I'd like to hit or virtually Yakov.
Unknown Executive: Thank you, Lars. Next slide, please.
Speaker Change: Thank you Lasse next slide please with that we're now ready for the Q&A, where kindly ask all participants to limit her or himself to one maximum two questions, including sub questions. Operator, we're now ready to take the first question.
Jakob Gorder: With that, we're now ready for the Q&A, where I kindly ask all participants to limit themselves to one or a maximum of two questions, including sub-questions. Operator, we are now ready to take the first...
Operator: With that, we're now ready for the Q&A. We're kindly asked all participants to limit her or himself to one or a maximum of two questions, including subquestions.
Operator: Operator, we're now ready to take the first question. Thank you. Once again, as a reminder, if you would like to ask a question, please press star, one, and one on your telephone and wait for your name to be announced. To store your question, please press star one and one again.
Speaker Change: Thank you once again as a reminder, if you would like to ask a question. Please press star one on one on your telephone and wait for your name to P&L to withdraw your question. Please press star one on one again.
Emily Field: We will now take your first question. And your first question comes from the live of Emily Field from Bargley's; please go ahead. Hi, thanks for taking my questions.
Operator: We will now take your first question, and your first question comes from the line of Emily Field from Barclays. Please go ahead.
Speaker Change: We will now take your first question.
Speaker Change: And your first question comes from the line of Emily Field from Barclays. Please go ahead.
Emily Field: Hi, thanks for taking my questions. I'll ask one on Wgobi pricing and one on Wgobi supply. The first question on pricing, in terms of the growth to net in the US widening from 1Q to 2Q, can you help us understand the moving parts here? Is there a component of seasonality?
Emily Field: I like one on Wogovi pricing and one on Wogovi supply. The first question on pricing, in terms of the growth to net in the U.S. widening from one Q to two Q. Can you help us understand the moving parts here? Is there a component of seasonality? How much to the competition or how much do the channel mix? As you talked about more penetrating into the Medicaid channel and you can also the select population in Medicare.
Emily Field: Hi, Thanks for taking my questions I'll ask one on <unk> pricing and one on <unk>.
Emily Field: The first question on pricing in terms of the gross to net in the U S. Widening from <unk> can you help us understand the moving parts here is there a component of seasonality how much due to competition or how much due to channel mix as you've talked about more penetrating into the Medicaid channel and you've announced also the black population and Medicare.
Emily Field: And then secondly, on supply, it's great to see the 0.5 and one big doses of Wogovi coming off the FDA drug shortage list. Although it does seem like you're voluntarily keeping the 0.25 dosage capped in order to limit new patients. Do you expect this cap to continue throughout the rest of the year? Or could it be worth it before the end of 2024?
Speaker Change: And then secondly on supply it's great to see that <unk>, five and one that doses of will that will be coming off the FDA drug shortage list. Although it does seem like you're voluntarily keeping that two five dosage capped in order to limit new patients do you expect this cap to continue throughout the rest of the year or could it be western before the end of 2024. Thank you.
Lars Joergensen: Thank you. Thank you, Emily, for those two questions. For the first question, I'll hand it over to Lars on overall pricing dynamics. If before choice we're sitting to dock on U.S. specific dynamics pricing wise and also on the supply situation. Lars. Thank you. Emily, thank you. I would say overall the current market structure is one where we really compete and secure success based on ability to supply. So it's not, it's not one where, say, classical commercial tactics is dominating. And you should see, I would say, how commercial strategies in that perspective, you will look to the channel mix.
Lars Rødgaard Jørgensen: How much due to competition? Or how much due to channel mix, as you talked about more penetration into the Medicaid channel, and you can now sell to the select population in Medicare? And then secondly, on supply, it's great to see the 0.5 and 1 mg doses of Wgobi coming off the FDA drug shortage list. Although it does seem like you're voluntarily keeping the 0.25 dosage capped in order to limit new patients. Do you expect this cap to continue throughout the rest of the year? Or could it be listed before the end of 2024? Thank you.
Loss: Thank you Emily and for those two questions for the first question I'll hand, it over to loss on overall pricing dynamics before trading to talk on U S specific dynamics pricing wise and also on your supply situation plus yes. Thank you Emily and thank you all.
Lars Rødgaard Jørgensen: Thank you, Emily, for those two questions. For the first question, I'll hand it over to Lars on overall pricing dynamics before turning to Doug on US specific dynamics pricing-wise and also on the supply situation. Lars? Yeah, thank you.
Lars Rødgaard Jørgensen: Yeah, thank you, Emilio, thank you, Jaap. So I would say overall, the current market structure is one where we really compete and secure success based on ability to supply. So it's not it's not one where, say, classical commercial tactics are dominating. And you should see our, our commercial strategies in that perspective. And you will look at the channel mix.
Loss: Or.
Speaker Change: The current market structure is one where we really compete and secure success based on our ability to supply. So it's not it's not one where let's say classical commercial tactics.
Speaker Change: Is dominating and you should see.
Speaker Change: I'll say, our commercial strategies in that perspective.
Doug Lange: And we also just learned in our briefs that we are now expanding access to Wicovi in Medicaid. So we have 20 states adopting Wicovi in Medicaid. And of course, with that expansion, as we know from all drug categories, when you move into some of these channels, it comes at a lower, say, net price in these channels, which then has no impact. But I would say we are encouraged by a stable competitive dynamics. And our focus is really on securing supply to make sure that we can serve as many patients as possible, more than other, say, tougher commercial tactics.
Speaker Change: You alluded to the channel mix and we also just had in our belief that we are now expanding access in Medicaid. So we have 20 states adopting we go we can mitigate and of course with that expansion as we know from all four categories. When you move into some of these channels. It comes at a lower <unk>.
Lars Joergensen: And we also just had in our briefs that we are now expanding access in Medicaid. So we have 20 states adopting Wogovi in Medicaid. And of course, with that expansion, as we know from all drug categories, when you move into some of these channels, it comes at a lower, say net price in these channels, which then has no all impact. But I would say we, we are in Kurds with a stable competitive dynamics. And our focus is really on securing supply to make sure that we can serve as many patients as possible, more than all, say, tougher commercial tactics.
Speaker Change: Net price in these channels.
Speaker Change: <unk> has no impact, but I would say.
Speaker Change: We are encouraged with let's say a stable competitive dynamics and our focus is really on on securing supply to make sure that we can serve as many patients as possible more than OSA.
Speaker Change: Tougher commercial tactics.
Doug Langa: Thank you, Lars. And with that, I'll hand over to you, Doc, on the U.S. specifics as well as on the supply situation. Yeah, thanks, Lars. And thanks for the question, Emily. So overall, I'd start with, you know, we're pleased with the Wogovi performance, whether you look at the MBRX moving from roughly 5,000 new branded prescriptions in the beginning of the year to 35 currently, or the TRX, which moved from 100,000 beginning of the year to roughly 200,000, or doubling. We're pleased with that. We're serving more patients than ever before, as Lars mentioned earlier. And market access continues to be robust.
Speaker Change: Thank you Lasse and with that I'll hand over to you talk on the specifics as well as anti supply situation.
Lasse: Yes, Thanks, Laura and thanks for the question Emily So overall I would start with we're pleased with the will go via performance, whether you look at the <unk> moving from roughly 5000, new branded prescriptions at the beginning of the year to 35 currently or the Trs, which moved from 100000 in the beginning of the year to roughly 200000 or doubling.
Lars: We're pleased with that we're serving more patients than ever before as Lars mentioned earlier and market access continues to be robust as I had mentioned there is over 50 million people with obesity and importantly around 10 million vulnerable patients that have access via Medicaid and around 20 states. So that's robust and we're pleased with that.
Doug Langa: As I had mentioned, there's over 50 million people with obesity, and importantly, around 10 million vulnerable patients that have access via Medicaid in around 20 states. So that's robust. And we're pleased with that. And in doing that, we're seeing that almost or above 80% of the patients are paying $25 or less. And that is our ambition. Our goal is to grow market access. , I don't want to get into specifics there, but it is in line with expectations. Our focus remains in building even stronger access for AOM treatments across all channels. And again, I'd say that we are pleased with the overall performance, and we're serving more patients than ever before.
Lars: And in doing that we're seeing that.
Speaker Change: Almost or above 80% of the patients are paying $25 or less and that is our ambition or our goal is to grow market access and it's fair to assume as volume goes up prices will come down and we have seen lower will gobi prices in the first half I don't want to get into specifics there, but it is in line with expectations.
Doug Lange: And it's fair to assume, as volume goes up, prices will come down. And we have seen lower Wolgogi prices in the first half. I don't want to get into specifics there, but it is in line with expectations.
Speaker Change: Our focus remains on building, even stronger access for <unk> treatments across all channels and again I'd say that we are pleased with the overall performance and we're serving more patients than ever before.
Doug Langa: Thank you so much, Doug.
Doug Lange: Thank you so much, Doug. And finally, also on the lower two strings of WGOBI and the update there.
Doug Langa: And finally, also on the lower dose strength of the Gobi and the update there? Yeah, and so we don't believe that the 0.25; that was a choice we made. Again, as we've said consistently, quarter after quarter, continuity of care is incredibly important to us and maybe what separates us. You know, we think it's really important that patients are able to titrate through the appropriate doses. So we'll continue to dynamically manage that, but we're also confident in the levels that we see with all the other dose strength. So you shouldn't anticipate that 0.25 changing throughout this year to the question.
Speaker Change: Thank you so much Doug and finally also on the lower dose strengths of <unk> and the update there.
Speaker Change: Yeah, and so we don't believe that the <unk> five with that was that was a choice. We made again as we've said consistently quarter after quarter continuity of care.
Speaker Change: Is incredibly important to us and maybe what separates US we think it's really important that patients are able to titrate to the appropriate doses. So we will continue to dynamically manage that but we're also confident in the levels that we see with all the other dose strength. So you shouldn't anticipate that point to five changing throughout this year.
Doug Langa: Thank you, Doug.
Speaker Change: To the question.
Doug Langa: And thank you, Emily.
Operator: We are now ready to take the next question, please.
Speaker Change: Thank you Doug and thank you Emily we're now ready to take the next question. Please.
Luis 10: Thank you.
Luis 10: Your next question comes from a line of Luis 10 from Council.
Operator: Your next question comes from the line of Louise Chen from Cantor. Please go ahead. Hi, thanks for taking my questions here. So the first one I have was just on
Operator: Your next question comes from the line of Louise Chen from Cantor. Please go ahead.
Speaker Change: Thank you.
Speaker Change: Your next question comes from the line of Louise Chen from Cantor. Please go ahead.
Luis 10: Please go ahead.
Luis 10: Hi, thanks for taking my questions here. So first one I have was just on my new band wanted to see what type of efficacy and safety you expect to see or want to see to move forward with this product.
Louise Chen: Hi, Thanks for taking my questions here. So first one I have was just on my Luna band wanted to see what type of efficacy and safety you expect to see you want to see them move forward with this product and then second question was just on assets out of the 12 patients enrolled in the phase III study, how many patients are expected to be part of the F. Two F. Three biopsies.
Luis 10: And then the second question was just on essence out of the 1200 patients enrolled in the space study. How many patients are expected to be part of the F2 F3 biopsy readout? Thank you.
Speaker Change: Thank you.
Luis 10: Thank you, Luis, for those two questions.
Martin Holtz-Lange: Thank you, Louise, for those two questions. I'll hand both of them to you, Martin, first on Maluno-Banded Expectations, as well as on Patients Enrolled in Essence. Yeah, absolutely.
Martin: Thank you Luis for those two questions a handful from them to you Martin first on melena and expectations as well as on patients enrolled in essence, yes, absolutely.
Martin Holtz Langa: I'll hand over to them to you, Martin. First on Maluno band, the expectations as well as on patients enrolled in essence. Yeah, absolutely. So we continue to be excited about the potential for Maluno Band. We don't have a lot of news yet. We expect the readout from the dedicated obesity trial in Q3 of this year and from the diabetes kidney disease trial at the end of this year. Based on our modeling, we expect around a 15% weight loss, and obviously our focus is on demonstrating that together with an attractive safety profile. But we don't have a lot of news at this point.
Speaker Change: We continue to be excited about the potential from our lunar bet.
Speaker Change: We don't have a lot of news yet we expect the readout.
Speaker Change: From a dedicated obesity trial in Q3 of this year and from the diabetes kidney disease trial.
Speaker Change: At the end of this year.
Speaker Change: Based on our modeling.
Speaker Change: We expect around a 15% weight loss.
Speaker Change: And obviously our focus.
Speaker Change: Is on demonstrating that together with an attractive safety profile, but we don't have a lot of news at this point you have to wait a couple of months before that.
Martin Holtz Langa: You have to wait a couple of months before that.
Martin Holtz Langa: And on the Essence trial, you probably recall we sort of have a two-tier trial. The first proportion of the trial includes 800 patients, which will serve as the regulatory submission. We will see the readout of those 800 patients this year. They will all have liver biopsies, and they will be in the F2 F3 category. We then go to the full 1200 patients for a hard outcomes proportion of the trial. It will basically also be patients who have liver biopsies and B&D F2 F3 categories. But first step is to see the regulatory readout, which we will receive at the end towards the end of the year.
Martin Holtz-Lange: And on the essence trial, you probably recall, we sort of have a two-tier trial; the first proportion of the trial includes 800 patients, which will serve as the regulatory submission, and we'll see the readout of those 800 patients this year.
Speaker Change: In the essence trial Youll, probably recall we had.
Speaker Change: Sort of have a two tier trial. The first proportion of the trial includes 800 patients, which will serve as the regulatory submission.
Speaker Change: We'll see the readout of those 800 patients this year.
Speaker Change: We'll all have.
Speaker Change: Liver biopsies and they will be <unk> to a free category.
Speaker Change: We then go through the full 1200 patients for a hot incomes.
Speaker Change: <unk> proportion of the trial it will basically also be patients who have.
Speaker Change: Liver biopsies and <unk>.
Speaker Change: Three categories, but first step is to see the regulatory readout, which we will receive at the end of towards the end of the year.
Operator: Thank you, Martin, and thank you, Luis. We are now ready to take the next question, please.
Speaker Change: Thank you Martin and thank you Luis we are now ready to take the next question. Please.
Evan Vigerman: Thank you. Your next question comes to the line of Evan Vigerman from BMO Capital Markets. Please go ahead.
Operator: Thank you. Your next question comes from the line of Evan Feigerman from BMO Capital Markets.
Speaker Change: Thank you. Your next question comes from the line of Evan <unk> from BMO capital markets. Please go ahead.
Evan Vigerman: Thank you so much for taking my questions and for all of the calls on the call today.
Evan Feigerman: Please go ahead. Hi guys. Thank you so much for taking my questions and for all of the color on the call today. A few from me just on the Catalan transaction.
Evan: Hi, guys. Thank you so much for taking my questions and for all the color on the call today.
Evan Vigerman: A few from me, just on the cattle and transaction, maybe we'll just walk us through kind of the update there, and more specifically, as you think of a billion out capacity, what are the levers can you pull to kind of get your supply and curtains up to meet demand. I know that was a key theme on the call today.
Speaker Change: Wonderful.
Evan: A few from me just on the Cat on transaction, maybe walk us through kind of the update there and more specifically as you think about building out.
Speaker Change: <unk> what are the levers can you pull to kind of get your supplier and curtains up to meet demand I know that was a key theme on the call today and then maybe you can kind of walk us through some of the expectations for the.
Evan Vigerman: And then maybe we'll kind of walk us through some of the expectations for the CB1 inverse agonist data that's coming later in third quarter.
Speaker Change: <unk> inverse agonist data that's coming later third quarter. Thank you so much.
Evan Vigerman: Thank you so much.
Karsten Womknusen: Thank you, Evan, for those two questions.
Karsten Munch: Thank you, Evan, for those two questions. Firstly, to Karsten on Catalan and overall supply chain strategy.
Carsten: Thank you and then for those two questions firstly true to Carsten on catalyst and overall supply chain strategy.
Karsten Womknusen: Firstly, true to Karsten on Catalan and overall supply chain strategy. Yeah, thanks, Evan, for this question and good to connect there. So on Catalan, it is still our expectation that the transaction closes towards the end of 2024. We're in active dialogue with the different regulators in terms of antitrust reviews. So, but re-it's rate closing towards the end of the year. And with Catalan, we are significantly expanding our fill finish network with the three additional sites on top of the site. We already have oven running, and by the way, also our expanding. So our all supply chain strategy is really one of scaling our API facilities in Catalan Park on the peptide type.
Carsten: Yep. Thanks, Evan for this question then.
Carsten: Chuck.
Speaker Change: So on <unk>. It is still our expectation that that transaction closes.
Speaker Change: Towards the end of 2024.
Speaker Change: We're in active dialogue with the different regulators in terms of antitrust reviews and so.
Speaker Change: To reiterate closing towards the end of the year.
Speaker Change: And with <unk>, we are significantly expanding our offer finish network with the with the three additional sites on top of the sites, we already have up and running and by the way also are expanding so.
Speaker Change: All supply chain strategy is really one off of scaling our API.
Speaker Change: Searches in calendar <unk>.
Karsten Womknusen: And in Hilod, Denmark, on the antibody site linked to our pipeline progression. And then scaling our fill finish site on a global scale to be able to accommodate a significant in many more patients than we've been able to do so historically. And that ties into our all-coverage strategy of being able to reach many, many more patients than we've ever done before.
Speaker Change: On the peptide type and in Denmark on the antibody side.
Speaker Change: Linked to our pipeline progression and then scaling fill finish sites on a global scale to be able to accommodate significantly many more patients than we've been able to do so historically and that ties into our corporate strategy.
Speaker Change: Being able to reach many many more patients.
Speaker Change: Patients than we've ever done before linked to the unmet need in the cardio metabolic space.
Karsten Womknusen: Link to the on-met need in the cardiometabolic space.
Karsten Womknusen: Thank you, Karsten.
Martin Holtz-Lange: Thank you, Karsten. And secondly, on the Moluna band expectations again for Martin. Yes.
Martin Holtz Langa: And secondly, on Moulinabal expectations again from Martin. Yeah, so again, not a lot of news. We are expecting two data readouts: one from obesity, one from diabetes. Later this year, that will be exciting. Our focus will obviously be on the efficacy in terms of the weight loss. Our current modeling is suggesting at least a 15% weight loss. That will be an attractive all monotherapy in and of itself, but also with the potential of being combined with the mental side. But these are the days; these are model data.
Costa: Thank you Costa and secondly on Malone about expectations again for Maarten.
Martin Holtz-Lange: Yeah, so again, not a lot of news. We're expecting two data readouts, one from obesity and one from diabetes later this year. That will be exciting. Our focus will obviously be on the efficacy in terms of weight loss. Our current modeling is suggesting at least a 15% weight loss. That will be an attractive oral monotherapy in and of itself, but also with the potential to be combined with somalicide. But these are early days, these are model data, and we'll see stronger readouts in Q3 and Q4 of this year.
Speaker Change: So so so again not a lot of news, we're expecting two data readouts.
Speaker Change: One from obesity one for diabetes.
Speaker Change: Later this year that will be exciting I'll focus it will obviously be on the efficacy in terms of to weight loss.
Speaker Change: Current modeling, suggesting a lease of 15%.
Speaker Change: Yeah.
Speaker Change: Weight loss that will be an attractive.
Speaker Change: All monotherapy in and of itself, but also with the potential of being combined with maiden side, but these are early days. These are modern data and we'll see the stronger readouts.
Martin Holtz Langa: And we'll see the stronger readouts in Q3 and Q4 this year.
Speaker Change: In Q3, and Q4 of this year.
Martin Holtz Langa: Thank you, Martin. And thank you, Evan.
Speaker Change: Thank you Martin and thank you Evan we are ready to take the next question. Please.
Sachin Jain: We are ready to take the next question, please. Thank you. Your next question comes from the line of Satya and Jane from Bank of America. Please go ahead.
Speaker Change: Thank you your.
Speaker Change: Your next question comes from the line of Sachin Jain from Bank of America. Please go ahead.
Sachin Jain: I don't know if I have any questions, too, please. Firstly, a big picture on for Karsten, just on guidance. At midpoint, I believe, implies underlying acceleration. 2H relative to the underlying growth in the first half. Given there's a lot of moving parts, and one of you could just talk through some of the key drivers, pushes and pulls, particularly around regoverly and is epic. And then the second question is, try and get a bit more color. Dodd-Plast and Lars on the Wigavy price. Around the commentary of this volume's growth price comes down. If you would give us some sense of magnitude of price pressure short.
Sachin Jain: I'll take my questions. Two please firstly, a big picture one for cost and just on guidance.
Speaker Change: Point I believe implies underlying acceleration.
Speaker Change: Relative to the underlying growth in the first half.
Speaker Change: Given there's a lot of moving parts I Wonder if you could just talk through some of the key drivers pushes and pulls particularly around we gave you an SMP and.
Sachin Jain: And then the second question is to try and get a bit more color, Doug, Karsten, and Lars on the Wegovy price.
And then the second question is to try and get a bit more color Doug processing loss, although we gave a price.
Speaker Change: Around the common share base volumes go up price comes down if you would give us some sense of magnitude of price pressure short and mid term its all going to frame. The question. Let me ask you've loosely comments to around 10% plus pressure payer for us and.
Sachin Jain: And midterm.
Sachin Jain: So I'm going to frame the question like this. You've loosely commented to around 10% price pressure per year for a Zen pick. Should we think about Wigavy as more or less than that? And can you give any specific color on 2H trends relative to 1H? Thank you.
Speaker Change: Should we think about we gave you is more or less than that and can you give any specific color on <unk> trends relative to <unk>. Thank you.
Karsten Womknusen: Thank you, Sachin, for the first one on guidance building blocks. I'll hand that to you, Karsten? Yeah, thank you for that question, Sachin, and there's noted in our release, then we are operating our top line guidance by a couple of points, and narrowing the guidance range also, really supporting the fact that we are off to a really strong start in this year, and see strong trends both commercially as well as supply chain wise. So that's a backdrop for our increasing guidance, and then to the second half acceleration part of your question, yes, that is correct, and you could say, the 25 cent growth we have in the first half of this year benefits from the rebate adjustments we've been talking to related to the US both in the first quarter and in the second quarter, as well as to an easier comparator linked to the facing of rebates in 2023. So we delivered 25 cent with both tailwind and an easy comparator, and then delivering that for the full year clearly in tails and acceleration into the second half in terms of growth, despite the fact that the comparator is tougher linked to the rebate facing of last year. And that acceleration is really a function of continued trends of what you are seeing already in the marketplace today, in terms of the Vigovie penetration in the US, where we doubled number of scripts from the beginning of the year until now, weekly scripts, also an acceleration in terms of Vigovie sales in international operations, and a continuation of the same performance into the second half. So on the line, clearly an acceleration during the second half compared to the first half.
Karsten Munch: Thank you, Sachin. For the first one on guidance building blocks, I'll hand that to you, Karsten.
Speaker Change: Okay.
Speaker Change: Thank you Sachin for the first one on guidance building blocks I'll hand that to your customer.
Speaker Change: Yeah, Matt and thank you for that question Sachin and as noted in our release.
Speaker Change: Then we are upgrading our topline guidance.
By a couple of points and narrowing the guidance range also so so really supporting the fact that we are off to a really strong start.
Speaker Change: And this year and see strong trends, both commercially as well as our supply chain wise. So thats the backdrop for our increase in guidance and then two to the second half exploration part of your question, Yes that is correct and you could say the 25% growth we have been.
Speaker Change: In the first half of this year benefits from it.
Speaker Change: From the rebate adjustments, we've been talking to are related to the U S. Both in the first quarter and in the second quarter.
Speaker Change: As well as to an easier comparator linked to the phasing of rebates in 2023, so so we delivered 25%.
Speaker Change: With both the tailwind and an easier comparison, and then delivering that for the full year Chilean sales and exploration in into the second half in terms of growth. Despite the fact that the comparator.
Speaker Change: As tougher linked to the rebate facing off of last year and that exploration is really a function of continued trends of what you're seeing already in the marketplace. Today in terms of the penetration in the U S, where we doubled the number of scripts from the beginning of the year until.
Speaker Change: Until now our weekly scripts also on exploration in terms of geography sales in international operations and the continuation of.
Speaker Change: <unk> performance in into the second half so so underlying clearly an acceleration during the second half compared to the first half.
Lars Joergensen: Thank you, Kastu, and secondly, on overall pricing dynamics last?
Karsten Munch: Thank you, Karsten. And secondly, on overall pricing dynamics, Lars.
Speaker Change: Thank you Carsten and secondly on overall pricing dynamics last yes.
Lars Joergensen: Yes, so thanks, Satyansaro, we would prefer not to get into very detailed comments on pricing, because that turns into a quarter or quarter store line then. So I would like to say on the line what I mentioned in my opening that, and also as Kastu has alluded to, this is a marketplace where we compete on bringing, say, volumes to the market, so it's not one where we feel that we are into a price competition. Having said that, there are different segments of the market, and we feel that it's relevant to also be present in the segments where we have the most vulnerable patients, and they are typically served by Medicaid. So we have now, as we mentioned, 20 states having adopted Vigovie, and we all know that for any product, when you go into Medicaid, it comes at a somewhat lower price point, so that should be affected in. So it's a stable competitive setting, and it's really for us about scaling the volumes to the demand, sorry, on the access we have delivered, and we can see the demand is there, so it's about scaling to meet the demand, I would say more than any other tactics, so to say. And as Kastu just mentioned, we have the capacity to scale and accelerate serving many more patients in the second half, and I think that's the encouraging part of our release here that we upgrade to do that against a somewhat tougher competitor in the second half of the year. So I think there's a sign of strong momentum and also execution from a supply chain point of view.
Lars Rødgaard Jørgensen: We prefer not to get into very detailed comments on pricing because that turns into a quarterly over quarter storyline, then, but I would like to underline what I mentioned in my opening, that it's a stable competitive setting, and it's really for us about scaling the volumes to deliver on the access we have delivered. And, you know, we can see the demand is there. So it's about scaling to meet the demand, I would say more than any other tactic, so to say.
Speaker Change: As such and so.
Speaker Change: We prefer not to get into very detailed comments on pricing because that's that turns interested.
Speaker Change: Over a quarter.
Speaker Change: Storylines, and so but I would like to say underlying what I mentioned in my opening that.
Carsten: And also as cutting cost just alluded to this is.
Carsten: This is a marketplace, where we compete on bringing.
Carsten: The volumes to the market so it's not one where.
Carsten: We feel that.
Carsten: We have introduced a price competition, having said that the different segments of the market and we feel that it's at.
Carsten: Relevant to also be present in the segments, where we had the most vulnerable patients and they are typically.
Speaker Change: <unk> Bye bye Medicaid so we have for now as we mentioned 20 states.
Speaker Change: Having adopted <unk> and we all know that.
Speaker Change: New product when you when you go into mitigate it comes at a somewhat lower price point, so that should be factored in so it's a.
Lars Rødgaard Jørgensen: And as Karsten just mentioned, we have the capacity to scale and accelerate, you know, serving many more patients in the second half. And I think that's, I think the encouraging part of our release here that we upgrade to do that against a somewhat tougher competitor in the second half of the year. So I think there's a sign of strong, strong momentum and also execution from a supply chain point of view.
Speaker Change: It's a stable competitive setting.
Speaker Change: Switching and it's really for us about.
Speaker Change: Scaling the volumes to deliver on the demand or sorry on the on the access we have delivered.
Speaker Change: And.
Speaker Change: We can see the demand is there so so it's about <unk>.
Speaker Change: Scaling to meet the demand I.
Speaker Change: I would say more than Montana.
Speaker Change: Texas, So to say and is causing you had mentioned we have the capacity to scale and accelerate.
Speaker Change: So having many more patients in the second half and I think Thats I think the encouraging part of our release here that we operate.
To do that against somewhat tougher comparator in the second half of the year. So I think there is a sign of strong strong momentum and also execution from a supply chain point of view. Thank you.
Lars Joergensen: Thank you.
Operator: Thank you. Last question, just as a clarification, then, where are you with Medicaid penetration? Should we expect a major uptick in 2H relative to 1H?
Lars Joergensen: Last but not least, that's the classification, and where are you with Medicaid penetration? Should we expect a major optic in 2-H relative to 1-E? I don't have detailed insight into that, and I'm not sure we can comment specifically on that. So, if I can give one data point, we have Medicaid coverage into the June of 20 states.
Speaker Change: Thanks for such as Transportation, and then where are you with Medicaid penetration should we expect a major uptick into rates relative to what age.
Speaker Change: So I don't have detailed insight into that and I'm not sure we can comment specifically on that.
So I'm sorry, if I can.
Speaker Change: Yes.
Speaker Change: The one data point, so we have Medicaid coverage into the June of 20 states.
Lars Joergensen: How exactly the volumes are going to fall out in the second half between Medicaid and commercial? Of course, it's very speculative. But we have actually a very strong Medicaid-based access of 20 states and around 10 million people with obesity covered that way, around.
Speaker Change: How exactly the volumes kind of fallout in the second half between Medicaid and commercial.
Speaker Change: Of course is very speculative, but but we have actually a very strong Medicaid based access of 20 states in and around 10 million people with obesity covered that way round.
Lars Joergensen: Thank you, Lars. Thank you, Karsten, and thank you, Sachin.
Speaker Change: Thank you Lasse. Thank you Karsten and thank you Sachin and with that we're ready for the next set of questions. Please.
Operator: And with that, we are ready for the next set of questions, please. Thank you.
Richard Foster: Your next question comes from the line of Richard Foster, JP Morgan. Please go ahead. Thanks for taking my question.
Speaker Change: Thank you.
Speaker Change: Your next question comes from the line of Richard <unk> Jpmorgan. Please go ahead.
Operator: Hi, thanks for taking my question. Maybe one on McGovey in the US as well.
Richard: Alright, Thanks for my taking my question.
Richard Foster: Maybe one on we'll go via the US as well. You know, based on the new patient, I know you've said that you're 35,000 scripts a week; you'll limit those data doses. But based on the new patients, you've already accrued on that level of patients and your knowledge of the pull-through of patients to hire doses. How do you see the TRX developing? You've obviously doubled in the first half. But some idea of how that could develop, I think, would be helpful to people.
Speaker Change: Maybe one on <unk> in the U S as well.
Unknown Attendee: You know, based on the new patients, I know you've said that you're 35,000 scripts a week, you'll limit those starter doses, but based on the new patients you've already accrued and that level of patients and your knowledge of the pull through of patients to higher doses, how do you see the TRX developing? You've obviously doubled in the first half, but some idea of how that could develop would be helpful to people.
Speaker Change: Based on the new patient I know, you've said that you're 75000.
Speaker Change: Scripts, a week, you'll limit nice delta doses, but based on the new patients you've already accrued in that level of patients and your knowledge of the pull through of patients to higher doses.
Speaker Change: How do you see the Trs developing you've obviously doubled in the first half, but some idea of how that could develop I think would be helpful to people.
Richard Foster: And I suppose the question is, at what point do you expect TRX to exceed scripts from a ZMPIC on a weekly basis? And then one other question just on a ZMPIC XUS supply. I think you alluded to that could improve in the second half, but just when can you anticipate supply being resolved there so that we can expect strong growth in the second half? When can we expect strong growth for a ZMPIC to resume in LAO?
Unknown Attendee: And I suppose the question is, at what point do you expect TRX to exceed scripts from Zempik on a weekly basis? And then one other question just on Zempik X US supply. I think you alluded to that this could improve in the second half, but just when can you anticipate supply being resolved there so that we can expect strong growth in the second half? When can we expect strong growth for Zempik to resume in IO? Thanks very much.
Speaker Change: And I suppose the question is at what point do you expect <unk> to exceed scripts from the Zen pick on a weekly basis and then one other question just on <unk> ex U S supply.
Speaker Change: You alluded to that that could improve in the second half, but just when can you anticipate supply being resolved faster that we can expect.
Speaker Change: <unk> growth in the second half when can we expect strong growth for us Mpeg two or is that.
Speaker Change: Resume.
Richard Foster: Thanks very much.
Speaker Change: Thanks very much.
Doug Langa: Thank you, Richard. On the first one, in terms of the strong TRX trends in the US, I'll hand it over to you, Doug. Yep, thank you, Richard.
Speaker Change: Thank you Richard on the first one in terms of the strong TX trends in the U S. I'll hand, it over to you Doug.
Doug Langa: And let me just clarify. We're not precisely limited to 35. We're dynamically managing that because, again, critically important to us is patient continuity of care. So that is the starting doses. You know, and so that's the one we will manage. It's not to limit. And so you may see fluctuations when that. What I would anticipate is a steady, consistent TRX trend. I don't want to get into where that may go or where that may cross a ZMPIC. Again, we're pleased with the performance. As Carson and both Lars alluded to, we've more than doubled that from the beginning of the year to currently.
Doug: Yes, Thank you Richard and let me just clarify we are not.
Speaker Change: Precisely eliminate the 35, we are dynamically managing that because again critically important to us is patient continuity of care so that as the starting dose as you know and so that's the one we will manage its not to limit and so you may see fluctuations within that.
Speaker Change: What I would anticipate as a steady consistent terex trend I don't want to get into where that may go or where that may cross sell <unk> again, we're pleased with the performance as Carsten and both Lars alluded to with more than double that from the beginning of the year to currently.
Doug Langa: We're seeing strong NBRX, and we're serving more patients. So I don't want to get into predictions of one more cross.
Speaker Change: We're seeing strong <unk> and we're serving more patients. So I don't want to get into predictions at one mill Cros.
Doug Lange: So I don't want to get into predictions of which one will cross.
Karsten Womknusen: Thank you, Doug.
Karsten Munch: Thank you, Doug. And on the gradual supply scaling, over to you, Karsten. Yeah.
Karsten Womknusen: And on the gradual supply scaling over to you, Carson. Yeah, so talking about XUS and scaling there, then, first of all, I'd just like to elude to the performance in SNF operations where repels are also magnetized, is doing really well in the first half, growing 66%. So actually contributing as much as ZMPIC in SNF operations. And then looking at IO between the first half and second half, then clearly our ambition and what's implied in guidance is an acceleration from the 11%. We delivered in the first half, and that acceleration will come from the STEMF franchise.
Kasper: Thank you, Doug and undergraduate supply scaling over to you Kasper.
Karsten Munch: Yeah, so talking about XUS and scaling there, first of all, I'd just like to allude to the performance in international operations, where Rebelsis, our ultimacro site, is doing really well in the first half, growing 66%, so actually contributing as much as USEMPIC in international operations. And then looking at IO between the first half and the second half, then clearly, our ambition and what's implied in guidance is an acceleration from the 11% we delivered in the first half, and that acceleration will come from the Stemmer franchise, but as you see, we have now launched in 12 markets with Wigovi in international operations, so clearly you should also expect to see some pick-up there, driving higher sales growth in the second half.
Kasper: So so we're talking about.
Kasper: Ex U S and scaling there than the first of all I just like to allude to the performance in our international operations were repulsive.
Speaker Change: <unk> is doing really well and in the first half growing six 6%. So so actually contributing as much as <unk>.
Speaker Change: In international operations.
Speaker Change: And then looking at at Io between the first half and second half and then clearly our ambition and what's implied in guidance is an acceleration from the 11% we delivered in the first half and that's exploration.
Speaker Change: But it will come from from the <unk> franchise, but there as you see we have now launched in 12 markets with the with recovery in international operations. So so so clearly you should also expect to see some some pickup that drive driving our highest sales growth in the second half of the Nio.
Karsten Womknusen: But as you see, we have now launched in 12 markets with we go in SNF operations. So clearly, you should also expect to see some pick up that driving high sales brought in the second half in IO.
Operator: Thank you, Karsten, and thank you, Richard, for those two questions. We're now ready to take the next set of questions, please.
Operator: Thank you, Karsten, and thank you, Richard, for those two questions. We are now ready to take the next set of questions, please.
Speaker Change: Yeah.
Speaker Change: Thank you Karsten and thank you Richard for those two questions. We are now ready to take the next set of questions. Please.
Operator: Thank you. Your next questions come from Peter Fedort from Citigroup. Please go ahead.
Peter Fadol: Thank you.
Peter Fadol: Your next questions come from Peter Fadol, from Citigroup. Please go ahead. Thank you, people in the city. Two questions, Doug: just some of the obligatory, any latest data or intel in terms of average duration of use on the week over.
Speaker Change: Thank you. Your next question comes from Pizza dough from Citigroup. Please go ahead.
Peter: Thank you Peter <unk> Citi two questions, Doug just the obligatory any latest data or Intel in terms of average duration of use one week IV and then secondly carcinoma $3 would it be when we last spoke.
Peter Fadol: And then secondly, Karsten, on the 340, when we last spoke, my understanding was, Novo has been very conservative in revenue recognition from 340B, leaving risks very much to the upside. And I think when we last discussed, there's my rail miss, you know, the should the rulings go your way, it could be quite a material uplift, I think to the tune of 5%. So I can just checking with you whether that is still the case or have you any updated thoughts there.
My understanding was that it was being very conservative and revenue recognition.
Speaker Change #100: From $3 40 be leaving risks very much of the upside and I think when we last discussed this am I right on this.
Speaker Change #101: Should the rulings go your way like it could be quite a material uplift.
Speaker Change #102: 3% to 5% so can I, just just checking with you with advice still.
Speaker Change #103: The case or have you any updated thoughts there. Thank you.
Doug Langa: Thank you. Thank you, Pete. On the first one on the gov state time, I'll give that to you, Doug. Yep, thanks, Pete, for the question. So, in the US, we're still seeing around six months. And that's, you know, given the pure act supply constraints, and we have to work through that. What I would tell you this, we are confident that over time, the state time will improve more towards 12 months and beyond, which would reflect the clinical profile of the product and what we saw in some clinical trials. So, still around six months, we're working through that more to come as we see more stability and supply over time.
Speaker Change #103: Thank you Pete on the first one on the Golden State time, I'll give that to you Doug.
Speaker Change #103: Yes.
Kasper: for the question. So in the US, we're still seeing around six months, and that's, you know, given the periodic supply constraints, and we have to work through that. But I would tell you this, we are confident that over time, the stay time will improve more towards 12 months and beyond, which would reflect the clinical profile of the product and what we saw in some of the clinical trials. So still around six months, we're working through that, more to come as we see more stability and supply over time.
Pete: Thanks Pete.
For the question so in the U S. We're still seeing around six months and thats given the periodic supply constraints and we have to work through that what I would tell you. This we are confident that over time. The stay time will improve more towards 12 months and beyond which would reflect the clinical profile of the product and what we saw in some of the clinical trial. So.
Still around six months, we're working through that more to come as we see more stability in supply over time.
Karsten Womknusen: Thank you, Doug.
Pete: Okay.
Karsten Womknusen: And over to cast on 340B. Yeah.
Pete: Thank you, Doug and over to cost around 340 B.
Karsten Womknusen: Thanks, Pete, for that comment. And first of all, I'd just like to refer also to our company announcement and the update on 340B that we included on the legal legal matters there. And I'll say the only new item compared to when we discussed in connection with Q1 is that there's one additional ruling that has come out in this case complex, which is a DC Circuit ruling, which ruled similarly to the ruling we had in our case. So all supporting our case, but we still have one key ruling outstanding in the 7th Circuit. And then, as to our accounting, I don't remember us discussing it being conservative.
Dan: Yeah, Dan Thanks, Pete.
Speaker Change #106: That comment and.
Dan: And first of all I'd, just like to refer also to a company announcement and the update on 340 B that we included on the legal legal matters, there and I would say the only new item compared to when we discussed in connection with the with Q1 is that there's one additional ruling that has come out.
Dan: And in this case complex, which is a DC circuit ruling which which route.
Dan: Similarly to the ruling we had.
Dan: In our case, so so all supporting our case, but.
Dan: But we still have <unk> ruling outstanding in the seven circuits and and then as for our accounting.
Speaker Change #107: I don't.
Speaker Change #107: Remember us discussing it being conservative I remember us discussing would be being prudent and aligned to towards the accounting standards.
Karsten Womknusen: I remember us discussing it being prudent and aligned to the accounting standards of revenue recognition, where revenue recognition has to be highly proper in order to prove it as revenue. So that's how we do it. But we also call out that there is a scenario where that could have a material impact on our financial position. And that's what we call out in our announcement. And then let's see how the 7th Circuit rules and what level of appeals we'll be looking at in the coming months. It could be any day that could be news, but I don't know anything further as of today.
Speaker Change #107: Of revenue recognition, where revenue recognition has to be highly profitable.
Speaker Change #107: In order to prove it as revenue. So that's that's how we do it and but we also call out that there is a scenario where that could have a material impact on our financial position and thats, what we called out in our announcement and then.
Speaker Change #108: Let's see how the seventh circuit.
Speaker Change #109: <unk> and <unk> and what level of appeals will be looking at in the coming months. It could be could be any day that could be news, but I don't know anything further as of today.
Kasper: Thank you. Thank you, Kasper, and thank you, Pete as well.
Karsten Womknusen: Thank you.
Karsten Womknusen: Thank you, Kaster. And thank you, Pete, as well.
Speaker Change #109: Thank you thank you Catherine and.
Operator: We're now ready to take the next question, please.
Speaker Change #109: Thank you Pete as well.
Speaker Change #109: We are now ready to take the next question. Please.
James Quigley: Thank you. Your next question comes from James Quigley from Goldman Sachs. Please go ahead.
Speaker Change #110: Thank you. Your next question comes from James Quigley from Goldman Sachs. Please go ahead.
James Quigley: Great. Thank you for taking my questions. I've got two, please. So, firstly on some of the obesity portfolio considerations, you've got a number of obesity readouts in the second half of the year. But how are you thinking of the relative positioning and weight loss expectations for step up? So, there's 7.2 milligrams, Emma. And I'll obviously carry Emma then as well.
James Quigley: Great. Thanks for taking my questions.
James Quigley: Can you. Please so firstly on <unk>.
Speaker Change #112: <unk> portfolio of considerations you got a number of readouts in the second half of the year.
Speaker Change #113: But how are you thinking of your relative positioning.
Speaker Change #114: Weight loss expectations for step up sort of $7, two milligram sema, and obviously Calgary feminine as well will it be an overall approach from a commercial perspective.
James Quigley: Will it be an either-or approach from a commercial perspective, or will it be purely data dependent? And could summer 7.2 million potentially be more desirable given the known CV benefits from summer across all the trials we've seen, and then we haven't necessarily seen that the category yet.
Speaker Change #115: Purely data dependent.
Speaker Change #115: <unk> signed a $7 2 million potentially be more desirable given the known CV benefits from summer.
Speaker Change #115: Charles we've seen and we haven't necessarily seen that mctaggart yet.
James Quigley: And then second question on oral therapy. So, obviously there's been some competitive data, some early competitive data that's been out the market recently. But in terms of your oral offering, so it raises for how how would you characterize the competitiveness of the data you've seen so far for the 25 milligrams dose and how you think about positioning in the market or even a market fit a fit approach on on the launch. And then maybe also related to that on the oral snack technology, key or minus where you are in terms of the latest generations. And so at what point you'll be able to have a peptide-based oral with the snack technology that could be as convenient as a typical small molecule.
Speaker Change #116: And then second question on oral therapy.
Speaker Change #116: Obviously, there's been some competitive data.
Speaker Change #117: As I said, it's been on the market.
Speaker Change #118: Recently, but in terms of your offerings are wages for how how would you characterize the competitiveness of the data you've seen so far for 25 milligram dose and how you're thinking about positioning in the market or even a market fit approach on.
Speaker Change #118: On the launch.
Speaker Change #119: And then maybe also related to that on the oral snack technology can you remind us where you are in terms of the latest generations.
Speaker Change #120: And what point, you will be able to have a peptide based or snack technology that could be as convenient as it is.
Speaker Change #120: Okay.
James Quigley: Thank you.
Speaker Change #120: Typical small molecule.
Camilla Street West: Thank you, James.
Camilla Street West: I think I counted a little bit more than two questions there, but first over to Camila on the overall BC portfolio, and after that we'll turn to Martin on the other second. Yeah, thanks a lot. First of all, I'd just like to say that we are very encouraged about the progression of our pipeline in obesity. And of course we look forward to the readouts that we are having in the second half of this year. It's going to be an exciting second half from a number of face three readouts that we have. And both in the all and also in the injectable space.
Speaker Change #121: Thank you James I think I counted a little bit more than two questions there, but first over to camillo on the overall PC portfolio and after that we will turn to margin enhancement.
Camilla Sylvest: Yeah, thanks a lot. First of all, I just like to say that we are very encouraged about the progression of our pipeline in obesity. And, of course, we look forward to the readouts that we are having in the second half of this year. It's going to be an exciting second half for a number of phase three readouts that we have, both in the oil and also in the injectable space.
Hamzah: And Hamzah.
Hamzah: Yes. Thanks, a lot first of all I'd, just like to say that yeah.
Speaker Change #123: Very encourage about the progression of our pipeline in obesity and of course, we look forward to the Readouts that we are having in the second half of this year, it's going to be an exciting second half from a number of phase III readouts that we have and.
Camilla Sylvest: And I think, let's await those readouts. And then later on, of course, when we get closer to launches, we can talk about positioning and how we are going to commercially utilize the strong pipeline that we have.
Speaker Change #123: Both in the oil and also in the injectable space and I think and Lithuania OS Readouts and then later on of course, when we get closer to launches. We can talk about positioning and how we are going to commercially utilized the strong pipeline that we have.
Camilla Street West: And I think let's away those readouts, and then later on, of course, when we get closer to launches, we can talk about positioning and how we are going to commercially utilize the strong pipeline that we have.
Martin Holtz Langa: Thanks a lot, Camila, and over to you, Martin, on snack. Yeah, so specifically in the clinical space, we've been testing obviously generating one, two, and three as you know, and I mean the research space we continue to evolve. This goes without saying, will not take any new generation into the clinical unless we see a potential for step change in terms of our availability, and this is an ongoing journey and an ongoing effort for us. With respect to the sort of dosing restrictions, we actually don't see them as limitations, but I also have to say we don't see a potential of removing those limitations anytime soon.
Martin Holtz-Lange: Thanks a lot, Camilla. And over to you, Martin, on SNAC.
Speaker Change #123: Okay.
Martin: Thanks, a lot Camilla and over to you Martin on snack, yes, so specifically in the clinical space. We have been testing, obviously generated one two and three as you know and the <unk>.
Martin: Research space, we continue to evolve this goes without saying, we will not take any new generation into the clinic unless we see a potential for step change in terms of bioavailability and this is an ongoing journey in an ongoing effort for us.
Speaker Change #124: With respect to.
Speaker Change #124: <unk>.
Martin: Sort of dosing.
Martin: Restrictions, we actually don't see them as limitations.
Martin: But I also have to say, we don't see a potential of removing those limitations.
Martin: Anytime soon.
Martin Holtz Langa: Thank you, Martin.
Martin: Okay.
Martin Holtz Langa: And just a reminder in the complaint announcement team should also see the approval in EMA of the new doses related to all tobacco sites, such as in the EU.
Martin: Thank you Martin and just reminding the company announcement James you will also see.
James Quigley: The approval of the year of the new doses related to also back lit sites less for doses.
Operator: Thanks a lot, Martin, and thanks a lot, James. We're now ready for the next set of questions.
James Quigley: In the EU.
James Quigley: Thanks, a lot Martin and thanks a lot.
James Quigley: <unk>, we're now ready for the next set of questions.
Emmanuel Papadakis: Thank you.
Emmanuel Papadakis: Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank. Please go ahead.
James Quigley: Thank you.
James Quigley: Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank. Please go ahead.
Emmanuel Papadakis: Thank you for taking the question. Maybe a question on Samara Adapts, Central Inclusion in 2027, IRA price negotiation. Perhaps you could just enlighten us as to what managed you to price cut, either seen in your midterm planning and your latest perspectives on potential.
Emmanuel Papadakis: Thank you for taking the question maybe a question on Zemarai since inclusion in 2027 right price negotiation.
Unknown Attendee: Perhaps you could just enlighten us as to what magnitude of price cut you've assumed in your midterm planning and your latest perspectives on potential. And then on CAGRI-SEMA, how do the first redefined results look? Just talk to us a little bit about your device capacity for the dual chamber pen device at launch. Would that be enough to switch a significant proportion of patients from SEMA to CAGRI-SEMA over that 2026-27 Or, indeed, is there any reason why you wouldn't expect the majority of patients to start switching over?
Emmanuel Papadakis: Perhaps you could just enlighten us as to what magnitude of price cut you've assumed in your midterm planning in your latest perspectives on potential.
Karsten Womknusen: In fact, in the commercial channel from reduced pricing and Medicare. And then on Kagerie Semmer ahead of the first three defined results, just talk to us a little bit about your device capacity for the dual chamber pen device at launch. Would that be enough to switch a significant portion of patients from summer to Kagerie Semmer over that 2026 27 timeframe. Indeed, is there any reason why you wouldn't expect the majority of patients to start switching over?
Speaker Change #126: In fact in the commercial channel from reduced pricing in Medicare.
Operator: Thank you.
Speaker Change #127: And then on Congress them ahead of the first read upon results just told us a little bit of that your device capacity. The dual chamber pen device launch would that be enough to switch a significant proportion of patients from semi to concrete Zimmer.
Speaker Change #128: 'twenty six 'twenty seven timeframe or indeed is there any reason why you wouldn't expect the majority of patients to start switching thank you.
Karsten Womknusen: Thank you.
Doug Langa: Thank you, Emmanuel. The first one on the IRA and the latest there that goes to you, Doc. Yep, thanks, Emmanuel, for the question.
Speaker Change #128: Thank you Manuel the first one on the IRA and the latest there that goes to you Doug.
Doug Langa: Maybe, as a starting point, I'd like to say that we fundamentally disagree with the principles of price setting. It hurts innovation. It potentially creates higher out-of-pocket costs for seniors and less choice. So that's not good. What I would say is that we're not going to comment on price, but, you know, we've worked through the first negotiations on no vlog in FIASP. And as you know, that's a minor part of our business. So we expect limited impact there. And then I would say, as it relates to a read through to Samantha Todd, it's just way too early.
Speaker Change #129: Yes. Thanks, you may ask the question, maybe as a starting point I would like to say that we fundamentally disagree with the principles of price setting it hurts innovation it potentially creates higher out of pocket costs for seniors and less choice. So that's not good.
Doug Lange: What I would say is that we're not going to comment on price. But you know, we worked through the first negotiations on Novolog and FIASP. And as you know, that's a minor part of our business, so we expect a limited impact there. And then I would say as it relates to a read through to Semaglutide, it's just way too early. This has been a new process for both us and the government. We're learning a lot. I'm sure they're learning a lot, too. But I don't want to speculate on what that may mean for Semaglutide read through.
Speaker Change #130: What I would say is is that we're not going to comment on price, but we've worked through the first negotiations on novolog and <unk> and.
Speaker Change #131: And as you know that's a minor part of our business. So we expect a limited impact there and then I would say as it relates to a read through to some anger Todd. It's just way too early this has been a new process for both us and the government. We're learning a lot I'm sure. They learned a lot, but I don't want to speculate on what that May mean for us Michael tag read through.
Doug Langa: This has been a new process for both us and the government. We're learning a lot. I'm sure they learned a lot, but I don't want to speculate on what that may mean for us.
Karsten Womknusen: Thank you, Doc.
Speaker Change #130: Yeah.
Karsten Munch: Thank you, Doug. And for the second question on charismatic capacity, over to you, Karsten.
Karsten Womknusen: And for the second question on Kagerie Semmer, capacity over to you, Carson. Yeah, hi, Emmanuel.
Speaker Change #130: Thank you Doug and for your second question on <unk> capacity over to you.
Karsten Womknusen: Thank you for the question for Kagerie Semmer and supply to Australia. Then of course, we learned we learned a lot from the goby and we have full speed in terms of scaling our capacity linked to Kagerie Semmer. It is a dual chamber device, so scalability is different compared to multi-use devices that we have in another part of our portfolio. But we are rapidly scaling the Kagerie Semmer device. We are exploring a co-formulation also to improve scalability. It's not without risk. And that's why I say we're exploring the opportunity to do so. And then bear in mind, behind Kagerie Semmer in our pipeline, we have a concrete in a subcutaneous version, which we report out in the first quarter of next year, which is another offering together with the step up.
Speaker Change #130: Yes, Hi, Manuel and thank you for the question.
Chris: Okay Chris.
Speaker Change #133: And in supply chain strategy, and then of course, we learned.
Speaker Change #133: And a lot from <unk> from <unk> and.
Speaker Change #133: And we are full speed in terms of scaling our capacity linked.
Speaker Change #134: A link to <unk>. It is a dual chamber device. So so scalability is different compared to most of you said devices.
Speaker Change #134: That we have in other parts of our portfolio, but we are rapidly scaling the <unk> device. We are exploring a co formulation also true.
Speaker Change #134: Improved scalability.
Speaker Change #134: It's not without risk and that's why I say, we are exploring the opportunity.
Speaker Change #134: But to do so and then bear in mind.
Speaker Change #134: Behind <unk> in our pipeline we have.
Speaker Change #134: Accretion in a in a subcutaneous version.
Speaker Change #134: Which we'll report out in the first quarter of next year, which is another offering together with the with the step up and then as my last comment I would say given the clinical profile of <unk>.
Karsten Womknusen: And then, as my last comment, I would say, given the clinical profile of Semmer Glutite, we believe that we will be selling Semmer Glutite for many, many years to come, and we are building the infrastructure to compete on that at a global scale for many years to come.
Speaker Change #134: We believe that that will be selling Sim igloo tight for many many years to come and we are building the infrastructure to compete on that at a global scale for for many years to come.
Karsten Womknusen: Thank you, Carson.
Speaker Change #134: Yeah.
Operator: And also, thanks for the questions. With that, we are ready for the next set of questions, please.
Speaker Change #135: Thank you Karsten and also thanks for the questions with that we are ready for the next set of questions. Please.
Simon Baker: Thank you. Your next questions come from the line of Simon Baker, Redburn Atlantic. Please go ahead. Thank you for taking my questions too, if I may.
Operator: Thank you. Your next questions come from the line of Simon Baker, Redburn Atlantic. Please go ahead.
Speaker Change #136: Thank you.
Speaker Change #137: Our next questions come from the line of Simon Baker, but that Atlantic. Please go ahead.
Simon Baker: Thank you for taking my questions two if I may firstly Gary.
Simon Baker: Firstly, going back to the obesity pipeline, you announced that you terminated the development of the once-monthly injectable glipgip due to portfolio considerations. I wonder if you could elaborate on that and also update us on your appetite for a monthly injector.
Simon Baker: Back to the <unk> pipeline, you announced that you terminated the development of the <unk>.
Simon Baker: Once monthly injectable gap due to portfolio considerations I wonder if you could elaborate on that and also update us on your your.
Simon Baker: Right.
Speaker Change #139: For a monthly injectable obesity treatment.
Simon Baker: And then a question on icodec in the US, given the complete response letter and leaving aside the questions on manufacturing, is a type one carve out from the application a possible solution to expediting this? Because I assume that one wasn't just thinking about icodec but also icosemma, which is potentially the bigger opportunity and also held up by this. Any thoughts on that will be much. I appreciate it. Thank you.
Jack: And then a question on Jack in the U S.
Speaker Change #141: Given the complete response letter and leaving aside the questions on manufacturing.
Jack: Yes.
Speaker Change #142: A quick one.
Speaker Change #143: Carve out from the application of possible solution to expedite units because I assume that what do you think about.
Speaker Change #144: Codec, but also like a semi which is potentially the bigger opportunity obviously held up quite as any thoughts on that would be much appreciated. Thank you.
Martin Holtz Langa: Thank you, Simon. Both of those go to you, Martin. Firstly, on the once monthly geo to one gip and secondly on icodec. Yeah, absolutely.
Okay.
Martin: Thank you Simon both of those go to Martin Firstly on D. Once monthly <unk>, one Kip and secondly on iconic.
Martin Holtz-Lange: Yeah, absolutely. So I just want to iterate, I think we all along stated that the once monthly GLP-1-GIP study that we conducted was an exploratory study, more assessing the concept of once monthly technology than the actual GLP-1-GIP component, either next generation of this technology or alternative technologies, and specifically on on I could take we are in ongoing dialogue with the FDA so I don't want to speculate too much but obviously part of this is a potential cover out of the type 1 diabetes you should not see this impact the the ICOSIMA dialogue
Martin: Yes, absolutely. So so I just want to reiterate I think we will all alone stated that the once monthly.
Martin Holtz Langa: So, so I just want to reiterate, I think we all along stated that the once monthly geo to one gip study that we conducted was an exporter started more assessing the concept of once monthly technology that then the actual gip component. It was exploratory and, while we we definitely can use the data, the current profile was not something that we would take into further clinical development. So, so basically we still have this focus. We do see once monthly as convenience more than anything else; our primary focus is efficacy and safety. And as we already discussed that we have a very competitive pipeline and portfolio, but we will maintain this focus with either next generation of this technology or alternative technologies.
Martin: One Gi Pea study that we conducted an exploratory study.
Martin: More assessing the concept of once monthly or technology that <unk>.
Speaker Change #145: <unk> IP component.
Speaker Change #146: It was exploratory and while we definitely can use the data. The current profile was not something that we would take into further clinical development. So basically we still have this focus we do see once monthly.
Speaker Change #146: As convenience more than anything else. Our primary focus is efficacy safety and as we already disclosed that we have a very competitive pipeline and portfolio, but we will maintain this focus.
Speaker Change #146: With.
Speaker Change #146: The next generation of this technology or alternative technologies.
Martin Holtz Langa: And specifically on I could take we are not going to dialogue with the days or I don't want want to speculate too much, but obviously part of this is a potential cover out of the type one diabetes, you should not see this impact the icosemma dialogue. Thanks so much.
Speaker Change #146:
Speaker Change #147: Specifically on AWN I could take.
Speaker Change #148: We are in ongoing.
<unk> with the FDA, so I don't want to speculate too much but obviously part of this as a potential carve out of the type one diabetes.
Speaker Change #148: Should not see this impact the iqos and the dialog.
Operator: Thank you. Thank you, Martin, and also thank you, Simon, for those two questions.
Operator: Thank you, Martin, and also thank you, Simon, for those two questions. Now we have time for one final set of questions, please.
Speaker Change #149: Alright. Thanks, so much thank you thank.
Speaker Change #150: Thank you Martin and also thank you Simon for those two questions. Then we have time for one final set of questions. Please.
Mark Purcell: Then we have time for one final set of questions, please. Thank you.
Operator: Thank you. Your final questions come from the line of Mark Purcell from Morgan Stanley. Please go ahead.
Mark Purcell: Your final questions come from a line of Mark Purcell from Morgan Stanley. Please go ahead.
Speaker Change #151: Thank you. Your final question comes from the line of Mark Purcell from Morgan Stanley. Please go ahead.
Mark Purcell: Yeah, thank you very much for taking my questions.
Mark Purcell: Thank you very much for taking my questions.
Martin Holtz Langa: We'll go the hot failure. Could you help us understand the additional data you're looking to file and whether you're going for a CV death and hot failure? Endpoints of hard endpoints in terms of a claim from the studies. I guess you the poor analysis of the step HF programs should a strong six times and risk reduction in CV death and hot failure events, but the significant numbers of patients in select and flow, which I guess could be relevant. So an understanding of what you're aiming to achieve. That would be great.
Mark Purcell: Could you help us understand the additional targets here looking to fall on whether youll caring for CV death and heart failure.
Speaker Change #153: Point sort of hard endpoints in terms of the claim from the studies I guess here. The pooled analysis further step HFF programs showed a strong six 9% risk reduction in CV death, and heart failure event.
Mark Purcell: Ken.
Mark Purcell: Number of patients.
Mark Purcell: Flex and flow, which I guess could be relevant.
Speaker Change #154: And understanding of what you're aiming to achieve that would be great. Thank you.
Martin Holtz Langa: Thank you.
Martin Holtz Langa: And then the second one just as a follow-up to IV202. Could you help us understand Martin how IV347 differs compared to IV, IV202 in terms of PK and CNS distribution and selectivity to the CB1 versus CB2 receptors. Just try not to understand whether this could actually leap frog a long band into phase three.
Speaker Change #155: Second one just a follow up to IV to <unk> could you help us understand Martin how RMB 347 differs compared to IV and V 202 in terms of PK and CNS distribution and selectivity. The CB one versus CBT receptors, just trying to understand whether this could actually leapfrog.
Speaker Change #154: No longer bound into into phase III.
Martin Holtz Langa: Thank you, Mark, and both of those two.
Speaker Change #155: Yeah.
Speaker Change #155: Thank you Marc and both of those two <unk> Martin Firstly, some appetite in his turf and secondly, within <unk> 3447, yes. Thank you very.
Martin Holtz Langa: To you, Martin, firstly, is a nucleotide in HEPF, and secondly, with an investigatory INV347. Thank you very much, Mark, for those questions. First of all, on HEPF, as you recall, we conducted two dedicated HEPF trials and patients with established HEPF1 in diabetes, and one in patients without diabetes, but with obesity. When we do the meat analysis of the two trials, we see a 69% decrease in risk of CV death or hospitalization for heart failure, so absolutely very strong data, and something that has encouraged us a lot. This was also why the FDA granted us breakthrough designation.
Martin Holtz-Lange: Yeah, thank you very much, Mark, for those questions. First of all, on HFPAF, as you recall, we conducted two dedicated HFPAF trials in patients with established HFPAF, one in diabetes and one in patients without diabetes but with obesity. When we do the meta-analysis of the two trials, we see a 69% decrease in risk of CV death or hospitalization for heart failure. So, absolutely very strong data and something that has encouraged us a lot.
Speaker Change #156: Much Mark for those questions first of all on half PFS, you'll recall, we conducted two dedicated his past trials in patients with established.
Jeff: Jeff one in diabetes and one in patients.
Jeff: Without diabetes, but with obesity.
Speaker Change #158: When we do the mute analysis of the two trials, we see a 69% decrease in risk of CV death, or hospitalization for heart failure. So absolutely very strong data and something that has encouraged us a lot. This was also why.
Martin Holtz-Lange: This was also why the FDA granted us breakthrough designation. As we discussed last quarter, we had fairly few events in these two reasonably small studies. And through our dialogue with the FDA, it was very clear that if we could sort of increase the volume of events to further substantiate this, the likelihood of getting heart aid points added to the U.S. label would increase. On the monolunar band, the second generation is still early days. There is a potential for a longer half-life, and thus a potential for less frequent than once daily dosing, which is obviously attractive. And furthermore
Speaker Change #158: The FDA granted us breakthrough designation as we discussed last quarter.
Martin Holtz Langa: As we discussed last quarter, we had failed a few events in these two reasonably small studies, and through our dialogue with the FDA, it was very clear that if we could sort of increase the volume of events to further substantiate this, the likelihood of getting heartache points into the U.S. label would increase. Given that we have some strong, have had and will have some strong readouts in the not-so-distant future, it was a reasonably easy decision to say, we can accept a small delay, and then increase our likelihood of getting heartache points into the label as compared to the more functional test.
Speaker Change #159: Fairly few events in the east.
Speaker Change #159: Two reasonably small studies and through our dialogue with the FDA was very clear that if we could sort of increase the volume of events to further substantiate this the livelihood of getting hotter it puts into the.
Speaker Change #159: The U S label.
Speaker Change #159: The increase.
Speaker Change #159: Given that we have some some stronger have had and will have some strong readouts in the not so distant future.
Speaker Change #159: It was it was a reasonably easy decision to say, we can we can accept a small delay.
Speaker Change #159: And then increase our likelihood of getting.
Speaker Change #159: Yes.
Speaker Change #159: Hot endpoints into the label as compared to the more functional test. So we saw that.
Martin Holtz Langa: So we saw that as a really good bargain.
Speaker Change #159: It's a really good pattern.
Martin Holtz Langa: On one lunar band, second generation is still early days. There is a potential for a longer half-life, so a potential for less frequent than once-daily dosing, which is obviously attractive. Further, a potential for even less brain penetration. Again, we are quite confident with the safety profile of lunar band, but again, a second generation could have an even lower likelihood of potential adverse events that would be attractive. I don't think you will see anything surpass our progress of more lunar band. We see this as a really, really strong life cycle management opportunity.
Speaker Change #159: Yes.
Speaker Change #159: On balloon event second generation, that's still early days, there is a potential for a longer half life.
So a potential for less frequent than once daily dosing, which is obviously attractive and further.
Speaker Change #159: A potential full for even less.
<unk> penetration there again, we are quite confident with the safety profile of <unk>.
But again its second generation could have an even lower likelihood of potential.
Speaker Change #159: Adverse events that would be attractive I don't think youll see.
Speaker Change #160: Anything surpass our progress of Malouda NBC. This.
Speaker Change #161: Really really strong lifecycle management opportunities.
Jacob Martin: Thank you, Martin; thank you, Mark; and thank you to everyone else who have asked questions during this session.
Lars Rødgaard Jørgensen: Thank you Martin, thank you Mark, and thank you to everyone else who has asked questions during the session. This concludes the Q&A session. Thanks a lot for participating, and feel free to contact Investor Relations regarding any follow-up questions you might have. Thank you, Jakob. I hope it comes across that we are very pleased with the momentum in our business, in particular our GF1 business in diabetes and obesity, and not least the strong growth for the GOVI script trends in the US, which is really fueling the upgrade we have communicated today, which also means that our supply is on track to being able to serve many more patients, both short and longer term.
Speaker Change #161: Thank you Martin Thank you Marc and thank you to everyone else with ask questions. During decision. This concludes the Q&A session. Thanks, a lot for participating and feel free to contact Investor relations regarding any follow up questions you might have.
Operator: This concludes the Q&A session. Thanks a lot for participating, and feel free to contact Investor Relations regarding any follow-up questions you might have.
Lars Joergensen: Before we close the call, I'd like to hand it over to you last for any final remarks. Thank you, Jacob. I hope it comes across that we are very pleased with the momentum in our business, in particular our GF1 business, in diabetes and obesity. Not least, the strong growth for the GOV script trends in the US, which is really fueling the upgrade we have communicated today, which also means that our supply is on track in being able to serve many more patients both short and longer term. We are also excited about our pipeline, news we have announced recently, but also what we have coming up later in the year.
<unk>: Before we close the call I'd like to hand, it over to <unk> for any final remarks. Thank you Yakov.
Lars Rødgaard Jørgensen: We're also excited about our pipeline, news we have announced recently, but also what we have coming up later in the year. So with that, thank you also from my side for your questions and attention today. With that, we close the call. Thank you.
Speaker Change #163: I hope it comes across that we are very pleased with the momentum in our business in particular, our tier one business in diabetes and obesity.
<unk>: The strong growth for recovery.
Speaker Change #164: The script trends in the U S, which is really shooting the upgrades we have communicated today.
Speaker Change #165: It also means that our supply is on track.
Speaker Change #165: Being able to serve many more patients both short and longer term.
Speaker Change #165: We are also excited about our pipeline.
Speaker Change #165: We have announced.
Speaker Change #165: Recently, but also what we have coming up later in the year. So thats. Thank you also from my side for your questions and attention today would that be closer call. Thank you.
Lars Joergensen: So that, thank you also for my side for your questions and attention today. With that, we close the call.
Operator: Thank you.
Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
Operator: This concludes today's conference call. Thanks for participating.
Speaker Change #166: Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.
Operator: You may now disconnect.
Speaker Change #166: Yeah.
Speaker Change #166: [music].
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Speaker Change #166: Okay.
Unknown Executive: Thanks for watching my video. I hope you enjoyed it, and I'll see you in the next video. Hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey
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