Novo Nordisk - Q4 2025

Transcript

Operator (participant)

Good day, and thank you for standing by. Welcome to the Q4 2025 Novo Nordisk Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask 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. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your first speaker today, Michael Novod, Head of Investor Relations. Please go ahead.

Michael Novod (Head of Investor Relations)

Thank you very much, and welcome to this Novo Nordisk earnings call for the full year of 2025. My name is Michael Novod. I'm the Head of Investor Relations at Novo Nordisk. With me today, I have CEO of Novo Nordisk, Maziar Doustdar; EVP, Product and Portfolio Strategy, Ludovic Helfgott; EVP, U.S. Operations, Dave Moore; EVP, Research and Development, and Chief Scientific Officer, Martin Holst Lange; and Chief Financial Officer, Karsten Munk Knudsen. All speakers will be available for the Q&A session. Today's call is being webcasted live, and a recording will be made available on our website. The call is scheduled to last one hour. Next slide, please. The presentation is structured as outlined on slide two. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified. Next slide, please.

We need to advise you that this call will contain forward-looking statements. These are subject to risk and uncertainty that could cause actual results to differ materially from expectations. For further information on the risk factors, please see the company announcement for the full year 2024 and the slides prepared for this presentation. With that, over to you, Mike, for an update on our strategic aspirations.

Maziar Doustdar (CEO)

Thank you, Michael. Next slide, please. In 2025, Novo Nordisk delivered 10% sales growth and operating profit growth of 6%. We sharpened our strategic focus in 2025, doubling down in our core therapeutic areas of obesity and diabetes. This year marks the conclusion of the 2025 strategic aspirations that were established back in 2019. Since then, we have more than doubled our sales and operating profit, and our obesity care sales have increased from DKK 6 billion in 2019 to DKK 82 billion in 2025. Rare disease is now positioned for sustained growth with the late-stage pipeline assets Mim8, now called denecimig, and Etavopivat. Furthermore, over DKK 300 billion has been returned to our shareholders since 2019. Most importantly, we have increased our reach by an additional 16 million people with our obesity and diabetes treatments.

This quarter, we saw several exciting readouts, including the next-generation treatment for type 2 diabetes, with the phase II readout of senagametide and phase III readout for CagriSema. Novo Nordisk also continued to build upon its pipeline across therapy areas. Martin will discuss this in more details later in the call. By late 2025, we received FDA approval for the Wegovy pill, the first oral GLP-1 for obesity, and submitted CagriSema in the U.S. Dave will speak more to the Wegovy pill later, but we are encouraged by the early uptake of the pill and what we see these milestones would mean for people living with obesity. We are treating nearly 46 million people with our innovative medicines, reflecting Novo Nordisk's commitment to innovation and the ongoing efforts to expand access to our therapies worldwide.

Finally, Karsten will come back to it, but we have released our 2026 guidance, which reflects a year of pricing headwinds. We do not take this lightly, and we will do all we can to pursue the volume opportunities in obesity and diabetes. Next slide, please. Yesterday, we also announced changes to the executive management team. Dave Moore has decided to leave Novo Nordisk for personal reasons after more than eight years with the company. Dave began his Novo journey in 2017 and returned to Novo in 2022 after a time outside of the company to lead our global business development area, before returning to the U.S. as the Executive Vice President of the U.S. Operations in January of 2025.

Dave has moved the needle throughout his time at Novo, from driving the blockbuster launch of Ozempic to leading the acquisition of 3 Catalent manufacturing sites to overseeing the launch of the Wegovy pill in the U.S.. In addition, Ludovic Helfgott has decided to leave Novo Nordisk to pursue new opportunities. Ludo joined Novo Nordisk back in 2019 to lead what was back then called biopharm business and eventually became our rare disease therapy area. Ludovic's patient-first leadership is reflected in Novo Nordisk's strong presence in rare blood and endocrine disorders today. Ludovic was able to translate this passion across all of our therapy areas over the last 10 months as the Head of Product and Portfolio Strategy. On behalf of Novo Nordisk and myself, I would like to thank Dave and Ludovic for their bold and steady leadership.

After a thoughtful selection process over the last few months, I'm very pleased to announce the addition of Jamie Miller and Hong Chow to Novo Nordisk and the executive management team. Next slide, please. Starting February fifth, Jamie Miller joins Novo Nordisk as an Executive Vice President of U.S. Operations. Jamie brings more than 30 years of extensive leadership experience in the pharmaceutical industry, with proven track record in launching major therapies and shaping commercial strategy. He joins us from UnitedHealth Group, where he served as the CEO of Optum Specialty Holdings, and brings deep expertise in U.S. market access and product lifecycle management. Beginning February fifteenth, Hong Chow will join Novo Nordisk as an Executive Vice President of Product and Portfolio Strategy.

Hong brings deep global leadership experience to Novo Nordisk, serving as the Executive Vice President and Head of China and International at Merck Healthcare, and leading their global cardiovascular, metabolism, and endocrine portfolio. Her leadership in advancing innovation, health equity, and large-scale products strategies at companies such as Merck, Roche, and Bayer, demonstrates her outstanding capability to drive our vision forward. We look forward to welcoming Jamie and Hong to Novo Nordisk this month, and both Dave and Ludo will help to ensure successful transition to their successors throughout the end of this quarter. I will now hand over to Ludo for an update on our commercial execution in 2025.

Ludovic Helfgott (EVP)

Thank you, Mike, and please turn to next slide. The global GLP-1 market grew over 30% in 2025. Novo Nordisk's total sales increased by 10%, as U.S. operations grew 8% and international operations grew 14%. Sales growth was positively impacted by one-offs in the U.S. Our GLP-1 sales in diabetes increased by 6%, driven by U.S. operations +5%, and international operations growing 7%. Insulin sales decreased by 1%. U.S. operations increased by 2%, positively impacted by positive channel and payer mix, and partially countered by a decline in volume. International operations decreased by 2%, impacted by market share losses. Obesity care sales increased 31% in 2025, driven by both operating units. U.S. operations grew 15%, and IO grew 73%. In both geographies, growth was driven by Wegovy.

Rare disease sales increased by 9%. This was driven by sales increase in the U.S. operations of 7% and in international operations of 10%. In both operating units, the sales increase was primarily driven by the rare endocrine disorder products, mainly due to Sogroya launch uptake. Next slide, please. Sales in international operations were driven by GLP-1 products in obesity and diabetes care. The GLP-1 volume growth in international operations was 44% in 2025, and Novo Nordisk remains the overall GLP-1 market leader with a 62% volume market share. GLP-1 diabetes sales increased by 7%, driven by the sales growth of Ozempic. In region China, GLP-1 diabetes sales decreased by 5%, which was negatively impacted by wholesaler inventory movements. Total obesity care sales grew up to DKK 31 billion in 2025.

Wegovy was launched in 35 new countries in 2025, more than tripling the number of launches back in 2024. Sales of Wegovy reached DKK 28 billion in 2025, growing 134%. We continue to see GLP-1 market growth in international operations. A large unmet need remains, and penetration rates are low. Looking into 2026, we plan to further expand the obesity and diabetes markets in IO through new online channels and partnerships, and by bringing new products to patients with the ongoing rollout of semaglutide 7.2 mg for weight loss and Ozempic 2 mg for diabetes in certain markets. And with that, I would like to thank my colleagues and the entire Novo Nordisk organization for a tremendous seven years.

It has been a privilege to work on impactful medicines that have already, and hopefully soon will, make it to the hands of patients. And now I will hand it over to Dave for an update on U.S. operations.

Dave Moore (EVP)

Thank you, Ludo. Next slide, please. Sales of GLP-1 diabetes care products in the U.S. increased by 5% in 2025. The sales increase was driven by continued uptake of Ozempic, partially countered by Victoza and Rybelsus. Ozempic sales in the U.S. were positively impacted by gross-to-net sales adjustments and GLP-1 diabetes market growth, partially countered by market share losses and lower realized prices. Weekly Ozempic prescriptions are currently around 610,000. The GLP-1 diabetes market grew just over 10% in the fourth quarter of 2025 compared to the fourth quarter of 2024. In the U.S., we continue to meet people with type two diabetes where they are, including through our self-pay offering for Ozempic, that is currently now around 8,000 prescriptions per week.

We also received FDA approval for the updated formulation of the Ozempic pill, formerly known as Rybelsus, and that happened last week. Next slide, please. As Mike noted earlier, 2025 ended with an exciting milestone for Novo Nordisk, and importantly, people living with obesity in the U.S.. The Wegovy pill was approved by FDA on December 22, and thanks to outstanding efforts across our entire organization, we were able to bring the first and best-in-class oral GLP-1 for weight management to the U.S. market on January 5. The Wegovy pill is the only GLP-1 peptide formulated into a pill, delivering the weight loss efficacy of injectable Wegovy in a once-daily oral tablet. When looking separately at the phase III trial data in obesity for the Wegovy pill and for orforglipron, the Wegovy pill shows around 35% greater reported weight loss.

We have seen encouraging early uptake of the Wegovy pill. Our compiled data shows that total prescriptions are around 50,000 for the week ending January 23rd, with around 45,000 of these prescriptions coming through self-pay. The uptake is over twice that of any prior anti-obesity drug launches in the United States. Though it is still early in the launch, most prescriptions appear to be for patients new to these medications, suggesting the market is expanding. The Wegovy pill is offered at over 70,000 retail pharmacies and through NovoCare Pharmacy and numerous telehealth partners. Commercial access for the Wegovy pill is progressing, with coverage currently via CVS, Prime, Optum, and Anthem, amounting to just below half the covered lives we have for injectable Wegovy.

We continue working to develop reimbursed access and broaden reach through more partnerships in order to provide people with obesity an oral therapeutic option with a competitive label of Wegovy and best-in-class weight loss. Next slide, please. Wegovy sales increased by 16% in U.S. operations in 2025. The Wegovy sales growth was driven by increased volumes, partially countered by lower realized prices. In the holiday week, ending January 23, Wegovy had around 230,000 weekly prescriptions. The recent decline in injectable Wegovy prescriptions at the start of 2026 is largely attributed to benefit changes at the turn of the year, including several states that are dropping Medicaid coverage of anti-obesity medicines. The combined injectable and pill Wegovy brand is currently now more than 75,000 weekly NBRXs, and that makes it the leading anti-obesity medication franchise measured by NBRX in the U.S.

In the last year, the branded anti-obesity market has more than doubled in size. U.S. operations has prioritized making our anti-obesity medications available to more people through multiple avenues to meet the outstanding unmet need. Novo Nordisk launched NovoCare Pharmacy in March 2025, and together with retail and telehealth, total self-pay now makes up around 30% of total injectable Wegovy prescriptions. In under one year, our increased efforts in the self-pay channel have resulted in close to 120,000 current weekly TRXs across Wegovy and Ozempic brands, and we continue to add more patients daily. Novo Nordisk will continue to invest in the expansion of the direct-to-patient initiatives, like the recently announced collaboration with Amazon Pharmacy. In November, we announced that Novo Nordisk entered an agreement with the U.S. administration, including coverage for obesity medicines in U.S. Medicare Part D via the CMMI pilot program.

We are encouraged that more patients will have affordable access to our medicines, and we anticipate that coverage will begin around the middle of the year. In addition to access, we remain focused on bringing innovation to the market. Novo Nordisk submitted the high-dose semaglutide, 7.2 mg, to FDA in November. It's under the CMPV pilot program, and we anticipate a decision during the first quarter of 2026. Furthermore, CagriSema has been submitted to the FDA in December, and we expect a decision towards the turn of the year. As my time at Novo Nordisk comes to an end, I'm excited about its future and proud of the positive impact I've witnessed on patients worldwide, and I look forward to seeing Novo Nordisk continue with this mission. Now I'll turn it over to Martin for an update on R&D.

Martin Holst Lange (EVP and Chief Scientific Officer)

Thank you, Dave. Please turn to the next slide. This week, we announced the top-line readout from REIMAGINE 2, a phase III trial for CagriSema and type 2 diabetes.

... The trial included around 2,700 people with type 2 diabetes, inadequately controlled with metformin, with or without an SGLT2 inhibitor. People were randomly assigned to receive either CagriSema 2.4 mg or 1 mg, semaglutide 2.4 mg or 1 mg, or cagrilintide 2.4 mg or placebo. The study assessed superiority of CagriSema versus semaglutide on A1c as the primary endpoint, with change in body weight as one of the secondary endpoints. Approximately 40% of all participants were using an SGLT2 inhibitor before initiating the trial. Please go to the next slide. In REIMAGINE 2, CagriSema 2.4 mg demonstrated superior A1c reduction and weight loss versus semaglutide 2.4 mg.

Assuming all people adhere to treatment, and from a mean A1c baseline of 8.2%, CagriSema 2.4 mg achieved a superior A1c reduction of 1.91 percentage points. This is compared to 1.76 percentage points with semaglutide 2.4 mg. In addition, CagriSema 2.4 mg achieved a superior weight loss reduction of 14.2%. More than 40% of the participants treated with CagriSema 2.4 mg achieved over 15% weight loss, and around one in four achieved over 20% weight loss. In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal, with the vast majority being mild to moderate and decreasing over time.

This data is in line with the recent top-line readout of REIMAGINE 3 with CagriSema as an add-on to basal insulin. In that study, people treated with CagriSema 2.4 mg achieved an A1c reduction of 2.33 percentage points and a weight loss of 12% at 40 weeks, all superior to placebo. Results from the pivotal REIMAGINE 1 trial are anticipated in the first quarter of 2026. In addition, we await the long-term safety and efficacy cardiovascular outcomes trial, REDEFINE 3. Following these results, Novo Nordisk will approach authorities to discuss the regulatory pathway for CagriSema in type 2 diabetes. In summary, CagriSema has demonstrated superior results in both glycemic control and weight reduction. These results represent a highly effective treatment option for individuals with type 2 diabetes, seeking weight management solutions in addition to glycemic control. Next slide, please.

In November, we announced positive headline results from the first evaluation of senagametide, formerly called amycretin, in people with type 2 diabetes. The trial investigated the efficacy, safety, and pharmacokinetics of once-weekly subcutaneous and once-daily oral senagametide compared to placebo. The trial included around 450 people with type 2 diabetes, inadequately controlled on metformin, with or without an SGLT2 inhibitor, a standard of care. About 40% of participants were using an SGLT2 inhibitor at baseline. The trial was a combined multi-ascending dose study, investigating six subcutaneous doses ranging from 0.4 mg to 40 mg, and three oral doses ranging from 6 mg, 25 mg to 50 mg.

From a mean baseline HbA1c of 7.8%, once-weekly senagametide lowered A1c by up to 1.8 percentage points at week 36 in a dose-dependent manner, assuming all people adhere to treatment. The proportion of people achieving A1c below 7% was up to 89.1%. Furthermore, people treated with oral senagametide achieved dose-dependent reductions of A1c of up to 1.5 percentage points by week 36 from a baseline of 8%. Almost 78% of people achieved an A1c level below 7%. The estimated improvements in A1c were all statistically significant versus placebo, confirming the primary endpoint on the trial. Both subcutaneous and oral senagametide appear to have a safe and well-tolerated profile, consistent with other incretin and amylin-based therapies.

The data further support the potential of senagametide as a next-generation treatment for type 2 diabetes, and we look forward to bringing it into an extensive phase III program called AMBITION in type 2 diabetes and other indications in the second half of 2026. In addition, the phase III obesity program, called AMAZE, will start in the first quarter of 2026. As a reminder, the phase Ib/IIa clinical trial with amycretin in people with obesity or overweight demonstrated a 22% weight loss with a 20 mg dose after 36 weeks of treatment. The AMBITION and the AMAZE programs will both investigate the subcutaneous maintenance dose up to 40 mg. Next slide, please. We have an exciting year ahead across therapy areas here at Novo Nordisk....

Beginning with diabetes, you just heard about the advances that we made with our late-stage internal assets, CagriSema and senagametide. We've also achieved progress through external innovation that we have done throughout the last three years. We expect phase II data from our in-licensed UBT251 asset, a GLP-1/GIP/glucagon triple agonist in a Chinese type 2 diabetes population in the first half of this year, with plans to initiate our own phase II study in type 2 diabetes in the second half of this year. Within the diabetes-associated comorbidities, the first readout of zsiltivekimab from the phase III trial is anticipated in the second half of this year. The trial is assessing 3-point MACE relative risk reduction on top of standard of care.

Ziltivekimab holds the potential to be a first-in-class treatment, targeting systemic inflammation in people living with atherosclerotic cardiovascular disease and chronic kidney disease. In obesity, we expect results from the REDEFINE 4 trial in the first quarter of this year, assessing weight loss efficacy compared to setmelanotide. The study's primary endpoint is percent change in body weight assessed for non-inferiority. We are assessing further CagriSema weight loss potential in the ongoing REDEFINE 11 trial, with the results expected early in 2027. A new phase III trial with CagriSema high dose is also planned to initiate later this year. For our triple agonist, we expect phase II data from our in-licensed UBT251 asset in a Chinese obese and overweight population in the first half of this year, and we have already initiated our own phase Ib study in obesity.

We would also like to highlight the first human dose trial with our internal triagonist, a GLP-1/GIP/amylin-targeted agonist that was completed in the third quarter of 2025. Single doses up to 1.5 mg and multiple weekly subcutaneous doses up to 1.2 mg-2.4 mg were tested. The primary endpoint was treatment emergent adverse events. The safety profile of the triagonist was consistent with GLP-1-based therapies. The percentage change in body weight from baseline ranged from -3.6% to 5.3% for the triagonist versus 0.5% for placebo at 4 weeks. The 4-week data confirm our belief in the potential for high weight loss efficacy with the triagonist. We recently initiated a phase Ib/II trial in obesity, with expected readout during the first half of 2027.

In addition, we have several ongoing submissions in obesity in the U.S. and globally. We anticipate the EU's decision on oral semaglutide 25 mg and injectable semaglutide 7.2 mg during the second half of this year. We also anticipate forthcoming decisions regarding semaglutide 7.2 mg, and later in the year, CagriSema in the U.S.. 2026 is an exciting year in rare disease as well. The phase III HIBISCUS readout for eztavopivat in sickle cell disease is expected in the second quarter of this year. Etavopivat has a novel mechanism of action, with the potential to improve both hemoglobin health and vaso-occlusive crisis event rates in people living with sickle cell disease. Finally, we are awaiting regulatory decision for Denecimig, previously known as Mim8.

Denecimig is a once monthly, once every two weeks, or once weekly prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in people with hemophilia A, with or without inhibitors. Regulatory decisions in the U.S. and the EU are expected in the second half of 2026. With that, over to you, Karsten.

Karsten Munk Knudsen (CFO)

Thank you, Martin. Please turn to the next slide. In 2025, our sales grew by 10% at constant exchange rates, driven by both operating units. In the U.S., sales growth was positively impacted by gross-to-net sales adjustments. The gross margin decreased to 81% compared to 84.7% in 2024. The decrease in gross margin is impacted by amortizations and depreciation related to the acquisition of the three Catalent manufacturing sites, as well as one-off restructuring costs related to the company-wide transformation we announced in the third quarter. Operating profit decreased by 1% in DKK and increased by 6% at constant exchange rates, reflecting higher sales and distribution costs tied to Wegovy promotional activities and launches, as well as increased early and early research and development stage investments.

The main impact on operating profits was, however, the company-wide restructuring costs of around DKK 8 billion. Excluding this, operating profit would have increased by 6% in Danish kroner and 13% at constant exchange rates. Please go to the next slide. In 2025, from a net profit of 102 billion Danish kroner, we generated close to 120 billion Danish kroner in cash from operating activities. Our deployment of capital followed our allocation principles, investing in the business with around DKK 60 billion going towards manufacturing capacity expansion through capital expenditure and around DKK 30 billion to expand the R&D pipeline through business development activities. We also returned around DKK 52 billion to shareholders in the form of dividends.

At the annual general meeting on March 26, 2026, the board of directors will propose a final dividend of DKK 7.95, for an expected total 2025 dividend of DKK 11.70, including the interim dividend paid out in August 2025. This is a 2.6% increase compared to last year, making it the thirtieth consecutive year with increasing dividend per share. Novo Nordisk will continue to deliver returns to shareholders in 2026, with total cash returns anticipated to be over DKK 60 billion. In addition, the board of directors has approved a new share repurchase program of up to DKK 15 billion to be executed during the next twelve months. Please turn to the next slide.

In 2026, sales and operating profit will be positively impacted by a reversal of sales rebate provisions of $4.2 billion, related to the 340B drug pricing program in the U.S.. In order to enhance transparency and comparability of underlying operating performance, Novo Nordisk will present outlook and expectations on adjusted sales and adjusted operating profit growth basis at constant exchange rates going forward. This is introduced to exclude certain exceptional and non-recurring effects, primarily of non-cash nature, including the provision, reversal. Adjusted operating profits will likewise exclude the impact of the 340B provision reversal, as well as other exceptional and non-recurring effects, related to effects such as major impairment losses and major legal matters.

For 2026, adjusted sales growth is expected to be -5% to -13% at constant exchange rates. Given the current exchange rate versus Danish kroner, growth reported in Danish kroner is expected to be 3 percentage points lower than at constant exchange rates. The outlook reflects expectations for sales growth within international operations and expectations for sales decline within U.S. operations. The global GLP-1 market expansion is assumed to continue in 2026, enabling Novo Nordisk to increase patient reach and expand volumes. However, this is countered by lower realized prices, including impacts from the most favored nations agreements in the U.S. and loss of exclusivity for the semaglutide molecule in certain markets in international operations. Lastly, positive impacts related to U.S. gross to net sales adjustments during 2025 are not anticipated to reoccur.

In international operations, the outlook is based on current growth trends, including continued volume penetration from GLP-1 treatments and market expansion, mainly within obesity, as well as intensifying competition and negative impacts from the patent expiry of semaglutide in certain markets. In U.S. operations, the outlook is based on current prescription trends for the injectable GLP-1 portfolio, intensifying competition, as well as negative impact from reduced anti-obesity medication coverage in Medicaid. Furthermore, lower realized prices linked to investments in market access are amplified by the MFN agreement with the U.S. administration. Uptake related to the launch of the Wegovy pill is reflected based on a range of assumptions related to market penetration, potential negative impact on the growth of the injectable anti-obesity medication category, as well as tirzepatide. Adjusted operating profit growth is expected to be -5% to -13% at constant exchange rates.

Given the current exchange rates versus the Danish kroner, reported operating profit growth in Danish kroner is expected to be around 5 percentage points lower than at constant exchange rates. The expectation for adjusted operating profit growth primarily reflects the sales growth outlook, combined with targeted investments in current and future growth opportunities within R&D and commercial. Other key modeling considerations for 2026 are shown on the slides. Of note, as of 2026, Novo Nordisk defines free cash flow as net cash generated from operating activities, less purchase of property, plant and equipment, and is expected to be DKK 35 billion-DKK 45 billion. Capital expenditure is expected to be around DKK 55 billion in 2026. In the coming years, the capital expenditure investments are expected to decline following expansion project finalizations. That covers the outlook for 2026.

Now back to you, Mike.

Maziar Doustdar (CEO)

Thank you, Carsten. Please turn to the next slide. Our 2025 strategic aspirations have run their course, and while we acknowledge 2025 presented significant challenges affecting our performance and share price, those adversaries have also made us more resilient. We have plenty of work left to do in order to meet the vast unmet needs for people living with diabetes, obesity, and their related comorbidities, as well as those with rare diseases, which we aim to treat in the future. We expect to introduce new strategic aspirations as part of Capital Markets Day, which will be held on September 21st in London.

... Until then, we will of course, continue to report and track progress across key dimensions of the business. With that, I will turn it back to you, Michael.

Michael Novod (Head of Investor Relations)

Thank you, Mike. Next slide, please. With that, we're now ready for the Q&A, where I 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.

Operator (participant)

Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now take the first question. Your first question today comes from the line of James Quigley from Goldman Sachs. Please go ahead.

James Quigley (Analyst)

Great, thank you for taking my question. I've got two, please. So firstly, just to try to triangulate your guidance, you're suggesting low single-digit growth in international operations, and again, that would still suggest -20, also in the U.S.. So could you give us a sense of how this breaks down between volumes and price at a high level, please? Particularly given that your key competitor suggested low-to-mid-teens pricing on a global basis this morning. And the second question: on the Medicare unlock, how are you thinking about the potential speed here? Again, your competitor suggests the unlock could be pretty fast, starting from July first. But your, but the guidance and the suggest slower uptake here. So what are the basis of your assumptions around the speed of unlock? Thank you.

Michael Novod (Head of Investor Relations)

Thank you, James. Two questions, both for Karsten.

Karsten Munk Knudsen (CFO)

Yeah. Thank you, James, and thank you for listening in and posing your question. As to the guidance first, with the international operations delivering 8% growth in the fourth quarter of last year and around 10% in the second half, that's the run rate we are entering in 2026. Then adjust for LOE in specific markets on Sema, then you get to mid-single digit growth for international. And consequently, based on our guidance, then the residual leaves the U.S. growth to be in the teens in terms of sales decline. So that's the key factors.

I would say the U.S. decline is driven by price declines, and it's driven by both investments in market access, being a key driver, build of the cash channel in the U.S. at a different price point, so channel mix, and then the MFN impact, where we, a few quarters ago or one quarter ago, announced that it will have a low single-digit impact on group sales, so meaning roughly double on U.S. So the key notion is, of course, with these price reductions, to what extent are we then able to convert that into expanding volume reach and volumes in the marketplace? It's early days. We have built assumptions in.

Clearly, we've looked at the first four weeks of the Wegovy pill launch, where we're very encouraged, as Dave showed just before. And the same on the Wegovy injectable. We're actually looking at to the tune of 30% of the Wegovy injectable scripts now being cash driven. So we are seeing a volume response to the lower prices. Exactly how the year pans out remains to be seen because we have a number of variables at play. But net-net, it is price declines that drive U.S. down.

On Medicare and impact from Medicare Part D and the MFN deal, we do expect that we'll have a benefit starting around mid this year, having Wegovy reimbursed in Medicare Part D, and hence being available for seniors under a reimbursed setting. We have included that in our guidance, but at this point, given the lag times of educating physicians and admin staff understanding how it works and for patients to access that benefit, it will be a gradual ramp with limited benefit this year and a bigger benefit into 2027.

James Quigley (Analyst)

Great. Thank you.

Operator (participant)

Thank you. Your next question today comes from the line of Sachin Jain from Bank of America. Please go ahead.

Hi there. Thanks for taking my questions. I've got two more on guidance, if I may ask, and apology. So maybe framing James's question slightly differently. I asked that pushes and pulls question at third quarter, and I... Not without misspeaking, but I think you roughly phrased it as underlying growth, less three sets of headwinds, or roughly low single digit each. So I'm just trying to understand between three Q and the guidance today, what shifted you from that sort of low single digit to now -5 to 13? So the mid to high single digit delta versus consensus, how much that is volume and price, and within price, what's the new component if it seems to be cash channel?

And then second, more specifically, a question I've had frequently overnight is, what needs to happen for you to achieve the bottom end of your guidance? Multiple investors trying to work out how conservative that is, particularly around your oral assumptions being driven by injectable switch. Thank you.

Michael Novod (Head of Investor Relations)

Thanks, Sachin. Also, two questions for Karsten on guidance and also on the sort of pushes and pulls between high and low.

Karsten Munk Knudsen (CFO)

Yeah, thanks for these questions, Sachin. And as you recall, I didn't guide for 2026 at our Q3 call. So that's the starting point. And as we also note in our current release, we base our guidance based on the latest trends we see in the market. So the guidance we put out now is based on, of course, the run rate we left 2025 with, so Q4 performance, as I alluded to before, and then whatever triggering events and expectations and assumptions around the future we are building in. So those are really the key points that we built in.

What do we know more today compared to Q3? We have some more nuances on the run rate in international operations. You see the 8% growth in the fourth quarter, and of course, some more market intel on more specific and detailed pricing and reimbursement choices in some of the markets there. And then in the U.S., what we know there beyond the Q4 closeout is really about, I would say, the Wegovy pill uptake in the first month, as Dave alluded to, which we're very happy with, and then the Wegovy injectable cash business and the response to the lowering of the initiation prices to $199.

So that's really kind of the key fundamental changes since three months ago.

Michael Novod (Head of Investor Relations)

Hi, hello.

Karsten Munk Knudsen (CFO)

Hi, hello. Yeah, thanks, Michael, for reminding me on that one. It's important to remember, and we've been experiencing this for, you know, some years now. The obesity market is just significantly more dynamic than most other markets, where it's much more stable prescription trends through normal GPs. So, the macro variable that is—can both be positive and negative is the dynamics in the obesity market. It's... We're not concerned about the expansion of the markets. We saw it more than double in 2025. So, we're very confident in continued expansion of the market space.

But the variables I'm alluding to is really, of course, as always, competitive dynamics, as always, gross to nets, dynamics that are being forecasted with a lag, and then also the sourcing dynamics and channel dynamics impacting pricing and volume of the Wegovy pill and how that is impacting both Wegovy injectable, but also how a competitive launch plays into all of this. So I'd say it's classic variables, but it's in a very dynamic market segment.

Michael Novod (Head of Investor Relations)

Thanks, Karsten. Thanks for that. Next question, please.

Operator (participant)

Thank you. Your next question comes from the line of Richard Vosser from JPMorgan. Please go ahead.

Richard Vosser (Analyst)

Hi. Thanks for taking my question. Just one follow-up, thinking about formulary access for Wegovy. You highlighted the access for oral Wegovy in a pill, but are you seeing, and how you're thinking about that access in the commercial channel this year? Seems like maybe employers would be incentivized to maybe reduce access, given the availability of products in the cash channel at lower prices. So just thoughts on that and how that might affect the mix, and volumes in that channel. And maybe a second question, just compounder volume. Obviously, a very strong oral launch, and you're saying new patients, but any evidence that those lower prices are stymieing the compounder volume, and any idea that you're taking share using the oral from compounders? Thanks very much.

Michael Novod (Head of Investor Relations)

Great. Thanks, Richard. So two questions for Dave, one on the formulary access and also the other one on compounder.

Dave Moore (EVP)

Yeah. Thanks very much, Richard. On the injectable side, we see relatively stable access. Of course, we have discussions every year to maintain that level of access. And as you've heard us talk about before, we're very interested in reducing that friction and making the experience easier for patients. We did have some states that have decided to not cover AOMs, for example, California is a big one. But I will say that with the lower prices that are available today, we will continue to reengage with those states, with the hopes that we can increase access in Medicaid as well. On the pill side, what you heard me mention is, we've actually seen some positive progress in just the first month.

We started out the month of January having CVS covering it right out of the gate, and then we quickly were able to add Prime, Optum, and Anthem, and we will continue to build that over the course of the year. You know, expecting, that, that there will be, both plans, as well as employers that will be interested in covering the pill. On your second question about compounding, we haven't seen a change yet. It's early days. The compounding market, what we're seeing right now is what we would consider relatively stable. I can tell you, you know, as of this week, we have over 170,000 people that are on the Wegovy pill, and most of that is self-pay. And we get daily feeds because of the way that we went to market.

... And so we certainly expect that there could be some switching that's coming from compounding, but it's a little bit early to tell, and we don't get any of that longitudinal data, but we'll certainly be researching that as more data comes in.

Michael Novod (Head of Investor Relations)

Thank you very much, Dave. Thank you, Richard. Next question, please.

Operator (participant)

Thank you. Your next question comes from the line of Peter Verdult from BNP Paribas. Please go ahead.

Peter Verdult (Analyst)

Yeah, thank you, Peter, BNP. Two questions. Just firstly on Martin, I realize you're not gonna change the messaging on REDEFINE 4 at this juncture, but can you at least remind us on trial design, was flexible dosing allowed, as we saw in REDEFINE 1, or was it more fixed in nature for CagriSema in REDEFINE 4? Basically, any major trial differences we need to be aware of when we compare REDEFINE 4 to 1. And then, Carsten, Mike, forgive me, going back to guidance, but I'm not gonna ask you to go line by line, every assumption, but just the spirit of the guidance you've provided.

I mean, is this reflecting sort of genuine concerns on cannibalization and competition, or are you simply starting the year as conservatively as you can to finally prevent, you know, this persistent earnings downgrade story from continuing through 2026? Thank you.

Michael Novod (Head of Investor Relations)

Thank you, Pete. So, two questions. First to Martin on REDEFINE 4, and then second to Mike on high-level guidance dynamics.

Martin Holst Lange (EVP and Chief Scientific Officer)

Absolutely. So, REDEFINE 1, you're absolutely right. We basically have no new news, so we're not gonna change the story. REDEFINE 4 is comparing CagriSema and tirzepatide in an obese population on weight loss, testing for non-inferiority first, followed by superiority testing. The dosing was similar to REDEFINE 1. As you recall, we took some learnings from REDEFINE 1, including that we needed to do longer studies. And I think we maintain what we've always said for REDEFINE 4, but we also are looking forward to REDEFINE 11, where we'll see the full weight loss potential of CagriSema.

Maziar Doustdar (CEO)

Very good. So Peter, I think, I'll start by saying we have all acknowledged how volatile and dynamic the obesity market is with a lot of and lots of moving parts. The way we guide is we discuss and talk, of course, to our operating units. We take a look at the macro trends, and we put the latest information we have in place. We start by looking at the last year's finish and the run rate to that, especially Q4, but even more so, granularly looking at the three months within the Q4, data that we have available. So that's kind of a starting point. Then we basically go ahead and try to see the new data we have available. Carsten alluded to it. We have four weeks of pill data.

It's incredibly encouraging, and we consider that, and it's in the guidance, basically. Of course, not fully knowing what's going to happen the next 11 months, but we make some good assumptions around that. Then there are things that we have actually previously discussed with all of you. Think about the LOE in international operations. That hasn't really changed. It was there before, it is now. We have not seen the impact of that yet. It will come into place starting from Q2, and so will some of the other things on the upside that will come in in Q2. We just touched upon it, Medicare. Medicare is a group of people that we would love to provide GLP-1 products to, but we haven't started yet, and it's going to basically get going in the second part of the year. So we make, again, assumptions around that.

We put the midpoint and our own targets, and then we give it the plus and minus the four points on each side, and that's how we've done it in the past. That's how we've done it this year.

Michael Novod (Head of Investor Relations)

Great. Thanks, Mike. Thanks, Martin, and thanks, Pete. Next question, please.

Operator (participant)

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

Mike Nedelcovych (Analyst)

Hi. Thanks so much. I have two questions. My first is on Wegovy pill supply. Given the strong launch of Wegovy pill, is there any risk of supply outages in 2026? For example, if adoption persists at this current high level, could Novo service that demand through the end of the year with its current capacity? And then my second question is on CagriSema and REDEFINE 4. Martin, I have to admit, your response to the earlier question struck me as somewhat ominous. Why do you think we will have to wait for REDEFINE 11 readout to see the full weight loss potential of CagriSema? Why could it not be revealed by REDEFINE 4, given the changes that were made to the trial? Thank you.

Michael Novod (Head of Investor Relations)

Thank you very much. Two questions. First to Mike on the Wegovy supply, or Wegovy pill supply, and the second one to Martin on both REDEFINE 4 and REDEFINE 11.

Maziar Doustdar (CEO)

Yeah. Thanks very much, Mike. Over the last period, a number of occasions, I have spoken to how confident we are with regards to the Wegovy pill supply. We basically have said that we launched the pill in the U.S. at a time where we will be confident enough to know we will not run into a supply situation anymore. We have seen an incredible uptake, I would say, in the first month, and today I will reaffirm to you that we feel incredibly confident that we will be able to supply the U.S. market.

Michael Novod (Head of Investor Relations)

Very clear.

Martin Holst Lange (EVP and Chief Scientific Officer)

... Yeah, on REDEFINE 4, we always have to think about when we do amendments to ongoing trials, we cannot fully guide what will happen. We can extend the study, but we also had to acknowledge that the learnings that we took from REDEFINE 1 was in part, we needed to do longer treatment duration. But it was actually also paradoxically in part to drive even more flexible dosing, securing that we actually get more patients to the highest target, but using longer time. That we cannot change in REDEFINE 4. We have optimized that in REDEFINE 11. So the trial duration, we have tried to optimize in REDEFINE 4, but in REDEFINE 11, we've taken all the learnings on titration, what we call flexible titration.

I'm not sure I still like the word, but what we call flexible titration, and put that to use in REDEFINE 11, and we can already now see that that does really make a difference to the patients and how they act in the trial. So I still have a lot of optimism on REDEFINE 4, but I think the full weight loss potential we will only learn when we do the full trial duration and the flexible dosing that really will drive patients to use CagriSema in the optimized way.

Michael Novod (Head of Investor Relations)

Great. Thank you, Martin. Thanks, Mike. Over to the next question, please.

Operator (participant)

Thank you. Your next question comes from the line of Harry Sephton from UBS. Please go ahead.

Harry Sephton (Analyst)

Brilliant. Thanks very much for taking my questions. I have two on the Wegovy pill, please. Just want to start with what your expectations are for the sustainability of the Wegovy pill demand. If you wouldn't mind, is there any evidence from, Novo's Rybelsus experience that points to, any variation in the stay time on therapy versus the injectable? And how do you think about also the demand for the pill through the competitor orforglipron launch? And then my second question is on the economics of the Wegovy pill. So given the much lower price point and the much higher API demand, how does the gross margin contribution of the Wegovy pill compare to the injectable? Thank you very much.

Michael Novod (Head of Investor Relations)

Thank you very much, Harry. Two questions. The first one on the Wegovy pill demand and dosing to Mike, and then the second one around economics to Karsten.

Maziar Doustdar (CEO)

Thanks very much. When you think about the sustainability of a growth and demand, then two things comes to my mind. One, of course, competitive pressure, as well as how much you push yourself into doing something despite the competitors. Let me start with the first one. We have gone all in. This has been the best launch, partially also because we have really put in all the activities and the promotions that we could think of, not least, of course, what it was alluded to earlier on, the partnership with all of our e-health players being available in 70,000 retail pharmacies today, has been partially due to that, has been partially the reason behind that incredible uptake. But then, of course, the question comes: What happens after competition arrives? Can you uphold this? Is it sustainable?

I would say that the last two years has taught us something very specific with the obesity market. It has taught us that the number one criteria for a patient picking up anti-obesity medication is the magnitude of weight loss. And when you take a look at this, then you realize, based on our latest trial, we have shown that when you take the drug, then Wegovy pill gives you 16.6% weight loss, in addition to all the CV benefits and the great stuff that it has, but 16.6% weight loss. We've also read the data from our competing product, and and we have seen that they are at 12.4%. If you round those things up, then you get to 17% and 12%.

If you ask pretty much any patient, and certainly ask me, which one would you rather take, losing 17% weight loss or 12? I know my answer, and we have seen the answer from 170,000 employees coming on very quickly, recognizing that this is not just a pill, it's a peptide. It's a large protein inside a pill that gives you that incredible efficacy. And that has been giving us a lot of optimism, and we will continue, of course, pushing this through and promoting it. Don't be surprised if you've seen the big game on Sunday, you see us visible, and we will basically make sure that we'll do our utmost to make this pill a success.

Michael Novod (Head of Investor Relations)

Thanks, Mike and Karsten?

Martin Holst Lange (EVP and Chief Scientific Officer)

Yeah. Thanks, Harry, for the manufacturing economics question. On gross margin, the short version is that the gross margin on the Wegovy pill is below that of the Wegovy injectable, but it's important to know that it's lower on gross margin level, but it's still an attractive gross margin. So, we are all in pushing the pill, and of course, the overarching intention is to expand the markets and not cannibalize from our own products.

Michael Novod (Head of Investor Relations)

... Thank you very much, Karsten. Thanks, Harry. Next question, please.

Operator (participant)

Thank you. Your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead.

Thibault Boutherin (Analyst)

Thank you very much. First question, just on Ozempic and the timing of implementation of the MFN price. When does the MFN negotiated price kick in for Medicare and Medicaid this year? And is there any associated volume uplift, given it's already covered, or should we expect market share loss to sort of erase the benefit? And then just the second question, I guess for Martin on the profile of Wegovy pill. Just in order to understand the adherence, could you help us with what happened to a patient if they missed a pill for a day or a couple of day? How does that impact efficacy in terms of weight loss?

And then, you know, similarly on tolerability, if a patient is in the highest dose and for some reason missed a few days of pill, can they go back and resume on 25 milligram? And what do side effects look like? Thank you.

Michael Novod (Head of Investor Relations)

Okay, two questions. First, on Ozempic and MFN, for you, Dave, and then the second question for you, Martin.

Dave Moore (EVP)

Yeah, thank you, Thibault. With respect to Ozempic, as you know, we have Medicare coverage right now in the diabetes. And so, with respect to MFN as well as MFP, that's more of a 2027 event. Of course, you know, we did make Ozempic available in self-pay. As I mentioned, we're seeing about 8,000 scripts a week now in self-pay for those patients that don't have coverage. But the MFN and MFP is more of a 2027 event.

Martin Holst Lange (EVP and Chief Scientific Officer)

Thanks, Dave.

Yeah, absolutely. On the Wegovy pill, we do know that in general, when patients are on chronic treatment, sometimes they skip a dose. It is important to remind ourselves that semaglutide is semaglutide, and the half-life of semaglutide, once in steady state, is very long. Basically, as you know, also in the subcutaneous state, allowing for once-weekly doses. That basically means that when you are on a stable dose on the Wegovy pill, and then you skip a dose, it doesn't have a huge impact on your blood exposure, in that period of time, and you can also then reinitiate at the 25 mg dose without experiencing any untoward effects.

So from that perspective, semaglutide is semaglutide, and we are benefiting from the long half-life of semaglutide, also in the oral delivery. Other orals would have, with shorter half-life, a much different profile because that would both impact the potential efficacy but also the potential tolerability, if you skip one or two doses.

Michael Novod (Head of Investor Relations)

Great. Thank you very much, Martin. Operator, next question. We'll do two more questions.

Operator (participant)

Thank you. Your next question comes from the line of Carsten Lønborg Madsen from Danske Bank. Please go ahead.

Carsten Lønborg Madsen (Analyst)

Thank you very much. In terms of CapEx, where again, this year guide for a relatively high CapEx level in terms of DKK billions being spent, can you confirm that the API build-out is on track? Because it feels like this entire program is taking longer and is being much more expensive than what we expected some years ago. And secondly, on the high doses Wegovy approval, which we hopefully see soon, also, will you be launching immediately? Can you confirm that? And in which type of pen will you be launching?

Michael Novod (Head of Investor Relations)

Great. Thank you, Carsten. The first on CapEx to Karsten, and then the second question on 7.2 to Mike.

Karsten Munk Knudsen (CFO)

Yes, thank you for that question, Carsten. And, as I said, earlier on, then, we are moving downwards in terms of CapEx. This is the first step down, and then we expect to see a steeper slope in the coming years. And it really links to finalization of projects approved in prior years. As it is with projects, some are ahead, some are behind, but in the broad scheme, we are on track. Specifically for API, we do expect to have, you know, some of the new major API facilities online already this year and more to come in the coming years.

Michael Novod (Head of Investor Relations)

Thank you, Karsten.

Maziar Doustdar (CEO)

Carsten, with regards to the 7.2 Wegovy high dose, then, as you know, we have filed in December last year under the CMPV voucher program. And we have announced that we should expect the approval, hopefully, in this quarter. As soon as we get the approval, we are ready to launch, so we will not sit on that regulatory approval. And we will go all in again, because I think this is really, really important that the world little bit understands that medicine is dosed differently, and depending on how you dose things, you get different effect of it. And right now, semaglutide at 2.4 mg is giving us 15%-16% weight loss. Tirzepatide at 15 mg dosing gives you 20%-21%.

We have shown in a step up that when you increase the dose of Sema to 7.2, you get very close on par with tirzepatide, and I think it's actually very important that the world gets to know this, and then they can judge that on top of on par weight loss, you have also CV benefits, kidney benefits and liver benefits, and then people can pick and choose which option they want. So it's very important that we go all in with that, and we're planning to do so. And we will actually, I think there was a question, and we will launch it in the same type of devices that we currently have available to start with.

Michael Novod (Head of Investor Relations)

Great. Thank you, Mike. Thanks, Karsten. The last question, operator, please.

Operator (participant)

Thank you. Your final question for today comes from the line of Simon Baker from Rothschild & Co. Please go ahead.

Simon Baker (Analyst)

Thank you for squeezing me in. Two quick questions, if I may. The first one really is just going back to the guidance question that's been repeatedly asked. Conceptually, would it be fair to say that because you have high visibility on pricing impact and low visibility on volume uplift, that is one of the key things that is reflected in your guidance? And there's sort of second part that's related to that. I just wonder if you could update us on your assumptions for generic competition in IO, specifically Canada. The reason I ask is we understand that all of the semaglutide generics have had Notices of Deficiency slapped on them by Health Canada, and the expectation is they will not resolve until the mid-year. So generic semaglutide in Canada is a 2H rather than a 1H phenomenon.

I'd be interested to get your thoughts on that and the extent, if any, to which that's reflected in the guidance. Thanks so much.

Michael Novod (Head of Investor Relations)

Great. Thank you very much. Two questions, more or less boiled down to one on the guidance dynamics again. Karsten?

Karsten Munk Knudsen (CFO)

Yeah. So Simon, thanks for these questions. How we detail build it, I would say for mature reimbursed brands, I think they're very mature, established trend lines for volume trends measured as TRX. And we have a good feeling for the prices being contracted, et cetera. So for our mature reimbursed brands, that's. I would say that's reasonably straightforward. For us where we see the uncertainty is, how can I put it? In the self-pay type channel, because the price elasticity in the self-pay channel is something that we're still exploring. And as Dave was covering before, then we've seen a fantastic uptake of the Wegovy pill here the first four weeks.

But we also know that obesity self-pay is a super dynamic segment. So exactly how that works across the year, you know, to what extent there are seasonalities, et cetera, stay time, sourcing, cannibalization, competition, clearly the uncertainty is there. And we put our best assumptions in, and they, you know, it can go both ways. You know, we can both have an upside and a downside, and that's why we work with a range. For Canada specifically, and in our guidance, as we said, in prior quarters, that Sema LOE in international markets will impact group sales by low single digits.

Canada is the biggest contributor, and of course, we put in assumptions around the timing of generic launches, approvals and launches. We don't have detailed insights into the status of those files and regulation of these notices of deficiencies. But obviously, you know, the time is the key variable in terms of impact. I think the direction of travel is the same, but there could be both an upside and a downside to our guidance, depending on the pace of approval of generics in Canada. So remains to be seen.

Michael Novod (Head of Investor Relations)

Great. Thank you, Karsten. Thank you, Simon. This also concludes the Q&A session. Thank you for participating, and please feel free to contact Investor Relations regarding any follow-up questions you might have. Before we close the call, I would like to hand over to you, Mike, again, for the final remarks.

Maziar Doustdar (CEO)

Thank you very much, Michael. I want to start by thanking Ludovic and Dave for all you have done for Novo Nordisk over the many, many years. I also want, once again, to welcome Jamie and Hong, and stress that I'm looking very much forward to working with both of you. 2026 will be basically a year where we will face some headwinds, especially on the back of the price declines, and we have shown that in our guidance today. But I also like to say that price reduction, in some ways, is our investment for the future and for capturing more patients. Perhaps no other company better than Novo Nordisk is geared in improving health at scale within the field of diabetes and obesity, and we're ready to do that.

I believe much stronger than with affordable prices, we can get to those higher volumes faster. We are looking very much forward, of course, as we go forward, to share more information with you, not least about the continuous uptake of the phenomenal Wegovy pill success that we have seen, but maybe also much more exciting readouts and regulatory milestones throughout the year across all of our therapy areas. With that, I'd like to thank all of you guys for joining us today. Thank you.

Operator (participant)

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