Novo Nordisk A/S

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 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Michael Novot, Head of Investor Relations. Please go ahead.

Thank you very much, and welcome to this Novo Nordisk earnings call for the full year of 2025. My name is Michael Novot. I'm the Head of Investor Relations at Novo Nordisk. With me today I have CEO of Novo Nordisk, Mike Dustar, EVP Product and Portfolio Strategy, Ludovic Helfgott, EVP US Operations, Dave Moore, EVP Research and Development and Chief Scientific Officer, Martin Holtz-Lange, and Chief Financial Officer, Carsten Munch-Nusen. 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.

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 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 profits, and our obesity care sales have increased from 6 billion DKK in 2019 to 82 billion DKK in 2025. Rare disease is now positioned for sustained growth with the late-stage pipeline assets MyMate, now called Desinemic, and Etabo Pivad. Furthermore, over 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 2 readout of xenogamotide and phase 3 readout for catricema. Novo Nordisk also continued to build upon its pipeline across therapy areas. Martin will discuss this in more detail later in the call. By late 2025, we received FDA approval for the Vigobi pill, the first oral GLP-1 for obesity, and submitted Cagrisema in the US. Dave will speak more to the Vigobi pill later. But we are encouraged by the early uptake of the pill and what we see these milestones meaning 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 US as the executive vice president of the US operations in January of 2025. Dave has moved the needle throughout his time at Noble, from driving the blockbuster launch of Ozempic to leading the acquisition of three Catalan manufacturing sites to overseeing the launch of the Vigobi pill in the US. 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 Chao 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 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 Holding and brings deep expertise in U.S. market access and product lifecycle management. Beginning February 15th, Ong Chao will join Novo Nordisk as an Executive Vice President of Product and Portfolio Strategy. Ong 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 product 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 Hung 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.

Thank you, Mike, and please turn to next slide. The global GLP-1 market grew over 30% in 2025. Novel notice, 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, plus 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. RS 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 but the rare endocrine disorder products may need you to support your 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 Advenpick. 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 31 billion Danish kroner in 2025. Wegovi was launched in 35 new countries in 2025, more than tripling the number of launches back in 2024. Cells of Wegovy reached 28 billion denish kroner in 2025, growing 134%. We continue to see GFP1 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 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.

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 Rebelsis. 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 2 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 Rebelsis, and that happened last week. Next slide, please. As Mike noted earlier, 2025 ended with an exciting milestone for Novonordisk and, importantly, people living with obesity in the U.S. 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 first 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 III trial data in obesity for the Wegovy pill and for Orfoglipron, 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 Wigovi pill is offered at over 70,000 retail pharmacies and through Novocare Pharmacy and numerous telehealth partners. Commercial access for the Wigovi pill is progressing, with coverage currently via CVS, Prime, Optum, and Anthem, amounting to just below half the covered lives we have for injectable Wigovi. 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 WGOBI sales growth was driven by increased volumes, partially countered by lower realized prices. In the holiday week ending January 23rd, WGOBI had around 230,000 weekly prescriptions. The recent decline in injectable WGOBI 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 Wigovi 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 Wagobe prescriptions. In under one year, our increased efforts in the self-pay channel have resulted in close to 120,000 current weekly TRXs across Wigovi 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 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 milligram, to FDA in November. It's under the CNPV pilot program, and we anticipate a decision during the first quarter of 2026. Furthermore, Kagrisema 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 am 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.

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 cacrosemma 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 cacrosemma 2.4 mg or 1 mg, semaglutide 2.4 mg or 1 mg, or cagrelentide 2.4 mg or placebo. The study assessed superiority of cagliosema versus senaglutide 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 reimagined tube, cagliosema 2.4 milligram demonstrated superior A1C reduction and weight loss versus semaglutide 2.4 mg. Assuming all people adhered to treatment and from a mean A1c baseline of 8.2%, cagrezema 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, cagrezema 2.4 mg achieved a superior weight loss reduction of 14.2%. More than 40% of the participants treated with CacroSemma 2.4 mg achieved over 15% weight loss and around 1 in 4 achieved over 20% weight loss. In the trial, CacroSemma 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 re-imaging 3 with calcosema as an add-on to basal insulin. In that study, people treated with calcosema 2.4 mg achieved an A1c reduction of 2.33% and a weight loss of 12% at 40 weeks, all superior to placebo. Results from the pivotal re-imaging 1 trial are anticipated in the first quarter of 2026. In addition, we await the long-term safety and efficacy cardiovascular outcomes trial, redefined III. Following these results, Novo Nordisk will approach authorities to discuss the regulatory pathway for cagrezima in type 2 diabetes. In summary, cagrezima 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 senagamtine, formerly called amitritin, in people with type 2 diabetes. The trial investigated the efficacy, safety, and pharmacokinetics of once-weekly subcutaneous and once-daily all-senagamtine compared to placebo. The trial included around 450 people with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor as 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 free all doses ranging from 6 mg, 25 mg to 50 mg. From a mean baseline HbA1c of 7.8%, once weekly Senegantia lowered A1c by up to 1.8 percentage points at week 36 in a dose-dependent manner, assuming all people adhered to treatment. The proportion of people achieving A1c below 7% was up to 89.1%. Furthermore, people treated with oral Sanaganside 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 input on the trial. Both subcutaneous and oral Senna Gametide appear to have a safe and well-tolerated profile, consistent with other incretin and amylin-based therapies. The data further support the potential of Senna Gametide as a next-generation treatment for type 2 diabetes, and we look forward to bringing it into an extensive phase 3 program called Ambition in type 2 diabetes and other indications in the second half of 2026. In addition, the Phase 3 obesity program called AMAZE will start in the first quarter of 2026. As a reminder, the Phase 1B-2A clinical trial for dimocretin 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 milligrams. 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 make with our late-stage internal assays . We've also achieved progress through external innovation that we have done throughout the last few years. We expect Phase II data from our in-licensed UBT251 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 II study in type 2 diabetes in the second half of this year. Within the diabetes-associated comorbidities, The first readout of ciltivecumab from the through-space retrial is anticipated in the second half of this year. The trial is assessing three-point MACE relative risk reduction on top of standard of care. Ciltivecumab 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 separate types. The study's primary endpoint is percent change in body weight assessed for non-inferiority. We are assessing further CACOSEMA weight loss potential in the ongoing REDEFINE-11 trial with the results expected early in 2027. A new phase 3 trial with CACOSEMA high-dose is also planned to initiate later this year. For our triple agonist, we expect phase 2 data from our in-licensed UBT251 acid in a Chinese obese and overweight population in the first half of this year, and we've already initiated our own phase 1 B2 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 1.24 mg were tested. The primary endpoint was treatment emergent adverse events. The safety profile of the agonist was consistent with increased attempt-based therapies. The percentage change in body weight from baseline rates from minus 3.6% to 5.3% for the triagonist versus 0.5% for placebo at four weeks. The four-week data confirm our belief in the potential for high weight loss efficacy with the triagonist. We recently initiated a phase 1b2 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, Caprisema in the U.S. 2026 is an exciting year in rare disease as well. The phase 3 hibiscus readout for itabopivate in sickle cell disease is expected in the second quarter of this year. Itabopivate 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 denesimic previously known as MyMed. Anatomic 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 is expected in the second half of 2026. With that, over to you, Karsten.

Thank you, Martin. Please turn to the next slide. In 2025, our sales grew by 10% across the exchange rates driven by both operating units. In the U.S., sales growth was positively impacted by growth-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 of 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 Google promotional activities and launches, as well as increased early research and development stage 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 2025. This is a 2.6% increase compared to last year, making it the 30th consecutive year with increasing dividend per share. Nordisk will continue to deliver returns to shareholders in 2076 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 US dollars related to the 340B drug pricing program in the US. In order to enhance transparency and comparability of underlying operating performance, 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 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 minus 5% to minus 13% at constant exchange rates. Given the current exchange rate versus Danish kroner, growth reported in Danish kroner is expected to be 3% 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 deal-to-one market expansion is assumed to continue in 2026, enabling New North to increase patient reads 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 markets. Lastly, positive impacts related to U.S. growth 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 pattern 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 MFL agreement with the U.S. administration. Uptake related to the launch of the Vigobi 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 minus 5% to minus 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% 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. Of note, as of 2026, NoNorth defines free cash flow as net cash generated from operating activities, less purchase of property, plant, 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 finalizations. That covers the outlook for 2026. Now back to you, Mike.

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 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 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.

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

Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 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.

Great, thanks 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 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 competitor suggested loads of mid-teens pricing on a global basis this morning. And the second question is, On the Medicare unlock, how are you thinking about the potential speed here? Again, the competitors suggest the unlock could be pretty fast, starting from July 1st, but the guidance only suggests slower uptake here. So what are the basis of your assumptions around the speed of unlock? Thank you.

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

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 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 built 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 would have a low-signature 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 Vigobi Pill launch, where we're very encouraged, as Dave showed just before. And the same on Vigobi Injectable. We're actually looking at to the tune of 30% of Vigobi Injectable scripts now being cash-driven, so also building that. 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 US down. On Medicare and impact from Medicare Part D and the MFN field, we do expect that we will have benefits starting around mid this year, having Vigovi 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 lack 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. Great.

Thank you.

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

Hi there. Thanks for my questions. I've got two more on guidance if I may cast an apology. So maybe framing Jain's question slightly differently. I asked Precious and Paul's question at third quarter, and I'm not going to misspeak, but I think you roughly phrased it as underlying growth, less three sets of headwinds, a roughly low single-digit each. 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 minus 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? It seems to be cash channels. 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.

Thanks, Sachin. Also two questions for Carsten on guidance and also on the sort of push and pull between high and low.

Yeah, thanks for these questions, Sachin. And And as you recall, I didn't guide for 2026 at our Q3 goal. So that's the starting point. And as you 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 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 U.S., what we know there beyond the Q4 closeout is really about, I would say, the Vigobi pill uptake in the first month, as Dave alluded to, which we're very happy with. and then the Gobi injectable cash business and the response to the lowering of the initiation prices to $1.99. So that's really kind of the key fundamental changes since three months ago. Hello. Hello. Thanks, Michael, for reminding me on that one. It's important to remember and we've been experiencing this for 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 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, growth to net dynamics that are being forecasted with a lag. And then also, the sourcing dynamics and channel dynamics impacting pricing and volume of Vigobi pill and how that is impacting both Vigobi 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. Thanks, Karsten. Thanks, Gretchen. Next question, please.

Thank you. Your next question comes from the line of Richard Foster from J.P. Morgan. Please go ahead.

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? It 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, this 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.

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

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 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 PIL 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, you know, as of this week, we have over 170,000 people that are on the Wagobe 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.

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

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

Yeah, thank you, Peter Fadalt, BNP. Two questions. Just firstly, on Martin, realise 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 is it more fixed in nature for Cagri-Semarin to Zapatine in Redefine 4? Basically, any major trial differences we need to be aware of when we compare Redefine 4 to 1. And then, Carson, Mike, forgive me, going back to guidance, that 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 and competition, or are you simply starting the year as conservatively as you can to finally prevent this persistent downgrade story from continuing through 2026? Thank you.

Thank you, Pete. So two questions, first to Martin on Redefine4, and then second to Mike on high-level guidance dynamics.

Absolutely. So, Redefine-1, you're absolutely right. We basically have no new news, so we're not going to change the story. Redefine-4 is comparing Cacrosema and Ticepatide 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. I think we maintain what we've always said for redefined form, but we also are looking forward to redefine 11, where we'll see the full weight loss potential of Capri 7.

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. Carson 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 off-site 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 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.

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

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

Hi. Thanks so much. I have two questions. My first is on WeGoVPill supply. Given the strong launch of WeGoVPill, 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 CAGRASema 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 CAGRASema? Why could it not be revealed by Redefine-4 given the changes that were made to the trial? Thank you.

Thank you very much. Two questions. First to Mike on the Vigobi supply, Vigobi pill supply, and the second one to Martin on both V-Define 4 and V-Define 11.

Thanks very much, Mike. Over the last period, a number of occasions I have spoken to how confident we are with regards to the Vigobi 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. Thank you.

Yeah, on Redefine4, we 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 One 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 redefined form. We have optimized that in redefined 11. So the trial duration, we have tried to optimize in redefined form, but in redefined 11, we have 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 is 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'll only learn when we do the full trial duration and the flexible dosing that really will drive patients to use Calcosema in the optimized way.

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

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

Brilliant. Thanks very much for taking my questions. I have two on the Wagovi pill, please. Just want to start with what your expectations are for the sustainability of the Wagovi pill demand. If you wouldn't mind, is there any evidence from Novo's ribeltis experience that points to any variation in the stay time on therapy versus the injectable and how to think about also the demand for the pill through the competitor or for glipron launch. And then my second question is on the economics of the Wagobe 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.

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

Thanks very much. When you think about the sustainability of a growth and demand, then then two things come to my mind. One, of course, competitive and 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 competitors e-health players being available in 70,000 retail pharmacies today has been partially the reason behind that incredible update. 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 Vigovipil 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 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 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 see in 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. Thanks, Mike. And Carsten? Yeah.

Thanks, Harry, for the manufacturing economics question. On gross margin, the short version is that the gross margin on the Goovey pill is below that of the Goovey 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.

Thank you very much, Carsten. Thanks, Harry. And the next question, please.

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

Thank you very much. First question just on the OZENPIC. and the timing of implementation of the MSN price. When does the MSN-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 shareholders to sort of array the benefits? And then just a second question, I guess, for Martin on the profile of WeGoVPIL. Just in order to understand the adherence, Could you help us with what happens to a patient if they miss the pill for a day or a couple of days? How does that impact efficacy in terms of weight loss? And then, you know, similarly on tolerability, if a patient is at a higher dose and for some reason misses a few days of pill, can they go back and resume on 25 milligrams? And how do side effects look like? Thank you.

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

Yeah, thank you, Thilo. 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 Ozemp 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. Thanks, Dave.

Absolutely. On the regoid 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 and then we go 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 on-towards 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.

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

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

Thank you very much. In terms of CapEx, again, this year, a guy for a 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 there's The entire program is taking longer and is being much more expensive than what we expected some years ago. And secondly, on the high doses approval, which we hopefully will see soon, also will you be launching immediately? Can you confirm that? And in which type of pen will you be launching?

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

Yes, thank you for that question, Carsten. And as I said earlier on, 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.

Thank you, Carson. And, Carson, with regards to the 7.2, we go behind those. 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, really important that the world a 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 milligram is giving us 15, 16% weight loss. Trisepatide at 15 milligram 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 trisepatide. 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. Great. Thank you, Mike.

Thanks, Karsten. And the last question, operator, please.

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

Thank you for squeezing me into 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 price impact and low visibility on volume uplift, that is one of the key things that is reflected in your guidances? And the sort of second part that's related to that, I just wonder if you could update us on your assumptions for generic competition in IOs, 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 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.

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

Yeah.

So Simon, thanks for these questions. Whether, how we detail build it, I'll 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 brands, reverse brands, I'd say that's reasonably straightforward. 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 Megubi 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, daytime, sourcing, cannibalization, competition, clearly there are uncertainties there. And we put our best assumptions in. And they, you know... it 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 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 timing of generic launches, approvals and launches. We don't have detailed insights into the status of those files and remediation of these notices of deficiencies. But obviously, time is a key variable in terms of impact. 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 it remains to be seen.

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.

Thank you very much, Michael. I want to start by thanking Judith again, Dave, for all you have done for Nova Nordics over the many, many years. I also want, once again, to welcome Jamie and Hung 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 Vigovi 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.

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