Novo Nordisk A/S Q4 2025 earnings conference call
Key Takeaways (AI-Generated)
Financial Performance
- Sales grew 10% in 2025 with operating profit growth of 6% at constant exchange rates
- Gross margin decreased to 81% from 84.7% in 2024, impacted by acquisition and restructuring costs
- Generated close to 120 billion DKK in cash from operating activities from net profit of 102 billion DKK
- Obesity care sales increased 31% to 82 billion DKK, up from 6 billion DKK in 2019
Business Highlights
- FDA approved Wegovy pill on December 22nd, launched January 5th with 50,000 prescriptions in first week
- Treating nearly 46 million people with innovative medicines, up 16 million since 2019
- Wegovy launched in 35 new countries in 2025, more than tripling launches from 2024
- Phase 3 Cagrisema trial showed superior A1C reduction and 14.2% weight loss
Financial Guidance
- 2026 adjusted sales growth expected -5% to -13% at constant exchange rates
- Adjusted operating profit growth expected -5% to -13% at constant exchange rates
- Free cash flow expected 35-45 billion DKK in 2026
- Capital expenditure expected around 55 billion DKK in 2026, declining in coming years
Opportunities
- Medicare Part D coverage for obesity medicines starting mid-2026 expands market access
- Multiple pipeline readouts expected: Redefine 4 (Q1 2026), Sushi trial (H2 2026)
- Self-pay channels now represent 30% of Wegovy prescriptions, improving operational efficiency
- Strategic partnerships including Amazon Pharmacy collaboration and telehealth partnerships
Risks
- Intensifying competitive landscape and generic semaglutide launches in certain international markets
- Pricing headwinds including MFN agreements and reduced Medicaid coverage in several US states
- Potential supply constraints if Wegovy pill adoption exceeds current capacity assumptions
Full Transcript (AI-Generated)
Operator
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 the 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 *1 and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press *1 and one again. Please be advised that today's conference is being recorded.
I would now like to turn the over to your first speaker today, Michael Novart, Head of Investor Relations. Please go ahead.
Michael Novart
Thank you very much and welcome to this Novo Nordisk earnings call for the full year of 2025. My name is Michael Novart. I'm the Head of Investor Relations at Novo Nordisk. With me today I have CEO of Novo Nordisk Mike Duston, EVP Product and Portfolio Strategy Ludwig Healthscott, EVP, US Operations, Dave Moore, EVP Research and Development and Chief Scientific Officer Martin Hutzlanger and Chief Financial Officer Karsten Mcnusen. 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 2025 and the slides prepared for this presentation. With that, over to you Mike for an update on our strategic aspirations.
Mike Duston
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 therapeutical 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 six billion DKK in 2019 to 82 billion DKK in 2025.
Rare disease is now positioned for sustained growth with the late stage pipeline assets MIME 8 now called Denismic and Italo Pivas. Furthermore 300 billion Danish crowns 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 two readout of Senaganside and phase three 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 US. 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 meaning 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 US as the Executive Vice President of the US 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 three Catalan manufacturing sites, to overseeing the launch of the Wegovy pill in the US. In addition, Ludovic Healthscott 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 the thoughtful selection process over the last few months, I'm very pleased to announce the addition of Jamie Miller and Hong Chou to Novo Nordisk and the Executive management team. Next slide please.
Starting February 5th, Jamie Miller joins Novo Nordisk as an Executive Vice President of US 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 United Health Group where he served as the CEO of Optum Specialty Holding and brings deep expertise in U.S. market access and product life cycle management.
Beginning February 15th, Peng Chao will join Novo Nordisk as an executive vice president of product and portfolio strategy. Peng 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 Peng 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.
Ludwig Healthscott
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 US operations grew 8% and international operations grew 14%. Sales growth was positively impacted by one off in the US. Our GLP-1 sales in diabetes increased by 6%, driven by US operations plus 5% and international operations growing 7%.
Insulin sales decreased by 1%. US 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. US 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 US 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 percent, 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 to 31 billion Danish Kroner 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 28 billion Danish krone in 25, 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 26, we plan to further expand the obesity and diabetes markets in IO through new online channels and partnerships and by bringing in new products to patients with the ongoing rollout of Semaglutide 7.2 milligram for weight loss and Ozempic 2 milligram for diabetes in certain markets.
And with that, I would like to thank my colleagues and the entire Novo Nordisk organization for a tremendous 7 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 US operations.
Dave Moore
Thank you, Ludo. Next slide, please. Sales of GLP-1 diabetes Care products in the US 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 US 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 US. We continue to meet people with Type 2 diabetes where they are including through our self pay offering for Ozempic that is currently now around 8000 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 US. The Wegovy pill was approved by FDA on December 22nd and thanks to outstanding efforts across our entire organization, we were able to bring the 1st and best in class oral GLP-1 for weight management to the US market on January 5th.
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 three 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 Novo Care 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 options with a competitive label of Wegovy and best in class weight loss. Next slide, please.
Wegovy sales increased by 16% in US operations in 2025. The Wegovy sales growth was driven by increased volumes partially countered by lower realized prices. In the week ending January 23rd, 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 have dropped Medicaid coverage of anti obesity medicines.
The combined injectable and Pill Wegovy brand is currently now more than 275,000 weekly NBRXs and that makes it the leading anti obesity medication franchise measured by NBRX in the US. In the last year, the branded anti obesity market has more than doubled in size.
US Operations has prioritized making our anti obesity medications available to more people through multiple avenues to meet the outstanding unmet need. Novo Nordisk launched Novo Care 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 paid 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 US administration including coverage for obesity medicines in US Medicare Part D via the CMS 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 of semaglutide 7.2 milligram to FDA in November. It's under the CNPV 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. And now I'll turn it over to Martin for an update on R&D.
Martin Hutzlanger
Thank you, Dave. Please turn to the next slide. This week we announced the top line readout from Reimagine 2, a phase three trial for Cagrisema in Type 2 diabetes. The trial included around 2700 people with type 2 diabetes inadequately controlled with metformin, with or without an SGLT-2 inhibitor. People were randomly assigned to receive Cagrisema 2.4 milligram or 1 milligram, semaglutide 2.4 milligram or 1 milligram, or Cagrisema 2.4 milligram or placebo.
The study assessed superiority of Cagrisema versus semaglutide A1C as the primary endpoint with change in body weight as one of the secondary endpoints. Approximately 40% of all participants were using an SGLT-2 inhibitor before initiating the trial. Next slide.
In Reimagine 2, Cagrisema 2.4 milligram demonstrated superior A1C reduction and weight loss versus semaglutide 2.4 milligram assuming all people adhere to treatment. From a mean A1C baseline of 8.2%, Cagrisema 2.4 milligram achieved a superior A1C reduction of 1.91 percentage points. This is compared to 1.76% for semaglutide 2.4 milligram.
In addition, Cagrisema 2.4 milligram achieved a superior weight loss reduction of 14.2%. More than 40% of the participants treated with Cagrisema 2.4 milligram 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 for Cagrisema 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 milligram 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 One trial are anticipated in the first quarter 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 Senaganside, formerly called Amicretin in people with type 2 diabetes. The trial investigated the efficacy, safety and pharmacokinetics of once weekly subcutaneous and once daily oral Senaganside compared to placebo. The trial included around 450 people with type 2 diabetes inadequately controlled on metformin with or without an SGLT-2 inhibitor as standard of care. About 40% of participants were using an SGLT-2 inhibitor at baseline.
The trial was a combined multi ascending dose study investigating 6 subcutaneous doses ranging from 0.4 milligram to 40 milligram and 3 oral doses ranging from 6 milligram, 25 milligram to 50 milligram. From a baseline HbA1c of 7.8% once weekly Senaganside 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 Senaganside achieved dose dependent reductions of A1C up to 1.5 percentage points by week 36 from a baseline of 8%, with almost 78% of people achieving an A1C level below 7%. The improvements in A1C were all statistically significant versus placebo confirming the primary endpoint of the trials.
Both subcutaneous and oral Senaganside appear to have a safe and well tolerated profile consistent with other incretin and amylin based therapies. The data further support the potential of Senaganside as the next generation treatment for type 2 diabetes and we look forward to bringing it into an extensive phase three program called Ambition in Type 2 diabetes and other indications in the second-half of 2026.
In addition, the phase three obesity program called Amaze will start in the first quarter of 2026. As a reminder, the Phase 1B/2 weight clinical trials with Amicretin in people with obesity or overweight demonstrated 22% weight loss with a 20 milligram dose after 36 weeks of treatment. The Ambition and Amaze programs will both investigate the subcutaneous maintenance dose of 20 milligrams. Next slide, please.
We have an exciting year ahead across all therapy areas here at Novo Nordisk, beginning with diabetes. You just heard about the advances that we made with our late stage assets Cagrisema and Senaganside. We've also achieved progress through external innovation that we have done throughout the last three years. We expect phase two data from our in licensed UPT 251 acid, a GLP-1 GIP Glucagon triagonist in a Chinese type 2 diabetes population in the first half of this year with plans to initiate our own phase two study in Type 2 diabetes in the second-half of this year.
Within the diabetes associated complications, the first readout of Selnoflibagon from the Sushi phase three trial is expected in the second-half of this year. The trial is assessing 3 point MACE relative risk reduction on top of standard of care. It has 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 semaglutide. 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 and a new phase three trial with Cagrisema high dose is also planned to initiate later this year.
For our triagonists, we expect phase two data from our in licensed UPT 251 acid in a Chinese obese and overweight population in the first half of this year and we've already initiated our own Phase 1B/2 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 milligram and multiple weekly subcutaneous doses up to 1.2 milligram were tested. The primary endpoint was treatment emerging adverse events. The safety profile of the triagonist was consistent with incretin 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 four week data confirm our belief in the potential for high weight loss efficacy with the triagonist. We recently initiated a Phase 1B/2 trial in Obesity with expected readout during the first half of 2027. In addition, we have several ongoing submissions in obesity in the US and globally. We anticipate the EU's decision on oral semaglutide 25 milligram and injectable semaglutide 7.2 milligram during the second-half of this year.
We also anticipate forthcoming decision regarding semaglutide 7.2 milligram and later in the year Cagrisema in the US. 2026 is an exciting year in rare disease as well. The phase three Hibiscus readout for Eteplirsen preventing Sickle Cell Disease is expected in the second quarter of this year. Eteplirsen has a novel mechanism of action with the potential to improve both hemoglobin levels and vaso occlusive crisis event rates in people living with sickle cell disease.
Finally, we are awaiting regulatory decision for Denismic. Previously known as Mim8, Denismic 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 haemophilia with or without inhibitors. Regulatory decisions in the US and the EU is expected in the second-half of 2026. With that, over to you Karsten.
Karsten Mcnusen
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 US 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 amortization and depreciation related to the acquisition of the three Catalan 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 Danish Kroner and increased by 6% at constant exchange rates, reflecting higher sales and distribution costs tied to the GLP-1 promotional activities and launches as well as increased early research and development investments. The main impact on operating profits was however, the company wide restructuring costs of around 8 billion Danish kroner. 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 60 billion DKK going towards manufacturing capacity expansion through capital expenditure and around 30 billion DKK to expand the R&D pipeline through business development activities. We also returned around 52 billion DKK 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 7 kroner and 95 øre for an expected total 2025 dividend of 11 kroner and 70 øre including the interim dividend paid out in August 25. This is a 2.6% increase compared to last year, making it the 30th consecutive year with increasing dividend per share.
Novo will continue to deliver returns to shareholders in 2026 with total cash returns anticipated to be over 60 billion DKK. In addition, the Board of Directors has approved a new share repurchase program of up to 15 billion DKK to be executed during the next 12 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 U.S. Dollars related to 340B drug pricing program in the US. In order to enhance transparency and comparability of underlying operating performance we 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 krona, growth reported in Danish krona 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 US operations.
The global GLP-1 market expansion is assumed to continue in 2026 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 US and loss of exclusivity for semaglutide in certain markets in international operations. Lastly, positive impacts related to US 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 US 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 US 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 channel mix. 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 slide. As of 2026, Novo Nordisk defines free cash flow as net cash generated from operating activities less purchase of property, plants and equipment and is expected to be 35 to 45 billion Danish kroner.
Capital expenditure is expected to be around 55 billion Danish kroner in 2026. In the coming years, the capital expenditure investments are expected to decline following expansion project finalisations. That covers the outlook for 2026. Now back to you, Mike.
Mike Duston
Thank you, Karsten. 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 adversities 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 treat and aim to treat in the future.
We expect to introduce new strategic aspirations as part of Capital Market 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 Novart
Thank you, Mike. Next slide please. With that, we're now ready for the Q&A. We kindly ask all participants to limit themselves to one or maximum 2 questions, including sub questions. Operator, we're now ready to take the first question.
Operator
Thank you. To ask a question, you will need to press *1 and one on your telephone and wait for your name to be announced. To withdraw your question, please press *1 and one again. We will now take the first question. And your first question today comes from the line of James Quigley from Goldman Sachs. Please go ahead.
James Quigley
Great, thanks for taking my question. I've got two please. So firstly, just trying to understand your guidance. You're suggesting low single digit growth in international operations and that would suggest minus 20% also in the US. 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 competitors suggested 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 competitors suggest the unlock can be pretty fast starting from July 1st, but the guidance suggests slower uptake here. So what are the basis of your assumptions around the speed of unlock? Thank you.
Karsten Mcnusen
Thank you, James. Two questions both for Karsten. Yeah, thank you, James and thank you for listening in and posting 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're entering 2026. Then adjust for LOE in specific markets on semaglutide, then you get to mid single digit growth for international and consequently based on our guidance then the residual leaves the US growth to be in the teens in terms of sales decline.
So that's the key factors. I would say the US decline is driven by price declines and it's driven by both investments in market access being a key driver and the cash channel in the US at a different price point. So channel mix. And then the MFN impact where we a few quarters ago announced that it will have a low single digit impact on group sales, so meaning roughly double on US.
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 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 it is price declines that drive US down on Medicare and impact from Medicare party and the MFN field. We do expect that we'll have benefits starting around mid this year having Wegovy reimbursed in Medicare party and hence being available for seniors under reimbursed setting.
We have included that in our guidance, but at this point given the lag times of educating physicians and 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
Great, thank you.
Operator
Thank you. Your next question today comes from the line of Sachin Jain from Bank of America. Please go ahead.
Sachin Jain
Hi there, thanks for my questions. I've got two more on guidance, if I may Karsten, apologies. So maybe framing James's question slightly differently, I asked that pushes and pulls question at third quarter and I think you roughly phrased as underlying growth less three sets of headwinds roughly low single digit. So I'm just trying to understand between 3Q 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 components? It seems to be cash channel.
And then second, more specifically, a question of how 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.
Karsten Mcnusen
Thanks, Sachin. Also two questions for Karsten on guidance and also on the sort of pushes and pulls between high and low. 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 build in. What have we known more? 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 US, what we know beyond the Q4 closeout was is really about 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 change just since three months ago. It's important to remember and we've been experiencing this for some years now the US 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 can both be positive and negative is the dynamics in the US market. We're not concerned about the expansion of the markets. More than doubled 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 net 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 the Wegovy injectable.
But also how competitive landscape plays into all of this so classic variables, but it's in a very dynamic market segment.
Sachin Jain
Thanks, Karsten.
Operator
Thanks, Sachin. Next question please. Thank you. Your next question comes from the line of Richard Fosser from JP Morgan. Please go ahead.
Richard Fosser
Hi, thanks for taking my question. Just one follow up, thinking about formulary access for Wegovy, you highlighted the access for oral Wegovy 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 stemming the compounder volume? And any idea that you're taking share using the oral from compounders? Thanks very much.
Dave Moore
Yeah, thanks very much, Richard. On the injectable side, we see relatively stable access. And 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.
Expecting 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, 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.
Richard Fosser
Thank you very much, Dave.
Operator
Thank you, Richard, next question please. Thank you. Your next question comes from the line of Peter Fedor from BNP Paribas. Please go ahead.
Peter Fedor
Yeah, thank you, Peter. BNP 2 questions. Just firstly on Martin, realize you're not going to 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 into the appetite in Redefine 4? Basically, any major trial differences we need to be aware of when we compare Redefine 4 to 1?
And then pass the mic? Forgive me going back to guidance, but I'm not going to 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 this persistent earnings downgrade story from continuing through 2026? Thank you.
Martin Hutzlanger
Absolutely. So Redefine 1. You're absolutely right. We have no new news. So we're not going to change the story. Redefine 4 comparing Cagrisema and semaglutide 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.
Mike Duston
Very good. So Peter, I think I'll start by saying we have all acknowledged how volatile and dynamic the obesity market is with 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. Karsten alluded to it. We have 4 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 we'll see the other things on the upside that will come 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.
Peter Fedor
Great. Thanks, Mike. Thanks, Martin, and thanks, Pete.
Operator
Next question please. Thank you. Your next question comes from the line of Mike Nedulkovich from TD Cowen. Please go ahead.
Mike Nedulkovich
Hi, thanks so much. I have two questions. My first is on Wegovy Pill supply. Even 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.
Mike Duston
Yeah, thanks very much, Mike. Over the last period, on 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 US at a time where we will be confident enough to know we will not run into 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 US market very clearly.
Martin Hutzlanger
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 more flexible dosing, securing that we actually get more patients to higher 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're taking 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 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.
Mike Nedulkovich
Great, thank you, Martin. Thanks, Mike.
Operator
Over to the next question please. Thank you. Your next question comes from the line of Harry Sefton from UBS. Please go ahead.
Harry Sefton
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 to think about also 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? Thanks very much.
Mike Duston
Thanks very much. When you think about the sustainability of 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 was alluded to earlier on the partnership with all of our telehealth 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. 16.6% weight loss.
We've also read the data from our competing product 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 patients 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 patients 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 still a success.
Karsten Mcnusen
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're all in pushing the pill and of course the overarching intention is to expand the markets and not cannibalize from our own products.
Harry Sefton
Thank you very much, Karsten. Thanks, Harry.
Operator
And the next question please. Thank you. Your next question comes from the line of Tibo Rotherin from Morgan Stanley. Please go ahead.
Tibo Rotherin
Thank you very much. First question just on the Ozempic and the timing of implementation of the MFN price. When does the MFN negotiated price kick in for Medicare this year? And is there any associated volume uplift given it's already covered or should you expect market share 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 the pill for a day or a couple of day, what does that impact efficacy in terms of weight loss?
And then similarly on tolerability, if a patient is on a higher dose and for some reason miss a few days of pill, can they go back and resume on 25 milligram and how do side effects look like? Thank you.
Dave Moore
Yeah, thank you, Tibo. With respect to Ozempic, as you know, we have Medicare coverage right now in diabetes. And so with respect to MFN as well as MFP, that's more of a 2027 event. Of course, we did make those available in self pay. As I mentioned, we're seeing about 8000 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 Hutzlanger
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 for once weekly doses.
That basically means that when you are on a stable dose and then 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 milligram dose without experiencing any adverse effects. So from that perspective, semaglutide is semaglutide and we are benefiting from the half life of semaglutide also in the oral delivery. Other compounds would have with shorter half life a much different profile because that would both impact the potential efficacy, but also the potential ability if you skip one and two doses.
Tibo Rotherin
Great. Thank you very much, Martin.
Operator
Operator, next question, we'll do two more questions. Thank you. Your next question comes from the line of Karsten Lomberg Madsen from Danske Bank. Please go ahead.
Karsten Lomberg Madsen
Thank you very much. In terms of CapEx, you again guide for relatively high CapEx level in terms of 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 dose Wegovy approval which we hopefully see soon, will you be launching immediately, can you confirm that and then which type of pen will you be launching?
Karsten Mcnusen
Yes, thank you for that question, Karsten. And as I said earlier 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're on track specifically for API, we do expect to have some of the new major API facilities online already this year and more to come in the coming years.
Mike Duston
And Karsten, with regards to the 7.2 Wegovy high dose then as you know, we have filed in December last year under the CNPV 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 important that the world 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 milligram is giving us 15-16% weight loss. Tirzepatide at 15 milligram dosing gives you 20-21%. We have shown in a step up that when you increase the dose of semaglutide 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 launch it in the same type of devices that we currently have available to start with.
Karsten Lomberg Madsen
Great, thank you, Mike. Thanks, Karsten.
Operator
And the last question, operator, please. Thank you. Your final question for today comes from the line of Simon Baker from Rothschild and Co. Please go ahead.
Simon Baker
Thank you for squeezing me in. 2 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 these 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 1H phenomenon and be interested to get your thoughts on that and the extent if any, to which that's reflected in the guidance. Thank you very much.
Karsten Mcnusen
So Simon, thanks for these questions. How we build it. I'd say for mature reimbursed brands, I think there are very mature established trend lines for volume trends measured as TRXs and we have a good feeling for the prices being contracted etcetera. So for our mature reimbursed brands, that's I'd say that's reasonably straightforward.
Where we see the uncertainty is in the self paid type channel because the price elasticity in the self paid 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, to what extent that seasonalities, etcetera. And it's dynamic sourcing, cannibalization competition clearly there's uncertainty there.
And we put our best assumptions in and they can go both ways. 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 semaglutide LOE in international markets will impact sales by low single digits. Canada is the biggest.
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 resolution of these notices of deficiencies. But obviously time is the key variable in terms of impacts. I think the direction of travel is the same. But that 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.
Simon Baker
Great, thank you, Karsten.
Michael Novart
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.
Mike Duston
Thank you very much, Michael. I want to start by thanking Ludovic again, Dave, for all you have done for Novo Nordisk over the many, many years. I also want once again to welcome Jamie and Peng 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. And 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 for joining us today. Thank you.
Operator
Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
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