Novo Nordisk increased net profit by 32% in 2007
Underlying operating profit increased by close to 25% primarily driven by a 13% sales growth in local currencies
Underlying operating profit increased by close to 25% primarily driven by a 13% sales growth in local currencies
o Sales of modern insulins increased by 35% (29% in Danish kroner).
o Sales of NovoSeven® increased by 10% (4% in Danish kroner).
o Sales of Norditropin® increased by 11% (6% in Danish kroner).
o Sales in North America increased by 22% (12% in Danish kroner).
o Sales in International Operations increased by 18% (12% in Danish kroner).
Lars Rebien Sørensen, president and CEO, said: "We are very pleased with the 2007 results. They are driven by robust sales growth in all major markets of our portfolio of modern insulins and strong gross margin improvement. This makes us confident that we will also be able to deliver solid underlying growth in 2008."
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Page |
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Consolidated financial statement 2007 |
3 |
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Long-term financial targets |
4 |
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Sales development by segments |
5 |
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Sales development by regions |
5 |
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Diabetes care |
5 |
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Biopharmaceuticals |
6 |
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Costs, licence fees and other operating income |
7 |
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Net financials and tax |
8 |
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Capital expenditure and free cash flow |
8 |
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Outlook 2008 |
9 |
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Research and development update |
9 |
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Equity |
12 |
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Corporate governance |
13 |
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Sustainability issues update |
15 |
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Legal issues update |
15 |
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Financial calendar |
16 |
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Conference call details |
16 |
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Forward-looking statement |
17 |
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Contacts for further information |
18 |
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Appendices: |
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Appendices 1-2: Quarterly numbers in DKK and EUR |
19 |
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Appendices 3-4: Income statement and balance sheet |
21 |
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Appendix 5: Cash flow statement |
23 |
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Appendix 6: Statement of changes in equity |
24 |
Consolidated financial statement 2007
These financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS). The accounting policies used in this report are in all materiality consistent with those used in the Annual Report 2006.
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Profit and loss |
2007 |
2006 |
2005 |
2004 |
2003 |
% change 2007 vs 2006 |
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(Amounts below in DKK million)
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Sales |
41,831 |
38,743 |
33,760 |
29,031 |
26,158 |
8% |
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Gross profit |
32,038 |
29,158 |
24,583 |
20,981 |
18,749 |
10% |
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Gross margin |
76.6% |
75.3% |
72.8% |
72.3% |
71.7% |
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Sales and distribution costs |
12,371 |
11,608 |
9,691 |
8,280 |
7,451 |
7% |
|
Percent of sales |
29.6% |
30.0% |
28.7% |
28.5% |
28.5% |
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|
|
|
|
|
|
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Research and development costs |
8,538 |
6,316 |
5,085 |
4,352 |
4,055 |
35% |
|
-hereof costs related to discontinuation of AERx® |
(1,325) |
- |
- |
- |
- |
|
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Percent of sales |
20.4% |
16.3% |
15.1% |
15.0% |
15.5% |
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Percent of sales (excl AERx®)1) |
17.2% |
- |
- |
- |
- |
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Administrative expenses |
2,508 |
2,387 |
2,122 |
1,944 |
1,857 |
5% |
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Percent of sales |
6.0% |
6.2% |
6.3% |
6.7% |
7.1% |
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Licence fees and other operating income |
321 |
272 |
403 |
575 |
1,036 |
18% |
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Operating profit |
8,942 |
9,119 |
8,088 |
6,980 |
6,422 |
(2%) |
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Operating margin |
21.4% |
23.5% |
24.0% |
24.0% |
24.6% |
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Operating profit (excl AERx®)1) |
10,267 |
- |
- |
- |
- |
13% |
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Operating margin (excl AERx®)1) |
24.5% |
- |
- |
- |
- |
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Net financials |
2,029 |
45 |
146 |
477 |
954 |
- |
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Profit before income taxes |
10,971 |
9,164 |
8,234 |
7,457 |
7,376 |
20% |
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Income taxes |
2,449 |
2,712 |
2,370 |
2,444 |
2,543 |
(10%) |
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Income tax rate |
22.3% |
29.6% |
28.8% |
32.8% |
34.5% |
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Net profit |
8,522 |
6,452 |
5,864 |
5,013 |
4,833 |
32% |
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Net profit margin |
20.4% |
16.7% |
17.4% |
17.3% |
18.5% |
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1) Excluding costs related to the discontinuation of AERx®.
Consolidated financial statement 2007- continued
These financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS). The accounting policies used in this report are in all materiality consistent with those used in the Annual Report 2006.
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Other key numbers
(Amounts below in DKK million except earnings per share, dividend per share and number of employees)
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2007 |
2006 |
2005 |
2004 |
2003 |
% change 2007 vs 2006 |
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Depreciation, amortisation, etc |
3,007 |
2,142 |
1,930 |
1,892 |
1,581 |
40% |
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Depreciation, amortisation, etc (excl AERx®)1) |
2,137 |
- |
- |
- |
- |
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Capital expenditure |
2,268 |
2,787 |
3,665 |
2,999 |
2,273 |
(19%) |
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Free cash flow |
9,012 |
4,707 |
4,833 |
4,278 |
3,846 |
91% |
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Equity |
32,182 |
30,122 |
27,634 |
26,504 |
24,776 |
7% |
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Total assets |
47,731 |
44,692 |
41,960 |
37,433 |
34,564 |
7% |
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Equity ratio |
67.4% |
67.4% |
65.9% |
70.8% |
71.7% |
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Diluted earnings per share (in DKK) |
13.39 |
10.00 |
8.92 |
7.42 |
7.08 |
34% |
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Dividend per share (in DKK)2) |
4.50 |
3.50 |
3.00 |
2.40 |
2.20 |
29% |
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Payout ratio3) |
32.8% |
34.4% |
33.2% |
31.8% |
30.8% |
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Payout ratio (adjusted)4) |
34.9% |
- |
- |
- |
- |
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Average number of full-time employees |
24,344 |
22,590 |
21,146 |
19,520 |
18,381 |
8% |
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1) Excluding costs related to the discontinuation of AERx®.
2) Proposed dividend for the financial year 2007.
3) Total dividends for the year as a percentage of net profit.
4) Total dividends for the year as a percentage of net profit adjusted for impact of Dako and AERx® discontinuation.
Long-term financial targets
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2007 |
2006 |
2005 |
2004 |
2003 |
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Performance against long-term financial targets |
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Long-term target ratio |
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Operating profit growth |
(1.9%) |
12.7% |
15.9% |
8.7% |
8.4% |
15% |
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Operating profit growth (excl AERx®)1) |
12.6% |
- |
- |
- |
- |
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Operating margin |
21.4% |
23.5% |
24.0% |
24.0% |
24.6% |
25% |
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Operating margin (excl AERx®)1) |
24.5% |
- |
- |
- |
- |
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Return on invested capital |
27.2% |
25.8% |
24.7% |
21.5% |
20.4% |
30% |
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Cash to earnings |
105.7% |
73.0% |
82.4% |
85.3% |
79.6% |
70%2) |
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Cash to earnings (excl AERx®)3) |
94.2% |
- |
- |
- |
- |
|
1) Excluding costs related to the discontinuation of AERx®.
2) Long-term target ratio measured as three years' average.
3) Earnings adjusted for net profit impact of AERx® discontinuation.
Sales development by segments
Sales increased by 13% measured in local currencies and by 8% in Danish kroner. While growth was realised within both diabetes care and biopharmaceuticals, the primary growth contribution originated from modern insulins. The reported sales growth realised in 2007 was in line with the previously communicated guidance of '6-9%' reported sales growth.
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Sales |
Growth |
Growth |
Share of |
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2007
DKK million |
as reported |
in local
currencies |
Growth
in local currencies |
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The diabetes care segment |
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Modern insulins |
14,008 |
29% |
35% |
76% |
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Human insulins |
12,572 |
(7%) |
(3%) |
(8%) |
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Insulin-related sales |
1,749 |
9% |
13% |
4% |
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Oral antidiabetic products |
2,149 |
8% |
14% |
6% |
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Diabetes care - total |
30,478 |
9% |
14% |
78% |
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The biopharmaceuticals segment |
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NovoSeven® |
5,865 |
4% |
10% |
11% |
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Growth hormone therapy |
3,511 |
6% |
11% |
7% |
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Other products |
1,977 |
2% |
8% |
4% |
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Biopharmaceuticals - total |
11,353 |
4% |
10% |
22% |
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Total sales |
41,831 |
8% |
13% |
100% |
Sales development by regions
In 2007, sales growth was realised in all regions measured in local currencies. The main contributors to growth were North America and International Operations providing 53% and 23%, respectively, of the total sales growth. Europe contributed 21% and Japan & Oceania 3% of the sales growth in 2007 measured in local currencies.
Diabetes care
Sales of diabetes care products increased by 14% measured in local currencies and by 9% in Danish kroner to DKK 30,478 million compared to last year.
Modern insulins, human insulins and insulin-related products
Sales of modern insulins, human insulins and insulin-related products increased by 14% measured in local currencies and by 9% in Danish kroner to DKK 28,329 million. All regions contributed to growth measured in local currencies, with North America and International Operations having the highest growth rates. Novo Nordisk continues to be the global leader with 53% of the total insulin market and 43% of the modern insulin market, both measured by volume.
Sales of modern insulins increased by 35% in local currencies in 2007 and by 29% in Danish kroner to DKK 14,008 million. All regions realised solid growth rates, with North America and Europe as the primary contributors to growth. Sales of modern insulins contributed 76% of the overall growth in local currencies and now constitute 53% of Novo Nordisk's sales of insulins.
North America
Sales in North America increased by 26% in local currencies in 2007 and by 16% in Danish kroner, reflecting a solid penetration of the modern insulins Levemir®, NovoLog® and NovoLog® Mix 70/30. Novo Nordisk continues to consolidate its leadership position in the US insulin market with 42% of the total insulin market and 30% of the modern insulin market, both measured by volume. Currently, more than 35% of Novo Nordisk's modern insulin volume is being sold in FlexPen®.
Europe
Sales in Europe increased by 7% in local currencies and 7% measured in Danish kroner, reflecting continued progress for the portfolio of modern insulins. Novo Nordisk holds 57% of the total insulin market and 50% of the modern insulin market, both measured by volume, and is capturing the main share of growth in the modern insulin market.
International Operations
Sales within International Operations increased by 20% in local currencies and by 14% in Danish kroner. The main contributor to growth in 2007 was sales of modern insulins, primarily in Turkey and China. Furthermore, sales of human insulins continue to add to overall growth in the region, driven by China. The key contributor to growth in International Operations continues to be China, accounting for around 50% of the region's sales growth in 2007.
Japan & Oceania
Sales in Japan & Oceania increased by 4% in local currencies and decreased by 4% measured in Danish kroner. The sales development reflects sales growth for the modern insulins NovoRapid® and NovoRapid Mix® 30. In December 2007, Novo Nordisk launched Levemir® in Japan and is now also in Japan the only company with a full portfolio of modern insulins. Modern insulins are increasingly being sold in the leading prefilled delivery device, FlexPen®. Novo Nordisk holds 73% of the total insulin market in Japan and 63% of the modern insulin market, both measured by volume.
Oral antidiabetic products (NovoNorm®/Prandin®)
Sales of oral antidiabetic products increased by 14% in local currencies and by 8% in Danish kroner to DKK 2,149 million compared to 2006. This primarily reflects increased sales in International Operations and North America, mainly due to an increased market share in China and a higher average sales price in the US market.
Biopharmaceuticals
Sales of biopharmaceutical products increased by 10% measured in local currencies and by 4% measured in Danish kroner to DKK 11,353 million compared to last year.
NovoSeven®
Sales of NovoSeven® increased by 10% in local currencies and by 4% in Danish kroner to DKK 5,865 million compared to last year. Sales growth for NovoSeven® was primarily realised in North America. The sales growth for NovoSeven® during 2007 primarily reflected increased sales within the congenital bleeding disorder segments, where Novo Nordisk is the global leader. Treatment of spontaneous bleeds for congenital inhibitor patients remains the largest area of use.
Growth hormone therapy (Norditropin®)
Sales of Norditropin® (ie growth hormone in a liquid, ready-to-use formulation) increased by 11% measured in local currencies and by 6% measured in Danish kroner to DKK 3,511 million. All regions, and especially North America and Europe, contributed to growth measured in local currencies. Novo Nordisk continues to gain market share in the growth hormone market and is the second-largest company in this market with 23% market share measured in volume.
Other products
Sales of other products within biopharmaceuticals, which predominantly consist of hormone replacement therapy (HRT)-related products, increased by 8% in local currencies and by 2% in Danish kroner to DKK 1,977 million. This development primarily reflects continued sales progress in the US market for Vagifem®, Novo Nordisk's topical oestrogen product. Novo Nordisk continues to be the second-largest participant within the global HRT market.
Costs, licence fees and other operating income
The cost of goods sold was DKK 9,793 million in 2007 representing a gross margin of 76.6% compared to 75.3% in 2006. This improvement reflects improved production efficiency, a lower level of write-downs and impairment in 2007 compared to 2006 and higher average prices in the US. The gross margin was negatively impacted by around 0.8 percentage points due to currency developments, primarily the lower value of US dollars and Japanese yen versus Danish kroner compared to last year.
Total non-production-related costs increased by 15% to DKK 23,417 million. The increase primarily reflects costs related to research and development as well as sales and distribution. Research and development costs increased more than sales, primarily reflecting the non-recurring costs related to the discontinuation of AERx® of DKK 1,325 million, of which DKK 870 million relates to write-down and impairment of tangible and intangible assets, DKK 326 million relates to the discontinuation of clinical trials and, finally, DKK 129 million relates to other exit costs such as leasing and investment commitments. Sales and distribution costs increased slightly more than sales, primarily reflecting the increase in the US diabetes care sales force.
In 2007, Novo Nordisk expensed costs in relation to share-based long-term incentive programmes for senior management and other senior employees (around 525 participants in total) amounting to DKK 130 million. The comparable expense for 2006 was DKK 113 million (around 425 participants in total).
Licence fees and other operating income were DKK 321 million in 2007, positively impacted by an income in the first quarter of 2007 related to the out-licensing of an oral antidiabetic compound.
As a consequence of the non-recurring costs related to the discontinuation of AERx®, operating profit in 2007 decreased by 2% to DKK 8,942 million compared to 2006 and is thereby significantly below the previously communicated expectations of growth in operating profit of 'close to 10% as reported'. Adjusted for the non-recurring costs related to the discontinuation of AERx®, operating profit growth was 13%.
Net financials and tax
Net financials showed a net income of DKK 2,029 million in 2007 compared to a net income of DKK 45 million in 2006.
Included in net financials is the result from associated companies with an income of DKK 1,233 million, primarily related to the non-recurring tax-exempt income of approximately DKK 1.5 billion from Novo Nordisk's divestment of the ownership of Dako's business activities as well as Novo Nordisk's share of losses in ZymoGenetics, Inc of approximately DKK 0.3 billion. In 2006, the result from associated companies was an expense of DKK 260 million.
The foreign exchange result was an income of DKK 910 million compared to an income of DKK 141 million in 2006. This development reflects gains on foreign exchange hedging activities due to the lower value of especially US dollars and Japanese yen versus Danish kroner in 2007 compared to the exchange rate level prevailing in 2006. Foreign exchange hedging gains of DKK 691 million have been deferred for future income recognition, primarily in 2008.
The realised results for net financials in 2007 were slightly higher than the previously communicated expectation of a total net financial income of around 'DKK 1,950 million'.
The effective tax rate for 2007 was 22.3%, a decrease from 29.6% in 2006. The significantly lower effective tax rate for 2007 primarily reflects a non-recurring reduction of around 3 percentage points from Novo Nordisk's divestment of the ownership of Dako's business activities as well as a non-recurring effect of close to 2 percentage points from the re-evaluation of the company's deferred tax liabilities as a consequence of the reduction in the Danish corporation tax rate to 25%, introduced in 2007.
The realised effective tax rate for 2007 was in line with the previously communicated expectation of a tax rate of 'around 22%' for the full year of 2007.
Capital expenditure and free cash flow
Net capital expenditure for property, plant and equipment for 2007 was realised at DKK 2.3 billion compared to DKK 2.8 billion for 2006. The main investment projects in 2007 were capacity for AERx® insulin strip manufacturing, expansion of FlexPen® assembly capacity as well as expansion of the purification and filling capacity for insulin products. The realised capital expenditure was slightly lower than the previously communicated expectation of 'around DKK 2.5 billion'.
Free cash flow for 2007 was realised at DKK 9.0 billion compared to DKK 4.7 billion for 2006. Novo Nordisk's financial resources at the end of 2007 were DKK 13.6 billion and higher than the level at the end of 2006. Included in the financial resources are unutilised committed credit facilities of approximately DKK 7.5 billion. The realised cash flow was significantly above the previously communicated expectation of 'around DKK 7.5 billion' and is reflecting a stronger operating performance, improvements in working capital requirements as well as a lower level of investments in the fourth quarter of 2007.
Outlook 2008
Novo Nordisk expects slightly more than 10% growth in sales measured in local currencies for 2008. This is based on expectations of continued market penetration for Novo Nordisk's key strategic products within diabetes care and biopharmaceuticals as well as expectations of increased competition during 2008. Given the current level of exchange rates versus Danish kroner, the reported sales growth in 2008 is expected to be around 3.5 percentage points lower than the growth rate measured in local currencies.
For 2008, reported operating profit is expected to increase by at least 25% despite the negative currency environment. The guidance for reported operating profit for 2008 includes an estimate of non-recurring costs of DKK 300 million in relation to the discontinuation of AERx® to cover severance payments and other costs. Adjusting for the impact from currency and the non-recurring costs in 2007 and 2008 related to the discontinuation of AERx®, underlying operating profit is expected to grow by at least 20%.
For 2008, Novo Nordisk expects a net financial income of DKK 450 million, reflecting significant foreign exchange hedging gains, primarily related to the US dollar.
The effective tax rate for 2008 is expected to be approximately 24%.
Capital expenditure is expected to be around DKK 2.5 billion in 2008. Expectations for depreciations, amortisation and impairment losses are around DKK 2.5 billion, and free cash flow is expected to be around DKK 7.5 billion.
All of the above expectations are provided that currency exchange rates, especially the US dollar and related currencies, remain at the current level versus the Danish krone for the rest of 2008. All other things being equal, movements in key invoicing currencies will impact Novo Nordisk's operating profit as illustrated below:
|
Invoicing currency |
Annual impact on Novo Nordisk's operating profit
of a 5% movement in currency |
|
USD |
DKK 470 million |
|
JPY |
DKK 140 million |
|
GBP |
DKK 85 million |
|
USD-related |
DKK 100 million |
Note: For 2008 onwards the currency sensitivity for 'USD-related' currencies has been
focused to solely reflect the impact from CNY and CAD.
focused to solely reflect the impact from CNY and CAD.
Novo Nordisk has hedged expected net cash flows in relation to US dollars, Japanese yen and British pounds for 17, 15 and 10 months, respectively. The financial impact from foreign exchange hedging is included in 'Net financials'.
Research and development update
Novo Nordisk has finalised the two planned phase 3 studies in Japan assessing the effect of the once-daily human GLP-1 analogue, liraglutide, for the treatment of type 2 diabetes in monotherapy and in combination with sulfonylurea, a widely used oral antidiabetic treatment.
The 24-week monotherapy study included 411 Japanese subjects with type 2 diabetes previously treated with diet and exercise or a single oral antidiabetic medication. After a four-week wash-out period subjects were randomised to either liraglutide or sulfonylurea (glibenclamide) therapy. From an average baseline HbA1c of close to 9%, Hba1c levels decreased by close to 2 percentage points in the liraglutide-treated group. The change in HbA1c was statistically significantly better than that observed for the glibenclamide group. At the end of the study approximately 50% of patients in the liraglutide group were below the American Diabetes Association (ADA) target of HbA1c < 7%. The improvements in HbA1c levels in liraglutide-treated subjects were obtained through lowering of both fasting and postprandial blood glucose levels. At the beginning of the study, average BMI was close to 25 and average body weight was around 65 kg. A body weight difference of approximately 2 kg in favour of liraglutide treatment was observed when compared to treatment with glibenclamide. Treatment with liraglutide was generally well tolerated. Subjects treated with liraglutide experienced a low rate of hypoglycaemic events, and this was statistically significantly lower than the rate observed in subjects treated with glibenclamide. Nausea was reported in less than 10% of the subjects.
The 24-week sulfonylurea add-on study included 267 Japanese subjects with type 2 diabetes where either placebo or two different doses of liraglutide were added to existing sulfonylurea therapy. From an average baseline HbA1c of around 8.5%, a statistically significant improvement in HbA1c was observed following liraglutide treatment. The average HbA1c at the highest dose tested was reduced to below 7.0%, thereby bringing around 70% of the subjects to a target HbA1c level below 7.0%. From an average starting weight of around 65 kg and an average BMI of around 25 there was no weight change from baseline in the liraglutide-treated subjects, in spite of the improvements in glycaemic control. Similarly, there were no subjects reporting major hypoglycaemic events. Subjects randomised to liraglutide treatment experienced the highest completion rate in the study (around 95%). Overall, reporting of side effects occurred at a low level and the most frequently reported side effects in liraglutide-treated subjects were constipation and diarrhoea (in around 10% of subjects). Nausea was reported in less than 5% of the subjects.
Based on the results from the two Japanese phase 3 studies Novo Nordisk expects to file for regulatory approval in Japan before the end of the third quarter of 2008.
In December 2007, and as previously communicated, Novo Nordisk announced clinical results from the last of five phase 3 studies (the LEAD(TM) 3 study) to be used for the regulatory filing in Europe and the US of the once-daily human GLP-1 analogue liraglutide. Patients in the one-year study were randomised to treatment with one of two doses of liraglutide or 8 mg of glimepiride, a widely used oral antidiabetic medication. At both doses tested, liraglutide provided statistically significantly better glucose control than glimepiride. On average, the patients treated with liraglutide experienced a lowering of HbA1c of more than 1 percentage point. Patients treated with liraglutide who had previously only been treated with diet and exercise saw HbA1c drop by more than 1.5 percentage points. The ADA treatment goal of HbA1c < 7% was reached by more than 50% of the patients receiving the highest dose of liraglutide. As has been seen in previous studies where liraglutide has been given as monotherapy, patients receiving liraglutide in this study experienced a very low level of hypoglycaemia, contrasting with the glimepiride-treated group where hypoglycaemia occurred in a larger number of patients. Furthermore, a statistically significant improvement in systolic blood pressure and a reduction of body weight of between 3 and 4 kg were seen in patients treated with liraglutide when compared to patients treated with glimepiride. Novo Nordisk expects to
file for regulatory approval of liraglutide for the treatment of type 2 diabetes in Europe and the US before the end of the second quarter of 2008.
In November 2007 and as previously communicated, Novo Nordisk announced clinical results of a phase 2 study comparing liraglutide with orlistat, a lipase inhibitor, for treatment of obesity in people who do not have diabetes. The study demonstrated that liraglutide given once daily over 20 weeks at the highest dose led to a weight loss of just above 7 kg in comparison to a weight loss of just below 3 kg in the placebo group and a weight loss of just above 4 kg in the orlistat-treated group. All doses of liraglutide reduced body weight. More than 75% of the people treated with the highest dose experienced a weight loss larger than 5%, and more than 25% experienced a weight loss larger than 10% relative to their body weight at randomisation. Finally, the study revealed a beneficial effect on systolic blood pressure after treatment with liraglutide. Approximately 30% of the 564 participants in the study showed signs of prediabetes at randomisation. Following 20 weeks of treatment with any dose of liraglutide, between 80% and 90% of these participants no longer showed any sign of prediabetes, as opposed to around 40% in the placebo- and orlistat-treated groups. Liraglutide was generally well tolerated. Novo Nordisk expects to initiate a phase 3 obesity programme with liraglutide before the end of 2008.
For two of the expected next-generation modern insulin candidates, Novo Nordisk has initiated clinical phase 2 studies. The studies involve NN1250, a neutral, soluble, long-acting modern insulin with a flat and predictable profile providing more than 24-hour coverage by once-daily injection, and NN5401, a neutral, soluble, modern insulin fixed combination with improved properties. Novo Nordisk expects to finalise both these phase 2 studies in the first quarter of 2009.
In December 2007, Novo Nordisk submitted NovoMix® 70 for regulatory approval in Japan. NovoMix® 70 is intended to expand the treatment options for the approximately 50% of the Japanese patients who are currently on a premixed treatment regimen.
Finally, and as communicated on 14 January 2008, Novo Nordisk has decided to refocus its activities within inhaled insulin and to discontinue clinical development of AERx® inhaled insulin (AERx® iDMS). The decision was based on a detailed analysis of the future prospects for inhaled insulin and a review of the medical and commercial potential of the AERx® inhaled insulin system. The decision to discontinue the development of AERx® was not due to safety concerns. Novo Nordisk intends to increase research and development activities targeted at inhalation systems for long-acting analogues of insulin and GLP-1. The activities will take place at two centres of excellence in Hayward, California, and Hillerød, Denmark.
Biopharmaceuticals
Novo Nordisk has finalised the phase 2 safety study for the use of NovoSeven® in cardiac surgery. A total of 172 cardiac surgery patients were included in the study. Preliminary results from the study confirm the safety profile known from the cardiac surgery setting and from previous studies of NovoSeven® outside of haemophilia with inhibitors. While the primary endpoint of this trial was safety, the trial also demonstrated the biologic haemostatic effect of NovoSeven®. Novo Nordisk expects to communicate next steps for NovoSeven® in cardiac surgery during the first half of 2008, following consultations with regulatory authorities and external experts.
A subcutaneously administered formulation of rFVIIa has entered phase 1 clinical development. The possibility of administering rFVIIa by means of subcutaneous injection is expected to significantly improve convenience for haemophilia patients with inhibitors.
The heat-stable version of NovoSeven® was submitted in December 2007 for regulatory approval in Japan. Regulatory submissions of the heat-stable version of NovoSeven® in Europe and the US took place in mid-2007.
Driven by a higher aspiration level within the haemophilia portfolio of Novo Nordisk, the company is now actively pursuing the development of new molecules for the treatment of haemophilia with and without inhibitors. The portfolio includes clotting factors targeting different parts of the coagulation pathway and aim at on-demand as well as prophylactic therapy. Among the preclinical projects, the most advanced of these are expected to enter clinical development within the next couple of years.
The R&D strategy for the emerging biopharmaceuticals area has been updated. Based on an evaluation of the general competence level required, the level of investments needed and the likelihood of success, Novo Nordisk has decided to increase and focus activities on inflammatory diseases. As a consequence, research and development activities within oncology will be terminated and resources applied to the growing inflammation portfolio. Existing oncology projects, including the IL-21 programme and the anti-KIR project, are expected to be out-licensed. The ongoing development activities for these two projects will continue while discussions with potential new partners are taking place. The first two compounds targeting inflammatory diseases are expected to enter clinical development in 2008.
As a strategic life-cycle management initiative supporting the growth hormone franchise, Novo Nordisk has initiated a phase 1 study with a longer-acting human growth hormone. Based on Novo Nordisk's PEGylation technology, the compound is designed for once-weekly treatment with expected administration in a convenient injection device.
In December 2007, Novo Nordisk filed Vagifem® low dose (10 micrograms oestradiol) for marketing approval with the FDA.
Equity
Total equity was DKK 32,182 million at the end of 2007, equal to 67.4% of total assets, compared to 67.4% at the end of 2006. Please refer to appendix 6 for further elaboration of changes in equity during 2007.
Proposed dividend and share repurchase programme
At the Annual General Meeting on 12 March 2008, the Board of Directors will propose a 29% increase in dividend to DKK 4.50 per share of DKK 1, corresponding to a pay-out ratio of 34.9%, when adjusted for the non-recurring costs related to the discontinuation of AERx® and the non-recurring income from the divestment of Dako's business activities, compared to 34.4% for the financial year 2006. No dividend will be paid on the company's holding of treasury B shares.
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 (Safe Harbour Regulation). For that purpose Novo Nordisk has appointed J. P. Morgan Securities Ltd. as lead manager to independently and without influence from Novo Nordisk execute the first part of its share repurchase programme. The purpose of the programme is reduction of 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 billion during the trading period starting today and ending on 6 August 2008. A maximum of 172,967 shares can be bought during one single trading day, equal to 15% of the average daily trading volume of Novo Nordisk B shares on the OMX Nordic Exchange Copenhagen during the month of December 2007, and a maximum of 22,312,788 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.
Holding of treasury shares and reduction of share capital
As per 30 January 2008, Novo Nordisk A/S and its wholly-owned affiliates owned 25,815,130 of its own B shares, corresponding to 4% of the total share capital.
In order to maintain capital structure flexibility, the Board of Directors will at the Annual General Meeting in 2008 also propose a reduction in the B share capital from DKK 539,472,800 to DKK 526,512,800 by cancelling 12,960,000 B shares of DKK 1 from the Company's own holdings of B shares at a nominal value of DKK 12,960,000, equal to 2% of the total share capital. After implementation of the share capital reduction, the Company's share capital will amount to DKK 634,000,000 divided into an A share capital of DKK 107,487,200 and a B share capital of DKK 526,512,800.
Corporate governance
Election of new member of the Board of Directors
At the Annual General Meeting on 12 March 2008, the Board of Directors will propose that Pamela J Kirby is elected to the Board. Dr Kirby, a British national, is chairman of the Board of Scynexis Inc, US, and is also a board member of Smith & Nephew plc, UK, among other board positions. Dr Kirby has extensive executive experience from the international pharmaceutical and biotech industry and holds a PhD in clinical pharmacology from the University of London, UK.
Remuneration policy
Novo Nordisk's existing remuneration policy aims to attract, retain and motivate members of the Board of Directors and Executive Management of Novo Nordisk. Remuneration levels are designed to be competitive and to align the interest of the executives with those of the shareholders. In light of recent changes in Danish legislation, Novo Nordisk will present for approval at the Annual General Meeting in 2008 its guidelines for incentive-based remuneration for the Board of Directors and Executive Management of Novo Nordisk.
Long-term share-based incentive programme for senior management
As from 2004, members of Novo Nordisk's Executive Management (currently five) and the other members of the Senior Management Board (currently 22) have participated in a performance-based incentive programme where a proportion of the calculated shareholder value creation has been allocated to a joint pool for the participants. For members of Executive Management and the other members of the Senior Management Board the joint pool operates with a yearly maximum allocation per participant equal to eight months' fixed base salary plus pension contribution. Once the joint pool has been approved by the Board of Directors the total cash amount is converted into Novo Nordisk A/S B shares at market price. The shares in the joint pool are locked up for a three-year period before they potentially may be transferred to the participants.
For 2004, 252,688 shares were allocated to the joint pool and the market value of the scheme was expensed in 2004. The number of shares in the 2004 joint pool has not been reduced as the financial performance in the subsequent years (2005-2007) reached specified threshold levels. Accordingly, the original number of shares allocated to the joint pool will, according to the principles of the scheme, be transferred to 22 current and former members of senior management immediately after the announcement of the full-year 2007 financial results on 31 January 2008.
For 2007 and based on an assessment of the economic value generated in 2007, as well as the performance of the R&D portfolio and key sustainability projects, the Board of Directors on 30 January 2008 approved the establishment of a joint pool for the financial year of 2007 by allocating a total of 166,445 Novo Nordisk B shares, corresponding to a cash value of DKK 43 million. This allocation amounts to 6.5 months of fixed base salary on average per participant. This amount was expensed in 2007.
As the long-term share-based incentive programme is evaluated by the Board of Directors to have worked successfully in 2007, it is planned to continue in 2008 with an unchanged structure. Novo Nordisk has, however, decided to make this decision subject to the formal approval by the Annual General Meeting in March 2008 of the guidelines for incentive-based remuneration for the Board of Directors and Executive Management of Novo Nordisk.
Long-term share-based incentive programme for vice presidents
As from 2007, around 500 key employees below top level management also participate in a share-based programme with similar performance criteria as the programme for the members of Executive Management and the other members of the Senior Management Board. The share-based incentive programme for key employees will, as is the case for the programme for Executive Management and the other members of the Senior Management Board, be based on an annual calculation of shareholder value creation compared to the planned performance for the year. The pool will operate with a maximum contribution per participant equal to four months' fixed base salary. The shares in the pool are also locked up for a three-year period before they potentially may be transferred to the participants.
Based on an assessment of the economic value generated in 2007 as well as the performance of the R&D portfolio and key sustainability projects, the Board of Directors on 30 January 2008 approved the establishment of a pool for 2007 by allocating a total of 527,665 Novo Nordisk B shares, corresponding to a cash value of DKK 135 million. This allocation amounts to 3.25 months of fixed base salary on average per participant. This amount will be amortised over four years.
Compliance with Sarbanes-Oxley requirements
In 2007, Novo Nordisk was, as was also the case in 2006, compliant with the US Sarbanes-Oxley Act section 404 that requires detailed documentation of how financial reporting processes, systems and controls are designed and operating. Management's conclusion and the external auditor's certification of the 2007 compliance are included in the Form 20-F, which Novo Nordisk as a listed company on the New York Stock Exchange is required to prepare. The Form 20-F is expected to be filed mid-February 2008.
Sustainability issues update
The World Diabetes Foundation (WDF) is dedicated to supporting the prevention and treatment of diabetes in the developing world through the funding of sustainable projects. At its core lies the promise of equal access to diabetes care. The WDF was established by Novo Nordisk A/S in 2002 through a commitment to donate an amount not exceeding DKK 65 million per year until 2010. The WDF is an independent trust and is governed by a board of six experts in the field of diabetes, access to health and development assistance. Since 2002, the WDF has successfully funded 138 projects in more than 70 developing countries, and it is estimated that these projects will potentially influence the diabetes treatment of 55 million people directly.
The Board of Directors of Novo Nordisk wishes to secure that the WDF is able to continue its activities after expiry in 2010 of the original donation period, and will propose that the Annual General Meeting approves a donation by Novo Nordisk to the WDF of an amount up to a total of DKK 575 million to be granted as individual annual contributions over a period of 10 years as from the financial year 2008 through to the financial year 2017.
Implementation of the UN Resolution on diabetes
On the first UN-observed World Diabetes Day, 14 November 2007, Novo Nordisk organised events to mark the day across the world. Around 250,000 people in 50 countries took part. The company's global advocacy effort to promote awareness of and action on diabetes is a response to the UN Resolution on diabetes, adopted in December 2006, in recognition of diabetes as a major global health challenge and in respect of the human right to proper care. Novo Nordisk continues to take an active leadership role in its implementation via its National Changing Diabetes® programmes, which offer awareness, education and guidelines on prevention, treatment and care of diabetes.
Changing Diabetes® Barometer
The Changing Diabetes® Barometer, launched in November 2007, will measure and share the worldwide progress in the fight against diabetes on an annual basis. The Barometer is a tool that will provide healthcare professionals, patient organisations, politicians, institutions and news media with valuable information on how to improve the quality of diabetes care, bring down diabetes-related complications, extend patients' life expectancy and reduce costs. An annual report will include key findings from the Barometer. The first report covers 21 countries and highlights that significant savings, potentially as much as a 20% reduction of lifelong healthcare costs, can be achieved if people with diabetes are diagnosed earlier and before any complications arise.
Legal issues update
US hormone therapy litigation
As of 30 January 2008, Novo Nordisk Inc., as well as the majority of hormone therapy product manufacturers in the US, is a defendant in product liability lawsuits related to hormone therapy products. These lawsuits currently involve a total of 45 individuals who allege use of a Novo Nordisk hormone therapy product. These products (Activella® and Vagifem®) have been sold and marketed in the US since 2000. Until July 2003, the products were sold and marketed exclusively in the US by Pharmacia & Upjohn Company (now Pfizer Inc.). Further, 27 individuals currently allege, in relation to similar lawsuits against Pfizer Inc., that they also have used a Novo Nordisk hormone therapy product. Novo Nordisk does not have any court trials scheduled for 2008 and does not presently expect to have a trial before late 2008. Novo Nordisk does not expect the pending claims to impact Novo Nordisk's financial outlook.
Additional information on contingent liabilities is available in the financial notes in the Annual Report 2007, which is expected to be available on Novo Nordisk's website on 4 February 2008.
Financial calendar
4 February 2008 - PDF version of the Annual Report available on novonordisk.com, online Annual Report launched
15 February 2008 - Printed version of the Annual Report
12 March 2008 - Annual General Meeting
13 March 2008 - Shareholders' meeting (in Danish only)
30 April 2008 - Financial statement for the first quarter of 2008
7 August 2008 - Financial statement for the first half of 2008
30 October 2008 - Financial statement for the first nine months of 2008
29 January 2009 - Financial statement for 2008
Conference call details
At 13.00 CET today, corresponding to 7.00 am New York time, a conference call will be held. Investors will be able to listen in via a link on novonordisk.com, which can be found under 'Investors - Download centre'. Presentation material for the conference call will be made available approximately one hour before on the same page.
Forward-looking statement
Novo Nordisk's reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document as well as the company's Annual Report 2007 and Form 20-F both expected to be filed with the SEC in February 2008, 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' 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 (i) statements of plans, objectives or goals for future operations, including those related to Novo Nordisk's products, product research, product introductions and product approvals as well as cooperations in relation thereto, (ii) statements containing projections of revenues, income (or loss), earnings per share, capital expenditures, dividends, capital structure or other net financials, (iii) statements of future economic performance , future actions and outcome of contingencies such as legal proceedings, and (iv) statements of the assumptions underlying or relating to such statements. In this document, examples of forward-looking statements can be found under the headings 'Outlook 2008', 'Research and development update' and 'Legal issues update'.
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 in this document, could cause actual results to differ materially from those contained 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 development projects, unplanned loss of patents, interruptions of supplies and production, product recall, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk's products, introduction of competing products, reliance on information technology, Novo Nordisk's ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees and failure to maintain a culture of compliance. Please also refer to 'business strategy, opportunities and key risks' on pp 8-9 of the Annual Report 2007 expected to be available on our website (novonordisk.com) from 4 February 2008.
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.
Bagsværd 31 January 2008
Board of Directors
Contacts for further information
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Media: |
Investors: |
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Outside North America: |
Outside North America: |
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Mike Rulis |
Mads Veggerby Lausten |
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Tel (direct): (+45) 4442 3573 |
Tel (direct): (+45) 4443 7919 |
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Hans Rommer |
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Tel (direct): (+45) 4442 4765 |
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In North America: |
In North America: |
|
Sean Clements |
Christian Qvist Frandsen |
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Tel (direct): (+1) 609 514 8316 |
Tel (direct): (+1) 609 919 7937 |
Further information on Novo Nordisk is available on the company's internet homepage at the address: novonordisk.com
Encl 1: Quarterly numbers in DKK
|
(Amounts in DKK million, except number of employees,
earnings per share and number of shares outstanding.) | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
%
change |
|
|
2007 |
|
2006 |
|
Q4
2007
vs | ||||||
|
|
Q4 |
Q3 |
Q2 |
Q1 |
|
Q4 |
Q3 |
Q2 |
Q1 |
|
Q4
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales |
10,946 |
10,504 |
10,563 |
9,818 |
|
10,487 |
9,583 |
9,727 |
8,946 |
|
4% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
8,345 |
7,990 |
8,205 |
7,498 |
|
7,906 |
7,246 |
7,475 |
6,531 |
|
6% |
|
Gross margin |
76.2% |
76.1% |
77.7% |
76.4% |
|
75.4% |
75.6% |
76.8% |
73.0% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and
distribution
costs |
3,220 |
2,993 |
3,110 |
3,048 |
|
3,331 |
2,699 |
2,850 |
2,728 |
|
-3% |
|
Percent of
sales |
29.4% |
28.5% |
29.4% |
31.0% |
|
31.8% |
28.2% |
29.3% |
30.5% |
|
|
|
Research and
development
costs |
3,413 |
1,724 |
1,754 |
1,647 |
|
1,910 |
1,489 |
1,498 |
1,419 |
|
79% |
|
Hereof costs
related to
discontinua-
tion of
AERx®* |
1,325 |
|
|
|
|
|
|
|
|
|
|
|
Percent of
sales |
31.2% |
16.4% |
16.6% |
16.8% |
|
18.2% |
15.5% |
15.4% |
15.9% |
|
|
|
Percent of
sale (excl.
AERx®)* |
19.1% |
|
|
|
|
|
|
|
|
|
|
|
Administra-
tive expenses |
677 |
623 |
594 |
614 |
|
645 |
605 |
557 |
580 |
|
5% |
|
Percent of
sales |
6.2% |
5.9% |
5.6% |
6.3% |
|
6.2% |
6.3% |
5.7% |
6.5% |
|
|
|
Licence fees
and other
operating
income (net) |
92 |
31 |
60 |
138 |
|
88 |
49 |
59 |
76 |
|
5% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
profit |
1,127 |
2,681 |
2,807 |
2,327 |
|
2,108 |
2,502 |
2,629 |
1,880 |
|
-47% |
|
Operating
margin |
10.3% |
25.5% |
26.6% |
23.7% |
|
20.1% |
26.1% |
27.0% |
21.0% |
|
|
|
Operating
profit (excl.
AERx®)* |
2,452 |
|
|
|
|
|
|
|
|
|
16% |
|
Operating
margin (excl.
AERx®)* |
22.4% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share of
profit/(loss)
in associated
companies |
0 |
(57) |
1,350 |
(60) |
|
(112) |
(30) |
(58) |
(60) |
|
- |
|
Financial
income |
375 |
322 |
297 |
309 |
|
579 |
139 |
102 |
111 |
|
-35% |
|
Financial
expenses |
155 |
90 |
60 |
202 |
|
165 |
77 |
182 |
202 |
|
-6% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit before
income taxes |
1,347 |
2,856 |
4,394 |
2,374 |
|
2,410 |
2,534 |
2,491 |
1,729 |
|
-44% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net profit |
977 |
2,184 |
3,652 |
1,709 |
|
1,724 |
1,774 |
1,743 |
1,211 |
|
-43% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation,
amortisation
and
impairment
losses |
1,396 |
586 |
516 |
509 |
|
574 |
600 |
508 |
460 |
|
143% |
|
Depreciation,
amortisation,
etc (excl.
AERx®)* |
526 |
|
|
|
|
|
|
|
|
|
-8% |
|
Capital
expenditure |
719 |
597 |
508 |
444 |
|
899 |
671 |
622 |
595 |
|
-20% |
|
Cash flow
from
operating
activities |
2,498 |
3,500 |
1,438 |
2,551 |
|
359 |
3,520 |
1,768 |
2,091 |
|
596% |
|
Free cash
flow |
3,198 |
2,888 |
826 |
2,100 |
|
(439) |
2,684 |
996 |
1,466 |
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
32,182 |
33,161 |
33,475 |
29,676 |
|
30,122 |
28,288 |
28,908 |
27,042 |
|
7% |
|
Total assets |
47,731 |
48,423 |
48,300 |
44,742 |
|
44,692 |
43,744 |
43,145 |
41,299 |
|
7% |
|
Equity ratio |
67.4% |
68.5% |
69.3% |
66.3% |
|
67.4% |
64.7% |
67.0% |
65.5% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Full-time
employees at
the end of
the period |
25,516 |
25,206 |
24,729 |
24,045 |
|
23,172 |
23,071 |
22,792 |
22,556 |
|
10% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
earnings per
share (in
DKK) |
1.56 |
3.46 |
5.75 |
2.69 |
|
2.72 |
2.77 |
2.70 |
1.87 |
|
-43% |
|
Diluted
earnings per
share (in
DKK) |
1.55 |
3.43 |
5.71 |
2.68 |
|
2.70 |
2.76 |
2.69 |
1.86 |
|
-43% |
|
Average
number of
shares
outstanding
(million)** |
624.4 |
632.0 |
635.8 |
635.0 |
|
634.2 |
640.2 |
645.8 |
647.2 |
|
-2% |
|
Average
number of
shares
outstanding
incl |
|
|
|
|
|
|
|
|
|
|
|
|
dilutive effect
of options 'in
the money'
(million)** |
629.6 |
636.4 |
640.2 |
639.4 |
|
638.4 |
643.6 |
649.0 |
650.4 |
|
-1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales by
business
segments: |
|
|
|
|
|
|
|
|
|
|
|
|
Modern
insulins
(insulin
analogues) |
3,911 |
3,568 |
3,464 |
3,065 |
|
3,122 |
2,701 |
2,678 |
2,324 |
|
25% |
|
Human
insulins *** |
3,116 |
3,098 |
3,222 |
3,136 |
|
3,519 |
3,306 |
3,301 |
3,325 |
|
-11% |
|
Insulin-
related sales
*** |
448 |
445 |
437 |
419 |
|
431 |
391 |
406 |
378 |
|
4% |
|
Oral
antidiabetic
products
(OAD) |
512 |
585 |
529 |
523 |
|
508 |
516 |
483 |
477 |
|
1% |
|
Diabetes
care total |
7,987 |
7,696 |
7,652 |
7,143 |
|
7,580 |
6,914 |
6,868 |
6,504 |
|
5% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NovoSeven® |
1,519 |
1,427 |
1,508 |
1,411 |
|
1,470 |
1,393 |
1,507 |
1,265 |
|
3% |
|
Growth
hormone
therapy |
925 |
878 |
924 |
784 |
|
897 |
821 |
882 |
709 |
|
3% |
|
Hormone
replacement
therapy |
437 |
414 |
411 |
406 |
|
455 |
383 |
396 |
373 |
|
-4% |
|
Other
products |
78 |
89 |
68 |
74 |
|
85 |
72 |
74 |
95 |
|
-8% |
|
Biopharma-
ceuticals
total |
2,959 |
2,808 |
2,911 |
2,675 |
|
2,907 |
2,669 |
2,859 |
2,442 |
|
2% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales by
geographic
segments: |
|
|
|
|
|
|
|
|
|
|
|
|
Europe
**** |
4,348 |
4,036 |
4,035 |
3,931 |
|
4,013 |
3,843 |
3,903 |
3,541 |
|
8% |
|
North
America |
3,608 |
3,500 |
3,424 |
3,214 |
|
3,486 |
3,062 |
2,968 |
2,764 |
|
3% |
|
International
Operations
**** |
1,776 |
1,870 |
1,953 |
1,696 |
|
1,690 |
1,539 |
1,648 |
1,617 |
|
5% |
|
Japan &
Oceania |
1,214 |
1,098 |
1,151 |
977 |
|
1,298 |
1,139 |
1,208 |
1,024 |
|
-6% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment
operating
profit: |
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes
care |
(75) |
1,487 |
1,600 |
1,247 |
|
1,198 |
1,296 |
1,490 |
998 |
|
- |
|
Diabetes
care (excl.
AERx®)* |
1,250 |
|
|
|
|
|
|
|
|
|
4% |
|
Biopharma-
ceuticals |
1,202 |
1,194 |
1,207 |
1,080 |
|
910 |
1,206 |
1,139 |
882 |
|
32% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*) Excluding costs related to the discontinuation of AERx® |
|
|
|
|
|
| |||||
|
**) For Q4 2007 the exact numbers of 'Average number
of shares outstanding' and 'Average number of shares
outstanding incl dilutive effect of options
in the money'' are 624,376,552 and 629,555,043 respectively. | |||||||||||
|
***) As from Q2 2007 sales figures for Human insulins
and Insulin-related sales are presented separately.
Comparative figures are adjusted accordingly. | |||||||||||
|
****) Comparative figures from 2006 have been adjusted
in order to reflect a changed organisational structure from
1 January 2007 which transfers 8 countries, incl. Bulgaria and
Romania, from International Operations to Europe. | |||||||||||
Encl 2: Quarterly numbers in EUR
|
(Amounts in EUR million, except number of employees,
earnings per share and number of shares outstanding.) | |||||||||||||||||
|
Key figures are translated into EUR as supplementary information -
the translation is based on average exchange rate
for income statement and exchange rate at the balance sheet date
for balance sheet items. | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
%
change | ||||||
|
|
2007 |
|
2006 |
|
Q4 2007
vs | ||||||||||||
|
|
Q4 |
Q3 |
Q2 |
Q1 |
|
Q4 |
Q3 |
Q2 |
Q1 |
|
Q4
2006 | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Sales |
1,468 |
1,411 |
1,418 |
1,317 |
|
1,406 |
1,285 |
1,304 |
1,199 |
|
4% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Gross profit |
1,119 |
1,074 |
1,101 |
1,006 |
|
1,060 |
972 |
1,002 |
875 |
|
6% | ||||||
|
Gross margin |
76.2% |
76.1% |
77.7% |
76.4% |
|
75.4% |
75.6% |
76.8% |
73.0% |
|
| ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Sales and
distribution
costs |
432 |
402 |
417 |
409 |
|
447 |
361 |
382 |
366 |
|
-3% | ||||||
|
Percent of
sales |
29.4% |
28.5% |
29.4% |
31.0% |
|
31.8% |
28.2% |
29.3% |
30.5% |
|
| ||||||
|
Research
and
development
costs |
458 |
232 |
235 |
221 |
|
256 |
200 |
201 |
190 |
|
79% | ||||||
|
-Hereof costs
related to
discontinua-
tion of
AERx®* |
178 |
|
|
|
|
|
|
|
|
|
| ||||||
|
Percent of
sales |
31.2% |
16.4% |
16.6% |
16.8% |
|
18.2% |
15.5% |
15.4% |
15.9% |
|
| ||||||
|
Percent of
sales (excl.
AERx®)* |
19.1% |
|
|
|
|
|
|
|
|
|
| ||||||
|
Administra-
tive
expenses |
91 |
84 |
80 |
82 |
|
86 |
82 |
74 |
78 |
|
5% | ||||||
|
Percent of
sales |
6.2% |
5.9% |
5.6% |
6.3% |
|
6.2% |
6.3% |
5.7% |
6.5% |
|
| ||||||
|
Licence fees
and other
operating
income (net) |
12 |
4 |
8 |
19 |
|
11 |
7 |
8 |
10 |
|
5% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Operating
profit |
151 |
360 |
377 |
312 |
|
283 |
336 |
352 |
252 |
|
-47% | ||||||
|
Operating
margin |
10.3% |
25.5% |
26.6% |
23.7% |
|
20.1% |
26.1% |
27.0% |
21.0% |
|
| ||||||
|
Operating
profit (excl.
AERx®)* |
329 |
|
|
|
|
|
|
|
|
|
16% | ||||||
|
Operating
margin (excl.
AERx®)* |
22.4% |
|
|
|
|
|
|
|
|
|
| ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Share of
profit/(loss)
in
associated
companies |
0 |
(7) |
181 |
(8) |
|
(15) |
(4) |
(8) |
(8) |
|
- | ||||||
|
Financial
income |
49 |
44 |
40 |
41 |
|
78 |
18 |
14 |
15 |
|
-35% | ||||||
|
Financial
expenses |
21 |
12 |
8 |
27 |
|
22 |
11 |
24 |
27 |
|
-6% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Profit before
income
taxes |
180 |
384 |
589 |
319 |
|
324 |
339 |
334 |
232 |
|
-44% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Net profit |
131 |
294 |
490 |
229 |
|
231 |
238 |
234 |
162 |
|
-43% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Depreciation,
amortisation
and
impairment
losses |
188 |
78 |
70 |
68 |
|
77 |
80 |
68 |
62 |
|
143% | ||||||
|
Depreciation,
amortisation,
etc (excl
AERx®)* |
71 |
|
|
|
|
|
|
|
|
|
-8% | ||||||
|
Capital
expenditure |
96 |
80 |
68 |
60 |
|
121 |
90 |
83 |
80 |
|
-20% | ||||||
|
Cash flow
from
operating
activities |
335 |
470 |
193 |
342 |
|
48 |
472 |
237 |
280 |
|
596% | ||||||
|
Free cash
flow |
430 |
387 |
111 |
282 |
|
(59) |
360 |
134 |
196 |
|
- | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Equity |
4,316 |
4,449 |
4,498 |
3,983 |
|
4,040 |
3,793 |
3,875 |
3,624 |
|
7% | ||||||
|
Total
assets |
6,401 |
6,496 |
6,490 |
6,005 |
|
5,994 |
5,866 |
5,784 |
5,534 |
|
7% | ||||||
|
Equity ratio |
67.4% |
68.5% |
69.3% |
66.3% |
|
67.4% |
64.7% |
67.0% |
65.5% |
|
| ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Full-time
employees
at the end
of the
period |
25,516 |
25,206 |
24,729 |
24,045 |
|
23,172 |
23,071 |
22,792 |
22,556 |
|
10% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Basic
earnings
per share
(in EUR) |
0.21 |
0.47 |
0.77 |
0.36 |
|
0.37 |
0.37 |
0.36 |
0.25 |
|
-43% | ||||||
|
Diluted
earnings
per share
(in EUR) |
0.21 |
0.47 |
0.76 |
0.36 |
|
0.36 |
0.37 |
0.36 |
0.25 |
|
-43% | ||||||
|
Average
number of
shares
outstanding
(million)** |
624.4 |
632.0 |
635.8 |
635.0 |
|
634.2 |
640.2 |
645.8 |
647.2 |
|
-2% | ||||||
|
Average
number of
shares
outstanding
incl |
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Dilutive
effect
of options
'in the
money'
(million)** |
629.6 |
636.4 |
640.2 |
639.4 |
|
638.4 |
643.6 |
649.0 |
650.4 |
|
-1% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Sales by
business
segments: |
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Modern
insulins
(insulin
analogues) |
525 |
479 |
465 |
411 |
|
418 |
363 |
359 |
311 |
|
25% | ||||||
|
Human
insulins
*** |
418 |
416 |
432 |
421 |
|
472 |
443 |
442 |
446 |
|
-11% | ||||||
|
Insulin-
related
sales
*** |
60 |
60 |
59 |
56 |
|
57 |
53 |
54 |
51 |
|
4% | ||||||
|
Oral
Antidiabetic
products
(OAD) |
68 |
79 |
71 |
70 |
|
68 |
69 |
65 |
64 |
|
1% | ||||||
|
Diabetes
care total |
1,071 |
1,034 |
1,027 |
958 |
|
1,015 |
928 |
920 |
872 |
|
5% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
NovoSeven® |
204 |
191 |
203 |
189 |
|
197 |
186 |
202 |
170 |
|
3% | ||||||
|
Growth
hormone
therapy |
124 |
118 |
124 |
105 |
|
121 |
110 |
118 |
95 |
|
3% | ||||||
|
Hormone
replacement
therapy |
59 |
55 |
56 |
54 |
|
61 |
51 |
53 |
50 |
|
-4% | ||||||
|
Other
products |
10 |
12 |
9 |
10 |
|
12 |
9 |
10 |
13 |
|
-8% | ||||||
|
Biopharma-
ceuticals
total |
397 |
376 |
392 |
358 |
|
391 |
356 |
383 |
328 |
|
2% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Sales by
geographic
segments: |
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Europe
**** |
583 |
542 |
542 |
527 |
|
538 |
515 |
523 |
475 |
|
8% | ||||||
|
North
America |
484 |
470 |
460 |
431 |
|
467 |
411 |
398 |
370 |
|
3% | ||||||
|
International
operations
**** |
238 |
251 |
262 |
228 |
|
227 |
206 |
221 |
217 |
|
5% | ||||||
|
Japan &
Oceania |
163 |
147 |
155 |
131 |
|
174 |
153 |
162 |
137 |
|
-6% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Segment
operating
profit: |
|
|
|
|
|
|
|
|
|
|
| ||||||
|
Diabetes
care |
(10) |
200 |
215 |
167 |
|
161 |
173 |
200 |
134 |
|
- | ||||||
|
Diabetes
care
(excl.
AERx®)* |
168 |
|
|
|
|
|
|
|
|
|
4% | ||||||
|
Biopharma-
ceuticals |
162 |
160 |
162 |
145 |
|
122 |
162 |
153 |
118 |
|
32% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
*) Excluding costs related to the discontinuation of AERx® |
|
|
|
|
| ||||||||||||
|
**) For Q4 2007 the exact numbers of 'Average number
of shares outstanding' and 'Average number of shares
outstanding incl dilutive effect of options
in the money'' are 624,376,552 and 629,555,043 respectively. | |||||||||||||||||
|
***) As from Q2 2007 sales figures for Human insulins
and Insulin-related sales are presented separately.
Comparative figures are adjusted accordingly. | |||||||||||||||||
|
****) Comparative figures from 2006 have been adjusted
in order to reflect a changed organisational structure from
1 January 2007 which transfers 8 countries,
incl. Bulgaria and Romania, from International Operations to Europe. | |||||||||||||||||
Encl 3: Income Statement
|
|
12M |
12M |
|
DKK million |
2007 |
2006 |
|
|
|
|
|
|
|
|
|
Sales |
41,831 |
38,743 |
|
Cost of goods sold |
9,793 |
9,585 |
|
Gross profit |
32,038 |
29,158 |
|
|
|
|
|
Sales and distribution costs |
12,371 |
11,608 |
|
Research and development costs |
8,538 |
6,316 |
|
- Hereof costs related to discontinuation of AERx® |
1,325 |
- |
|
Administrative expenses |
2,508 |
2,387 |
|
Licence fees and other operating income (net) |
321 |
272 |
|
Operating profit |
8,942 |
9,119 |
|
Operating profit
(excl. costs related to discontinuation of AERx®) |
10,267 |
- |
|
|
|
|
|
Share of profit/(loss) in associated companies |
1,233 |
(260) |
|
Financial income |
1,303 |
931 |
|
Financial expenses |
507 |
626 |
|
Profit before income taxes |
10,971 |
9,164 |
|
|
|
|
|
Income taxes |
2,449 |
2,712 |
|
NET PROFIT |
8,522 |
6,452 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share (DKK) |
13.49 |
10.05 |
|
Diluted earnings per share (DKK) |
13.39 |
10.00 |
|
|
|
|
|
|
|
|
|
Segment sales: |
|
|
|
Diabetes care |
30,478 |
27,866 |
|
Biopharmaceuticals |
11,353 |
10,877 |
|
|
|
|
|
Segment operating profit: |
|
|
|
Diabetes care |
4,259 |
4,982 |
|
Operating margin |
14.0% |
17.9% |
|
Diabetes care (excl. AERx®)* |
5,584 |
- |
|
Operating margin (excl. AERx®)* |
18.3% |
- |
|
|
|
|
|
Biopharmaceuticals |
4,683 |
4,137 |
|
Operating margin |
41.2% |
38.0% |
|
|
|
|
|
*) Excluding costs related to the
discontinuation of AERx® |
|
|
Encl 4: Balance sheet
|
DKK million |
31Dec2007 |
31Dec2006 |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Intangible assets |
671 |
639 |
|
Property, plant and
equipment |
19,605 |
20,350 |
|
Investments in associated
companies |
500 |
788 |
|
Deferred income tax assets |
2,522 |
1,911 |
|
Other financial assets |
131 |
169 |
|
TOTAL LONG-TERM
ASSETS |
23,429 |
23,857 |
|
|
|
|
|
Inventories |
9,020 |
8,400 |
|
Trade receivables |
6,092 |
5,163 |
|
Tax receivables |
319 |
385 |
|
Other receivables |
1,493 |
1,784 |
|
Marketable securities and
financial derivatives |
2,555 |
1,833 |
|
Cash at bank and in hand |
4,823 |
3,270 |
|
TOTAL CURRENT ASSETS |
24,302 |
20,835 |
|
|
|
|
|
TOTAL ASSETS |
47,731 |
44,692 |
|
|
|
|
|
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
|
|
|
|
Share capital |
647 |
674 |
|
Treasury shares |
(26) |
(39) |
|
Retained earnings |
30,661 |
28,810 |
|
Other comprehensive
income |
900 |
677 |
|
TOTAL EQUITY |
32,182 |
30,122 |
|
|
|
|
|
Long-term debt |
961 |
1,174 |
|
Deferred income tax
liabilities |
2,346 |
1,998 |
|
Provision for pensions |
362 |
330 |
|
Other provisions |
1,239 |
911 |
|
Total long-term liabilities |
4,908 |
4,413 |
|
|
|
|
|
Short-term debt and financial
derivatives |
405 |
338 |
|
Trade payables |
1,947 |
1,712 |
|
Tax payables |
929 |
788 |
|
Other liabilities |
4,959 |
4,863 |
|
Other provisions |
2,401 |
2,456 |
|
Total current liabilities |
10,641 |
10,157 |
|
|
|
|
|
TOTAL LIABILITIES |
15,549 |
14,570 |
|
|
|
|
|
TOTAL EQUITY AND
LIABILITIES |
47,731 |
44,692 |
Encl 5: Cash flow statement
|
DKK million |
2007 |
2006 |
|
|
|
|
|
Net profit |
8,522 |
6,452 |
|
|
|
|
|
Adjustment for non-cash
items: |
|
|
|
Income taxes |
2,449 |
2,712 |
|
Depreciation, amortisation
and impairment losses |
3,007 |
2,142 |
|
Interest income and interest
expenses |
(16) |
(73) |
|
Other adjustment for
non-cash items |
(309) |
959 |
|
Income taxes paid |
(2,607) |
(3,514) |
|
Interest received and
interest paid (net) |
(29) |
95 |
|
Cash flow before change
in working capital |
11,017 |
8,773 |
|
|
|
|
|
Change in working capital: |
|
|
|
(Increase)/decrease in trade
receivables and other receivables |
(702) |
(804) |
|
(Increase)/decrease in inventories |
(617) |
(686) |
|
Increase/(decrease) in trade
payables and other liabilities |
289 |
455 |
|
Cash flow from operating
activities |
9,987 |
7,738 |
|
|
|
|
|
Investments: |
|
|
|
Acquisition of subsidiaries
and business units |
(59) |
- |
|
Sale of intangible assets and
long-term financial assets |
- |
175 |
|
Purchase of intangible assets
and long-term financial assets |
(118) |
(419) |
|
Sale of property, plant and
equipment |
40 |
111 |
|
Purchase of property, plant
and equipment |
(2,308) |
(2,898) |
|
Net change in marketable
Securities
(maturity exceeding three months) |
(541) |
514 |
|
Dividend received |
1,470 |
- |
|
Net cash used in investing
activities |
(1,516) |
(2,517) |
|
|
|
|
|
Financing: |
|
|
|
New long-term debt |
- |
- |
|
Repayment of long-term debt |
(18) |
(23) |
|
Purchase of treasury shares |
(4,835) |
(3,000) |
|
Sale of treasury shares |
241 |
210 |
|
Dividends paid |
(2,221) |
(1,945) |
|
Cash flow from financing
activities |
(6,833) |
(4,758) |
|
|
|
|
|
NET CASH FLOW |
1,638 |
463 |
|
|
|
|
|
Unrealised gain/(loss) on
exchange rates and
marketable securities |
|
|
|
included in cash and cash
equivalents |
(6) |
39 |
|
Net change in cash and
cash equivalents |
1,632 |
502 |
|
|
|
|
|
Cash and cash equivalents
at the beginning of the year |
2,985 |
2,483 |
|
Cash and cash equivalents
at the end of the year |
4,617 |
2,985 |
|
|
|
|
|
Bonds with original term to
maturity exceeding three
months |
1,486 |
1,001 |
|
Undrawn committed
credit facilities |
7,457 |
7,456 |
|
FINANCIAL RESOURCES
AT THE END OF THE YEAR |
13,560 |
11,442 |
|
|
|
|
|
|
|
|
|
Cash flow from operating
activities |
9,987 |
7,738 |
|
+ Net cash used in investing
activities |
(1,516) |
(2,517) |
|
- Net change in marketable
securities (maturity exceeding
three months) |
(541) |
514 |
|
FREE CASH FLOW |
9,012 |
4,707 |
Encl 6: Statement of changes in equity
|
|
|
|
|
|
Other
comprehen-
sive income |
|
|
|
|
DKK million |
Share
capital |
Trea-
sury
shares |
Retained
earnings |
Exchange
rate
adjust-
ments |
Deferred
gain/loss
on cash
flow hedges |
Other
adjust-
ments |
Total |
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at the
beginning
of the year |
674 |
(39) |
28,810 |
156 |
420 |
101 |
30,122 |
|
|
Exchange
rate
adjustment
of investments
in subsidiaries |
|
|
|
53 |
|
|
53 |
|
|
Deferred
(gain)/loss
on cash flow
hedges at the
beginning of
the year
recognised in
the Income
statement for
the year |
|
|
|
|
(420) |
|
(420) |
|
|
Deferred
gain/(loss) on
cash flow
hedges at the
end of the year |
|
|
|
|
691 |
|
691 |
|
|
Fair value
Adjustments
on financial
assets
available
for sale |
|
|
|
|
|
12 |
12 |
|
|
Novo Nordisk
share of equity
recognised by
associated
companies |
|
|
|
|
|
(41) |
(41) |
|
|
Tax on equity
adjustments |
|
|
|
|
|
(93) |
(93) |
|
|
Other
adjustments |
|
|
|
|
|
21 |
21 |
|
|
Net income
Recognised
directly in
equity for
the year |
- |
- |
- |
53 |
271 |
(101) |
223 |
|
|
Net profit
for the year |
|
|
8,522 |
|
|
|
8,522 |
|
|
Total income
for the year |
- |
- |
8,522 |
53 |
271 |
(101) |
8,745 |
|
|
Share-based
payment |
|
|
130 |
|
|
|
130 |
|
|
Purchase of
treasury
shares |
|
(16) |
(4,819) |
|
|
|
(4,835) |
|
|
Sale of
treasury
shares |
|
2 |
239 |
|
|
|
241 |
|
|
Reduction of
the B share
capital |
(27) |
27 |
|
|
|
|
- |
|
|
Dividends |
|
|
(2,221) |
|
|
|
(2,221) |
|
|
Balance at
the end of
the year |
647 |
(26) |
30,661 |
209 |
691 |
- |
32,182 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At the end of the year proposed dividends
(not yet declared) of DKK 2,795 million are
included in Retained earnings. No dividend
is declared on treasury shares. |
||||||||
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
the
beginning of
the year |
709 |
(61) |
26,962 |
142 |
(345) |
227 |
27,634 |
|
|
Exchange
rate
adjustment
of investments
in subsidiaries |
|
|
|
14 |
|
|
14 |
|
|
Deferred
(gain)/loss on
cash flow
hedges at the
beginning of
the year
recognised in
the Income
statement for
the year |
|
|
|
|
345 |
|
345 |
|
|
Deferred
gain/(loss) on
cash flow
hedges at the
end of the
year |
|
|
|
|
420 |
|
420 |
|
|
Fair value
adjustments
on financial
assets
available
for sale |
|
|
|
|
|
(27) |
(27) |
|
|
Novo Nordisk
share of
equity
recognised by
associated
companies |
|
|
|
|
|
36 |
36 |
|
|
Tax on equity
adjustments |
|
|
|
|
|
(129) |
(129) |
|
|
Other
adjustments |
|
|
5 |
|
|
(6) |
(1) |
|
|
Net income
recognised
directly in
equity for
the year |
- |
- |
5 |
14 |
765 |
(126) |
658 |
|
|
Net profit
for the year |
|
|
6,452 |
|
|
|
6,452 |
|
|
Total income
for the year |
- |
- |
6,457 |
14 |
765 |
(126) |
7,110 |
|
|
Share-based
payment |
|
|
113 |
|
|
|
113 |
|
|
Purchase of
treasury
shares |
|
(15) |
(2,985) |
|
|
|
(3,000) |
|
|
Sale of
treasury
shares |
|
2 |
208 |
|
|
|
210 |
|
|
Reduction of
the B share
capital |
(35) |
35 |
|
|
|
|
- |
|
|
Dividends |
|
|
(1,945) |
|
|
|
(1,945) |
|
|
Balance at
the end of
the year |
674 |
(39) |
28,810 |
156 |
420 |
101 |
30,122 |
|
|
|
|
|
|
|
|
|
|
|
|
At the end of the year proposed dividends (declared in 2007)
of DKK 2,221 million are included in Retained earnings.
No dividend is declared on treasury shares. |
||||||||
Stock Exchange Announcement no 3 / 2008