UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT
OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange
Act of 1934
FEBRUARY 8, 2012
NOVO
NORDISK A/S
(Exact name of Registrant as specified in its charter)
Novo Allé
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
Form 20-F [X]
|
Form 40-F [ ]
|
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ]
|
No [X]
|
If Yes is marked, indicate below the file number assigned to the registrant in connection with Rule 12g-32(b):82-_____________________
Financial,
social and
environmental performance
Key figures
2011
2011
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2010
|
Change
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Financial performance | ||||||||
Sales total |
DKK
million
|
66,346 | 60,776 | 9.2% | ||||
Diabetes care |
DKK
million
|
50,425 | 45,710 | 10.3% | ||||
of which modern insulins |
DKK
million
|
28,765 | 26,601 | 8.1% | ||||
of which Victoza® |
DKK
million
|
5,991 | 2,317 | 158.6% | ||||
Biopharmaceuticals |
DKK
million
|
15,921 | 15,066 | 5.7% | ||||
Gross profit |
DKK
million
|
53,757 | 49,096 | 9.5% | ||||
Gross margin |
%
of sales
|
81.0 | 80.8 | |||||
Sales and distribution costs |
%
of sales
|
28.6 | 29.9 | |||||
Research and development costs |
%
of sales
|
14.5 | 15.8 | |||||
Administrative expenses |
%
of sales
|
4.9 | 5.0 | |||||
Operating profit |
DKK
million
|
22,374 | 18,891 | 18.4% | ||||
Net profit |
DKK
million
|
17,097 | 14,403 | 18.7% | ||||
Effective tax rate |
%
|
22.0 | 21.2 | |||||
Capital expenditure, net |
DKK
million
|
3,003 | 3,308 | (9.2% | ) | |||
Free cash flow |
DKK
million
|
18,112 | 17,013 | 6.5% | ||||
Long-term financial targets | Long-term financial targets | 1 | ||||||
Operating profit margin |
%
|
33.7 | 31.1 | 35% | ||||
Growth in operating profit |
%
|
18.4 | 26.5 | 15% | ||||
Operating profit after tax to net operating assets1 |
%
|
77.9 | 63.6 | 90% | ||||
Cash to earnings (three-year average) |
%
|
112.8 | 115.6 | 90% | ||||
Social performance | ||||||||
Healthcare professionals trained or educated in diabetes |
1,000
|
835 | 373 | 123.9% | ||||
Donations |
DKK
million
|
81 | 84 | (3.6% | ) | |||
Employees (total) |
Number
|
32,632 | 30,483 | 7.0% | ||||
Average of full-time employees |
Number
|
31,499 | 29,423 | 7.1% | ||||
Employee turnover |
%
|
9.8 | 9.1 | |||||
Relevant employees trained in business ethics |
%
|
99 | 98 | |||||
Long-term social targets | ||||||||
Least developed countries where Novo Nordisk | Long-term social targets | |||||||
sells insulin according to the differential pricing policy |
%
|
75 | 67 | 100% | ||||
Engaging culture |
Scale
1 5
|
4.3 | 4.3 | 4.0 | ||||
Diverse senior management teams |
%
|
62 | 54 | 100% by 2014 | ||||
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Environmental performance | ||||||||
Energy consumption |
1,000GJ
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2,187 | 2,234 | (2.1% | ) | |||
Water consumption |
1,000m3
|
2,136 | 2,047 | 4.3% | ||||
CO2 emissions from energy consumption |
1,000
tons
|
93 | 95 | (2.1% | ) | |||
Long-term | ||||||||
Long-term environmental targets | environmental targets | |||||||
Energy consumption (change compared with 2007) |
%
|
(21 | ) | (20 | ) | 11% reduction by 2011 | ||
Water consumption (change compared with 2007) |
%
|
(34 | ) | (37 | ) | 11% reduction by 2011 | ||
CO2 emissions from energy consumption (change compared with 2004) % | (56 | ) | (55 | ) | 10% reduction by 2014 | |||
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Share performance | ||||||||
Diluted earnings per share/ADR |
DKK
|
29.99 | 24.60 | 21.9% | ||||
Dividend per share (proposed) |
DKK
|
14.00 | 10.00 | 40.0% | ||||
Closing share price (B shares) |
DKK
|
660 | 629 | 4.9% | ||||
Market capitalisation (B shares)2 |
DKK
billion
|
296 | 292 | 1.4% |
1. | The long-term financial targets were updated in February 2012. Please refer to p 6. |
2. | Novo Nordisk B shares (excluding treasury shares). |
See more performance highlights on pp 14 15. |
For nearly 90 years, Novo Nordisk has combined drug discovery with technology to turn science into solutions for people with diabetes. We also provide treatments for people with haemophilia and growth hormone deficiency and for women experiencing symptoms of menopause. We leverage our expertise with protein molecules, chronic disease management and device technology to provide innovative treatments that make a difference in quality of care.
Novo Nordisk has more than 32,000 employees in 75 countries and markets products in more than 190 countries. Our B shares are listed on NASDAQ OMX Copenhagen and our ADRs are listed on the New York Stock Exchange under the symbol NVO. For more information about our company, visit novonordisk.com.
We
leverage our expertise to make a difference in quality of care. |
We report on our financial, social and environmental performance in one integrated report and we report additional information online. This public filing contains references and links to information posted on the companys website; such information is not incorporated by reference into the public filing. The management review, as defined by the Danish Financial Statements Act, is com prised of pp 254 and 100101.
Material and business-critical information is reported in the annual report. Information for specific stakeholder groups is reported at annualreport2011.novonordisk.com. We value feedback and welcome questions or comments about this report or our performance at annualreport@novonordisk.com.
Novo Nordisk Annual Report 2011 1
Our 2011 accomplishments and results |
Sten
Scheibye Novo Nordisk has been a focused pharmaceutical company specialising in therapeutic proteins, primarily for diabetes care, for nearly 90 years. Our company is characterised by a deep disease knowledge within diabetes, a long-term focus and a commitment to making innovative treatments broadly available also in areas outside diabetes. According to new data announced in 2011, diabetes affects around 366 million people globally and is responsible for the deaths of nearly 4.6 million adults each year. In comparison, 1.8 million people died from HIV/AIDS in 2009. Diabetes and other chronic diseases are becoming more prevalent all over the world as urbanisation increases and more people live longer. There has never been more need for a company like Novo Nordisk. While the short-term outlook for the global economy and for many parts of the healthcare industry is uncertain, the Board of Directors is of the firm belief that Novo Nordisk must continue to invest in innovations in treatment and in expanding its business footprint in all corners of the world. As the company expands globally, we only do business the Novo Nordisk Way. This means we operate in ways that balance financial, social and environmental responsibility for the benefit of patients, employees, healthcare professionals, share holders and society at large. The results achieved in 2011 in terms of both sales and new product development are remarkably strong in light of the difficult economic and regulatory climate. Novo Nordisks balance sheet and cash flow remain strong, and the Board has confidence in the strategic direction and growth prospects for the company. We have |
therefore consistently increased the dividend in recent years, raising dividends by 33% to 10.00 Danish kroner per share for 2010. The proposed dividend for 2011 is 14.00 kroner per share, a 40% increase. We have also continued our share repurchase programme, repurchasing shares worth 12 billion kroner in the 12-month period ending January 2012. The coming years will be extraordinarily important for Novo Nordisks long-term development. On one hand the company has never had a more promising pipeline of new products than it has today. Extremely important launches are on the horizon. On the other hand, the pharmaceutical industry is under immense pressure globally from measures to reform healthcare and reduce spending on pharmaceuticals, particularly for new and innovative products. In light of this, the Board has concluded that Lars Rebien Sørensen, Novo Nordisks president and chief executive officer, is the right person to steer the company through this exciting and challenging period. I am therefore pleased that Lars has accepted the Boards proposal to extend his contract by three years, so that it now expires in 2019. Novo Nordisk has in 2011 continued to increase sales and expand its business at a remarkable pace, and the Board would like to express its appreciation for the leadership shown by Lars Rebien Sørensen and his Executive Management team and the hard work and dedication of the entire Novo Nordisk organisation.
Sten
Scheibye |
2 Novo Nordisk Annual Report 2011
Our 2011 accomplishments and results |
Lars Rebien
Sørensen
President
and chief executive officer
Just as we thought the global economy was recovering from the financial crisis in 2008, we were reminded midway through 2011 that there is still a long way to go.
We saw slow or no economic growth and growing public debts in European countries and the US, with the focus swinging between the instability in the euro zone and the political stalemate in the US Congress preventing adoption of long-term financial measures to deal with soaring public debt.
Innovation
is the only sustainable engine for growth. |
The situation has been likened to the Great Depression in the 1930s, with hardship felt today by millions of people who have lost their jobs or their savings, but the situation today is different nevertheless. It seems more like a crisis of confidence confidence in our financial systems, in our democracies ability to agree on long-term solutions, and in ourselves and each other.
What we are witnessing is a giant transfer of wealth and jobs from economies in the West to emerging economies in Asia, the Middle East, Latin America and, to some extent, Africa. This is painful for those affected negatively, but we must not forget that more jobs are being created than lost and that the livelihood of hundreds of millions of people is improving, creating the foundation for more equal growth in the future. I am confident that many companies will emerge from the crisis as more innovative, having realised
that innovation is the only sustainable engine for growth. This means finding better ways of providing goods and services and solving unmet needs in a financially, socially and environmentally responsible way.
With public spending under pressure, provision of healthcare has again been in focus and, consequently, the pharmaceutical industry has had to make significant adjustments. No market we serve has been untouched by this trend. In 2011, Novo Nordisk faced the consequences of healthcare reforms in many markets with our business in the US and Europe particularly affected.
Review
of 2011
Given the current
climate, it is rewarding that Novo Nordisk was able to grow sales by 11% in
local currencies in 2011. This growth was driven by our full portfolio of
modern insulins, NovoRapid®,
Levemir® and NovoMix®,
but most significantly by the increasing demand for Victoza®,
our treatment for type 2 diabetes, which became the leader in the GLP-1 category
of diabetes treatments.
This sales growth, combined with continued focus on efficiency of our operations, resulted in operating profit growth of 18% reported and 22% in local currencies. This is significantly above results for the general pharmaceutical industry.
Equally significant were the finalisation of the clinical activities and filing for regulatory approval in Europe, Japan and the US of a new generation of insulin products. These are based on the ultra-long principle of Degludec, allowing for a half-life twice as long as the basal insulins most commonly used today. With these products it is our hope that we can offer both the worlds longest-acting basal insulin, Degludec, and a combination of this basal insulin with the worlds leading short-acting insulin, NovoRapid® (NovoLog®), DegludecPlus, which will offer people with diabetes superior
Novo Nordisk Annual Report 2011 3
Our 2011 accomplishments and results |
glucose control, reducing the risk of hypoglycaemia (too low blood sugar) and providing greater dosing flexibility. Degludec is also designed to provide people with diabetes the flexibility to administer their insulin at any time of day, at different times from day to day.
We also saw innovation across a broad range of our therapeutic areas, with progress in the development of a new clotting factor, vatreptacog alfa, intended to improve treatment for haemophilia patients with inhibitors. We also made progress in the development of molecules to support the expansion of our presence into haemophilia A and B, as well as in a strong portfolio of inflammation development projects.
In
2011, all UN member states pledged to develop diabetes strategies and set targets for improvement. |
The year was also a success for the millions of people with diabetes and other chronic conditions. I was encouraged by the outcome of the United Nations High-Level Meeting on non-communicable diseases in New York in September. Novo Nordisk played a part in the adoption of a UN declaration on diabetes in 2006, and last year we again played a role as all UN member states pledged to develop diabetes strategies and set targets for improvement in screening, treatment and outcomes. This was a moment for celebration for people with diabetes throughout the world. We believe the pledge by UN member states can be translated into concrete action to increase awareness of the threat diabetes poses.
Our new vision statement and updated guiding principles and values, The Novo Nordisk Way, clearly states that we never compromise on quality and business ethics. With this we want to send a clear signal, internally as well as externally, regarding what our stakeholders can expect from each of us at Novo Nordisk. To support this commitment to integrity and high standards, in 2011 we further strengthened our efforts to ensure adherence to our global policies and procedures.
Not all went according to plan, however, in 2011.
Healthcare reforms in Europe, combined with the anaemic expectations of the future pharmaceutical market, forced us to re-allocate resources from our European organisation to fast-growing markets in the US and Asia. This led to the unfortunate redundancy of approximately 300 positions. We value our people and we did not take this decision lightly. Securing cost-efficiency, however, is the only guarantee for the long-term success of our company.
In Asia, a major earthquake off the coast of Japan caused a giant tsunami which killed thousands and caused severe property damage as well as contributing to a nuclear meltdown close to our factory in Koriyama.
We were proud to see our Japanese colleagues standing firm while confronted with great personal hardship, ensuring our ability to deliver life-saving medicines to the people of Japan while protecting the assets of our company.
Looking
ahead
We have significant
confidence in our people, our pipeline and our products. Unlike most of the
pharmaceutical industry, Novo Nordisk will undertake a year of major investments
in 2012. This includes investment in further market expansion of our current
portfolio, in preparing for the launch of our new-generation insulins and
in research and development activities for the medium to long term.
Our focus in 2012 will be on:
| The regulatory process for approval of Degludec and DegludecPlus in our main markets and preparations for the launch of these new-generation insulins. |
| Execution and monitoring of the phase 3 clinical programme for liraglutide in obesity. |
| Clinical development of fixed combinations of Degludec and Victoza®, which may offer a new option for intensification of the treatment of type 2 diabetes. |
| Clinical development of vatreptacog alfa, for improved treatment of haemophilia with inhibitors. |
| Expansion of our international organisation, particularly in fast-growing regions in the areas of sales and marketing, production and research and development. |
| Co-organising the European Diabetes Leadership Forum under the auspices of the Danish EU presidency to reach consensus about what it will take to address the current challenges and change diabetes. |
With significant investment and continued focus on development, we expect continued growth for Novo Nordisk in 2012 and beyond.
I would like to thank the entire Novo Nordisk organisation for their contributions to our success this year, our stakeholders and partners for their collaboration, and our shareholders for their confidence and continued support.
Lars
Rebien Sørensen
President and chief executive officer
4 Novo Nordisk Annual Report 2011
Our 2011 accomplishments and results |
Despite continued global economic turmoil, 2011 was a positive year for Novo Nordisk with strong sales growth, good performance against long-term financial, social and environmental targets and very significant progress in the clinical development pipeline.
Sales increased by 9% in Danish kroner and by 11% measured in local currencies during 2011 compared to 2010. Sales growth was realised in both diabetes care and biopharmaceuticals. Victoza® and modern insulins were the main contributors to growth, with Victoza® sales increasing by 159% (166% in local currencies) and sales of modern insulins increasing 8% (11% in local currencies). Sales growth was realised in all regions. Sales in North America increased by 13% and in International Operations by 12%, both in Danish kroner, and by 18% and 17% respectively in local currencies. Sales growth in 2011 was reduced by approximately 2 percentage points due to healthcare reforms in the US, several European markets, Turkey and China.
2011
was a positive year for Novo Nordisk with strong sales growth. |
Novo Nordisk achieved a significant milestone in 2011, as applications for marketing authorisation of two new-generation insulins, Degludec1 and DegludecPlus2, were filed in major markets. We made significant progress in the development of solutions for the range of haemophilia and other rare bleeding disorders, including initiation of a phase 3 trial programme for a fast-acting treatment of haemophilia with inhibitors. A phase 1 trial was also initiated for a long-acting growth hormone formulation.
In addition, we exceeded long-term targets for resource optimatisation, both in terms of reduced energy and water consumption for production and CO2 emissions from energy consumption for production. We also continued to exceed our long-term target for employee engagement. Notable progress was made in reaching targets for insulin sales in least developed countries and increasing diversity in our senior management teams.
Financial performance
2011
performance against long-term
financial targets
By focusing on growth, profitability, operating assets and generation
of cash, our four long-term financial targets guide Novo Nordisks financial
development. Our historic long-term financial targets are operating profit
growth, operating margin, operating profit after tax to net operating assets
and cash conversion. The realised performance for three of the four ratios
exceeded the target level while the operating margin performance was progressing
towards the target. See p 6 for an update on the long-term financial targets.
Diabetes
care sales development
Sales of diabetes care products increased by 13% measured in
local currencies and by 10% in Danish kroner to DKK 50,425 million in 2011
compared to 2010. Novo Nordisk is the world leader in diabetes care and now
holds a global value market share of 24% compared to 23% at the same point
in time last year.
Modern
insulins, human insulins and protein-related products
In 2011, sales of modern insulins, human insulins and protein-related
products increased by 5% measured in local currencies and by 3% in Danish
kroner to DKK 41,859 million compared to 2010, driven by North America, International
Operations and Region China. Global insulin sales growth was negatively impacted
by healthcare reforms in the US, Europe, Turkey and China as well as by a
decline in human insulin sales in Europe, the US and Japan.
1. | Internal designation for insulin degludec. |
2. | Internal designation for insulin degludec/insulin aspart. |
Novo Nordisk Annual Report 2011 5
Our 2011 accomplishments and results |
Sales of modern insulins increased by 11% in local currencies and by 8% in Danish kroner to DKK 28,765 million compared to 2010, reflecting steady sales growth. North America, International Operations and Europe were the main contributors to the growth. Sales of modern insulins constitute more than 72% of Novo Nordisks sales of insulin. North
America Europe International
Operations |
Currently, around 58% of Novo Nordisks insulin volume in International Operations non-tender markets is being sold for use in devices. Region
China Japan
& Korea Victoza®
(GLP-1 therapy for type 2 diabetes) |
Long-term financial Novo Nordisk operates with four long-term financial targets to balance short- and long-term considerations, thereby ensuring a focus on shareholder value creation. The target Return on Invested Capital (ROIC) has been changed to Operating profit after tax to net operating assets to more accurately describe the financial elements included in the ratio. Further, the target level has been increased to 90% from 70%. The previous target level assumed that proposed accounting rules regarding treatment of operating leases, the draft International Financial |
Reporting Standard Leases (ED/2010/09), would be implemented in the near future. However, the implementation has now been postponed and the actual content is currently unclear and as such, this assumption no longer applies. The target levels are based on the assumption of a continuation of the current business environment and the current scope of business activities and have been prepared assuming that currency exchange rates remain at the levels outlined in Outlook 2012 on p 13. Should any of these assumptions change, the time horizon for achieving the long-term targets may be extended or it may be necessary to revise the targets. |
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Performance against long-term financial targets |
Result
2011
|
Previous
targets
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Updated
targets
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Operating profit growth |
18%
|
15%
|
15%
|
|||||
Operating margin |
34%
|
35%
|
35%
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|||||
Operating profit after tax to net operating assets (previously ROIC) |
78%
|
70%
|
90%
|
|||||
Cash to earnings |
106%
|
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Cash to earnings (three-years average) |
113%
|
90%
|
90%
|
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6 Novo Nordisk Annual Report 2011
Our 2011 accomplishments and results |
North
America
Sales of Victoza®
in North America increased by 167% in local currencies and by 155% measured
in Danish kroner in 2011 compared to 2010. This reflects continuous GLP-1
market expansion driven by Victoza®,
and the value market leadership position Victoza®
achieved during 2011.
Victoza®
reached global market share leadership in the GLP-1 segment in 2011. |
Europe
Sales in Europe increased by 114% in local currencies and by
115% measured in Danish kroner in 2011. This reflects continued roll-out across
Europe and in particular solid sales growth in France, the UK and Italy.
International
Operations
Sales in International Operations increased by 781% in local
currencies and by 776% measured in Danish kroner in 2011. This reflects a
low comparison base from 2010 but also very solid sales performance especially
in Brazil and the countries of the Middle East.
Region
China
Victoza®
was launched in China during the fourth quarter of 2011 and although initial
market feedback is positive, actual sales are limited.
Japan
& Korea
Sales in Japan & Korea increased, from a relatively low base
in 2010, by 348% in local currencies and by 370% measured in Danish kroner
in 2011. The sales performance in 2011 is encouraging and reflects the expiry
of the 14 days prescription limitation mid-2011 and a significant commercial
focus on Victoza® throughout
the year.
NovoNorm®/Prandin®/PrandiMet®
(oral antidiabetic products)
In 2011, sales of oral antidiabetic products declined by 3% measured
in local currencies and by 6% in Danish kroner to DKK 2,575 million compared
to 2010. The sales development primarily reflects lower sales in Europe due
to generic competition in several European markets.
Biopharmaceuticals
sales development
In 2011, sales of biopharmaceutical products increased by 8% measured in local currencies and by 6% measured in Danish kroner to DKK 15,921 million compared to 2010 primarily driven by North America and International Operations.
NovoSeven®
(bleeding disorders therapy)
Sales of NovoSeven®
increased by 7% in local currencies and by 4% in Danish kroner to DKK 8,347
million compared to 2010. All regions contributed to the sales growth of NovoSeven®;
International Operations was the primary contributor to growth followed by
Europe and North America.
Novo Nordisk Annual Report 2011 7
Our 2011 accomplishments and results |
Norditropin®
(growth hormone therapy)
Sales of Norditropin®
increased by 5% measured in local currencies and by 5% measured in Danish
kroner to DKK 5,047 million compared to 2010. The sales growth was driven
by International Operations, North America and Japan & Korea, partly offset
by a decline in Europe. Novo Nordisk is the second-largest company in the
global growth hormone market with a 24% share measured in volume.
Other
products
Sales of other products
within biopharmaceuticals, which primarily consist of hormone replacement
therapy (HRT)-related products, increased by 15% measured in local currencies
and by 13% in Danish kroner to DKK 2,527 million compared to 2010. This development
primarily reflects continued sales progress for the low dose Vagifem® that was launched in North America and Europe in 2010. Sales growth was
furthermore supported by GlucaGen®
sales in the US and Japan, and partly off-set by a decline in Activelle®
sales following patent expiry in Europe.
Development
in costs
and operating profit
The cost of goods sold grew by 8% to DKK 12,589 million in 2011. Reported gross margin increased by 0.2 percentage point to 81.0% compared to 80.8% in 2010. Measured in local currencies the gross margin increased by 0.4 percentage point in 2011 reflecting a positive product mix impact due to the upgrade from human insulins to modern insulins.
In 2011, total non-production-related costs increased by 5% in local currencies and by 3% in Danish kroner to DKK 31,877 million compared to 2010.
Sales and distribution costs increased by 4% to DKK 19,004 million primarily as a result of increased sales promotion in the US and China, sales force expansion in the US in the fourth quarter of 2010 and costs related to the Manufacturers fee part of US healthcare reform.
Research and development costs of DKK 9,628 million remained at an absolute level similar to 2010. Whereas the cost level in 2010 reflects execution of the phase 3a programmes for both Degludec and DegludecPlus, the cost level in 2011 reflects the initiation of pivotal trial activities within diabetes care, obesity and haemophilia.
Operating
profit in 2011 increased by 18% to DKK 22,374 million. |
Licence fees and other operating income constituted DKK 494 million in 2011 compared to DKK 657 million in 2010. This decline is primarily due to a non-recurring income from a patent settlement during the first quarter of 2010.
Operating profit in 2011 increased by 18% to DKK 22,374 million compared to 2010. In local currencies the growth was 22%.
Net financials and tax
Net financials showed a net expense of DKK 449 million in 2011 compared to a net expense of DKK 605 million in 2010. As of 31 December 2011, foreign exchange hedging losses of around DKK 1,200 million have been deferred for recognition in the income statement in 2012.
For 2011, the foreign exchange result was an expense of DKK 322 million compared to an expense of DKK 1,341 million in 2010. The foreign exchange loss in 2011 reflects losses on foreign exchange hedging contracts primarily related to the Japanese yen due to the appreciation versus the Danish krone in 2011 compared to the exchange rate level prevailing in 2010 and in the last quarter of 2009.
Also included in net financials is the result from associated companies with an expense of DKK 4 million. In 2010, the result from associated companies was an income of DKK 1,070 million as Novo Nordisk recorded a non-recurring income of approximately DKK 1.1 billion from the sale of shares in ZymoGenetics, Inc.
The effective tax rate for 2011 was 22%.
Capital
expenditure
and free cash flow
Net capital expenditure for property, plant and equipment for 2011 was DKK 3.0 billion compared to DKK 3.3 billion in 2010. The main investment projects in 2011 were the insulin filling plant in Tianjin, China, filling capacity for biopharmaceuticals and new device manufacturing capacity in Denmark and the US.
Free cash flow for 2011 was DKK 18.1 billion compared to DKK 17.0 billion in 2010.
Equity
Total equity was DKK 37,448 million at the end of 2011, equivalent to 57.9% of total assets, compared to 60.2% at the end of 2010. Please refer to p 59 for further elaboration of changes in equity during 2011.
8 Novo Nordisk Annual Report 2011
Our 2011 accomplishments and results |
Treasury
shares and 2011 share repurchase programme Employee
share programmes in 2011 Holding
of treasury shares and reduction of share capital In order to maintain capital structure flexibility, the Board of Directors will, at the Annual General Meeting in 2012, propose a reduction in the B share capital from DKK 472,512,800 to DKK 452,512,800 by cancelling 20,000,000 B shares of DKK 1 from the companys own holdings of B shares at a nominal value of DKK 20,000,000, equivalent to 3.4% of the total share capital. After implementation of the share capital reduction, the companys share capital will amount to DKK 560,000,000 divided into an A share capital of DKK 107,487,200 and a B share capital of DKK 452,512,800. Proposed
dividend and 2012 share repurchase programme The Board of Directors has approved a new DKK 12 billion share repurchase programme to be executed during the coming 12 months. Novo Nordisk will initiate its share repurchase programme in accordance with the provisions of the European Commission's Regulation no 2273/2003 of 22 December 2003 (the Safe Harbour Regulation). For that purpose, Novo Nordisk has appointed J.P. Morgan Securities Ltd. as lead manager to execute a part of its share repurchase programme independently and without influence from Novo Nordisk. The purpose of the programme is to reduce the company's share capital. Under the agreement, J.P. Morgan Securities Ltd. will repurchase shares on behalf of Novo Nordisk for an amount of up to DKK 2.5 billion during the trading period starting 2 February 2012 and ending on 25 April 2012. A maximum of 128,433 shares can be bought during one single trading day, equal to 20% of the average daily trading volume of Novo Nordisk B shares on NASDAQ OMX Copenhagen during the month of January 2012, and a maximum of 7,320,681 shares in total can be bought during the trading period. At least once every seven trading days, Novo Nordisk will issue an announcement in respect of the transactions made under the repurchase programme. |
Social performance We actively manage three dimensions of social performance: improving care for people whose healthcare needs we serve; developing our employees and ensuring a healthy and safe work environment; and making a positive contribution to the communities in which we operate. 2011 performance against long-term social targets Adoption of our long-established differential pricing policy, a measure of our progress to expand access to diabetes care, continued during 2011. During the year, we met targets related to employee engagement and made progress towards the target of diversity in all senior management teams. Patients Access
to care Novo Nordisks long-term efforts to expand access to care and treatment include the establishment of the World Diabetes Foundation (WDF) in 2002. In 2011, the company donated DKK 65 million to the foundation, which supports sustainable initiatives to
|
Novo Nordisk Annual Report 2011 9
Our 2011 accomplishments and results |
build healthcare capacity to prevent and treat diabetes in developing countries. The companys regular contribution was DKK 51 million, equivalent to 0.125% of net insulin sales for the year, in accordance with obligations previously agreed to by the companys shareholders. During 2011, the company made a special contribution of DKK 14 million to WDF for activities relating to the UN High-Level Meeting on non-communicable diseases, including diabetes. Novo Nordisk also supports the Novo Nordisk Haemophilia Foundation (NNHF), established in 2005. In 2011, we donated DKK 16 million to NNHF. For more information on the foundations, see pp 34 and 39.
Clinical
trials
The number of people participating in Novo Nordisks clinical
trials increased by 16% in 2011 compared with 2010. A total of 22,445 people
participated in Novo Nordisks clinical trials in 2011, compared with
19,361 in 2010.
Pricing
Our goal is for our differential pricing policy to be accepted
in all least developed countries. We sold human insulin at or below the policy
price, not to exceed 20% of the average prices in the western world, in 75%,
or 36 of 48, of the least developed countries during 2011.
Capacity
building
To achieve sustainable improvements in access to care and personal
health, we seek to improve the ability to diagnose and treat diabetes. Over
the years, our investments in training and education of healthcare professionals
have been significantly scaled up. During 2011, approximately 835,000 healthcare
professionals worldwide attended training programmes conducted or sponsored
by Novo Nordisk. We also reached approximately 626,000 people with diabetes,
providing training on how to manage their condition.
In addition to enrolling about 3,400 children with type 1 diabetes in our Changing Diabetes® in Children programme during 2011, taking the total to nearly 5,000, we trained about 1,000 healthcare providers and established more than 40 clinics. The programme supports diagnosis and treatment of diabetes in children in developing countries.
Employees
Our global growth continued as projected, with new employees primarily added in International Operations, North America and Region China. At the end of 2011, the total number of full-time employees was 31,499, an increase of 7% compared to 2010. At the end of 2011, Novo Nordisk employed 32,632 people. In the same period, employee turnover increased to 9.8% from 9.1%.
Engagement
The ability to manage global growth and stimulate productivity
and innovation is tracked through a set of engagement scores from our annual
employee survey, eVoice. In 2011, the consolidated engagement score (on a
scale of 1 to 5, with 5 being the best score) was 4.3, which was consistent
with 2010. Annual scores have met our target of 4.0 or above consistently
since 2006.
Diversity,
a prerequisite for global growth, increased in senior management teams in 2011. |
Diversity
We believe that fostering workplace diversity is a prerequisite
for achieving global growth. Our ambition is that by 2014 all senior management
teams will include employees of both genders and different nationalities.
While pursuing this objective we insist that all positions are filled by the
best candidate. Though we have chosen two dimensions of diversity to track
at the senior level, our focus is broader, ensuring equal opportunities, non-discrimination
and an inclusive working culture.
At the end of 2011, diversity in terms of gender and nationality was reflected in 62% of the 29 senior management teams, compared with 54% of 28 at the end of 2010.
Health
and safety
The frequency of occupational injuries decreased to 3.4 per million
working hours in 2011, compared with 4.9 per million working hours in the
previous year.
Regrettably, a Novo Nordisk sales representative in Bangladesh died in a car accident while on Novo Nordisk business in 2011. With thousands of employees on the roads around the world, we introduced a new global company car guideline in 2011 that includes the stipulation that company cars must have above-average safety ratings using regional benchmarks.
Assurance
Quality
As sales and production output have increased, quality levels,
measured in terms of inspection findings, have been maintained. In 2011, 76
inspections of Novo Nordisks production facilities were concluded with
no significant re-inspections or warning letters.
In 2011, Novo Nordisk had five instances of products recalled from the market, in line with 2010. Three recalls were implemented in single countries due to product storage issues in the distribution chain. Two recalls, involving several countries, were the result of product defects relating to production. None of the products recalled caused any harm to patients. In all cases, we cooperated with local health authorities to ensure appropriate information was provided to pharmacies, medical practitioners and patients.
Values
In 2011, we rolled out an updated version of our values-based
management system, the Novo Nordisk Way, with significant focus on ensuring
that the values are actively lived across the organisation.
10 Novo Nordisk Annual Report 2011
Our 2011 accomplishments and results |
The Novo Nordisk Way outlines expectations for employee behaviour, and adherence to the corporate values is audited as part of our ongoing internal assurance process. Values audits, called facilitations, are conducted by our global facilitator team, consisting of senior people with deep understanding of our business and the business environment. From 1 October 2010 to 30 September 2011, 59 facilitations were conducted at unit level, covering more than 13,000 employees. Nearly 2,000 employees were interviewed to determine how corporate values are being complied with throughout the organisation. The primary finding during the facilitation year was that the rollout and training related to the new, updated Novo Nordisk Way was effectively implemented. Business
ethics Business ethics audits are conducted using a risk-based approach, with on-site interviews and documentation reviews to assess compliance with Novo Nordisks business ethics procedures. During 2011, 43 business ethics audits were conducted, an increase from 35 in 2010. Our employees have an obligation to report any instances of suspected misconduct. This obligation can be met by reporting to a manager or company legal counsel. Novo Nordisk also provides the option to report suspected business ethics misconduct anonymously through a compliance hotline monitored by the Audit Committee. During 2011, 66 cases were reported through the compliance hotline, compared with 53 in 2010. Cases reported concerned potential instances of business ethics issues, fraud, violations of the Novo Nordisk Way, quality concerns and other issues. With the introduction of the new Novo Nordisk Way, the most significant area of increase was in failures to comply with the company values. Disciplinary actions were taken in all substantiated cases. None of these cases had any material impact for Novo Nordisk. Supplier
audits |
Environmental performance 2011 performance against long-term environmental targets Performance on environmental dimensions improved and we successfully exceeded long-term targets for reduction of energy consumption, water consumption and CO2 emissions. Water and energy consumption for production decreased in 2011 by 34% and 21% respectively compared with the 2007 baseline, exceeding the long-term targets of 11% reductions in both areas by 2011 compared with 2007. Consumption decreases were mainly due to optimisations in insulin bulk production of diabetes care products. With CO2 emissions from energy consumption in 2011 down 56% compared with the 2004 baseline, the company remains on track to achieve its long-term target of an absolute reduction by 2014. Inputs Energy consumed for production decreased in 2011 by 2.1%, to 2.2 million GJ. Water consumption, however, increased from 2.0 million cubic metres in 2010 to 2.1 million cubic metres in 2011, an increase of 4.3%.
|
Novo Nordisk Annual Report 2011 11
Our 2011 accomplishments and results |
Outputs
The total volume of waste increased 62% to 41,376 tons in 2011 from 25,627 tons in 2010. The increase was primarily due to the fact that yeast slurry, previously reused as pig feed, is now disposed of at biogas plants and therefore treated as recycled waste. For this reason, 70% of waste was recycled in 2011 compared with 51% in 2010.
Energy
consumption and CO2
emissions decreased in 2011. |
While sales and production increased in 2011, CO2 emissions related to production fell by 2% compared with 2010 levels. This was due to increased energy efficiency in all production facilities globally.
Environmental target update With the achievement in 2011 of the companys long-term targets for energy and water consumption, we have framed a new environmental strategy towards 2020 and set interim targets for 2014. Focusing on resource productivity, the new target levels are to keep the annual rate of increase below the projected rate of growth in production. We believe that the new targets for 20122014 are ambitious. We have achieved a 34% reduction in water consumption for production since 2007. Because a substantial portion of the water used by Novo Nordisk is for fermentation and purification of insulin, finding opportunities to further reduce water consumption is challenging. While we have reduced energy consumption for production by 21% since 2007, we have more options regarding energy usage. The target for constraining growth in energy consumption is therefore lower than the target for constraining growth in water consumption. |
|||||
Performance against | Result | Annual targets | |||
environmental targets | 2011 | 20122014 | |||
|
|
|
|
||
Energy consumption | (2.1)% | < 3.3% | |||
(change compared to prior year) | |||||
Water consumption | 4.3% | < 5.4% | |||
(change compared to prior year) | |||||
|
|
|
|
||
The target levels are based on the assumption of a continuation of the current business environment and given the current scope of business activities.
12 Novo Nordisk Annual Report 2011
Our 2011 accomplishments and results |
The current expectations for 2012 are summarised in the table below:
|
|
|
Expectations are as reported, | Current expectations | |
if not otherwise stated | 2 February 2012 | |
|
|
|
Sales growth | ||
in local currencies | 711% | |
as reported | Around 4 percentage points higher | |
Operating profit growth | ||
in local currencies | Around 10% | |
as reported | Around 7 percentage points higher | |
Net financials | Expense of around DKK 1,000 million | |
Effective tax rate | 2223% | |
Capital expenditure | Around DKK 3.5 billion | |
Depreciation, amortisation and impairment losses | Around DKK 2.9 billion | |
Free cash flow | Around DKK 18 billion | |
|
||
Novo Nordisk expects sales growth in 2012 of 711% measured in local currencies. This is based on expectations of continued market penetration for Novo Nordisks key products, as well as expectations of continued intense competition, generic competition to oral antidiabetic products, and a continued impact from the implementation of healthcare reforms primarily in the US and Europe. Given the current level of exchange rates versus Danish kroner, the reported sales growth is expected to be around 4 percentage points higher than growth measured in local currencies.
For 2012, growth in operating profit is expected to be around 10% measured in local currencies. The outlook for growth in operating profit reflects significant expenditure related to the expected launch of the ultra-long-acting insulin Degludec. Given the current level of exchange rates versus Danish kroner, the reported operating profit growth is expected to be 7 percentage points higher than growth measured in local currencies.
For 2012, Novo Nordisk expects a net financial expense of around DKK 1,000 million. The current expectation primarily reflects a net loss on the foreign exchange contracts hedging Novo Nordisks exposure in US dollar, Japanese yen and Chinese yuan. The accounting effect of foreign exchange hedging contracts has, in line with Novo Nordisks accounting policies, been deferred for loss recognition in 2012 when the hedged operating cash flows will be realised.
The effective tax rate for 2012 is expected to be 2223%.
Capital expenditure is expected to be around DKK 3.5 billion in 2012, primarily related to investments in filling capacity for biopharmaceuticals in Denmark, filling capacity for insulin in Russia, and new prefilled device production capacity in Denmark and the US. Expectations for depreciation, amortisation and impairment losses are around DKK 2.9 billion and free cash flow is expected to be around DKK 18 billion.
All of the above expectations are based on the assumption that the global economic environment will not significantly change business conditions for Novo Nordisk in 2012 and that currency exchange rates, especially the US dollar, will remain at the current level versus the Danish krone during the remaining part of 2012.
|
|
|
Key | Annual impact on Novo Nordisks | Hedging |
invoicing | operating profit of a 5% | period |
currency | movement in currency | (months) |
|
|
|
USD | DKK 775 million | 11 |
JPY | DKK 170 million | 12 |
CNY | DKK 100 million | 121 |
GBP | DKK 75 million | 11 |
1. USD used as proxy when hedging Novo Nordisks CNY currency exposure.
The financial impact from foreign exchange hedging is included in note 28 pp 8082.
Forward-looking statements
Novo Nordisks reports filed with or furnished to the US
Securities and Exchange Commission (SEC), including this document and Form
20-F, both expected to be filed with the SEC in February 2012, and written
information released, or oral statements made, to the public in the future
by or on behalf of Novo Nordisk, may contain forward-looking statements. 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, and |
| statements regarding the assumptions underlying or relating to such statements. |
In this document, examples of forward-looking statements can be found under the headings Performance in 2011, Outlook 2012 and elsewhere.
These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this document, 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, inter ruptions 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 related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees and failure to maintain a culture of compliance.
Please also refer to the overview of risk factors in Risk Management on pp 2224.
Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this document, whether as a result of new information, future events or otherwise.
Novo Nordisk Annual Report 2011 13
Our 2011 accomplishments and results |
DKK million |
2007
|
2008
|
2009
|
2010
|
2011
|
2010
2011
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial performance | Change | |||||||||||
Sales | ||||||||||||
Modern insulins (insulin analogues) | 14,008 | 17,317 | 21,471 | 26,601 | 28,765 | 8.1% | ||||||
Human insulins | 12,572 | 11,804 | 11,315 | 11,827 | 10,785 | (8.8% | ) | |||||
Victoza® | | | 87 | 2,317 | 5,991 | 158.6% | ||||||
Protein-related products | 1,749 | 1,844 | 1,977 | 2,214 | 2,309 | 4.3% | ||||||
Oral antidiabetic products (OAD) | 2,149 | 2,391 | 2,652 | 2,751 | 2,575 | (6.4% | ) | |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes care total | 30,478 | 33,356 | 37,502 | 45,710 | 50,425 | 10.3% | ||||||
NovoSeven® | 5,865 | 6,396 | 7,072 | 8,030 | 8,347 | 3.9% | ||||||
Norditropin® | 3,511 | 3,865 | 4,401 | 4,803 | 5,047 | 5.1% | ||||||
Hormone replacement therapy | 1,668 | 1,612 | 1,744 | 1,892 | 2,054 | 8.6% | ||||||
Other products | 309 | 324 | 359 | 341 | 473 | 38.7% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Biopharmaceuticals total | 11,353 | 12,197 | 13,576 | 15,066 | 15,921 | 5.7% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Total sales by business segment | 41,831 | 45,553 | 51,078 | 60,776 | 66,346 | 9.2% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
North America | 13,746 | 15,154 | 18,279 | 23,609 | 26,586 | 12.6% | ||||||
Europe | 16,350 | 17,219 | 17,540 | 18,664 | 19,168 | 2.7% | ||||||
International Operations1 | 5,870 | 6,353 | 6,835 | 8,335 | 9,367 | 12.4% | ||||||
Japan & Korea | 3,843 | 4,196 | 4,888 | 5,660 | 6,223 | 9.9% | ||||||
Region China1 | 2,022 | 2,631 | 3,536 | 4,508 | 5,002 | 11.0% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Total sales by geographical segment | 41,831 | 45,553 | 51,078 | 60,776 | 66,346 | 9.2% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Underlying sales growth in local currencies | 13% | 12% | 11% | 13% | 11% | |||||||
Currency effect (local currency impact) | (5% | ) | (3% | ) | 1% | 6% | (2% | ) | ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Total sales growth as reported | 8% | 9% | 12% | 19% | 9% | |||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Other financial performance | ||||||||||||
Depreciation, amortisation and impairment losses | 3,007 | 2,442 | 2,551 | 2,467 | 2,737 | 10.9% | ||||||
Operating profit | 8,942 | 12,373 | 14,933 | 18,891 | 22,374 | 18.4% | ||||||
Net financials | 2,029 | 322 | (945 | ) | (605 | ) | (449 | ) | (25.8% | ) | ||
Profit before income taxes | 10,971 | 12,695 | 13,988 | 18,286 | 21,925 | 19.9% | ||||||
Net profit for the year | 8,522 | 9,645 | 10,768 | 14,403 | 17,097 | 18.7% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets | 47,731 | 50,603 | 54,742 | 61,402 | 64,698 | 5.4% | ||||||
Equity | 32,182 | 32,979 | 35,734 | 36,965 | 37,448 | 1.3% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditure, net | 2,268 | 1,754 | 2,631 | 3,308 | 3,003 | (9.2% | ) | |||||
Free cash flow2 | 9,012 | 11,015 | 12,332 | 17,013 | 18,112 | 6.5% | ||||||
|
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|
|
|
|
|
|
|
|
|
|
|
Financial ratios | ||||||||||||
Percentage of sales | ||||||||||||
Sales outside Denmark | 99.2% | 99.2% | 99.2 | % | 99.4% | 99.3% | ||||||
Sales and distribution costs | 29.6% | 28.2% | 30.2 | % | 29.9% | 28.6% | ||||||
Research and development costs | 20.4% | 17.2% | 15.4 | % | 15.8% | 14.5% | ||||||
Administrative expenses | 6.0% | 5.8% | 5.4 | % | 5.0% | 4.9% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin2 | 76.6% | 77.8% | 79.6% | 80.8% | 81.0% | |||||||
Net profit margin2 | 20.4% | 21.2% | 21.1% | 23.7% | 25.8% | |||||||
Effective tax rate2 | 22.3% | 24.0% | 23.0% | 21.2% | 22.0% | |||||||
Equity ratio2 | 67.4% | 65.2% | 65.3% | 60.2% | 57.9% | |||||||
Return on equity (ROE)2 | 27.4% | 29.6% | 31.3% | 39.6% | 46.0% | |||||||
Cash to earnings2 | 105.7% | 114.2% | 114.5% | 118.1% | 105.9% | |||||||
Payout ratio2 | 32.8% | 37.8% | 40.9% | 39.6% | 45.3% | |||||||
Payout ratio excl non-recurring events3 | 34.9% | 36.6% | 40.9% | 42.8% | 45.3% | |||||||
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|
Long-term
|
||||||||||||
Ratios for long-term financial targets | financial targets4 | |||||||||||
Operating profit margin2 | 21.4% | 27.2% | 29.2% | 31.1% | 33.7% | 35% | ||||||
Operating profit growth | (1.9% | ) | 38.4% | 20.7% | 26.5% | 18.4% | 15% | |||||
Operating profit after tax to net operating assets | 27.2% | 37.4% | 47.3% | 63.6% | 77.9% | 90% | ||||||
Cash to earnings, (three-year average) | 87.0% | 97.6% | 111.5% | 115.6% | 112.8% | 90% | ||||||
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14 Novo Nordisk Annual Report 2011
Our 2011 accomplishments and results |
2007
|
2008
|
2009
|
2010
|
2011
|
2010
2011
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Social performance |
Change
|
|||||||||||
Patients: | ||||||||||||
People with diabetes using Novo Nordisk | ||||||||||||
injectable products (million) (estimate) |
N/A
|
N/A
|
N/A
|
N/A
|
24
|
|||||||
Healthcare professionals trained or educated | ||||||||||||
in diabetes (1,000) |
N/A
|
N/A
|
425
|
373
|
835
|
123.9%
|
||||||
People with diabetes trained (1,000) |
N/A
|
N/A
|
416
|
494
|
626
|
26.7%
|
||||||
Donations (DKK million) |
76
|
78
|
83
|
84
|
81
|
(3.6%
|
)
|
|||||
New patent families (first filings) |
116
|
71
|
55
|
62
|
80
|
29.0%
|
||||||
Employees: | ||||||||||||
Employees (total) |
26,008
|
27,068
|
29,329
|
30,483
|
32,632
|
7.0%
|
||||||
Average of full-time employees |
24,344
|
26,069
|
27,985
|
29,423
|
31,499
|
7.1%
|
||||||
Employee turnover |
11.6%
|
12.1%
|
8.3%
|
9.1%
|
9.8%
|
|||||||
Assurance: | ||||||||||||
Relevant employees trained in business ethics |
N/A
|
N/A
|
N/A
|
98%
|
99%
|
|||||||
Fulfilment of action points from facilitations | ||||||||||||
of the Novo Nordisk Way |
91%
|
92%
|
93%
|
93%
|
93%
|
|||||||
Product recalls |
3
|
2
|
2
|
5
|
5
|
|
||||||
Warning Letters and re-inspections |
0
|
0
|
0
|
0
|
0
|
|
||||||
Company reputation with external | ||||||||||||
key stakeholders (scale 17) |
N/A
|
N/A
|
N/A
|
N/A
|
5.6
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term
|
||||||||||||
Long-term social targets |
social
targets
|
|||||||||||
Least developed countries where Novo Nordisk sells insulin according to the differential pricing policy |
72%
|
64%
|
73%
|
67%
|
75%
|
100%
|
||||||
Engaging culture (employee engagement) (scale 1 5) |
4.1
|
4.2
|
4.3
|
4.3
|
4.3
|
4.0
|
||||||
Diverse senior management teams |
N/A
|
43%
|
50%
|
54%
|
62%
|
100%
by 2014
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Environmental performance |
Change
|
|||||||||||
Inputs: | ||||||||||||
Energy consumption (1,000 GJ) |
2,784
|
2,533
|
2,246
|
2,234
|
2,187
|
(2.1%
|
)
|
|||||
Water consumption (1,000 m3) |
3,231
|
2,684
|
2,149
|
2,047
|
2,136
|
4.3%
|
||||||
Outputs: | ||||||||||||
CO2 emissions from energy consumption (1,000 tons) |
236
|
215
|
146
|
95
|
93
|
(2.1%
|
)
|
|||||
Wastewater (1,000 m3) |
2,764
|
2,542
|
2,062
|
1,935
|
2,036
|
5.2%
|
||||||
Total waste (tons) |
23,345
|
24,314
|
26,362
|
25,627
|
41,376
|
61.5%
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term
|
||||||||||||
Long-term environmental targets |
environmental
targets
|
|||||||||||
Energy consumption |
11%
reduction
|
|||||||||||
(change compared with 2007) |
N/A
|
(9%
|
)
|
(19%
|
)
|
(20%
|
)
|
(21%
|
)
|
by
2011
|
||
Water consumption |
11%
reduction
|
|||||||||||
(change compared with 2007) |
N/A
|
(17%
|
)
|
(34%
|
)
|
(37%
|
)
|
(34%
|
)
|
by
2011
|
||
CO2 emissions from energy consumption |
10%
reduction
|
|||||||||||
(change compared with 2004) |
12%
|
2%
|
(31%
|
)
|
(55%
|
)
|
(56%
|
)
|
by
2014
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
Share performance | ||||||||||||
Basic earnings per share/ADR in DKK2 |
13.49
|
15.66
|
17.97
|
24.81
|
30.24
|
|||||||
Diluted earnings per share/ADR in DKK2 |
13.39
|
15.54
|
17.82
|
24.60
|
29.99
|
|||||||
Dividend per share in DKK |
4.50
|
6.00
|
7.50
|
10.00
|
14.00
|
|||||||
Total dividend |
2,795
|
3,650
|
4,400
|
5,700
|
7,742
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
1. | As of 1 January 2011, Region China is reported as a separate geographical region. Before 2011, Region China was part of International Operations. The historical figures for 20072010 have been restated and are comparable with the 2011 regional set-up. |
2. | For definitions, please refer to p 65. |
3. | Impact of Zymogenetics, Inc. share divestment, discontinuation of all pulmonary diabetes projects and impact of DAKO A/S share divestment. |
4. | The long-term financial targets were updated in February 2012. Please refer to p 6. |
Novo Nordisk Annual Report 2011 15
Our business |
JENNY PETTERSSON
The Young Leaders in Diabetes programme involves young people like Jenny from Stockholm, Sweden, working with and for young people with diabetes to improve awareness and address the particular challenges involved in being young with diabetes. Representing her countrys diabetes association, Jenny took part in the Young Leaders in Diabetes Programme in Dubai during the World Diabetes Congress held by the International Diabetes Federation in December 2011. Novo Nordisk is proud to be among the founding partners of this programme.
16 Novo Nordisk Annual Report 2011
Our business |
Novo Nordisk is its people. As the company grows and globalises, it is important that we continue to build on a strong foundation of shared values. The Novo Nordisk Way, our values-based management system, was updated in 2011. In a concise and compelling form it makes clear to employees what the companys ambitions are, how we will achieve them, and what we value as an organisation. To support it, we have framed 10 essentials that describe how our values are put into action in the way we work and collaborate and the way we interact with other people.
During 2011, employees around the world explored the essence of the Novo Nordisk Way and what it means to them. Nearly every one, 97% of employees, participated in training activities. The updated and simplified format has been welcomed, in particular the emphasis on patients at the front and centre of everything we do and the clear language on respect for everyone. The values are also consistent
with the universal principles for responsible business conduct expressed by the UN Global Compact, to which Novo Nordisk has been a signatory since 2002.
The
Novo Nordisk Way expresses our deeply rooted values. |
A follow-up methodology involving values audits, or facilitations, helps us assess and manage the degree to which the Novo Nordisk Way is actively put into practice throughout our company. To support this process, we have a global facilitator team of senior people with deep understanding of our business and business environment. The head of the team has a formal reporting line to the chairman of the Board.
For some units, these audits take place annually; for others, the process takes place once every three to five years. Observations from this process are reported to the Board of Directors each year. See more about facilitations on pp 11 and 43.
The Novo Nordisk Way | The Essentials | ||||
In 1923, our Danish founders began a journey to change diabetes. Today, we number thousands of employees across the world with the passion, the skills and the commitment to continue this journey to prevent, treat and ultimately cure diabetes. |
The Essentials are 10 statements describing what the Novo Nordisk Way looks like in practice. The Essentials are meant as a help for managers and employees in evaluating the extent to which their organisational units are acting in accordance with the Novo Nordisk Way, ie the degree to which we are walking the talk. The Essentials are helpful in identifying actions which business units can take to further align processes and procedures with the thinking and values that characterise the Novo Nordisk Way. 1. We create value by having a patient-centred business approach. 2. We set ambitious goals and strive for excellence. 3. We are accountable for our financial, environmental and social performance. 4. We provide innovation to the benefit of our stakeholders. 5. We build and maintain good relations with our key stakeholders. 6. We treat everyone with respect. 7. We focus on personal performance and development. 8. We have a healthy and engaging working environment. 9. We optimise the way we work and strive for simplicity. 10. We never compromise on quality and business ethics.
|
||||
| Our ambition is to strengthen our leadership in diabetes. | ||||
| We aspire to change possibilities in haemophilia and other serious chronic conditions where we can make a difference. | ||||
| Our key contribution is to discover and develop innovative biological medicines and make them accessible to patients throughout the world. | ||||
| Growing our business and delivering competitive financial results is what allows us to help patients live better lives, offer an attractive return to our shareholders and contribute to our communities. | ||||
| Our business philosophy is one of balancing financial, social and environmental considerations we call it the Triple Bottom Line. | ||||
| We are open and honest, ambitious and accountable, and treat everyone with respect. | ||||
| We offer opportunities for our people to realise their potential. | ||||
| We never compromise on quality and business ethics. | ||||
Every day we must make difficult choices, always keeping in mind what is best for patients, our employees and our shareholders in the long run. | |||||
Its the Novo Nordisk Way. | |||||
Novo Nordisk Annual Report 2011 17
Our business |
18 Novo Nordisk Annual Report 2011
Our business |
and the best method of oral delivery, one that will ensure that the active ingredients are not destroyed or degraded in the gastrointestinal tract before being absorbed.
We also seek to expand our leadership within GLP-1 treatment. With the successful launch of Victoza® (liraglutide), our once-daily GLP-1 analogue, we have the leading GLP-1 treatment for the early stages of type 2 diabetes in adults.
Our
goal is to offer treatments that are as safe and convenient as possible. |
We are now building a GLP-1 portfolio with the intention to provide an even broader range of treatment options, including longer-acting versions to improve convenience. Our late-stage GLP-1 pipeline includes two new treatments, a fixed combination of Victoza® with Degludec, which may offer the benefits of both compounds in a convenient solution, and a novel once-weekly GLP-1 analogue, semaglutide.
While there is not yet a cure for type 1 diabetes, we are conducting research in cooperation with leading academic centres to tackle the roots of the condition. At our Hagedorn Research Institute, we are making progress towards preventing and ultimately curing diabetes through projects involving stem cell biology and beta cell regeneration. For information on our efforts to find a cure, see annualreport2011.novonordisk.com.
Establish presence in obesity treatment
Obesity is known to be a major risk factor in developing type 2 diabetes, cardiovascular disease and a range of other life-threatening diseases. Despite the growing prevalence of severe and morbid obesity globally, there are currently only a few treatment options.
In studies of people with diabetes and people with obesity who do not have diabetes, liraglutide has shown the potential to reduce food intake with the result of controlling weight. We are therefore exploring the option of using liraglutide as a new way of treating high-risk patients, those with obesity-related medical conditions such as high blood pressure and high cholesterol levels.
Gaining regulatory approval for antiobesity medications remains a major challenge. Compounds developed by other pharmaceutical companies to target obesity have experienced significant challenges in obtaining regulatory approval due to concerns about side effects outweighing potential benefits. However, given the results seen so far in randomised controlled trials, we believe liraglutide can offer benefits for people with severe obesity and co-morbidities.
Achieve leadership in haemophilia
Our ambition is to achieve leadership in haemophilia by improving the efficacy of prevention and treatment of bleeding episodes with improved treatment options for all patients. With a significant number of compounds in clinical development, we are set to build a strong portfolio of recombinant products, covering all the main segments of the haemophilia market.
We introduced NovoSeven® for the treatment of haemophilia patients with inhibitors 15 years ago and it remains the leading recombinant bypassing agent available for the 3,500 people with haemophilia who have developed inhibitors to conventional treat ments. To further improve treatment of bleeding episodes for people with inhibitors, we have a fast-acting recombinant factor VIIa analogue, vatreptacog alfa, with improved efficacy in phase 3 clinical development.
We are leveraging our core protein capabilities and our understanding of haemophilia to develop factor VIII and factor IX com pounds for the treatment of haemophilia A and B respectively. The primary focus of these development projects is to treat and prevent bleeding episodes and consequently reduce damage to joints. In 2011, these projects were either recruiting patients in phase 3 trials or approved to initiate phase 3 trials.
Novo Nordisk filed for regulatory approval of a recombinant factor XIII treatment in the US and Europe during 2011. This treatment, if approved, will be the only recombinant treatment option for the 600 people worldwide diagnosed with congenital factor XIII deficiency.
Achieve leadership in growth disorders
Novo Nordisks strategy in growth hormone therapy is to achieve leadership by providing innovative and convenient products and devices as well as a full range of service offerings for physicians and patients in markets where services can be delivered. Norditropin® is the only liquid, room temperature-stable growth hormone product available in a prefilled pen device, the ergonomic Norditropin® FlexPro® with an easy-touch dosing mechanism.
We are also developing a long-acting growth hormone formulation, currently in phase 1 trials.
Establish presence in inflammation
Our expertise in design of therapeutic proteins and chronic disease care can be leveraged to address the significant unmet medical needs in diseases caused by chronic autoimmune inflammation. Initial clinical tests of first-in-class, protein-based therapuetic agents that reduce the overactive immune response indicate the potential to offer significant benefit to patients, but these projects are still at an early stage of clinical development.
There are a significant number of people with autoimmune inflam- matory diseases who do not adequately respond to current treatments. In order to successfully build a presence in treatment of inflammation, we are investing in early-stage research with the hope of finding the underlying mediators of inflammatory conditions and developing new treatments, particularly for patients who are unresponsive to current treatments.
Novo Nordisk Annual Report 2011 19
Our business |
We aim to grow our business in ways that are both profitable and responsible. Recognising that long-term business success relies on a healthy economy, environment and society, we manage our business in a way that addresses multiple dimensions of performance: financial, social and environmental. We apply the Triple Bottom Line principle as a lens for decision making. This approach supports long-term success by creating shared value for society and our investors.
Our Triple Bottom Line business principle is anchored in our company bylaws, the Articles of Association, and the Novo Nordisk Way. We drive our social and environmental performance with the same diligence and focus as our financial performance. All business units are responsible for monitoring and reporting on their performance in all three dimensions, based on long-term goals and targets cascaded through the balanced scorecard process. Managers and employees are also encouraged to take initiatives that extend beyond compliance measures.
Helping
people live better lives is at the core of our business. |
Our corporate priorities reflect initiatives in support of business objectives as well as broader sustainability goals. Our main contributions include expanding access to healthcare and promotion of healthy lifestyles, offering an inclusive, healthy and engaging working environment, driving carbon reduction and climate advocacy, pursuing resource efficiency, combating corruption and ensuring consistent responsible business practices and good governance.
In 2011, we strengthened internal governance and oversight of our corporate sustainability efforts and made progress in embedding the Triple Bottom Line more firmly across the organisation. The Sustainability Committee, with representation from all parts of the business, has overall responsibility for setting direction for strategic and proactive management of the sustainability agenda. This includes implementation of initiatives in support of the companys long-term sustainable growth and in accordance with the UN Global Compact and other voluntary commitments. For more about the internal Novo Nordisk boards and committee structure for managing multiple dimensions of performance, see annualreport2011.novonordisk.com.
The financial, social and environmental priorities that determine the indicators we use to manage performance are listed on pp 1415.
Deliver competitive financial results
Growing our business and delivering competitive financial results is what allows us to help patients live better lives, offer an attractive return to our shareholders and contribute to our communities.
Our targets for operating profit margin, operating profit growth and the ratio of operating profit after tax to net operating assets provide a guide to the level of growth and profitability to which
we aspire. The targets also help management establish a balance between growing our business profitably in the near term and ensuring the company is able to make investments in longer-term growth, including investments in clinical development of improved therapies.
The growth target for operating profit has been viewed as the cornerstone financial target since we began using financial targets in 1996. It allows for deviations in individual years if necessitated by business opportunities, market conditions or exchange rate movements. The continued improvement in efficiencies at our manufacturing facilities around the world and, longer term, in the productivity of our global sales force supports improvements in our operating margin, as does improvement in the ratio of administrative costs to sales. Our cash to earnings helps ensure that we are able to pay an attractive dividend.
Offer a healthy and engaging working environment
We believe that having a healthy and engaging working environment helps attract, motivate and retain employees and that this is critical to sustaining our companys growth and positive contributions to society. Employees around the world advocate healthy lifestyles, improved prevention, detection and treatment of diabetes, and patient support activities through their work as well as through voluntary initiatives. On World Diabetes Day in November 2011, for instance, more than 7,500 employees in more than 50 countries engaged over 1 million people in activities to raise awareness about the diabetes pandemic.
We have a long-term target to maintain a high level of employee engagement, which is assessed through the annual company-wide survey, eVoice. Survey questions also assess adherence to company values, employees perceptions of the quality of management, their working environment and well-being. This information is used by local and corporate management to address any issues discovered through employees feedback.
As our business becomes increasingly global, it becomes even more important to embrace diversity and embody a global mindset. We believe that diverse management teams are best suited to drive performance, foster innovative thinking and nurture collaboration between people with different perspectives. We aim to increase diversity because we believe doing so offers a competitive advantage.
Our leadership development programmes emphasise personal leadership and respect for the integrity of each individual. Training for managers includes decision-making that balances short- and long-term considerations and considers multiple dimensions of performance.
Helping people live better lives
Helping people live better lives is at the core of our business. We act on the premise that everyone has a right to health. Access to care is not only an issue in developing countries. As we seek to reach out to more people, we have now begun to report estimates of the number of people treated using Novo Nordisk diabetes care products.
20 Novo Nordisk Annual Report 2011
Our business |
A decade ago we began addressing the issues of inadequate access to health, introducing a preferential pricing policy in all of the least developed countries, launching dedicated programmes for underprivileged populations, including women and children, and advocating the need for Changing Diabetes® and Changing Possibilities in Haemophilia®. While we have made progress, we also realise that a different approach is needed to increase the scale of our impact, particularly as global health becomes a higher priority on the political agenda. In 2011, we announced a new approach to access to health, informed by candid stakeholder dialogues and high-level engagements with policymakers. See novonordisk.com/sustainability. We have also reaffirmed that low-priced insulin will remain in the companys portfolio in low-income countries. Much more can be done, yet success hinges on the ability of governments, industry and civil society acting together to deliver sustainable, effective responses. In 2011, Novo Nordisk worked on several fronts to forge partnerships that have the potential to be transformational over time. Promoting responsible business practices We never compromise on quality and business ethics. In a business environment in which compliance requirements constantly increase, Novo Nordisk has further geared up to manage developments. This is the result of significant efforts invested in expanding the business ethics compliance programme with global policies and procedures, governance structure, training, audits and investigations. All relevant Novo Nordisk employees are required to be trained annually in business ethics guidelines and we train third parties who act on our behalf to align understanding of compliance requirements and Novo Nordisks ethical standards. We have also now improved tracking and disclosure of financial interactions with healthcare providers. We drive progress through systematic management and oversight. While seeking to exploit opportunities to act in ways that are both responsible and profitable, we also vigilantly manage risks to our business by monitoring trends and continuously adapting our business practices. Our enterprise risk management system considers both financial and non-financial risks, along with plans or processes to manage these risks. From this platform, focused on mitigating risks, we are reinforcing a strong ethical mindset in every aspect of the way we do business. Expectations for working with integrity are embedded in job descriptions, management systems and internal audit processes. Adherence to voluntary guidelines and participation in stakeholder dialogues helps us anticipate and prepare for new requirements. Prior to the adoption of the United Nations Guiding Principles on Business and Human Rights, Novo Nordisk has been actively engaged in shaping the agenda for businesses responsibility to respect human rights, and in 2011 we commissioned an analysis to assess which additional steps will be necessary to take in order to live up to the guidelines. |
Decoupling environmental impacts from business growth While growing our business and increasing sales, we seek to reduce the consumption of natural resources and manufactured inputs, such as packaging, generated by our business activities and supply chain. In addition to reducing negative impacts, our approach focuses on contributing to solving global challenges such as climate change. Over the past decade, we have demonstrated the ability to decouple resource consumption and emissions from sales growth. In 2011, we expanded our environmental management from a focus on resource productivity optimisation related to production to include sustainability aspirations across the entire value chain for our customer footprint and our contribution to communities. Contributing to sustainable growth Case studies of our business approach in different markets quantify benefits to patients, cost savings in healthcare systems and productivity gains resulting in sustainable societal value. Through our Blueprint for Change programme we document shared value creation and assess the potential for enhanced value. Our most recent study is from the US and shows how concerted efforts to improve prevention and early detection of type 2 diabetes can improve quality of life and reduce healthcare costs. Doing so has given us a competitive edge in terms of strong relations with stakeholders, a highly engaged workforce in the US and recognition as a great place to work. See novonordisk.com/ sustainability.
|
Novo Nordisk Annual Report 2011 21
Our business |
We believe that our dynamic approach to risk management ensures that key risks are proactively identified, assessed and managed. For shorter-term risks, we have an ongoing assessment process that takes into account the likelihood of an event, its potential impact on the business and the need for mitigating action.
Maintaining and monitoring a systematic, integrated process to continually assess business risks is the responsibility of Executive Management. The Risk Management Board, which has representatives of senior management from all parts of the business and is chaired by the chief financial officer, sets the strategic direction for the risk management process and challenges the overall risk profile for Novo Nordisk.
Novo Nordisks risk policy | ||
Our policy for risk management is to proactively manage risk to ensure continued growth of our business and to protect our people, assets and reputation. This means that we will: | ||
| utilise an effective and integrated risk management system while maintaining business flexibility | |
| identify and assess material risks associated with our business | |
| monitor, manage and mitigate risks. | |
Our risk willingness | ||
Our risk willingness is characterised by the following: | ||
| We develop new innovative products to improve treatment of serious diseases such as diabetes and haemophilia. We accept the high level of risk involved in bringing such products to market to meet the needs of patients in terms of both safety and efficacy. | |
| We make every effort to reduce safety risks to the lowest level possible in both clinical trials and already marketed products. The well-being of patients is paramount. | |
| We take a conservative approach to the management of financial risks. | |
| We strive to reduce supply chain risks through proactive business continuity planning, regular inspections and back-up facilities. | |
| We never compromise on quality and business ethics. | |
For more about our risk management process, see annualreport2011.novonordisk.com. | ||
Most important risks
Below are the risks we assess as having the greatest potential impact on our business. The risks are not ranked, but are categorised and described, including 2011 developments in each risk area.
In the process of setting our strategy, we also identify risks that are potential barriers to the achievement of our long-term ambitions. For these risks, see pp 1821.
Market
risks
Price pressures
Healthcare costs are rising and, in many countries, are outstripping
the pace of economic growth. There is increasing economic, political and regulatory
pressure to contain these costs, including spending on pharmaceutical products.
The continued global economic crisis has further exacerbated this trend. Examples
of how Novo Nordisks key markets are affected include:
| US: Healthcare reform legislation was enacted in 2010. Continued federal budget issues could lead to further pricing reforms for products purchased through the Medicare and Medicaid programmes. |
| Europe: As the region's debt crisis builds, a number of European governments have announced or implemented several rounds of healthcare reforms, intensifying an already challenging operating environment with significant pricing pressures. |
| China: Price reductions for pharmaceutical products were introduced in September 2011 as part of healthcare reforms. Provincial-level tenders have been introduced in some parts of the country. |
Documenting treatment benefits is one way to ensure that innovation is properly valued. Novo Nordisk conducts a considerable number of clinical and health-economic studies to substantiate the benefits of our products for patients and society, particularly for improved diabetes treatment.
Biosimilar
competition
The market for therapeutic proteins is becoming more accessible
to biosimilar producers. Regulatory processes in Europe and the US may change
to facilitate potential approval of biosimilar products without full clinical
development once patents expire. Increasing pressure on governments to contain
healthcare costs makes this scenario more likely.
To address this risk, Novo Nordisk is continuously developing innovative medicines to address unmet medical needs. One example is our new generation of insulins, Degludec and DegludecPlus. In 2011, more than half of Novo Nordisks diabetes care sales were for modern insulins under patent protection. Novo Nordisk anticipates that the expiration of certain patents could impact sales within the next five years, but the potential launch of new products should offset the impact of currently protected products going off patent.
Earlier generations of insulin products have been off patent for years so this is a risk with which Novo Nordisk is familiar and has considerable experience addressing. Biosimilar human insulin products have been present on the European market for several decades but have had only a marginal impact. In countries such
22 Novo Nordisk Annual Report 2011
Our business |
as India and China, where Novo Nordisk has long had biosimilar competition, Novo Nordisk has maintained an insulin volume market share of more than 60%.
Research
and development risks
Bringing new products to market
Continued growth in our business depends on Novo Nordisks
ability to develop and offer better treatments to patients. At each stage
of the development process, which includes extensive non-clinical tests
and clinical trials as well as an elaborate regulatory approval process,
we may encounter serious obstacles which may delay our product initiatives
and add substantial expense, or which could cause us to abandon a project
altogether. Significant delays in bringing new products such as Degludec
and DegludecPlus to market would impact our ability to reach long-term
financial targets.
In our experience, there is a less than 35% chance of a diabetes product candidate in phase 1 in the pipeline ultimately being approved for marketing, while the chance of success is around 40% for phase 2 product candidates and rises to around 70% for phase 3, although there remains significant uncertainty regarding the timing and success of the regulatory approval process. As the Novo Nordisk pipeline becomes more diversified, these figures are likely to decline towards industry standards over a longer period. The reasons for delays or failure include, for instance, failure of the product candidate in non-clinical studies because of safety concerns; problems in completing formulation and other testing and work necessary to support a regulatory approval process; adverse reactions to the product candidate or indications of other safety concerns; failure of clinical trial data to support the safety or efficacy of the product candidate; inability to manufacture, in a timely and cost-efficient manner, sufficient quantities of the product candidate for development or commercialisation activities; and failure to obtain, or delays in obtaining, the required regulatory approvals for the product candidate or the facilities in which it is manufactured.
As a result of the risks and uncertainties involved in progressing through non-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.
Production
and quality risks
Supply disruptions
Failure or breakdown in any of the companys vital production facilities
could adversely affect the results of operations and could potentially
cause employee injuries or infrastructure damage. Fire-prevention design,
alarms and fire instructions, annual inspections, back-up facilities and
safety inventories are aimed at mitigating this risk. To spread this risk
geographically and optimise costs and supply logistics, we have established
production capacity on five continents. See the map of our production
facilities on pp 2829.
Significant decisions were made in 2011 with regard to the geographical spread of our facilities. The Board of Directors approved investment plans for implementation of new filling and packaging facilities for biopharmaceutical products, ensuring back-up production capacity for all filled biopharmaceutical products. After the earthquake, tsunami and nuclear power plant failure in Japan in March, our packaging plant in Koriyama, 60 kilometres from the affected nuclear power plant, had to close
for two weeks. An additional warehouse has been established 450 kilometres from the affected area and a number of measures are in place or are being considered to ensure supply to the Japanese market in the event of a future emergency.
Risk
of product recalls
Product safety is directly linked to patient well-being,
so product safety and quality are paramount concerns from both financial
and reputational perspectives. While the gross risk is high, with product
safety issues having the potential to adversely affect operations, we
believe that our vigorous efforts to proactively manage and mitigate this
risk effectively reduce the companys net risk profile.
Product
safety and quality are paramount concerns, so we vigorously manage quality risks. |
We have a global quality system in place, which ensures effective mitigation of risks to patient safety and product quality by structured and controlled design, development and production risk reductions. The risk reduction activities span the entire life cycle of any of our products and are ensured by the completeness and full compliance of our quality management system with all regulatory requirements including standard operating procedures, quality audits, quality improvement plans and systematic senior management reviews.
For information on Novo Nordisks product recalls from 2007 to 2011, see pp 10 and 96.
Financial
risks
Exchange rates
Novo Nordisks reporting currency and the functional
currency of corporate operations is the Danish krone, which is closely
linked to the euro in a narrow range of ±2.25. The majority of
our sales, however, are in US dollars, European euros, Chinese yuan, Japanese
yen and British pounds. Exchange rate risk is therefore the companys
biggest financial risk and the risk has grown in importance as the size
of international markets and the share of sales in different currencies
have increased. To manage this risk, the company hedges expected future
cash flows for selected key currencies.
For more information on how the company manages this risk, see note 27 to the Consolidated financial statements on pp 7980.
Tax
cases
In the course of conducting a global business, transfer pricing
disputes may occur. Our policy is to pursue a competitive tax level, meaning
at or below the average for the companys peer group, in a responsible
way. This means paying relevant tax in jurisdictions where business activity
generates profits. Generally, Novo Nordisk affiliates pay tax in the countries
in which they operate.
We also seek to keep tax levels stable and predictable. To manage uncertainties regarding tax, we have negotiated multi-year agreements in key jurisdictions.
For details on taxes paid by the company in 2011, see note 9 on p 69.
Novo Nordisk Annual Report 2011 23
Our business |
Ethical
risks In May 2009, Novo Nordisk entered into a Deferred Prosecution Agreement (DPA) for a three-year period with the US Department of Justice relating to certain actions undertaken by Novo Nordisk under the Oil For Food Programme for Iraq. We must comply with the terms of the DPA in order for the case to be dismissed. Novo Nordisk has subsequently enacted a detailed programme to ensure compliance with the DPA, including a reinforced governance structure, enhanced third-party due diligence systems and periodic testing of systems, policies and procedures. In February 2011, the office of the US Attorney for the District of Massachusetts served Novo Nordisk with a subpoena calling for the production of documents regarding potential criminal offences relating to the companys marketing and promotion practices for the products NovoLog®, Levemir® and Victoza®. Novo Nordisk is cooperating with the US Attorney in this investigation. In June 2011, Novo Nordisk settled a civil case with the US Department of Justice and two individuals regarding alleged improper marketing of NovoSeven®. As part of the settlement, Novo Nordisk paid 25 million US dollars in total, but denied any wrongdoing. In addition to the financial settlement related to marketing practices in the United States regarding NovoSeven®, as part of the agreement with the US Department of Justice, our US affiliate entered into a five-year Corporate Integrity Agreement with the Office of the Inspector General of the US Department of Health and Human Services. Under that agreement, our US affiliate will add additional reporting and other procedures to its already robust compliance programme. Corporate Integrity Agreements are customary in this type of settlement and most of the major pharmaceutical companies operating in the US are party to similar types of agreement. Significant legal issues relating to marketing practices are included in note 31 on pp 8687. Legal
risks
|
Other
legal risks For more information on significant legal issues, see note 31 on pp 8687. |
24 Novo Nordisk Annual Report 2011
Our business |
WINNIE MARGIT HANSEN
Winnie works as a process operator at our production site in Hjørring, Denmark, where she is responsible for quality control of NovoTwist® needles. By aligning processes, Winnie and her colleagues are now able to produce more needles with shorter lead times, without compromising high quality standards. Winnie sees her role as delivering the highest-quality products to people with diabetes exactly when they need them.
Novo Nordisk Annual Report 2011 25
Our business |
In 2011, progress was made throughout Novo Nordisks clinical development pipeline. This overview illustrates key development activities, including entries into the pipeline and progression of development compounds. See more at novonordisk.com/investors and clinicaltrials.gov. |
Phase
1 |
Therapy area |
Indication
|
Compound
|
Description
|
||
Diabetes care | |||||
Type 1 and 2 | Insulin degludec | Ultra-long-acting basal insulin. Submitted for marketing authorisation in five markets in 2011. | |||
diabetes | |||||
|
|
|
|
|
|
Type 1 and 2 | Insulin degludec/ | Ultra-long-acting basal insulin in combination with a boost of bolus insulin | |||
diabetes | insulin aspart | aspart. Submitted for marketing authorisation in four markets in 2011. | |||
|
|
|
|
|
|
Type 2 diabetes | Insulin degludec/ | Liraglutide and insulin degludec in a combination. Phase 3 trials ongoing. | |||
liraglutide | |||||
|
|
|
|
|
|
Type 2 diabetes | Semaglutide | Once-weekly GLP-1 analogue. Phase 2 completed. | |||
|
|
|
|
|
|
Diabetes | Type 1 and 2 | NN1218 | Ultra-fast-acting insulin. Phase 1 trials ongoing. | ||
diabetes | |||||
|
|
|
|
|
|
Type 1 and 2 | NN1953 | Long-acting oral insulin analogue. Phase 1 trial ongoing. | |||
diabetes | |||||
|
|
|
|
|
|
Type 2 diabetes | Liraglutide depot | Once-weekly liraglutide formulation. Phase 1 trial initiated during 2011. | |||
|
|
|
|
|
|
Type 2 diabetes |
NN9924
|
Long-acting, oral GLP-1 analogue formulation. Phase 1 trial ongoing. | |||
|
|
|
|
|
|
Type 2 diabetes |
NN9926
|
Long-acting, oral GLP-1 analogue formulation. Phase 1 trials ongoing. | |||
|
|
|
|
|
|
Obesity | Obesity | Liraglutide | Once-daily GLP-1 analogue. Phase 3a programme ongoing. | ||
Biopharmaceuticals | |||||
Congenital FXIII | Catridecacog | Recombinant coagulation factor XIII. Submitted for regulatory approval | |||
deficiency | in the US in the first quarter and in the EU in the second quarter of 2011. | ||||
|
|
|
|
|
|
Haemophilia A | Turoctocog alfa | Recombinant coagulation factor VIII. Phase 3 completed in 2011. | |||
|
|
|
|
|
|
Haemophilia with | Vatreptacog alfa | Fast-acting recombinant coagulation factor VIIa analogue. | |||
inhibitors | Phase 3 trial initiated during the second quarter of 2011. | ||||
Haemophilia |
|
|
|
|
|
Haemophilia B | N9-GP | Long-acting recombinant coagulation factor IX derivative. | |||
Phase 3 trial initiated during the second quarter of 2011. | |||||
|
|
|
|
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Haemophilia A | N8-GP | Long-acting recombinant coagulation factor VIII derivative. | |||
Phase 3 start planned for 2012. | |||||
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Haemophilia | NN7415 | Novel haemophilia treatment in the form of a monoclonal | |||
antibody
against a tissue factor pathway inhibitor.
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Growth | Growth hormone | NN8640 | Long-acting growth hormone formulation. Phase 1 trial initiated January 2012. | ||
hormorne | deficiency | ||||
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Rheumatoid | Anti-IL-20 | Humanised recombinant monoclonal antibody. Phase 2a trial completed. | |||
arthritis | |||||
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Crohns disease | Anti-NKG2d | Humanised recombinant monoclonal antibody. Phase 2a trial ongoing. | |||
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Rheumatoid | Anti-NKG2d | Humanised recombinant monoclonal antibody. Phase 2a trial ongoing. | |||
arthritis | |||||
Inflammation |
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Rheumatoid | Anti-C5aR | Humanised recombinant monoclonal antibody. Phase 1 trial ongoing. | |||
arthritis | |||||
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Rheumatoid | Anti-IL-21 | Humanised recombinant monoclonal antibody. Phase 1 trial ongoing. | |||
arthritis | |||||
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Rheumatoid | Anti-NKG2a | Humanised recombinant monoclonal antibody. Phase 1 trial ongoing. | |||
arthritis | |||||
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26 Novo Nordisk Annual Report 2011
Our business |
Phase
2 |
Phase
3 |
Intended clinical benefit | Phase 1 | Phase 2 | Phase 3 |
Filed/regulatory
approval
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Long-acting basal insulin with duration of action of more than 24 hours for flexible once-daily treatment and an improved safety profile. | |||||
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A soluble fixed combination of long-acting insulin combining basal insulin coverage with a distinct meal peak of insulin. | |||||
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Combination of basal insulin degludec and the GLP-1 analogue liraglutide providing the benefits of the two components in a single preparation. | |||||
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Provides the clinical benefits of a GLP-1 analogue with less frequent injections. | |||||
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Ultra-fast-acting insulin for further improvement of glycaemic control in relation to a meal. | |||||
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Basal insulin delivered as a tablet. | |||||
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Provides the clinical benefits of a GLP-1 analogue with less frequent injections. | |||||
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A long-acting GLP-1 analogue delivered as a tablet. | |||||
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A long-acting GLP-1 analogue delivered as a tablet. | |||||
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Sustainable weight loss for people with severe obesity, including those at particular risk of developing diabetes. | |||||
Prophylactic treatment of people with FXIII congenital deficiency. | |||||
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Prevention and treatment of bleeds in people with haemophilia A. | |||||
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Effective and sustained resolution of bleeds in people with haemophilia and inhibitors, reducing the need for re-treatment and the time to pain relief. | |||||
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Prophylaxis and treatment of bleeds in people with haemophilia B. | |||||
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Prophylaxis and treatment of bleeds in people with haemophilia A. | |||||
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Potential prophylactic treatment of haemophilia with subcutaneous administration. | |||||
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Provides the clinical benefits of growth hormone with less frequent injections. | |||||
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Novel mechanism of action intended to improve treatment outcomes in patients who do not respond adequately to existing treatments. | |||||
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Novel mechanism of action intended to improve treatment outcomes in patients who do not respond adequately to existing treatments. | |||||
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Novel mechanism of action intended to improve treatment outcomes in patients who do not respond adequately to existing treatments. | |||||
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Novel mechanism of action intended to improve treatment outcomes in patients who do not respond adequately to existing treatments. | |||||
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Novel mechanism of action intended to improve treatment outcomes in patients who do not respond adequately to existing treatments. | |||||
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Novel mechanism of action intended to improve treatment outcomes in patients who do not respond adequately to existing treatments. | |||||
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Novo Nordisk Annual Report 2011 27
Our business |
Novo Nordisk is a world leader in diabetes care and has a leading position in haemophilia treatment. We also provide growth hormone therapy and hormone replacement therapy and have development projects targeting inflammation, obesity and the full spectrum of rare bleeding disorders. We have more than 32,000 employees working in 75 countries. See pp 8990 for a list of our subsidiaries.
28 Novo Nordisk Annual Report 2011
Our business |
Novo Nordisk Annual Report 2011 29
Diabetes care |
TRACEY SAVERINO
Tracey, from Bronxville, New York, was diagnosed with gestational diabetes while expecting her baby. Tracey was able to manage the condition by focusing on portion control, healthier eating and getting more exercise. Gestational diabetes affects 315% of all pregnancies. Managing the condition is important to avoid complications for both the mother and infant.
30 Novo Nordisk Annual Report 2011
Diabetes care |
Novo Nordisk has pioneered many therapeutic breakthroughs in diabetes care and today diabetes remains our primary focus. We are the market leader in diabetes care, with about 50% of the total insulin market, 43% of the modern insulin (insulin analogue) market and 58% of the Glucagon-Like Peptide (GLP-1) analogue market based on volume at year-end.
While diabetes care has improved greatly in recent decades, there are still millions of people dying, losing their eyesight or requiring amputations because of poorly controlled diabetes. We know that people with diabetes often suffer complications because of poor blood glucose control.1
This is a result of a number of factors, including undertreatment because of fear of hypoglycaemia or weight gain, a common side effect of insulin treatment. People with diabetes also struggle to follow complex treatment regimens exactly, and insulin doses are sometimes missed. Lack of access to diabetes medicine and care is still a barrier to treatment for millions.
In our efforts to defeat diabetes, we have focused our research and development activities on addressing the unmet medical need to reduce blood glucose without the side effect of low blood glucose episodes, called hypoglycaemia. Findings from a landmark study in the UK showed that reducing blood glucose levels by close to 1% would reduce diabetes-related deaths by more than 20% and reduce microvascular complications by nearly 40%.2 Microvascular complications include diabetic retinopathy, which causes 10,000 cases of blindness annually in the US alone.3
We are dedicated to Changing Diabetes® and improving the health of people with diabetes. We do this by developing innovative treatments intended to serve individual needs and different stages of diabetes. In addition, we work with governments, healthcare providers, patient organisations and people with diabetes to improve standards of care throughout the world.
Diabetes is a chronic disease currently estimated to affect more than 366 million people. If current trends persist, the International Diabetes Federation predicts that the number of people affected by diabetes will rise to more than 550 million by 2030. Globally, diabetes accounted for 11% of total spending on healthcare in 2011.4
For diabetes, the rule of halves tells the story of missed opportunities along the care pathway, which includes prevention, diagnosis, access to care, achieving treatment targets and achieving desired outcomes. Of the estimated 366 million people with diabetes, only about half have been diagnosed.
The millions of people whose diabetes is undiagnosed and therefore untreated are at risk of developing complications that will significantly impair their quality of life and increase healthcare costs. The cost of treatment is usually a small fraction of overall spending on diabetes care, with most spending allocated for serious complications related to inadequate medical care. In the US and Europe, for instance, insulin accounts for 3% of the total cost associated with treating diabetes.
Key events in diabetes | |
| Degludec filed for regulatory approval in five markets and DegludecPlus filed in four markets. |
| Levemir® approved for paediatric use in the EU. |
| Levemir® approved for treatment of gestational diabetes in the EU. |
| Levemir® approved for add-on therapy to Victoza® for type 2 patients in the EU. |
| Phase 3 trial initiated for insulin degludec/liraglutide fixed-dose combination. |
| FlexTouch®, our newest innovation in prefilled devices, approved in the EU and introduced in the UK. |
Diabetes rule of halves
Novo Nordisk Annual Report 2011 31
Diabetes care |
Unfortunately, it is not only those with undiagnosed diabetes who go untreated. Only half of people diagnosed have access to treatment. Ensuring access to care can prevent complications and support human, social and economic development by reducing the burden untreated diabetes places both on healthcare systems and families. Of those people whose diabetes has been diagnosed and who are receiving treatment, it is estimated that only half achieve treatment targets and only half of those are achieving desired |
outcomes. Unfortunately, only by achieving treatment targets can the risk of developing severe complications be substantially reduced. |
What is diabetes? Diabetes is a metabolic disorder affecting the way our bodies use digested food for growth and energy. Over 4 million people die of complications caused by diabetes every year and millions more suffer disabling, costly and life-threatening complications such as heart attack, stroke, kidney failure, blindness and amputation. Diabetes has two main forms: type 1 and type 2 diabetes. Type 1 diabetes is a lifelong autoimmune disease that develops when the body creates an immune reation against its own cells, destroying beta cells in the pancreas. As a result, the pancreas stops producing insulin, typically at a young age. At least 90% of people with diabetes have type 2, which is caused by a combination of lifestyle and genetic factors. People with type 2 diabetes may still make their own insulin in the pancreas, but the insulin produced is insufficient and is not used as effectively by the body. Most of the long-term health complications associated with diabetes are due to persistent high blood glucose levels, which can cause kidney damage, neurological damage, cardiovascular damage, damage to the retina or damage to the feet and legs. Diabetes-related deaths could be reduced by 20% if average blood glucose levels (HbA1c) were reduced by 1%2. |
Diabetes treatment For type 2 diabetes, the first step is lifestyle changes diet and exercise and initiation of tablet therapy (metformin). If treatment targets are not met, GLP-1 therapy, such as Victoza®, or basal insulin, such as long-acting Levemir®, may be added. As a third step, treatment guidelines call for a transition to intensive insulin treatment to maintain good glycaemic control. This may include adding a rapid-acting modern insulin at mealtimes, such as NovoRapid®, in addition to a basal insulin. For insulin initiation, a modern premix insulin such as NovoMix® with dual release to cover both mealtime and basal requirements may also be used. One challenge in managing diabetes is to maintain appropriate blood glucose levels, adjusting insulin dosing as necessary to balance the impact of food and exercise. Low blood glucose levels cause hypoglycaemia, which, if untreated, can lead to seizures or unconsciousness. In rare cases, hypoglycaemia can lead to permanent brain damage or death. |
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32 Novo Nordisk Annual Report 2011
Diabetes care |
Different pathways to diabetes control
Modern insulin portfolio
Using protein engineering, we have created a portfolio of insulins that offers options for individual treatment needs, accommodating different treatment norms and capabilities worldwide. Modern insulins are designed to mimic the bodys own physiological insulin regulation of blood glucose levels more closely than injected human insulin, resulting in better glucose control, lower levels of hypoglycaemia and increased convenience for people with diabetes.
We
seek to help people control their diabetes to live longer, more productive lives. |
Novo Nordisks modern insulin portfolio includes:
| Levemir®, a soluble, long-acting modern insulin for once-daily use for type 1 and 2 diabetes. When it is time to begin insulin, Levemir® provides glucose control with a favourable weight profile. Weight maintenance is important because insulin has long been associated with weight gain, a barrier to beginning insulin treatment according to diabetes experts. Levemir® is also the first and only basal insulin analogue approved for two- to five-year-olds with diabetes |
| NovoRapid® (NovoLog® in the US), the worlds most widely used rapid-acting insulin for use at mealtimes. For people with type 2 diabetes who have uncontrolled blood glucose levels while on a basal insulin, intensification with NovoRapid® helps attain and maintain treatment goals. NovoRapid® is used by people with both type 1 and type 2 diabetes. It is also approved in some markets for women who are pregnant or breastfeeding. |
| NovoMix® 70/50/30 (NovoLog® Mix 70/30 in the US) is a dual-release modern insulin that covers both mealtime and basal requirements. It can be used either to initiate or intensify insulin therapy. |
We are committed to producing safe treatments. All of our modern insulins have been investigated in many randomised, controlled trials and in observational studies in real-life use.
New-generation insulins
Our focus on improving the lives of people with diabetes led us to develop two new-generation insulins, Degludec and DegludecPlus, which were filed for regulatory approval in key markets in 2011. These new-generation insulins are designed to have an ultra-long action for the treatment of type 1 and type 2 diabetes, providing stable and consistent blood glucose control while reducing the rate of hypoglycaemia, particularly at night when hypoglycaemic events are difficult to manage. It is known that many healthcare providers and people with diabetes intentionally undertreat to
avoid incidences of hypoglycaemia, allowing higher levels of blood glucose with the potential for health complications.
Degludec is designed to provide greater dosing flexibility, with more than 40 hours' glucose control. This flexibility can give people with diabetes the flexibility to administer once-daily treatment at a different time from day to day. DegludecPlus combines ultra-long-acting insulin degludec and the most pre- scribed rapid-acting insulin, NovoRapid®, providing both basal and mealtime glucose control.
The regulatory filings for Degludec and DegludecPlus were largely based on results from the BEGIN and BOOST clinical trial programmes. Data from the 17 trials have shown Degludec to effectively lower blood glucose levels, while demonstrating a lower rate of hypoglycaemia, particularly at night, relative to insulin glargine. In addition, Degludec will offer greater flexibility as to time of administration and, when used with FlexTouch®, can allow larger single doses than other insulin devices on the market. At present, many people need to take two injections to get their total insulin dose.
BEGIN and BOOST were the largest clinical trial programmes in the history of insulin therapy, involving nearly 10,000 people with type 1 and type 2 diabetes. The programmes were designed after consulting with regulatory agencies in the EU, Japan and the US.
Innovative early treatment
Victoza®, or liraglutide, is the first and only human Glucagon-Like Peptide (GLP-1) analogue with 97% similarity to the natural gut hormone. Like natural GLP-1, once-daily Victoza® works by stimulating the beta cells in the pancreas to release insulin only when blood sugar levels are high.
Until recently, most available treatments for diabetes involved trade-offs for physicians and people with diabetes. While effective at lowering blood glucose, they carried a high risk of inducing low blood sugar episodes (hypoglycaemia) and weight gain.
GLP-1 therapies are a major innovation in the treatment of type 2 diabetes because they lower glucose while having a very low risk of triggering hypoglycaemia, and, for most people with diabetes, they also support weight loss. In type 2 diabetes, the ability of the pancreas to release insulin in response to glucose is impaired. GLP-1 therapies help address this defect by acting directly on beta cells in the pancreas so that more insulin is released when blood glucose is high.
Victoza®, the only once-daily GLP-1 analogue, can be used by adults with type 2 diabetes who are unable to achieve blood glucose goals with lifestyle changes and metformin. For most people with type 2 diabetes, Victoza® offers significant blood glucose reduction with the benefit of some weight loss in a flexible dose that can be taken once daily. Treatment guidelines now call for the use of GLP-1 as an option for early treatment of type 2 diabetes.
Victoza® is the leading GLP-1 treatment globally and has steadily expanded the market for GLP-1 treatment. Now available in nearly 50 markets, Victoza® was also approved for use in China during 2011. Victoza® achieved blockbuster status in 2011 with sales of more than 1 billion US dollars globally. It has been used to treat approximately 600,000 people worldwide.
Novo Nordisk Annual Report 2011 33
Diabetes care |
We are exploring longer-acting formulations for GLP-1 treatment. Liraglutide depot, a slow-release formulation, is being tested for once-weekly use in phase 1 clinical trials. We are also exploring the GLP-1 analogue semaglutide for once-weekly use. For more information, see pp 2627. Device technology supports innovative treatments We continue to focus on making the most preferred treatment devices even better. FlexTouch®, our latest innovation in prefilled devices, which has been designed to improve the experience of performing daily injections, was launched in Europe in 2011. We intend to make Degludec and DegludecPlus available in FlexTouch®, the first insulin pen that will have the potential to deliver up to 160 insulin units in a single injection. Usability studies have shown that FlexTouch® features are valued by patients and healthcare providers. FlexTouch® has a conical shape, which is more ergonomic and may help to improve stability when injecting. Patients especially appreciate that FlexTouch® is the first insulin pen with no push-button extension. FlexTouch® also has an easy-touch button, a large, easy-to-read scale, accurate and consistent dosing, and an audible click that provides a signal when dialling doses up or down or when the full dose has been administered.7,8,9 FlexPen®, the worlds most widely used prefilled insulin pen, is available for all Novo Nordisk modern insulins and Victoza®. It eliminates the need to manually load treatment into a delivery device or use a separate vial and syringe. A global commitment to people with diabetes Changing Diabetes® is Novo Nordisks global commitment to improve conditions for the millions of people who live with diabetes around the world today, and those who are at risk of developing diabetes tomorrow. It is a global advocacy and partner platform from which we advocate the prevention and earlier detection of diabetes, as well as improved treatment, care and health outcomes. It is also the framework for a series of partnership programmes for interventions and outreach activities, many of which address the specific needs of vulnerable groups such as those with low incomes, women and children. 2011 marked a turning point in our fight against diabetes when the United Nations convened a special General Assembly to address the global challenge of non-communicable diseases, including diabetes. Novo Nordisk, represented by President and CEO Lars Rebien Sørensen, participated in this historic event, which highlighted the serious threat non-communicable diseases present to global social and economic development, and the need for concerted action. We welcome and support the call to action resulting from the meeting and have reaffirmed our commitment to continue our long-term efforts to change diabetes through partnerships. |
Concerted action to improve access to diabetes care Ahead of the UN High-Level Meeting, we revisited our access to health strategy in consultation with key stakeholders, notably the World Health Organization, representing different viewpoints, insights and regional perspectives. Ten years ago, Novo Nordisk launched its first Access to Health strategy, which resulted in the establishment of the independent World Diabetes Foundation, our differential pricing policy in least developed countries, initiatives to improve healthcare capacity and efforts aimed at vulnerable population groups, such as the Changing Diabetes® in Children programme and the Changing Diabetes® in Pregnancy programme. Our insights from the past 10 years were captured in a report released in 2011, Access to Diabetes Care Our Approach. While our stakeholders recognise that Novo Nordisk has done much to improve access to diabetes care in the least developed countries of the world, the lack of access to insulin remains a significant concern. Dialogues with stakeholders have helped inform our priorities going forward with a better understanding of where to strengthen our efforts. See novonordisk.com/sustainability. Our commitment to discover and develop innovative biological medicines and make them accessible to patients throughout the world is part of the Novo Nordisk Way. Because healthcare systems are at different stages of development, different solutions are needed in different countries. Novo Nordisk has the unique advantage of the broadest portfolio of diabetes treatments. We have also committed to keeping low-priced insulin as a key building block of our portfolio and making it available in low- and middle-income countries. Access to diabetes care is a global concern and this will be the premise for our access to diabetes care strategy. Many barriers to insulin access are linked to distribution systems, tendering and government policies. As part of our efforts to find an innovative, integrated approach to diagnosis, treatment and diabetes control for those at the base of the economic pyramid, we launched a pilot project in Kenya in December 2011. A public-private partnership involving the Kenyan government and other stakeholders, the project seeks to reduce direct and indirect costs of treatment by limiting price mark-ups in the supply chain and reducing travel costs and lost work days by printing prices on insulin packaging and distributing insulin at more locations. In our search for a sustainable business model for the base of the pyramid, additional projects will be launched in 2012 in rural India and Nigeria. To improve access to affordable insulin, Novo Nordisk has conducted pilot projects in eight least developed countries and recruited staff to address barriers in supply chains. Another priority is to strengthen the capacity of healthcare systems by training healthcare providers to diagnose and treat diabetes and its complications. In 2011, Novo Nordisk either trained or sponsored training for about 835,000 healthcare providers. To empower people with diabetes to better care for themselves, in 2011 we also trained or funded training for about 626,000 people. In our efforts to strengthen healthcare system capacity, Novo Nordisk established the World Diabetes Foundation in 2002. This independent and non-profit foundation supports the prevention and treatment of diabetes where it is needed most, providing funding for local initiatives that improve healthcare system |
34 Novo Nordisk Annual Report 2011
Diabetes care |
capacity. To date it has supported 278 projects in 100 countries. We contribute a portion of our insulin sales to the Foundation each year, in line with an agreement with our shareholders. These contributions totalled 606 million Danish kroner during the period from 2002 to 2011. In financial terms, this is our biggest single commitment to the improvement of diabetes care in low- and middle-income countries. Novo Nordisk also has two seats on the Foundations board. See pp 9 and 86 for more information.
Better treatment and care for all
The 2011 UN High-Level Meeting concluded in a UN Declaration that calls attention to the threat diabetes and other chronic con- ditions pose, and stresses the need for prevention, early detection and early intervention. This focus is in line with our long-term efforts to increase awareness of diabetes among policymakers. We are committed to engaging with stakeholders to explore how the UN Declaration can be translated into concrete action to achieve this objective.
Through 87 Diabetes Leadership Forums and regional or national roundtables in 78 countries since 2005, we have engaged more than 10,000 key stakeholders to date, helping to reach consensus about what it will take to address the current challenges and change diabetes. During 2012, the European Diabetes Leadership Forum will be held in Copenhagen under the auspices of the Danish EU Presidency. The event will be hosted by the Danish Diabetes Association and the OECD, and Novo Nordisk will co-organise the Forum. We will also continue our efforts to follow up on previous leadership forums in Russia, China, sub-Saharan Africa, the Middle East and North Africa, all of which involve commitments to action that will benefit people with diabetes.
Through our national Changing Diabetes® programmes, we promote better education of healthcare professionals and wider availability of screening for diabetes to help save lives and reduce long-term economic costs. One example is our Ask.Screen.Know initiative in the US, which supports diabetes screening for people in the USs Medicare programme who are at risk of diabetes. It is estimated that only 10% of people with risk factors have been screened since Medicare began offering screenings in 2005. We encourage physicians to have at-risk patients screened and to talk with their patients about blood sugar numbers and healthy lifestyle changes. See AskScreenKnow.com and the Ask.Screen. Know page on Facebook.
Understanding the needs of people with diabetes is a cornerstone of our advocacy work. The second Diabetes Attitudes, Wishes and Needs (DAWN) study represents one of the most significant new initiatives from Novo Nordisk to learn from people with diabetes and those who care for them. It is a follow-up to our landmark study in 2001 to assess the needs of people with diabetes globally, with the aim of improving patient involvement, self-management and psychosocial support. The largest study of its kind, the new DAWN study will involve more than 16,000 people worldwide to establish a new understanding and awareness of the needs of people with diabetes and those who care for them.
Working in partnership across healthcare systems
Most developing countries have no facilities for treating children with diabetes. Children with type 1 diabetes have high mortality rates, with life expectancies of less than one year in some countries in sub-Saharan Africa. Our Changing Diabetes® in Children programme provides the necessary medical and laboratory equipment, organises training of healthcare professionals, puts in place patient education and creates systems for adequate monitoring and follow-up. In addition, insulin and diabetes supplies are provided free of charge for the duration of the programme. With the ambition of reaching 10,000 children with diabetes within five years, we made a 25 million US dollar commitment in 2008.
In 2011, we expanded the programme to India and Ethiopia, enrolled about 3,400 children and established more than 40 new clinics under the Changing Diabetes® in Children programme, which now provides treatment for about 5,000 children.
As part of our contribution to the UN Secretary Generals Every Woman Every Child programme, Novo Nordisk has launched its Early Origins of Health initiative with the aim of preventing future cases of diabetes through screening and treatment of gestational diabetes. The initiative is based on partnerships with industry peers, the World Diabetes Foundation and the United Nations Foundation where each will contribute their expertise in the field of health literacy, nutrition, research, access to health, and connecting people, ideas and resources.
Our ongoing Changing Diabetes® in Pregnancy programme ties to the Early Origins of Health initiative. We have set up local publicprivate partnerships in India, Colombia and Nicaragua with an ambition to reach 60,000 pregnant women. We work with local health authorities and other partners to train healthcare professionals, build capacity in the health system for gestational diabetes screening and management, and test innovative ways to effect lifestyle change. The hope is to identify cost-effective ways of reducing the burden of diabetes.
1. | Global Attitudes of Patients and Physicians in Insulin Therapy (GAPP) survey, Novo Nordisk, 2010. |
2. | UKPDS, Stratten et al. BMJ 2000; vol 321:405412. |
3. | Fong DS, Aiello LP, Ferris FL 3rd, Klein R: Diabetic retinopathy. Diabetes Care 2001; 27:25402553. |
4. | International Diabetes Foundation. IDF Diabetes Atlas, fifth edition, 2011. |
5. | Hart JT. Rule of halves: implications of increasing diagnosis and reducing dropout for future workload and prescribing costs in primary care. Br J Gen Pract 1992, March; 42(356):116119. |
6. | Wilkerson HL, Krall LP. Diabetes in a New England town. JAMA 1947;135:209-246. |
7. | Wielandt JO, Niemeyer M, Hansen MR, Bucher D, Thomsen NB. FlexTouch®: A Prefilled Insulin Pen with a Novel Injection Mechanism with Consistent High Accuracy at Low- (1 U), Medium- (40 U), and High- (80 U) Dose Settings. J Diabetes Sci Technol 2011; 5(5):11951199. |
8. | Dyer D, Narendran P, Qvist M, Niemeyer M, Nadeau DA. Ease of use and preference assessment of a new prefilled insulin pen versus a widely available prefilled insulin pen in people with diabetes, physicians and nurses. Expert Opin Drug Deliv 2011; doi:10.1517/17425 247.2011.615830. |
9. | Bailey T, Thurman J, Niemeyer M, Schmeisl G. Usability and preference evaluation of a prefilled insulin pen with a novel injection mechanism. Curr Med Res Opin 2011; 27:204352. |
Novo Nordisk Annual Report 2011 35
Biopharmaceuticals |
ALFRED MONAMETSI
Alfred, from Johannesburg, South Africa, was diagnosed with haemophilia at birth and has been more mobile since beginning to use NovoSeven®. As a pastor and certified coach, being able to get out into the community is an important part of doing what Alfred loves: helping people. He hopes that future improvements in treatment will make it even easier for people with haemophilia to lead normal lives.
36 Novo Nordisk Annual Report 2011
Biopharmaceuticals |
Biopharmaceuticals
We use our understanding of chronic conditions to make a difference for people with haemophilia and other rare bleeding disorders, growth hormone disorders, symptoms of menopause and inflammatory diseases. Our specialised expertise in proteins gives us an advantage in developing innovative treatments in these therapy areas.
We see a future where all people with haemophilia have the opportunity to live the life they desire. Our commitment to haemophilia builds on our 20 years of research into bleeding disorders and our promise to work with and listen to patients to improve treatment. For details of our strategy to achieve our haemophilia ambition, see p 19.
We developed our recombinant, activated factor VII product, NovoSeven®, for the 3,500 people with haemophilia who have developed inhibitors, or neutralising antibodies, to their normal treatment. NovoSeven® provides effective treatment for bleeding episodes. It was a significant innovation when launched in 1996 and remains the only room temperature-stable recombinant bypassing agent available for people who have haemophilia with inhibitors.
NovoSeven® is also the only recombinant medication approved for the treatment of bleeding episodes in acquired haemophilia, factor VII deficiency and, in Europe, Glanzmanns thrombasthenia. Thanks to its therapeutic properties, 15 years after launch NovoSeven® achieved sales growth of 4% in Danish kroner. We are continuing to look for ways to make treatment for people with haemophilia with inhibitors even more effective.
To support our ambition and also help people with general haemophilia, we have developed the broadest pipeline of haemophilia research and development projects in the pharmaceutical industry, including treatments for haemophilia A and B. See p 38.
As we seek to expand our portfolio and achieve leadership in the treatment of haemophilia, we are developing compounds targeting faster, more efficient long-acting and even subcutaneous (as opposed to intravenous) prevention and treatment of bleeding. During 2011, we made significant progress in the development of solutions for the range of haemophilia and other rare bleeding disorders. See pp 19 and 2627.
Key events in biopharmaceuticals | |
| Phase 3 trial programme completed for recombinant factor VIII treatment for haemophilia A. |
| Phase 3 trial programme initiated for long-acting recombinant treatment for people with haemophilia B. |
| Phase 3 trial programme initiated for a fast-acting recombinant treatment for haemophilia with inhibitors. |
| Phase 1 trial completed for long-acting recombinant treatment for people with haemophilia A. Decision made to initiate a phase 3 trial in 2012. |
| Regulatory approval sought in the US and Europe for the only recombinant treatment for ultra-rare congenital factor XIII deficiency. |
| Phase 1 trial initiated for long-acting growth hormone formulation. |
Novo Nordisk aspires to offer treatment for all people with haemophilia
Source: Stonebraker JS et al. Haemophilia 2010; 16:2032. Haemophilia A and B patients represent those characterised as severe.
Novo Nordisk Annual Report 2011 37
Biopharmaceuticals |
38 Novo Nordisk Annual Report 2011
Biopharmaceuticals |
Expanding access to care
We partner with physicians, policymakers and the wider haemophilia community to secure optimal care for people affected by haemophilia globally.
To give surgical teams an understanding of options for managing necessary surgical procedures for people with haemophilia, we launched an ongoing training programme in 2009. People with haemophilia may suffer joint damage from repeated bleeds. Joint replacement may end chronic pain, but there are special challenges in performing surgery on people with haemophilia with inhibitors. Four-day training programmes are being held at haemophilia centres worldwide, with each session accommodating up to four surgical teams.
We
partner with the haemophilia community to deliver access to care and empower patients. |
Our commitment to the global haemophilia community includes efforts to close the gap in care between developed and developing countries. We established the non-profit Novo Nordisk Haemophilia Foundation (NNHF) in 2005 to address the significant need to improve access to care and treatment in developing countries. An estimated 75% of the global population of people with haemophilia and other rare bleeding disorders live in the developing world, and many go undiagnosed or receive inadequate care and treatment. Without adequate care, quality of life and life expectancy are often significantly reduced.
Our donations to the NNHF, totalling 90 million Danish kroner from 2005 to 2011, support projects and fellowships in 33 developing and emerging countries. NNHF programmes improve access to care by focusing on capacity building, awareness creation and diagnosis and registries. By working with partners across all areas of the haemophilia and allied bleeding disorder community with local ownership of projects, the NNHF aims to ensure the sustainability of development programmes. See nnhf.org for more information.
As a focused healthcare company, we consider our core strengths in protein engineering and chronic disease treatment when
determining which therapy areas to enter. We also assess the potential for global market leadership.
Growth hormone therapy
Through our 40-year commitment to growth hormone therapy and our expertise in protein molecules, we have become one of the worlds leading producers of human growth hormone. Growth hormone deficiency is due to a defect in the pituitary gland at the base of the brain. If the pituitary gland does not produce enough growth hormone, growth is slower than normal. Children need growth hormone to grow to normal height. In adults, growth hormone is needed to maintain the proper amounts of body fat, muscle and bone to reduce metabolic complications and maintain a good quality of life.
Norditropin® is the only liquid growth hormone product with a formulation that does not require refrigeration after first use and is available in a prefilled, ready-to-use device.1 Although Norditropin® is a man-made form of growth hormone, it is identical to growth hormone produced by the body. Norditropin® is approved for the treatment of certain growth hormone deficiencies in children and adults. In some markets, it is approved to help children of short stature as a result of Noonan syndrome or Turner syndrome grow taller. Research shows that children of short stature may be more likely to experience difficulty at school, while adults with growth hormone deficiency may have below-average health-related quality of life.
Our commitment to growth hormone therapy includes development of a long-acting formulation, which is currently in phase 1 clinical trials. One example of our ongoing efforts to build upon scientific research to improve patient care is the NordiNet® International Outcome Study, an electronic patient data registry intended for endocrinologists. We also engage in activities to raise awareness of the need for diagnosis and treatment of growth hormone disorders among general health practitioners.
We have drawn on our technological expertise in injection devices to improve growth hormone delivery systems and products. In 2011, we launched a new prefilled device, Norditropin® FlexPro®, in Australia. Norditropin® FlexPro® was first launched in 2010 in Europe, Japan and the US. Its features include an easy-touch dose button and an audible click, which lets the user know when the full dose has been delivered. The pen is also shorter, with the intention to make it easier to hold and handle for both children and adults.
Hormone replacement therapy
Our market-leading hormone therapy products Vagifem® and Activelle® (Activella® in the US) build on our 35 years of experience with hormone treatment for menopausal symptoms. Vagifem® 10 µg, the lowest effective dose available for the local treatment of vaginal atrophy, was launched in Spain, Finland and Norway during 2011.
Our long-standing position is that hormone replacement therapy for women should be prescribed at the lowest effective dose and for a time period consistent with treatment goals and assessed risks.
1. | Only the 5 µg and 10 µg sizes are room temperature-stable. All Norditropin® products must be refrigerated prior to first use. Do not freeze. After initial use, FlexPro® 5 mg/1.5 ml and 10 mg/1.5 ml delivery pens can either be stored outside the refrigerator (at up to 25°C or 77°F) for use within three weeks, or in the refrigerator (between 36°F and 46°F) for use within four weeks. The FlexPro® 15 mg/1.5 ml and NordiFlex® 30 mg/3 ml delivery pens must always be refrigerated (between 36°F and 46°F) both prior to and after the initial injection for use within four weeks. |
Novo Nordisk Annual Report 2011 39
Governance, remuneration and leadership |
NANCY SHAMMOUT
For Nancy, a diabetes product specialist in Amman, Jordan, working for Novo Nordisk means being a part of improving life for people with diabetes. She works with healthcare providers and patients in Jordan to improve awareness of modern insulins and how they can improve glucose control.
40 Novo Nordisk Annual Report 2011
Governance, remuneration and leadership |
Novo Nordisk seeks to create sustainable value and our corporate governance framework is designed to support this. While our corporate governance framework complies with applicable laws and requirements, it is designed specifically for Novo Nordisk.
Framework
The Novo Nordisk Way forms the foundation of our internal values-based framework, with values that are consistent with the principles of good governance. Our corporate governance framework aligns with internal principles as well as external regulations and codes. This includes compliance with applicable securities laws and corporate governance standards in Denmark and the US, including the Danish Corporate Governance Recommendations.
The values of the Novo Nordisk Way reflect the shared values of the Novo Group, of which Novo Nordisk is a member. The holding company of the Novo Group is Novo A/S, a Danish limited liability company wholly owned by the Novo Nordisk Foundation, a commercial foundation. See novonordiskfonden.dk.
Our
corporate governance framework supports sustainable value creation. |
Novo Nordisk adheres to the Charter for Companies in the Novo Group, which is available online at novo.dk. However, all strategic and operational matters are solely decided by the Board and Management of Novo Nordisk.
Governance structure
Our company holds itself accountable to shareholders for its performance. We seek to enhance the accuracy, completeness and reliability of the information provided in annual reporting through internal controls, assurance and independent audits. Reporting helps shareholders assess the actions of the Board and Management.
Shareholders
Novo Nordisks share
capital is divided into A shares and B shares. All A shares are held by Novo
A/S, which also holds B shares, as reported on p 53. The B shares are traded
on NASDAQ OMX Copenhagen and in the form of ADRs on the New York Stock Exchange.
Each A share (nominal value 1 Danish krone) carries 1,000 votes and each B
share (nominal value 1 Danish krone) carries 100 votes. Special rights attached
to A shares include pre-emptive subscription rights in the event of an increase
of the A share capital and pre-emptive purchase rights in the event of a sale
of A shares and priority dividend if the dividend is below 0.5%, while B shares
take priority for dividends between 0.5% and 5% and for winding-up proceedings.
Shareholders have ultimate authority over the company and exercise their right to make decisions at general meetings in person, by proxy or by correspondence. Resolutions can generally be passed by a simple majority. However, resolutions to amend the Articles of Association require two-thirds of votes cast and capital represented, unless other adoption requirements are imposed by the Danish Companies Act. We are not aware of the existence of any agreements with or between shareholders on the exercise of votes or control.
At the annual general meeting, shareholders approve the annual report and any amendments to the companys Articles of Association. Shareholders also elect board members and the independent auditor.
The Board has decided that general meetings should be conducted by physical attendance. Shareholders may, however, vote by proxy or correspondence, either electronically or by mail. The meeting is webcast and can be viewed online at novonordisk.com.
General meetings must be called with three to five weeks notice. The meeting agenda is sent out with a combined proxy and voting form, allowing shareholders to vote on each agenda item separately. A shareholders right to attend and vote at a general meeting is determined by shares owned as of the record date, which is one week prior to the general meeting. All shareholders may, no later than six weeks prior to the general meeting, request that proposals for resolution be included on the agenda. The deadline for applying for an admission card to a general meeting is no later than three days prior to the general meeting. All documents relating to general meetings are published on Novo Nordisks website at least three weeks prior to the event.
Board
of Directors
The company has a two-tier
board structure consisting of the Board of Directors and Executive Management.
The two bodies are separate and no one serves as a member of both. On behalf
of shareholders, the Board determines the companys overall strategy
and actively contributes to developing the company as a focused, sustainable,
global pharmaceutical company. The Board supervises Executive Management in
its decisions and operations. It may also issue new shares or buy back shares
in accordance with authorisations granted by the general meeting and recorded
in the meeting minutes. For minutes from the general meeting, see novonordisk.com/about_us.
The Board has 12 members, eight of whom are elected by shareholders at general meetings and four by employees in Denmark. Shareholder-elected board members serve a one-year term and may be re-elected. Members must retire at the first general meeting after reaching the age of 70. The majority of the shareholder-elected board members, five out of eight, are independent as defined by the Danish Corporate Governance Recommendations. See p 50.
A proposal for nomination of board members is presented by the Chairmanship to the Board, taking into account required competences as defined by the Boards competence profile, and reflecting the result of a self-assessment process facilitated in some years by external consultants. The assessment process is based on written questionnaires and evaluates the Boards composition and the skills of its members, including whether each board member and executive participates actively in board discussions and contributes with independent judgement.
Novo Nordisk Annual Report 2011 41
Governance, remuneration and leadership |
The self-assessment and the Boards competence profile are used in the nomination process. The competence profile was significantly revised in 2011 to include special competences relating to the chairmanship, aspirations regarding Board diversity and a 12-year guiding principle on Board tenure.
To ensure that discussions include multiple perspectives representing the complex, global pharmaceutical environment, the Board aspires to be diverse in gender and nationality. Currently, about 40% of the Board is either female or a citizen of a country other than Novo Nordisks home market. Half of the shareholder-elected board members are non-Danes. While the Board is 8% female, no shareholder-elected board members are female.
The self-assessment conducted in 2011 resulted in enhancements in the succession process and preparedness as well as improvements to nomination criteria for new board members. In order to support continued fulfilment of the Novo Nordisk Way, criteria for board members include integrity, accountability, financial literacy and desire for innovation. Members are also expected to have experience managing major companies that develop, manufacture and market products and services globally. The competence profile, which includes nomination criteria, is available online at novonordisk.com/about_us.
Under Danish law, Novo Nordisks employees in Denmark are entitled to be represented by half of the total number of board members elected at the general meeting. In 2010, employees elected four board members from among themselves. Board members elected by employees serve a four-year term and have the same rights, duties and responsibilities as shareholder-elected board members.
The Board met seven times during 2011. Four meetings were attended by all board members; three of the members were excused from attending one meeting each during the year. With the exception of agenda items reserved for the Boards internal discussion at each meeting, executives attend and may speak, without voting rights, at board meetings to ensure that the Board is adequately informed of the companys operations. Executives provide regular feedback from meetings with investors to give board members an insight into major shareholders views of the company.
Chairmanship
The annual general
meeting directly elects the chairman and the vice chairman. In 2011, the
Chairmanship held seven meetings and both members attended all meetings.
The Chairmanship carries out administrative tasks such as planning board meetings to ensure a balance between overall strategy setting and financial and managerial supervision of the company. It also reviews the fixed asset investment portfolio. Other tasks include recommending the remuneration of directors and executives, and suggesting candidates for election by the general meeting.
In practice, the Chairmanship has the roles and responsibilities of a nomination committee and a remuneration committee, and presents proposals to the Board. The Board has not established separate committees, believing that each board member must have the opportunity to contribute actively to discussions and have access to all relevant information about remuneration and nomination.
In March 2011, the annual general meeting elected Sten Scheibye as chairman and Göran A Ando as vice chairman. See novonordisk. com/about_us for a detailed report on the Chairmanships activities.
Ad
hoc nomination team
To enhance focus on
the succession preparedness of the Board and of Executive Management,
an ad hoc nomination team, consisting of the Chairmanship plus Jørgen
Wedel and Henrik Gürtler, was established to prepare the Board's
discussions regarding nomination of board members and succession in Executive
Management. This team served throughout 2011 but is not intended to be
a permanent committee of the Board.
Audit
Committee
The three members of
the Audit Committee are elected by the Board from among its members. All
members qualify as independent and have been designated as financial experts
as defined by the US Securities and Exchange Commission (SEC). Under Danish
law, all members qualify as financial experts and two of the members also
qualify as independent. In 2011, the Audit Committee held four meetings,
attended by all members.
The Audit Committee assists the Board of Directors with oversight of the external auditors, the internal audit function, complaints regarding fraud or violations of ethics, values or quality controls, the financial and non-financial reporting process and post-investment reviews. The Audit Committee conducts a self-assessment annually, evaluating whether each member participates actively in discussions and contributes with independent judgement. In March 2011, the Board re-elected Kurt Anker Nielsen as chairman and re-elected Jørgen Wedel and Hannu Ryöppönen as members of the Audit Committee. See novonordisk.com/about_us for a detailed report on the Audit Committees activities.
Possible
business ethics misconduct may be raised through the global compliance hotline. |
Concerns regarding possible breaches of business ethics or financial fraud, violations of the Novo Nordisk Way or quality lapses may be raised anonymously by employees and other stakeholders through the global compliance hotline. Complaints made through the compliance hotline are received by the Audit Committee Secretariat. Complaint handling is monitored by the Chairmanship or the Audit Committee, depending on the nature of the complaint. As such the hotline works independently of Executive Management. The compliance hotline is accessible by telephone and online in nine languages.
Novo Nordisks risk management and internal controls in relation to financial processes are designed to effectively control the risk of material misstatements. A detailed description of the internal controls and risk management system implemented in relation to financial reporting processes is available at novonordisk.com/ about_us. Novo Nordisk is in compliance with US SarbanesOxley Act section 404, which requires Novo Nordisk to design and implement an adequate system of internal controls over financial reporting processes to ensure that there are no material mis-statements in the financial reporting. The companys conclusion and the auditors evaluation of the internal controls over financial
42 Novo Nordisk Annual Report 2011
Governance, remuneration and leadership |
reporting are included in its Form 20-F filing to the US Securities and Exchange Commission. Executive
Management Assurance External
audit |
Internal
audit To ensure that the internal financial audit function works independently of Management, its charter, audit plan and budget are approved by the Audit Committee. The Audit Committee must approve the appointment, remuneration and dismissal of the head of the internal audit function. Three other types of internal audit quality audits, organisational audits and values audits, called facilitations help ensure that the organisation adheres to high quality standards and operates in accordance with the Novo Nordisk Way. For information on facilitations see pp 10 and 17. |
Corporate governance codes and practices
The applicable corporate governance codes for each stock exchange and a review of Novo Nordisk's compliance are available at novonordisk.com/about_us. In accordance with Section 107b of the Danish Financial Statements Act, Novo Nordisk has disclosed the mandatory corporate governance report at novonordisk.com/about_us/corporate_governance/ compliance.asp.
Novo Nordisk follows the
majority of the Danish Corporate Governance Recommendations, but does not
conform in the following ways:
| The Board does not have a remuneration committee. |
| The Board does not have a nomination committee (as defined by the Danish Corporate Governance Recommendations). |
| Existing executive employment contracts allow for severance payments of more than 24 months' fixed base salary plus pension contribution. |
Explanations of deviations from these recommendations are given on pp 42 and 47.
As a foreign listed private
issuer, Novo Nordisk is in compliance with the corporate governance standards
of the New York Stock Exchange, where Novo Nordisk's ADRs are listed.
Novo Nordisk Annual Report 2011 43
Governance, remuneration and leadership |
In keeping with our aim to attract, retain and motivate talented individuals, remuneration at Novo Nordisk is designed to be competitive. For executives and employees, remuneration rewards short- and long-term performance and is aligned with the interest of the shareholders. Novo Nordisks remuneration principles provide guidance for remuneration of the Board and Executive Management. The principles are online at novonordisk.com/about_us. Remuneration is assessed on an annual basis against a benchmark of Scandinavian companies and European pharmaceutical companies that are similar to Novo Nordisk in size and complexity in accordance with the remuneration principles for the Board of Directors and Executive Management. The results of the annual remuneration bench marking for board members are presented to the Board by the chairman at its October meeting. At the 2012 annual general meeting a proposal will be made to align the remuneration benchmarks for the Board and Executive Management. Board of Directors remuneration The remuneration of the Board of Directors is comprised of a fixed base fee, a multiplier of the fixed base fee for the Chairmanship and members of the Audit Committee, fees for ad hoc tasks and a travel allowance. At the December meeting, the Board agrees on recommendations for remuneration levels for the next financial year. In connection with the approval of the annual report, the Board endorses the actual remuneration for the past financial year and the recommendation on remuneration levels for the current financial |
year. This is then presented to the annual general meeting for approval. Based on the benchmark assessment in October 2010, the Board determined that, in order to continue to attract and retain talented board members, it would be appropriate to make an adjustment to the annual fixed base fee paid to each board member. As a consequence, the Board proposed to the 2011 annual general meeting an adjustment of the fixed base fee to 500,000 Danish kroner, and this was approved. The benchmark assessment also led the Board to propose to the annual general meeting that the chairman receive 3.0 times the base fee and the vice chairman and the audit committee chairman receive 2.0 times the base fee. The proposal for other members of the audit committee was 1.5 times the base fee. These proposals were approved by the 2011 annual general meeting. Travel
and other expenses Variable
remuneration |
|
|
|
|
Board of Directors | ||
In 2011, the base fee for members of the Board of Directors was DKK 500,000 (DKK 400,000 in 2010). | ||
20111 | 2010 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
DKK
million
|
Fixed
base fee |
Fee
for
ad hoc tasks and committee work2 |
Travel
allowance |
Total
|
Fixed
base fee |
Fee
for
ad hoc tasks and committee work2 |
Travel
allowance |
Total
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Sten Scheibye (chairman of the Board) | 1.5 | | | 1.5 | 1.0 | | | 1.0 | |||||||||
Göran A Ando (vice chairman of the Board) | 1.0 | 0.1 | 0.1 | 1.2 | 0.6 | 0.3 | 0.1 | 1.0 | |||||||||
Kurt Anker Nielsen (chairman of the Audit Committee) | 0.5 | 0.5 | | 1.0 | 0.4 | 0.5 | | 0.9 | |||||||||
Hannu Ryöppönen (Audit Committee member) | 0.5 | 0.3 | 0.1 | 0.9 | 0.4 | 0.2 | 0.1 | 0.7 | |||||||||
Jørgen Wedel (Audit Committee member) | 0.5 | 0.3 | 0.3 | 1.1 | 0.4 | 0.2 | 0.1 | 0.7 | |||||||||
Bruno Angelici3 | 0.4 | | 0.1 | 0.5 | | | | | |||||||||
Henrik Gürtler | 0.5 | | | 0.5 | 0.4 | | | 0.4 | |||||||||
Johnny Henriksen4 | | | | | 0.1 | | | 0.1 | |||||||||
Ulrik Hjulmand-Lassen | 0.5 | | | 0.5 | 0.3 | | | 0.3 | |||||||||
Pamela J Kirby4 | 0.1 | | | 0.1 | 0.4 | | 0.1 | 0.5 | |||||||||
Thomas Paul Koestler3 | 0.4 | | 0.2 | 0.6 | | | | | |||||||||
Anne Marie Kverneland | 0.5 | | | 0.5 | 0.4 | | | 0.4 | |||||||||
Søren Thuesen Pedersen | 0.5 | | | 0.5 | 0.4 | | | 0.4 | |||||||||
Stig Strøbæk | 0.5 | | | 0.5 | 0.4 | | | 0.4 | |||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Total | 7.4 | 1.2 | 0.8 | 9.4 | 5.2 | 1.2 | 0.4 | 6.8 | |||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
1. | 2011 amounts reflect changes in base payment, multiples and travel allowance approved at the 2011 general meeting.These changes were proposed based on benchmark assessments and the need to continue to attract and retain talented board members. |
2. | Ad hoc fees are for the research and development facilitator, a position that was abolished for 2011. Göran A Ando received 0.3 million Danish kroner in 2010. |
3. | First elected at the annual general meeting in March 2011. |
4. | Johnny Henriksen resigned as of March 2010. Pamela J Kirby resigned as of March 2011. |
|
|
44 Novo Nordisk Annual Report 2011
Governance, remuneration and leadership |
Executive remuneration Executive remuneration is proposed by the Chairmanship and subsequently approved by the Board. Remuneration packages for executives comprise a fixed base salary, a cash-based incentive, a share-based incentive, a pension contribution and other benefits. The split between fixed and variable remuneration is intended to result in a reasonable part of the salary being linked to performance, while promoting sound long-term business decisions to achieve the companys objectives. The aggregate maximum amount that may be granted as an incentive for a given year is currently equal to 14 months fixed base salary plus pension contribution. All incentives are subject to claw-back if it is subsequently determined that payment was based on information that was manifestly misstated. Fixed
base salary
|
Cash-based
incentive The Chairmanship of the Board evaluates the degree of achievement for each member of Executive Management based on input from the chief executive officer. Share-based
incentives Aligned with Novo Nordisks long-term financial targets, the calculation of shareholder value creation is based on reported operating profit after tax reduced by a weighted average cost of capital-based return requirement on average net operating assets. A proportion of the calculated shareholder value creation is allocated to a joint pool for the participants, who include Executive Management and senior vice presidents. The allocation to the joint pool can also be adjusted by the Board to reflect achievement of development milestones in the research and development pipeline and sustainability targets, which include long-term environmental targets, employee training objectives and company reputation objectives. Once the joint pool has been approved by the Board, the total cash amount is converted into Novo Nordisk B shares at market |
|
|
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|
Novo Nordisk Annual Report 2011 45
Governance, remuneration and leadership |
Executive Management and other members of the Senior Management Board
DKK
million
|
Fixed
base
salary
|
Cash-based
incentive
|
Pension
|
Other
benefits
|
Share-based
incentive
|
Total
remuneration
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 Executive Management: | ||||||||||||
Lars Rebien Sørensen | 7.3 | 3.1 | 2.7 | 0.3 | | 13.4 | ||||||
Jesper Brandgaard | 4.5 | 1.5 | 1.5 | 0.3 | | 7.8 | ||||||
Lise Kingo | 4.1 | 1.4 | 1.3 | 0.3 | | 7.1 | ||||||
Kåre Schultz | 4.9 | 1.7 | 1.7 | 0.3 | | 8.6 | ||||||
Mads Krogsgaard Thomsen | 4.5 | 1.9 | 1.5 | 0.3 | | 8.2 | ||||||
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|
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|
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|
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|
|
Executive Management in total | 25.3 | 9.6 | 8.7 | 1.5 | | 45.1 | ||||||
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|
|
|
Other members of the Senior Management Board in total1 | 70.8 | 26.3 | 22.4 | 10.8 | | 130.3 | ||||||
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|
Joint pool2 | 56.9 | 56.9 | ||||||||||
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|
|
2010 Executive Management: | ||||||||||||
Lars Rebien Sørensen | 6.6 | 2.2 | 2.2 | 0.3 | | 11.3 | ||||||
Jesper Brandgaard | 4.3 | 1.4 | 1.4 | 0.3 | | 7.4 | ||||||
Lise Kingo | 3.9 | 1.3 | 1.3 | 0.3 | | 6.8 | ||||||
Kåre Schultz | 4.7 | 1.6 | 1.7 | 0.3 | | 8.3 | ||||||
Mads Krogsgaard Thomsen | 4.3 | 1.4 | 1.4 | 0.3 | | 7.4 | ||||||
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|
Executive Management in total | 23.8 | 7.9 | 8.0 | 1.5 | | 41.2 | ||||||
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|
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|
Other members of the Senior Management Board in total1 | 62.5 | 23.8 | 20.9 | 10.3 | | 117.5 | ||||||
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|
|
|
|
|
|
|
|
|
Joint pool2 | 64.3 | 64.3 | ||||||||||
|
|
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|
|
|
|
|
|
|
|
|
|
1. | The total remuneration for 2011 includes remuneration to 26 (24 in 2010) senior vice presidents, one (three in 2010) of whom retired or left the company. The 2011 remuneration for one retiring, senior vice president (three in 2010) is included in the table above, whereas a settlement of 5 million Danish kroner (25 million Danish kroner in 2010) is not included. |
2. | The joint pool is locked up for three years before it is transferred to the participants employed at the end of the three-year period. The value is the cash amount of the share bonus granted in the year using the grant-date market value of Novo Nordisk B shares. Based on the split of participants at the time of establishment of the joint pool, approximately 30% of the pool will be allocated to the members of Executive Management and 70% to other members of the Senior Management Board (2010: 30% and 70% respectively). In the lock-up period, the joint pool may potentially be reduced in the event of lower-than-planned value creation in subsequent years. |
Managements long-term incentive programme
The shares allocated to the joint pool for 2008 (166,302 shares) were released to the individual participants subsequent to the approval of the Annual Report 2011 by the Board of Directors and the announcement on 2 February 2012 of 2011 full year financial results. Based on the share price at the end of 2011, the value of the released shares is as follows:
Value
as at 31 December 2011 of shares released 2 February 2012
|
Number
of shares |
Market
value1 (DKK million) |
||
|
|
|
|
|
Executive Management: | ||||
Lars Rebien Sørensen |
15,578
|
10.2 | ||
Jesper Brandgaard |
10,381
|
6.9 | ||
Lise Kingo |
10,381
|
6.9 | ||
Kåre Schultz |
10,381
|
6.9 | ||
Mads Krogsgaard Thomsen |
10,381
|
6.9 | ||
|
|
|
|
|
Executive Management in total |
57,102
|
37.8 | ||
|
|
|
|
|
Other members of the Senior Management Board in total2 |
98,820
|
65.2 | ||
|
|
|
|
|
1. | The market value of the shares released in 2011 is based on the Novo Nordisk B share price of 660 Danish kroner at the end of 2011. |
2. | In addition, 10,380 shares (market value: 6.9 million Danish kroner) were released to retired members of Management. |
Lars Rebien Sørensen serves as a member of the Board of Directors of Danmarks Nationalbank, from which he received remuneration of 21,841 Danish kroner in 2011 (compared with 20,000 kroner in 2010), as a member of the Board of Directors of DONG Energy A/S, from which he received remuneration of 175,000 kroner in 2011 (compared with 175,000 kroner in 2010) and as a member of the Supervisory Board of Bertelsmann AG, from which he received remuneration of 85,000 euros in 2011 (compared with 50,000 euros in 2010). As of 12 July 2011, Mr Sørensen has also served as a member of the Board of Directors of Thermo Fisher Scientific Inc, but has not received any remuneration. Jesper Brandgaard serves as chairman of the Board of Directors of SimCorp A/S, from which he received remuneration of 753,455 kroner in 2011 (compared with 794,425 kroner in 2010). Kåre Schultz serves as a member of the Board of Directors of LEGO A/S, from which he received remuneration of 300,000 kroner in 2011 (compared with 300,000 kroner in 2010). Kåre Schultz also serves as chairman of the Board of Directors of Royal Unibrew A/S, from which he received remuneration of 625,000 kroner in 2011 (compared with 156,250 kroner in 2010). Mads Krogsgaard Thomsen serves as a member of the Board of Directors of Cellartis AB, from which he received remuneration of 50,000 Swedish kroner in 2011 (50,000 kroner in 2010). |
46 Novo Nordisk Annual Report 2011
Governance, remuneration and leadership |
price, which is calculated as the average trading price on NASDAQ OMX Copenhagen in the open trading window following the release of financial results for the prior year. The shares in the joint pool are allocated to the participants on a pro rata basis: the chief executive officer has three units, executive vice presidents have two units each and senior vice presidents have one unit each.
The shares in a joint pool in any given year are locked up for three years before they are transferred to participants. If a participant resigns during the lock-up period, his or her shares will remain in the joint pool for the benefit of the other participants. In the lock-up period, the Board may remove shares from the joint pool in the event of lower-than-planned value creation. The value of the joint pool will change during the lock-up period depending on the development in the share price, aligning the interests of participants with those of shareholders.
Pension
The pension contribution
is 2530% of the fixed base salary including bonus. Pension contributions
are made to provide an opportunity for executives to build up an income for
retirement.
Remuneration
rewards short- and long-term performance. |
Other
benefits
Other benefits are added
to ensure that overall remuneration is competitive and aligned with local
practice. Executives receive non-monetary benefits such as company cars and
phones. Such benefits are approved by the Board by delegation of powers to
the Chairmanship. In addition, executives may participate in employee benefit
programmes such as employee share purchase programmes.
Severance
payment
Novo Nordisk may terminate
employment by giving executives 12 months notice. Executives may terminate
their employment by giving Novo Nordisk six months notice. In addition
to the notice period, executives are entitled to a severance payment. Existing
employment contracts allow severance payments of up to 36 months fixed
base salary plus pension contributions in the event of a merger, acquisition
or takeover of Novo Nordisk. If an executive is terminated by Novo Nordisk
for other reasons, the severance payment is three months fixed base
salary plus pension contribution per year of employment as an executive, taking
into account previous employment history.
In no event will the severance payment be less than 12 months or more than 36 months fixed base salary plus pension contribution. For new employment contracts, the severance payment will be no more than 24 months fixed base salary plus pension contribution, which will bring Novo Nordisk into alignment with the Danish Corporate Governance Recommendations in the long term.
Organisation
On a global basis, compensation packages for employees are guided by five broad principles:
| A total rewards approach In addition to a fixed base salary, incentives and benefits, non-financial remuneration such as continuing education, |
career progression and working environment are important elements of the total rewards package. | |
| Market-linked Salaries, incentives and benefits are positioned and maintained at the level required to be competitive in local markets, generally between the local market median and upper quartile. Novo Nordisk also provides adequate life insurance, healthcare and pension provisions irrespective of local competitive practice. |
| Performance-linked There is a transparent, direct link between employee performance and remuneration. Variable pay is used to reward performance, with base pay increases reflecting market conditions. |
| Transparency Clear communication of remuneration programmes is a priority, and all costs associated with compensation practices are known and publicly disclosed. |
| Flexibility Subject to corporate governance or legal requirements, flexibility is encouraged. Flexible solutions must be cost neutral to Novo Nordisk, and adequate levels of insurance must be maintained. |
Novo Nordisk Annual Report 2011 47
Governance, remuneration and leadership |
Sten
Scheibye |
||
Management duties: Trade Council of Denmark (chair), the Danish Industry Foundation (chair), the Denmark-America Foundation (chair), the Board of Governors of the Technical University of Denmark (chair), the Danish Fulbright Commission (vice chair), member of the board of Gambro AB, Sweden, Rambøll Gruppen A/S, Dades A/S, RM Rich. Müller A/S, the Rich. Müller Foundation, the Aase and Ejnar Danielsen Foundation and the Knud Højgaards Foundation. Special competences: Knowledge of the healthcare industry, particularly in relation to patients requiring chronic care, and managerial skills relating to international organisations. Education: BComm (1983) from Copenhagen Business School, Denmark, PhD in Organic Chemistry (1981) and MSc in Chemistry and Physics (1978), both from the University of Aarhus, Denmark. |
Göran
A Ando |
||
Management duties: Symphogen A/S, Denmark (chair), S*Bio Pte Ltd, Singapore (vice chair), member of the board of Novo A/S, Denmark, EDBI Pte Ltd, Singapore, EUSA Pharma, UK, Chroma Therapeutics, UK, and Molecular Partners AG, Switzerland. Scientific Advisory Board, Southwest Michigan First, US (chair), Scientific Advisory Board of Bausch & Lomb, US, and senior adviser to Essex Woodlands Health Ventures Ltd., UK. Special competences: Medical qualifications and extensive executive background within the international pharmaceutical industry. Education: Specialism in general medicine (1978) and degree in medicine (1973), both from Linköping Medical University, Sweden. |
Bruno
Angelici |
||
Management duties: Member of the board of Smiths Group plc, UK, and Wolters Kluwer, NL, member of the Global Advisory Board at Takeda Pharmaceutical Company Limited, Japan. Special competences: Extensive global experience with two companies in the fields of pharmaceuticals and medical devices |
and in-depth knowledge of strategy, sales, marketing and governance of major companies. Education: AMP (1993) from Harvard Business School and MBA (1978) from Kellogg School of Management at Northwestern University, both in the US. Law degree (1973) from Reims University and BA in Business Administration (1971) from École Supérieure de Commerce de Reims, both in France. |
Henrik
Gürtler |
||
Management duties: Novozymes A/S (chair), Copenhagen Airports A/S (chair) and COWI Holding A/S (chair), all in Denmark. Special competences: Knowledge of the Novo Groups business and its policies, and knowledge of the international biotech industry. Education: MSc in Chemical Engineering (1976) from the Technical University of Denmark. |
Ulrik
Hjulmand-Lassen |
||
Education: CISM (2011). Trained as an MCSA/IT Security (2009) and as an ISO 9001 lead auditor (2006). BSc (1985) from the Technical University of Denmark/DIA-E. |
Thomas
Paul Koestler |
||
Management duties: Member of the board of Momenta Pharmaceuticals Inc., US. Special competences: Extensive R&D knowledge, both generally and within the field of regulatory affairs. Significant know-how about the pharmaceutical industry in general and how large international corporations operate. Additional knowledge of the US market. Education: PhD in Medicine & Pathology (1982) from the Roswell Park Memorial Institute and BSc in Biology (1975) from Daemen College, both in the US. |
48 Novo Nordisk Annual Report 2011
Governance, remuneration and leadership |
Anne
Marie Kverneland |
||
Education: Degree in medical laboratory technology (1980) from the Copenhagen University Hospital, Denmark. |
Kurt
Anker Nielsen |
||
Management duties: Dalhoff Larsen & Horneman A/S (chair), Reliance A/S (chair), Collstrups Mindelegat (chair), Novozymes A/S (vice chair), and member of the board of the Novo Nordisk Foundation, Veloxis Pharmaceuticals A/S and Vestas Wind Systems A/S, all in Denmark. Chairman of the audit committees of Novozymes A/S, Veloxis Pharmaceuticals A/S and Vestas Wind Systems A/S, all in Denmark. Special competences: In-depth knowledge of Novo Nordisk A/S and its businesses, working knowledge of the global pharmaceutical industry and experience in working with accounting, financial and capital market issues. Education: MSc in Commerce and Business Administration (1972) from Copenhagen Business School, Denmark. |
Søren
Thuesen Pedersen |
||
Management duties: Member of the board of the Novo Nordisk Foundation since 2002. Education: BSc in Chemical Engineering (1988) from the Engineering Academy of Denmark. |
Hannu
Ryöppönen |
||
Management duties: Private equity funds Altor 2003 GP Limited (chair), Altor Fund II GP Limited (chair) and Altor III GP Limited (chair), all in Jersey, Rautaruukki Oyj (vice chair), member of the board of Tiimari Oyj, Neste Oil Oyj and Amer Sports Oyj, all in Finland, Korsnäs AB, Sweden, and the private equity fund |
Value Creation Investments Limited, Jersey. Chairman of the audit committees of Amer Sports Oyj and Rautaruukki Oyj and member of the audit committee of Neste Oil Oyj, all in Finland. Special competences: International executive background and thorough understanding of managing finance operations in global organisations, in particular in relation to accounting, financial and capital markets issues, but also experience in private equity and Mergers & Acquisitions (M&A). Education: BA in Business Administration (1976) from Hanken School of Economics, Helsinki, Finland. |
Stig
Strøbæk |
||
Management duties: Member of the board of the Novo Nordisk Foundation since 1998. Education: Diploma as an electrician. Diploma in further training for board members (2003) from the Danish Employees Capital Pension Fund (LD). |
Jørgen
Wedel |
||
Special
competences:
Education: MBA (1974) from the University of Wisconsin in the US and MSc in Commerce and Business Administration (1972) from Copenhagen Business School, Denmark, majoring in accounting and financing. |
Novo Nordisk Annual Report 2011 49
Governance, remuneration and leadership |
|
|
|
|
|
|
|
Name (male/female) |
First
elected
|
Term
|
Nationality
|
Date
of birth
|
Independence1
|
|
Sten Scheibye (m) |
2003
|
2012
|
Danish
|
3 Oct
1951
|
Independent
|
|
Göran A Ando (m) |
2005
|
2012
|
Swedish
|
6 Mar
1949
|
Not
independent2
|
|
Bruno Angelici (m) |
2011
|
2012
|
French
|
20
Apr 1947
|
Independent
|
|
Henrik Gürtler (m) |
2005
|
2012
|
Danish
|
11
Aug 1953
|
Not
independent2
|
|
Ulrik Hjulmand-Lassen3 (m) |
2010
|
2014
|
Danish
|
28
Apr 1962
|
Not
independent
|
|
Thomas Paul Koestler (m) |
2011
|
2012
|
American
|
11
Jun 1951
|
Independent
|
|
Anne Marie Kverneland3 (f) |
2000
|
2014
|
Danish
|
24
Jul 1956
|
Not
independent
|
|
Kurt Anker Nielsen (m) |
2000
|
2012
|
Danish
|
8 Aug
1945
|
Not
independent2,4
|
|
Søren Thuesen Pedersen3 (m) |
2006
|
2014
|
Danish
|
18
Dec 1964
|
Not
independent
|
|
Hannu Ryöppönen (m) |
2009
|
2012
|
Finnish
|
25
Mar 1952
|
Independent4,5
|
|
Stig Strøbæk3 (m) |
1998
|
2014
|
Danish
|
24
Jan 1964
|
Not
independent
|
|
Jørgen Wedel (m) |
2000
|
2012
|
Danish
|
10
Aug 1948
|
Independent4,5
|
1. | As designated by NASDAQ OMX Copenhagen in accordance with section 5.4.1 of Recommendations on Corporate Governance. |
2. | Member of Management or the Board of Novo A/S or the Novo Nordisk Foundation. |
3. | Elected by employees of Novo Nordisk. |
4. | Mr Nielsen, Mr Ryöppönen and Mr Wedel qualify as independent Audit Committee members as defined by the US Securities and Exchange Commission (SEC). |
5. | Mr Ryöppönen and Mr Wedel qualify as independent Audit Committee members as defined under part 8 of the Danish Act on Approved Auditors and Audit Firms. |
1. | Employee total includes those who work for NNE Pharmaplan A/S, NNIT A/S and Steno Diabetes Center A/S. Morten Nielsen (NNE Pharmaplan) and Per Kogut (NNIT) are also members of the Senior Management Board. |
2. | From 1 January 2012. |
50 Novo Nordisk Annual Report 2011
Governance, remuneration and leadership |
Lars
Rebien Sørensen |
||
Board positions: DONG Energy A/S and Danmarks Nationalbank, both in Denmark, Thermo Fisher Scientific Inc., US, and member of the Bertelsmann AG Supervisory Board, Germany. Education: BSc in International Economics (1983) from Copenhagen Business School, Denmark, and MSc in Forestry (1981) from the Royal Veterinary and Agricultural University (now the Faculty of Science of the University of Copenhagen), Denmark. |
Jesper
Brandgaard |
||
Board positions: SimCorp A/S (chair), NNE Pharmaplan A/S (chair) and NNIT A/S (chair), all in Denmark. Education: MBA (1995) and MSc in Economics and Auditing (1990) from Copenhagen Business School, Denmark. |
|
Lise
Kingo |
|
Board position: Steno Diabetes Center A/S (chair). Education: MSc (Hons) in Responsibility and Business Practice (2000) from the University of Bath, UK, BCom in Marketing Economics (1991) from Copenhagen Business School, Denmark, and BA in Religions and Ancient Greek Art (1986) from the University of Aarhus, Denmark. |
Kåre
Schultz |
||
Board positions: Royal Unibrew A/S (chair) and LEGO A/S, both in Denmark. Education: MSc in Economics (1987) from the University of Copenhagen, Denmark. |
Mads
Krogsgaard Thomsen Mads Krogsgaard Thomsen joined Novo Nordisk in 1991.He was appointed executive vice president and chief science officer in November 2000. He sits on the editorial boards of international journals. He is a former president of the National Academy of Technical Sciences (ATV), Denmark. Since 2000 he has served as adjunct professor of pharmacology at the Royal Veterinary and Agricultural University(now the Faculty of Science of the University of Copenhagen), Denmark. |
||
Board position: Cellartis AB, Sweden, and the University of Copenhagen, Denmark.1 Education: DSc (1991), PhD (1989) and DVM (1986) from the Royal Veterinary and Agricultural University (now the Faculty of Science of the University of Copenhagen), Denmark. |
1. From 1 January 2012.
Novo Nordisk Annual Report 2011 51
Shares and capital structure |
We aim to communicate openly with shareholders about the companys financial and operational development as well as strategies and targets. Through active dialogue, we seek to obtain fair and efficient pricing of Novo Nordisk shares.
To keep investors updated on financial and operating performance as well as the progress of clinical development programmes, Novo Nordisk hosts conference calls with Executive Management following key events and the release of financial results, which are also accessible by webcast. Executive Management and Investor Relations also travel extensively to ensure that all investors with a major holding of Novo Nordisk shares can meet with Novo Nordisk on a regular basis and that a number of smaller investors and potential investors also have access to the companys management.
Roadshows are primarily held in major European and North American financial centres. In addition, a wide range of other investor activities are held during the year. In 2011, meetings with investor groups were held in Brazil, China, Denmark, India, Switzerland and the US. Investors and analysts are also invited to join presentations of the most recent scientific results in connection with the two major scientific diabetes conferences, the American Diabetes Association and the European Association for the Study of Diabetes.
We
aim to communicate openly with shareholders about the companys financial development. |
Share
price performance
Novo Nordisks share price increased by 4.9% from its 2010
close of 629 Danish kroner to its 31 December 2011 close of 660 kroner. This
was more than the 2011 performance of the NASDAQ OMX Copenhagen 20 Index,
which decreased by 14.8% in 2011. In 2010, Novo Nordisks share price
and the NASDAQ OMX Copenhagen 20 Index increased by 89.5% and 35.6%, respectively.
In 2011, Novo Nordisks share price increased slightly less than the MSCI Europe Health Care Index, which increased by 10.0% measured in Danish kroner. Measured in US dollars, the price of Novo Nordisk B shares increased by 2.5%, which is below the dollar gain of 10% for the MSCI US Health Care Index. We believe the development of the companys share price is a reflection of our leading position in the growing diabetes care market, coupled with a continued improvement in operating performance and encouraging progress in research and development.
Factors believed to have positively contributed to share price
performance in 2011 include solid operating performance driven by strong sales growth and continuous productivity increases, which led to an improvement in the operating margin of 2.6% in 2011 up from 31.1% in 2010. Significant progress in the clinical development pipeline has also been positive for Novo Nordisk. Sales growth was driven by the successful global rollout of Victoza® and continued penetration of our modern insulins.
The regulatory submission of the two new-generation insulins, Degludec and DegludecPlus, represented a historic milestone for Novo Nordisk, and is believed to have had a positive impact on the share price. Other notable examples of progress in the clinical development pipeline included initiation of phase 3 trials for a fixed combination of insulin degludec and liraglutide, a fast-acting treatment for haemophilia patients with inhibitors, a long-acting factor IX compound for the treatment of haemophilia B, and the use of liraglutide for obesity. On the negative side Novo Nordisk experienced increased competitive pressure, especially in the US market, in the first half of 2011.
Capital
structure
The Board of Directors believes that the current capital and
share structure of Novo Nordisk serves the interests of the shareholders and
the company. Our guiding principle is that any excess capital, after the funding
of organic growth opportunities and potential acquisitions, is returned to
investors. We apply a pharmaceutical industry payout ratio to dividend payments
complemented by share repurchase programmes. As decided at the 2011 Annual
Shares and capital structure |
General Meeting, a reduction of the companys B share capital, corresponding to approximately 3.3% of the total share capital, was implemented in May 2011 by cancellation of treasury shares. This enables Novo Nordisk to continue to buy back shares without exceeding the limit for a holding of treasury shares of 10% of the totalt share capital. During 2011 and January 2012, Novo Nordisk repurchased shares worth 12 billion Danish kroner, compared to 9.5 billion kroner in 2010.
For the coming 12 months, Novo Nordisk has initiated a new share repurchase programme with an expected total repurchase value of B shares amounting to a cash value of 12 billion kroner. Since 2008, the share repurchase programme has primarily been conducted in accordance with the provisions of European Commission Regulation No 2273/2003 of 22 December 2003, also known as the Safe Harbour Regulation. This programme gives the selected financial institutions the mandate to purchase shares independently of Novo Nordisk.
At the 2012 annual general meeting, the Board of Directors will propose a further reduction of the companys B share capital, corresponding to approximately 3.4% of the total share capital, by cancellation of 20 million treasury shares. After implementation of the share capital reduction, the companys share capital will amount to DKK 560,000,000 divided into an A share capital of DKK 107,487,200 and a B share capital of DKK 452,512,800.
Share
capital and ownership
Novo Nordisks total share capital of 580,000,000 Danish
kroner is divided into A share capital of nominally 107,487,200 kroner and
B share capital of nominally 472,512,800 kroner, of which 24,440,186 kroner
is held as treasury shares (figures as of 31 December 2011). The companys
A shares (nominal value 1 krone) are not listed and are held by Novo A/S,
a Danish public limited liability company that is 100% owned by the Novo Nordisk
Foundation. More information on share capital is included in note 18 on p
75. According to the Articles of Association of the Foundation, the A shares
cannot be divested by Novo A/S or the Foundation. Novo A/S also held 40,412,800
kroner of B share capital (figures as of 31 December 2011). Each holding of
1 krone of the A share capital carries 1,000 votes. Each holding of 1 krone
of the B share capital carries 100 votes. With 25.5% of the total share capital,
Novo A/S controls 73.2% of the total number of votes, excluding treasury shares.
Our
guiding principle is that excess capital, after the funding of organic growth opportunities, is returned to investors. |
The total market value of Novo Nordisks B shares excluding treasury shares was 296 billion kroner at the end of 2011. Novo Nordisks B shares are quoted on NASDAQ OMX Copenhagen and on the New York Stock Exchange in the form of ADRs. The B shares are traded in units of 1 krone and the ratio of Novo Nordisks B shares to ADRs is 1:1. The B shares are issued to the bearer but may, on request, be registered in the holders name in Novo Nordisks register of shareholders. As Novo Nordisk B shares are in bearer form, no official record of all shareholders exists. Based on available sources of information about the companys shareholders as of 31 December 2011, it is estimated that shares were distributed as shown in the charts on this page. At the end of 2011, the free float of listed B shares was 70.3%.
Form
20-F
We expect to file our Form 20-F Report for 2011 with the United
States Securities and Exchange Commission in February 2012. The report can
be downloaded from novonordisk.com/investors.
Payment
of dividends
Shareholders enquiries concerning dividend payments, transfer
of share certificates, consolidation of shareholder accounts and tracking
of lost shares should be addressed to Novo Nordisks transfer agents
(see back cover). Novo Nordisk does not pay a dividend on its holding of treasury
shares. As illustrated in the figure above, Novo Nordisk has consistently
increased both the payout ratio and the dividend paid over the last five years.
The dividend for 2010 paid in March 2011 was 10.00 Danish kroner per share
of 1 krone.
At the 2012 annual general meeting, the Board of Directors will propose a 40% increase in the dividend for 2011 to 14.00 Danish kroner per share of 1 krone.
Shares and capital structure |
Proposed dividend payment for 2011 | ||
|
|
|
A shares of DKK 1 |
B
shares of DKK 1
|
ADRs
|
|
||
DKK 14.00 | DKK 14.00 | DKK 14.00 |
|
|
|
Analyst
coverage
Our company is currently covered by 40 analysts, including the
major global investment banks that regularly produce research reports about
Novo Nordisk. A list of analysts covering Novo Nordisk can be found at novonordisk.com/investors.
Internet
Our homepage for investors is novonordisk.com/investors.
It includes historical and updated information about Novo Nordisks activities:
press releases from 1995 onwards, financial and non-financial results, a calendar
of investor-relevant events, investor presentations, background information
and recent annual reports.
|
|
|
Financial calendar 2012 | ||
Annual general meeting 21 March 2012 | ||
|
|
|
Dividend |
B
shares
|
ADRs
|
Ex-dividend | 22 March 2012 |
22
March 2012
|
Record date | 26 March 2012 |
26
March 2012
|
Payment | 27 March 2012 |
3
April 2012
|
|
|
|
Announcement of financial results | ||
First three months |
27
April 2012
|
|
Half year |
9
August 2012
|
|
First nine months |
31
October 2012
|
|
Full year |
31
January 2013
|
|
|
|
|
Consolidated financial, social and environment statements 2011 |
Novo Nordisk Annual Report 2011 55
Income
statement and Statement of comprehensive income for the year ended 31
December
|
Consolidated financial statements |
DKK
million
|
Note
|
2011
|
2010
|
2009
|
||||
|
|
|
|
|
|
|
|
|
Income statement | ||||||||
Sales | 2, 3 | 66,346 | 60,776 | 51,078 | ||||
Cost of goods sold | 2, 4, 6 | 12,589 | 11,680 | 10,438 | ||||
|
|
|
|
|
|
|
|
|
Gross profit | 53,757 | 49,096 | 40,640 | |||||
Sales and distribution costs | 2, 4, 6 | 19,004 | 18,195 | 15,420 | ||||
Research and development costs | 2, 4, 6 | 9,628 | 9,602 | 7,864 | ||||
Administrative expenses | 2, 4, 5, 6 | 3,245 | 3,065 | 2,764 | ||||
Licence fees and other operating income, net | 2, 4, 6 | 494 | 657 | 341 | ||||
|
|
|
|
|
|
|
|
|
Operating profit | 22,374 | 18,891 | 14,933 | |||||
Share of profit/(loss) of associated companies, net of tax | 13 | (4 | ) | 1,070 | (55 | ) | ||
Financial income | 7 | 514 | 382 | 375 | ||||
Financial expenses | 8 | 959 | 2,057 | 1,265 | ||||
|
|
|
|
|
|
|
|
|
Profit before income taxes | 21,925 | 18,286 | 13,988 | |||||
Income taxes | 9 | 4,828 | 3,883 | 3,220 | ||||
|
|
|
|
|
|
|
|
|
Net profit for the year | 17,097 | 14,403 | 10,768 | |||||
|
|
|
|
|
|
|
|
|
Earnings per share: | ||||||||
Basic earnings per share (DKK) | 10 | 30.24 | 24.81 | 17.97 | ||||
Diluted earnings per share (DKK) | 10 | 29.99 | 24.60 | 17.82 | ||||
|
|
|
|
|
|
|
|
|
Statement of comprehensive income | ||||||||
Net profit for the year | 17,097 | 14,403 | 10,768 | |||||
Other comprehensive income: | ||||||||
Realisation of previously deferred (gains)/losses on cash flow hedges | ||||||||
to Income statement | 658 | (422 | ) | 900 | ||||
Deferred gains/(losses) on cash flow hedges arising during the period | (1,170 | ) | (643 | ) | 352 | |||
Exchange rate adjustments of investments in subsidiaries | (173 | ) | 300 | 528 | ||||
Deferred gains/(losses) on equity investments | 8 | (14 | ) | (1 | ) | |||
Share of other comprehensive income of associated companies, net of tax | | (9 | ) | 9 | ||||
Other | (28 | ) | 27 | 10 | ||||
Tax on other comprehensive income, income/(expense) | 9 | 190 | 346 | (25 | ) | |||
|
|
|
|
|
|
|
|
|
Other comprehensive income for the year, net of tax | (515 | ) | (415 | ) | 1,773 | |||
|
|
|
|
|
|
|
|
|
Total comprehensive income for the year | 16,582 | 13,988 | 12,541 | |||||
|
|
|
|
|
|
|
|
|
56 Novo Nordisk Annual Report 2011
Balance
sheet at 31 December
|
Consolidated financial statements |
DKK
million
|
Note
|
2011
|
2010
|
|||
|
|
|
|
|
|
|
Assets | ||||||
Intangible assets | 11 | 1,489 | 1,458 | |||
Property, plant and equipment | 12 | 20,931 | 20,507 | |||
Investments in associated companies | 13 | 39 | 43 | |||
Deferred income tax assets | 20 | 2,414 | 1,847 | |||
Other financial assets | 14 | 234 | 254 | |||
|
|
|
|
|
|
|
Total non-current assets | 25,107 | 24,109 | ||||
|
|
|
|
|
|
|
Inventories | 15 | 9,433 | 9,689 | |||
Trade receivables | 14, 16 | 9,349 | 8,500 | |||
Tax receivables | 883 | 650 | ||||
Other receivables and prepayments | 14, 17 | 2,376 | 2,403 | |||
Marketable securities | 14 | 4,094 | 3,926 | |||
Derivative financial instruments | 14, 28 | 48 | 108 | |||
Cash at bank and in hand | 14 | 13,408 | 12,017 | |||
|
|
|
|
|
|
|
Total current assets | 39,591 | 37,293 | ||||
|
|
|
|
|
|
|
Total assets | 64,698 | 61,402 | ||||
|
|
|
|
|
|
|
Equity and liabilities | ||||||
Share capital | 18 | 580 | 600 | |||
Treasury shares | 18 | (24 | ) | (28 | ) | |
Retained earnings | 37,111 | 36,097 | ||||
Other reserves | (219 | ) | 296 | |||
|
|
|
|
|
|
|
Total equity | 37,448 | 36,965 | ||||
|
|
|
|
|
|
|
Loans | 14, 19 | 502 | 504 | |||
Deferred income tax liabilities | 20 | 3,206 | 2,865 | |||
Retirement benefit obligations | 21 | 439 | 569 | |||
Provisions | 22 | 2,324 | 2,023 | |||
|
|
|
|
|
|
|
Total non-current liabilities | 6,471 | 5,961 | ||||
|
|
|
|
|
|
|
Current debt | 14, 19 | 351 | 562 | |||
Trade payables | 14 | 3,291 | 2,906 | |||
Tax payables | 1,171 | 1,252 | ||||
Other liabilities | 14, 23 | 8,534 | 7,954 | |||
Derivative financial instruments | 14, 19, 28 | 1,492 | 1,158 | |||
Provisions | 22 | 5,940 | 4,644 | |||
|
|
|
|
|
|
|
Total current liabilities | 20,779 | 18,476 | ||||
|
|
|
|
|
|
|
Total liabilities | 27,250 | 24,437 | ||||
|
|
|
|
|
|
|
Total equity and liabilities | 64,698 | 61,402 | ||||
|
|
|
|
|
|
|
Novo Nordisk Annual Report 2011 57
Statement
of cash flows for the year ended 31 December
|
Consolidated financial statements |
DKK
million
|
Note
|
2011
|
2010
|
2009
|
||||
|
|
|
|
|
|
|
|
|
Net profit for the year |
17,097
|
14,403
|
10,768
|
|||||
Adjustment for non-cash items |
24
|
9,117
|
8,449
|
6,701
|
||||
Change in working capital |
25
|
434
|
297
|
(279
|
)
|
|||
Interest received |
332
|
218
|
284
|
|||||
Interest paid |
(215
|
)
|
(252
|
)
|
(98
|
)
|
||
Income taxes paid |
9
|
(5,391
|
)
|
(3,436
|
)
|
(1,998
|
)
|
|
|
|
|
|
|
|
|
|
|
Net
cash generated from operating activities
|
21,374
|
19,679
|
15,378
|
|||||
|
|
|
|
|
|
|
|
|
Proceeds from the divestment of ZymoGenetics, Inc. |
|
1,155
|
|
|||||
Purchase of intangible assets and other financial assets |
11,
14
|
(259
|
)
|
(513
|
)
|
(415
|
)
|
|
Proceeds from sale of property, plant and equipment |
70
|
68
|
1
|
|||||
Purchase of property, plant and equipment |
12
|
(3,073
|
)
|
(3,376
|
)
|
(2,632
|
)
|
|
Net change in marketable securities |
(197
|
)
|
(2,913
|
)
|
|
|||
|
|
|
|
|
|
|
|
|
Net
cash used in investing activities
|
(3,459
|
)
|
(5,579
|
)
|
(3,046
|
)
|
||
|
|
|
|
|
|
|
|
|
Repayment of loans |
(507
|
)
|
|
|
||||
Purchase of treasury shares, net |
18
|
(10,595
|
)
|
(8,820
|
)
|
(6,395
|
)
|
|
Dividends paid |
10
|
(5,700
|
)
|
(4,400
|
)
|
(3,650
|
)
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in financing activities
|
(16,802
|
)
|
(13,220
|
)
|
(10,045
|
)
|
||
|
|
|
|
|
|
|
|
|
Net cash generated from activities |
1,113
|
880
|
2,287
|
|||||
Cash and cash equivalents at the beginning of the year |
26
|
11,960
|
11,034
|
8,726
|
||||
Exchange gains/(losses) on cash and cash equivalents |
(16
|
)
|
46
|
21
|
||||
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at the end of the year
|
13,057
|
11,960
|
11,034
|
|||||
|
|
|
|
|
|
|
|
|
Additional information:1 | ||||||||
Cash and cash equivalents at the end of the year |
26
|
13,057
|
11,960
|
11,034
|
||||
Marketable securities at the end of the year |
14
|
4,094
|
3,926
|
1,013
|
||||
Undrawn committed credit facilities2 |
4,832
|
4,473 | 4,465 | |||||
|
|
|
|
|
|
|
|
|
Financial resources at the end of the year |
21,983
|
20,359 | 16,512 | |||||
|
|
|
|
|
|
|
|
|
Net cash generated from operating activities |
21,374
|
19,679 | 15,378 | |||||
Net cash used in investing activities |
(3,459
|
)
|
(5,579 | ) | (3,046 | ) | ||
Net change in marketable securities |
197
|
2,913 | | |||||
|
|
|
|
|
|
|
|
|
Free cash flow |
18,112
|
17,013 | 12,332 | |||||
|
|
|
|
|
|
|
|
|
1. | Additional non-IFRS measures. Please refer to p 65 for definition. |
2. | At year-end, the Group had an undrawn committed credit facility amounting to DKK 4,832 million (DKK 4,473 million in 2010). The undrawn committed credit facility is a EUR 650 million (EUR 600 million in 2010 and 2009) facility committed by a portfolio of international banks. The facility matures in 2016. |
58 Novo Nordisk Annual Report 2011
Statement
of changes in equity 31 December
|
Consolidated financial statements |
Share
capital |
Treasury
shares |
Retained
earnings |
Other
reserves
|
Total
other reserves |
Total
|
|||||||||||
|
|
|
|
|
||||||||||||
DKK million |
Exchange
rate adjustment |
Cash
flow hedges |
Tax
and
other adjustments |
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 | ||||||||||||||||
Balance at the beginning of the year | 600 | (28 | ) | 36,097 | 571 | (672 | ) | 397 | 296 | 36,965 | ||||||
Net profit for the year | 17,097 | 17,097 | ||||||||||||||
Other comprehensive income for the year | (173 | ) | (512 | ) | 170 | (515 | ) | (515 | ) | |||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income for the year | 17,097 | (173 | ) | (512 | ) | 170 | (515 | ) | 16,582 | |||||||
Transactions with owners: | ||||||||||||||||
Dividends (note 10) | (5,700 | ) | (5,700 | ) | ||||||||||||
Share-based payments (note 29) | 319 | 319 | ||||||||||||||
Purchase of treasury shares (note 18) | (18 | ) | (10,821 | ) | (10,839 | ) | ||||||||||
Sale of treasury shares (note 18) | 2 | 242 | 244 | |||||||||||||
Tax on sale of treasury shares | (123 | ) | (123 | ) | ||||||||||||
Reduction of the B share capital (note 18) | (20 | ) | 20 | | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the year | 580 | (24 | ) | 37,111 | 398 | (1,184 | ) | 567 | (219 | ) | 37,448 | |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share
capital |
Treasury
shares |
Retained
earnings |
Other reserves |
Total
other reserves |
Total
|
|||||||||||
|
|
|
|
|
||||||||||||
DKK million |
Exchange
rate adjustment |
Cash
flow hedges |
Tax
and
other adjustments |
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 | ||||||||||||||||
Balance at the beginning of the year | 620 | (32 | ) | 34,435 | 271 | 393 | 47 | 711 | 35,734 | |||||||
Net profit for the year | 14,403 | 14,403 | ||||||||||||||
Other comprehensive income for the year | 300 | (1,065 | ) | 350 | (415 | ) | (415 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income for the year | 14,403 | 300 | (1,065 | ) | 350 | (415 | ) | 13,988 | ||||||||
Transactions with owners: | ||||||||||||||||
Dividends (note 10) | (4,400 | ) | (4,400 | ) | ||||||||||||
Share-based payments (note 29) | 463 | 463 | ||||||||||||||
Purchase of treasury shares (note 18) | (20 | ) | (9,478 | ) | (9,498 | ) | ||||||||||
Sale of treasury shares (note 18) | 4 | 674 | 678 | |||||||||||||
Reduction of the B share capital (note 18) | (20 | ) | 20 | | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the year | 600 | (28 | ) | 36,097 | 571 | (672 | ) | 397 | 296 | 36,965 | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Novo Nordisk Annual Report 2011 59
Notes
Consolidated financial statements
|
Consolidated financial statements |
Notes to the Consolidated financial statements
1 Basis of preparation of the Consolidated financial statements The Consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB), as well as in accordance with International Financial Reporting Standards (IFRS) as endorsed by the European Union. Furthermore, the Annual Report has been prepared in accordance with additional Danish disclosure requirements for the annual reports of listed companies. The Consolidated financial statements have been prepared on the historical cost basis except for the revaluation of available-for-sale financial assets such as equity investments and marketable securities measured at fair value through Other comprehensive income and derivative financial instruments measured at fair value through the Income statement. Key
accounting estimates and assumptions Management bases its estimates on historical experience and various other assumptions that are held to be reasonable under the circumstances. These form the basis for making judgements about the reported financial position and result of operations and cash flow that are not readily apparent from other sources. Actual results could differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis and, if necessary, changes are recognised in the period in which the estimate is revised. Management regards the following to be the key accounting estimates and assumptions used in the preparation of the Consolidated financial statements. Sales
rebates and provisions Such estimates are based on analyses of existing contractual or legal obligations, historical trends and the Groups experience. They are calculated on the basis of a percentage of sales for each product as defined by the contracts with the various customer groups. Sales discounts and sales rebates are predominantly issued in Region North America. In that region, significant sales rebates and discounts comprise rebates from sales covered by Medicare and Medicaid, the US state and federal programmes for public healthcare insurance. Provisions for Medicaid and Medicare rebates have been calculated using a combination of historical experience, product and population growth, price increases, the impact of contracting strategies and specific terms in the individual agreements. For Medicaid, the calculation of rebates involves interpretation of relevant regulations that are subject to challenge or change in interpretative guidance by government authorities. Although accruals are made for Medicaid and Medicare rebates at the time sales are recorded, the actual rebates related to the specific sale will typically be invoiced to Novo Nordisk up to six months later. Due to the time lag, the rebate adjustments to sales in any particular period may incorporate revisions of accruals for prior periods. Customer rebates are offered to a number of managed healthcare plans. These rebate programmes imply that the customer receives a rebate after attaining certain performance parameters relating to product purchases, formulary status and pre-established market share milestones relative to competitors. Since they are contractually agreed upon, rebates are |
estimated according to the specific terms in each agreement, historical experience, anticipated channel mix, product growth rates and market share information. Novo Nordisk considers the sales performance of products subject to managed healthcare rebates and other contract discounts, and adjusts the provision periodically to reflect actual experience. Wholesaler charge-backs relate to contractual arrangements existing between Novo Nordisk and indirect customers, mainly in the US, whereby products are sold at prices lower than the list price charged to wholesalers. A wholesaler charge-back represents the difference between the invoice price to the wholesaler and the indirect customers contract price. Provisions are calculated for estimated charge-backs using a combination of factors such as historical experience, current wholesaler inventory levels, contract terms and the value of claims received but not yet processed. Wholesaler charge-backs are generally settled within one to three months of incurring the liability. The carrying amount of provisions for sales rebates is DKK 5,666 million as at 31 December 2011. Please refer to note 22 for further information on provisions for sales rebates. Furthermore, please refer to note 3 for a gross-to-net sales reconciliation. Novo Nordisk considers the provision established for sales rebates to be reasonable and appropriate based on currently available information. However, the actual amount of rebates and discounts may differ from the amounts estimated by Management as more detailed information becomes available. Indirect
production costs (IPCs) IPCs are measured based on a standard cost method which is reviewed regularly to ensure relevant measures of utilisation, production lead time and other relevant factors. Changes in the parameters for calculation of IPCs could have an impact on the gross margin and the overall valuation of inventories. The carrying amount of IPCs on inventory is DKK 5,125 million as at 31 December 2011. Please refer to note 15 for further information. Novo Nordisk considers the carrying amount of IPCs on inventory to be reasonable and appropriate based on currently available information. However, the actual amount of IPCs may differ from the amounts estimated by Management as more detailed information becomes available. Allowances
for doubtful trade receivables Novo Nordisk maintains allowances for doubtful trade receivables in anticipation of estimated losses resulting from the subsequent inability of customers to make required payments. If the financial circumstances of the customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances could be required in future periods. Management analyses trade receivables and examines historical bad debt, customer concentrations, customer creditworthiness, current economic trends and changes in customer payment terms when evaluating the adequacy of the allowance for doubtful trade receivables. As a result of the generally troubled economic climate in Europe and thereby also the Eurozone countries, Novo Nordisk has increased its focus on the development in the outstanding trade receivables from this region. Payment history as well as current economic conditions and indicators are taken into account in the valuation of trade receivables. Please refer to note 2 for a geographical split of trade receivables and the allowance for trade receivables. The carrying amount of trade receivables is DKK 9,349 million and allowances for doubtful trade receivables is DKK 892 million as at 31 December 2011. Please refer to note 16 for further information. Provisions
and contingencies |
Notes
Consolidated financial statements
|
Consolidated financial statements |
tax positions. Novo Nordisk recognises deferred income tax assets if it is probable that sufficient taxable income will be available in the future against which the temporary differences and unused tax losses can be utilised. Management has considered future taxable income in assessing whether deferred income tax assets should be recognised.
The carrying amount of deferred income tax assets and deferred income tax liabilities is DKK 2,414 million and DKK 3,206 million respectively as at 31 December 2011. Please refer to note 20 for further information.
Legal disputes
Provisions for legal disputes consist of various types of provisions
linked to ongoing legal disputes. Management makes judgements about provisions
and contingencies, including the probability of pending and potential future
litigation outcomes which by their very nature are dependent on inherently
uncertain future events. When determining likely outcomes of litigations etc,
Management considers the evaluation of external counsels input about each
case, as well as known outcomes in case law.
The carrying amount of provisions for legal disputes is DKK 1,554 million as at 31 December 2011. Please refer to note 22 for further information and note 31 for a description of significant pending litigations.
Although Management believes that the total provisions for legal proceedings are adequate based upon currently available information, there can be no assurance that there will not be any changes in facts or matters or that any future lawsuits, claims, proceedings or investigations will not be material.
Financial
accounting policies
The principal accounting policies set out below have been applied
consistently in the preparation of the Consolidated financial statements for
all the years presented.
Adoption
of new and revised IFRSs
Novo Nordisk has adopted all new or amended and revised accounting
standards and interpretations (IFRSs) issued by IASB and IFRSs
endorsed by the European Union effective for the accounting year 2011. Based
on an analysis by Novo Nordisk, the application of the new IFRSs has not had
a material impact on the Consolidated financial statements in 2011 and we
do not anticipate any significant impact on future periods from the adoption
of these new IFRSs.
New IFRSs that have
been issued but not yet come into effect
In addition to the above, IASB has issued a number of new or
amended and revised accounting standards and interpretations (IFRSs) that
have been endorsed by the European Union but not yet come into effect. Novo
Nordisk has thoroughly assessed the impact of these IFRSs which are not yet
effective and determined that we do not anticipate any significant impact
on the Consolidated financial statements from the adoption of these standards.
IASB has issued IFRS 9 Financial Instruments which is required to be adopted by 1 January 2015. This is part of the IASBs project to replace IAS 39 and the new standard will substantially change the classification and measurement of financial instruments and hedging requirements. Furthermore, IASB has issued an amendment to IAS 19 Employee Benefits that makes changes to the recognition and measurement of defined benefit pension expenses and termination benefits, and to the disclosure of all employee benefits. The amendment is required to be adopted by 1 January 2013. Novo Nordisk has assessed the impact of the standard and the amendment and determined that they will not have any significant impact on the Consolidated financial statements. The new standards and the amendment have not yet been endorsed by the European Union.
Defining
materiality
Novo Nordisks Consolidated financial statements are a
result of processing large numbers of transactions and aggregating those transactions
into classes according to their nature or function. When aggregated, the transactions
are presented separately in classes of similar items in the consolidated financial
statements. If a line item is not individually material, it is aggregated
with other items of a similar nature in the statements or in the notes.
Throughout IFRS there are substantial disclosure requirements. Novo Nordisk provides specific disclosures required by an IFRS unless the information is immaterial or not applicable.
Principles
of consolidation
The Consolidated financial statements incorporate the financial
statements of Novo Nordisk A/S and entities controlled by Novo Nordisk A/S.
The results of subsidiaries acquired or disposed of during the year are included
in the consolidated income statement from the effective date of acquisition
and up to the effective date of disposal, as appropriate. Comparative figures
are not restated for disposed or acquired companies.
Where necessary, adjustments are made to the financial statements of subsidiaries to bring their accounting policies in line with Novo Nordisk policies. All intra-Group transactions, balances, income and expenses are eliminated in full when consolidated.
When Novo Nordisk loses control of a subsidiary, the profit or loss on disposal is calculated as the difference between (i) the aggregate of the fair value of the consideration received and the fair value of any retained interest and (ii) the previous carrying amount of the assets (including goodwill) and liabilities of the subsidiary.
Translation
of foreign currencies
Functional and presentation currency
Items included in the financial statements of each of Novo
Nordisks entities are measured using the currency of the primary economic
environment in which the entity operates (functional currency). The Consolidated
financial statements are presented in Danish kroner (DKK), which is the functional
and presentation currency of the Parent company.
Translation of transactions
and balances
Foreign currency transactions are translated into the functional
currency using the exchange rates prevailing at the dates of the transactions.
Foreign exchange gains and losses resulting from the settlement of such transactions
and from the translation at year-end exchange rates of monetary assets and
liabilities denominated in foreign currencies are recognised in the Income
statement.
Translation differences on non-monetary items, such as financial assets classified as available for sale, are included in the fair value reserve in Other comprehensive income.
Translation of Group
companies
Financial statements of foreign subsidiaries are translated
into Danish kroner at the exchange rates prevailing at the end of the reporting
period for assets and liabilities, and at average exchange rates for income
statement items.
All effects of exchange rate adjustment are recognised in the Income statement, with the exception of exchange gains and losses arising from:
| the translation of foreign subsidiaries net assets at the beginning of the year at the exchange rates at the end of the reporting period |
| the translation of foreign subsidiaries income statements using average exchange rates, whereas balance sheet items are translated using the exchange rates prevailing at the end of the reporting period |
| the translation of non-current intra-Group receivables that are considered to be an addition to net investments in subsidiaries |
| the translation of investments in associated companies. |
The above exchange rate gains and losses are recognised in Other comprehensive income.
Sales
and revenue recognition
Sales are measured at the fair value of the consideration received
or receivable. Sales are reduced for realised and estimated customer returns,
rebates and other similar allowances.
Revenue from the sale of goods is recognised when all the following conditions are satisfied:
| Novo Nordisk has transferred to the buyer the significant risks and rewards of ownership of the goods. |
| Novo Nordisk retains neither continuing managerial involvement to the degree usually associated with ownership nor effective control over the goods sold. |
| The amount of revenue can be measured reliably. |
| It is probable that the economic benefits associated with the transaction will flow to the entity. |
| The costs incurred or to be incurred in respect of the transaction can be measured reliably. |
Novo Nordisk Annual Report 2011 61
Notes
Consolidated financial statements
|
Consolidated financial statements |
Provisions for rebates and discounts granted to government agencies, wholesalers, retail pharmacies, managed care and other customers are recorded as a reduction of revenue at the time the related revenues are recorded or when the incentives are offered. They are calculated on the basis of historical experience and the specific terms in the individual agreements. The sales rebate accruals and provisions are included in Other current liabilities and Provisions for other liabilities.
Where there is historical experience or a reasonably accurate estimate of expected future returns can otherwise be made, a provision for estimated sales returns is recorded. Revenue recognition for new product launches is based on specific facts and circumstances relating to those products, including estimated demand and acceptance rates for well-established products with similar market characteristics. Where shipments of new or existing products are made on a sale or return basis, without sufficient historical experience for estimating sales returns, revenue is only recorded when there is evidence of consumption or when the right of return has expired.
Provisions for revenue deductions are adjusted to actual amounts as rebates, discounts and returns are processed.
Research
and development
All internal research costs are expensed in the Income statement
as incurred.
Due to the long duration and significant uncertainties relating to the development of new products, including risks associated with clinical trials and regulatory approval, it is concluded that Novo Nordisks internal development costs in general do not meet the capitalisation criteria. This is because the technical feasibility criteria are not considered to be fulfilled until a high probability of regulatory approval can be determined. Hence, internal research and development costs are expensed in the Income statement as incurred. The same principles are applied to property, plant and equipment with no alternative use developed as part of a research and development project. However, property, plant and equipment with alternative use or used for general research and development purposes is capitalised and depreciated over its estimated useful life.
For acquired in-process research and development projects, the effect of probability is reflected in the cost of the asset, and the probability recognition criteria are therefore always considered satisfied. As the cost of acquired in-process research and development projects can often be measured reliably, these projects fulfil the capitalisation criteria as intangible assets upon acquisition. However, further internal development costs subsequent to acquisition are treated in the same way as other internal development costs.
Licence
fees and other operating income
Licence fees and other operating income comprise licence fees
and income of a secondary nature in relation to the main activities of Novo
Nordisk. Non-Novo Nordisk-related net profit from the two wholly owned subsidiaries
NNIT A/S and NNE Pharmaplan A/S is recognised as other operating income. Licence
fees are recognised on an accrual basis in accordance with the terms and substance
of the relevant agreement. Licence fees and other operating income also include
income from sale of intellectual property rights.
Intangible
assets
Goodwill
Goodwill represents any cost in excess of identifiable net
assets, measured at fair value, in the acquired company. Goodwill recorded
under Intangible assets is related to subsidiaries.
Patents and licences
Patents and licences, including acquired patents and licences
for in-process research and development projects, are carried at historical
cost less accumulated amortisation and any impairment loss. Amortisation is
calculated using the straight-line method to allocate the cost of patents
and licences over their estimated useful lives. Estimated useful life is the
shorter of the legal duration and the economic useful life. The estimated
useful life of intangible assets is regularly reviewed. The amortisation of
patents and licences begins after regulatory approval has been obtained, which
is the point in time from which the intangible asset is available for use
in the production of the product.
Other intangible assets
Internal development of computer software and other development
costs related to major IT projects for internal use that are directly attributable
to the design and testing of identifiable and unique software products controlled
by Novo Nordisk are recognised as intangible assets under Other intangible
assets if the recognition criteria are met. The computer software has to be
a significant business system and the expenditure must lead to the creation
of a durable asset.
In order for an internally generated intangible asset to qualify for recognition, it is required that the related internal development project is at a sufficiently advanced stage and that the project is economically viable. Amortisation is calculated using the straight-line method over the estimated useful life of 3 10 years. The amortisation commences when the asset is available for use, ie when it is in the location and condition necessary for it to be capable of operating in the manner intended by Management.
Property,
plant and equipment
Property, plant and equipment is measured at historical cost
less accumulated depreciation and any impairment loss. The cost of self-constructed
assets includes costs directly attributable to the construction of the assets.
Subsequent cost is included in the assets carrying amount or recognised
as a separate asset, as appropriate, only when it is probable that future
economic benefits associated with the item will flow to Novo Nordisk and the
cost of the item can be measured reliably. In general, constructions of major
investments are self-financed and thus no material interest on loans (borrowings)
is capitalised as part of the cost.
Depreciation is provided under the straight-line method over the estimated useful lives of the assets as follows:
| Buildings: 12 50 years |
| Plant and machinery: 5 16 years |
| Other equipment: 3 16 years |
| Land: not depreciated |
The assets residual values and useful lives are reviewed and adjusted, if appropriate, at the end of each reporting period. An assets carrying amount is written down to its recoverable amount if the assets carrying amount is higher than its estimated recoverable amount.
Gains and losses on disposals are determined by comparing the proceeds with the carrying amount and are recognised in the Income statement.
Leasing
Leases are classified as finance leases whenever the terms
of the lease substantially transfer all the risks and rewards of ownership
to the lessee. All other leases are classified as operating leases. The use
of finance leases in the Consolidated financial statements is immaterial and
they are part of property, plant and equipment.
Operating lease payments are recognised in the Income statement as an expense on a straight-line basis over the lease term, except where another systematic basis is more representative of the time pattern in which economic benefits from the leased asset are consumed. Contingent rentals arising under operating leases are recognised as an expense in the period in which they are incurred.
Impairment
of assets
Intangible assets with an indefinite useful life and intangible
assets not yet available for use are not subject to amortisation and are tested
annually for impairment irrespective of whether there is any indication that
they may be impaired.
Assets that are subject to amortisation, such as intangible assets in use or with definite useful life, and other non-current assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. Factors considered material that could trigger an impairment test include the following:
| Development of a competing drug |
| Changes in the legal framework covering patents, rights or licences |
| Advances in medicine and/or technology that affect the medical treatments |
| Lower-than-predicted sales |
| Adverse impact on reputation and/or brand names |
| Changes in the economic lives of similar assets |
| Relationship with other intangible or tangible assets |
| Changes or anticipated changes in participation rates or reimbursement policies. |
62 Novo Nordisk Annual Report 2011
Notes
Consolidated financial statements
|
Consolidated financial statements |
If the carrying amount of goodwill, intangible assets or other non-current assets exceeds the recoverable amount based upon the existence of one or more of the above indicators of impairment, any impairment is measured based on discounted projected cash flows.
Intangible assets and other non-financial assets (other than goodwill) that have suffered impairments are reviewed at each reporting date for possible reversal of the impairment.
Investments
in associated companies
Investments in associated companies are accounted for under
the equity method of accounting (ie at the respective share of the associated
companies net asset value applying Novo Nordisks accounting policies).
Goodwill relating to associated companies is recorded as part of the investment
under Investments in associated companies.
Financial
assets
Novo Nordisk classifies its investments in the following categories:
| Available-for-sale financial assets |
| Loans and receivables |
| Financial assets at fair value through the Income statement (derivatives). |
The classification depends on the purpose for which the investments were made. Management determines the classification of its investments on initial recognition and re-evaluates this at the end of every reporting period to the extent that such a classification is permitted and required.
Recognition and measurement
Purchases and sales of investments are recognised on the settlement date.
Investments are initially recognised at fair value.
Available-for-sale financial assets and financial assets at fair value are subsequently carried at fair value. Loans and receivables are carried at amortised cost using the effective interest method.
Fair value disclosures are made separately for each class of financial instruments at the end of the reporting period.
Derecognition
Investments are derecognised when the rights to receive cash flows from
the investments have expired or have been transferred, and Novo Nordisk has
transferred substantially all risks and rewards of ownership.
Available-for-sale
financial assets
Available-for-sale financial assets consist of equity investments and marketable
securities and are included in Other financial assets unless Management intends
to dispose of the investment within 12 months of the end of the reporting
period. If that is the case, the current part is included as Other receivables
and prepayments.
Unrealised gains and losses arising from changes in the fair value of financial assets classified as available for sale are recognised in Other comprehensive income. When financial assets classified as available for sale are sold or impaired, the accumulated fair value adjustments are included in the Income statement.
The fair values of quoted investments (including bonds) are based on current bid prices at the end of the reporting period. Financial assets for which no active market exists are carried at cost if no reliable valuation model can be applied.
Loans and receivables
Loans and receivables are non-derivative financial assets with fixed or
determinable payments that are not quoted in an active market. If collection
is expected within one year (or in the normal operating cycle of the business
if longer), they are classified as Current assets. If not, they are presented
as Non-current assets.
Trade receivables and Other receivables and prepayments are recognised initially at fair value and subsequently measured at amortised cost using the effective interest method, less provision for allowances. Provision for allowances is made for trade receivables when there is objective evidence that Novo Nordisk will not be able to collect all amounts due according to the original terms of the receivables.
The provision for allowances is deducted from the carrying amount of Trade receivables and the amount of the loss is recognised in the Income statement under Sales and distribution costs. When a trade receivable is uncollectible, it is written off against the allowance account for trade receivables. Subsequent recoveries of amounts previously written off are credited against Sales and distribution costs in the Income statement.
Financial assets at
fair value through the Income statement (derivatives)
Novo Nordisk uses forward exchange contracts, currency options,
interest rate swaps and cross-currency swaps to hedge forecast transactions,
assets and liabilities, and net foreign currency investments in foreign subsidiaries
in accordance with the specific rules of IAS 39 Financial Instruments:
Recognition and Measurement.
Upon initiation of the contract, Novo Nordisk designates each derivative financial contract that qualifies for hedge accounting as one of:
| Hedges of the fair value of a recognised asset or liability or a firm commitment (fair value hedge) |
| Hedges of the fair value of a forecast financial transaction (cash flow hedge) |
| Hedges of a net investment in a foreign operation (net investment hedge). |
All contracts are initially recognised at fair value and subsequently remeasured at their fair values based on current bid prices at the end of the reporting period.
Forward exchange contracts and currency swap hedges recognised as assets or liabilities in foreign currencies are measured at fair value at the end of the reporting period. Value adjustments are recognised in the Income statement along with any value adjustments of the hedged asset or liability that is attributable to the hedged risk.
The value adjustments on forward exchange contracts and interest rate swaps designated as hedges of forecast transactions are recognised directly in Other comprehensive income, given hedge effectiveness. The cumulative value adjustment of these contracts is transferred from Other comprehensive income to the Income statement as a reclassification adjustment under Financial income or Financial expenses when the hedged transaction is recognised in the Income statement.
Currency swaps used to hedge net investments in subsidiaries are measured at fair value based on the difference between the swap exchange rate and the exchange rate at the end of the reporting period. The value adjustment is recognised in Other comprehensive income.
Furthermore, Novo Nordisk uses currency option hedges of forecast transactions. Currency options are initially recognised at cost, which equals fair value of considerations paid, and subsequently re-measured at their fair values at the end of the reporting period. The cumulative value adjustment of the currency options for which hedge accounting is applied, which is the intrinsic value of the options, is transferred from Other comprehensive income to the Income statement as a reclassification adjustment under Financial income or Financial expenses when the hedged transaction is recognised in the Income statement. Gains and losses on currency options that do not meet the detailed requirements for allowing hedge accounting are recognised directly in the Income statement under Financial income or Financial expenses.
The fair value of financial assets and liabilities is measured on the basis of quoted market prices of financial instruments traded in active markets. If an active market exists, fair value is based on the most recently observed market price at the end of the reporting period.
If a financial instrument is quoted in a market that is not active, Novo Nordisk bases its valuation on the most recent transaction price. Adjustment is made for subsequent changes in market conditions, for instance by including transactions in similar financial instruments that are assumed to be motivated by normal business considerations.
If an active market does not exist, the fair value of standard and simple financial instruments, such as foreign exchange forward contracts, interest rate swaps, currency swaps and unlisted bonds, is measured according to generally accepted valuation techniques. Market-based parameters are used to measure fair value.
Novo Nordisk Annual Report 2011 63
Notes
Consolidated financial statements
|
Consolidated financial statements |
When a hedging instrument expires or is sold, or when a hedge no longer meets the criteria for hedge accounting, any cumulative gain or loss existing in equity at that time remains in equity and is recognised when the forecast transaction is ultimately recognised in the Income statement. When a forecast transaction is no longer expected to occur, the cumulative gain or loss that was reported in equity is immediately transferred to the Income statement under Financial income or Financial expenses. Inventories
If the expected sales price less completion costs and costs to execute sales (net realisable value) is lower than the carrying amount, a write-down is recognised for the amount by which the carrying amount exceeds its net realisable value. Inventory manufactured prior to regulatory approval is capitalised as an asset but provided for until there is a high probability of regulatory approval of the product. Before that point a provision is made against the carrying amount to its recoverable amount and recorded as R&D costs. At the point when a high probability of regulatory approval is obtained, the provision recorded is reversed, up to no more than the original cost. Tax Deferred income taxes arise from temporary differences between the accounting and taxable values of the individual consolidated companies and from realisable tax-loss carry-forwards using the liability method. The tax value of tax-loss carry-forwards is included in deferred tax assets to the extent that the tax losses and other tax assets are expected to be utilised in future taxable income. The deferred income taxes are measured according to current tax rules and at the tax rates expected to be in force on elimination of the temporary differences. Unremitted earnings are retained by subsidiaries for reinvestment. No provision is made for income taxes that would be payable upon the distribution of such earnings. Employee
benefits Pensions Actuarial gains and losses are recognised as income or expenses when the net cumulative unrecognised actuarial gains and losses for each individual plan at the end of the previous reporting period exceed 10% of the higher of the defined benefit obligation and the fair value of plan assets at that date. These gains or losses are recognised over the expected average remaining working lives of the employees participating in the plans. Past service costs are allocated over the average period until the benefits vest. |
Pension assets are only recognised to the extent that Novo Nordisk is able to derive future economic benefits such as refunds from the plan or reductions of future contributions. Novo Nordisks contributions to the defined contribution plans are charged to the Income statement in the year to which they relate. Share-based compensation The total amount to be expensed over the vesting period is determined by reference to the fair value of the options or shares granted, excluding the impact of any non-market vesting conditions. The fair value is fixed at grant date. Non-market vesting conditions are included in assumptions about the number of options or shares that are expected to vest. At the end of each reporting period, Novo Nordisk revises its estimates of the number of options or shares that are expected to vest. Novo Nordisk recognises the impact of the revision of the original estimates, if any, in the Income statement and in a corresponding adjustment to Equity (change in proceeds) over the remaining vesting period. Adjustments relating to prior years are included in the Income statement in the year of adjustment. Liabilities Loans are recognised initially at fair value, net of transaction costs incurred. Loans are subsequently stated at amortised cost; any difference between the proceeds (net of transaction costs) and the redemption value is recognised in the Income statement over the period of the loans using the effective interest method. Loans are classified as Current debt unless Novo Nordisk has an unconditional right to defer settlement of the liability for at least 12 months after the end of the reporting period. Provisions
Provisions are measured at the present value of the anticipated expenditure for settlement of the legal or constructive obligation using a pre-tax rate that reflects current market assessments of the time value of money and the risks specific to the obligation. The increase in the provision due to the passage of time is recognised as interest expense. Product returns
Treasury
shares Statement
of cash flows
|
64 Novo Nordisk Annual Report 2011
Notes
Consolidated financial statements
|
Consolidated financial statements |
Financial definitions
ADRs
An American Depositary Receipt (or ADR) represents ownership
in the shares of a non-US company and trades in US financial markets.
Basic
earnings per share (EPS)
Net profit divided by the average number of shares outstanding.
Diluted
earnings per share
Net profit divided by the sum of average number of shares outstanding,
including the dilutive effect of share options in the money. The
dilutive effect of share options in the money is calculated as
the difference between the following:
1) the number of shares that could have been acquired at fair value with proceeds from the exercise of the share options
2) the number of shares that would have been issued assuming the exercise of the share options.
The difference (the dilutive effect) is added to the denominator as an issue of shares for no consideration.
Effective
tax rate
Income taxes as a percentage of profit before income taxes.
Equity
ratio
Total equity at year-end as a percentage of total assets at
year-end.
Gross
margin
Gross profit as a percentage of sales.
Net profit
margin
Net profit as a percentage of sales.
Number
of shares outstanding
The total number of shares, excluding the holding of treasury
shares.
Operating
profit margin
Operating profit as a percentage of sales.
Other
comprehensive income (OCI)
Other comprehensive income comprises all items recognised in
equity for the year other than those related to transactions with owners of
the company. Examples of items that are required to be presented in OCI are:
| Foreign exchange rate adjustments in foreign subsidiaries |
| Actuarial gains and losses arising on defined benefit plans |
| Changes in fair value of financial instruments in a cash flow hedge. |
Payout
ratio
Total dividends for the year as a percentage of net profit.
Return
on equity (ROE)
Net profit for the year as a percentage of shareholders
equity (average).
Non-IFRS
financial measures
In the Annual Report 2011, 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 2011 are: | |
| Cash to earnings |
| Financial resources at the end of the year |
| Free cash flow |
| Operating profit after tax to net operating assets. |
Cash
to earnings
Cash to earnings is defined as free cash flow as a percentage
of net profit.
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.
Free
cash flow
Novo Nordisk defines free cash flow as net cash generated
from operating activities less net cash used in investing activities
excluding Net change in marketable securities.
Operating
profit after tax to net operating assets
Operating profit after tax to net operating assets is defined
as operating profit after tax (using the effective tax rate) as a percentage
of average inventories, receivables, property, plant and equipment, intangible
assets and deferred tax assets less non-interest bearing liabilities including
provisions and deferred tax liabilities (where average is the sum of above
assets and liabilities at the beginning of the year and at year-end divided
by two).
Novo Nordisk Annual Report 2011 65
Notes
Consolidated financial statements
|
Consolidated financial statements |
2 Segment information Operating segments are reported in a manner consistent with the internal reporting provided to Management and the Board of Directors. Business segments Novo Nordisk operates in two business segments based on different therapies: Diabetes care and Biopharmaceuticals. The Diabetes care business segment includes research, development, manufacturing and marketing of products within the areas of insulin, GLP-1 and related delivery systems, oral antidiabetic products (OAD) and obesity. The Biopharmaceuticals business segment includes research, development, manufacturing and marketing of products within the areas of haemophilia, growth hormone therapy, hormone replacement therapy, inflammation therapy and other therapy areas. |
Management monitors the operating results of its business segments separately for the purpose of making decisions about resource allocation and performance assessment. Segment performance is evaluated on the basis of operating profit consistent with the Consolidated financial statements. Financial income and expenses and income taxes are managed on a Group basis and are not allocated to business segments. There are no sales or other transactions between the business segments. Costs have been split between business segments according to a specific allocation with the addition of a minor number of corporate overheads allocated systematically between the segments. Licence fees and other operating income has been allocated to the two segments based on the same principle. Segment assets comprise the assets that are applied directly to the activities of the segment, including intangible assets, property, plant and equipment, other financial assets, inventories, trade receivables, and other receivables and prepayments. No single customer represents more than 10% of the total sales and no operating segments have been aggregated to form the reported business segments. |
Business segments
DKK
million
|
2011
|
2010
|
2009
|
2011
|
2010
|
2009
|
2011
|
2010
|
2009
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Segment
sales
|
Diabetes
care
|
Biopharmaceuticals
|
Total
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NovoRapid®/ NovoLog® | 12,804 | 11,900 | 9,749 | |||||||||||||||
NovoMix®/ NovoLog®Mix | 8,278 | 7,821 | 6,499 | |||||||||||||||
Levemir® | 7,683 | 6,880 | 5,223 | |||||||||||||||
Total modern insulins | 28,765 | 26,601 | 21,471 | |||||||||||||||
Human insulins | 10,785 | 11,827 | 11,315 | |||||||||||||||
Victoza® | 5,991 | 2,317 | 87 | |||||||||||||||
Protein-related products | 2,309 | 2,214 | 1,977 | |||||||||||||||
Oral antidiabetic products (OAD) | 2,575 | 2,751 | 2,652 | |||||||||||||||
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Diabetes care total sales | 50,425 | 45,710 | 37,502 | |||||||||||||||
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NovoSeven® | 8,347 | 8,030 | 7,072 | |||||||||||||||
Norditropin® | 5,047 | 4,803 | 4,401 | |||||||||||||||
Hormone replacement therapy | 2,054 | 1,892 | 1,744 | |||||||||||||||
Other products | 473 | 341 | 359 | |||||||||||||||
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Biopharmaceuticals total sales | 15,921 | 15,066 | 13,576 | |||||||||||||||
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Total business segments | ||||||||||||||||||
other key figures | ||||||||||||||||||
Total sales | 50,425 | 45,710 | 37,502 | 15,921 | 15,066 | 13,576 | 66,346 | 60,776 | 51,078 | |||||||||
Change in DKK (%) | 10.3% | 21.9% | 12.4% | 5.7% | 11.0% | 11.3% | 9.2% | 19.0% | 12.1% | |||||||||
Change in local currencies (%) | 12.6% | 15.7% | 11.1% | 7.6% | 5.4% | 9.3% | 11.4% | 13.0% | 10.6% | |||||||||
Cost of goods sold | 10,762 | 10,131 | 9,001 | 1,827 | 1,549 | 1,437 | 12,589 | 11,680 | 10,438 | |||||||||
Sales and distribution costs | 16,476 | 14,815 | 12,877 | 2,528 | 3,380 | 2,543 | 19,004 | 18,195 | 15,420 | |||||||||
Research and development costs | 6,402 | 6,744 | 5,257 | 3,226 | 2,858 | 2,607 | 9,628 | 9,602 | 7,864 | |||||||||
Administrative expenses | 2,485 | 2,260 | 2,044 | 760 | 805 | 720 | 3,245 | 3,065 | 2,764 | |||||||||
Licence fees and other operating | ||||||||||||||||||
income, net | 285 | 342 | 187 | 209 | 315 | 154 | 494 | 657 | 341 | |||||||||
Operating profit | 14,585 | 12,102 | 8,510 | 7,789 | 6,789 | 6,423 | 22,374 | 18,891 | 14,933 | |||||||||
Depreciation, amortisation and | ||||||||||||||||||
impairment losses included in costs | 2,051 | 1,887 | 1,973 | 686 | 580 | 578 | 2,737 | 2,467 | 2,551 | |||||||||
Additions to non-current assets | ||||||||||||||||||
(other than financial assets and | ||||||||||||||||||
deferred tax assets) | 2,654 | 3,068 | 2,129 | 678 | 795 | 896 | 3,332 | 3,863 | 3,025 | |||||||||
Assets allocated to business segments | 34,853 | 34,947 | 29,703 | 8,998 | 7,906 | 8,984 | 43,851 | 42,853 | 38,687 | |||||||||
Assets not allocated to business | ||||||||||||||||||
segments1 | 20,847 | 18,549 | 16,055 | |||||||||||||||
Total assets | 64,698 | 61,402 | 54,742 | |||||||||||||||
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1. | The part of total assets that has not been allocated to either of the two business segments includes Cash at bank and in hand, Marketable securities, Derivative financial instruments and tax assets etc. |
66 Novo Nordisk Annual Report 2011
Notes
Consolidated financial statements
|
Consolidated financial statements |
2 Segment information (continued)
Geographical segments
Novo Nordisk operates in five geographical regions:
| North America: the US and Canada |
| Europe: the EU, EFTA, Albania, Bosnia-Hercegovina, Croatia, Macedonia, Serbia, Montenegro and Kosovo |
| Japan & Korea: Japan and Korea |
| Region China: China, Hong Kong and Taiwan |
| International Operations: all other countries |
Sales are attributed to geographical regions according to the location of the customer. Allocation of property, plant and equipment and total assets are based on the location of the assets.
The country of domicile is Denmark, which is part of Region Europe. Denmark is immaterial in relation to Novo Nordisks activities in terms of geographical size and the operational business segments. Less than 1% of the total sales is realised in Denmark. Sales to external customers attributed to the US are collectively the most material to the company. The US is the only country where sales contribute more than 10% of total sales. Sales to the US represent more than 90% of sales in Region North America.
Geographical segments
DKK million | 2011 | 2010 | 2009 | 2011 | 2010 | 2009 | ||||||
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|
North America | Europe | |||||||||||
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Sales | 26,586 | 23,609 | 18,279 | 19,168 | 18,664 | 17,540 | ||||||
Change in DKK (%) | 12.6% | 29.2% | 20.6% | 2.7% | 6.4% | 1.9% | ||||||
Change in local currencies (%) | 17.9% | 22.4% | 15.2% | 2.4% | 4.6% | 5.2% | ||||||
Property, plant and equipment | 1,329 | 987 | 905 | 15,681 | 15,669 | 15,445 | ||||||
Trade receivables | 2,081 | 1,689 | 1,255 | 3,652 | 3,437 | 3,243 | ||||||
Hereof allowance for trade receivables | (22 | ) | (19 | ) | (22 | ) | (333 | ) | (200 | ) | (187 | ) |
Total assets | 5,465 | 3,680 | 3,232 | 47,202 | 46,654 | 42,933 | ||||||
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DKK million | 2011 | 2010 | 2009 | 2011 | 2010 | 2009 | ||||||
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International
Operations2
|
Japan & Korea | |||||||||||
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Sales | 9,367 | 8,335 | 6,835 | 6,223 | 5,660 | 4,888 | ||||||
Change in DKK (%) | 12.4% | 21.9% | 7.6% | 9.9% | 15.8% | 16.5% | ||||||
Change in local currencies (%) | 17.1% | 22.3% | 14.9% | 5.1% | 3.3% | 1.8% | ||||||
Property, plant and equipment | 1,672 | 1,929 | 1,785 | 207 | 213 | 188 | ||||||
Trade receivables | 2,052 | 1,995 | 1,555 | 377 | 446 | 361 | ||||||
Hereof allowance for trade receivables | (535 | ) | (408 | ) | (391 | ) | (2 | ) | 0 | 0 | ||
Total assets | 6,419 | 6,327 | 5,439 | 1,388 | 1,158 | 1,003 | ||||||
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DKK million | 2011 | 2010 | 2009 | 2011 | 2010 | 2009 | ||||||
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Region
China2
|
Total
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Sales | 5,002 | 4,508 | 3,536 | 66,346 | 60,776 | 51,078 | ||||||
Change in DKK (%) | 11.0% | 27.5% | 25.6% | 9.2% | 19.0% | 12.1% | ||||||
Change in local currencies (%) | 11.7% | 19.9% | 26.4% | 11.4% | 13.0% | 10.6% | ||||||
Property, plant and equipment | 2,042 | 1,709 | 903 | 20,931 | 20,507 | 19,226 | ||||||
Trade receivables | 1,187 | 933 | 649 | 9,349 | 8,500 | 7,063 | ||||||
Hereof allowance for trade receivables | 0 | 0 | 0 | (892 | ) | (627 | ) | (600 | ) | |||
Total assets | 4,224 | 3,583 | 2,135 | 64,698 | 61,402 | 54,742 | ||||||
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2. | As of 1 January 2011, Region China is reported as a separate geographical region. Before 2011, Region China was part of International Operations. The historical figures for 2010 and 2009 have been restated and are comparable with the 2011 regional set-up. |
Novo Nordisk Annual Report 2011 67
Notes
Consolidated financial statements
|
Consolidated financial statements |
3 Gross-to-net sales reconciliation
DKK million |
2011
|
2010
|
2009
|
|||
|
|
|
|
|
|
|
Gross sales | 84,386 | 75,811 | 62,459 | |||
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|
US Medicaid and Medicare rebates | (5,075 | ) | (4,124 | ) | (2,447 | ) |
US managed healthcare rebates | (2,551 | ) | (2,494 | ) | (2,121 | ) |
US wholesaler charge-backs | (5,894 | ) | (4,994 | ) | (3,720 | ) |
Non-US healthcare plans and programme rebates | (695 | ) | (543 | ) | (431 | ) |
Sales returns and discounts | (3,825 | ) | (2,880 | ) | (2,662 | ) |
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|
Total gross-to-net sales adjustments | (18,040 | ) | (15,035 | ) | (11,381 | ) |
|
|
|
|
|
|
|
Total net sales | 66,346 | 60,776 | 51,078 | |||
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4 Employee costs
DKK million |
2011
|
2010
|
2009
|
|||
|
|
|
|
|
|
|
Wages and salaries | 16,127 | 14,520 | 13,231 | |||
Share-based payment costs (note 29) | 319 | 463 | 259 | |||
Pensions defined contribution plans | 1,155 | 1,052 | 958 | |||
Pensions retirement benefit | ||||||
obligations (note 21) | (2 | ) | 210 | 152 | ||
Other social security contributions | 1,189 | 1,067 | 898 | |||
Other employee costs | 1,491 | 1,510 | 1,332 | |||
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|
|
Total employee costs for the year | 20,279 | 18,822 | 16,830 | |||
Change in employee costs included in assets under construction | (496 | ) | (559 | ) | (485 | ) |
Change in employee costs included in inventories | (37 | ) | 76 | (21 | ) | |
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|
Total employee costs expensed in the Income statement | 19,746 | 18,339 | 16,324 | |||
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|
Included in the Income statement: | ||||||
Cost of goods sold | 4,302 | 4,006 | 3,952 | |||
Sales and distribution costs | 7,961 | 7,240 | 6,063 | |||
Research and development costs | 3,980 | 3,697 | 3,218 | |||
Administrative expenses | 1,993 | 2,059 | 1,811 | |||
Licence fees and other operating income, net | 1,510 | 1,337 | 1,280 | |||
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|
Total included in the Income statement | 19,746 | 18,339 | 16,324 | |||
|
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|
|
Average number of full-time employees | 31,499 | 29,423 | 27,985 | |||
Year-end number of full-time employees | 32,136 | 30,014 | 28,809 | |||
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|
DKK million | 2011 | 2010 | 2009 | |||
|
|
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|
|||
Remuneration to Executive | ||||||
Management: | ||||||
Salary | 35 | 32 | 30 | |||
Pension | 9 | 8 | 8 | |||
Other benefits | 1 | 1 | 1 | |||
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Total | 45 | 41 | 39 | |||
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