NOVO NORDISK A S [NVO] Filings

20-F 1 nvo-20211231.htm 20-F nvo-20211231

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, 2021
						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 Allé 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 Allé 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 0.20 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 0.20 each:			537,436,000
B shares, nominal value DKK 0.20 each:			1,772,564,000

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

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filling:

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:

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


TABLE OF CONTENTS

TABLE OF CONTENTS


INTRODUCTION		2
Part I
ITEM 1	IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISORS	3
ITEM 2	OFFER STATISTICS AND EXPECTED TIMETABLE	3
ITEM 3	KEY INFORMATION	3
ITEM 4	INFORMATION ON THE COMPANY	4
ITEM 4A	UNRESOLVED STAFF COMMENTS	10
ITEM 5	OPERATING AND FINANCIAL REVIEW AND PROSPECTS	10
ITEM 6	DIRECTORS, EXECUTIVE MANAGEMENT AND EMPLOYEES	13
ITEM 7	MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS	17
ITEM 8	FINANCIAL INFORMATION	18
ITEM 9	THE OFFER AND LISTING	19
ITEM 10	ADDITIONAL INFORMATION	19
ITEM 11	QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISKS	22
ITEM 12	DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES	22
Part II
ITEM 13	DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES	24
ITEM 14	MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS	24
ITEM 15	CONTROLS AND PROCEDURES	24
ITEM 16A	AUDIT COMMITTEE FINANCIAL EXPERTS	25
ITEM 16B	CODE OF ETHICS	25
ITEM 16C	PRINCIPAL ACCOUNTANT FEES AND SERVICES	25
ITEM 16D	EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES	26
ITEM 16E	PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS	26
ITEM 16F	CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT	27
ITEM 16G	CORPORATE GOVERNANCE	27
ITEM 16H	MINE SAFETY DISCLOSURE	30
ITEM 16I	D ISCLOSURE REGARDING FOREIGN JURISDICTIO N S THAT PREVENT INSPECTIONS	30
Part III
ITEM 17	FINANCIAL STATEMENTS	31
ITEM 18	FINA NCIAL STATEMENTS	31
ITEM 19	EXHIBITS	36
SIGNATURES	SIGNATURES	38


			Novo Nordisk Form 20-F 2021


INTRODUCTION

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 2021 Form 20-F of Novo Nordisk A/S set out herein is being incorporated by reference from the Company's statutory Annual Report 2021, including the consolidated financial statements of Novo Nordisk A/S (hereafter “Annual Report 2021”) and the Company’s Remuneration Report 2021 and Remuneration Report 2020, as specified elsewhere in this Form 20-F (with the exception of the items and pages so specified, the Annual Report 2021, Remuneration Report 2021 and Remuneration Report 2020 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 our Annual Report 2021 and our Remuneration Report 2021 (see Exhibits 15.1 and 15.5, respectively) and our Remuneration Report 2020, which was furnished to the SEC on Form 6-K on February 3, 2021.

The Company publishes its financial statements in Danish kroner (DKK).

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 are used 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 2021, examples of forward-looking statements can be found under the heading 'Strategic aspirations' in our Annual Report 2021, and elsewhere.

These statements are based on current plans, estimates and projections. By their 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 2021, 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, 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, failure to recruit and retain the right employees, failure to maintain a culture of compliance, epidemics, pandemics or other public health crises, 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 2021.

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.


			Novo Nordisk Form 20-F 2021


ITEM 1 IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISORS

PART I

ITEM 1 IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISORS

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 our Annual Report 2021 ‘Risk management’ on pages 41-42. Outlined in greater detail below, we are subject to cybersecurity risks and the risk related to the epidemics, pandemics or other public health crises.

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 occuring 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 sensitive data, including 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 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.

Our financial and operating performance may be adversely affected by epidemics, pandemics or other public health crises

In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. The COVID-19 virus has spread to most countries including the United States, Denmark and other EU countries. Many governments imposed stringent restrictions to seek to mitigate, or slow down, the spread of COVID-19, including restrictions on international and local travel, public gatherings and participation in business meetings, as well as closures of workplaces, schools, and other sites, and are requesting “social distancing”. Despite the rollout of national vaccination programs around the globe, the number of newly reported cases and related deaths continues to fluctuate as new variants of the disease emerge. Therefore, there are still restrictions in place and more measures may be again imposed, as uncertainties still exist as to the efficacy of vaccines against new variants or mutations of COVID-19. The COVID-19 pandemic has resulted in a significant deterioration in economic conditions globally, including reduced productivity, inflationary pressures, increased tax rates and/or disruptions to credit and capital markets, and the recovery of the economy during


			Novo Nordisk Form 20-F 2021


ITEM 3 KEY INFORMATION

the following months remains uncertain. COVID-19 and other epidemics, pandemics or public health crises pose risks to employee health and safety, and the Company may experience reduced sales due to fewer patient visits to doctors, reduced ability to promote products to doctors, less healthcare spending on chronic diseases as resources are diverted to epidemiology management, a slowdown or temporary suspension in production and disruptions in the Company’s supply chain, and may be otherwise adversely affected by the impact on international trade and business activities. Any of the factors above could have a material adverse effect on the Company’s business, financial condition, rating and results of operations. The magnitude of the impact of the COVID-19 pandemic on the Company will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak and counter-measures, among others.

In addition to the risks identified above, we may be subject to other material risks that as of the date of this report are not currently known to us or that we deem less material at this point in time.

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 American Depositary Receipts (ADR) are listed on the New York Stock Exchange (NVO).


Legal name:						Novo Nordisk A/S
Commercial name:						Novo Nordisk
Date of incorporation:						28 November 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 96-97 in our Annual Report 2021 for information on domicile.

Important events in 2021

Reference is made to ‘Introducing Novo Nordisk’, pages 4-9 and ‘2021 performance and 2022 outlook’, pages 33-36 in our Annual Report 2021 for a description of important events in 2021.

Capital expenditure in 2021, 2020 and 2019

For capital expenditure in 2021, 2020 and 2019 reference is made to the section entitled ‘Cash flow and capital allocation’ on page 36 in our Annual Report 2021. No significant divestments took place in the period from 2019–2021.

For capital expenditures expected in 2022, reference is made to page 36 in the subsection ‘2022 Outlook’ in our Annual Report 2021. Such expenditures are expected to be financed with cash flow from operating activities.

Public takeover offers in respect of the Company’s shares

No such offers occurred during 2021 or 2022 to date.

B. BUSINESS OVERVIEW

Novo Nordisk is a global healthcare company and a world leader in Diabetes care. The Company has one of the broadest diabetes product portfolios in the industry, including new generation insulin, a full portfolio of modern insulin and human insulin as well as a portfolio of GLP-1 receptor agonists administered both via subcutaneous injection and as a tablet.

Furthermore, Novo Nordisk launched its first product to treat obesity, Saxenda®, in the United States in April 2015. In June 2021, the Company’s second obesity treatment product, Wegovy® was approved and launched in the United States. Through most of the second half of 2021, Novo Nordisk faced supply constraints in relation to Wegovy®, due to, on the one hand, overwhelming demand and, on the other hand, manufacturing constraints at a contract manufacturing organization which occurred later in 2021. The disruption is


			Novo Nordisk Form 20-F 2021


ITEM 4 INFORMATION ON THE COMPANY

expected to continue through the first half of 2022. For more information regarding the Wegovy® supply constraints, reference is made to page 31 of the Annual Report 2021.

In addition, Novo Nordisk's marketed portfolio includes haemophilia and growth hormone therapies.

Novo Nordisk 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 45,000 employees in 80 countries, and markets its products in approximately 170 countries.

In December 2021, Novo Nordisk completed the acquisition of Dicerna Pharmaceuticals, Inc. (Dicerna). The acquisition of Dicerna's ribonucleic acid interference (RNAi) platform is a strategic addition to Novo Nordisk's existing research technology platforms and supports the strategy of using a broad range of technology platforms applicable across all of Novo Nordisk's therapeutic focus areas. The purchase price of the acquisition was approximately USD 3.3 billion.

Reference is made to the sections 'Novo Nordisk at a glance' on page 6 and ‘Strategic aspirations’ on pages 11-39 in our Annual Report 2021.

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) Biopharm. Reference is made to Note 2.2 ‘Segment information’ in the Annual Report 2021.

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. There is no raw material supply shortage that is expected to significantly impact the Company’s ability to supply any significant market. Regarding the Wegovy® supply constraints, reference is made to page 31 of the Annual Report 2021.

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 geographical areas. As of April 1, 2020, the Company’s financial reporting has been 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 countries except for North America) and North America (covering the United States and Canada). For 2021, the Company's most important markets in terms of sales were the United States, China, Japan, the major European countries and Canada.

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 and 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.

During 2021, Novo Nordisk and competitor products in China faced increased price competition. In November 2021, the Chinese National Healthcare Security Administration proffered a tender (known as Volume Based Procurement) for insulin sold at hospitals in which Novo Nordisk participated. All Novo Nordisk insulins were included in the tender except for two (Ryzodeg® and Xultophy®).

As a result of reduced prices and reduced volumes of insulin sold in China, Novo Nordisk currently expects an estimated negative impact on global sales of around 3% in 2022. This Volume Based Procurement is expected to be implemented during the first half of 2022.

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


			Novo Nordisk Form 20-F 2021


ITEM 4 INFORMATION ON THE COMPANY

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.

Tresiba®, the Company's latest generation of basal insulin, was launched broadly in the United States in January 2016 and maintains wide commercial and Medicare Part D formulary coverage. Tresiba® has been launched globally, performing well in markets with reimbursement levels at a similar level to insulin glargine U100. In particular, the product was approved in China in 2017. In 2019, it achieved broad access by being added to China's National Reimbursement Drug List (NRDL), going into effect as of January 2020.

Ryzodeg®, a soluble formulation of insulin degludec and insulin aspart, is commercially available in 44 countries. In markets where the premix insulin segment is preferred, the uptake of Ryzodeg® has been solid.

The novel mealtime insulin Fiasp®, fast-acting insulin aspart, received marketing authorization from the European Commission and approval in the United States in 2017. Globally, Fiasp® is commercially available in 49 countries.

Moreover, the use of glucagon-like peptide-1 (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. Novo Nordisk is the global market leader in the GLP-1 segment with a 52.7% value market share (Source: IQVIA, November 2021 data MAT).

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 been marketed in 69 countries in International Operations. As of December 31, 2021, Ozempic® had achieved a 44% NBRx (New-to-Brand Prescriptions) market share in the United States and global sales in 2021 of DKK 33.7 billion.

In September 2019, the FDA approved Rybelsus®, the first and only GLP-1 analog in a tablet for the treatment of adults with Type 2 diabetes in the United States. Novo Nordisk launched Rybelsus® broadly in the United States in 2020. In April 2020, the European Commission approved Rybelsus® for the treatment of adults with insufficiently-controlled type 2 diabetes to improve glycemic control as an adjunct to diet and exercise. In June 2020, the Japanese Ministry of Health, Labour and Welfare approved Rybelsus® for the treatment of adults with type 2 diabetes. Rybelsus is currently commercially available in 30 countries including the United States and Canada.

In June 2021, the FDA approved Wegovy® as a treatment option for obesity or overweight. Wegovy® was subsequently approved by the MHRA in the UK (September 2021) and EMA in the EU (January 2022). Due to the current supply constraints, described under Item 4.B, a limited commercial launch outside of the US is expected in the second half of 2022.

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 ‘Product overview' on page 97 in our Annual Report 2021.

In addition to the compound patents discussed in 'Patent status for marketed products' on page 29 in our Annual Report 2021, the patent protection of our key products within each business segment is considered in the following section. For key products with recent patent expiration or with patent expiration occurring within the coming years, geographical 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 2021 (in DKK million)	International Operations		Hereof						North America Operations		Hereof
Product				EMEA		Region China		Rest of World				USA



Victoza®	15,054	45	%	24	%	10	%	11	%	55	%	53	%
Obesity care (Saxenda® and Wegovy®)	8,400	37	%	21	%	1	%	15	%	63	%	58	%


			Novo Nordisk Form 20-F 2021


ITEM 4 INFORMATION ON THE COMPANY

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, biosimilars to Levemir®, Tresiba®, NovoRapid® and NovoMix® are being developed in China by local competitors.

The total sales of Victoza® were DKK 15,054 million in 2021 (DKK 18,747 million in 2020). Victoza® is protected by patents in the U.S., Japan and Germany. In Japan, the drug compound patent expires in 2022; in the U.S. and Germany, the drug compound patent expires in 2023. The drug compound patent has expired in China.

In February 2017, Teva Pharmaceutical Industries Ltd. filed an Abbreviated New Drug Application (ANDA) for liraglutide, the active pharmaceutical molecule in Victoza® for the treatment of type 2 diabetes, with the U.S. Food and Drug Administration. Following a settlement between Novo Nordisk and Teva announced in March 2019 and the subsequent approval of Victoza® for children and adolescent usage in the U.S., Teva is not expected to launch a generic version of Victoza® until June 2024. In August 2019, it was announced that Mylan had also filed an ANDA for liraglutide in the U.S., and in December 2019, Mylan filed a petition for Inter Parties Review against a formulation patent covering Victoza® until February 2026. In July 2020, Pfizer joined this Inter Parties Review. Following a settlement between Novo Nordisk, Mylan and Pfizer announced in March 2021, Pfizer and Mylan are not expected to launch a generic version of Victoza® until June 2024.

In April 2020, Sandoz provided notice that they had also filed an ANDA for liraglutide in the U.S. Novo Nordisk will continue to defend its intellectual property associated with Victoza®.

In January 2022, Rio Biopharmaceuticals Inc. (Rio), Aurobindo Pharma USA Inc. (Aurobindo), Sun Pharmaceutical Industries Limited (Sun), and Zydus Worldwide DMCC (Zydus) notified Novo Nordisk, that they have filed Abbreviated New Drug Applications (ANDAs) for semaglutide, the active pharmaceutical molecule in Ozempic® for the treatment of Type 2 diabetes, with the U.S. Food and Drug Administration.

The total sales of obesity care products (Saxenda® and Wegovy®) were DKK 8,400 million in 2021 (DKK 5,608 million in 2020), of which the majority of the sales comes from Saxenda®. Saxenda® (liraglutide) is protected by patents in the U.S. and Germany. In the U.S. and Germany, the drug compound patent expires in 2023. The drug compound patent has expired in China and Japan.

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, Chinese Food and Drug 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 2021, 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 Biopharm 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 five 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 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


			Novo Nordisk Form 20-F 2021


ITEM 4 INFORMATION ON THE COMPANY

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. NNE A/S currently holds an open receivable from such a GOI-controlled entity related to such sales. It is uncertain when NNE A/S will receive payment from the Iranian customer with respect to the outstanding receivable.

NNE A/S is party to a contract with an Iranian blood fractionation company that Novo Nordisk has learned may be GOI-owned or controlled for the provision of certain engineering services to the Iranian customer. There were no activities conducted under this contract in 2019, 2020 and 2021 but unpaid amounts remain due from the Iranian customer for services performed in prior years by NNE A/S’ subsidiaries. It is uncertain when NNE A/S will receive payment from the Iranian customer with respect to these unpaid amounts.

Novo Nordisk’s gross revenue related to transactions with GOI-owned or controlled entities in 2021 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 2021.

The purpose of Novo Nordisk’s Iran-related activities is to provide access to important and life-saving 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 ‘Shares and capital structure’ on pages 37-39 and ‘Corporate governance’ on pages 20-23 in our Annual Report 2021.

Companies in the Novo Nordisk Group are listed in our Annual Report 2021 on page 81, ‘Companies in the Novo Nordisk Group.’

D. PROPERTY, PLANT AND EQUIPMENT

The Company has its headquarters in Bagsværd, Denmark, where it occupies a number of buildings.

The Company believes that its current production facilities, including facilities under construction and planned for construction, are sufficient to meet its capacity requirements, including the capacity for meeting growing demand in the future for the products NovoLog®/ NovoRapid®, NovoLog Mix®/ NovoMix®, Levemir®, Victoza®, Tresiba®, Ryzodeg®, Xultophy®, Fiasp®, Ozempic®, Saxenda®, Rybelsus®, Glucagen®, NovoSeven®, NovoEight®, Rebinyn®/ Refixia®, NovoThirteen®/ Tretten®, Norditropin®, Esperoct®, Sogroya® and devices. Reference is made to the sections ‘Capital expenditures in 2021, 2020 and 2019’ 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, 2021 and 2020, reference is made to Note 3.1 ‘Intangible assets and property, plant and equipment’ in our Annual Report 2021.

On December 17, 2021, the Company announced supply challenges for its product Wegovy® in the United States. The Company does not expect to be able to meet demand in the United States in the first half of 2022 and few new patients are expected to be able to initiate treatment. The priority for the Company is patients who have already initiated treatment with Wegovy®. The Company expects to be able to meet demand in the United States in the second half of 2022. For more information regarding the Wegovy® supply constraints, reference is made to page 31 of the Annual Report 2021.

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 32 and 36 years.


			Novo Nordisk Form 20-F 2021


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, United States, although a new API production site in Clayton, North Carolina in the United States is being established.

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