Novo Nordisk A/S Q4 2024 Earnings Call Transcript

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Provided by Quartr
February 5, 2025
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Operator

Good day and thank you for standing by. Welcome to the Full Year twenty twenty four Novo Nordisk Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there'll be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone.

Operator

You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your first speaker today, Jakob Martin Vibovol, Head of Investor Relations. Please go ahead, sir.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you. Welcome to this Novo Nordisk earnings call for the full year of 2024. My name is Jakob Raul and I'm the Head of Investor Relations at Novo Nordisk. With me today, I have CEO of Novo Nordisk, Lars Vorko Janssen Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camille Srivast Executive Vice President, U. S.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Operations and Head of Global Business Development, Dave Moh Executive Vice President and Head of Development, Martin Holtslanger and finally, Chief Financial Officer, Karsten Moklosen. All speakers will be available for the Q and A session. Today's announcement and the slides for this call are available on our website, nomenordis.com. Please note that the call is being webcasted live and a recording will be made available on our website as well. The call is scheduled to last one hour and fifteen minutes.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

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. Please turn to the next slide. We need to advise you that this call will contain forward looking statements.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

These are subject to risk and uncertainty that could cause actual results to differ materially from expectations. For further information on risk factors, please see the company announcement for the full year of 2024 and the slides prepared for this presentation. With that, over to you, Lars, for an update on our strategic aspirations.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

Thank you, Jarep. Next slide please. In 2024, we delivered 26% sales growth and 26% operating profit growth. I'd like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues. Starting with our focus on purpose and sustainability, we are now serving more than 45,000,000 patients without diabetes and obesity treatments.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

This is an increase of almost 4,000,000 patients compared to last year and reflects our continued capacity expansion efforts. Our total carbon emissions rose by 23% compared to 2023. This was mainly driven by our increased production volumes and increased investments in capital expenditure to meet the high demand for our innovative treatments. To uphold our commitment of being a sustainable employer, we expanded the number of women in senior leadership positions to 42% compared to around 41% last year. In R and D, we had several exciting obesity readouts this quarter, such as Cagliacema, semaglutide seven point two milligram and amicretin.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

These results reinforce our strategic aspiration of developing superior treatment solutions for people living with obesity. For KAKRISEMA, we remain confident in its potent biology and look forward to further exploring its potential and to making it available to patients. Martin will come back to this and overall R and D milestones later. The quarterly sales growth reflects solid commercial execution across both operating units. Emil and Dave will go through the details later.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

Karsten will go through the financial details, but I'm pleased with the sales growth of 26% in 2024 as well as an attractive growth outlook for 2025. Now, I would like to hand over the word to Camille for an update on commercial execution in 2024.

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

Thank you, Lars, and please turn to the next slide. In 2024, our total sales increased by 26%. The sales growth was driven by both operating units with North America operations growing 30% and international operations growing 19%. In The U. S, sales growth was positively impacted by gross to net sales adjustments.

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

Our GLP-one sales in diabetes increased by 22% driven by North America operations growing 23% and international operations growing 18%. Insulin sales increased by 17% driven by North America operations growing 52% positively impacted by gross to net sales adjustments and international operations growing 6%. Obesity care sales increased 57% driven by North America operations growing 45% and international operations growing 107%. In both geographies, growth was driven by Vgovy partly offset by declining Saxenda sales as the obesity care market is moving towards once weekly treatments. Rare disease sales increased by 9%, driven by a 20% increase in North America operations and rare disease sales in international operations remained unchanged compared to last year.

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

Please turn to the next slide. I would like to reiterate our commitment to continue reaching more patients with our innovative treatments. Today Novo Nordisk is the global GLP-one volume market leader serving nearly two thirds of all patients on GLP-one treatments across diabetes and obesity. Our ongoing scaling efforts have supported an almost tripling of GLP-one patient reached over the last three years. In December 2024, we announced that the acquisition of the Catalent sites from Nova Holdings was completed.

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

This transaction supports our ongoing scaling efforts and would expand Nova Nordisk global fill and finish footprint from 11 to 14 sites. We still expect the three sites to gradually increase market supply beyond our pre existing CMO contracts to the market from '26 and allow us to reach significantly more patients in the years to come. Please turn to the next slide. Within diabetes care, sales growth was 20% driven by our TLP1 portfolio and insulins. We sustained our diabetes value market share leadership with an unchanged market share of 33.7% compared to last year.

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

This remains above our strategic aspiration of reaching one third of the global diabetes value market in 2025. Please turn to the next slide. In international operations, diabetes care sales increased by 12% in 2024, which was mainly driven by GLP-one diabetes care sales growing 18%. Novo Nordisk remains the market leader in international operations with a GLP-one diabetes value market share of almost 64%. And with that, I would hand over the word to Dave.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

Thank you, Camilla. Please turn to the next slide. Sales of GLP-one diabetes care products in The U. S. Increased by 24%.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

The sales increase was mainly driven by the continued uptake of Ozempic and the GLP-one class growth. Novo Nordisk remains the market leader in The U. S. With more than 52% market share measured by total monthly prescriptions. Please turn to the next slide.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

Wegovy sales increased by 86% globally, driven by a 59% growth in North America operations and Wegovy sales in international operations have reached more than DKK 11,000,000,000. The global total branded obesity market more than doubled with a growth rate of 119%. In The U. S, the WEGOVY sales growth was driven by increased volumes, partially countered by lower realized prices in The U. S.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

The positive volume development was also reflected in the Wegovy prescription trends in The U. S, which currently is around 200,000 weekly prescriptions. That's compared to around 100,000 weekly prescriptions in January 2024. We have reached broad formulary access for Wegovy in The U. S.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

And continue to work on expanding it further. Currently, Wegovy has coverage for around fifty five million people living with obesity in The United States. In international operations, Wegovy has now been launched in more than 15 countries, underlining our commitment to reaching more patients. Next slide please. Our rare disease sales increased by 9%.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

This was driven by sales in North America operations of 20%, while sales in international operations were unchanged. Sales of rare endocrine disorder products increased by 31%, driven by launches of Sogroya and increased nordatropin supply as well as a positive impact from gross to net sales adjustments in The U. S. Rare Blood Disorder sales increased by 3% driven by an increase in hemophilia B sales. Now I will turn it over to Martin for an R and D update.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Thank you, Dave. Please turn to the next slide. In December, Novo Nordisk released the headline results from the first pivotal trial with CALCRISEMA, REDEFINE one, in people living with obesity or overweight. Before getting into the results, I would like to quickly touch upon the trial design. Based on the Calclysema weight loss data observed in Phase one and two trials, we incorporated a flexible protocol in REDEFINE1.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

The protocol followed a sixteen week titration schedule and permitted dose modifications based on tolerability or concerns about excessive weight loss throughout the trial. This was done to balance efficacy, tolerability and trial dropout. REDEFINE one was a 68 efficacy and safety trial with 3,417 people enrolled. People were randomly assigned to either receive Caglizemma, a fixed dose combination of Cagglintide two point four milligram and semaglutide two point four milligram or Cagglintide two point four milligram in monotherapy, semaglutide two point four milligram in monotherapy or placebo. In line with regulatory guidelines, the purpose of the trial was to demonstrate superiority of Caglutide over placebo, caquilentide and semaglutide on body weight reduction.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Next slide please. Previous trials and our modeling indicated that Cagrusema could provide a potential weight loss of approximately 25%. While the 25% weight loss was not observed in REDEFINE one, we are encouraged by the weight loss profile of Cagrusema, which stands out as one of the most substantial weight reductions observed in a clinical Phase IIIa trial. From a mean baseline body weight of one hundred and six point nine kilograms, Cagresema demonstrated a superior and clinically relevant loss of 22.7% of body weight after sixty eight weeks compared to reductions of 11.8% with cabiglentide, sixteen point one percent with semaglutide and 2.3% with placebo. In the trial, Tagrusema appeared to have a safe and well tolerated profile.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

The most common adverse events were gastrointestinal with the vast majority being mild to moderate and decreasing over time in line with GLP-one receptor agonist class. Generally, we observed a low level of gastrointestinal adverse events. People on cabozema experienced 2.8 gastrointestinal events per patient per year compared to 1.2 on cabozantide and 2.6 on semaglutide two point four milligram. Discontinuation rates due to gastrointestinal related adverse events were also low with three percent three point six percent in the CapriSEM arm. For both the caprilinetide and the semaglutide arm, the gastrointestinal discontinuation were one point three percent.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Notably, the severity of gastrointestinal events for Calcucime was similar to the comparator arm. As a reference, in step one, semaglutide two point four milligram head of this infinuation rate due to gastrointestinal related adverse events of four point five percent. Lastly, the overall discontinuation rate for KAKU SEMA was eleven point seven percent. For comparison, semaglutide showed a discontinuation rate of seventeen percent in step one. In the REDEFINE one trial, the extent of dose modification prompted us to conduct a more in-depth analysis of people receiving the highest dose at sixty eight weeks, followed by an analysis of people on lower doses at sixty eight weeks.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

In the following slide, I will guide you through a post hoc analysis based on these two subgroups and share some reflections and considerations regarding the data. Next slide please. The first subgroup comprised fifty seven percent of the total population and consisted of people in the trial who ended on the highest two point four milligram dose of CagliSime at sixty eight weeks. The second group accounted for twenty nine percent of the population consisted of those who were at lower doses of Cacocema at sixty eight weeks. The remaining fourteen percent of the population were on either treatment pause or had been discontinued at sixty eight weeks.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

The first job group achieved a 12.7% mean weight loss at twenty weeks and a full 22.2% mean weight loss at sixty eight weeks. The weight loss trajectory for the first job group did not plateau at sixty eight weeks. Cagrusema showed a high tolerability with fewer gastrointestinal adverse events compared to semaglutide two point four milligram. This suggests that additional weight loss could be achieved with a trial of longer duration. The second subgroup showed a potent treatment response by achieving 15.9% mean weight loss at twenty weeks and 25.1% at sixty eight weeks, approaching a normal BMI at the end of treatment.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

The average treatment dose was one point one milligram at sixty eight weeks. Dose reductions occurred from the mid trial to end of treatment and did not occur to gastrointestinal adverse events alone. This group of people could potentially achieve higher weight loss with high doses through increased focus on dose escalation, dose re escalation as well as longer treatment duration. Overall, catrecema demonstrates a potent treatment response resulting in a superior weight loss efficacy compared to somaglutide. Furthermore, the REDEFINE one data indicate that a patient centric and individualized treatment regimen, which take the initial dose escalation, dose re escalation and trial duration into account, could potentially enhance efficacy of cabucosema while maintaining a favorable safety profile.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

While it may appear counterintuitive that lower doses of Calcutta leads to more substantial weight loss, this pattern is consistent with the observations from the STEP and STEP UP trials with somaglutide. However, it appears to be more pronounced with the potent biology of CACQUESEMA. In addition, we have previously observed varied responses to anti obesity medications across different population. Based on the insights from REDEFINE one and the reflection I've just shared with you on the data, we'll further explore Calcrilefema potential in a new Phase three trial, REDEFINE 11. The trial will have a longer trial duration and focus on dose escalation and re escalation.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Next slide please. Turning towards the next step for Calcuchema, we are currently anticipating the results of REDEFINE two in the first quarter of twenty twenty five. The REDEFINE 11 trial will be initiated in the first half of twenty twenty five and we now expect to submit cagliastema in the first quarter of twenty twenty six. The adjusted timelines are not related to the REDEFINE development program, but driven by supply chain reticentness when launching into a large and rapidly expanding market like obesity. Next slide please.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Earlier this year, Novo Nordisk announced the headline results from the Phase three trial STEP UP with semaglutide seven point two milligram. The seventy two week efficacy and safety trial investigated subcutaneous semaglutide seven point two milligram compared to semaglutide two point four milligram and placebo. Fourteen oh seven people with obesity were enrolled in the trial with a BMI of thirty or higher without diabetes. The mean baseline body weight was one hundred and thirteen kilograms. When evaluating the effects of treatment when all people adhere to treatment after seventy two weeks, semaglutide seven point two milligram achieved a superior weight loss of 20.7% compared to a reduction of 17.5% for semaglutide two point four milligram and 2.4% with placebo.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

In the trial, semaglutide seven point two milligram appeared to have a safe and well tolerated profile. We have also completed the STEP UP trial in an obese population with type two diabetes and are now evaluating the next steps in light of our overall obesity portfolio. Next slide please. Recently, we announced the headline results from the Phase 1b to a trial with once weekly subcutaneous amicretin in one hundred and twenty five people with overweight OBC. The trial was a combined single ascending dose, multiple ascending dose and dose response trial investigating three different maintenance doses with a total treatment duration of up to thirty six weeks.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

The primary endpoint was a treatment emergent adverse events. The most common adverse events with amatretin were gastrointestinal and the vast majority were mild to moderate in severity. Overall, the safety profile of amatretin was consistent with IngridSyn based therapies. People in the dose response part of the trial had a baseline body weight of ninety two point seven kilograms. People treated with Avicretin achieved an estimated body weight loss of 0.7%, sixteen point two % and twenty two % at the respective doses.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

This was achieved on one point two five milligrams, five milligrams and twenty milligrams respectively. This compared to a body weight gain of between 1.9% to 2.3% for people treated with placebo. The effect of treatment was evaluated if all people were adhering to treatment. We are very encouraged by the results for subcutaneous amatretin for people living with overweight or obesity. And based on the results, we are now planning for further clinical development of amatretin in people with overweight or obesity.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Next slide, please. Overall, we have a competitive portfolio in obesity underlined by the recent readouts from Caglizemar, semaglutide seven point two milligrams and subcutaneous emacretin. Our strategic ambitions remains to build a portfolio of superior treatment options in obesity and a focus on efficacy, safety and scalability, be it injectable or all. Our marketed portfolio started with Saxenda. We then set the bar with WIGO is attractive clinical profile with double digit weight loss and a proven cardiovascular risk reduction from the SELECT trial.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

In the short term, we expect to increase our competitiveness further with somaglutide seven point two milligram as well as oral somaglutide twenty five milligram. As illustrated on the right hand side of the slide, the next generation anti obesity medications in our pipeline feature multiple different mode of actions that can address different segments in the obesity market. Selected highlights are the planned Phase three trial with cabiglentide in Molotapine, further development based on the promising amicretin Phase onetwo data and the initiation of our triple agonist Phase one trial. We look forward to sharing data from all of these trials when they read out. Next slide please.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Turning to the upcoming R and D milestones, we look forward to a year with many exciting trial readouts. Before turning to 2025, I would like to highlight a few milestones from the last few months. We continue our focus on investigating how our innovative treatments impact related comorbidities in diabetes and obesity. Positively, Ozempic is now the only GLP-one receptor agonist proven to reduce the risk of chronic kidney disease in people with Type two diabetes and chronic kidney disease. This is based on the data from the FLOW trial and positive opinion from the European regulatory authorities and a U.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

S. FDA approval. We've also submitted the label extension applications for oral semaglutide fourteen milligram alternative the Rybaltis brand to U. S. And the European authorities based on the data from the sole Calcutta Alkenform.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Further, we have resubmitted the results from the STEPHepPEV trial with semaglutide two point four milligram in people with obesity to the U. S. FDA. The submission includes data from FLOW and SOUL, further substantiating the benefits of semaglutide for patients with heart failure. Excitingly, we have initiated a Phase one trial with a once weekly subcutaneous triagonist in people with overweight or obesity in the fourth quarter of twenty twenty four.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Moving to the milestone in 2025, I would like to start with a few exciting data readouts in type two diabetes in the second half that supports our aspirations of raising the innovation bar. Specifically, we expect the first Phase three results from Cakruzema as well as Phase two results for both subcutaneous emacretin and once weekly GIP GLP-one co agonist. Moving to obesity in the first half of twenty twenty five, we are now expecting to submit oral semaglutide twenty five milligram for people with obesity to The U. S. Regulatory authorities in the first quarter.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Furthermore, we also expect Phase II results from the once weekly GLP-one GIP co agonist. For Caglizemma specifically, we expect results from REDEFINE2 and REDEFINE4 during 2025 and to initiate the new REDEFINE 11 trial later during the first half of twenty twenty five. Within rare disease, we expect regulatory submissions of MIMEID in The U. S. And in The EU in the first half sorry, in the second half of twenty twenty five five.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Within cardiovascular and emerging therapy areas, we look forward to readout the sorry, we look forward to the readout of the EVOKE and the EVOKE plus trials in patients with early Alzheimer's disease. With that, over to you, Karsten.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

Thank you, Martin. Please turn to the next slide. In 2024, our sales grew by 25% in Danish kroner and by 26% at constant exchange rates, driven by both operating units. In The U. S, sales growth was positively impacted by gross to net sales adjustments.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

The gross margin increased to 84.7% compared to 84.6% in 2023. The increase is mainly driven by positive price impact due to gross to net sales adjustments in The U. S. And the positive product mix. This is partially countered by costs related to ongoing capacity expansions.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

Sales and distribution costs increased by 9% in Danish kroner and by 10% at constant exchange rates. In North America operations, the cost increase is mainly driven by promotional activities related to VIGOVI. In international operations, the increase is mainly related to Obesity Care market development activities, VIGOVI launch activities as well as promotional activities for GLP-one diabetes products. Additionally, the increase in sales distribution costs is negatively impacted by an adjustment to legal provisions in 2023. Research and development costs increased by 48, both measured in Danish kroner and at constant exchange rates.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

The increase in cost is mainly reflecting increased late stage clinical trial activity, increased early research activities as well as impairment losses related to intangible assets. Administration cost increased by 9% in both Danish kroner and at constant exchange rates. Operating profit increased by 25% measured in Danish kroner and by 26% at constant exchange rates. Operating profit is positively impacted by gross to net sales adjustments in The U. S.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

And negatively impacted by impairment losses. EBITDA increased by 32%, a measured DKK 30 3 percent at constant exchange rates. Net financial items showed a net loss of DKK 1,100,000,000.0 compared to a net gain of DKK 2,100,000,000.0 last year. This primarily reflects losses on non hedged currencies. The effective tax rate was 20.6 in 2024 compared to 20.1% in 2023.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

Net profit increased by 21% and diluted earnings per share increased by 22% to DKK 22.63. Net profit and diluted earnings per share are impacted by the impairments related to intangible assets. Cash flow from operating activities in 2024 was realized at DKK 121,000,000,000, an increase of DKK12 billion versus 2023. Perks for allocation of DKK47 billion to CapEx for supply chain and around DKK82 billion related to Catalent site acquisition results in free cash flow of minus DKK 14,700,000,000.0. This compares to DKK 68,300,000,000.0 in 2023.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

Please go to the next slide. In line with our strategic aspiration to deliver attractive capital allocation to shareholders, we have returned DKK 64,300,000,000.0 to shareholders via dividends and share buyback during 2024. At the Annual General Meeting on twenty seven March twenty twenty five, the Board of Directors will propose a final dividend of DKK 7.9 for a total 2024 dividend of DKK 11.4, including the interim dividend paid in August 2024. This is a 21% increase compared to 2023, making it the twenty ninth consecutive year with increasing dividend per share. In addition to the dividends, the DKK 20,000,000,000 share buyback program for the past twelve months has been concluded.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

Novo Nordisk Capital allocation priorities prioritizes attractive investments into the company, including supply chain expansions and R and D as well as consistent dividend payouts. Consequently, following the further step up in CapEx, Novo Nordisk is not initiating a new share buyback program at this point in time. Please go to the next slide. We continue the growth momentum in 2025 and expect the sales growth to be between 1624% at constant exchange rates. This is based on several assumptions as described in the company announcements.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

The guidance reflects expansion expectations for sales growth in both North America operations and international operations. The sales growth is expected to be mainly driven by volume growth of GLP-one based treatments for obesity and diabetes care, also reflecting our continued scaling of our supply chain. Our reported sales are expected to be three percentage points higher compared to constant exchange rates and operating profit is expected to be five percentage points higher compared to constant exchange rates. We expect that the operating profit will grow between 1927% at constant exchange rates. This primarily reflects the sales growth outlook and continued investments in current and future growth drivers within research development and commercial.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

And negative mid single digit operating profit growth impact related to the acquisition of the three cattle and manufacturing sites is also included in the guidance. For 2025, we expect net financial items to amount to a loss of around DKK 9,000,000,000. This mainly reflects losses on hedge currencies, primarily the U. S. Dollar and increased interest expenses related to funding of the Catalent site transaction as the acquisition was mainly debt financed.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

The effective tax rate for 2025 is expected to be in the range of 21% to 23%. The increase compared to 2024 is mainly driven by country and therapy sales mix. CapEx is expected to be around DKK 65,000,000,000 in 2025, reflecting expansion of the supply chain. In the coming years, CapEx to sales ratio is still expected to be in the low double digits. The free cash flow is expected to be DKK 75,000,000,000 to DKK 85,000,000,000, reflecting the sales growth, favorable impact from rebates in The U.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

S, countered by increased investments in manufacturing facilities. That covers the outlook for 2025. Now back to you Lars.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

Thank you, Carsten. Please turn to the final slide. We are pleased with the performance in 2024, where 26% sales growth reflects that more than 45,000,000 people are now benefiting from our treatments. Further, we completed the acquisition of three Catalent sites and during the year we progressed our R and D pipeline, including obesity projects such as KAKISIMA and AMETRITION. With the attractive 2025 outlook, we will continue to focus on strong commercial execution and the progression of our early and late stage R and D pipeline and on the expansion of our production capacity.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

With that, I would like to hand the word back to Jacob.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Lars. Next slide please. With that, we're now ready for Q and A. We are kindly ask all participants to limit her or himself to one or maximum two questions, including sub questions. Operator, we're now ready to take the first question please.

Operator

Thank you. And your first question comes from the line of Richard Foster from JPMorgan. Please go ahead.

Richard Vosser
Richard Vosser
Stock Analyst at JP Morgan

Hi. Thanks for taking my questions. Two questions, please. Firstly, on WEGOVY, could you give us some more details of what's holding back The U. S.

Richard Vosser
Richard Vosser
Stock Analyst at JP Morgan

Prescriptions in the last quarter of twenty twenty four and the early part of twenty twenty five? What can you do about it? And how should we anticipate the growth in prescriptions from here? And second question, just thanks for all the dosing data. But based on that and what you've seen in REDEFINE one and the tolerability that you've shown, how do you think the profile of Cagrusema will stack up versus Z band in REDIFINE four?

Richard Vosser
Richard Vosser
Stock Analyst at JP Morgan

Thanks very much.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Richard, for those two questions. On the first one on Viggoi prescription trends, we'll turn to you, Dave.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

Thank you, Richard, for the question. I think it's important to remember that the total market for anti obesity medicines grew in The U. S. Last year by one hundred and sixty percent. And so the story continues to be about market expansion for obesity.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

And for our own brand, Rigovy, recall we started last year with around 100,000 prescriptions and ended with over 200,000 prescriptions. And so the scaling efforts are recognized and that's being pulled through in the market. In the beginning of the year, and this is normal, there are movements in benefit plans and patients changing in terms of their co pays and coinsurance. This is normal, but it does have an impact with total prescriptions in the beginning of the year as well as coming through holidays as well as Martin Luther King holiday in the beginning of the year. It's important to remember, we're treating one point two million patients with WEGOVI today and we have accessed of fifty five million people living with obesity in The U.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

S. Driving new prescriptions is of course our focus. And what we can say about that is we are shipping more of the starter doses as we speak. Those starter doses are making their way through the supply chain from the wholesaler to retailer, which is also new for us to have these this amount of new starter doses. And now it's our opportunity to pull through this market expansion and connect more people with Wegovy in The U.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

S.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Dave. Then we turn to the second question, which goes to you, Martin, on current thoughts on the Cagliacema profile also looking ahead to REDEFINE four.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Yes. Thank you very much, Richard. So REDEFINE four, as you rightly mentioned, is head to head trial, Cagliacema versus tirzepatide. The first statistical testing will be non inferiority and based on what we've seen with REDEFINE one, there's a good assumption that will come out with non inferiority established. Second test is then test for superiority.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

And again, I think it's too early to speculate, but we will see the data when we will see them, but that is test number two.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Martin and thank you, Richard. Then we are ready for the next set of questions, please.

Operator

Thank you. Your next question comes from Harry Sefton from UBS. Please go ahead.

Harry Sephton
Harry Sephton
Director - Equity Research at UBS Group

Hi there. Thank you for taking my questions. It's Harry Sefton from UBS. I'd like to start with the REDEFINE ONE results. And can we address this difference between the weight loss profile that doesn't show a typical dose response?

Harry Sephton
Harry Sephton
Director - Equity Research at UBS Group

You talked about the fact that fewer patients finished at the higher dose in the initial results as a potential explanation for the weaker weight loss versus your modeling. But the data you've shown today somewhat contradicts this. So what have you seen to explain this discrepancy? Is it a speed of titration issue or are there other factors you can help explain this? And what read across can you take from these data for the imminent REDEFINE two data?

Harry Sephton
Harry Sephton
Director - Equity Research at UBS Group

My second question is following the Amicretin subcut data. How do you see the positioning of this product versus Cadbury SEMA in the future? Do we need incremental efficacy from here or does the benefit from amikretin more come from scalability and the flexibility of both the injectable and oral formulations? And what is the timing for the initiation of your Phase three program for amikretin? Thank you.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Harry, for those two questions. On the first one, in terms of REDEFINE one data, we'll turn it to you, Martin.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Yes. Thank you very much, Harry. So first of all, I think it's important to call out, we don't really see discrepancies. We see a picture emerging that we've seen to an extent in the STEP certainly in the STEP UP study programs and we see that also now in REDEFINE I. We see a group of people who titrate with very strong safety and solubility to the fullest dose.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

They have a very substantial weight loss. And specifically in REDEFINE one, we see the potential for even further weight loss with longer treatment duration. Then we see some early responders, who clearly lose weight faster than the other group, they also have appear to have the potential to lose more than the other group. And what we can see from this is basically that on average that group, which is bigger than what we've normally seen in our trials, loses actually a mean of 25.2 percentage point at end of trial, approaching a BMI that would indicate non obesity. That actually then plays into a dynamic because these patients have slightly more gastrointestinal side effects.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

They also some of them expressed concerns about the speed of weight loss. And therefore, they start to titrate a little bit down. That again is a big potential because they can actually lose more weight. It's to your point, allowing them to do individual dose titration, titrate a little bit slower and then coming up to higher doses, balancing the speed of their weight loss and the gastrointestinal side effects. Obviously, this population also seems to be benefiting from an even or could be benefiting from an even longer trial duration.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

And that basically means we see two distinct groups, one being what we call early or high responders, but both groups actually showing more weight loss potential. We can utilize that in the future programs for KAKROSEMA, specifically starting with REDEFINE 11, but we can certainly also use those data when we design the emicretin program using the same biology.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Martin. And for the second question on amicrotin, Caglucin and having a portfolio, I'll turn to you Camilla.

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

Thank you very much. Yes, there's no doubt that with the size of the obesity market, it will be a key strength to have a broad portfolio of products like Martin shared with you in the slides just before. We believe we have a very strong portfolio that enables us to work with optionality, optionality in terms of different patient segments and different markets to address the big unmet need that there is. Remember that it's a very few percentage points of the total population that is currently being treated. And I think historically we've talked about sort of the people with obesity as one group.

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

But as we expand our portfolio, we will be able to target different needs of different segments as well as different geographies. So we have remained very confident, of course, in Cagrusema and also in amicretin.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Camilla. Thank you, Martin. And thank you, Harry, for those two questions. Then we're ready for the next set of questions, please.

Operator

Thank you. Your next question comes from the line of Michael Nedelkovic from TD Cowen. Please go ahead.

Michael Nedelcovych
Director - Equity Research at TD Cowen

Thank you for the questions. I have two. My first is on supply. Lilly has indicated that it can boost its increase in supply by 60% in the coming months. You all have never quantified capacity, but do you feel that your efforts to boost production will be competitive with this number?

Michael Nedelcovych
Director - Equity Research at TD Cowen

This might be an oversimplification, but if we grant that prescription trends in The U. S. Are largely reflective of supply rather than demand, then it would seem your competitor may be ramping capacity more swiftly. Do you think that's a fair interpretation? And then my second question is on oral semaglutide twenty five milligrams, which you now plan to file for weight loss in The U.

Michael Nedelcovych
Director - Equity Research at TD Cowen

S. It's notable that you are not pursuing the fifty milligram dose. I assume this decision was related to supply considerations, but please correct me if I'm wrong. And how should we think about the eventual launch of this offering? Just as an example, you've used the term capped as it relates to Wegovy's ex U.

Michael Nedelcovych
Director - Equity Research at TD Cowen

S. Launches. Should we also think of oral semaglutide's weight loss launch as capped?

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Mike, for those two questions. One on supply and then on launch considerations around oral sema. First, on supply, we turn to you, Carsten.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

Yes. Michael, thanks for this question. And let me start basing my answer on the slide we showed early on. So we scaled our patient reach with Novogeal bronze by almost a factor three over the last three years. And latest data point from IQ and this is based on IQVIA latest data point, we are serving almost two thirds of the global GLP-one market and then competition sitting on the remaining one third.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

Specifically for the last year, just to have hard data, we have expanded patient reach, again, based on IQVIA numbers more in absolute numbers, more than any other competitor in this market. So factually, we have grown faster in terms of serving more patients over the last twelve months based on IQVIA. Then I'd say as a forward looking statement in terms of our scaling into 2025, With the guidance we have and the size of the base we have, you can say a sales growth in, say, a midpoint of 20%, then you apply rebate enhancement and due mix impacts and share of the total portfolio, then you get to a scaling volume scaling of our GLTR-one franchise in terms of patients served nicely in excess of 30% into this year. So I think we are very competitive in terms of scaling.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Carsten. And then on oral semaglutide, the twenty five milligram, probably you already talked about launch and positioning, but the high level value proposition of oral semaglutide?

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

Yes, high level value proposition in fact, what we talked about before. It is likely that there will be an oral segment in obesity as there has been actually also before, but due to tolerability issues, this has been quite small. Now we have a product that is proven in terms of clinical trials and efficacy with a 16% weight loss or sebaclutide twenty five milligram. And of course, that gives us an opportunity to launch this in semaglutide in general, and this gives us optionality to address an oral more specifically. So that's part of our plans and our broader portfolio.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Camilla. And thank you, Mike, for those two questions. Then we turn to the next set of questions, please.

Operator

Thank you. Your next question comes from Fatim James, Bank of America. Please go ahead.

Sachin Jain
Sachin Jain
Vice President at Bank of America

Hi. Thanks for having my two questions. I have similar topics, if I may. So back on KEGGRI CEMA, Martin, thanks for the detailed explanation. I wondered if Dave or Camilla could touch on how you're going to translate that into a commercial message.

Sachin Jain
Sachin Jain
Vice President at Bank of America

So very simply, what doses should patients be on, how to titrate and at the doses they get to, what do you think the profile versus tersor is? And how are you thinking about positioning this relative to Wegovy? It just seems quite confusing to me. And the second one is just for Karsten on the wide guidance range. You started with the 8% as you did beginning of last year.

Sachin Jain
Sachin Jain
Vice President at Bank of America

At bottom to top end, what are the key areas of uncertainty or deltas for you as you think about 25%? Thank you.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Sachin, for those two questions. Firstly, on KAKU SEMA, the value of the individualized treatment on Eukarywilin?

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

Yes. So Cakasyma, of course, with the results we have seen, we are very confident in the product. We are very confident in our portfolio. And it's really the optionality that we are working with on how to target specific segments and specific geographies. I think it's a little bit premature for us to reveal our full commercial approach as to how we are utilizing the benefits of these different options that we have in our pipeline.

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

But it is the sum of the pipeline that we just talked to that will really enable us to address more and more people living with obesity. So that's how we are moving forward and why you will also see us addressing different types of products with different optionalities. As we just discussed, all now Calcutta SEMA, Amacretin and of course, also higher dose Vigovir. This is all part of our opportunity play in obesity.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Camilla. And on the second question, we turn to you, Kai.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

Yes. Sachin, thank you for that question. So our guidance range breadth is in line with what we had last year and is also reflective of the rapid growth rate that we're delivering as a company. The main swing factors which can all be both positive and negative, I would call out three main ones, one being supply as we've seen in prior years. And more supply can make us reach more patients and more markets.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

And of course, negative supply fluctuations would impact the other way. So that's number one. Number two is competition and magnitude of competition, which, of course, we do not have forward looking visibility to we see what's in the market today. So it's based on our current read of the markets. And then the third factor is gross to net adjustments where we've seen some sizable gross to net adjustments in The U.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

S. Over the past few years, reflecting a 69% spread between gross and net sales in The U. S. And that swing factor can also both be positive and negative. So that would be the main three factors.

Karsten Knudsen
Karsten Knudsen
Executive VP, CFO & Member of the Management Board at Novo Nordisk

Thank you.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Carsten. And thank you to you as well Sachin. Then we're ready for the next question please.

Operator

Thank you. Your next question comes from the line of Richard Parks, BNP Paribas. Please go ahead.

Richard Parkes
Head of Pharmaceutical & Biotechnology & Equity Research at BNP Paribas

Yes. Thanks for taking my questions. Firstly on Caglizemar, I've got sales still a little bit confused on the inverse dose response. I'm just wondering why is this not been seen in any of the trials today? And should I not just conclude that not all patients need the 20% plus weight loss that can be achieved?

Richard Parkes
Head of Pharmaceutical & Biotechnology & Equity Research at BNP Paribas

So I'm just wondering kind of why that's not been seen before? And then in terms of the prescription demand currently, I mean, you flagged formulary changes, but your net access sounds like it hasn't changed. So have there been some kind of big formulary changes, but the net access overall is the same? I'm just wondering what impact compounding pharmacies are having on demand currently? Thank you very much.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you for those two questions. Firstly, on Kakehsema, we'll turn to you, Elias.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

Yes. So thank you, Richard. So just to give a perspective on how we see this. So Martin alluded to that also in the past have we seen a difference in how patients respond. That has been based on, say, a lower potency product.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

So we saw similar when we developed WEGOVI, but with less, say, spread, so to say. And in our view, we have to relate to that when you develop highly potent bioresis like what we see with Crekasyma, these differences will be amplified. So the fact that patients are different and respond in different way means that we'll see increasingly as we move up and develop highly efficacious products, you will see this difference in response. And in terms of use in the market also to the prior question, I think it's perhaps less confusing for physicians than we believe because they're actually used to patients responding quite differently on treatment. And that goes for obesity, but it also goes for any, say, chronic disease that patients respond differently to medicines.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

So physicians are used to a more, say, patient centric treatment regime. And I think what really matters here is that we have a highly potent biology that kind of does the job. And then I think it's up for the rest of us to acknowledge that this is a new sign we get in large scale clinical development, but it's really linked to the potency of the product. And I anticipate that we see similar signals as we develop equally potent biologies in the future. So I'm quite comfortable with the profile and also that it works for patients and that it will also work in the hands of physicians who are used to more individualized treatment of patients.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Lars. And then on the for the next question, I'll turn to you Dave on the excessformulary movements in The U. S.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

Yes. Thank you for the question, Richard. It's important that we reiterate that it's our belief that building a sustainable obesity market for the long term is through market access and having patients have a reasonable co pay and access to the medicine. I'm happy to say for 2025 that we have maintained our broad access for Wegovy covering fifty five million people with obesity. There were no major changes with opt ins and opt outs.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

It's important to note that these patients have Wegovy available at a low out of pocket cost, more than eighty percent of them paying less than $25 for a prescription. And this is also in addition, we have now more than 20 states that also cover Wegovy through Medicaid. You also had a question about compounding. Our latest market intelligence does tell us and show us that it is having impact and it is growing faster than we had anticipated. I want to remind everyone that we do not supply compounding and we have significant actions in place to curtail this.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

Our focus is on patient safety and educating patients and providers that this is not sema, and also to work with the regulators to curtail compounding as well.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Dave. And thank you, Richard, for those two questions. Then we turn to the next questions, please.

Operator

Thank you. Your next question comes from Emily Fields from Barclays. Please go ahead.

Emily Field
Emily Field
Director at Barclays Capital

Just to follow-up on the compounding point, for a few months now all the doses of semaglutide have been marked as available on the FDA drug shortage website, but the molecule is still marked as in shortage. When do you expect that to be removed? And then would that lead to a similar kind of off ramp from the FDA for the compounders that we saw FDA issue a directive in December for tirzepatide? And then secondly, another question on REDEFINE one. The gray curve for the patients that were on a lower dose at the end of treatment, is it fair to say that a significant number of those patients did go up to 2.4 and then titrated down whether for tolerability or that they were very, very fast responders to the weight loss?

Emily Field
Emily Field
Director at Barclays Capital

Thank you.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Emily. And on the first one, the follow-up question on compounding, we'll turn to you, Dave.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

Yes. As you mentioned, we are still listed on the drug shortage list. We are in active dialogue with FDA. It is ongoing. Of course, as we increase the resilience in our supply, that has an impact on our ability to get off the drug shortage list.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

And we are focused on doing that as fast as possible as we believe this will help our further actions to curtail compounding in the future.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Dave. And then on the early responder curve, we'll turn to you, Martin.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Yes, absolutely. I want to go back to Lars' point that obesity is a complex disease and patient have individual response to treatment. So in the group where patients did not titrate to full dose at end of trial, the mean dose at week twenty was around one point five milligrams, indicating that very few actually opted to try to try to say to the full two point four milligram dose. This is more to be seen as a group of fast and high response. And therefore, with the weight loss that they accrued, which was then also faster than the other group, they started to slow down to balance the speed of their weight loss, their gastrointestinal side effects, but also the fact that they were approaching a level below the definition of obesity.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

And therefore, again, it speaks to the very powerful priority that we see, but also the need to individualize treatment. And again, I'll just remind you, this is the trial at a population level where we've seen very few gastrointestinal side effects at the level of WIGO. And therefore, that is not the key driver of how patients choose to titrate. I think Lars has a really good point. Patients know how to do this together with their physicians.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thanks a lot Martin and thank you Emily for the two sets of questions. With that we are ready for the next questions please.

Operator

Thank you. Your next question comes from the line of Florent Cespedes from Bernstein. Please go ahead.

Florent Cespedes
Senior Sell-Side Analyst - European BioPharmaceuticals at Bernstein

Good afternoon. Thank you for taking my questions. Two quick ones, please. First for Dave. Could you give us your view on the situation in U.

Florent Cespedes
Senior Sell-Side Analyst - European BioPharmaceuticals at Bernstein

S. For semaglutide regarding IRA Inflation Reduction Act? Because now you're on the list. So could you remind us how you will manage the situation for 2027? And when should we have the final level of rebates?

Florent Cespedes
Senior Sell-Side Analyst - European BioPharmaceuticals at Bernstein

If you could remind us that the process would be great. Second question for Martin, on Mont Lulardin, maybe could you give us some color on the Phase IIe from the kidney trial? Not to be on the tolerance, if there is any readout on the tolerance side that could maybe help you to design or adjust the rest of the clinical ongoing clinical trials? Thank you.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thanks a lot, Florent. On the first one, Ira, of course, I have to speak too much, but with that over to you, Judith.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

Yes. Thank you, Florent. As expected, semaglutide containing products Ozempic, Rybelsus and Magovy, They are selected for the second round of CMS negotiations. It's too early to speculate on the potential impact. As we've stated in the past, we oppose government price setting like we have from the beginning.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

The process though is as follows. The negotiations will end in the November. The maximum fair price will be published by the November and it will be effective in the 01/01/2027. And just for background, the rough U. S.

David Moore
David Moore
Executive VP of Corporate Development & Member of Management Board at Novo Nordisk

Channel mix across our portfolio is about 50% commercial, 30% Medicare, 10% Medicaid and 10% other.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Dave. And on the next question on the Lunabant in the diabetic kidney disease, we'll turn to you, Martin.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Thank you very much for that question. So two reminders. One being, we never did the acquisition of Vonluniband to develop it purely for diabetic kidney disease. Our focus was on the weight loss potential. And second, I'll just remind you that these are small studies.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

So obviously, we try to see them in the context of the full picture. So we are not discouraged by the fact that we did not see impact on the actual diabetic kidney disease. That study did confirm a weight loss potential for Molnupand. And when we look at the safety and tolerability profile, it was comparable, albeit with slightly lower rates than in the dedicated rubricity story, basically indicating that we can still have an aspiration of exploring this further in Phase 2b with lower doses looking at weight loss potential, but obviously also and this has been the intent from the get go, also ruling out a potential safety concern.

Florent Cespedes
Senior Sell-Side Analyst - European BioPharmaceuticals at Bernstein

Thank you very much.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Martin. Yes, thanks to you as well, Thwan. Then we're ready for the next set of questions, please.

Operator

Thank you. Your next question comes from the line of Evan Feigerman from BMO Capital Markets. Please go ahead.

Evan Seigerman
Evan Seigerman
MD & Senior Research Analyst at BMO Capital Markets

Hi, all. Thank you so much for taking my questions. Kind of a big picture question. There seems to be an obsession with absolute weight loss, whether a percent more or less can make a winner or loser, I'm specifically referring to KaguyaSema. Maybe walk me through how you view the ideal product profile of an asset?

Evan Seigerman
Evan Seigerman
MD & Senior Research Analyst at BMO Capital Markets

Is it better weight loss, no plateauing, tolerability, longer acting, better delivery? As you think about your portfolio, what would you like to see in kind of your next generation product? Thank you.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Evan. I think on the high level obesity question, we'll turn to you, Lars.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

Yes. Thank you, Evan, for bringing that up. I think it's really, really good topic to discuss and obviously, it's a quite broad topic. And I think the discussion opens up with what we now see in terms of efficacious biologies because you could say that with former generation products like we go, we you could in principle say load patients up and all would say tolerate the weight loss they see and also the GI tolerability window is very good. But when you get into, say, the next generation products where you amplify the weight loss, you tease out the difference between different patients who we're still trying to look into the omics and figure out what defines the difference.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

And we have a lot of data, so we can start actually finding ideas about who will respond in certain ways and from a speed of weight loss, etcetera. So that then we're into the topic of say quality of weight loss. And I think in the early days of obesity, we have all been obsessed by the percentage over time. And I think that's a problematic ratio because if you have lived with obesity a good part of your life and suddenly you lose, say, 25%, some even more percent weight loss in a matter of, say, half a year to a year, that's a very dramatic, say, change in your life and not necessarily what anyone would like. So that's one.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

And then, of course, we have all the comorbidities. And increasingly, I think with the establishment of CV benefits, liver benefits, etcetera, it also becomes a matter of, say, the health outcome improvements you have. So in this, say, opportunity space, I think it's important to be able to address those opportunities with different type of agents to cater for these differences. Short term, as I mentioned before, I think patients together with the physician are quite comfortable in managing this journey. And I think we are perhaps struggling a bit in doing the perfect segmentation of what this market will look like.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

But I think we can look into all the data we have and find ways to also more targeted direct specific products to certain subsegments. So I think this is another example of the fact that we're in the early days of understanding obesity, how patients are different. I think it's all opportunity for us with the breadth of the portfolio we have and all the data we have. So yes, percentage of weight loss matters, but quality of weight loss and benefit on comorbidities, etcetera, also matters. And it's in that total equation that that I think we have a really exciting opportunity for continuous leadership in the space.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

Thank you, Evan.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Lars, and thank you, Evan, for the questions. Then we have time for two more sets of questions. And let's start with the first one, please.

Operator

Thank you. The next question comes from the line of Luisa Hector from Berenberg. Please go ahead.

Luisa Hector
Head of Global Pharma Equity Research at Berenberg

Hello, thanks for taking my questions. For REDEFINE one, could you just comment on what percentage of patients down titrated and any color on the timing at which that happened? And perhaps on the highest dose, what the discontinuation rate was? And then I wonder if I could ask you a question on amicretin and progression there. So when I pull together your comments on KAGRISEMA, the high potency individual patient responses and then we layer in the proposed FDA guidelines that say Phase two data should be sufficient to capture maximal or near maximal weight reduction effects with the dosing regime.

Luisa Hector
Head of Global Pharma Equity Research at Berenberg

Do you feel that you have enough data to progress into Phase III or would perhaps another Phase II be advisable? Thank you.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you for those two questions, Luisa. I think both of them are for you. Martin, let's start with the first one. So on the data in REDEFINE one.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Yes. So first of all, we had these two very clear distinct groups. The larger group of fifty seven percent of the people titrating to two point four percent. Just to give you an example, they were at a mean dose of two point two milligram at twenty weeks and they then continued to the full two point four and appeared to stay on that. There were a few patients doing ups and downs, but it would not be meaningful to try to tease them out.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Similarly, just want to remind you at week twenty, the other group were at one point five and they downtry traded a little bit as a group to add end of trial one point one. While basically securing a weight loss that was higher than what we've seen before, namely 25.2. At the same time, this way of allowing patients to do, I don't want to say personal titration, but close to XEA allowed us to see the lowest overall dropout ever seen in a phase IIIEA pivotal trial, but also very low and again the lowest gastrointestinal dropouts seen in the pivotal trial. And just a reminder, Calcusoma in REDEFINE one, three point six percent dropout, semaglutide in step one, four point five percent dropout due to gastrointestinal side effects. So we are actually quite encouraged by the data.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

And as Lars also alluded to, by employing this individual approach to patients moving forward, we can really leverage the full benefit of not only Calcosyma, but also our pipeline products.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thanks for that, Martin. Thanks a lot. And then on the second question on Amycotene, we turn to you, Martin, again and on

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

the next steps. Yes. So as you know, we have generated data on the oral version of amicretin. They are very consistent with the data that we see with the subcutaneous version of amicretin in patients with obesity. We have an ongoing Phase II trial in patients with type two diabetes.

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Our current assessment is that we live up to the spirit of the FDA draft guidance. Obviously, as in any progression of clinical development, we had to discuss with the regulatory authorities, which will do in short order.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Martin. And thanks to you as well, Louisa. And then we are ready for a final set of questions, please.

Operator

Thank you. Your final questions today come from the line of Michael Novart from Nordea. Please go ahead.

Michael Novod
Managing Director at Nordea Markets

Thank you very much. Michael Novart from Nordea. Also two questions. So the first one with the data on hand with CakriSeva and the flexibility and more sort of individualized treatment as well as sort of your plans for emicrease. And have you changed any sort of view on whether how to sort of whether the LOE on semaglutide in 02/1932 and the way of sort of replacing Vigovia with either of these drugs?

Michael Novod
Managing Director at Nordea Markets

And then secondly, can you tease out also on when you look at the very early data on Calcasema and also Amicretin, anything more to add on whether Amicretin looks different in terms of tolerability? I know it's very early data you have, but more to sort of try to pin down on how this could look in later stage trials, whether it's just as tolerable as KAKU SEMA?

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Hi, Michael. Thanks for those two questions. I think first on the overall view on KAKISIMA and Amikrotin, we'll turn to you, Camilla. And afterwards on Amikrotin tolerability, we'll turn to you, Martin. Over to you, Camilla.

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

Yes. Thanks a lot. So in terms of whether we have changed anything in our view towards loss of exclusivity, I would say we have not. What we have learned now is, of course, that a little bit more clarity on different segments. We talked about individualized treatment.

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

We learned more about how each product works, but it only gives rise to us getting more information about how we are going to position this portfolio of opportunities that we have. So the short answer is no. And we also continue to, of course, build on semaglutide franchise. You just saw the new indications that we got. So full speed on that going forward, but also full speed on the new innovation simply establishing this full portfolio.

Camilla Sylvest
Camilla Sylvest
Executive VP of Commercial Strategy & Corporate Affairs and Member of the Management Board at Novo Nordisk

So no radical changes to that at all.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Camilla. And then on the Amicatin data to you, Martin. Yes, it's

Martin Lange
Martin Lange
Executive VP of Development & Member of the Management Board at Novo Nordisk

Thank you very much. It's early days and obviously what we can say at this point in time is we're working with two powerful biologists. They appear to have similar efficacy, but also safety and tolerability potential. And obviously, that also means that we had to think in the power of the combination of biology into our AMICRETIN development program to accrue the full potential, both in terms of weight loss, but also safety and tolerability and potentially also comorbidities when we do develop AMICRETIN and Cacocema moving forward.

Jacob Martin Wiborg Rode
Jacob Martin Wiborg Rode
Head of IR at Novo Nordisk

Thank you, Martin, and also thank you to you, Michael. Now that concludes the Q and A session. Thank you for participating and feel free to contact Investor Relations regarding any follow-up questions that you may have. Before we fully close the call, I would like to hand over the word to you, Lars, for final remarks.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

Thank you, Jaap. I'm very pleased with 2024 sales growth of 26%, driven by our GLP-one portfolio in both operating units. And within R and D, we see a strong momentum, as we just discussed, in our pipeline, as underlined by the recent readouts in obesity, both for Kagesema and amatricin. Of course, I'm also very pleased with the expected 2025 outlook. We continue to focus heavily on commercial execution and on the progression of our R and D pipeline and the expansion of our production capacity.

Lars Fruergaard Jørgensen
Lars Fruergaard Jørgensen
President & CEO at Novo Nordisk

So the plan is very clear, and we know what it takes to execute on this. So also thank you from me on behalf of management on your time today. We appreciate the opportunity to discuss our business with you. Thank you very much. Bye bye.

Operator

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

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