Copyright Benzinga
Novo Nordisk A/S (NASDAQ:NVO) reported third-quarter financial results on Wednesday. The transcript from the company’s third-quarter earnings call has been provided below. NVO is having a challenging session. See if it is worth your attention here. This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation. Jacob Rode (Head of Investor Relations) Welcome to this Novo Nordisk earnings call for the first nine months of 2025. My name is Jakob Ohl and I’m the Head of Investor Relations. With me today are CEO of Novo Nordisk, Mike Dubbs, Executive Vice President, Product and Portfolio Strategy, Nourbeek Heathcott, Executive Vice President, US Operations Dave Moore, Executive Vice President, Research and Development and Chief Scientific Officer Martin Hoitschlangen and Chief Financial Officer Carsten Munklossen. All speakers will be available for the Q and A session. Please note that the call is being webcast live and a recording will be made available on our website as well. The call is scheduled to last a little more than one hour. Please turn to the next slide. The presentation is structured as outlined on slide 2. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified. Next slide please. We need to advise you that this call will contain forward looking statements. These are subject to risks and uncertainty that could cause actual results to differ materially from expectations. For further information on risk factors, please see the company announcement for the first nine months of 2025 as well as the slides prepared for this presentation. And with that, over to you Mike for an update on our strategic aspirations. Mike Doustdar (Chief Executive Officer) Thank you, Jakob. Next slide please. In the first nine months of 2025 we delivered 15% sales growth and 10% operating profit growth. They’ve also narrowed our guidance range to 8 to 11% on sales and 4 to 7% for operating profit. This is because we expect lower growth for our GLP1 treatments in diabetes and obesity. Carsten will get back to the guidance update later in the call looking into the R and D in diabetes. Rybelsus is now approved in the US and EU with CV indications based on the sole trial within obesity and business development. We have progressed on a number of projects that Martin will come back to later in rare disease. We have not submitted MIMED for regulatory approval in both US and EU. We are now serving around 46 million people living with diabetes and obesity. This is around 3 million more people with our GLP1 treatment compared to just 12 months ago. Furthermore, I would like to note that 2025 strategic aspirations is our current framework for reporting and we look forward to updating this next year as the current strategic aspiration runs out. Next slide please. Since I became CEO, I have said several times that Novo Nordisk will sharpen its focus on core areas, specifically diabetes and obesity. I want to take a moment to explain how we have refined our strategy for more than 100 years. We have been guided by a simple purpose to identify and solve major unmet medical needs. This commitment is unchanged. There are many people who can benefit from expertise in diabetes and obesity and we believe we can serve them better than anyone else. Going forward, we will concentrate on these areas where we can make the greatest difference. Our strategy begins with patients at the center of everything we will do. Way more than 1 billion people are affected by diabetes or obesity. We will work tirelessly to develop products that help them live healthier, fuller lives. Some of these products will be developed internally. Others will be added to our portfolio through partnerships and acquisitions. Many of these assets can address multiple unmet needs. We will explore those opportunities and expand indications where appropriate to serve our patients. Speaking of patients, it is a known fact that obesity and diabetes vary by individual and often comes with comorbidities that lack effective treatments. As with the Akira acquisition, Novo Nordisk will keep pursuing innovation with identification within research and then advancing those to development. To address comorbidities within our core and the overlaps with those cores, we are now shaping our focus, sharpening our focus. In the past, we spread our resources into areas a bit further away from our core. Think about stem cell research for Parkinson disease. Therefore, during this last quarter we have discontinued several non core assets and redirected resources to areas aligned with our strength. We will intensify our commercial efforts to strengthen competitiveness to meet evolving market dynamics and increasingly consumer like behavior. We will, for example, expand telehealth capabilities across markets. In short, we remain disciplined about where we will compete within diabetes, obesity and related comorbidities in the years ahead. We will also continue our targeted research and commercial work in rare disease. And to support this strategy, we have launched a company wide transformation which I would like to give you an update on its progress right now, please go to the next slide. We previously announced a company wide transformation designed to simplify our operating model, accelerate decision making and reallocate capital and resource towards the highest growth opportunities in diabetes and obesity. This program supports our strategy to capture rising global demand and strengthening our competitive position in the increasingly consumer like obesity market. As part of the plan, we expect a reduction of approximately 9,000 positions globally. While this decision was not taken lightly, it is expected to drive approximately 8 billion DKK in annual saving by the end of 2026. Those savings will be redeployed to expand our diabetes and obesity franchises and fund strategic priorities. We recognize the human impact of these changes and remain committed to responsible transition for affected colleagues. At the same time, we’re confident this transformation will increase operational efficiency and strengthen our long term future and enhance return for our shareholders. I will now hand over to Ludovic for an update on our commercial execution for the first nine months of 2025. Ludovic Helfgott (Executive Vice President, Product and Portfolio Strategy) Thank you very much Mike and please turn to the next slide. In the first nine months of 2025, our total sales increased by 15%. The sales growth was driven by both operating units. US operations grew 15% and international operations grew 16%. Sales growth in the first nine months of 2025 was positively impacted by one offs in the US of around 6 billion Danish krone. Our GLP-1 sales in diabetes increased by 10% driven by both operating units growing. At the same rate. Insulin sales increased by 3% driven by US operations growing 18%. The sales increase was positively impacted by gross to net adjustments related to prior years as well as channel and payer mix. This was partially countered by a decline in volume. International operations sales decreased 2%. For Biopharmaceuticals sales increased 41% driven by US operations growing 24% and international operations growing 83%. Our rare disease sales increased by 13%. This was driven by sales increase in the US of 14% and in international operations of 13%. Next slide please. Sales in international operations grew by 16% in the first nine months of 2025 driven by GLP-1 product. GLP-1 diabetes sales increased by 10% driven by sales growth of Ozempic and Rybelsus. In region China, GLP-1 diabetes sales decreased by 4% which was negatively impacted by wholesaler inventory movements. Obesity care grew by 83% to 22.4 billion Danish Krone. Sales of WeGovy reached approximately 20 billion, growing at 168% driven by sales growth across all regions. Please go to next slide. In the Combined Diabetes and Obesity GLP-1 Market, Novo Nordisk remains the market leader in international operations with a volume market share of 68%. Rybelsus is now available in more than 40 countries and Ozempic continues to be the leading GLP-1 diabetes product within international operations. Having launched in around 80 countries. In obesity, Wegovy is now launched in more than 45 countries with more to come. Oral semaglutide 25mg or WeGovy in appeal has been submitted in the EU for potential launch in selected EU markets. The GLP on class growth of 35% in international operations is encouraging and while competition in diabetes and obesity across international operations is amplifying, the unmet needs remain substantial. And with that I would like to hand it over to Dave for An Update on our U.S. operations. David Moore (Executive Vice President, US Operations) Thank you Ludovig. Please go to the next slide. Sales of GLP-1 diabetes care products in the US increased by 10% in the first nine months of 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 wholesaler stocking. Weekly Ozempic prescriptions are currently around 670,000 in standard units compared to 690,000 standard units in the second quarter of 2025. The GLP-1 diabetes market grew around 10% in the third quarter of 2025 compared to the third quarter of 2024 in the U.S. we continue to invest in commercial activities and have recently launched Ozempic in our direct to patient cash offering. Please go to the next slide. Wegovy sales increased by 25% in the US operations in the first nine months of 2025. The WeGovy sales growth was driven by increased volumes partially countered by lower realized prices. Wegovy has around 270,000 weekly prescriptions compared to 280,000 weekly prescriptions. If at the end of last quarter in August we announced that the U.S. fDA approved WeGovy for the treatment of MASH in U.S. operations, we have established a sales force targeting U.S. hepatologists and gastroenterologists. While we work to build access in this segment generally, we also continue to work on expanding access to safe and authentic WeGovy. Around 55 million people with obesity have WeGovy coverage in the US with more than 10 million people estimated to be covered with Medicaid. However, looking into 2026, several states have already announced changes to coverage for obesity medicines in response to budgetary concerns which will affect Medicaid access to Wegovy. Regrettably, Novo Nordisk market research shows that compounding has continued to increase. Multiple entities continue to market and sell compounded GLP-1s and it is now estimated to be well above 1 million patients in the US that are currently on compounded GLP-1. Novo Nordisk launched Novo Nordisk Pharmacy in March of 2025 and together with retail channel total cash market is up around 10% of total WeGovy prescriptions. Novo Nordisk will continue to invest in the expansion of direct to patient initiatives like the recently announced collaborations with Goodrx and Costco. We continue to anticipate a regulatory decision regarding Wegovian appeal later this year which then we will be ready to launch in early 2026. Now back to you, Ludovic. Ludovic Helfgott (Executive Vice President, Product and Portfolio Strategy) Thanks Dave. Please turn to the next slide. Yesterday we confirmed that we submitted an updated proposal to acquire Medsera to further strengthen our research and development portfolio in diabetes and obesity. As we said before, unlocking the full potential of the obesity market will require a broad and deep portfolio with treatment options, formats, serving different patient groups and their very different preferences. Obesity treatment is still in its early stage and in Novo Nordisk we foresee future patient segments that for example, could be categorized based on bmi, age, gender, lifestyle behaviors and comorbidities. We believe that Medsera’s innovative pipeline would further enhance our opportunity to meet all these very different needs. Of all these very different groups, MET-97 is a potential best in class once monthly GLP1 treatment and MET-233 is a next generation amylin asset. The pipeline of Medsera also includes a combination of the two mentioned above, as well as innovative oral and injectable preclinical assets. Furthermore, medsera’s institutional knowledge and capabilities around peptide engineering and synthesis, high flight extension technologies and oral peptide delivery nicely complements Novo Nordisk’s core strength in research. The proposed deal structure includes an upfront payment of US$62.2 per share in cash, equal to an approximate enterprise value of US$6.7 billion. The cash consideration is paid at signing in exchange for a non voting preferred stock representing 50% of Medsera’s share capital. In addition, up to US$2.8 billion in contingent value rights will be issued upon the closing of the acquisition in exchange for the remaining shares. The CVRs are based on the achievement of certain clinical and regulatory milestones. In total, Medsera is eligible to receive up to USD 10 billion or 86.2 per share. Novon Nordisk believes that the proposal, including the structure of the transaction, complies with all applicable laws and is in the best interest of patients who will benefit from our commitment to innovation as well as Medsera’s shareholder. The offer highlights Novo Nordisk’s commitment to investing in the US and interest in continuing to grow the scale of its US investment. Now over to you, Martin. Martin Holst Lange (Executive Vice President, R&D and Chief Scientific Officer) Thank you, Ludovic. Please turn to the next slide. As Mike described, we are intensifying our focus on key therapeutic areas such as diabetes and obesity, while continuing our commitment to related comorbidities as well as rare disease. The strategy aligns with our recent acquisition agreements of Accuro, Enomeros, and Salzanibar assets. In early October, we announced the agreement to acquire Akira and Nephroxy Ferment a once weekly subcutaneous long acting FGF21 analog with potential to be first to market in F4 and best in class Froxy Fermin complements a strategic position in novo nordisk mesh pipeline. Current treatment options such as Wegoe primarily target patients with F2 and F3 disease stages. Consequently, there remains a significant unmet need in the F4 cirrhosis population for which no approved therapies are currently available. The phase 2 data for fyroxil fermin are encouraging across F2 to F4. Specifically, the Symmetry Phase 2b trial demonstrates that after 96 weeks of treatment, 29% of it for patients for improvement of at least one fibrosis stage with no worsening of mesh and 42% achieved mesh resolution without fibrosis worsening. This is the first phase 2 trial to show statistically significant fibrosis regression in F4 patients for an FGA21 analog effroxib fermin is currently in the phase 3 synchrony program with pivotal readouts in the coming years and expected launch by the end of this decade. As a result, efroxyphurmin has the potential to be first in class FGF21 analog targeting the F4 population as well as playing a role in F2 and F3 patients, including people who are not responsive to existing treatments. We look forward to leveraging our capabilities to further optimize the synchrony program trials, assess the potential combinations with our current GLT1 based portfolio and explore opportunities for additional indications such as alcohol liver disease. Also in October we announced the agreement to acquire the clinical stage mesh 3 inhibitor celtinibar from Ameris for rare blood and kidney disorders. This action aligns with the rare disease strategy with a key focus on rare blood disorders. Centenabad is currently in Phase two for the acquired rare blood disease, paroxysmal nocturnal hemoglobinuria or PNH. Plans are in place to begin a global phase 3 program for Saltinepad in PNA. The molecule holds big potential in a number of additional indications within rare disease and kidney disorders which will be evaluated at a later point in time. We believe our extensive expertise in the development, manufacturing and commercialization of medicines within these fields makes us well positioned to advance these assets, optimize the value of their innovation and ensure they reach the patients in need of these treatments in a very timely fashion. Please turn to the next slide. Looking towards our internal pipeline, we recently published a shop analysis of Redefine1 focusing on Cagillinside in the trial Cagillanside achieved 11.8% weight loss at 68 weeks. Assuming full treatment adherence, about 1 in 3 patients on Cragrilinside lost at least 15% of their body weight. Overall, caglintide was very well tolerated. The most common side effects were gastrointestinal of nature and the discontinuation rate due to gastrointestinal adverse events was 1.3%. Obesity is a global challenge that requires continued scientific innovation. More treatment options also focusing on tolerability are needed to meet the diverse individual needs and preferences. We are very encouraged by the first phase three data for CaguInside from Redefine1 and we look forward to studying it further. In phase three, the so called ReNew program, ReNu1 and ReNu2 will assess the 2.4mg dose in people with obesity with and without type 2 diabetes thryspectomy. Both trials have already been initiated and additional studies evaluating higher doses of caglantide are anticipated in the beginning of first half of 2026. Let’s turn to the next slide. Turning to the upcoming RD milestones, we’re looking forward to the remainder of 2025 with a number of read readouts and milestones. In the first half of 2026 we anticipate the readout of the Reimagine3 which is the first of three pivotal trials for Cachlecema and people with type 2 diabetes. Reimagine3 is a smaller study with Cagrisema as an add on to basal insulin. Reimagine 2 is the larger study which will provide comparison to semaglutide and will read out in the first quarter of 2026. We also look forward to the Phase 2 results of the subcutaneous and oral amitritin in type 2 diabetes in Q4 this year within obesity, we completed the Phase 1 trial with our internal GLP1 GIP AMYN triagonist. The study assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of the triagonist in the trial. All multiple doses tested appear to have a safe and well tolerated profile. The results of this study allowed progression to a Phase 1b2 trial in individuals with overweight or obesity which was initiated in October of 2025. Looking forward, we expect the FDA decision regarding the new drug application for the wegoe pill by the end of this year. Further, the submission of caicosima as well as the readout of the redefined portfolio remains on track for the first quarter 2026 within rare disease. We have filed MIMATE as of once monthly, once every 2 weeks and once weekly prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in people with hemophilia A with and without inhibitors for regulatory approval in the US and in eu. Finally, we anticipate the results of the evoke trials in patients with early Alzheimer’s disease later this year. While there are a number of high unmet need for the treatment of Alzheimer’s disease, it is important to remind you that this represents a high risk opportunity. And as the very final remark, while it is not on the slide, I would be remiss if I don’t mention that the first readout of Celcivicumab is anticipated to read out in the second half of 2026. With that, over to you Carsten. Karsten Munk Knudsen (Chief Financial Officer) Thank you Martin. Please turn to the next slide. In the first nine months of 2025 our sales grew by 12% in Danish krona and by 15% at constant exchange rates driven by both operating units. In the third quarter, 9 billion DKK in costs related to the restructuring was booked. The gross margin decreased to 81.0% compared to 84.6% in 2024. The decline in gross margin mainly reflects impacts of around 3 billion DKK from the one off restructuring costs and impairments related to a few production assets. Further, cost of goods sold are impacted by amortization and depreciations related to Catalans as well as costs related to ongoing capacity expansions. Sales and distribution costs increased by 12% at Danish krona and by 15% at constant exchange rates. The increase in costs is driven by both US operations and international operations and is primarily related to wegovy. S and D costs are impacted by one off restructuring costs of around 2 billion DKK. Research and development costs increased by 9% at Krona and by 10% at constant exchange rates. This reflects increased R and D activity across the early and late states portfolio, particularly within obesity care. R and D costs are impacted by one off restructuring costs of around 4 billion Danish krona and impairments related to the closure of early non core projects to free up resources for projects in core therapy areas. This is partially countered by the impairment loss related to Osadurnan of 5.7 billion Danish krona and other impairments of intangible assets. In 2024, operating profit increased by 5% measured in Danish kroner and by 10% at constant exchange rates. Operating profit adjusted for costs related to the restructuring increased by 16% measured in Danish krona and 21%. At constant exchange rates, net profit increased by 4% and diluted earnings per share increased by 4% to 16 krona and 99er. Free cash flow in the first nine months of 2025 was 63.9 billion Danish krona compared to 71.8 billion in the first nine months of 2024 driven by increased capital expenditures. And finally in the first nine months of 2025, we have returned 53 billion Danish krona to shareholders mainly through dividend payments. Please go to the next slide for 2025. Sales growth is now expected to be 8 to 11% at constant exchange rate. The new range reflects lower expectations for sales growth of our GF1 treatments in diabetes and obesity. Given the current exchange rate versus the Danish krona, sales growth reported in Danish krona is expected to be around 4 percentage points lower than constant exchange rate growth in international operations. The updated outlook reflects current growth Trends driven by GLP1 penetration in diabetes and obesity, partially offset by intensifying competition within both diabetes and obesity in US Operations. The outlook is based on current prescription trends for Wegovy and Ozempic as well as intensifying competition and pricing pressure within both diabetes and obesity. Operating profit is now expected to be 4 to 7% at constant exchange rates, negatively impacted by 8 billion Danish krona in restructuring costs. Given the current exchange rate versus Danish krona, growth reported in Danish krona is expected to be around 6 percentage points lower than at constant exchange rates. The narrowing of the guidance range mainly reflects the lower sales growth outlook and costs related to the agreed acquisitions of Akiro and Omros, partially countered by reduced spending. Novo Nordisk expects net financial items to show a gain of around 2.6 billion Danish krona driven by gains on hedge currencies, whereas capital expenditure is now expected to be around 60 billion Danish krona driven by adjustments to expansion plans. Free cash flow is now expected to be 20 to 30 billion Danish krona, reflecting lower than expected trade receivables in the US and reduction in capital expenditure. Furthermore, the free cash flow guidance assumed an impact from the acquisition of Accuro contingent on final timing of closing. Potential financial impacts related to the potential acquisition of Matera has not been included for the coming years. No Norsk has previously informed that the compound Patnaix Bari of Semaglutide molecule in certain countries in international operations is expected to have an estimated negative low single digit impact on global sales growth in 2026. In 2026, the agreed acquisition of Accuro is expected to lead to increased R and D costs with an estimated negative impact on full year operating profit growth of around 3 percentage point depending on the timing of closing. Lastly, no Norsk accepted the Inflation Reduction Act’s maximum fair price for osimpic rebelsys and wegovy in Medicare Part D for 2027. The estimated direct impact of Semaglutide MFP in Medicare Part D had it been introduced 1st of January 2025 would have been a negative low single digit impact on global sales growth for the full year of 2025. The MFPS for Semagloside will be effective as of 1st of January 2027 in Medicare Part D in the US that covers the remaining details on the outlook for 2025. Now back to you Mike. Mike Doustdar (Chief Executive Officer) Thank you Carson. Please turn to the next slide. It’s been a busy and productive quarter throughout the first nine months of 2025. We delivered 15% sales growth and nearly 46 million people are now benefiting from our treatments. We have also advanced our R and D pipeline, launched a company wide transformation program and announced a few strategically aligned R and D acquisitions and agreements. With that, back to you Jakob. Thank you, Mike. Jacob Rode (Head of Investor Relations) Next slide please. And with that we are now ready for the Q and A please, where I kindly ask all participants to limit him or herself to one or maximum two questions, including the sub questions. With that operator, let’s take the first question please. Operator Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now go to your first question. And your first question comes from the line of Carson Lomberg Madsen from Danske Bank. Please go ahead. Danske Bank (Equity Analyst) Yes, thank you very much for taking my question here. I think I’ll start. I have to. I’ll start out with a sort of a relatively basic question for Mike. Now, it’s the first time we have you on a sort of a real quarterly conference call here. If we look at your roadshow presentation, we can see that in the combined obesity and the diabetes market, the GLP-1. Market, you lost 9 percentage points global Market share over the last 12 months. That’s quite a massive loss of share. We obviously knew about this trend, but still, when you look at what you can actually do in terms of strategic initiatives to turn this around, what is it? The intangible initiatives that you are thinking about implementing? You tried pricing in US in Q3. It doesn’t really seem to have a. Kind of a big delta effect on. Your momentum in the US market So maybe if you could give some examples. And question two is for Carsten the acquisitions you have done or planning to do will lead to sort of a. Quite significant cash outflow, especially if you get them at Sarah. So if you have a Care home at Sarah, you have CAPEX. You also need to pay dividends next year, I assume. Is there anything you can talk about. The capital planning, capital allocation and also. How high in the hierarchy is the. Dividend payout ratio in terms of being. Extremely important for investors? Of course. Very good. Thanks for those two questions. On the first one on market share development and perhaps market growth also, we’ll. Turn to you Mike. Mike Doustdar (Chief Executive Officer) Thank you very much, Carsten. So as someone who has been part of the commercial organization for so long, then I would not lie and say I don’t like losing market share. But our job right now is to focus the company’s strategy around diabetes and obesity, predominantly because we see a huge expansion potential as we go forward. We are expanding our pipeline through our own activities as well as of course acquisitions. We are getting our cost under control to invest and really make sure that no stone is unturned. And we are really putting most of our efforts at this point in expanding the market. There are millions and millions of diabetes and obesity patients out there, including in us that are not getting their treatments. Launching new products like our Vigovy pill is one way to get there. Other ways is through increasing our commercial partnerships. You have seen Costco, Walmart, GoodRx, LifeMD, RO, all of those are ways for us to expand the market and really make sure that through that we succeed and have a successful future. But it does take time for those measures to take effect. It’s a marathon, as I have said a number of times now, not a sprint. Jacob Rode (Head of Investor Relations) Thank you Mike. And for the second question on capital allocation, we’ll turn to you Carsten. Karsten Munk Knudsen (Chief Financial Officer) Yeah, thank you for the capital allocation question. We have a clearly articulated capital allocation framework which says invest in the business provided attractive return, pay our dividend in a consistent manner, do pipeline additions through BD and MA, and finally if excess cash do share buyback. So that’s our framework which has remained unchanged for quite a while. And with that I’m saying that we do have a consistent approach on dividend and have no intentions, intention of changing that. The starting point is clearly to convert our earnings into cash flow which we focus on each and every day and then looking at value generating opportunities both organically and inorganically, as in the case with Accuro as an example. So I hope that’s clear. Back to you. Jacob Rode (Head of Investor Relations) Very much so. Thank you, Carsten. And also thanks to you, Carsten, for the two questions with that operator. Let’s turn to the next set of questions, please. Thank you. Your next question comes from the line of Peter Ferdolt from BNP Paribas, please go ahead. BNP Paribas (Equity Analyst) Yeah, thanks. Pete Berdalt, BNP Paribas, Two questions please. For Mike and Martin. Mike, don’t shoot the messenger, but there are many people that view your pursuit of Medsera as an implicit signal that the or your confidence in the internal pipeline has waned over the past 12 months. My question is, where do you see. The clinical differentiation between the assets you’re looking to acquire versus a Cagrisema and Amocretin and amocretin? Is it just the monthly dosing angle or are there other factors at play? And then secondly, and this is a Very simple question, we’ve heard overnight from our network that Novo has been contacted by FTC for information relating to Metsera. I know you’re not going to go into any details, but can you at least confirm if this is factually the case? Thank you. Jacob Rode (Head of Investor Relations) Thank you, Pete. And on the first question on medsara, we’ll turn to you first, Mike and then Martin. You can add on the different assets. Mike Doustdar (Chief Executive Officer) Thanks very much, Pete. I would say, Pete, that I am very excited about our own pipeline. I think we have a fantastic pipeline, but when you have an ambition to go to hundreds of millions of people and treat them, then no pipeline is broad enough. So we have been looking at Medsera for a long time. We are very excited about these assets. The proposal to acquire Medsera really supports our long term strategy and it’s mainly because these assets are differentiated and complemented to our products and portfolio. That’s why we’re doing it. I’ll pass it on to Martin, who can more easily explain you the differentiation to our own assets. But. But I would say it works very complementary to what we have. Martin Holst Lange (Executive Vice President, R&D and Chief Scientific Officer) I can only echo that. What we are looking for is complementary to our pipeline. You’ve heard us speak to many, many times. Obesity is not just one disease, it’s many different diseases with many different presentations, different patients coming in with different age, different bmi, different behaviors, different needs, different body composition and different comorbidities. They have different focus areas and for us to really serve the full palette of patients suffering from obesity and their comorbidities, we need a diversified pipeline. What we’ve seen is differentiation and complementarity. And when we see that, then. If. We can progress that with diligence and in assumption, then obviously we’re interested. Jacob Rode (Head of Investor Relations) Thank you, Mike. Thank you, Martin. And then on the second question the FCC will change to you, Carsten. Karsten Munk Knudsen (Chief Financial Officer) Yeah, so the short answer is that at this point we don’t want to get into any details around the process. It’s still to TPD where everything lands out. We know that Medcera board assessed our to be superior and that’s what we can relate to. And then I can say as part of this due diligence, as with any other due diligence, we do comprehensive homework in terms of living up to all laws and regulations in order for the deal to close. We always do that and we did that here also with the assistance and challenge of external experts. So we are confident that this deal can close according to the regulations. Jacob Rode (Head of Investor Relations) And thank you Pete, for those two deal questions. Let’s turn to the next set of questions please. Thank you. Your next questions come from the line of Florence Jespers from Bernstein. Please go ahead. Bernstein Research (Equity Analyst) Good afternoon. Thank you for taking my questions. One question I follow up about Medicare. Maybe could you share with us your view on Medicare? On one hand, the opportunity is there. Is a broader coverage of people with. Obesity on this channel and the second. About the potential risk or the ira. The next step on ira. You gave some color on the press release about that. So any comments about this opportunity and. Risk on Medicare would be great. Thank you. David Moore (Executive Vice President, US Operations) Thank you Ferrand for those two questions. For both of those we’ll turn to you Dave on Medicare potential and then on ira. Thank you for the question. Tron. The Medicare opportunity is very important to us and something we’ve been pursuing since we launched into obesity over a decade ago. We know that there’s roughly 30 million people of Medicare age that are suffering from obesity and that is something that we feel is really important that those individuals have access to anti obesity medicines. We can’t speculate on what the potential is and how many of those patients will be able to reach, but we do see this as a very important development for us. Regarding your second question about ira, as Karsten mentioned gave an understanding of the expected impact in the company announcement as as well. Well, and it’s not something that we are able to comment on. We are under strict confidentiality with CMS and CMS will be making the announcement of what those prices are at some point in the near future. Jacob Rode (Head of Investor Relations) Thank you Dave and also thanks to you for an. Thank you. And let’s move to the next set of questions in line please. Thank you. Your next Question comes from the line of Martin Pakoy from seb. Please go ahead. Yes, good afternoon Martin Pacquari. Seb, two questions. SEB (Equity Analyst) I have to come a little bit back to the question that getting from. Carsten because I think he was a little bit kind to you Mike with respect to market share loss because if. We look at the old area I/O and look at reporteds sales than Lilly. Have actually done a sprint. Two years ago you had a market share of 80% on GLP-1 sales on reported numbers and today you are at 50%. So can you talk a little bit. About. What has gone not wrong for you but what have they done right. In I O to basically capture so much more share than than you? Is it commercial execution in IO across. The context or is just due to product superiority? Why can they sprint and you cannot? And then second question is just on device strategy, a bit of a setback. For Vigoi Flexcharge in us. You had argued for that to be. An important part of flexibility in the consumer channel. What are you going to 26 are. Your device strategy overall also respect to. Launch of products in vials and in. Which market would that be relevant? Jacob Rode (Head of Investor Relations) Thank you Martin. On the first question on I O I’ll turn it over to you Mike. Mike Doustdar (Chief Executive Officer) Yes, thanks very much. So a couple of different ways to answer your question Martin. There are markets that we are clearly competing well and gaining market share within IO and there are markets that we are losing. So it is market dynamics that dictates IO and averages sometimes cloud the picture in certain markets. Take China as an example. The market is not growing as much. As we had anticipated. We have said it in the past predominantly because we had never launched a previous version of obesity drugs in that market. At the same time we have seen in the same market that we’re losing in the online battle to our competitor predominantly because obesity drugs so wegovy is not allowed to be sold online. While if you have a mega brand then it’s a very different picture. So that’s I would say for China. If you take a look at some of the European markets, take UK as an example. We have seen how our share of growth over a period of 1/4 has now bypassed on initiation our competitors numbers. So this is a dynamic market that changes and it is ready to be seen on a longer horizon and not quarter by quarter. We still have a patient base more than two times more than our competitor in international operations. The volume strategy and the future potential of international is still incredibly attractive for us. But we came to this market with a very high level of market share, 100% on our own. So losing market share is something that we had anticipated. And as our competitor comes and as we go also into next year it will not just be Eli Lilly but also in some of the markets other players as we lose LOE. So we have to look at this longer term and when we do look at it longer term I am incredibly optimistic for the volumes and the level of unmet need that existing in international operations. Jacob Rode (Head of Investor Relations) Thank you Mike. And let’s move to Dave for the device question please. Thank you Martin. David Moore (Executive Vice President, US Operations) Yes, as you mentioned it’s a setback to receive the complete response letter and Wegovy FlexTouch looking into 2026. We are looking at other presentations. This includes vials, it includes other devices that we’re thinking about entering into the market which would lead to more optionality especially as we continue to grow in the Cash channel as well. On the FlexTouch specifically we are in active dialogue with FDA and working through the complete response letter but can’t comment on any specific timelines yet at this point. Jacob Rode (Head of Investor Relations) Thank you Dave. Thank you Martin for the set of two questions and let’s move to the next questions please. Thank you. Your next questions come from Sachin Jain, bank of America. Please go ahead. Hi there. Bank of America (Equity Analyst) Two questions please. One commercial, one financial commercial on Wegovy pill. Just wondering if you could talk about how your scenario planning around our thought on on pricing given some news overnight and given your API restriction and ability, your ability to compete on price and any further color. You can give on launch cadence as. We think about that launch and the second one from Carsten, I’m sure you’re expecting the question but the last couple of years you’ve given some high level color on year forward so if you’d be willing to just share moving parts as we think about 26 a lot of factors there gross-to-net in the base semi IO patterns Accuro consensus sitting at roughly 7% sales low teens EBIT. So just any high level thoughts? Thank you. David Moore (Executive Vice President, US Operations) Thank you Sachin. The first question on oral semi let’s go to you to you Dave. In terms of preparedness of course for competitive reasons we cannot go into any details but high level picture Dave yeah. Thanks a lot Sachin. We’re incredibly excited as we move closer to the approval date of the Wegovy pill. I think this is a big step forward in terms of expanding the market and for those individuals that align better with taking a pill for their obesity we can’t comment on specific pricing of course but what I would say is we are going to have the Wegovy pill available in all channels and this is different from previous launches because we will have the ability to focus on Medicaid, Medicare and commercial, but also have a cash offering available through all of our different telehealth partnerships as well as our own NovoCare pharmacy and the retail partnerships that we’ve aligned as well. This is a new way to launch for us and we’re also thinking about the competitiveness. This is a competitive profile with respect to efficacy and tolerability and we’re really looking forward to bringing this to people living with obesity in the U.S. Jacob Rode (Head of Investor Relations) Thank you, Dave. That’s very clear. The second question, we’ll turn it to you Carsten. Karsten Munk Knudsen (Chief Financial Officer) Yeah, thank you for that question, Satyan. And I think you actually already captured some of the key elements going into your own question. So the starting point is we do not guide for next year today. We’ll come back to guidance for next year at a later point in time as we normally do. What I can say is, as always, current momentum is the foundation for future trends in the business. Not saying everything continues, but current momentum is where we start. Then we have a few specific items worth calling out in relation to next year, next year’s growth rates. One is this year we have some growth to net favorability. I would estimate it to around 2 percentage point on group sales growth this year that will not repeat into next year. So that needs to be factored into growth rate then loss of exclusivity in certain IO markets. We’ve been calling that out for quite some time, including in our in our release that will have a estimated negative impact of low single digits on next year’s sales growth, on group sales. Then on sales. Dave was covering the VGOV pill, which of course is our main launch into next year and upon regulatory approval by the fda. And then the final discretionary factor to call out is a kiro and the step up in RNG costs associated with that transaction pending closing expected late this year. That will have a 3% negative impact on operating profit growth in 2026. Jacob Rode (Head of Investor Relations) Thank you Carsten. And thank you to you Satchin for those two questions. Now let’s move to the next one in line and those set of questions please. Thank you. Your next questions come from the line of Mike Nidolkovich from TD Cowan. Please go ahead. Hi, thank you for the questions. TD Cowen (Equity Analyst) I have two. My first is actually a follow up on Metsera. Martin, can you articulate what specifically about. The MTSERA agents is differentiated from Novo’s. Own pipeline candidates other than the potential for once monthly dosing. In response to the previous question, you restated that medsera is differentiated and complementary. But I’m wondering what public data lead you to that conclusion or if those. Data are not public, could you confirm that? That’s my first question. And then my second question is on. The evoke trials, we are now less. Than a month away from the CTAD presentation. So I’m assuming that Novo has the data in house and is simply cleaning them up before top line release ahead of the presentation. So my question is, if it is an unequivocally negative result, would Novo cancel its CTAD presentation? Jacob Rode (Head of Investor Relations) Thank you. Thank you, Mike for those two questions. Now let’s start with the first one on revisiting Medsera and the view on differentiations from your side. Martin? Martin Holst Lange (Executive Vice President, R&D and Chief Scientific Officer) Yeah, thank you very much for the question. I don’t want to go into specifics, but maybe just iterate what we’re looking at. Where we look for complementarity to our pipeline, it’s data on efficacy and those can be differentiated at many levels. It’s data on safety and tolerability, a little bit of the same consideration its scalability and then obviously in this case the dose and frequency. We on more than one parameter see complementarity to our pipeline and therefore this is an attractive proposition for us on Nivoq. I do want to iterate we do not know the data in house in this room. If we did, we would actually have to issue a corporate announcement immediately. So no knowledge amongst any of us in this room. Our starting point is to disclose data, good or bad. So we currently aim to present whatever data that we will have at Cedar in the beginning of December. Jacob Rode (Head of Investor Relations) Thanks Martin, that’s very clear. And also thank you to you Mike for both of those questions. Now let’s move to next question please. Thank you. Your next questions come from Harry Sefton from ubs. Please go ahead. UBS (Equity Analyst) Brilliant. Thank you very much for taking my questions. Two on the US please. So just in light of the agreed IRA direct negotiation discounts on Semaglutide and also some of the press reports yesterday. On potential obesity, Medicare coverage, I don’t. Want you to comment directly, but it appears you’ll end up with significantly different. Prices for your products across different channels. So I wanted to get your thoughts of how you expect that you’re able. To maintain this segmented pricing by channel. Or should we assume that all prices. Gradually trend towards the lowest level and then the second one on the US just on the Current US market trends. Can you discuss how you’re currently thinking about the levers to improve access and. Commercial insurance coverage on wegovia and Ozempic. Going into next year? Or do you expect that the majority of 2026 US growth is really going. To come from the launch of the Wegovy pill? Thank you. Jacob Rode (Head of Investor Relations) Thank you, Harry. Noted. Two questions here. I’ll send both to you, Dave. The first one on the pricing dynamics and then subsequently on the current exit. Over to you, Dave. David Moore (Executive Vice President, US Operations) Yeah, thank you much. As we mentioned, we can’t discuss any of the specifics around IRA or mfn, but we do appreciate the question and the fact that historically we have been able to maintain different prices in different channels given that be Medicaid, Medicare or commercial and now are increasingly expanding. Of course we can’t speculate what that will mean in the future, but historically we have been able to maintain the differentiation between those markets and the access that comes with it. To your second question around the trends in terms of the quality of access. It’s something that continues to be really important for us as sometimes receiving an obesity medication can be a challenge because of the friction that exists in the marketplace. So we are continuing to push for and invest in improved access. It’s a clear priority for us. This includes both our cash offerings. It’s also what we do with payers. But we haven’t seen a large uptake yet in terms of that opportunity. But it’s something that we’re going to continue to push for in 2026. Access. We don’t really expect the access to be largely changed in 2026, but we do know that each of the payers or Medicaid, as we mentioned earlier, you know, have budget constraints and there could potentially be some loss of coverage as well. Jacob Rode (Head of Investor Relations) Thank you, James. Thank you Dave for those two and also thanks to you. To you, Harry. Let’s move. Next question please. Thank you. Your next question comes from Emmanuel Papadakis from Deutsche Bank. Please go ahead. Deutsche Bank (Equity Analyst) Yeah, thanks. Few follow ups, perhaps maybe taking a step back on US commercial channel trends and obesity. Excuse the background noise. WeGovy scripts are pretty much flat since July despite the MASH launch. Even Zepbound has seen most of the growth coming from the Cash Channel. So talk us through what you think the obstacles actually are to better penetration. In that commercial channel. Is it on the demand side due. To product profile, lack of demand beyond a motivated minority, or is the barrier really on the access side? For example, as you referenced potential insurance companies making it difficult for patients to actually get on or remain on therapy, Maybe a follow up on Metzera, the deal structure and the risk associated with that. Can you just help us understand your comfort with the risk around? The way you are structuring your offer, seems there’s a reasonable chance you could end up with 50% of company you don’t control to little ultimate benefit except preventing someone else from owning them. So why are you comfortable with that possibility or how do you expect to avoid it? And then just a quick clarification on the Medicare access discussions. What would the upper limited discount you’re contemplating be? Would that be in line with the. MFP or this would be something in addition to that. Thank you. Jacob Rode (Head of Investor Relations) Thank you, Emmanuel. I noted two questions there. On the first one on the Gobi scriptions, I’ll turn it to you, Dave. And on the second one afterwards on the deal structure, I’ll turn to you, Ludovic. But first over to you, Dave. David Moore (Executive Vice President, US Operations) Yeah, thank you, Emmanuel. As we mentioned earlier, the quality of access remains a focus point and certainly a challenge in the reverse and the reimbursed channel, of course, we’ve got that combined with intense competition. And we also mentioned that compounding is continuing to increase as well. So that focus and investment in the quality of access we do think is an important factor with respect to expanding the market. And in addition, you’ll continue to see our efforts in expanding the Cash channel through more partnerships and certainly having our product offerings available in that channel as well. Thank you. And now I hand over to you a little bit. Ludovic Helfgott (Executive Vice President, Product and Portfolio Strategy) Thanks for the question, Emmanuel. Well, I think everything stems from, I guess, what you feel as an excitement for the portfolio of Medcera. We really believe in the assets, we believe in the team and we believe that the deal structure that we have now, which by the way, as Carlsen said, has been vetted and discussed with external councils and experts and believe that it’s in line with all legal standards, boils down to the quality of the asset and the data that we. The confidence we have in the data that we have. So of course we know when you get into such acquisition that this deal will be reviewed. But we’re comfortable that even the 50% of the shares that we would have in our pocket would be actually worth a lot if the product pans out to be the way we think it is. Products with an S, by the way, because as you said, Martin, it’s a combination of products. So in all cases, as it boils down to science, we believe that we. Have a good value proposition. Of course, we prefer at the end to have that in our portfolio from an operational perspective. But the value there we believe is really, really high in all scenarios. Jacob Rode (Head of Investor Relations) Thank you Ludovic. And now let’s turn to the last two questions for the second last question please go ahead operator. Thank you. The question comes from the line of Richard Fosser from J.P. morgan. JP Morgan (Equity Analyst) Hi, thanks for taking my questions. First question, Mike, you alluded to more telehealth involvement, particularly in the U.S. i think prior arrangements, particularly with HIMSS have. Faced challenges given they continued to bulk compound. So there’s been some discussion around continuing or new agreements with himss, but also the wider involvement of the telehealth. So I wondered what was different this time and whether there’s any evidence of any increased pressure around from the FDA. Or legal pressure to remove the compounders. And what could change on that front. And then the second question just you. Mentioned a couple of times about coverage maybe even getting a little bit worse. In Medicaid and maybe even the commercial payers, the barriers staying high. Well in that case, how should we think about the pricing? Normally we think about increased rebate levels. And increased pricing should remove barriers to get more reimbursement. So how should we think about that going into 26? Jacob Rode (Head of Investor Relations) Thanks very much. Thanks a lot Richard. On the first one I’ll turn to you Mike. Mike Doustdar (Chief Executive Officer) Yes, a couple of comments on that, Richard. There’s been no increased pressure to answer your question directly, but we have been quite consistent with regards to the illicit API that is coming from China and being used by compounders. We find since these are not FDA approved, their safety is questionable. And as a pharma company we don’t basically like that. That hasn’t changed at all. We also have been saying that we need to increase our access and we need to find ways to get to many more patients. The Cash Channel and E Health is definitely and attractive way to go about it in that context. We’re having dialogue and discussions with multiple players on how we could actually increase our access and then we will see with who we should go into partnership. We’ve made a number of those partnerships available. So we talked about Costco, we have talked about emed, we have talked about Walmart and ongoing dialogues with many, many more are ongoing in pursuit of our market expansion that I spoke to earlier on. Jacob Rode (Head of Investor Relations) Thank you Mike. That’s clear. And for the second one, let’s move to you again, Dave, please. David Moore (Executive Vice President, US Operations) Yeah, thanks very much Richard. We continue to have dynamics that we’ve discussed in the past. Continued pressure both in GLP1 as well as in obesity with respect to price as we look to unlock more volumes. But I think it’s. I do want to reiterate that the quality of access is a clear priority for us. We are working with payers to make sure that the experience is one that patients are able to receive their medicine more seamlessly. You know that means lower utilization management, right? That means less of a prior authorization criteria. When we say we’re investing in quality of access, that’s really what we mean. And that’s the focus conversation that we’re having with payers in 2026. We don’t really expect a large difference in terms of access in the commercial channel. As we mentioned, there may be some in Medicaid. But when we look at the commercial opportunity, I think it is important to note that we have been making progress in terms of the access. We continue to believe that the CVS opportunity remains there and that we will see WeGovy as the exclusive branded AOM at CVS in 2026 as well. Jacob Rode (Head of Investor Relations) Thanks a lot Dave. That’s clear. And let’s move to the final question before I hand over to you Mike for closing. So final question please. Thank you. Your final question today comes from the line of James Quigley from Goldman Sachs. Please go ahead. Goldman Sachs (Equity Analyst) Great. Thank you for taking my questions. I’ve got two left, please. So firstly on Redefine 4, how important is this in terms of demonstrating differentiation from a physician and a marketing perspective versus zepbound? Have you thought any more about how zepbound could behave in a flexible dosing scenario versus other trials and real world data? And can can you confirm that you still look to Launch Caguisema if redefined 4 shows no statistical significant difference? Second of all, can you talk through the launch preparations for our Govi in ex US you’ve highlighted in the release and in the comments that you could look to launch in select IO countries versus previously when it was likely to be mainly all focused on the us so what’s happened such that you consider also launching in the X US and how do you balance this with the US launch processes and pricing etc. As we head into an MFN world? Thank you. Jacob Rode (Head of Investor Relations) Thanks James. That’s two one on Redefine 4 and one on the oral simmer in IO. But on the Redefine 1 I’ll turn to you first Martin. Martin Holst Lange (Executive Vice President, R&D and Chief Scientific Officer) Yeah, Redefine 4, as you well know we’ve taken some learnings from Redefine 1. More specifically that we needed to do a number of study so we amended the redefined 4 study. That being said, our base case has always been non inferiority with an upside of superiority. In the case of non inferiority on weight loss we still see a potential for upside on gastrointestinal side effects and tolerability. But also we do believe that the CV benefits that we know from semaglutide could also potentially pan out and will read out from redefine free does clearly differentiate cagrosema vis a vis potential competitors. But I do want to iterate there is still the potential for superiority upside but obviously in an amended study that should be taken with a little bit of a risk. Jacob Rode (Head of Investor Relations) Thank you Marc and let’s turn to you Ludovic for the second one please. Ludovic Helfgott (Executive Vice President, Product and Portfolio Strategy) Absolutely. So let’s take a step back. The real focus and the priority of our WeGov launch is the US and will remain the US in 2020. As you rightly read, we are indeed opening, we’ve filed and we are opening the option to launch in selected market in the course of 2026 depending on of course on how things are ramping up and we are definitely ready in this market to be able to make the most, the best and the most of the WeGovi pill. And by the way we also very quickly transferring some knowledge from the tehealth channels for instance in the US into some IO markets. We are very active right now as we speak in many markets across the world, not just in Europe but also in Australia for instance or in other part of the world where we believe that we really are gaining progress on the telehealth side. So again we accelerating our overall experience curve on the telehealth and that will be we believe will be proven very helpful at the time we launched the wigovipil. It’s also noteworthy to say that the IO market are also markets where we have some of the nicest experience on rebelsys in Europe and elsewhere. Which means that we can also leverage our experience on the oil markets that. Have been successful rebelsus to build even. Quicker position with the WIG of epl. So priority to the US but fully ready to take on some selected markets in IEO when time comes. Jacob Rode (Head of Investor Relations) Thanks a lot Ludovic. And with that let’s conclude the Q and A session. Thank you for participating and please feel free to ask congratulations for any follow up question if that’s the case. Before we finally round off. I’ll just turn it over to you Mike for some final remarks. Mike Doustdar (Chief Executive Officer) Thank you Jakob. Thank you to everyone for calling in. Before closing I did want to make a few remarks. Although we have narrowed the full year outlook for this year and see currently competitive headwind, the unmet need is huge. The volume opportunity longer term in our core area is enormous. We are sharpening our focus on diabetes, obesity and associated comorbidities in order to address this unmet need. This is our home turf and this is for us to drive the commercial execution and raise the innovation bar to treat many more patients and treat them better than ever before. And we will not stop till we do that. Thank you. This transcript is to be used for informational purposes only. Though Benzinga believes the content to be substantially and directionally correct, Benzinga cannot and does not guarantee 100% accuracy of the content herein. Audio quality, accents and technical issues could impact the exactness and we advise you to refer to source audio files before making any decisions based upon the above. Read Next: Pfizer, Novo Nordisk Intensify Fight For Metsera As Buyout Offers Continue To Climb Image: JHVEPhoto/Shutterstock.com
