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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F
(Mark One) | | | | | | | | |
o | | REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| | OR |
x | | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| | For the fiscal year ended December 31, 2023 |
| | OR |
o | | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| | OR |
o | | SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number: 333-82318
NOVO NORDISK A/S
(Exact name of Registrant as specified in its charter) | | | | | |
Not applicable | The Kingdom of Denmark |
(Translation of Registrant’s name into English) | (Jurisdiction of incorporation or organization) |
Novo Alle 1
DK-2880 Bagsværd
Denmark
(Address of principal executive offices)
Karsten Munk Knudsen
Executive vice president and chief financial officer
Tel: +45 4444 8888
E-mail: kmkn@novonordisk.com
Novo Alle 1, DK-2880 Bagsværd, Denmark
(Name, Telephone, E-mail and Address of Company Contact Person) | | | | | | | | | | | |
Securities registered or to be registered pursuant to Section 12(b) of the Act: | |
Title of each class: | Trading Symbol(s): | Name of each exchange on which registered: | |
B shares, nominal value DKK 0.10 each | | New York Stock Exchange* | |
American Depositary Receipts, each representing one B Share | NVO | New York Stock Exchange | |
* Not for trading, but only in connection with the registration of American Depositary Receipts, pursuant to the requirements of the Securities and Exchange Commission. |
Securities registered or to be registered pursuant to Section 12(g) of the Act: None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the Annual Report: | | | | | |
A shares, nominal value DKK 0.10 each: | 1,074,872,000 | |
B shares, nominal value DKK 0.10 each: | 3,435,128,000 | |
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes x No o
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports to Section 13 or 15(d) of the Securities Exchange Act of 1934.
Yes o No x
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes x No o
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer”, “accelerated filer”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer x Accelerated filer o Non-accelerated filer o Emerging growth company o
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.x
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. o
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). o
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filling:
U.S. GAAP o International Financial Reporting Standards as issued by the International Accounting Standards Board x Other o
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow:
Item 17 o Item 18 o
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No x
1
| | | | | |
| Novo Nordisk Form 20-F 2023 |
INTRODUCTION
In this Form 20-F the terms ‘the Company’, ‘Novo Nordisk’ and ‘the Group’ refer to the parent company Novo Nordisk A/S together with its consolidated subsidiaries. The term ‘Novo Nordisk A/S’ is used when addressing issues specifically related to this legal entity.
Pursuant to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, certain information for the 2023 Form 20-F of Novo Nordisk A/S set out herein is being incorporated by reference from the Company's statutory Annual Report 2023, including the consolidated financial statements of Novo Nordisk A/S (hereafter “Annual Report 2023”) and the Company’s Remuneration Report 2023 as specified elsewhere in this Form 20-F (with the exception of the items and pages so specified, the Annual Report 2023 and Remuneration Report 2023 are not deemed to be filed as part of this Form 20-F). Therefore, the information in this Form 20-F should be read in conjunction with the Annual Report 2023 and the Remuneration Report 2023 (see Exhibits 15.1 and 15.3, respectively)
The Company publishes its financial statements in Danish kroner (DKK).
Novo Nordisk conducted a stock split whereby the trading unit of the Novo Nordisk B shares listed on NASDAQ OMX Copenhagen was changed from DKK 0.20 to DKK 0.10 as of September 13, 2023. The American Depositary Receipts (ADRs) listed on the New York Stock Exchange (NYSE) were similarly split as of September 20, 2023, to ensure that the ratio of B shares to ADRs remains 1:1. Historical data and comparative disclosures in this Form 20-F and our Annual Report 2023 have been adjusted to reflect the stock split.
Forward-looking statements
The information set forth in this Form 20-F contains forward-looking statements as the term is defined in the U.S. Private Securities Litigation Reform Act of 1995.
Words such as ‘believe’, ‘expect’, ‘may’, ‘will’, ‘plan’, ‘strategy’, ‘prospect’, ‘foresee’, ‘estimate’, ‘project’, ‘anticipate’, ‘can’, ‘intend’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to:
•statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk’s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto,
•statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures,
•statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and
•statements regarding the assumptions underlying or relating to such statements.
With reference to our Annual Report 2023, examples of forward-looking statements can be found under the heading 'Strategic Aspirations' in our Annual Report 2023 and elsewhere. These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in our Annual Report 2023, could cause actual results to differ materially from those contemplated in any forward-looking statements.
Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, such as interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, including as a result of interruptions or delays affecting supply chains on which Novo Nordisk relies, shortages of supplies, including energy supplies, product recalls, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk’s products, introduction of competing products, reliance on information technology including the risk of cybersecurity breaches, Novo Nordisk’s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, strikes and other labour market disputes, failure to recruit and retain the right employees, failure to maintain a culture of compliance, epidemics, pandemics or other public health crises, effects of domestic or international crises, civil unrest, war or other conflict, and factors related to the foregoing matters and other factors not specifically identified herein.
For an overview of some, but not all, of the risks that could adversely affect Novo Nordisk's results or the accuracy of forward-looking statements in this document, reference is made to the overview of risk factors in ‘Risk management’ on pages 41-42 of our Annual Report 2023. Unless required by law, Novo Nordisk has no duty and undertakes no obligation to update or revise any forward-looking statement after the date of this document, whether as a result of new information, future events or otherwise.
Enforceability of civil liabilities
The Company is a Danish corporation and a majority of its directors and officers, as well as certain experts named herein, are non-residents of the United States. A substantial portion of the assets of Novo Nordisk A/S, its subsidiaries and such persons are located outside the United States. As a result, it may be difficult for shareholders of the Company to effect service within the United States upon directors, officers and experts who are not residents of the United States or to enforce judgments in the United States. In addition, there can be no assurance as to the enforceability in Denmark against the Company or its respective directors, officers and experts who are not residents of the United States, or in actions for enforcement of judgments of United States courts, of liabilities predicated solely upon the federal securities laws of the United States.
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| Novo Nordisk Form 20-F 2022 |
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ITEM 1 IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISORS |
PART I
ITEM 1 IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2 OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3 KEY INFORMATION
A. [RESERVED]
B. CAPITALIZATION AND INDEBTEDNESS
Not applicable.
C. REASONS FOR THE OFFER AND USE OF PROCEEDS
Not applicable.
D. RISK FACTORS
For information on risk factors, reference is made to ‘Risk management’ on pages 41-42 of our Annual Report 2023, excluding the section ‘Mitigating actions’ on page 42. Outlined in greater detail below, we are subject to cybersecurity risks and the risk related to climate change.
The potential risk on our business as a result of cybersecurity breaches
We rely on our IT systems to protect our intellectual property, business confidential information, and personal data. Therefore, disruption as a result of cybersecurity breaches could negatively impact the Company’s business and operations or financial results.
IT systems act as a backbone for the Company. They support processes in research & development, manufacturing, sales and supply, and business administration. As we are a global company, the size and complexity of our IT systems are significant, and our IT infrastructure and networks are spread across the geographic regions in which we operate. The dedicated cybersecurity teams who operate our global IT security infrastructure may be unable to respond sufficiently to the threats facing us or may fail to prevent service interruptions or security breaches resulting from attacks by malicious third parties. Many of these cyber threats have the potential to cause significant downtime of critical IT systems or the unintended disclosure of confidential information and personal data. Although we have not previously experienced material losses as a result of such incidents, we cannot guarantee that we will be able to prevent similar incidents from occurring or adversely affecting our business in the future.
We are subject to data privacy regulation in the EU (including the General Data Protection Regulation) and to privacy laws in many other jurisdictions where we do business that impose obligations and restrictions on the collection and use of personal data. In the ordinary course of the Company’s business, it collects and stores personal data (including sensitive personal data) of patients, health care professionals, employees and other third parties.
Many third-party vendors provide support services in relation to our business processes and require access to sensitive information (including personal data) in the course of their work. Such vendors could themselves be susceptible to cybersecurity or personal data breaches. Any unauthorized access, disclosure, or other loss of personal data could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, and significant regulatory penalties, disrupt the Company’s operations and damage the Company’s reputation.
The potential risk on our business as a result of failure to meet regulatory or ethical expectations on environmental impact, including climate change
Climate change has global implications and poses a significant threat to human health and development. Companies are increasingly expected to behave in a responsible manner on a variety of environmental matters, by governmental and regulatory authorities, counterparties, such as vendors and suppliers, customers and investors. In particular, we recognize the environmental issues related to the pharmaceutical industry.
At Novo Nordisk, climate-related risks are identified and assessed through our risk management process. The risk assessment includes a natural hazards risk rating of supplier locations, provided by external insurance companies. The risk rating is related to
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various parameters, including natural events such as flooding, earthquakes, high-speed winds, tornados, hail storms, and lightning. The risk assessment serves to provide input for risk mitigation, and consequently prioritize actions to prevent or minimize the impact of supply disruptions on manufacturing.
The Company’s main production facilities are located in Denmark, where the risk of natural events is assessed lower; however, the Company also has other production facilities in countries that are at greater risk of natural disasters. For example, our production facility in Koriyama, Japan is exposed to a higher risk of earthquakes, our production facility in Tianjin, China is located in an area prone to storm surges due to rising sea levels and our production facility in North Carolina, United States is exposed to a higher risk of tornadoes and subsequent rainfall and lightening. In addition, availability of high-quality water is essential for the production of diabetes and biopharmaceutical products and hence the Company’s operations. The Company has production facilities in countries with high water stress levels or high seasonal variations, such as France, Brazil, China, United States, Iran and Algeria.
Despite our commitment to identify climate-related risks, we could be unable to meet our environmental objectives in an efficient and timely manner, or at all. Since 2020, all our production sites have sourced 100% renewable power; however, our CO2e emissions continue to rise as the company grows, in particular within Scope 3. We are committed to achieving net zero emission by 2045, and we have an interim target to reach zero CO2e emissions from operations and transport by 2030. To achieve this goal, we must also ensure our 60,000-plus suppliers play their part in this transformation, since their activities account for the majority of our total CO2e emissions. Our target is that all goods and services from suppliers will be based on 100% renewable power by 2030, which is an important milestone in achieving our greater net zero commitment.
Factors that may inhibit our ability to reach these targets or failure to maximize our environmental sustainability credentials could expose us to increased regulatory risk and put us at a commercial disadvantage relative to our peers. This could result in a material adverse effect on our business, financial condition, results of operations and prospects and lead to reputational damage.
ITEM 4 INFORMATION ON THE COMPANY
A. HISTORY AND DEVELOPMENT OF THE COMPANY
Novo Nordisk A/S was formed in 1989 by a merger of two Danish companies, Nordisk Gentofte A/S and Novo Industri A/S. Novo Industri A/S was the continuing company and its name was changed to Novo Nordisk A/S. The business activities of Nordisk Gentofte were established in 1923 by August Krogh, H. C. Hagedorn and A. Kongsted, and the business activities of Novo Industri A/S were established in 1925 by Harald and Thorvald Pedersen. From the beginning, the business of both companies was the production and sale of insulin for the treatment of diabetes.
Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (NOVO-B). Its ADRs are listed on the New York Stock Exchange (NVO).
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Legal name: | | Novo Nordisk A/S |
Commercial name: | | Novo Nordisk |
Date of incorporation: | | November 28, 1931 |
Legal form of the Company: | | A Danish public limited liability company |
Legislation under which the Company operates: | | Danish law |
Country of incorporation: | | Denmark |
Reference is made to ‘More information', on page 100 of our Annual Report 2023 for information on domicile.
Important events in 2023
Reference is made to ‘Introducing Novo Nordisk’, pages 3-9 and ‘2023 performance and 2024 outlook’, pages 34-37 of our Annual Report 2023 for a description of important events in 2023.
Capital expenditure in 2023, 2022 and 2021
For capital expenditure in 2023, 2022 and 2021, reference is made to the section entitled ‘Cash flow and capital allocation’ on page 36 of our Annual Report 2023. No significant divestments took place in the period from 2021–2023.
For capital expenditures expected in 2024, reference is made to page 37 in the subsection ‘2024 outlook’ in our Annual Report 2023. Such expenditures are expected to be financed with cash flow from operating activities.
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ITEM 4 INFORMATION ON THE COMPANY |
Public takeover offers in respect of the Company’s shares
No such offers occurred during 2023 or 2024 to date.
B. BUSINESS OVERVIEW
Reference is made to the sections 'Novo Nordisk at a glance' on page 6 and ‘Strategic Aspirations’ on pages 10-39 of our Annual Report 2023.
Novo Nordisk is a global healthcare company and a world leader in Diabetes and Obesity care. The Company manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. Headquartered in Denmark, Novo Nordisk employs more than 60,000 employees in 80 countries, and markets its products in approximately 170 countries.
The Company has a broad product portfolio across Diabetes and Obesity care and Rare disease, including a full portfolio of glucagon-like-peptide-1 (GLP-1) receptor agonists for the treatment of diabetes and obesity, modern insulins and human insulins. During 2023, there has been continued strong growth across therapy areas and geographic areas in which Novo Nordisk operates.
Combined with higher than expected demand, and temporary capacity limitations at some of our manufacturing sites, there have been periodic supply constraints for certain products, including the leading product by sales, Ozempic® for the treatment of type 2 diabetes1. The Company also markets two drugs - Saxenda® and Wegovy® - for the treatment of people with obesity. In it's third year after launch the GLP-1 product, Wegovy, grew more than 400% to DKK 31 billion. Further, Novo Nordisk has a Rare disease portfolio consisting mainly of growth hormone and hemophilia products.
From August to October 2023, Novo Nordisk acquired 100% of the share capital of a French company. Biocorp Production S.A., and its subsidiaries (Biocorp), whose primary assets are patents and know-how related to Mallya, a Bluetooth enabled add-on device that can be used in administering doses for injection pens and provide data for doctors and patients on correct dosing. The purchase price of the asset acquisition was approximately EUR 154 million.
In September 2023, Novo Nordisk completed the acquisition of a Canadian company Inversago Pharma Inc. (Inversago), whose primary asset, INV-202, is currently in phase 2. The asset is focused on the development of peripherally acting Cannabinoid (CB1) receptor blocker therapies which have potential to treat people living with obesity, diabetes, metabolic and fibrotic diseases. The purchase price of the asset acquisition was approximately USD 600 million with additional contingent payments of USD 475 million. Novo Nordisk also agreed to acquire the asset Ocedurenone for uncontrolled hypertension with potential application in cardiovascular and kidney disease from KBP Biosciences PTE., Ltd. in 2023. The purchase price of the asset acquisition was USD 800 million with additional contingent payments of USD 500 million.
Segment information
Novo Nordisk is engaged in the discovery, development, manufacturing and marketing of pharmaceutical products and has two business segments: (i) Diabetes and Obesity care and (ii) Rare disease. Reference is made to Note 2.2 ‘Segment information’ in our Annual Report 2023.
Seasonality
Sales of individual products in individual markets may be subject to fluctuations from quarter to quarter. However, the Company’s consolidated operating results have not been subject to significant seasonality.
Raw materials
The impact on the overall profitability of Novo Nordisk from variations in raw material prices is unlikely to be significant. Currently, there is no raw material supply shortage that is expected to significantly impact the Company’s ability to supply any significant market. Regarding the 2023 capacity constraints, reference is made to page 33 of the Annual Report 2023. Periodic supply constraints and related drug shortage notifications across a number of products and geographies are expected to continue in 2024. The supply capacity is gradually being expanded.
Market and competition
Novo Nordisk’s insulin and other pharmaceutical products are marketed and distributed through subsidiaries, distributors and independent agents each responsible for specific geographic areas. The Company’s financial reporting is divided into: EMEA (covering Europe, the Middle East and Africa), Region China (covering Mainland China, Hong Kong and Taiwan), Rest of World (covering all other
1 Product indications described in this Form 20-F are composite summaries of the major indications approved in the product’s principal markets. Not all indications are necessarily available in each of the markets in which the products are approved. The summaries presented herein for the purpose of financial reporting do not substitute for careful consideration of the full labelling approved in each market.
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ITEM 4 INFORMATION ON THE COMPANY |
countries except for North America) and North America (covering the United States and Canada). For 2023, the Company's most important markets in terms of sales were the United States, China, Japan, Canada, and the major European countries.
Due to the increasing number of people with diabetes, the global pharmaceutical market for treatment of diabetes continues to grow. Several of the major international pharmaceutical companies have entered the diabetes market, specifically in the area of oral products for the treatment of type 2 diabetes. In the global insulin market, Novo Nordisk, Eli Lilly and Sanofi are the most significant companies measured by market share.
The use of GLP-1 as a treatment option for people with type 2 diabetes has continued to increase resulting in significant growth of the GLP-1 market. Novo Nordisk and Eli Lilly are the most significant companies in the global GLP-1 market measured by market share.
In February 2018, Novo Nordisk launched the once-weekly GLP-1 product, Ozempic®, for the treatment of adults with type 2 diabetes in the United States and Canada. Since then, Ozempic® has become a market leading product and the Company's best performing product by sales, with global sales of DKK 95.7 billion in 2023.
The global branded obesity market grew 116% by volume in 2023. Wegovy® has been launched in the United States, Denmark, Norway, Germany, the UK, Iceland, Switzerland and the United Arab Emirates.
Market conditions within the pharmaceutical industry continue to change, including efforts by both private and governmental entities to reduce or control costs generally and in specific therapeutic areas. Most of the countries in which Novo Nordisk sells insulin subsidize or control pricing. In most markets insulin and GLP-1 products are prescription drugs.
In recent years, there has been a general trend in the United States of payers managing the cost of diabetes care to exert pressure on the price of Novo Nordisk’s and competitors' products. In spite of this external pressure, Novo Nordisk has maintained a leading position in the overall diabetes care market through the quality and innovation-driven value of the Company’s Diabetes care products. In the United States, pharmacy benefit managers and managed care organizations have continued to leverage their increasing size and control to demand higher rebates which has impacted the net realized prices. Furthermore, competition has intensified, including the authorization of the first interchangeable insulin in 2021, contributing to a downward pressure on manufacturers' net prices.
Patents
To maintain and expand competitiveness, Novo Nordisk strives for the strongest possible protection for those inventions that are created during the development of new products. Novo Nordisk anticipates that the expiration of certain patents could impact sales within the coming years. However, through continued investments in research and development, Novo Nordisk strives to bring novel and innovative products to the market and thereby sustain strong patent protection in the future, as new generations of products replace currently marketed products.
For patent information on all Novo Nordisk’s marketed products, reference is made to the section ‘Patent status for products with marketing authorisation' on page 29 in our Annual Report 2023.
For key products with recent patent expiration or with patent expiration occurring within the coming years, geographic sales splits are provided and factors that may influence the potential impact of competitive product launches are discussed.
Sales of key products with recent or upcoming patent expiration: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Total sales in 2023 (in DKK million) | | North America Operations | | Hereof | | International Operations | | Hereof |
Product | | | | USA | | | EMEA | | Region China | | Rest of World |
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Victoza® | | 8,664 | | | 3,814 | | | 3,613 | | | 4,850 | | | 2,166 | | | 1,256 | | | 1,428 | |
Saxenda® | | 10,289 | | | 3,887 | | | 3,306 | | | 6,402 | | | 3,780 | | | 146 | | | 2,476 | |
Patent situation of key Diabetes and Obesity care products
Today, biosimilar and/or interchangeable versions of insulin can be approved in the United States via the 351(k) pathway. In the EU, a biosimilar pathway and guidelines are available for insulins, and the guideline for biosimilar products issued in Japan is also relevant for insulin. A biosimilar to NovoRapid®/NovoLog® produced by a competitor was launched in 2020. An interchangeable biosimilar for NovoRapid®/NovoLog® produced by a competitor was approved in July 2021. Furthermore, biosimilar insulins are being developed in China by local competitors.
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ITEM 4 INFORMATION ON THE COMPANY |
The total sales of Victoza® were DKK 8,664 million in 2023 (DKK 12,322 million in 2022). The compound patents for Victoza® have expired. In Japan, the drug compound patent expired in 2022; in the U.S. and Germany, the drug compound patent expired in 2023. The drug compound patent expired in China in 2017 and in 2023 a biosimilar version of Victoza® was approved in China.
Novo Nordisk has received notifications from several manufacturers that they have filed Abbreviated New Drug Applications (ANDAs) for liraglutide, the active pharmaceutical molecule in Victoza® and in Saxenda®, respectively, and semaglutide, the active pharmaceutical molecule in Ozempic® and in Wegovy®, respectively, with the FDA. The ANDAs contain Paragraph IV certifications to obtain approval to engage in the commercial manufacture, use or sale of such products before the expiration of some or all of the patents currently listed for those products in the Orange Book. Novo Nordisk has filed complaints for patent infringement against these manufacturers.
Novo Nordisk has entered into settlement agreements with several manufacturers that have filed ANDAs for Victoza®. Consequently, these manufacturers are licensed to launch a generic version of Victoza® as of June 22, 2024, or earlier under certain circumstances. Moreover, Novo Nordisk has entered into settlement agreements regarding the U.S. patent litigation matters for Saxenda®. Novo Nordisk has now also entered into a settlement agreement with Alvogen Inc. regarding the U.S. patent litigation case for Ozempic®. All terms of the agreements are confidential. All agreements are subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
In March 2023, Mylan filed IPRs challenging the validity of the two patents which claim the semaglutide compound. Mylan also filed an IPR challenging the validity of a patent which claims a method of treating Type 2 diabetes using 1 mg of semaglutide. The Patent Trial and Appeal Board did not institute proceedings on the two compound patents, but did institute proceedings on the method of treatment patent. A hearing will take place in July 2024 with a decision by October 2024.
In China, the semaglutide compound patent was subject to invalidation actions and was upheld by the Beijing IP Court in November 2023. This decision has been appealed to the Supreme People's Court where the case is currently pending.
Novo Nordisk will continue to defend its intellectual property associated with liraglutide and semaglutide, including through litigation.
The total sales of obesity care products (Saxenda® and Wegovy®) were DKK 41,632 million in 2023 (DKK 16,864 million in 2022), of which the majority of the sales comes from Wegovy®. The drug compound patent for Saxenda® (liraglutide) has expired in all countries.
Patent expiry in the U.S. for the semaglutide branded products - Ozempic®, Rybelsus®, and Wegovy® - is 2032. For additional information, reference is made to the section 'Patent status for products with marketing authorisation on page 29 of our Annual Report 2023.
Impact of regulation
As a pharmaceutical company, Novo Nordisk depends on government approvals related to production, development, marketing and reimbursement of its products. Important regulatory bodies include the U.S. Food and Drug Administration, the European Medicines Agency, China's National Medical Products Administration and the Japanese Ministry of Health, Labour and Welfare. Treatment guidelines from non-governmental organizations such as the European Association for the Study of Diabetes and the American Diabetes Association may also impact the Company.
Disclosure pursuant to Section 219 of the Iran Threat Reduction and Syria Human Rights Act of 2012
Pursuant to Section 13(r) of the Securities Exchange Act of 1934 "("Section 13("r)"), Novo Nordisk is obliged to disclose if, during 2023, it or any of its affiliates have engaged in certain Iran-related activities or transactions with persons designated under Executive Order 13224 or Executive Order 13382 dealt with the Government of Iran (“GOI”). Novo Nordisk conducts limited business relating to pharmaceutical products and devices within the Diabetes care and Rare disease business segments in Iran, which is permitted under the U.S. sanctions against Iran. Set forth below is a description of the activities and transactions by Novo Nordisk’s subsidiaries that are required to be disclosed pursuant to Section 13(r). Novo Nordisk’s U.S. subsidiaries and U.S. person employees are not involved in any of Novo Nordisk’s activities in Iran. However, the United States maintains broad exceptions that permit the commercial sale and export of medicine and medical devices to Iran or the Government of Iran. Similar exceptions, like those encompassed in section 11 of Executive Order 13902, are also in place for the manufacturing of medicine and medical devices for use in Iran.
Novo Nordisk Pars (“NN Pars”), a wholly-owned subsidiary of Novo Nordisk A/S located in Iran, contracts with a number of companies that may be owned or controlled by the GOI to distribute its products. NN Pars also sponsors educational programs and congresses organized by GOI-controlled medical universities, and hosts and/or engages as scientific delegates or lecturers/speakers health care professionals employed by these medical universities at similar programs in Iran and other locations. Additionally, NN Pars makes
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ITEM 4 INFORMATION ON THE COMPANY |
donations to GOI-controlled public health organizations focusing on diabetes awareness and policy. NN Pars receives payments from, and makes payments to, Iranian banks (some of which may be GOI-owned or controlled) relating to the sales of pharmaceutical products and devices. NN Pars makes payments incidental to its ordinary business activities to Iranian government entities and entities that are or may be GOI-owned or controlled, such as taxes, customs fees, insurance, product registration fees and telecommunications services expenses.
In 2016, NN Pars purchased land from a GOI-owned or controlled holding company in order to construct a manufacturing facility in Iran. The facility opened and officially started production in August 2020 and is being used for assembly and packaging of insulin pens for use in Iran. NN Pars purchases utility services from a GOI-owned or controlled entity.
The German subsidiary of NNE A/S, a wholly-owned subsidiary of Novo Nordisk A/S, previously sold raw materials and spare parts for production of dialysis filters and leucocyte filters and syringes to a GOI-controlled company. This business relationship, however, was wound down during 2018 and the German subsidiary was sold in 2019. NNE A/S received final payment in 2023 from such a GOI-controlled entity related to such sales and there are no longer any outstanding amounts between the parties.
Novo Nordisk’s gross revenue related to transactions with GOI-owned or controlled entities in 2023 was not in excess of 1% of Group sales. Novo Nordisk does not allocate its net profit on a country-by-country or activity-by-activity basis, other than as set forth in Novo Nordisk’s consolidated financial statements prepared in accordance with IFRS as issued by the IASB; however, Novo Nordisk estimates that its net profit attributable to the transactions with the GOI discussed above would not exceed a de minimis percentage of the Group’s total net profit in 2023.
The purpose of Novo Nordisk’s Iran-related activities is to provide access to important and essential pharmaceutical products such as insulin and haemophilia products to patients in Iran, and to improve the healthcare of the Iranian people in accordance with Novo Nordisk’s access to care strategy. For that purpose, and because Novo Nordisk has determined that its activities comply with all applicable laws, Novo Nordisk intends to continue these activities (including local production of these products in Iran).
C. ORGANIZATIONAL STRUCTURE
For information regarding the organizational structure and securities exchange listings of Novo Nordisk A/S, the main shareholder Novo Holdings A/S and the Novo Nordisk Foundation and the ownership structure of Novo Nordisk A/S, reference is made to the sections ‘Corporate Governance’ on pages 19-22 and ‘Shares and capital structure’ on pages 38-39 of our Annual Report 2023.
Companies in the Novo Nordisk Group are listed in the section ‘Companies in the Novo Nordisk Group’ on page 81 of our Annual Report 2023.
D. PROPERTY, PLANTS AND EQUIPMENT
The Company has its headquarters in Bagsværd, Denmark, where it occupies a number of buildings.
Sales growth in 2023 has resulted in periodic supply constraints and related drug shortage notifications across a number of products and geographies.
Following higher than expected volume growth in recent years, including GLP-1-based products such as Ozempic® and Wegovy®, combined with the expectation of continued volume growth and capacity limitations at some manufacturing sites, the 2024 outlook also reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies . Novo Nordisk is investing in internal and external capacity to increase supply both short and long term.
The supply capacity is gradually increased, including the capacity for meeting growing demand in the future for the products Activelle®, Actrapid®, Alhemo®, Esperoct®, Estrofem®, Fiasp®, Glucagen®, Insulatard®, Kliogest®, Levemir®, MacrilenTM, Mixtard®, Norditropin®, NovoEight®, Novofem®, NovoLog®/ NovoRapid®, NovoLog Mix®/ NovoMix®, NovoNorm®, NovoSeven®, NovoThirteen®/ Tretten®, Ozempic®, Rebinyn®/ Refixia®, Rybelsus®, Ryzodeg®, Saxenda®, Sogroya®, Tresiba®, Trisequens®, Vagifem®, Victoza®, Wegovy®, Xultophy® and devices. Reference is made to the sections ‘Capital expenditures in 2023, 2022 and 2021’ under Item 4 for more information about the current expansion programs. For the nature of the Company’s property, plant and equipment, as of December 31, 2023 and 2022, reference is made to Note 3.2 ‘Property, plant and equipment’ in our Annual Report 2023.
The major production facilities owned by the Company are located at a number of sites in Denmark, and internationally in the United States, France, China and Brazil. There are no material encumbrances on the properties; however, the facilities in Tianjin, China are constructed on land where the remaining term of the leases is 30 and 34 years.
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ITEM 4 INFORMATION ON THE COMPANY |
Active pharmaceutical ingredient (API) production is located in Denmark, primarily in Kalundborg and with secondary locations in Hillerød and Gentofte, both in Denmark, as well as in New Hampshire and North Carolina, United States.
The following table sets forth certain information regarding our major production sites.
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MAJOR PRODUCTION FACILITIES | | Size of production area (square meters) | | Major Production Activities |
Kalundborg, Denmark | | 168,300 | | Active pharmaceutical ingredients for diabetes and obesity as well as products for Diabetes care |
| | | | Active pharmaceutical ingredients for haemophilia. |
| | | | Products for Rare disease |
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Hillerød, Denmark | | 156,900 | | Durable devices and components for disposable devices |
| | | | Products for diabetes and obesity |
| | | | Active pharmaceutical ingredients for haemophilia |
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Bagsværd, Denmark | | 111,200 | | Products for diabetes and obesity |
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Clayton, North Carolina, United States | | 89,000 | | Active pharmaceutical ingredients for diabetes and obesity (purification) |
| | | | Products for diabetes and obesity |
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Gentofte, Denmark | | 70,800 | | Active pharmaceutical ingredients for glucagon and growth hormone therapy |
| | | | Products for growth hormone therapy, glucagon and haemophilia |
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Tianjin, China | | 67,200 | | Products for diabetes |
| | | | Production of durable devices |
| | | | |
Måløv, Denmark | | 60,900 | | Products for hormone replacement therapy |
| | | | Products for oral antidiabetic treatment |
| | | | Products for oral diabetes treatment |
| | | | |
Chartres, France | | 58,700 | | Products for diabetes |
| | | | |
Montes Claros, Brazil | | 56,200 | | Products for diabetes |
| | | | Gel production for active pharmaceutical ingredients |
| | | | |
In December 2021, the Company announced the investment in construction of a new purification facility and a new recovery facility as well as rebuilding of one existing fermentation facility at the production site in Kalundborg, Denmark. The investment will establish additional capacity for manufacturing active pharmaceutical ingredients. The facilities are expected to increase the production area with approximately 59,900 square meters. The facilities are expected to be operational during 2027 and the expected amount of expenditures is DKK 16,500 million with realized spend of DKK 10,801 million as of December 31, 2023. The facilities will be financed by cash flow from operating activities.
In June 2022, the Company announced its investment in an expansion of an existing facility at the production site in Hjørring, Denmark. The investment will increase the capacity for production of NovoFine® Plus needles and is expected to increase the production area by 5,900 square meters. The expansion is expected to be finalized during 2025. The expected amount of expenditures is approximately DKK 560 million with realized spend of DKK 409 million as of December 31, 2023. The expansion will be financed by cash flow from operating activities.
In November 2022, the Company announced its investment in the expansion of its clinical manufacturing facilities in Bagsværd, Denmark. The investment will establish additional capacity in R&D for the manufacturing of active pharmaceutical ingredients to supply the Company’s global clinical trials. The expansion is expected to increase the production area with 7,000 square meters and it is expected to be finalized in 2025. The expected amount of expenditures is DKK 7,400 million with realized spend of DKK 4,111 million as of December 31, 2023. The expansion will be financed by cash flow from operating activities.
In June 2023, the Company announced its investment in expanding an existing API production facility in Hillerød, Denmark. The facility is expected to be operational during 2028 and its production area expected to be 65,000 square meters. The expected amount of expenditures for this facility is approximately DKK 15,900 million with realized spend of DKK 2,342 million as of December 31, 2023. The facility will be financed by cash flow from operating activities.
In November 2023, the Company announced its investment in the expansion of its API production facility in Kalundborg, Denmark. The facility is expected to be fully operational during 2029 and its production area expected to be 170,000 square meters. The expected amount of expenditures for this facility is approximately DKK 42,400 million with realized spend of DKK 2,140 million as of December 31, 2023. The facility will be financed by cash flow from operating activities.
In November 2023, the Company announced the investment in an expansion of an existing facility at the production site in Chartres, France. The investment will significantly increase the capacity of the manufacturing site, adding aseptic production and finished
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| Novo Nordisk Form 20-F 2023 |
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ITEM 4 INFORMATION ON THE COMPANY |
production processes and an extension of the current Quality Control Laboratory. The facility is expected to be gradually finalized from 2026 to 2028 and its production area expected to be 51,100 square meters. The expected amount of expenditures for this facility is approximately DKK 16,900 million with realized spend of DKK 426 million as of December 31, 2023. The facility will be financed by cash flow from operating activities.
ITEM 4A UNRESOLVED STAFF COMMENTS
None.
ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTS
New accounting pronouncements
Reference is made to Note 1.2 ‘Changes in accounting policies and disclosures’ in our Annual Report 2023.
A. OPERATING RESULTS
Reference is made to the section ‘Forward-looking statements’ on page 37 of our Annual Report 2023 and the discussion under the caption ‘Risk factors’ under Item 3 of this Form 20-F. Further reference is made to ‘Risk management’ on pages 41-42 of our Annual Report 2023.
The information in this section is based on our Annual Report 2023 and should be read in conjunction with such report. The analysis and discussion included in such report is primarily based on the Company's consolidated financial statements which are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).
2023 compared with 2022
The following portions of our Annual Report 2023 constitute the Board of Directors’ and Executive Management’s discussion and analysis of results of operations (incorporated herein by reference): ‘Introducing Novo Nordisk’ (pages 3-9) and ‘2023 performance and 2024 outlook’ (pages 34-37).
2022 compared with 2021
For a discussion of our results of operations for 2022 compared with 2021, see ‘Item 5.A. Operating Results, 2022 Compared with 2021‘ included in our 2022 Annual Report on Form 20-F (File No. 333-82318) filed with the SEC on February 1, 2023 (hereafter "Annual Report 2022").
Segment information
Reference is made to Note 2.2 ‘Segment information’ in our Annual Report 2023 for details on segmented results.
Sales in Russia and Ukraine constituted less than 1% of Novo Nordisk's global sales in 2023. Novo Nordisk's factory in Russia is still operating to supply insulin to patients in Russia only. While Novo Nordisk maintains supply of medicine in Russia to ensure that more than 700,000 patients can continue their treatment with essential medication, Novo Nordisk has suspended further marketing investments in Russia. Novo Nordisk has ceased filing for marketing authorizations of new medication and has suspended further clinical investments in Russia. Novo Nordisk has to the extent possible continued supply of medicines in Ukraine and Novo Nordisk medicines are currently available in more than 90% of Ukraine.
Foreign currencies
Reference is made to Note 4.4 ‘Financial risks’ in our Annual Report 2023 and for further description of foreign currency exposure and hedging activities, reference is made to the description of financial instruments in Note 4.5 ‘Derivative financial instruments’ in our Annual Report 2023.
Governmental policies
Please refer to pages 10-39 ‘Strategic Aspirations’ of our Annual Report 2023 and Item 4 hereof.
Off-balance sheet arrangements
Reference is made to Note 4.4 ‘Financial risks’ and Note 5.2 ‘Commitments’ in our Annual Report 2023.
B. LIQUIDITY AND CAPITAL RESOURCES
Novo Nordisk maintains a centralized approach to the management of the Group’s financial risks. The overall objectives and policies for Novo Nordisk’s financial risk management are outlined in the Novo Nordisk Treasury Policy, which is approved by the Board of Directors. The Treasury Policy governs the Group’s use of financial instruments. For further information, reference is made to Item 11.
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| Novo Nordisk Form 20-F 2023 |
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ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTS |
Financial resources
Reference is made to ‘Cash flow statement’ on page 51 and ‘Balance sheet’ on page 52 of our Annual Report 2023. In addition, Novo Nordisk has obtained a credit rating from two independent external rating agencies.
Novo Nordisk believes its financial resources are sufficient to meet its requirements for at least the next 12 months.
Cash flow in 2023, 2022 and 2021
Reference is made to ’Cash flow statement' on page 51 of our Annual Report 2023.
The most significant source of cash flow from operating activities is sales of Diabetes and Obesity care and Rare disease products. Generally, other factors that affect operating earnings, such as pricing, volume, product mix, costs and exchange rates, also have an impact on realized cash flow from operating activities. Except as disclosed in Note 4.7 'Cash and cash equivalents' in our Annual Report 2023, there are no material restrictions on the ability of subsidiaries with material cash amounts to transfer funds to the parent company, Novo Nordisk A/S.
Trade receivable program
Trade receivable program, as of December 31, 2023, 2022 and 2021, respectively, are shown in Note 4.4 ‘Financial risks’ in our Annual Report 2023.
Debt financing
Reference is made to ‘Balance sheet’ on page 52 and to Note 4.6 ‘Borrowings’ in our Annual Report 2023 for information on Current and Non-current debt.
Derivative financial instruments
Novo Nordisk only hedges commercial exposures and consequently does not enter into derivative transactions for trading or speculative purposes. Currency hedging is done with foreign exchange forwards and foreign exchange options. Reference is made to Note 4.4 ‘Financial risks’ and Note 4.5 ‘Derivative financial instruments’ in our Annual Report 2023 for further information on financial instruments including currency exposure.
Commitments for capital expenditure etc.
Contractual obligations for capital expenditure and other contingent liabilities as of December 31, 2023 and 2022, respectively, are shown in Note 5.2 ‘Commitments’ in our Annual Report 2023.
The Executive Management of the Group believes that the obligations are covered by the Group’s financial resources as well as expected future cash flows from operating activities.
C. RESEARCH AND DEVELOPMENT, PATENTS AND LICENSES, ETC.
Novo Nordisk research and development is mainly focused on:
–Insulins, GLP-1s and other therapeutic compounds for diabetes treatment
–GLP-1s, combinations and new modes of Action for Obesity care
–Blood-clotting factors and new modes of action for treatment of haemophilia and other rare blood disorders
–Human growth hormone and new modes of action for treatment of growth disorders and other rare endocrine disorders
–New indications with existing assets within cardiovascular disease, MASH and other rare diseases
–Research technology platforms including cell therapy and RNAi for treatment of diseases within Diabetes, Obesity, Rare disease and Other serious chronic diseases
The research activities mainly utilise biotechnological methods based on advanced protein chemistry and protein engineering. These methods have played a key role in the development of the production technology used to manufacture insulin, GLP-1, recombinant blood-clotting factors and human growth hormone. Research activities further utilise new technology platforms including stem cells, gene therapy and RNAi therapies. Research and development activities are carried out by Novo Nordisk's research and development centres, mainly in Denmark, the United States (US), the United Kingdom and China. Clinical trials are carried out all over the world. Novo Nordisk also enters into partnerships and licence agreements.
Reference is made to Note 2.3 ‘Research and development costs’ in our Annual Report 2023 for research and development costs in 2023, 2022 and 2021, respectively. Novo Nordisk’s research and development organization is comprised of approximately 10,000 employees as of December 31, 2023.
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| Novo Nordisk Form 20-F 2023 |
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ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTS |
Research costs comprise the early stages of the drug development cycle from the initial drug discovery until the drug is ready for administration to humans. The activities initially focus on identifying a single drug candidate with a profile that will support a decision to initiate development activities. Before selection of the final drug candidate, it is tested in animals to gather efficacy, toxicity and pharmacokinetic information. Development costs are incurred from the start of phase 1, when the drug is administered to humans for the first time; these are the projects captured in the ’Pipeline overview’ (page 27 of our Annual Report 2023). The final product is developed, and subsequent clinical trials (phases 2 and 3) are conducted to further test the drug in humans, using the results from these trials to attempt to obtain marketing authorization, permitting Novo Nordisk to market and sell the developed products. Historically, Novo Nordisk has spent approximately 70-80% of total research and development expenditures on clinical development activities, and approximately 20-30% on research activities. The split between research and development will fluctuate in individual years depending on the composition of the clinical development portfolio.
In general, Novo Nordisk expects that growth in research and development spending will follow a trend in line with or slightly above sales growth indicating that the research and development cost to sales ratio is expected to gradually increase in the foreseeable future. Thus, Novo Nordisk currently expects to modestly expand upon the current expenditure level of around 13-14% of sales in research and development activities going forward. Increased late-stage clinical trial activities, increased activities within Other serious chronic diseases and GLP-1, as well as increased business development activities are driving costs.
Novo Nordisk has multiple phase 3 programs currently in progress, see the below table for the full list.
The following Novo Nordisk compounds are currently in phase 3 development or have recently been filed for regulatory approval: | | | | | | | | |
COMPOUND / BRAND NAME / INDICATION | Year entered into phase 3 or filed with the regulatory authorities | Patent expiration |
Somapacitan (NN8640) Once-weekly human growth hormone / Growth disorder | Regulatory submission of the children and adolescent indication occurred in 2022. | 20341 |
| | |
Concizumab (NN7415) / Haemophilia A and B with or without inhibitors | FDA resubmission expected in 2024 | 20342 |
| | |
Nedosiran (NN7022) / An siRNA targeting lactate-dehydrogenase A (or LDHA) for once-montly subcutaneous treatment of Primary Hyperoxaluria | Regulatory submission occurred in 2022 | 2039 |
| | |
Insulin Icodec (NN1436) / Once-weekly basal insulin analogue | Regulatory submission in 2023 | 20363 |
| | |
Semaglutide (oral) 25 mg and 50 mg (NN9924) / Diabetes | Phase 3 completed in 2023 | 2032 |
| | |
Semaglutide (oral) 25 mg and 50 mg / Obesity | Phase 3 initiated in 2021 | 2032 |
| | |
Cagrisema (9388)/ Diabetes | Phase 3 initiated in 2023 | 2037 |
| | |
Cagrisema (NN9838)/ Obesity | Phase 3 initiated in 2022 | 2037 |
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IcoSema (NN1535) / A combination of GLP-1 semaglutide and insulin icodec | Phase 3 initiated in 2021 | 2036 |