UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F
(Mark One)
REGISTRATION STATEMENT PURSUANT TO SECTION
12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
OR
ANNUAL REPORT PURSUANT TO SECTION 13 OR
15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2012 |
OR
TRANSITION REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
OR
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
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The Kingdom of Denmark
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(Translation of Registrants name
into English)
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(Jurisdiction of incorporation or organization)
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Novo Allé
DK-2880 Bagsværd
Denmark
(Address of principal executive offices)
Jesper Brandgaard
Executive Vice President and Chief Financial Officer
Tel: +45 4444 8888
E-mail: jbr@novonordisk.com
Novo Allé
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: |
Name of each exchange on which registered:
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B shares, nominal value DKK 1 each |
New York Stock Exchange*
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American Depositary Receipts, each representing one B share |
New York Stock Exchange
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* 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 issuers classes
of capital or common stock as of the close of the period covered by the Annual
Report:
A shares, nominal value DKK 1 each: | 107,487,200 |
B shares, nominal value DKK 1 each: | 452,512,800 |
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes No
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 No
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 No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).
Yes No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer Accelerated filer Non-accelerated filer
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP
|
International Financial Reporting Standards
as issued
by the International Accounting Standards Board |
Other
|
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 Item 18
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 No
CONTENTS
1
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.
Throughout this Form 20-F the Company incorporates information on the various items by reference to its Annual Report 2012 and Annual Report 2011. Therefore the information in this Form 20-F should be read in conjunction with our Annual Report 2012 and Annual Report 2011, which were furnished to the SEC on Form 6-K on February 6, 2013 and on February 8, 2012, respectively.
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 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 Nordisks 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 |
| statements regarding the assumptions underlying or relating to such statements. |
With reference to our Annual Report 2012 and the Annual Report 2011, examples of forward-looking statements can be found under the headings, 2012 performance and 2013 outlook in our Annual Report 2012 and Performance in 2011 and Outlook 2012 in our Annual Report 2011, 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 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, including 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, product recall, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisks products, introduction of competing products, reliance on information technology, Novo Nordisks ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and 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 expenditure, failure to recruit and retain the right employees, and failure to maintain a culture of compliance.
Unless required by law, Novo Nordisk is under 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.
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Enforceability of civil liabilities
The Company is a Danish corporation and substantially all 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 the Company, 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.
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 |
SELECTED FINANCIAL DATA |
IFRS figures in DKK millions, except share
and American Depositary Receipts (ADR) data |
2012 | 2011 | 2010 | 2009 | 2008 |
Net sales | 78,026 | 66,346 | 60,776 | 51,078 | 45,553 |
Operating profit from continuing operations | 29,474 | 22,374 | 18,891 | 14,933 | 12,373 |
Operating profit | 29,474 | 22,374 | 18,891 | 14,933 | 12,373 |
Net profit from continuing operations | 21,432 | 17,097 | 14,403 | 10,768 | 9,645 |
Net profit | 21,432 | 17,097 | 14,403 | 10,768 | 9,645 |
Earnings per share/ADR | 39.09 | 30.24 | 24.81 | 17.97 | 15.66 |
Total assets | 65,669 | 64,698 | 61,402 | 54,742 | 50,603 |
Net assets | 40,632 | 37,448 | 36,965 | 35,734 | 32,979 |
Capital stock | 560 | 580 | 600 | 620 | 634 |
Treasury stock | (17) | (24) | (28) | (32) | (26) |
Dividends per share/ADR | 18.00* | 14.00 | 10.00 | 7.50 | 6.00 |
Dividends per share/ADR in USD | 3.18* | 2.44 | 1.78 | 1.45 | 1.14 |
Diluted earnings per share/ADR | 38.85 | 29.99 | 24.60 | 17.82 | 15.54 |
Number of shares (million) | 560 | 580 | 600 | 620 | 634 |
*) | Proposed dividend per share. For USD translation the exchange rate at December 28, 2012 from Danmarks Nationalbank (The Central Bank of Denmark) is used (USD 1 = DKK 5.6591) |
Reference is made to Consolidated financial, social and environmental statements 2012, pages 55-103 in our Annual Report 2012 for further data.
Exchange rates
The following tables set forth, for the calendar periods indicated, certain
information concerning Danmarks Nationalbanks daily official exchange
rates for U.S. dollars in terms of Danish kroner expressed in DKK per USD 1.00.
These rates closely approximate the noon buying rate for Danish kroner for cable
transfers in New York City as announced by the Federal Reserve Bank of New York
for customs purposes on the relevant dates.
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Month | High | Low | ||
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July 2012 | 6.1537 | 5.9035 | ||
August 2012 | 6.0772 | 5.9086 | ||
September 2012 | 5.9287 | 5.6934 | ||
October 2012 | 5.7897 | 5.6854 | ||
November 2012 | 5.8751 | 5.7414 | ||
December 2012 | 5.7799 | 5.6088 | ||
January 2013 | 5.7325 | 5.5065 |
Year | Average rate | Period end rate | High | Low | ||||
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2008 | 5.0848 | 5.2849 | 5.9811 | 4.6652 | ||||
2009 | 5.3504 | 5.1901 | 5.9344 | 4.9218 | ||||
2010 | 5.6538 | 5.6133 | 6.2286 | 5.1092 | ||||
2011 | 5.3622 | 5.7456 | 5.7734 | 5.0106 | ||||
2012 | 5.7972 | 5.6591 | 6.1537 | 5.5266 |
On January 31, 2013, the latest available date, the Danmarks Nationalbanks daily official exchange rate was 5.5065.
CAPITALIZATION AND INDEBTEDNESS |
Not applicable.
REASONS FOR THE OFFER AND USE OF PROCEEDS |
Not applicable.
RISK FACTORS |
For information on risk factors, reference is made to our Annual Report 2012 Risk overview on page 43. In addition to the risks included in the Risk overview in our Annual Report 2012, 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 time. Such risks include the risk that our IT security system may not prevent all forms of unauthorized access to our computer network systems for purposes of misappropriating assets, trade secrets or sensitive information, and the risks arising from current macro-economic conditions including the impact of fiscal austerity measures on our customers.
PCAOB INSPECTION OF OUR INDEPENDENT AUDITORS |
With Novo Nordisk being a public company listed in the U.S, our independent public accounting firm, PricewaterhouseCoopers, Statsautoriseret Revisionspartnerselskab, is registered with the Public Company Accounting Oversight Board (PCAOB) and therefore required to undergo regular PCAOB inspections to assess the registered accounting firms compliance with U.S. law and professional standards in connection with its audits of financial statements filed with the SEC. The PCAOB is currently unable to conduct inspections of Danish auditors audit work and procedures without the approval of the Danish authorities, which prevents it from regularly evaluating our auditors audits and its quality control procedures. As a result, investors who rely on our auditors audit report are deprived of the benefits of PCAOB inspections of our auditor.
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ITEM 4 | INFORMATION ON THE COMPANY |
HISTORY AND DEVELOPMENT OF THE COMPANY |
Novo Nordisk 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 were established in 1925 by Harald and Thorvald Pedersen. The business of both companies from the beginning was production and sale of insulin for the treatment of diabetes.
In November 2000 Novo Nordisk spun off its industrial enzyme division into a separate business, Novozymes A/S. Following the spin off, Novo Nordisk became a focused healthcare company, with close to 90 years of experience in diabetes care. Novo Nordisk also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy.
Novo Nordisks B shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO).
Legal name: Commercial name: Domicile: |
Novo Nordisk A/S
Novo Nordisk Novo Allé, DK-2880 Bagsværd, Denmark Tel:+45 4444 8888 Fax:+45 4449 0555 Website: novonordisk.com (The contents of this website are not incorporated by reference into this Form 20-F.) |
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Date of incorporation: |
November 28, 1931
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Legal form of the Company: |
A Danish limited liability company
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Legislation under which the Company operates: |
Danish law
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Country of incorporation: |
Denmark
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Important events in 2012
Reference is made to Accomplishments and results 2012, pages 1-14
in our Annual Report 2012 for a description of important events in 2012.
Capital expenditure in 2012, 2011 and 2010
The total net capital expenditure for property, plant and equipment was DKK
3.3 billion in 2012 compared with DKK 3.0 billion in 2011 and DKK 3.3 billion
in 2010. The capital expenditure in 2012 was primarily related to the ongoing
establishment of a new insulin filling facility in Tianjin, China, expansion
of the device capacity in Denmark and the U.S., filling capacity in biopharmaceuticals
and new office facilities in Denmark. The investments were financed from cash
flow from operating activities. No significant divestitures took place in the
period from 2010-2012.
Novo Nordisk expects to invest approximately DKK 3.5 billion in fixed assets in 2013. The expected level of investment in 2013 is primarily related to expansion of production facilities for GLP-1 and devices in Denmark and in the U.S., development of a new biopharmaceutical filling facility in Kalundborg, Denmark, development of a new facility for filling and formulation of insulin products in Kaluga, Russia, finalization of new office facilities in Denmark and the construction of new laboratory facilities in Måløv, Denmark and the installation of laboratory equipment in leased facilities in Beijing, China.
Public takeover offers in respect of the Companys shares
No such offers occurred during 2012 or 2013 to date.
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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 an advanced portfolio of modern insulins as well as a human once-daily GLP-1 analog. In addition, Novo Nordisk also has a leading position within haemophilia care, growth hormone therapy and hormone replacement therapy. 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 35,000 employees in 75 countries and markets its products in 180 countries.
Reference is made to the section Our business on pages 15-43 in the Annual Report 2012.
Segment information
Novo Nordisk is engaged in the discovery, development, manufacturing and marketing
of pharmaceutical products and has two business segments: diabetes care and
biopharmaceuticals. The diabetes care segment covers insulins, GLP-1, other
protein-related products (such as glucagon, protein-related delivery systems
and needles), obesity (Novo Nordisk currently has no marketed obesity products)
and oral antidiabetic drugs. The biopharmaceuticals segment covers the therapy
areas of haemophilia, growth hormone therapy, hormone replacement therapy and
inflammation (Novo Nordisk currently has no products marketed within inflammation).
For information on sales by business and geographic segment, reference is made to Note 2.2 Segment information in our Annual Report 2012.
Seasonality
Sales of individual products in individual markets may be subject to fluctuations
from quarter to quarter. However, the Companys 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. No raw material supply shortage
is expected to have a significant impact on the Companys ability to supply
any significant market. The Companys production is largely based on common
and readily available raw materials with relatively low price volatility. Certain
specific raw materials are, however, less available. For these raw materials,
it is the policy of Novo Nordisk to develop close and long-term relationships
with key suppliers as well as to secure at least dual sourcing whenever possible
and when relevant operate with a predefined minimum safety level of raw material
inventories.
Market and competition
Novo Nordisks insulin and other pharmaceutical products are marketed and
distributed through subsidiaries, distributors and independent agents with responsibility
for specific geographical areas. The most important markets are North America,
China, Japan and the major European countries. In addition, there is an increasing
contribution to Novo Nordisks total sales from key markets in the sales
region International Operations such as Algeria, Argentina, Australia, Brazil,
India and Turkey.
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.
Historically, the market for insulin has been more sensitive to the quality of products and services than to price. Most of the countries in which Novo Nordisk sells insulin subsidize or control pricing. During 2012 key markets including the U.S., China and various European countries have experienced an increased pricing pressure due to austerity measures. Additionally, certain European countries and certain countries in our International Operations sales region have also experienced competitive pressure and challenging market conditions. In Japan a bi-annual price cut is mandatory for products that are no longer patent protected. In most markets insulin is a prescription drug.
6
The Company enters into numerous contracts with customers, suppliers, agents and industry partners. Some of the most important contracts include: commercial contracts with healthcare providers, in- and out-licensing of patent rights, large tender orders and long-term sub-supplier agreements.
Several of the major international pharmaceutical companies have entered the diabetes market, specifically in the area of oral products for treatment of type 2 diabetes. In the insulin market, Novo Nordisk, Sanofi, France and Eli Lilly, U.S. are the most significant global companies.
The once-daily GLP-1 analogue, Victoza® has now been launched in 62 countries, including countries in Europe from 2009, the U.S. and Japan in 2010 and China in October 2011. In the GLP-1 market, Novo Nordisk and Bristol-Myers Squibb, U.S./AstraZeneca, United Kingdom are the most significant global companies.
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 next two to three years. However, with the continuing
transition from human to modern insulins, an increasing proportion of Novo Nordisks
diabetes care sales in major markets are protected by patents.
For patent information on all Novo Nordisks marketed products, reference is made to the section Consolidated social statement on page 99 in the Annual Report 2012.
In addition to the compound patents discussed in Consolidated Social Statement on page 99 in the Annual Report 2012, Novo Nordisks key delivery devices are protected by several patents of which the first will expire in January 2019.
In the following section the patent protection of our key products within each business segment is considered. For key products with recent patent expiration or with patent expiration occurring within the next two to three years, geographical sales splits are provided and factors that may influence the potential impact of competitive product launches are discussed. Note that in addition to the compound patents mentioned, Novo Nordisk has, like other companies engaged in production based upon recombinant DNA technology, obtained licenses under various patents which entitle Novo Nordisk to use processes and methods of manufacturing covered by such patents.
Sales of key products with recent or upcoming patent expiration:
Product | NovoLog®/ NovoRapid® |
NovoLog® mix / NovoMix® |
Prandin®/ NovoNorm® |
NovoSeven® |
Total sales in 2012 (in DKK million) | 15,693 | 9,342 | 2,679 | 8,933 |
Geographical split: | ||||
North America | 58% | 27% | 47% | 49% |
Europe | 24% | 27% | 10% | 25% |
International Operations | 9% | 18% | 6% | 17% |
Japan & Korea | 7% | 11% | 2% | 7% |
Region China | 2% | 17% | 35% | 2% |
Patent situation of key diabetes care products
The total sales of NovoLog®/NovoRapid® were DKK 15,693 million in 2012
(DKK 12,804 million in 2011).
The drug compound patent for NovoLog®/NovoRapid® has expired in Japan and in Europe. The patent in Japan expired in December 2010 and the European patent expired in August 2011. In the U.S. NovoLog®/NovoRapid® is patent protected until December 2014.
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In addition to the drug compound patent, Novo Nordisk holds a formulation patent on NovoLog®/NovoRapid®, which provides coverage until 2017 in all major markets.
The total sales of NovoLog® Mix /NovoMix® were DKK 9,342 million in 2012 (DKK 8,278 million in 2011).
NovoLog® Mix /NovoMix® is protected by patents in Japan, in Europe and in the U.S. In Japan the drug compound patent expires in June 2014, in the U.S. the drug compound patent expires in December 2014 and in Europe the drug compound patent expires on a country-by-country basis throughout 2014 and 2015.
Novo Nordisk holds a formulation patent on NovoLog® Mix /NovoMix® in the U.S., which provides coverage until June 2017.
Today, biosimilar versions of insulin can be approved in the U.S. via the 505(b)(2) pathway, and in the future the 351(k) pathway in the Public Health Service Act is also anticipated to be applicable. 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 insulins. However, we believe that the formulation patent for NovoLog®/NovoRapid® in all major markets and for NovoLog® Mix /NovoMix® in the U.S. makes it challenging to develop a biosimilar version of these compounds without infringing Novo Nordisks intellectual property. Therefore, we do not anticipate that the expiry of our original compound NovoLog®/NovoRapid® and NovoLog® Mix /NovoMix® patents will have a significant near-term impact on sales, results of operations and liquidity.
The total sales of Prandin®/NovoNorm® were DKK 2,679 million in 2012 (DKK 2,521 million in 2011) and together with other oral antidiabetic products of DKK 79 million in 2012 (DKK 54 million in 2011), the total sales of all Oral antidiabetic products (OAD) were DKK 2,758 million in 2012 (DKK 2,575 million in 2011).
Prandin®/NovoNorm®, an oral antidiabetic drug, is no longer protected as the drug compound patent has expired in all key markets.
In Europe, generic copies of NovoNorm® were first introduced in Germany in 2010 and introductions of generic copies have subsequently been observed, e.g. in France, Italy, Spain and Belgium. During 2012, generic competition has significantly reduced our European sales of NovoNorm® with most of the reduction, varying from country to country, occurring in the first 12 months following the introduction of generic competition. We expect that our European sales of NovoNorm® will continue to erode during 2013 due to generic competition.
In the U.S., Novo Nordisk holds a patent with claims directed toward the treatment of type 2 diabetes using a combination of repaglinide (Prandin®) and metformin. The patent expires in 2018 and is currently being challenged through legal proceedings.
An appeal to the U.S. Court of Appeals for the Federal Circuit
on January 19, 2011 of a District Court ruling finding Novo Nordisks combination
therapy patent to be invalid and unenforceable is fully briefed, and awaiting
oral argument. We expect a decision from the U.S. Court of Appeals for the Federal
Circuit on the patent appeal during the first half of 2013. Following U.S. Food
and Drug Administration (FDA) approval for marketing of a generic
repaglinide product in the U.S., we would expect a significant decline in sales
of Prandin® within the first 12 months, commensurate with past experience
from other branded tablet-based therapies following the introduction of a competing
generic product.
In China, NovoNorm® has been exposed to generic competition for several years without significantly impacting our sales. Therefore, we do not expect a significant decline in NovoNorm® sales in China in the short term due to generic competition.
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Patent situation of key biopharmaceuticals products
The total sales of NovoSeven® were DKK 8,933 million in 2012 (DKK 8,347
million in 2011).
The drug compound patent for NovoSeven® has expired in all major markets.
Novo Nordisk holds two formulation patents on the room temperature stable preparation of NovoSeven®, which provides coverage of this formulation until 2023 and 2024, respectively, in all major markets.
The expiry of the drug compound patent has had limited impact on sales of NovoSeven® due to the complexity of the molecular structure of NovoSeven® as well as the complexity relating to the regulatory pathways for biosimilar coagulation factors.
The active ingredient in NovoSeven® is a complex molecule, recombinant factor VIIa (rFVIIa). As a coagulation factor, the molecule is a complex protein as determined by its molecular weight and posttranslational modifications including glycosylated forms. We believe these characteristics make it difficult to develop a version that could be shown to be analytically highly similar and have similar safety and efficacy as established for NovoSeven®.
The U.S. Health Care Reform includes the establishment of a regulatory pathway for approving biosimilar versions of originator proteins. Therefore, in the future, a biosimilar version of rFVIIa could be submitted to the FDA as a Biologics License Application (BLA) under 351(k) of the U.S. Public Health Service Act and be approved if it fulfills the requirements, i.e. that the product is biosimilar to its reference product and that no clinically meaningful differences between the products in terms of safety, purity and potency are seen.
In Europe, guidelines for the development of biosimilar products have been available since late 2005; however, to date these guidelines do not apply to coagulation factors because of their complexity. The guideline for biosimilar products in Japan includes requirements similar to those established in Europe. In Iran, a biosimilar rFVIIa was approved and launched during 2012. There is to date no information available to assess if the clinical program for this compound could contribute towards fulfilling FDA requirements. To date, we have only seen approvals of competing rFVIIa products in Russia and Iran. As such, we still believe that the expiry of our compound patent for NovoSeven® will continue to have an insignificant impact in the near term on sales, results of operations and liquidity in all geographical segments.
Today, Norditropin® is not covered by a drug compound patent. However, the formulation used is covered by a formulation patent that expires in 2017 in the U.S., Europe and Japan. Furthermore, the pen devices that patients use to inject growth hormone are covered by separate patents. Today, all Novo Nordisk growth hormone products are supplied in pen devices.
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 FDA, the European Medicines Agency, the Japanese
Ministry of Health, Labour and Welfare and the Chinese State Food and Drug Administration.
Treatment guidelines from non-governmental organizations like the European Association
for the Study of Diabetes and the American Diabetes Association may also impact
the Company.
Novo Nordisk has in December 2012 received, and submitted its response to, a Warning Letter from FDA in relation to an inspection of an aseptic filling facility in Denmark. Novo Nordisk does not expect the letter to have an impact on products currently marketed in the U.S.
Iran related activities
Pursuant to Section 13(r) of the Securities Exchange Act of 1934, Novo Nordisk
is obliged to provide disclosure if, during 2012, 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.
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As a global organization, Novo Nordisk conducts business with customers in Iran, including the Government of Iran (the GOI), as described under the section Our business on pages 15-43 in the Annual Report 2012. Novo Nordisks activities in Iran relate primarily to sales of pharmaceutical products and devices within the diabetes care and biopharmaceutical business segments. Novo Nordisk has established a wholly-owned affiliate, Novo Nordisk Pars, in Tehran, Iran and has business dealings with a GOI-controlled local manufacturing partner that, under a license agreement with Novo Nordisk Pars, produces human insulins based on semi-finished products supplied by Novo Nordisk. A wholly-owned affiliate of Novo Nordisk, NNE Pharmaplan A/S, has entered into a contract with the Iranian Blood Research & Fractionation Company, which is owned by the Iranian Ministry of Health, for the engineering, procurement and construction of a human plasma fractionation plant for the production of human plasma derivates. Finally, Novo Nordisk conducts to a limited extent clinical research studies and trials, in collaboration with certain Iranian state universities, that are related to Novo Nordisks diabetes care and biopharmaceuticals businesses.
Novo Nordisk receives payments from, and makes payments to, certain GOI-owned or controlled banks with respect to the activities conducted by Novo Nordisk Pars. All payments by Novo Nordisk into and out of Iran are made through non-Iranian and non-sanctioned banks.
Novo Nordisks gross revenue related to transactions with GOI-owned or controlled entities in 2012 was not in excess of DKK 400 million. 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 Nordisks 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 small fraction of the gross revenue from such transactions.
The purpose of Novo Nordisks Iran-related activities is to provide access to important and life-saving pharmaceutical products such as insulins and haemophilia products to patients in Iran, and to improve the healthcare of the Iranian people in accordance with a key component of Novo Nordisks access to care strategy. For that purpose, Novo Nordisk intends to continue these activities.
ORGANIZATIONAL STRUCTURE |
For information regarding the organizational structure and securities exchange listings of Novo Nordisk A/S, reference is made to the sections Corporate governance on pages 46-48 and Shares and capital structure on pages 44-45 in the Annual Report 2012.
Reference is made to the section Shares and capital structure on pages 44-45 in the Annual Report 2012 regarding the parent company Novo A/S and the Novo Nordisk Foundation and the ownership structure.
Companies in the Novo Nordisk Group are listed in the Companys Annual Report 2012 on page 92, Companies in the Novo Nordisk Group.
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, are sufficient to meet its capacity requirements, including the capacity for meeting growing demand in the future for the insulin products NovoLog®/ NovoRapid®, NovoLog Mix®/NovoMix®, Levemir® as well as for Victoza®. In addition, the Company is ensuring that production capacity is in place for the next generation of insulins, Tresiba® and Ryzodeg® and devices. Reference is made to the sections Capital expenditures in 2012, 2011 and 2010 under Item 4 for more information about the current expansion programs. For the nature of the Companys property, plant and equipment, as of December 31, 2012 and 2011, reference is made to Note 3.2 Property, plant and equipment in our Annual Report 2012.
The major production facilities owned by the Company are located at a number of sites in Denmark, and internationally in the U.S., 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 on the lease is 34 years.
10
Active pharmaceutical ingredient production is located in Denmark, primarily in Kalundborg and with secondary locations in Hillerød, Bagsværd and Gentofte. Below is a tabular presentation of the production sites.
In addition, a new facility for filling and formulation of insulin products is being established in Kaluga, Russia, and is expected to be ready for use in 2016. The expected amount of expenditures for the new facility in Russia is approximately DKK 500 million. The production facility in Russia is financed by cash flow from operating activities.
In September 2011, Novo Nordisk initiated the construction of a new biopharmaceutical production facility in Kalundborg, Denmark, which is expected to be used for formulation, filling and packaging from 2015. The expected amount of expenditures for the new facility in Kalundborg is approximately DKK 1,000 million. The production facility in Kalundborg is financed by cash flow from operating activities.
Major Production
Facilities |
Size of production area
(square meters) |
Major Production Activities
|
Kalundborg, Denmark
|
119,400
|
Active pharmaceutical ingredients for diabetes
and products for diabetes.
Active pharmaceutical ingredients for haemophilia. |
Hillerød, Denmark
|
88,300
|
Durable devices and components for disposable
devices.
Products for diabetes. Active pharmaceutical ingredients for haemophilia. |
Tianjin, China
|
64,000
|
Products for diabetes.
Production of durable devices. |
Montes Claros, Brazil
|
47,000
|
Products for diabetes.
Gel production. Products for oral antidiabetes treatment. |
Gentofte, Denmark
|
41,100
|
Active pharmaceutical ingredients for glucagon
and growth hormone therapy.
Products for growth hormone therapy, glucagon and haemophilia. |
Clayton, North Carolina, U.S.
|
40,300
|
Products for diabetes.
|
Chartres, France
|
33,000
|
Products for diabetes.
|
Bagsværd, Denmark
|
17,600
|
Products for diabetes.
Products for hormone replacement therapy. |
Måløv, Denmark
|
15,300
|
Products for hormone replacement therapy.
Products for oral antidiabetes treatment. |
Koriyama, Japan
|
8,300
|
Packaging of products for the Japanese
market.
|
Hjørring, Denmark
|
8,300
|
Production of needles.
|
Værløse, Denmark
|
6,100
|
Products for growth hormone therapy.
|
Køge, Denmark
|
2,500
|
Gels and ALP for active pharmaceutical
ingredient production.
|
Tizi Ouzou, Algeria
|
1,700
|
Products for oral antidiabetes treatment.
|
The Companys research and development activities are increasingly performed globally. With the major sites located in Denmark, the Company is expanding its global presence with established research sites in Beijing, China and Seattle, U.S. In addition, the Company conducts clinical development work in more than 50 countries.
11
ITEM 4A | UNRESOLVED STAFF COMMENTS |
None.
ITEM 5 | OPERATING AND FINANCIAL REVIEW AND PROSPECTS |
CRITICAL ACCOUNTING ESTIMATES |
Reference is made to Note 1.1 Summary of significant accounting policies in our Annual Report 2012.
NEW ACCOUNTING PRONOUNCEMENTS |
Reference is made to Note 1.2 Other accounting policies in our Annual Report 2012.
OPERATING RESULTS |
Reference is made to the section Forward-looking statements contained on page 2 and the discussion under the caption Risk factors contained under Item 3. Reference is further made to our Annual Report 2012 Risk overview on page 43.
The financial condition of the Group and its development are described in our Annual Report 2012 and our Annual Report 2011. The information in this section is based on these reports and should be read in conjunction with the annual reports. The analysis and discussions included in the annual reports are primarily based on the consolidated financial statements which are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board (IASB) as well as in accordance with International Financial Reporting Standards (IFRS) as endorsed by the European Union.
2012 compared with 2011
The following portions of our Annual Report 2012 constitute the Board
of Directors and Executive Managements discussion and analysis of
results of operations (incorporated herein by reference):
Accomplishments and results 2012 (pages 1-14) |
2011 compared with 2010
The following portions of our Annual Report 2011 constitute the Board
of Directors and Executive Managements discussion and analysis of
results of operations (incorporated herein by reference):
Our 2011 accomplishments and results (pages 2-15) |
Segment information
The segmented reporting is based on two business segments Diabetes care
and Biopharmaceuticals. Reference is made to Note 2.2 Segment
information in our Annual Report 2012 for details on segmented
results.
Inflation
Inflation for the three most recent fiscal years has not had a material impact
on the Groups Net sales or Net profit.
Foreign currencies
The majority of Novo Nordisks sales are in foreign currencies, mainly
EUR, USD, JPY, CNY and GBP, while most production, research and development
costs are carried in DKK. Consequently, Novo Nordisk has significant exposure
to foreign exchange risks and engages in significant hedging activities where
the most significant exposure and hedging are related to USD, JPY, CNY and GBP,
12
while the EUR exchange rate risk is regarded as low due to the Danish fixed-rate policy towards EUR. Thus, Novo Nordisk does not hedge the EUR exchange rate risk. For further description of foreign currency exposure, reference is made to the disclosure in Note 4.3 Financial risk in our Annual Report 2012 and for further description of foreign currency exposure and hedging activities, reference is made to the description of financial instruments in Note 4.4 Derivative financial instruments in our Annual Report 2012.
Governmental policies
Please refer to 15-43 Our business and pages 44-54 Governance,
leadership and shares in our Annual Report 2012 and Item 4.
LIQUIDITY AND CAPITAL RESOURCES |
Novo Nordisk maintains a centralized approach to the management of the Groups financial risks. The overall objectives and policies for Novo Nordisks financial risk management are outlined in the Novo Nordisk Treasury Policy, which is approved by the Board of Directors. The Treasury Policy governs the Groups use of financial instruments. For further information, reference is made to Item 11.
Financial resources
Reference is made to page 57 Balance sheet and page 58 Statement
of cash flows for the year ended 31 December in our Annual Report 2012.
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 2012, 2011 and 2010
Reference is made to page 58 Statement of cash flows for the year ended
31 December in our Annual Report 2012 and to the consolidated cash
flow in Item 18.
The most significant source of cash flow from operating activities is sales of diabetes care and biopharmaceutical products. Generally, other factors that affect operating earnings, such as pricing, volume, costs and exchange rates, also flow through to have an impact on realized cash flow from operating activities.
There are no material restrictions on the ability of subsidiaries to transfer funds to the Company.
Asset securitization Novo Nordisks Japanese subsidiary employs an asset securitization program that is a full non-recourse off-balance sheet arrangement to improve liquidity and to take advantage of market opportunities by receiving funds prior to scheduled payment dates. At December 31, the Group had de-recognized receivables without recourse having due dates after December 31 amounting to: |
DKK million | 2012 | 2011 | 2010 | 2009 | 2008 |
Sold trade receivables | 2,027 | 2,485 | 2,066 | 1,611 | 1,587 |
Credit guarantee | 0 | 0 | 0 | 0 | 81 |
Furthermore, in 2012 Novo Nordisks Italian affiliate sold a significant part of its trade receivables through factoring transactions. The purpose of the full non-recourse off-balance sheet factoring arrangement was to sell overdue trade receivables to a third party at a discount in exchange for immediate cash settlement.
Finally, Novo Nordisks Spanish affiliate has in 2012 sold part of its overdue trade receivables on a full non-recourse off-balance sheet agreement to a third party at a discount in exchange for immediate cash settlement.
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Debt financing
Debt financing is obtained in DKK and in foreign currencies. Reference is made
to Notes 4.2 Debt and 4.4 Derivative financial instruments
in our Annual Report 2012 for information on currency structure, interest
rate structure and maturity profile.
Financial instruments
Novo Nordisk does not enter into speculative positions and only hedges commercial
exposure. The financial instruments used in conjunction with the Groups
financial risk management include currency forwards, currency options, interest
rate swaps and cross currency swaps. Current and non-current debt as well as
money-market deposit is also used in the financial risk management. Reference
is made to Note 4.4 Derivative financial instruments in our Annual
Report 2012 for further information on financial instruments including currency
and interest rate structure.
Commitments for capital expenditure etc.
Contractual obligations for capital expenditure and other contingent liabilities
as of December 31, 2012 and 2011, respectively, are shown in Note 5.4 Commitments
and contingencies in our Annual Report 2012.
The Executive Management of the Group believes that the obligations are covered by the Groups financial resources as well as expected future cash flows from operating activities.
RESEARCH AND DEVELOPMENT, PATENTS AND LICENSES, ETC. |
Novo Nordisks research activities utilize biotechnological methods based on genetic engineering, advanced protein chemistry and protein engineering. These methods have played a key role in the development of the production technology which is used in the manufacturing of insulin, GLP-1, recombinant factor VIIa, general haemophilia, human growth hormone and glucagon.
The focus of Novo Nordisks research and development is on therapeutic proteins within insulin, GLP-1, blood clotting factors, human growth hormone and inflammation.
Research and development costs were DKK 10.9 billion or 14.0% of sales, DKK 9.6 billion or 14.5% of sales and DKK 9.6 billion or 15.8% of sales in 2012, 2011 and 2010, respectively. Novo Nordisks research and development organization comprised approximately 6,400 employees as of December 31, 2012.
In general, we expect that the growth in research and development spending will follow a trend in line with sales growth indicating that the research and development cost to sales ratio is expected to be relatively constant in the foreseeable future. Thus, we expect to continue an expenditure level equivalent to 14-15% of sales in research and development activities going forward.
The development projects that accounted for the highest research and development spent in 2012 were related to the cardiovascular outcome trial for Victoza® (LEADER), the liraglutide obesity program, the phase 3 program for the insulin/GLP-1 project IDegLira, and the phase 3a and phase 3b development program for Degludec (insulin degludec) and DegludecPlus (insulin degludec/insulin aspart).
Historically Novo Nordisk has spent approximately 65-75% of total research and development expenditures on clinical development activities, and approximately 25-35% on research activities.This relative spend ratio is expected to continue in the foreseeable future. However, the proportion used on research and clinical development activities respectively may fluctuate in individual years depending on the composition of the clinical development portfolio.
Information related to selected research and development projects can be found under Pipeline overview on pages 30-31 in the Annual Report 2012. Furthermore, a broader overview of our business activities can be found on pages 15-43 Our business.
14
The following Novo Nordisk compounds are currently in phase 3 development or have been filed for regulatory approval:
Compound / Indication |
Year entered into phase 3 or filed
with the regulatory authorities
|
Patent
expiration |
Degludec (NN1250) / Type 1 & 2 diabetes
|
U.S.: filed for regulatory approval with the FDA in
September 2011. |
20241
|
DegludecPlus (NN5401) / Type 1 & 2
diabetes
|
U.S.: filed for regulatory approval with
the FDA in September 2011.
EU: approved January 21, 2013. Japan: approved December 25, 2012. |
20241
|
Liraglutide 3 mg (NN8022) / Obesity
|
Started phase 3 in 2008.
|
2022
|
IDegLira (NN9068) / Type 2 diabetes
|
Started phase 3 in 2011.
|
Protected by patents on individual compounds,
liraglutide (2022) and insulin degludec (2024), respectively
|
rFXIII (NN1841) / FXIII Congenital deficiency
|
U.S.: filed for regulatory approval with
the FDA in February 2011. Complete response letter from FDA received December
2011.
EU: approved September 7, 2012. |
US: 20212, ex-US patents have
expired
|
Turoctocog alfa (NN7008) / Haemophilia
A
|
U.S.: filed for regulatory approval with
the FDA in October 2012.
EU: filed for regulatory approval with the EMA in October 2012. |
Novo Nordisk does not expect to obtain
composition of matter patent protection
|
N9-GP (NN7999) / Haemophilia B
|
Started phase 3 in 2011
|
2027
|
N8-GP (NN7088) / Haemophilia A
|
Started phase 3 in 2012
|
20293
|
1 May receive a term extension of up to 5 additional
years
2 May receive a term extension of up to 2 additional
years
3 May receive a term extension of up to 5 additional
years
Despite Degludec and DegludecPlus being close to commercialization in many key markets, Novo Nordisk does not expect any significant cannibalization of sales of the existing insulin portfolio in the near term due to the continued growth opportunities for the existing insulin portfolio in countries like China and in various countries in our International Operations sales region.
In determining whether or not any project or group of related projects is significant, we consider the following qualitative and quantitative criteria:
| Assessment of the unmet medical need targeted with the specific project; |
| The inherent project risk including the risk of safety issues, unsatisfactory tolerability profile, limitations on the efficacy of the compound; |
| Timeline for completing the clinical testing and submitting an application for approval to regulatory authorities; |
| Regulatory authorities position towards approval and drug label; |
| Changes in competitive landscape during the development and approval cycle including competing drugs being developed by others; |
| Changes in medical practice during the development period; |
| Position of payers, the medical society and patients towards treatment with drug and price of drug; |
15
| Expected uptake in market following launch; and |
| Expected net present value of the project. |
In assessing the criteria listed above, and as described in the Risk overview on page 43 in the Annual Report 2012, it is important to note that at any one stage of development, due to the uncertainties inherent to clinical development and the regulatory approval process, there is a significant degree of uncertainty and risk that the project will not be successful. The nature of our development activities is such that a compound must first be proven to work by means of multiple clinical trials, which may require treatment of thousands of patients and could take years to complete. Even if initial results of preclinical studies or clinical trial results are promising, we may obtain different results that fail to show the desired levels of safety and efficacy, or we may not obtain applicable regulatory approval for a variety of other reasons. The compound must be accepted by either the FDA, the European Medicines Agency and similar agencies around the world, each of which may have differing requirements. During each stage, there is a substantial risk that we will encounter serious obstacles which will further delay us, or that we will not achieve our goals and, accordingly, may abandon a product in which we have invested substantial resources. Furthermore, the commercial potential of a project is dependent on the label granted by the regulatory authority upon approval. The label specifies for which indications a product can be used, major and minor safety concerns associated with drug treatment as well as if the drug can be combined with other types of medication. Thus a label can restrict usage substantially.
Due to the risks and uncertainties involved in progressing through pre-clinical development and clinical trials, and the time and cost involved in obtaining regulatory approvals, we cannot reasonably estimate the nature, timing, completion dates and costs of the efforts necessary to complete the development.
Given the uncertainties related to the process of product development, during the periods presented in our 2012 Form 20-F no single project in product development was significant based on the qualitative and quantitative criteria. However, during the periods presented two groups of projects were considered significant; the diabetes care group and biopharmaceuticals group.
Reference is made to the caption Risk factors contained under Item 3.
TREND INFORMATION |
The key drivers behind the performance of Novo Nordisk continue to be the changes in demographics globally reflecting the increasing proportion of elderly people and the growing problem of obesity. Both trends have contributed to the significant increase in the number of people with diabetes worldwide. According to the International Diabetes Federation, the number of people with diabetes is expected to increase to more than 550 million by 2030 from 371 million in 2012. Diabetes care is Novo Nordisks largest segment comprising approximately 78% of sales. The epidemic growth in the number of people with diabetes, continuing transition from human insulins to modern insulins, and new delivery devices and market share gains are all driving Novo Nordisks growth of the diabetes care segment.
The other segment of Novo Nordisk is biopharmaceuticals, which comprise haemophilia, growth hormone therapy, hormone replacement therapy and inflammation therapy. Within haemophilia, sales of NovoSeven® continued to increase in 2012. The growth hormone therapy franchise benefited from further penetration and increasing market share of the liquid formulation Norditropin®, delivered in ready-to-use prefilled devices.
For further information on trends, reference is made to the section Accomplishments and results 2012 on pages 1-14 in the Annual Report 2012. Information about expectations for the financial year 2013 can be found on page 9 in the subsection Outlook 2013.
16
OFF-BALANCE SHEET ARRANGEMENTS |
Reference is made to the section Asset securitization contained on page 13. Reference is further made to Note 5.4 Commitments and contingencies in our Annual Report 2012.
TABULAR DISCLOSURE OF CONTRACTUAL OBLIGATIONS |
Reference is made to Note 5.4 Commitments and contingencies in our Annual Report 2012.
ITEM 6 | DIRECTORS, EXECUTIVE MANAGEMENT AND EMPLOYEES |
DIRECTORS AND EXECUTIVE MANAGEMENT |
Reference is made to pages 52-53 in our Annual Report 2012 for name, position and period of service as director for the members of the Board of Directors.
Reference is made to page 54 in our Annual Report 2012 for name, position, age, year of appointment and year of joining Novo Nordisk for five of the seven the members of Executive Management. Effective January 31, 2013, Novo Nordisks Executive Management was expanded with two new members (from five to seven), Mr Jakob Riis and Mr Lars Fruergaard Jørgensen. Mr Jakob Riis, born April 1966, is appointed executive president with responsibility for Marketing & Medical Affairs and joined Novo Nordisk in 1996. Mr Lars Fruergaard Jørgensen, born November 1966, is appointed executive vice president with responsibility for IT, Quality & Corporate Development and joined Novo Nordisk in 1991.
The Board of Directors has the overall responsibility for the affairs of the Company. Reference is made to pages 46-48 in our Annual Report 2012.
The activities of the members of Board of Directors and members of Executive Management outside the Company are included in our Annual Report 2012 on pages 52-54. In addition hereto, Mr Lars Fruergaard Jørgensen represents Novo Nordisk as chairman of the board of Harno Invest A/S, Denmark, and as member of the supervisory board of Innate Pharma S.A., France. He is also vice chairman of the board of NNE Pharmaplan A/S and a member of the board of NNIT A/S, both in Denmark. Further, Mr Jakob Riis is on the board of Copenhagen Institute of Interaction Design.
There are no family relationships between the Board of Directors, Executive Management or between any of the members of the Board of Directors and any member of Executive Management. No director or member of Executive Management has been elected according to an arrangement or understanding with shareholders, customers, suppliers or others. As required by the Danish Companies Act, directors are elected at General Meetings by simple majority vote. In addition, four employee representatives are elected for four-year terms by the employees of Novo Nordisk A/S.
COMPENSATION |
Reference is made to the section Remuneration on page 49-51 and Notes 5.1 and 5.2 in our Annual Report 2012 regarding compensation.
BOARD PRACTICES |
Reference is made to Corporate governance on pages 46-48 in our Annual Report 2012 regarding board practices.
17
EMPLOYEES |
Reference is made to the section entitled Performance highlights on page 5 in our Annual Report 2012 regarding the total number of full-time employees in Novo Nordisk at year-end for the years 2008-2012.
Employees | 2012 | 2011 | 2010 | 2009 | 2008 |
Employees outside Denmark as a percentage of total number of employees | 57% |
57% |
56% |
54% |
52% |
Executive Management believes that the Company has a good relationship with its employees in general and with the labor unions of the Novo Nordisk employees.
Novo Nordisk believes that the current personnel policy results in low staff turnover, high morale, and ease in recruiting new employees. The Company has not experienced any significant labor disputes.
SHARE OWNERSHIP |
For information on the Board of Directors and Executive Managements individual holdings of share options, exercise of options and granting of shares, reference is made to the section Remuneration on page 49-51 and Note 5.2 Managements holdings of Novo Nordisk shares in our Annual Report 2012. The members of the Board of Directors and Executive Management and key management executives in the aggregate, including the two new members of Executive Management joining January 31, 2013, hold less than 1% of the beneficial ownership of the Company.
For information on the Board of Directors and Executive Managements individual holdings of and trading in Novo Nordisk shares during 2012, reference is made to the section Remuneration on page 49-51 and Note 5.2 Managements holding of Novo Nordisk shares in our Annual Report 2012. As of January 30, 2013 the Board of Directors and Executive Management owned 287,771 B shares. The two new members of Executive Management joining January 31, 2013, owned as of January 30, 2013, a total of 26,352 B shares.
In the period from January 1, 2013 until January 30, 2013, no B shares were sold or purchased by the members of the Board of Directors or Executive Management. The internal rules on trading in Novo Nordisk securities by members of the Board of Directors and Executive Management only permit trading in the 15 calendar-day period following each quarterly earnings announcement. Following the quarterly earnings announcement release on January 31, 2013, the Executive Management, including the two new members of Executive Management, received 68,268 B shares in accordance with the long-term incentive program and a total of 30,290 B shares were sold, hence as of January 31, 2013, the Board of Directors and Executive Management, including the two new members of Executive Management, owned 352,101 B shares.
In 2010, a general employee share program was implemented in Denmark, where approximately 11,000 employees purchased 567,000 B shares at a price of DKK 275 per share.
Outside Denmark the program was structured as share options with the same initial benefit per employee as in Denmark. Approximately 15,000 employees were granted approximately 273,000 options with a vesting period of three years.
In 2011, a general employee share program was implemented in the wholly owned affiliate NNIT and its subsidiaries. In Denmark approximately 965 employees purchased 38,600 B shares at a price of DKK 310 per share. Outside Denmark the program was structured as share options with the same benefit per employee as in Denmark. Approximately 350 employees were granted approximately 7,000 options with a vesting period of three years.
18
No new programs have been implemented in 2012.
Reference is made to Note 5.2 Share based payment schemes in our Annual Report 2012.
ITEM 7 | MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS |
MAJOR SHAREHOLDERS |
The total share capital of the Company is split in two classes, A shares and B shares, each with different voting rights. The A shares have 1,000 votes per DKK 1 of the A share capital and the B shares have 100 votes per DKK 1 of the B share capital.
All of the A shares of the Company are held by Novo A/S, a wholly-owned subsidiary of the Novo Nordisk Foundation (the Foundation). As of December 31, 2012, the A shares represented approximately 71% of the votes exercisable at the Annual General Meeting. Treasury shares have no votes at the Annual General Meeting.
The Foundation is a self-governing and self-owned organization whose main purposes are to be a stable base for the business and research activities of the subsidiaries of Novo A/S, and to support medical research and other scientific, humanitarian and social objectives.
Novo A/S was established in September 1999 with a contribution in kind of interest-bearing securities from the Foundation. In December 1999, the Foundation contributed its total holdings of A and B shares in Novo Nordisk A/S to Novo A/S in return for shares in Novo A/S. The purpose of Novo A/S in relation to Novo Nordisk A/S is to administer its portfolio of securities and minority capital interests and to administer and vote on the A shares and B shares in Novo Nordisk A/S, thereby creating a satisfactory financial return for the Foundation.
Under its statutes, the Foundation is governed by a Board of Governors, which must be comprised of at least six and not more than 12 members and at least two members must have a medical or scientific background. Members of the Foundations Board of Governors are typically nominated by the chairman and elected by a two-thirds vote of the members who have themselves been elected pursuant to the statutes. Any member can be removed as provided for in the Danish Act on Foundations (lov om erhvervsdrivende fonde). In addition, employee representatives are elected for four-year terms by the employees of the subsidiaries of the Foundation, in accordance with Danish law. No person or entity exercises any kind of formal influence over the Foundations Board. The Foundations Board currently consists of ten persons, four of whom are also members of the Board of Directors of Novo Nordisk A/S (Sten Scheibye, Kurt Anker Nielsen, Stig Strøbæk and Søren Thuesen Pedersen).
Under its statutes, Novo A/S is governed by a Board of Directors, which must be comprised of at least three and not more than six members who are elected annually by shareholder vote. According to the Foundations statutes, its Board of Governors can and shall provide for members of its own Board of Governors to be elected to Novo A/Ss Board of Directors. Novo A/Ss Board of Directors currently has five members, with two directors who are also members of the Board of the Foundation (Ulf J Johansson and Jørgen Boe) and one director who is also a member of the Board of Directors of Novo Nordisk A/S (Göran A Ando). The Chairman of the Foundations Board of Governors (Ulf J Johansson) serves as the Chairman of Novo A/Ss Board of Directors.
According to the statutes, the Foundation, in exercising its voting rights through Novo A/S at Novo Nordisk A/Ss General Meetings, must vote with regard for what is in Novo Nordisks best interest. A shares held by Novo A/S cannot be sold or be subject to any disposition so long as the Foundation exists. The dissolution of the Foundation or any change in its objectives requires the unanimous vote of the Foundations Board of Governors. Other changes in the Foundations statutes require the approval of two-thirds of the members of the Foundations Board of Governors. In addition, changes in the Foundations statutes require approval of the Danish Foundation Authorities. According to its statutes, the Foundation is required to maintain material influence over Novo Nordisk A/S and its majority vote in Novo A/S.
19
For further information reference is made to Corporate governance on pages 41-43 in our Annual Report 2011 and to Shares and capital structure on pages 44-45 in our Annual Report 2012.
The B shares of the Company are registered with Værdipapircentralen (VP Securities) and are not represented by certificates. Generally, VP Securities does not provide the Company with information with respect to registration. However, set forth below is information as of January 30, 2013 with respect to (a) any shareholder who is known to the Company to be the owner of more than 5% of any class of the Companys securities and (b) the total amount of any class owned by Novo Nordisk A/S and its affiliates (treasury shares) and by the directors and Executive Management as a group:
Title of class |
Identity of person or group
|
Shares owned | Percent of class | Percent of total votes |
A shares |
Novo A/S
|
107,487,200* | 100.00 | 71.2 |
B shares |
Novo A/S
|
35,312,800 | 7.80 | 2.3 |
B shares |
Novo Nordisk A/S and affiliates (treasury
shares)
|
18,442,009 | 4.08 | 0.0 |
B shares |
Board of Directors and Executive Management
|
287,771** | 0.06 | 0.02 |
*) | The number of A shares is calculated as an equivalent of the trading size (DKK 1) of the listed B shares but is not formally divided into number of shares. The A shares are not listed on any stock exchange. |
**) | As of January 31, 2013 the shares owned by Board of Directors and Executive Management was 352,101 (corresponding to 0.08 percent of class and 0.02 percent of total votes), including shares owned by the two new members of Executive Management joining January 31, 2013. |
In 2010 and 2011, shares with an aggregate purchase price of DKK 9.5 billion and DKK 12.0 billion, respectively, were repurchased under the Companys share repurchase program.
In February 2012, Novo Nordisk announced a new DKK 12 billion share repurchase program. Under this program and the previous share repurchase program completing in January 2012, 14,624,534 shares corresponding to DKK 12 billion have been repurchased during 2012. The share repurchase program was completed in January 2013.
After the shareholders approval of the proposed reduction of the Companys share capital at the Annual General Meeting on March 21, 2012, 20,000,000 shares were canceled in April 2012, reducing the number of treasury shares accordingly.
As the B shares are in bearer form, it is not possible to give an accurate breakdown of the holdings and number of shareholders per country. It is, however, estimated that approximately 27% of the B share capital was held in Denmark as of December 31, 2012. Approximately 44% of the B share capital is estimated to be held in North America. The estimated total number of shareholders is more than 130,000 of whom more than 100,000 are estimated to be Danish residents and more than 10,000 to be resident in the U.S.
RELATED PARTY TRANSACTIONS |
Related parties are considered to be the Novo Nordisk Foundation, Novo A/S, Novozymes A/S (due to shared controlling shareholder, Novo A/S), associated companies, the Board of Directors and officers of these entities and Management of Novo Nordisk. Novo Nordisk has access to certain assets of and can purchase certain services from Novo A/S and Novozymes A/S and vice versa. All agreements relating to such assets and services are based on the list prices used for sales to third parties where such list prices exist, or the price has been set at what is regarded as market price. The material terms of these agreements are renegotiated annually.
In 2012, Novo Nordisk A/S acquired 5,100,000 B shares, worth DKK 4.2 billion, from Novo A/S as part of the DKK 12 billion share repurchase program. The transaction price was DKK 823.11 per share and was calculated as the average market price from April 27 to May 1, 2012 in the open trading window, following the announcement of the financial results for the first quarter of 2012. For information
20
relating to 2010 and 2011, reference is made to Note 5.5 Related party transactions in our Annual Report 2012.
Related party transactions in 2012, 2011 and 2010 were primarily payments for services provided between the Novo Nordisk Group and the Novozymes Group and transactions with associated companies. The financial impact of these transactions is limited.
Since December 31, 2012, there have been no significant transactions with related parties out of the ordinary course of business. For further information reference is made to Note 5.5 Related party transactions in our Annual Report 2012 and Note 32 Related party transactions in our Annual Report 2011.
There have not been and are no loans to members of the Board of Directors or Executive Management in 2012, 2011 and 2010.
INTERESTS OF EXPERTS AND COUNSEL |
Not applicable.
ITEM 8 | FINANCIAL INFORMATION |
CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION |
The financial statements required by this item accompany this annual report in the form of the Novo Nordisk Annual Report 2012 (see Exhibit no. 15.1).
Legal proceedings
Reference is made to Note 5.4 Commitments and contingencies in the
Annual Report 2012 regarding legal proceedings.
Dividend policy
At the Annual General Meeting on March 20, 2013, the Board of Directors will
propose a dividend of DKK 18.00 per share corresponding to a pay-out ratio of
45%. No dividends will be paid on the Companys holding of its treasury
shares. It is the intention of the Board of Directors that the payout ratio
of Novo Nordisk should be at the level of comparable pharmaceutical companies.
SIGNIFICANT CHANGES |
No significant events have occurred since the date of the annual financial statements. For description of important events and achievements in the financial year of 2012, reference is made to Accomplishments and results 2012, on pages 1-14 in our Annual Report 2012.
ITEM 9 | THE OFFER AND LISTING |
Offer and listing details
The table below sets forth for the calendar periods indicated, in the first
two columns, high and low prices for the B shares as reported by the NASDAQ
OMX Copenhagen and, in the third and fourth columns, high and low ADR prices
as reported by the New York Stock Exchange.
21
DKK per B share | USD per ADR | |||
High | Low | High | Low | |
2008 | 353 | 246 | 73.73 | 41.90 |
2009 | 350 | 235 | 70.00 | 41.35 |
2010 | 645 | 331 | 113.77 | 63.85 |
2011 | 703 | 507 | 132.88 | 94.58 |
2012 | 981 | 648 | 170.27 | 114.13 |
2011 | ||||
1st Quarter | 703 | 603 | 129.26 | 110.00 |
2nd Quarter | 678 | 605 | 132.88 | 114.62 |
3rd Quarter | 674 | 507 | 128.05 | 96.00 |
4th Quarter | 663 | 513 | 115.69 | 94.58 |
2012 | ||||
1st Quarter | 818 | 648 | 144.92 | 114.13 |
2nd Quarter | 867 | 770 | 152.31 | 129.41 |
3rd Quarter | 981 | 843 | 161.05 | 143.42 |
4th Quarter | 979 | 852 | 170.27 | 144.52 |
July 2012 | 942 | 843 | 155.46 | 143.42 |
August 2012 | 981 | 915 | 160.00 | 151.01 |
September 2012 | 948 | 871 | 161.05 | 152.60 |
October 2012 | 979 | 912 | 170.27 | 156.68 |
November 2012 | 956 | 852 | 161.00 | 144.52 |
December 2012 | 942 | 904 | 163.91 | 159.64 |
January 2013 | 1,040 | 920 | 187.36 | 164.51 |
Reference is made to our Annual Report 2012 Shares and capital structure on page 44-45.
PLAN OF DISTRIBUTION |
Not applicable.
MARKETS |
The Companys share capital consists of A shares and B shares. As described above, the A shares are owned by the Novo Nordisk Foundation through its wholly-owned subsidiary Novo A/S and are not listed or traded on any stock exchange. The B shares have been publicly traded since 1974 and have been listed on the NASDAQ OMX Copenhagen since that time. The NASDAQ OMX Copenhagen is the main trading market for the B shares.
American Depositary Receipts representing the B shares (ADRs), as evidenced by American Depositary Receipts issued by JP Morgan Chase Bank of New York, as the Depositary, have been listed on the New York Stock Exchange since 1981. As of December 31, 2012, 48,944,355 B share equivalents (representing 11.25% of the outstanding B shares, adjusted for the treasury shares) were held in the form of ADRs.
22
SELLING SHAREHOLDERS |
Not applicable.
DILUTION |
Not applicable.
EXPENSES OF THE ISSUE |
Not applicable.
ITEM 10 | ADDITIONAL INFORMATION |
SHARE CAPITAL |
Not applicable.
MEMORANDUM AND ARTICLES OF ASSOCIATION |
This section summarizes certain material provisions of Novo Nordisk A/Ss Articles of Association, certain other constitutive documents and relevant Danish corporate law. See Exhibit 1.1 to this Form 20-F for a translation into English language of the Articles of Association.
General
Novo Nordisk A/S is a limited liability company organized under the laws of
Denmark and registered in the Danish Central Business Register under CVR number
24256790. Novo Nordisk A/Ss objects are to carry out research and development
and to manufacture and commercialize pharmaceutical, medical and technical products
and services as well as any other activity related thereto as determined by
its Board of Directors. It strives to conduct its activities in a financially,
socially, and environmentally responsible way. Novo Nordisk A/Ss objects
are set out in Article 2 of its Articles of Association.
Powers of the Board of Directors
All members of the Board of Directors have equal voting rights, and all resolutions
are passed by a simple majority of votes. However, in the event of a tie, the
Chairman shall have the casting vote. The Board of Directors forms a quorum
when a majority of its members is present.
According to the Danish Companies Act, no member of the Board of Directors or the Executive Committee may take part in the consideration of any business involving agreements between any member of the group and himself, legal actions brought against himself, or any business involving agreements between any member of the Group and any third party or legal actions brought against any third party, if he has a major interest therein that might conflict with Novo Nordisk A/Ss interests. The Danish Companies Act also prohibits Novo Nordisk A/S from granting loans or providing securities to any member of the Board of Directors and anyone particularly close to such a member of the Board of Directors.
The remuneration of the Board of Directors must be approved by Novo Nordisk A/Ss shareholders at the Annual General Meeting.
According to Novo Nordisk A/S Articles of Association a person cannot be nominated for election or re-election if such person has reached the age of 70 at the time of the General Meeting.
23
Rights, restrictions and preferences attaching to the shares
If the shareholders at an Annual General Meeting approve a recommendation by
the Board of Directors to pay dividends, dividends shall be distributed as follows:
a priority dividend of 1/2% of the nominal share capital to the holders of A
shares and then up to a dividend of 5% to the holders of B shares. Any distribution
of additional dividends shall be subject to the provision that the holders of
A shares shall never receive a total dividend exceeding the percentage rate
of the dividend paid to the holders of B shares. Dividends on A shares shall
be remitted to the shareholders at the addresses entered in the Companys
Register of Shareholders as at the date of the Annual General Meeting. Dividends
on B shares shall be paid with fully discharging effect for the Company through
a central securities depository and an account-holding bank to shareholders
registered by VP Securities at the time of payment. The right to dividends shall
lapse five years after the due date for payment thereof.
Subject to the preference mechanism described above, the A shares and the B shares rank as equal in the event of a return on capital by the company. Upon a winding-up, liquidation or otherwise, the B shares rank ahead of the A shares with regard to payment of each shares nominal amount. All shares rank as equal in respect of further distributions from a winding-up.
Each A share of DKK 1 carries 1,000 votes and each B share of DKK 1 carries 100 votes at the General Meeting. A shares are non-negotiable instruments whereas B shares are negotiable instruments.
The holders of A shares have a pro-rata right of first refusal with regard to any A shares sold by another shareholder. Such shares shall be offered to the Board of Directors on behalf of the other holders of A shares at a price not lower than the average of the buying price quoted for the B shares on the NASDAQ OMX Copenhagen during the last three months prior to the submission of such offer. Within 30 days of receipt of such offer, the Board of Directors shall inform the shareholder whether other holders of A shares wish to acquire the shareholding in question.
The share capital has been fully paid up and shareholders are not liable to further capital calls by Novo Nordisk A/S. No shareholder shall be obliged to have his shares redeemed in whole or in part. There is no sinking fund provision in the Articles of Association. There is no provision in the Articles of Association discriminating against any existing or prospective holder of such securities as a result of such shareholder owning a substantial number of shares. The members of the Board of Directors do not stand for reelection at staggered intervals and there is no cumulative voting arrangement.
Changes in shareholders rights
Changes in the rights of holders of A shares or B shares require an amendment
of the Articles of Association. Unless stricter requirements are made under
the Danish Companies Act for any such resolution to be passed, (i) at least
2/3 of the total number of votes in Novo Nordisk A/S shall be represented at
the General Meeting, and (ii) at least 2/3 of the votes cast and of the voting
share capital shall vote in favor of such a resolution. If the quorum requirement
in (i) is not fulfilled, the Board of Directors shall within two weeks convene
another General Meeting at which the resolution may be passed irrespective of
the number of votes represented.
General Meetings
Novo Nordisk A/Ss General Meetings shall be held at a venue in the Capital
Region of Denmark. The Annual General Meeting shall be held before the end of
April in every year. Extraordinary General Meetings shall be held as resolved
by the General Meeting or the Board of Directors, or upon the request of the
auditors or shareholders representing in total at least 5% of the share capital.
The Extraordinary General Meeting shall then be called not later than two weeks
after receipt of such request.
General Meetings shall be called by the Board of Directors not earlier than five weeks and not later than three weeks prior to the General Meeting. The notice calling such General Meeting, stating the agenda for the meeting, shall be published on the Companys website: novonordisk.com (the contents of this website are not incorporated by reference into this Form 20-F). The notice convening the meeting shall also be forwarded in writing to all shareholders entered in the Register of Owners who have so requested and be advertised in the IT system of the Danish Business Authority.
24
A shareholders right to attend and vote at a General Meeting shall be determined by the shares which such shareholder owns at the record date. The record date shall be one week prior to the General Meeting. The shares held by each shareholder at the record date shall be calculated based on the registration of the shareholders shares in the Register of Owners as well as any notification received by the Company with respect to registration of shares in the Register of Owners, which have not yet been entered in the Register of Owners. Any shareholder who is entitled to attend the General Meeting as previously described and who wants to attend the General Meeting is required to apply for an admission card to such General Meeting not later than three days prior to the date of such General Meeting.
Ownership restrictions
There are no limitations on the rights of non-resident or foreign owners to
hold or vote the shares imposed by the laws of Denmark, Novo Nordisk A/Ss
Articles of Association, or any other of its constituent documents.
Change of control
There is no provision in the Articles of Association, nor any other constituent
document, that would have an effect of delaying, deferring or preventing a change
in control of Novo Nordisk A/S and that would operate only with respect to a
merger, acquisition or corporate restructuring involving the company (or any
of its subsidiaries). However, based on the current shareholder structure, the
voting rights held by holders of A shares outlined above afford the Novo Nordisk
Foundation, acting through its wholly-owned subsidiary Novo A/S, veto power
against any change of control.
Ownership disclosure
According to the Danish Securities Trading Act, a shareholder of Novo Nordisk
A/S must disclose their ownership if they own more than 5% of the voting rights
and share capital. Also, shareholders must disclose change in holdings already
notified if these changes entail that thresholds of 5%, 10%, 15%, 20%, 25%,
50% or 90% and 1/3 and 2/3 of the voting rights or share capital are crossed.
Changes in capital
Novo Nordisk A/Ss Articles of Association do not contain conditions governing
changes in the capital more stringent than those contained in the Danish Companies
Act.
MATERIAL CONTRACTS |
There have been no material contracts outside the ordinary course of business.
EXCHANGE CONTROLS |
There are no governmental laws, decrees, or regulations in Denmark (including, but not limited to, foreign exchange controls) that restrict the export or import of capital, or that affect the remittance of dividends, interest or other payments to non-resident holders of the B shares or the ADRs.
There are no limitations on the right of non-resident or foreign owners to hold or vote the B shares or the ADRs imposed by the laws of Denmark or the Articles of Association of the Company.
TAXATION |
Danish Taxation
The following summary outlines certain Danish tax consequences to U.S. Holders
(defined below):
Withholding Tax
Generally, Danish withholding tax is deducted from dividend payments to U.S.
Holders at a 27% rate, the rate generally applicable to non-residents in Denmark
without regard to eligibility for a reduced treaty rate. Under the current Convention
between the Government of the United States of America and the Government of
the Kingdom of Denmark for the Avoidance of Double Taxation and the Pre-
25
vention of Fiscal Evasion with respect to Taxes on Income (the Current Convention), however, the maximum rate of Danish tax that may be imposed on a dividend paid to a U.S. Holder that does not have a permanent establishment (as defined therein) in Denmark is generally 15% and, for certain pension funds, 0% (each, the Treaty Rate). U.S. Holders eligible for the Treaty Rate may apply to the Danish tax authorities to obtain a refund to the extent that the amount withheld reflects a rate in excess of the Treaty Rate (any such amount, the Excess Withholding Tax).
The Danish tax authorities have approved a simplified withholding tax refund procedure for U.S. Holders of ADRs entitled to the benefits of the Current Convention. Under the simplified refund procedures, U.S. Holders of ADRs that provide a properly completed Internal Revenue Service (IRS) Form 6166 to the Depositary within a sufficient time prior to the dividend payment date will receive the Excess Withholding Tax upon the receipt of the dividend. U.S. Holders of ADRs that provide a properly completed Form 6166 to the Depositary after the dividend payment date, but no later than four months following such date, will receive a refund from the Depositary of the Excess Withholding Tax after the dividend payment date. U.S. Holders of ADRs that do not provide IRS Form 6166 to the Depositary within the period ending four months after the dividend payment date may claim a refund of the Excess Withholding Tax by filing a properly completed Danish Dividend Tax claim form 06.008 and a properly completed IRS Form 6166 with the Danish tax authorities within the three-year period following the year in which the dividend was paid.
Sale or Exchange of ADRs or B Shares
Any gain or loss realized on the sale or other disposition of ADRs or B shares
by U.S. Holder that is not either a resident of Denmark or a corporation that
is doing business in Denmark is not subject to Danish taxation. In addition,
any non-resident of Denmark may remove from Denmark any convertible currency
representing the proceeds of the sales of ADRs or B shares in Denmark.
U.S. Taxation
The following summary outlines certain U.S. tax consequences for U.S. Holders
(defined below) of owning and disposing of ADRs or B shares. A U.S. Holder
is a holder who, for U.S. federal income tax purposes, is a beneficial owner
of ADRs or B shares that is eligible for the benefits of the Current Convention
and is (i) a citizen or individual resident of the United States, (ii) a corporation,
or other entity taxable as a corporation, created or organized in or under the
laws of the United States or any political subdivision thereof, or (iii) an
estate or trust the income of which is subject to U.S. federal income taxation
regardless of its source. This discussion applies only to a U.S. Holder that
holds ADRs or B shares as capital assets for U.S. tax purposes and does not
apply to persons that own or are deemed to own 10% or more of Novo Nordisk voting
stock. In addition, this discussion does not describe all of the tax consequences
or potentially different tax consequences that may be relevant in light of the
U.S. Holders particular circumstances, including tax consequences applicable
to U.S. Holders subject to special rules, such as certain financial institutions,
entities classified as partnerships for U.S. federal income tax purposes, or
persons holding ADRs or B shares in connection with a trade or business conducted
outside of the United States. This discussion is based , in part, on certain
representations by the Depositary and assumes that each obligation under the
deposit agreement will be performed in accordance with its terms. This discussion
assumes that the Company is not, and will not become, a passive foreign investment
company for U.S. federal income tax purposes.
For U.S. federal income tax purposes, the holders of ADRs will be treated as the beneficial owners of the underlying B shares. Accordingly, no gain or loss for U.S. federal income tax purposes will be recognized if a U.S. Holder exchanges ADRs for the underlying B shares represented by those ADRs or B shares for ADRs.
The U.S. Treasury has expressed concern that parties to whom American depositary receipts are released before shares are delivered to the depositary (referred to as a pre-release), or intermediaries in the chain of ownership between holders and the issuer of the security underlying the American depositary receipts, may be taking actions that are inconsistent with the claiming of foreign tax credits by holders of American depositary receipts. These actions would also be inconsistent with the claiming of the reduced rate of tax, described below, applicable to dividends received by certain non-corporate U.S. Holders. Accordingly, the creditability of Danish taxes, and the availability of the reduced tax
26
rate for dividends received by certain non-corporate U.S. Holders, each described below, could be affected by actions taken by such parties or intermediaries.
Taxation of Distributions
For U.S. federal income tax purposes, distributions on ADRs or B shares received
by U.S. Holders, before reduction for any Danish tax withheld, generally will
be included in the holders income as foreign source dividend income and
will not be eligible for the dividends-received deduction generally available
to U.S. corporations. The amount of any dividend income paid in Danish kroner
will be the U.S. dollar amount calculated by reference to the exchange rate
in effect on the date of the U.S. Holders, or, in the case of ADRs, the
Depositarys receipt of the dividend regardless of whether the payment
is in fact converted into U.S. dollars at that time. If the dividend is converted
into U.S. dollars on the date of receipt, a U.S. Holder should not be
required to recognize foreign currency gain or loss in respect of the dividend
income. A U.S. Holder may have foreign currency gain or loss if the dividend
is converted into U.S. dollars after the date of receipt. U.S. Holders that
receive a refund of Danish withholding tax after the dividend is received, as
discussed above under the section Danish Taxation Withholding Tax,
may be required to recognize foreign currency gain or loss with respect to the
amount of the refund. U.S. Holders should consult their tax advisers regarding
whether any foreign currency gain or loss should be recognized in connection
with distributions on ADRs or B shares.
Subject to applicable limitations and conditions under U.S. federal income tax law and the discussion above regarding concerns expressed by the U.S. Treasury, dividends paid to certain non-corporate U.S. Holders may be taxable at favorable rates. In order to be eligible for the favorable rates, a non-corporate U.S. Holder must fulfill certain holding period and other requirements.
Subject to applicable limitations under U.S. federal income tax law and the discussion above regarding concerns expressed by the U.S. Treasury, a U.S. Holder may be eligible to credit against its U.S. federal income tax liability Danish taxes withheld from dividends on ADRs or B shares at a rate not exceeding the applicable rate under the Current Convention. Danish taxes withheld in excess of the applicable rate under the Current Convention will not be eligible for credit against a U.S. Holders federal income tax liability. The rules governing foreign tax credits are complex and, therefore, U.S. Holders should consult their tax advisers regarding the availability of foreign tax credits in their particular circumstances.
Alternatively, subject to applicable limitations, U.S. Holders may elect to deduct Danish taxes withheld from dividend payments. An election to deduct foreign taxes instead of claiming a foreign tax credit must apply to all taxes paid or accrued in the taxable year to foreign countries and possessions of the United States.
Sale or Exchange of ADRs or B Shares
A U.S. Holder will recognize capital gain or loss for U.S. federal income tax
purposes on a sale or other disposition of ADRs or B shares, which will be long-term
capital gain or loss if the U.S. Holder held the ADRs or B shares for more than
one year. The amount of the gain or loss will equal the difference between the
U.S. Holders tax basis in the ADRs or B shares disposed of and the amount
realized on the disposition, in each case as determined in U.S. dollars. Such
gain or loss will generally be U.S. source gain or loss for foreign tax credit
purposes.
Information Reporting and Backup Withholding
Payments of dividends and sales proceeds that are made within the United States
or through certain U.S. related financial intermediaries may be subject to information
reporting and backup withholding, unless (i) the U.S. Holder is a corporation
or other exempt recipient or (ii) in the case of backup
withholding, the U.S. Holder provides a correct taxpayer identification number
and certifies that it is not subject to backup withholding.
The amount of any backup withholding from a payment to a U.S. Holder will be allowed as a credit against the holders U.S. federal income tax liability and may entitle it to a refund, provided that the required information is timely furnished to the Internal Revenue Service.
27
Certain U.S. Holders who are individuals (and, under proposed Treasury regulations, certain entities) may be required to report information relating to securities issued by a non-U.S. person or foreign accounts through which such securities are held, subject to certain exceptions (including an exception for securities held in accounts maintained by U.S. financial institutions). U.S. Holders should consult their tax advisers regarding their possible reporting obligations with respect to the ADRs or B shares.
The foregoing sections offer a general description and U.S. Holders should consult their tax advisers to determine the U.S. federal, state, local and foreign tax consequences of owning and disposing of ADRs or B shares in their particular circumstances. |
DIVIDENDS AND PAYING AGENTS |
Not applicable.
STATEMENT BY EXPERTS |
Not applicable.
DOCUMENTS ON DISPLAY |
Documents referred to and filed with the SEC together with this Form 20-F can be read and copied at the SECs public reference room located at 100 F Street, NE, Washington, DC 20549. Please call the United States Securities and Exchange Commission at 1-800-SEC-0330 for further information on the public reference rooms.
Copies of the Form 20-F as well as the Annual Report 2012 can be downloaded from the
Investors pages at novonordisk.com. The contents of this website are not incorporated by reference into this Form 20-F. The Form 20-F is also filed and can be viewed via EDGAR on www.sec.gov.
SUBSIDIARY INFORMATION |
ITEM 11 | QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISKS |
Financial exposure and financial risk management
For a description and discussion of the Companys foreign exchange risk
management, interest risk management, counterparty risk management and equity
price risk management, reference is made to Note 4.3 Financial risk
and the Risk overview on page 43 in the Annual Report 2012.
Sensitivity analysis
When conducting a sensitivity analysis, the Group assesses the change in fair
value on the market-sensitive instruments following hypothetical changes in
market rates and prices. The rates used to mark-to-market the instruments are
market data as of December 28, 2012.
Interest rate sensitivity analysis
For information on Interest rate sensitivity analysis in the financial year
of 2012, reference is made to Note 4.3 Financial risk in the Annual
Report 2012.
Foreign exchange sensitivity analysis
For information on Foreign exchange sensitivity analysis in the financial year
of 2012, reference is made to Note 4.3 Financial risk and the Risk
overview on page 43 in the Annual Report 2012.
28
ITEM 12 | DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES |
ITEM 12A | DEBT SECURITIES |
Not applicable.
ITEM 12B | WARRANTS AND RIGHTS |
Not applicable.
ITEM 12C | OTHER SECURITIES |
Not applicable.
ITEM 12D | AMERICAN DEPOSITARY SHARES |
Novo Nordisks ADR program is administered by J.P. Morgan Depositary Receipts Group, JPMorgan Chase Bank, N.A., 4 One Chase Manhattan Plaza, New York, U.S., as Depositary.
The ADRs are traded under the code NVO on the New York Stock Exchange and the underlying security is the Novo Nordisk B share, NOVOb on the NASDAQ OMX Copenhagen. Each ADR represents one deposited Novo Nordisk B share. One ADR carries the same voting rights as one Novo Nordisk B share. The Depositary distributes relevant notices, reports and proxy materials to the holders of the ADRs. When dividends are paid to shareholders, the Depositary converts the amounts into U.S. dollars and distributes the dividends to the holders of the ADRs. No fees are charged to the holders of the ADRs in relation to these procedures.
The holder of an ADR has to pay the following fees and charges related to services in connection with the ownership of the ADR:
Service |
Fee
|
Issuance or delivery of an ADR, surrendering of an ADR for delivery of a Novo Nordisk B share, cancellation of an ADR, including issuance, delivery, surrendering or cancellation in connection with share distributions, stock splits, rights and mergers |
A maximum of USD 5.00 for each 100 ADRs
(or portion thereof), to be paid to the Depositary
|
Transfer of the Novo Nordisk B shares from the Danish custodian bank to the holder of the ADRs account in Denmark |
USD 20.00 cabling fee per transfer, to
be paid to the Depositary
|
Taxes and other governmental charges the holder of the ADR has to pay on any ADR or share underlying the ADR |
As necessary
|
J.P. Morgan, as Depositary, has agreed to reimburse certain reasonable expenses related to Novo Nordisks ADR program and incurred by Novo Nordisk in connection with the program. In the year ended December 31, 2012, the Depositary reimbursed USD 500,000 for costs related to investor relations programs and special investor relations promotional activities, and waived costs of USD 35,000 related to the maintenance of the ADR program and other services. The amounts the Depositary reimbursed are not related to the amount of fees collected by the Depositary from ADR holders.
29
PART II
ITEM 13 | DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES |
None.
ITEM 14 | MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS |
None.
ITEM 15 | CONTROLS AND PROCEDURES |
Evaluation of disclosure controls and procedures
Novo Nordisk maintains disclosure controls and procedures that are designed
to ensure that information required to be disclosed in reports that Novo Nordisk
files under the Securities Exchange Act of 1934 is recorded, processed, summarized
and reported within the time periods specified in the rules and forms of the
United States Securities and Exchange Commission.
Novo Nordisk Management has evaluated the Companys disclosure controls and procedures as of December 31, 2012. Based on this evaluation, the Companys Chief Executive Officer and Chief Financial Officer concluded that the Companys disclosure controls and procedures are effective at the reasonable assurance level for gathering, analyzing and disclosing the information the Company is required to disclose in the reports it files under the Securities Exchange Act of 1934, within the time periods specified in the SECs rules and forms.
In designing and evaluating the disclosure controls and procedures, Management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives.
Report of Novo Nordisk Management on Internal Control over
Financial Reporting
Novo Nordisks Board of Directors and Executive Management are responsible
for establishing and maintaining adequate internal control over financial reporting.
The Novo Nordisk Groups internal control system was designed to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation and fair presentation of its published consolidated financial statements.
All internal control systems no matter how well designed have inherent limitations. Therefore, even those systems determined to be effective may not prevent or detect misstatements and can provide only reasonable assurance with respect to financial statement preparation and presentation. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Novo Nordisk Management assessed the effectiveness of the Groups internal control over financial reporting as of December 31, 2012. In making this assessment, they used the criteria established in Internal Control Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this assessment the Chief Executive Officer and Chief Financial Officer have concluded that, as of December 31, 2012, the Novo Nordisk Groups internal control over financial reporting is effective based on those criteria.
The effectiveness of internal control over financial reporting as of December 31, 2012 has been audited by PricewaterhouseCoopers, Statsautoriseret Revisionspartnerselskab, Denmark, an independent registered public accounting firm, as stated on page 43 of this Form 20-F.
30
Changes in internal controls over financial reporting
There were no changes in the Companys internal control over financial
reporting that occurred during the year ended December 31, 2012 that have materially
affected, or are reasonably likely to materially affect, the Companys
internal control over financial reporting.
ITEM 16A | AUDIT COMMITTEE FINANCIAL EXPERTS |
The Audit Committee has three members elected by the Board among its members. All members qualify as independent as defined by the U.S. Securities and Exchange Commission (SEC). One member is designated as chairman and all members are designated as Audit Committee Financial Experts as defined by the SEC.
In March 2012, the board elected the following individuals to the Audit Committee: Hannu Ryöppönen (Audit Committee Chairman and Financial Expert), Kurt Anker Nielsen (Audit Committee Member and Financial Expert) and Liz Hewitt (Audit Committee Member and Financial Expert).
ITEM 16B | CODE OF ETHICS |
Novo Nordisk has a vision and a set of essentials named the Novo Nordisk Way. The Novo Nordisk Way describes who we are, where we want to go and how we work. The Novo Nordisk Way is principle-based and describes corporate essentials and the required values and mindset of employees on business conduct and ethics including a number of the topics required by the Sarbanes-Oxley Act and the NYSE Listed Company Manual. In addition to the Novo Nordisk Way, a number of policies and related procedures have been established including a business ethics policy and related business ethics procedures where the requirements for how to conduct business in Novo Nordisk are outlined.
For further information on the Novo Nordisk Way, reference is made to page 19 in the Annual Report 2012, and Novo Nordisk Way may be found on Novo Nordisks website at novonordisk.com (the contents of the website are not incorporated by reference into this Form 20-F).
ITEM 16C | PRINCIPAL ACCOUNTANT FEES AND SERVICES |
Reference is made to Note 5.7 Fee to statutory auditors in our Annual Report 2012 regarding fees paid to our statutory auditors.
Statutory audit fees
Statutory audit fees consist of fees billed for the annual audit of the Companys
Annual Report, the financial statements of the Parent Company, Novo Nordisk
A/S, and financial statements of fully-owned affiliates including audit of internal
controls over financial reporting (Sarbanes-Oxley Act, Section 404). The fees
also include fees billed for other audit services, which are those services
that only the statutory auditor can provide, and include the review of documents
filed with the SEC.
Audit-related fees
Fees for audit-related services consist of fees billed for assurance and related
services that are related to the performance of the audit or review of the Companys
social and environmental reporting included in the Annual Report and include
consultations concerning financial accounting, reporting standards and financial
due diligence.
Tax fees
Fees for tax advisory services include fees billed for tax compliance services,
tax consultations, such as assistance and representation in connection with
tax audits and appeals, transfer pricing and tax planning services.
31
All other fees
Fees for all other services comprise fees billed for other permitted services
such as audit or review opinions rendered to third parties regarding the Companys
compliance with contracts, compliance reviews in connection with healthcare
laws and regulations and assessment of their impact on the distribution chain,
reviews of business continuity plans, IT crisis management plans, HR Benchmark
reports and reviews of the risk management process.
Pre-approval policies
The Audit Committee assesses and pre-approves all audit and non-audit services
provided by the statutory auditors. The pre-approval includes the type of service
and a fee budget. Furthermore, the Audit Committee receives a quarterly update
on actual services provided and fees realized.
ITEM 16D | EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES |
Not applicable.
ITEM 16E | PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS |
Total Number of Shares Purchased (a)* |
Average Price Paid per Share
in DKK (b) |
Total Number of Shares Purchased
as Part of Publicly Announced Plans or Programs (c) |
Maximum Approximate Value of
Shares that may yet be purchased under the Plans or Programs in DKK (d)** |
|
2011 repurchase program | ||||
Year end 2011 | 18,261,205 | 598.92 | 18,261,205 | 1,062,934,549 |
January 1-31 | 1,567,117 | 678.27 | 19,828,322 | 0 |
Total | 19,828,322 | 605.19 | 19,828,322 | 0 |
2012 repurchase program |
12,000,000,000
|
|||
February 1-29 | 1,158,000 | 767.08 | 1,158,000 | 11,111,721,651 |
March 1-31 | 1,218,000 | 794.52 | 2,376,000 | 10,143,991,226 |
April 1-30 | 772,099 | 834.08 | 3,148,099 | 9,500,000,405 |
May 1-31 | 5,650,942 | 823.64 | 8,799,041 | 4,845,658,862 |
June 1-30 | 684,585 | 810.84 | 9,483,626 | 4,290,571,528 |
July 1-31 | 779,000 | 891.12 | 10,262,626 | 3,596,388,316 |
August 1-31 | 648,419 | 937.84 | 10,911,045 | 2,988,276,622 |
September 1-30 | 787,224 | 912.73 | 11,698,269 | 2,269,753,494 |
October 1-31 | 815,191 | 944.26 | 12,513,460 | 1,500,000,689 |
November 1-30 | 254,902 | 912.31 | 12,768,362 | 1,267,451,358 |
December 1-31 | 289,055 | 925.26 | 13,057,417 | 1,000,001,101 |
Total | 13,057,417 | 842.43 | 13,057,417 | 1,000,001,101 |
*ref (a); All shares purchased through a publicly announced program.
**ref (d); As of December 31, 2011 150,000 shares were purchased to a total value of DKK 98,359,000 with a value date between January 2, 2012 and January 4, 2012. The shares are included in this table in December 2011 but are also included in the Statement of changes in equity in our Annual Report 2012.
32
Note to column (a) and (d)
The Board of Directors has an authorization from the annual shareholders
meeting to acquire up to 10% of the share capital at the price quoted at the
time of the purchase with a deviation of up to 10%. This authorization is renewed
annually at the annual general meeting. If the limit of 10% is reached a number
of shares would have to be cancelled before further purchases can be made. The
cancellation of shares must be approved by the shareholders.
Under this authorization, a share repurchase program of DKK 12 billion was completed in January 2012. A new share repurchase program of DKK 12 billion initiated in February 2012 has been completed in January 2013. The shares have been purchased through a bank directly in the market or directly from named shareholders such as Novo A/S.
Notes to columns (c) and (d)
In order to maintain capital structure flexibility, the Board of Directors intends
to propose at the Annual General Meeting on March 20, 2013, a reduction in the
B share capital, by cancellation of 10 million shares (nominal value DKK 1)
of current treasury B shares, to DKK 442,512,800. This would correspond to a
1.79% reduction of the total share capital.
ITEM 16F | CHANGE IN REGISTRANTS CERTIFYING ACCOUNTANT |
Not applicable.
ITEM 16G | CORPORATE GOVERNANCE |
Novo Nordisk is a foreign private issuer whose ADRs are listed on the New York Stock Exchange (the NYSE). As such, Novo Nordisk is required to comply with U.S. securities laws, including the Sarbanes-Oxley Act and the NYSE Corporate Governance Standards except that, as permitted under these standards, Novo Nordisk continues to apply Danish corporate governance practices in certain areas.
As a non-U.S. NYSE-listed Company, Novo Nordisk is required to provide a concise summary in this annual report of the significant ways in which its corporate governance practices differ from the corporate governance standards of the NYSE applicable to domestic U.S.-listed companies. Below is an overview of these significant differences.
Listed Company Manual Section
303A
|
Corporate Governance standard
|
Novo Nordisk corporate governance practice
|
Rule 2.(a)
|
No director qualifies as independent
unless the board of directors affirmatively determines that the director
has no material relationship with the listed company (either directly
or as a partner, shareholder or officer of an organization that has a
relationship with the Company). Companies must identify which directors
are independent and disclose the basis for that determination.
|
Under the Danish Corporate Governance Recommendations,
at least half of the elected members of the Board, excluding any members
that have been elected by employees of the company, must be independent.
Employees are entitled to be represented by half of the total number of
board members elected at the general meeting.
The Board has determined whether Board members qualify as independent under the Danish Corporate Governance Recommendations. The Board has also determined whether the Board members, who are members of the Audit Committee, qualify as independent under Rule 10A-3 under the Securities Exchange Act. Such determination is disclosed in the Annual Report. Further, the Annual Report provides detailed and individual in- |
33
|
|
formation regarding the Board members,
but it does not explicitly identify which Board members the Board considers
independent under NYSE Corporate Governance Standards.
|
Rule 2.(b)(i)
|
In addition, a director is not independent
if the director is, or has been within the last three years, an employee
of the listed Company, or an immediate family member is, or has been within
the last three years, an executive officer, of the listed Company.
|
Rule 303A.02 defines listed company,
for purposes of the independence standards, to include any parent
or subsidiary in a consolidated group with the listed company or such
other company as is relevant to any determination under the independence
standards set forth in this Section 303A.02(b).
One Board member currently serves as executive of the majority shareholder, Novo A/S, and thus may be deemed as being non-independent. Also, four employees have in accordance with the requirements in the Danish Companies Act been elected as board members by the Danish employees of the company. No other Board member or the board members immediate family members have within the last three years been an employee or executive of Novo Nordisk or any parent or subsidiary in a consolidated group with Novo Nordisk. |
Rule 2.(b)(ii)
|
Furthermore, a director is not independent
if the director has received, or has an immediate family member who has
received, during any twelve months period within the last three years,
more than $120,000 in direct compensation from the listed company, other
than director and committee fees and pension or other forms of deferred
compensation for prior service (provided such compensation is not contingent
in any way on continued service).
|
Definition of listed company
is identical to what is stated under Rule 2.(b)(i). One Board member serves
as executive of the majority shareholder, Novo A/S, and thus may be deemed
as being non-independent due to the receipt of remuneration as executive
of Novo A/S.
No other Board member or immediate family member receives or has received such fees from Novo Nordisk. |
Rule.4(a)
|
Listed companies must have a nominating/corporate
governance committee composed entirely of independent directors.
|
The requirement does not apply if a company
is controlled, which the NYSE defines as having more than
50% of the voting power for the election of directors held by an individual,
a group or another company. Novo Nordisk is such a controlled company
and is therefore exempt from this requirement in the same manner as U.S.
companies are.
The Chairmanship serves as nomination committee and presents proposals to the Board. However, Novo Nordisk has not established a separate nomination committee because Novo Nordisk believes that each Board member must have the opportunity to contribute actively to discussions and have access to all relevant information about nomination. |
34
Rule 5.(a)
|
Listed companies must have a compensation
committee composed entirely of independent directors.
|
The requirement does not apply if a company
is controlled, which the NYSE defines as having more than
50% of the voting power for the election of directors held by an individual,
a group or another company. Novo Nordisk is such a controlled company
and is therefore exempt from this requirement in the same manner as U.S.
companies are.
The Chairmanship serves as a compensation committee and presents proposals to the Board. However, Novo Nordisk has not established a separate compensation committee because Novo Nordisk believes that each Board member must have the opportunity to contribute actively to discussions and have access to all relevant information about remuneration. |
Rule 7.(b)(i)
Rule 7.(b)(i)(A)
|
The audit committee must have a written charter that addresses the committees purpose which, at minimum, must be to: assist board oversight of (1) the integrity of the Companys financial statements, (2) the Companys compliance with legal and regulatory requirements, (3) the independent auditors qualifications and independence, and (4) the performance of the Companys internal audit function and independent auditors; and |
The Audit Committee charter addresses the Committees purpose. As stated in the charter, the Audit Committee is, amongst other things, responsible for oversight of and reporting to the Board on the elements described in the recommendation except compliance with legal and regulatory requirements which only consists of business ethics compliance. |
Rule 8
|
Shareholders must be given the opportunity
to vote on all equity-compensation plans and material revisions thereto.
|
The Remuneration Principles are approved
by the Annual General Meeting. The Remuneration Principles describe the
framework for incentive programs for the Board and Executive Management.
All incentive programs offered to the Board and/or Executive Management
shall comply with this framework. However, under Danish law, the practice
of voting on equity-compensation plans is not contemplated and accordingly,
equity compensation plans are only subject to shareholder approval if
it results in the issuance of new shares (and not if treasury shares are
used).
|
Rule 10
|
Listed companies must adopt and disclose a code of business
conduct and ethics for directors, officers and employees, and promptly
disclose any waivers of the code for directors or executive officers. |
Novo Nordisk has a framework of rules and
guidelines, including but not limited to the Novo Nordisk Way, which describe
corporate values and required mindsets on business conduct and ethics.
While certain topics mentioned in the Listed Company Manual are addressed in this framework of rules and guidelines there may be topics which are not covered. |
35
Protection and proper use
of company assets.
Compliance with laws, rules and regulations (including insider-trading laws). Encouraging the reporting of any illegal or unethical behaviour. |
||
Rule 12.(a)
|
Each listed company CEO must certify to
the NYSE each year that he or she is not aware of any violation by the
listed company of NYSE corporate governance listing standards, qualifying
the certification to the extent necessary.
|
Listed companies that are foreign private
issuers are permitted to follow home country practice in lieu of the provisions
of this section. Novo Nordisk has opted to follow Danish law and regulations
which do not contemplate such certifications.
|
ITEM 16H | MINE SAFETY DISCLOSURE |
Not applicable.
36
PART III
ITEM 17 | FINANCIAL STATEMENTS |
See response to Item 18.
ITEM 18 | FINANCIAL STATEMENTS |
The financial statements required by this item accompany this annual report in the form of the Novo Nordisk Annual Report 2012 (see Exhibit no. 15.1).
RECONCILIATION OF NON-IFRS FINANCIAL MEASURES |
In the Annual Report 2012, Novo Nordisk discloses certain financial measures of the Groups financial performance, financial position and cash flows that reflect adjustments to the most directly comparable measures calculated and presented in accordance with IFRS. These non-IFRS financial measures may not be defined and calculated by other companies in the same manner and may thus not be comparable with such measures:
The non-IFRS financial measures presented in the Annual Report 2012 are:
| Free cash flow; |
| Cash to earnings; |
| Operating profit after tax to net operating assets; |
| Financial resources at the end of the year; |
| Underlying sales growth in local currencies. |
Management believes free cash flow is an important liquidity metric because it measures, during a given period, the amount of cash generated that is available to make investments, fund acquisitions and for certain other activities. A positive free cash flow shows that the Group is able to finance its activities and that external financing is thus not necessary for the Groups operating activities. Therefore, management believes that this non-IFRS liquidity measure provides useful information to investors in addition to the most directly comparable IFRS financial measure Net cash generated from operating activities.
The following table shows a reconciliation of free cash flow to Net cash generated from operating activities.
Reconciliation
of free cash flow
|
||||
DKK
Million
|
2012
|
2011
|
2010
|
|
|
|
|
|
|
|
Free
cash flow
|
18,645
|
18,112
|
17,013
|
+
|
Net
purchase of marketable securities
|
(501)
|
(197)
|
(2,913)
|
+
|
Net
cash used in investing activities
|
4,070
|
3,459
|
5,579
|
=
|
Net
cash generated from operating activities
|
22,214
|
21,374
|
19,679
|
37
Cash to earnings
Cash to earnings is defined as free cash flow as a percentage of net profit.
Management believes that Cash to earnings is an important performance metric because it measures the Groups ability to turn earnings into cash and is, therefore, in the eyes of management a meaningful measure for investors to understand the development of the Groups net cash generated from operating activities. Because management wants this measure to capture the ability of the Groups operations to generate cash, free cash flow is used as the numerator instead of net cash flow.
The following table shows the reconciliation of Cash to earnings to the most comparable IFRS financial measure Cash flow from operating activities/earnings in %:
Reconciliation
of cash to earnings
|
||||
|
|
|||
DKK
Million
|
2012
|
2011
|
2010
|
|
|
|
|
|
|
|
Free
cash flow
|
18,645
|
18,112
|
17,013
|
/
|
Net
profit (as reported in Annual Report)
|
21,432
|
17,097
|
14,403
|
=
|
Cash
to earnings (as reported in the Annual Report) in %
|
87.0%
|
105.9%
|
118.1%
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash generated from operating activities
|
22,214
|
21,374
|
19,679
|
/
|
Net
profit (as reported in the Annual Report)
|
21,432
|
17,097
|
14,403
|
=
|
Cash
flow generated from operating activities / Net profit in %
|
103.6%
|
125.0%
|
136.6%
|
Management believes Operating profit after tax to net operating assets is a useful measure in providing investors and management with information regarding the Groups performance. The calculation of the financial target Operating profit after tax to net operating assets is a widely accepted measure of earnings efficiency in relation to total capital employed. Management believes that the income level relative to total capital employed, as measured by Operating profit after tax to net operating assets, is an effective measure of increases or decreases, as the case may be, in shareholder value generation.
The following table reconciles Operating profit after tax to net operating assets with Operating profit/equity in %, the most directly comparable IFRS financial measure:
Reconciliation of Operating profit after tax to net operating assets |
|
|
|
|
|
|
|
|
|
DKK
Million
|
2012
|
2011
|
2010
|
|
|
|
|
|
|
|
Operating
profit after tax
|
22,724
|
17,452
|
14,886
|
/
|
Average
non-interest bearing balance sheet items
|
22,943
|
22,406
|
23,390
|
=
|
Operating
profit after tax to net operating assets (as reported in the Annual Report)
in %
|
99.0%
|
77.9%
|
63.6%
|
38
|
Numerator
|
|||
|
Reconciliation
of Operating profit after tax to Operating profit
|
|||
|
|
|||
|
Operating
profit after tax
|
22,724
|
17,452
|
14,886
|
/
|
(1
minus effective tax rate) in %
|
77.1%
|
78.0%
|
78.8%
|
=
|
Operating
profit (as reported in the Annual Report)
|
29,474
|
22,374
|
18,891
|
|
|
|
|
|
|
Denominator
|
|
|
|
|
Reconciliation
of Average non-interest bearing balance sheet items to Equity
|
|
|
|
|
|
|
|
|
|
Non-interest
bearing balance sheet items at the beginning of the year
|
21,970
|
22,841
|
23,939
|
|
|
|
|
|
+
|
Non-interest
bearing balance sheet items at the end of the year
|
23,916
|
21,970
|
22,841
|
/
|
2
|
|
|
|
=
|
Average
non-interest bearing balance sheet items as used in Operating profit after
tax to net operating assets
|
22,943
|
22,406
|
23,390
|
|
|
|
|
|
|
Non-interest
bearing balance sheet items at the end of the year
|
23,916
|
21,970
|
22,841
|
+
|
Other
financial assets
|
228
|
273
|
297
|
+
|
Marketable
securities
|
4,552
|
4,094
|
3,926
|
+
|
Derivative
financial instruments
|
931
|
48
|
108
|
+
|
Cash
at bank and in hand
|
11,553
|
13,408
|
12,017
|
-
|
Loans
|
-
|
(502)
|
(504)
|
-
|
Current
debt
|
(500)
|
(351)
|
(562)
|
-
|
Derivative
financial instruments
|
(48)
|
(1,492)
|
(1,158)
|
=
|
Equity
(as reported in the Annual Report)
|
40,632
|
37,448
|
36,965
|
|
|
|
|
|
|
Operating
profit (as reported in Annual Report)
|
29,474
|
22,374
|
18,891
|
/
|
Equity
|
40,632
|
37,448
|
36,965
|
=
|
Operating
profit/Equity in %
|
72.5%
|
59.7%
|
51.1%
|
Financial resources at the end of the year
Financial resources at the end of the year is defined as the sum of cash and
cash equivalents at the end of the year, bonds with original term to maturity
exceeding three months and undrawn committed credit facilities.
Management believes that the Financial resources at the end of the year is an important measure of the Groups financial strength from an investors perspective, capturing the robustness of the Groups financial position and its financial preparedness for unforeseen developments.
Reconciliation
of financial resources at the end of the year
|
||||
|
|
|||
DKK
Million
|
2012
|
2011
|
2010
|
|
|
|
|
|
|
|
Financial
resources at the end of the year
|
20,454
|
21,983
|
20,359
|
-
|
Marketable
securities at the end of the year
|
(4,552)
|
(4,094)
|
(3,926)
|
-
|
Undrawn
committed credit facilities
|
(4,849)
|
(4,832)
|
(4,473)
|
= | Cash and cash equivalents at the end of the year (as reported in the Annual report) |
11,053
|
13,057
|
11,960
|
39
Underlying sales growth in local currencies
Underlying sales growth in local currencies is defined as sales for the year
measured at prior year average exchange rates compared with sales for prior
year measured at prior year average exchange rates.
Management believes that the underlying sales growth in local currencies is relevant information for investors in order to understand the underlying development in sales by adjusting for the impact of local currency fluctuations.
40
ITEM 19 | EXHIBITS |
a. | Annual Report |
The following pages from our Annual Report 2012, furnished to the SEC on Form 6-K, dated February 6, 2013, are incorporated by reference into this Form 20-F. The content of websites, scientific articles and other sources referenced on these pages are not incorporated by reference into this Form 20-F.
Page(s) in the Annual Report | ||
Accomplishments and results 2012 | 1-14 | |
Our business | 15-43 | |
Pipeline overview | 30-31 | |
Corporate governance | 46-48 | |
Risk overview | 43 | |
Remuneration | 49-51 | |
Board of Directors | 52-53 | |
Executive Management | 54 | |
Shares and capital structure | 44-45 | |
Consolidated Income statement and Statement of comprehensive income for the years ended 31 December 2010, 2011 and 2012 | 56 | |
Consolidated Balance sheet as of 31 December 2011 and 2012 | 57 | |
Consolidated Statement of cash flows for the years ended 31 December 2010, 2011 and 2012 | 58 | |
Consolidated Statement of changes in equity at 31 December 2011 and 2012 | 59 | |
Notes to the Consolidated financial statements | 60-93 | |
Companies in the Novo Nordisk Group | 92 | |
Statement by the Board of Directors and Executive Management on the Annual Report | 109 |
41
b. | Exhibits |
List of exhibits:
Exhibit No. |
Description
|
Method of filing
|
||
1.1 | ||||
8.1 |
Companies in the Novo Nordisk Group
|
Incorporated by reference to page 92 of
our Annual Report 2012 filed on Form 6-K dated February 6, 2013.
|
||
12.1 | ||||
12.2 | ||||
13.1 | ||||
15.1 |
Extracts from Registrants Annual
Report for the fiscal year ended December 31, 2012.
|
Incorporated by reference to the portions
of Registrants Report furnished to the SEC on Form 6-K on February
6, 2013 identified in Item 19.a of this Form 20-F.
|
||
15.2 |
Extracts from Registrants Annual
Report for the fiscal year ended December 31, 2011.
|
Incorporated by reference to the portions
of the Registrants Report furnished to the SEC on Form 6-K on February
8, 2012 identified in Item 19.a of the Form 20-F/A filed on February 8,
2012.
|
||
15.3 |
42
To the Board of Directors and Shareholders of Novo Nordisk A/S
In our opinion, the Consolidated Financial Statements listed in the accompanying index appearing under Item 19 (pages 56-93) present fairly, in all material respects, the financial position of Novo Nordisk A/S and its subsidiaries (the Company) as of 31 December 2012 and 31 December 2011, and the results of their operations and their cash flows for each of the three years in the period ended 31 December 2012 expressed in DKK and incorporated by reference to the Registrants Annual Report (the pages 56-93 listed in Item 19 of the Form 20-F) furnished to the SEC on Form 6-K dated 6 February 2013 in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board (IASB), and with International Financial Reporting Standards as adopted by the EU. Also in our opinion, the Company has maintained, in all material respects, effective internal control over financial reporting as of 31 December 2012, based on criteria established in Internal Control Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Companys management is responsible for these financial statements, for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Report of Novo Nordisk Management on Internal Control Over Financial Reporting, appearing in Item 15 in this Form 20-F. Our responsibility is to express opinions on these financial statements and on the Companys internal control over financial reporting based on our integrated audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the financial statements included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
A companys internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A companys internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Companys assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ PricewaterhouseCoopers
Statsautoriseret Revisionspartnerselskab
Bagsværd, Denmark
January 30, 2013
43
SIGNATURES
The Registrant hereby certifies that it meets all of the
requirements for filing on Form 20-F and that it has duly caused and authorized
the undersigned to sign this Annual Report on its behalf.
NOVO NORDISK A/S |
/s/ Lars Rebien Sørensen |
/s/ Jesper Brandgaard
|
|
|
|
|
Name: Lars Rebien Sørensen |
Name: Jesper Brandgaard
|
|
Title: President and Chief Executive Officer |
Title: Executive Vice President and Chief
Financial Officer
|
|
Bagsværd, Denmark | ||
Dated: 6 February 2013 |
44