诺和诺德公司 (NVO.US) 2025年第三季度业绩电话会
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会议摘要
Novo Nordisk anticipates regulatory decisions on diabetes treatments, plans early launches, and aims to strengthen its R&D portfolio through acquisitions. The company forecasts sales growth, increasing operating profit, and free cash flow, while addressing market share losses and regulatory challenges. It focuses on pipeline expansion, commercial partnerships, and patient access improvements, aiming for significant savings and long-term innovation in diabetes and obesity care.
会议速览
A live earnings call for the first nine months of 2025, featuring updates on strategic aspirations, financial performance, and a Q&A session with company executives. Forward-looking statements are included, subject to risks and uncertainties. Recording and webcast details are provided.
Novo Nordisk narrows its focus to diabetes and obesity, discontinuing non-core assets, enhancing patient-centric strategies, and expanding telehealth capabilities to better address unmet medical needs in these areas.
The company is undergoing a global transformation to streamline operations, cut costs, and reallocate resources towards diabetes and obesity, aiming for long-term growth and shareholder value. Initial sales in 2025 saw a 15% increase, with GLT 1 and insulin sales rising, and rare disease sales growing significantly. Despite the positive outlook, the plan involves reducing around 1,000 positions globally, with a commitment to a responsible transition for affected employees.
In the first nine months of 2025, international operations sales rose 16%, with GLP 1 diabetes products like Ozempic and Rebajent driving growth in China. Obesity care sales soared 83% to 22.4 billion Danish kena, led by Wegovy's 168% increase across all regions, despite a 4% dip in glep and diabetes sales due to wholesaler inventory shifts.
Novo Nordisk maintains market leadership in diabetes and obesity treatments globally, with significant growth in international operations. Despite increasing competition, unmet needs persist. In the US, sales of GLP-1 diabetes care products and Wegovy increased, driven by Ozempic's uptake and direct-to-patient initiatives. Challenges include Medicaid coverage changes and compounded GLP-1 products. The company continues to expand access and anticipates regulatory decisions for future launches.
Novo Nordisk proposes to acquire MedSra, enhancing its R&D portfolio with advanced treatments for diabetes and obesity. The deal includes a $6.7 billion upfront payment and up to $3.3 billion in contingent value rights, contingent on clinical and regulatory milestones. The acquisition aims to leverage MedSra's expertise in peptide engineering and oral delivery, complementing Novo Nordisk's strengths, and underscores the company's commitment to innovation and US investment.
The dialogue highlights strategic acquisitions and pipeline developments targeting diabetes, obesity, and rare diseases. Acquiring Acura, Omeros, and Cell Nipa introduces therapies like Fluxy Fermin for F4c.r.o. is population and Cenipa for rare blood and kidney disorders. Internal advancements include Caquintesi for obesity, showing significant weight loss with manageable side effects. These moves aim to address unmet medical needs, optimize treatment options, and leverage expertise in rare disease and obesity treatments.
The dialogue outlines significant advancements and upcoming milestones in clinical trials, including Phase Ii studies for obesity and type 2 diabetes, Phase I results for a novel GLP one Tri agonist, and pivotal trials for Caco Sema. It also highlights regulatory submissions, FDA decisions, and progress in Alzheimer's disease and hemophilia treatments, with a focus on the first half of 2026.
In Q3 2025, sales grew in Danish Krona with a decrease in gross margin to 81.0% due to restructuring costs and asset impairments. Operating profit and net profit increased, with free cash flow at 63.9 billion Danish Krona, reflecting higher capital expenditures. Shareholders received returns mainly through dividends.
The dialogue outlines a revised financial forecast for 2025, highlighting sales growth expectations, profit targets, and the impact of strategic acquisitions. It discusses the effects of exchange rates, competition, and regulatory changes on sales and operating profits. Key points include sales growth at constant exchange rates, restructuring costs, and the anticipated impact of acquisitions on R&D expenses and free cash flow. The summary also touches on the implications of the Inflation Reduction Act and patent expiries on global sales growth.
Discussed strategic initiatives to regain market share in diabetes and obesity, emphasizing new product launches, commercial partnerships, and market expansion. Addressed capital planning, including acquisitions, CapEx, and dividends, highlighting the importance of balancing investor priorities with strategic growth investments.
Speakers outline a consistent capital allocation framework prioritizing investments for attractive returns, steady dividends, and share buybacks with excess cash, emphasizing organic and inorganic growth opportunities.
A query about clinical differentiation between acquired assets and internal pipeline, focusing on dosing angles and other factors. Inquiry confirmed regarding FTC contact with Novo concerning MESA, with no further details provided.
The company expresses excitement over its existing pipeline but recognizes the need for expansion to address the multifaceted nature of obesity. An acquisition proposal is highlighted for its potential to complement current assets, offering differentiated solutions to cater to the diverse needs of patients suffering from obesity and related comorbidities. This strategic move aims to strengthen the company's long-term strategy by broadening its therapeutic offerings.
Speakers discuss the due diligence process and express confidence in the deal's compliance with regulations, emphasizing the role of external experts. The dialogue also mentions Medicare coverage as an opportunity.
Discussion highlights the importance of Medicare access for obesity medicines, targeting millions of Medicare-aged individuals with obesity. Also, addresses IRA's effect on CMS pricing, maintaining confidentiality until official CMS announcement.
Discusses market dynamics in IO, highlighting successful markets and challenges, emphasizing long-term potential and the impact of regulatory environments. Also addresses setbacks in US device strategy, questioning its future relevance in consumer channels and product launches.
The dialogue covers updates on FlexTouch's timeline with FDA dialogues, a setback in receiving CRL, and exploration of future devices for market entry to enhance optionality in growth areas.
The dialogue discusses the strategic planning for launching an oral obesity medication, emphasizing its competitive advantages and accessibility through various channels. It also touches on high-level financial outlooks, including grossing metrics and EBIT projections, aiming to provide insights into future market positioning and performance expectations.
The dialogue outlines the factors influencing next year's sales growth, emphasizing the non-repeating gross to net favorability, the impact of losing exclusivity in certain ion targets, the potential of a new vehicle launch pending FDA approval, and the effect of increased R&D costs related to the Akio transaction on operating profit growth.
A query explores the unique features of Met Sarah Martin compared to Novo's pipeline, seeking clarification on differentiating factors beyond monthly dosing. Another inquiry addresses Novo's strategy regarding the Evoke trial data presentation, questioning the likelihood of canceling the CTG presentation if results are negative.
A discussion highlighted the company's interest in data complementarity within its pipeline, emphasizing efficacy, safety, scalability, and dosing frequency as key areas. The speaker stressed the importance of transparent data disclosure, noting that internal data knowledge triggers immediate corporate announcements. The dialogue ended with a clear stance on data presentation at CA in the near future.
Discussion focuses on maintaining segmented pricing across different healthcare channels amidst new policies and enhancing access to obesity medications through payer negotiations and cash offerings.
Discusses obstacles in commercial obesity treatment channels, including demand, access, and insurance barriers, and addresses risk concerns regarding a deal structure that could lead to limited control and benefit.
The speaker expresses strong belief in the value of Messera's assets and the robustness of the acquisition deal structure, emphasizing legal compliance and high potential returns. They highlight the quality of the data and science backing the portfolio, asserting significant value in all scenarios, even if only a portion of shares is retained.
Discussion centered on expanding telehealth services, emphasizing partnerships for broader patient access while maintaining FDA compliance. Addressed concerns over unapproved APIs from China, highlighting the need for secure pharmaceutical sourcing. Pricing strategies were explored in response to potential Medicaid and commercial payer coverage challenges, focusing on balancing rebates and pricing to enhance reimbursement.
The dialogue focuses on improving patient access to medications by reducing barriers such as prior authorization criteria, while also discussing preparations for launching drugs globally, including considerations for different markets and balancing US and international launch processes. Key topics include differentiating products through clinical trials, potential for superiority in weight loss outcomes, and leveraging cardiovascular benefits to stand out against competitors.
The dialogue highlights the priority of launching WeGoVP in the US, with plans to expand into selected markets based on progress and telehealth advancements. It emphasizes leveraging global experience, particularly in Europe and Australia, to accelerate the launch. The focus remains on addressing unmet needs in diabetes, obesity, and associated conditions, driving innovation and commercial execution for better patient treatment.
要点回答
Q:What are the main topics covered in the Q3 2025 Novo Nordis earnings conference call?
A:The main topics covered in the Q3 2025 Novo Nordis earnings conference call include a presentation by the CEO on strategic aspirations, an update on sales and growth, a narrowing of guidance range for sales and operating profit, a focus on core areas of diabetes and obesity, and a discussion on the company's strategy and initiatives in these areas. There is also a mention of the discontinuation of non-core assets and the transformation program to simplify the operating model and reallocate resources.
Q:What is the updated guidance range provided during the call?
A:The updated guidance range provided during the call is narrowed to Ed to Ed on sales and Ed to Ed for operating profit.
Q:What is the current strategic focus of Novo Nordis?
A:The current strategic focus of Novo Nordis is on diabetes and obesity, with a commitment to identify and solve major unmet medical needs in these areas. The company aims to develop products that help affected individuals live healthier lives, combining internal development with partnerships and acquisitions. They intend to concentrate on areas where they can make the greatest difference.
Q:What changes have been made to the company's focus and operating model?
A:The company has made changes to its focus by sharpening its concentration on core areas of diabetes and obesity, discontinuing several non-core assets, and reallocating resources to areas aligned with the company's strengths. Additionally, a company-wide transformation has been initiated to simplify the operating model, accelerate decision-making, and reallocate capital and resources towards high growth opportunities in diabetes and obesity.
Q:What is the expected outcome of the company's transformation program?
A:The expected outcome of the company's transformation program is to simplify the operating model, accelerate decision-making, reallocate capital and resources towards high growth opportunities, and generate savings to be reinvested in the diabetes and obesity franchises and strategic priorities. This is expected to drive approximately Ed billion DKK in annual savings by the end of the next year and improve operational efficiency.
Q:How did the company's sales perform in the first nine months of 2025?
A:In the first nine months of 2025, the company's total sales increased by 15%, with both operating units contributing to growth. US operations grew by 15%, while international operations grew by 16%. GLT 1 sales in diabetes increased by 13%, and insulin sales increased by 3%. Viscer care sales increased by 41%, driven by strong performance in US operations. Red disease sales also increased by 13% due to growth in both the US and international operations.
Q:What is the market share position of Novo Nordis in the diabetes and obesity market internationally?
A:Novo Nordis remains the market leader in the diabetes and obesity GLP-1 market internationally with a volume market share of 68%. Ozempic is the leading GLP-1 diabetes product within international operations, available in around 60 countries. Novo Nordis is now working on expanding access to its products in various regions.
Q:What recent developments have been made in the US operations of Novo Nordis?
A:Recent developments in US operations include a 14% increase in sales of GLP-1 diabetes care products and a 20% increase in Wegovy sales. Ozempic saw a weekly prescription growth, and Wegovy's sales were driven by increased volumes. Novo Nordis has established a sales force targeting US hepatologists and gastroenterologists for Wegovy and is investing in direct to patient initiatives. The company has also announced the launch of Novocaine Pharmacy and continues to work on expanding access to Wegovy.
Q:How will the acquisition of Met SRA benefit Novo Nordisk's portfolio?
A:The acquisition of Met SRA is expected to further strengthen Novo Nordisk's research and development portfolio in diabetes and obesity, providing a broad and deep portfolio with different treatment options and formats to cater to various patient groups' needs. It includes potential best-in-class treatments and innovative assets in the pipeline that complement Novo Nordisk's core strengths in research.
Q:What is the proposed deal structure for the acquisition of Met SRA?
A:The proposed deal structure includes an upfront payment of $6.7 billion in cash per share in exchange for nonvoting preferred stock. Additionally, up to $10 billion in contingent value rights (CVRs) will be issued upon the closing of the acquisition in exchange for the remaining shares.
Q:What is the significance of the F 4 population in the context of the acquisition and how does the proposed treatment complement the strategic position in Novo Nordisk's pipeline?
A:The F 4 population represents a significant unmet need in the field of fibrosis for which no approved therapies are currently available. The potential of a treatment like fluxy fermin, which is being developed for this population, is to be first to market and best in class, complementing Novo Nordisk's strategic position in their pipeline and addressing the needs of patients who are not responsive to existing treatments.
Q:What recent phase II data were encouraging for the new obesity treatment candidate?
A:The phase II data for a fluxim fermin, a potential first to market and best in class treatment for obesity, were encouraging. Specifically, the symmetry phase IB trial showed that after one week of treatment, 40% of patients improved by at least one fibrosis stage without fibrosis worsening and 20% achieved mesh resolution with fibrosis.
Q:What are the potential clinical applications and future milestones for the new drug candidate mentioned in the speech?
A:The new drug candidate, a once weekly subcutaneous fGF21 analog, is in the Phase 3 Synchrony program with pivotal readouts expected in the coming years, aiming for a launch by the end of this decade. It has the potential to be first in class for Fj Fj 21 analogs targeting the A4 population and to play a role in treating true and free patients. Future milestones include beginning a global phase 3 program for the rare blood disease acquired from Emergent.
Q:How does the acquisition of a clinical-stage MFE inhibitor align with Novo Nordisk's strategy?
A:The acquisition of the clinical-stage MFE inhibitor, which is in phase 2 for a rare blood disorder, aligns with Novo Nordisk's strategy to focus on rare blood disorders. The molecule has potential in various additional indications within rare diseases and kidney disorders and is in line with the company's comprehensive approach to these conditions.
Q:What are the results and expectations for the new internal pipeline candidates mentioned?
A:The new internal pipeline candidate, caquinte, focusing on weight loss, showed an impressive 11.8% weight loss at 12 weeks in the trial, with well-tolerated side effects. First phase Ii data are encouraging and further studies with higher doses are anticipated to start in the first half of 2026. Notably, the full results of the reimagined one pivotal trial for caqui insight will be presented later this year.
Q:What are the upcoming R&D milestones that Novo Nordisk is looking forward to?
A:Novo Nordisk is looking forward to several key R&D milestones, including the readout of the reimagined free pivotal trial for Caco Sema in type 2 diabetes, the Phase Ii results of the shock tens and oral amere in type Ii diabetes, and the initiation of additional studies evaluating higher doses of covalent site in the first half of 2026.
Q:What is the expected FDA decision regarding the new drug application for the Go Pi and what other significant developments are anticipated in 2026?
A:The expected FDA decision regarding the new drug application for the Go Pi is by the end of the year. Other significant developments in 2026 include regulatory approval in the US and EU for a once monthly, once every two weeks, and once weekly prophylaxis to prevent or reduce bleeding episodes in people with hemophilia A without inhibitors, and the anticipated results of the book trials in patients with early Alzheimer's disease.
Q:How did Novo Nordisk's sales and profitability perform in the first quarter of 2025?
A:In the first quarter of 2025, sales grew by 12% in Danish krona and 8% at constant exchange rates, driven by both operating units. The gross margin decreased to 81.0% from 84.6% in the previous year, primarily due to one-off restructuring costs and impairments related to production assets. Net profit and diluted earnings per share increased, and free cash flow was 63.9 billion Danish kroner compared to 71.8 billion in the first quarter of 2024.
Q:What is the updated sales growth outlook for 2025 and what factors are influencing it?
A:The updated sales growth outlook for 2025 is 8% to 11% at constant exchange rates, which is lower than previous expectations due to the current exchange rate against the Danish krone. Sales growth in international operations is expected to be around 4 percentage points lower than constant exchange rates. The outlook is based on current prescription trends for semaglutide and osexaparine, and intensifying competition and pricing pressure within diabetes and obesity.
Q:How is the compound patent expiry of semaglutide molecule expected to impact global sales growth?
A:The compound patent expiry of the 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.
Q:What strategic initiatives are being considered to address the loss of market share in the combined obesity and diabetes market?
A:To address the loss of market share, strategic initiatives include focusing the company's strategy around diabetes and obesity due to a看到巨大的发展前景,扩大产品管线通过自家活动和并购,以及通过与Costco、Walmart、GoodRx和Live MD Row等公司合作来扩大市场。
Q:What is the company's capital allocation framework?
A:The company's capital allocation framework involves investing in the business for an attractive return, maintaining a consistent dividend payout, funding pipeline additions through acquisitions, and finally, if there is excess cash, sharing it back with the shareholders through share buybacks.
Q:Where does the company see clinical differentiation between the assets being looked at for acquisition and its own assets?
A:The company views clinical differentiation between the assets being looked at for acquisition and its own assets as primarily complementary, enhancing the company's ability to serve a full range of patients suffering from obesity and their comorbidities. The assets are seen as differentiated and complementary to the company's product portfolio.
Q:Can the company confirm it has been contacted by FTC for information relating to Meme?
A:The company confirmed that it has been contacted by the FTC for information relating to Meme, but they chose not to provide any further details on the process at this stage, mentioning that they will conduct comprehensive due diligence to ensure compliance with laws and regulations.
Q:What is the company's view on the potential impact of Medicare and the next steps on IRA?
A:The company is awaiting the outcomes regarding broader coverage of people with obesity under Medicare and the potential impacts of the next steps on IRA, as mentioned in a press release. They are not providing specific comments at this stage.
Q:Can the company discuss the potential impact of the expected announcement by CMS regarding drug prices?
A:The company is under strict confidentiality with CMS and cannot speculate or comment on the potential impact or the actual prices that CMS will announce in the near future.
Q:What could be the reasons for Gilead's outperformance compared to Lilly in the obesity market?
A:The reasons for Gilead's outperformance in the obesity market compared to Lilly could be attributed to commercial execution across the country or possibly due to prioritization of products. The market dynamics are such that while Gilead has performed well in some markets, they have faced challenges in others, particularly due to competitive disadvantages such as not having launched previous versions of obesity drugs in China and facing online sales restrictions for their competitor's drug. Gilead's performance in markets like the UK, where their share of growth has surpassed competitors', indicates that market conditions are dynamic and change over time.
Q:What are the setbacks and future plans for the device strategy, specifically regarding the flex touch and its FDA interactions?
A:The company has received a Complete Response Letter (CRL) for the flex touch and are assessing other devices including vials that they plan to bring to market for more optionality, especially as they continue to grow in the cash channel. They are in active dialogue with the FDA regarding the flex touch but cannot specify a timeline at this point.
Q:What is the company's readiness for the approval of the oral obesity pill and their strategy for market competitiveness?
A:The company is incredibly excited as they move closer to the approval date for the oral obesity pill. They cannot comment on specific pricing but intend to make the drug available in all channels, including Medicaid, Medicare, commercial, and cash through various telehealth partnerships and their own pharmacies. They are focusing on competitiveness with respect to efficacy and tolerability and are looking forward to bringing this to people living with obesity in the US.
Q:Can Novo provide an update on next year's sales growth guidance considering the current market dynamics?
A:Novo does not typically provide guidance for the next year. However, they acknowledge that current momentum is a foundation for future business trends. They note specific factors such as loss of exclusivity, gross-to-net favorability this year which won't repeat, and the impact of new product launches and a pending acquisition that will affect next year's sales growth and operating profit growth.
Q:Would Novo cancel the CTG presentation if the results are unequivocally negative?
A:The question raised whether Novo would cancel the CTG presentation if the results were unequivocally negative. The speaker referred to an upcoming event at the beginning of the next month where they aim to present data they have collected. However, they did not directly confirm whether they would cancel the presentation in the event of negative results.
Q:What data differentiation does the company see between the metform agents and its own pipeline candidates?
A:The company sees complementarity and differentiation in the metform agents compared to its own pipeline based on data on efficacy, safety, scalability, and dosing frequency. However, they emphasize that they do not have the actual data in-house and would be required to issue a corporate announcement immediately if they did. They intend to disclose any data, whether good or bad, at a future event.
Q:What are the expectations regarding maintaining segmented pricing by channel?
A:The company historically has been able to maintain different prices in different channels such as Medicaid, Medicare, and commercial, as well as through the increasingly expanding cash channel. However, they cannot speculate on future pricing dynamics.
Q:What is the company's view on the current access picture for their products?
A:The company recognizes the challenge of receiving obesity medication due to friction in the marketplace and continues to push for and invest in improved access. They are focusing on cash offerings and的合作关系, but have not seen a large uptake yet. They expect access to remain largely unchanged in 2026 due to budget constraints with payers potentially leading to coverage losses.
Q:What are the perceived obstacles to better penetration in the commercial channel for obesity treatments?
A:The obstacles to better penetration in the commercial channel for obesity treatments could be on either the demand side due to a lack of demand beyond a motivated minority, or on the access side, such as insurance companies making it difficult for patients to start or remain on therapy.
Q:What is the company's level of comfort with the risk associated with the deal structure for their assets?
A:The company feels comfortable with the risk associated with the way they are structuring their offers because they believe in the quality of the assets and the data supporting their value. They have confidence in the data they have and have discussed the deal structure with external counsels and experts, ensuring it aligns with legal standards. They believe that even owning 50% of the shares would be valuable if the products perform as expected.
Q:How does the company anticipate changes in coverage and pricing with potential Medicaid and commercial payer issues?
A:The company anticipates pressure from payers and continues to face challenges with price in GLP 1 and obesity treatment categories. However, they are focused on increasing access and reducing utilization management and prior authorization criteria to improve patients' experiences in obtaining their medicine. They expect to see some changes in Medicaid and not as much in the commercial channel. They do not expect a large difference in access within the commercial channel but recognize the need to invest in quality of access and continue to see potential in the commercial opportunity.
Q:What are the company's plans for the U.S. and international markets with their product launches?
A:The U.S. is the priority market for the company's We Go VP launch, which will remain the focus through 2026. However, they are also preparing to open the option to launch in selected international markets (Io) depending on how things ramp up. They are transferring knowledge from the payor channels in the U.S. to the international markets and are very active in many markets worldwide, leveraging their experience on telehealth and oral markets to build a position with We Go VP. The priority remains on the U.S., but they are fully ready to take on selected markets in the IO region when the time comes.

Novo Nordisk A/S
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