Novo Nordisk increased operating profit by 15% in the first nine months of 2008
Expectations for growth in full-year operating profit raised to 32-35%
- Novo Nordisk increased sales by 13% in local currencies and by 7% in Danish kroner due to a negative currency development.
o Sales of modern insulins increased by 29% (22% in Danish kroner).
o Sales of NovoSeven® increased by 14% (6% in Danish kroner).
o Sales of Norditropin® increased by 13% (8% in Danish kroner).
o Sales in North America increased by 18% (5% in Danish kroner).
o Sales in International Operations increased by 21% (13% in Danish kroner).
- Gross margin improved by 1.2 percentage points in local currencies and by 0.3 percentage points in Danish kroner to 77.0% in the first nine months of 2008, reflecting continued productivity improvements and a negative currency impact of around 0.9 percentage points.
- Operating profit increased by 15% to DKK 8,999 million. Adjusted for the impact from currencies, underlying operating profit increased by more than 25%.
- Net profit decreased by 3% to DKK 7,315 million due to the non-recurring tax exempt income of DKK 1.4 billion recorded in the second quarter of 2007 from Novo Nordisk's divestment of Dako's business activities. Excluding the effect from the non-recurring income, net profit increased by 19%.
- For 2008, the expectation for reported operating profit growth is increased by around 10 percentage points to 32-35%, primarily reflecting a significant positive development in Novo Nordisk's key invoicing currencies as well as lower operational costs.
- Novo Nordisk has achieved clinical proof of concept with a new generation of insulins, NN5401 and NN1250 and intends to initiate phase 3 clinical development in the second half of 2009.
Lars Rebien Sørensen, president and CEO, said: "We are pleased with the way our business has developed during the first nine months. This allows us to raise guidance for full-year 2008 operating profit growth. Furthermore, our preliminary plans for 2009 indicate continued double-digit growth in both sales and operating profit."
Financial statement for the first nine months of 2008
This interim report has been prepared in accordance with International Financial Reporting Standards (IFRS). The accounting policies used in the interim report are consistent with those used in the Annual Report 2007. The interim report has not been audited.
Amounts in DKK million, except average number of shares outstanding, earnings per share and full-time employees.
|
Income statement |
9M 2008 |
9M 2007 |
% change 9M 2007 to 9M 2008 |
|
|
|
|
|
|
Sales |
32,970 |
30,885 |
7% |
|
|
|
|
|
|
Gross profit |
25,397 |
23,693 |
7% |
|
Gross margin |
77.0% |
76.7% |
|
|
|
|
|
|
|
Sales and distribution costs |
9,308 |
9,151 |
2% |
|
Percent of sales |
28.2% |
29.6% |
|
|
|
|
|
|
|
Research and development costs |
5,417 |
5,125 |
6% |
|
- hereof costs related to discontinuation of pulmonary diabetes projects |
325 |
- |
|
|
Percent of sales |
16.4% |
16.6% |
|
|
|
|
|
|
|
Administrative expenses |
1,886 |
1,831 |
3% |
|
Percent of sales |
5.7% |
5.9% |
|
|
|
|
|
|
|
Licence fees and other operating income |
213 |
229 |
-7% |
|
|
|
|
|
|
Operating profit |
8,999 |
7,815 |
15% |
|
Operating margin |
27.3% |
25.3% |
|
|
|
|
|
|
|
Net financials |
626 |
1,809 |
-65% |
|
Profit before tax |
9,625 |
9,624 |
0% |
|
|
|
|
|
|
Net profit |
7,315 |
7,545 |
-3% |
|
Net profit margin |
22.2% |
24.4% |
|
|
|
|
|
|
|
Other key numbers |
|
|
|
|
|
|
|
|
|
Depreciation, amortisation and impairment losses |
1,690 |
1,611 |
5% |
|
Capital expenditure |
990 |
1,549 |
-36% |
|
|
|
|
|
|
Cash flow from operating activities |
9,659 |
7,489 |
29% |
|
Free cash flow |
8,594 |
5,814 |
48% |
|
|
|
|
|
|
Total assets |
48,990 |
48,423 |
1% |
|
Equity |
32,173 |
33,161 |
-3% |
|
Equity ratio |
65.7% |
68.5% |
|
|
|
|
|
|
|
Average number of shares outstanding (million) - diluted |
622.8 |
638.6 |
-2% |
|
|
|
|
|
|
Diluted earnings per share (in DKK) |
11.74 |
11.82 |
-1% |
|
|
|
|
|
|
Full-time employees at the end of the period |
26,360 |
25,206 |
5% |
Sales development by segments
Sales increased by 13% measured in local currencies and by 7% in Danish kroner. Growth was realised within both diabetes care and biopharmaceuticals, and the primary growth contribution originated from the modern insulins.
|
|
Sales |
Growth |
Growth |
Share of |
|
|
9M 2008
DKK million |
as reported |
in local
currencies |
growth
in local currencies |
|
The diabetes care segment |
|
|
|
|
|
Modern insulins |
12,289 |
22% |
29% |
75% |
|
Human insulins |
8,711 |
(8%) |
(4%) |
(10%) |
|
Insulin-related products |
1,367 |
5% |
10% |
3% |
|
Oral antidiabetic products |
1,789 |
9% |
17% |
7% |
|
Diabetes care - total |
24,156 |
7% |
13% |
75% |
|
|
|
|
|
|
|
The biopharmaceuticals segment |
|
|
|
|
|
NovoSeven® |
4,622 |
6% |
14% |
16% |
|
Norditropin® |
2,805 |
8% |
13% |
9% |
|
Other products |
1,387 |
(5%) |
1% |
0% |
|
Biopharmaceuticals - total |
8,814 |
5% |
12% |
25% |
|
|
|
|
|
|
|
Total sales |
32,970 |
7% |
13% |
100% |
Sales development by regions
In the first nine months of 2008, sales growth was realised in all regions. The main contributors to growth were North America and International Operations, providing 47% and 29% respectively of the total sales growth measured in local currencies. Europe contributed 22% and Japan & Oceania 2% of the sales growth.
Diabetes care
Sales of diabetes care products increased by 13% measured in local currencies and by 7% in Danish kroner to DKK 24,156 million compared to the first nine months of 2007.
Modern insulins, human insulins and insulin-related products
Sales of modern insulins, human insulins and insulin-related products in the first nine months of 2008 increased by 13% measured in local currencies and by 7% in Danish kroner to DKK 22,367 million compared to the same period last year. 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 52% of the total insulin market and 44% of the modern insulin market, both measured by volume.
Sales of modern insulins increased by 29% in local currencies and by 22% in Danish kroner to DKK 12,289 million. Sales of Levemir® increased by 61% in local currencies compared to the first nine months of 2007. All regions realised solid growth rates for the modern insulins, with North America and Europe as the primary contributors to growth. Sales of modern insulins now constitute 59% of Novo Nordisk's sales of insulin.
Sales of human insulin decreased by 4% in local currencies and by 8% in Danish kroner to DKK 8,711 million, mainly reflecting a continued robust conversion to modern insulins in all regions.
North America
Sales in North America increased by 21% in local currencies in the first nine months of 2008 and by 8% in Danish kroner, reflecting solid penetration of the modern insulins Levemir®, NovoLog® and NovoLog® Mix 70/30. Novo Nordisk maintains its leadership position in the US insulin market with 42% of the total insulin market and 32% of the modern insulin market, both measured by volume. In the US market, the amount of insulin delivered in prefilled and durable devices is increasing but is still only approaching 20% measured in volume and 30% measured in value.
Europe
Sales in Europe increased by 7% in local currencies and by 6% measured in Danish kroner, reflecting continued progress in the portfolio of modern insulins. Novo Nordisk holds 56% of the total insulin market and 51% of the modern insulin market, both measured by volume, and continues to capture the main share of growth in the modern insulin market.
International Operations
Sales within International Operations increased by 19% in local currencies and by 12% in Danish kroner. In the first nine months of 2008, sales of modern insulins continued to be a significant contributor to growth in the region, led by China and Turkey. Furthermore, sales of human insulins continue to add to overall growth in the region, driven by China.
Sales in Japan & Oceania increased by 3% in local currencies and by 2% measured in Danish kroner. The sales development reflects sales growth for the modern insulins NovoRapid®, NovoRapid Mix® 30 and Levemir®. Levemir® was launched in December 2007 in Japan and has a current volume market share of around 18% of the long-acting insulin market in Japan. Novo Nordisk holds 72% of the total insulin market in Japan and 64% of the modern insulin market, both measured by volume.
Oral antidiabetic products (NovoNorm®/Prandin®)
In the first nine months of 2008, sales of oral antidiabetic products increased by 17% in local currencies and by 9% in Danish kroner to DKK 1,789 million compared to the first nine months of 2007. This primarily reflects increased sales in International Operations and North America followed by Europe.
Biopharmaceuticals
In the first nine months of 2008, sales of biopharmaceutical products increased by 12% measured in local currencies and by 5% measured in Danish kroner to DKK 8,814 million compared to the first nine months of 2007.
NovoSeven®
Sales of NovoSeven® increased by 14% in local currencies and by 6% in Danish kroner to DKK 4,622 million compared to the first nine months of 2007. Sales growth for NovoSeven® was primarily realised in North America followed by International Operations and Europe. The sales growth for NovoSeven® primarily reflects increased sales in the congenital bleeding disorder indications, and treatment of spontaneous bleeds for congenital inhibitor patients remains the largest area of use. Sales of NovoSeven® in International Operations in the first nine months of 2008 were positively impacted by the timing of tender sales compared to the same period in 2007. Sales of NovoSeven® in the US were positively impacted by a minor inventory build-up in relation to the launch of room temperature-stable NovoSeven®.
Norditropin®
Sales of Norditropin® (ie growth hormone in a liquid, ready-to-use formulation) increased by 13% measured in local currencies and by 8% measured in Danish kroner to DKK 2,805 million. Growth was realised in all regions, with North America as the primary contributor. Novo Nordisk continues to gain market share in the global growth hormone market and has the second-largest global market share of 24% measured by volume.
Other products
Sales of other products within biopharmaceuticals, which predominantly consist of hormone replacement therapy (HRT)-related products, increased by 1% in local currencies and decreased by 5% in Danish kroner to DKK 1,387 million. This development reflects global sales growth for Vagifem®, a locally administered HRT product, offset by generic competition in the US to Activella®, a continuous-combined HRT product.
Costs, licence fees and other operating income
The cost of goods sold was DKK 7,573 million in the first nine months of 2008, representing a gross margin of 77.0% compared to 76.7% in the same period last year. Excluding the impact from currency developments, primarily reflecting the lower value of the US dollar and the British pound versus the Danish krone compared to the first nine months of 2007, the gross margin in the first nine months of 2008 was 77.9%. This improvement primarily reflects improved production efficiency.
In the first nine months of 2008, total non-production-related costs increased by 3% to DKK 16,611 million compared to the same period last year. Sales and distribution costs increased by 2%, reflecting the combined effect of a provision related to an antidumping case in Brazil recorded in the first quarter of 2007, and increased US costs in the first nine months of 2008 related to the expanded sales force. Research and development costs increased by 6%, reflecting an increased level of activity in late-stage clinical development as well as the non-recurring costs related to the discontinuation of AERx® and other pulmonary diabetes projects.
Licence fees and other operating income of DKK 213 million in the first nine months of 2008 represent a decrease of 7% compared to the same period last year, which was positively impacted by a non-recurring income from the out-licensing of an oral antidiabetic compound (OAD).
Net financials
Net financials showed a net income of DKK 626 million in the first nine months of 2008 compared to a net income of DKK 1,809 million in the same period last year, where a non-recurring and tax-exempt income of DKK 1.4 billion from the divestment of the ownership of Dako's business activities was recorded.
Included in net financials is the result from associated companies with an expense of DKK 128 million, primarily related to Novo Nordisk's share of losses in ZymoGenetics, Inc., partly countered by an additional income of around DKK 50 million recorded in 2008 related to the divestment of the business activities in Dako in 2007.
The net effect of foreign exchange hedging was an income of DKK 671 million compared to an income of DKK 664 million in the same period of 2007. This development reflects gains on foreign exchange hedging activities due to the lower value of especially US dollars versus Danish kroner. As a result of the significant positive development in Novo Nordisk's main invoicing currencies, a foreign exchange hedging loss of around DKK 500 million has been deferred, as per 30 September 2008, for future expense recognition, primarily in 2009.
Free cash flow
The free cash flow for the first nine months of 2008 was realised at DKK 8,594 million compared to DKK 5,814 million in the first nine months of 2007. The increase in free cash flow is primarily related to the higher cash contribution from operating activities and the lower investment level in the first nine months of 2008 compared to the same period last year.
Outlook
The current expectations for 2008 are summarised and compared to the previous expectations in the table below (changes highlighted in bold and italic):
|
Expectations are as reported, if not otherwise stated |
Current expectations
30 October 2008 |
Previous expectations
7 August 2008 |
|
Sales growth
- in local currencies
- as reported |
11-13%
Around 3 percentage points lower |
11-13%
Around 6 percentage points lower |
|
Operating profit growth
- underlying
- as reported |
More than 25% 32-35% |
Around 25%
22-25% |
|
Net financial income |
DKK 350 million |
DKK 800 million |
|
Effective tax rate |
Approximately 24% |
Approximately 24% |
|
Capital expenditure |
Around DKK 1.5 billion |
Lower than DKK 2 billion |
|
Depreciation, amortisation and impairment losses |
Around DKK 2.4 billion |
Around DKK 2.5 billion |
|
Free cash flow |
Around DKK 9.5 billion |
Around DKK 8.5 billion |
Novo Nordisk still expects a sales growth for 2008 of 11-13% measured in local currencies whereas reported sales growth is now expected to be around 3 percentage points lower, given the current level of exchange rates.
The expectation for growth in reported operating profit for 2008 is increased by around 10 percentage points to 32-35%. This primarily reflects a positive impact from the recent significant appreciation of Novo Nordisk's main invoicing currencies and lower operational costs, partly countered by costs related to the employee share programme as well as costs related to the discontinuation of the phase 3 study with Norditropin® in dialysis patients with low serum albumin. The forecast includes lowered non-recurring costs in relation to the discontinuation of all pulmonary diabetes projects (reduced from DKK 400 million to DKK 325 million).
Adjusted for the impact from currency and the non-recurring costs related to the discontinuation of all pulmonary diabetes projects in 2007 and 2008, the expectation for underlying operating profit is now increased to a growth of more than 25%.
For 2008, Novo Nordisk now expects a net financial income of DKK 350 million, reflecting the significant foreign exchange hedging gains in the first nine months of 2008, primarily related to the US dollar, partly being offset by the expected hedging losses in the fourth quarter of 2008 related to the recent significant appreciation of key invoicing currencies.
The expectation for the effective tax rate for 2008 is still 24%.
Capital expenditure is now expected to be around DKK 1.5 billion in 2008 whereas depreciations, amortisation and impairment losses are now expected to be around DKK 2.4 billion. Free cash flow is now expected to be around DKK 9.5 billion, primarily explained by higher operating profit expectations and the expected lower level of investments.
With regard to the financial outlook for 2009 it is Novo Nordisk's intention to provide detailed guidance on expectations in connection with the full-year release of financial results for 2008, scheduled for 29 January 2009. At present, the preliminary plans for 2009 indicate both sales growth and operating profit growth at the level of 10% measured in local currencies. The reported sales growth for 2009 is expected to be around 8 percentage points higher and the reported operating profit growth is expected to be at least 15 percentage points higher due to an expected positive currency impact following the recent significant appreciation of Novo Nordisk's main invoicing currencies. These preliminary plans reflect expectations of a continued solid penetration of the portfolio of modern insulins as well as progress for the key products within biopharmaceuticals, but also an expectation of continued intense competition in both the diabetes care and biopharmaceuticals areas. The preliminary plans for growth in operating profit in 2009 also reflect a continued improvement of the gross margin as well as increased spending for sales and distribution relative to sales due to an expected high level of sales and marketing activities for primarily liraglutide and the modern insulins.
All of the above expectations are provided that currency exchange rates, especially the US dollar and related currencies, remain at the current level (USD 583, GBP 936, JPY 6.01 as of 29 October 2008) versus the Danish krone for the rest of 2008 and throughout 2009. Please refer to appendix 7 for an outline of the assumptions for key currencies and operating profit sensitivity for 2008 and 2009.
Novo Nordisk has hedged expected net cash flows in relation to US dollars, Japanese yen and British pounds for 15, 14 and 13 months respectively. The financial impact from foreign exchange hedging is included in 'Net financials'. Provided the currency exchange rates remain at the current level throughout 2009, it is expected that the significant positive impact on reported operating profit will be offset by a similar significant foreign exchange hedging loss.
Research and development update
Novo Nordisk is the only company with a new generation of insulins in full clinical development. The ambition is to further improve the treatment success rate, tolerability and convenience of insulin therapy for people with type 1 or type 2 diabetes. Novo Nordisk has made significant progress in this area and has recently finalised two phase 2 studies with NN1250, a long-acting insulin analogue with a potential duration of action of more than 24 hours, and two phase 2 studies with NN5401, a neutral, soluble dual-acting insulin analogue preparation also with a potential duration of action of more than 24 hours. NN1250 was investigated in both type 1 and type 2 diabetes, whereas NN5401 was investigated in type 2 diabetes alone. NN1250 was studied in trials where insulin glargine served as insulin comparator whereas NN5401 was studied in trials where NovoMix® 30 and insulin glargine served as insulin comparators. In total, around 700 patients were enrolled in the four treat-to-target studies and all patients were treated for 16 weeks.
The headline data from the four studies show promising proof-of-concept results for both of the new insulins in terms of safe and long-lasting blood glucose lowering. Between half and two-thirds of people with type 2 diabetes treated with NN5401 achieved HbA1c levels below 7% with no incidences of hypoglycaemia during the last four weeks of treatment. For people with type 2 diabetes treated with once-daily NN1250, around half achieved HbA1c levels below 7% without occurrence of hypoglycaemia in the last four weeks of treatment. In the type 2 diabetes trial three weekly injections of NN1250, every Monday, Wednesday and Friday, were also compared to once-daily basal insulin. The blood glucose control achieved after three weekly NN1250 injections was found to be similar to that in the once-daily basal insulin arm, highlighting the very long action profile of NN1250.
Importantly, both insulins, NN5401 and NN1250, appear to be safe and well tolerated. Based on the positive phase 2 data, Novo Nordisk will now start a dialogue with the regulatory agencies regarding the design of the phase 3 programmes. Novo Nordisk plans to initiate phase 3 studies with both NN1250 and NN5401 in the second half of 2009.
At the annual meeting of the Canadian Diabetes Association in October, Novo Nordisk presented detailed results from the 26-week LEAD(TM) 6 phase 3b study in which the safety and efficacy of liraglutide, the once-daily human GLP-1 analogue, was compared to twice-daily exenatide in people with type 2 diabetes. As previously communicated, the study showed that patients treated with liraglutide achieved a statistically significantly better blood glucose control, compared to patients receiving exenatide treatment.
At its Capital Markets Day on 26 September, Novo Nordisk presented headline data from a 14-week extension of the LEAD(TM) 6 study. After an initial 26 weeks of treatment with either liraglutide or exenatide in the LEAD(TM) study, 376 patients with type 2 diabetes entered this 14-week non-randomised extension study where all patients received liraglutide. Patients from the initial liraglutide treatment arm continued previous treatment at an unchanged dose while patients from the initial exenatide treatment arm were switched to liraglutide 1.8 mg once daily, following a two-week dose escalation period. The study showed that patients who switched from exenatide to liraglutide experienced a reduction in HbA1c of 0.3 percentage points, a decrease in fasting plasma glucose of 0.9 mmol/l, a weight loss of approximately 1 kg as well as a reduction in systolic blood pressure of close to 4 mmHg - all differences being statistically significant. Furthermore, the tolerability profile of liraglutide was confirmed in the LEAD(TM) 6 extension.
As previously communicated, the phase 3 programme for liraglutide in obesity is expected to be initiated before the end of 2008 and will include 4,500-5,000 patients. One-year data from the study is expected in early 2011.
Biopharmaceuticals
Novo Nordisk has decided to discontinue the phase 3 study with Norditropin® in dialysis patients with low serum albumin (LSAD) which was started in July 2007. The decision to discontinue the study is not due to safety concerns. The discontinuation is based on an analysis of the significant delay in recruitment of patients for the study which is expected to have a negative impact on the outcome of the study. The analysis shows that the study is not expected to be completed before 2012 or potentially later and that actions undertaken to accelerate patient recruitment have not been sufficiently successful. The primary endpoint in the study is mortality and the plan was to enrol around 2,500 patients.
Novo Nordisk regrets the inconvenience this may cause to patients, doctors and medical staff, and is grateful to all who took part in the study. Novo Nordisk will do its utmost to ensure a smooth trial closure for the involved patients and clinical centres. In the study, growth hormone or placebo treatment has been added in addition to existing treatment, not as a replacement for another treatment. Novo Nordisk expects to finalise the discontinuation of the study during the first half of 2009.
Novo Nordisk is finalising the analysis of results from the phase 3 trial with NovoSeven® for the treatment of bleeding in patients with severe trauma. As previously announced the trial was discontinued earlier this year based on the results of an analysis for futility conducted by the independent Data Monitoring Committee. In total 541 patients with severe trauma completed the trial. The primary efficacy endpoint was 30-day mortality and the results show that there was no statistical difference between the mortality outcome for patients treated with NovoSeven® and placebo. As seen in previous trials with NovoSeven® in trauma, patients treated with NovoSeven® in this trial received statistically significantly fewer transfusions at 24 and 48 hours compared to placebo, thereby confirming its haemostatic effect. The safety profile of NovoSeven® was consistent with previous trials of NovoSeven® in critical bleeds. Novo Nordisk expects to publish detailed results from the phase 3 trial in peer-reviewed journals and at scientific conferences in 2009.
At the Capital Markets Day, Novo Nordisk provided an update of the haemostasis strategy including plans for extending activities into general haemophilia. This was underpinned by the announcement that phase 1 studies are expected to be initiated with a recombinant factor VIII compound and a long-acting recombinant factor IX compound during 2008 and 2009 respectively. Additionally, it was announced that the long-acting recombinant FVIIa derivative NN7128 has completed phase 1 and that a phase 2 study is expected to be initiated in 2009.
Within haemostasis Novo Nordisk also announced that the phase 3 study with recombinant FXIII in congenital factor XIII deficiency was initiated in August 2008. In addition, it was announced that a phase 2 study with recombinant factor XIII within prevention of bleeding in cardiac surgery is expected to be initiated in 2009.
Finally, at the Capital Markets Day, Novo Nordisk provided an update on the progress in the area of inflammation research and announced the progression of the first two projects, anti-IL-20 and anti-C5aR, to phase 1 clinical development.
Equity
Total equity was DKK 32,173 million at the end of the first nine months of 2008, equal to 65.7% of total assets, compared to 67.4% at the end of 2007. Please refer to appendix 6 for further elaboration of changes in equity during the first nine months of 2008.
Treasury shares and share repurchase programme
As per 29 October 2008, Novo Nordisk A/S and its wholly-owned affiliates owned 24,201,460 of its own B shares, corresponding to 3.8% of the total share capital. In 2008, Novo Nordisk has so far repurchased 12,605,207 B shares equal to a cash value of DKK 3.9 billion. Novo Nordisk still expects to repurchase B shares equal to a cash value of around DKK 4.7 billion in 2008 and around DKK 5 billion in 2009. In 2006 and 2007, Novo Nordisk repurchased B shares equal to a total cash value of DKK 7.8 billion.
Employee shares
As the opportunity to buy and own shares in Novo Nordisk is evaluated to have a positive impact on attraction, engagement and retention of employees worldwide, the Board of Directors has approved a global employee share programme to be implemented in November 2008. In Denmark each employee will get the opportunity to buy up to 100 B shares at a price of DKK 150. The shares will be tied up until 2014. Outside of Denmark each employee will be granted 50 restricted stock awards at a price of nil. The release of the awards will require employment for a three-year period following grant.
The global employee share programme is expected to include approximately 1.8 million shares and will be covered by the existing holding of treasury shares. The operating cost effect for 2008 is expected to be approximately DKK 200 million and for each of the years 2009-2011 approximately DKK 50 million.
Sustainability issues update
Call for Action initiative to improve conditions for women with diabetes
In support of the Danish Government's global Call for Action on the United Nation's Millennium Development Goal 3 - Promote gender equality and equal opportunities - Novo Nordisk has committed to address the impact of diabetes on women's empowerment and development. A first step was a roundtable meeting in New York in September, co-hosted with the Danish Minister for Development Cooperation Ms Ulla Tørnæs, the Global Alliance for Women's Health and the World Diabetes Foundation. The objective is to improve diabetes prevention, diagnosis and treatment for women.
Novo Nordisk achieves high score in Dow Jones sustainability indices
In the annual update of the global benchmark for the Dow Jones family of sustainability investment indices announced in September, Novo Nordisk achieved the same high score as in 2007, a total of 84 points out of 100 and came in as the second-best pharmaceutical company in the benchmark. The analysis measures companies' performance on three dimensions: economic, environmental and social.
Legal issues update
US hormone therapy litigation
As of 29 October 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 49 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.). A further 39 individuals currently allege, in relation to similar lawsuits against Pfizer Inc., that they have also 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 2009. Novo Nordisk does not expect the pending claims to impact Novo Nordisk's financial outlook.
As of 29 October 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 49 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.). A further 39 individuals currently allege, in relation to similar lawsuits against Pfizer Inc., that they have also 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 2009. Novo Nordisk does not expect the pending claims to impact Novo Nordisk's financial outlook.
Prandin® litigation
On 9 June 2005, Novo Nordisk filed in US District Court in Detroit, Michigan, a patent infringement lawsuit against Caraco Pharmaceutical Laboratories Ltd./Sun Pharmaceutical Industries Ltd. in response to their Abbreviated New Drug Application (ANDA) for repaglinide, the active ingredient in Prandin®. In their ANDA, Caraco requests approval to sell repaglinide following expiry in March 2009 of the primary US patent for repaglinide. Novo Nordisk's lawsuit asserts that Caraco, if permitted to market generic repaglinide following the 2009 patent expiry, will induce the infringement of Novo Nordisk's patent covering the combination of repaglinide with metformin (patent number US 6,677,358 which expires in 2018). The trial in the US District Court is scheduled to begin 12 January 2009.
Financial calendar for 2009
29 January Financial statement for 2008
2 February PDF version of the Annual Report 2008 available on novonordisk.com
16 February Printed version of the Annual Report 2008
18 March Annual General Meeting
18 March Shareholders' Meeting (Information meeting in Danish)
30 April Financial statement for the first quarter of 2009
6 August Financial statement for the first six months of 2009
29 October Financial statement for the first nine months of 2009
Conference call details
At 13.00 CET today, corresponding to 8.00 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.
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 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', 'guidance', '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 on the first page and under the headings 'Outlook', '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 available on our website (novonordisk.com).
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.
Management statement
Today, the Board of Directors and Executive Management reviewed and approved the interim report and accounts of Novo Nordisk A/S for the first nine months of 2008.
The interim report and accounts have been prepared in accordance with International Financial Reporting Standards and the additional Danish disclosure requirements applying to listed companies' interim reports and accounts.
In our opinion the accounting policies used are appropriate and the overall presentation of the interim report and accounts is adequate. Furthermore, in our opinion the management review includes a fair review of the development and performance of the business and the financial position of the group, together with a description of the material risks and uncertainties the group faces.
Bagsværd 30 October 2008
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Executive Management: |
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Lars Rebien Sørensen |
Jesper Brandgaard |
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President and CEO |
CFO |
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Lise Kingo |
Kåre Schultz |
Mads Krogsgaard Thomsen | ||||
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Board of Directors: |
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Sten Scheibye |
Göran A Ando |
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Chairman |
Vice chairman |
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Kurt Briner |
Henrik Gürtler |
Johnny Henriksen | ||||
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Pamela Kirby |
Anne Marie Kverneland |
Kurt Anker Nielsen | ||||
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Søren Thuesen Pedersen |
Stig Strøbæk |
Jørgen Wedel |
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Contacts for further information
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Media: |
Investors: |
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Mike Rulis |
Mads Veggerby Lausten |
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Tel: (+45) 4442 3573 |
Tel: (+45) 4443 7919 |
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E-mail: mike@novonordisk.com |
E-mail: mlau@novonordisk.com |
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Hans Rommer |
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Tel: (+45) 4442 4765 |
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In North America: |
E-mail: hrmm@novonordisk.com |
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Sean Clements |
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Tel: (+1) 609 514 8316 |
Kasper Roseeuw Poulsen |
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E-mail: secl@novonordisk.com |
Tel: (+45) 4442 4471 |
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E-mail: krop@novonordisk.com |
Further information on Novo Nordisk is available on the company's internet homepage at the address: novonordisk.com
Appendix 1: Quarterly numbers in DKK
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(Amounts in DKK million, except number of employees, earnings per share and number of shares outstanding.) | ||||||||||||||
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%
change |
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Q3
2008
vs |
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Q3 |
Q2 |
Q1 |
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Q4 |
Q3 |
Q2 |
Q1 |
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Q3
2007 |
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Sales |
11,246 |
11,110 |
10,614 |
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10,946 |
10,504 |
10,563 |
9,818 |
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7% |
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Gross profit |
8,640 |
8,556 |
8,201 |
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8,345 |
7,990 |
8,205 |
7,498 |
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8% |
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Gross margin |
76.8% |
77.0% |
77.3% |
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76.2% |
76.1% |
77.7% |
76.4% |
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Sales and
distribution
costs |
3,155 |
3,178 |
2,975 |
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3,220 |
2,993 |
3,110 |
3,048 |
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5% |
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Percent of
sales |
28.1% |
28.6% |
28.0% |
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29.4% |
28.5% |
29.4% |
31.0% |
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Research and
development
costs |
1,579 |
1,980 |
1,858 |
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3,413 |
1,724 |
1,754 |
1,647 |
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-8% |
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- Hereof costs
related to
discontinuation
of all
pulmonary
projects* |
50 |
(155) |
(220) |
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(1,325) |
- |
- |
- |
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Percent of
sales |
14.0% |
17.8% |
17.5% |
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31.2% |
16.4% |
16.6% |
16.8% |
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Percent of
sales (excl.
AERx®)** |
14.5% |
16.4% |
15.4% |
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19.1% |
16.4% |
16.6% |
16.8% |
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Administrative
expenses |
633 |
626 |
627 |
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677 |
623 |
594 |
614 |
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2% |
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Percent of
sales |
5.6% |
5.6% |
5.9% |
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6.2% |
5.9% |
5.6% |
6.3% |
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Licence fees
and other
operating
income (net) |
51 |
74 |
88 |
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92 |
31 |
60 |
138 |
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65% |
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Operating
profit |
3,324 |
2,846 |
2,829 |
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1,127 |
2,681 |
2,807 |
2,327 |
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24% |
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Operating
margin |
29.6% |
25.6% |
26.7% |
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10.3% |
25.5% |
26.6% |
23.7% |
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Operating
profit (excl.
AERx®)** |
3,274 |
3,001 |
3,049 |
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2,452 |
2,681 |
2,807 |
2,327 |
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22% |
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Operating
margin (excl.
AERx®)** |
29.1% |
27.0% |
28.7% |
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22.4% |
25.5% |
26.6% |
23.7% |
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Share of
profit/
(loss) in
associated
companies |
(58) |
(3) |
(67) |
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0 |
(57) |
1,350 |
(60) |
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- |
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Financial
income |
306 |
429 |
474 |
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375 |
322 |
297 |
309 |
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-5% |
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Financial
expenses |
66 |
21 |
368 |
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155 |
90 |
60 |
202 |
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-27% |
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Profit before
income taxes |
3,506 |
3,251 |
2,868 |
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1,347 |
2,856 |
4,394 |
2,374 |
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23% |
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Net profit |
2,664 |
2,471 |
2,180 |
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977 |
2,184 |
3,652 |
1,709 |
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22% |
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Depreciation,
amortisation
and
impairment
losses |
560 |
567 |
563 |
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1,396 |
586 |
516 |
509 |
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-4% |
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Depreciation,
amortisation,
etc (excl.
AERx®)
** |
560 |
567 |
563 |
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526 |
586 |
516 |
509 |
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-4% |
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Capital
expenditure |
448 |
328 |
214 |
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719 |
597 |
508 |
444 |
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-25% |
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Cash flow
from operating
activities |
3,673 |
2,916 |
3,070 |
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2,498 |
3,500 |
1,438 |
2,551 |
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5% |
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Free cash flow |
3,210 |
2,589 |
2,795 |
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3,198 |
2,888 |
826 |
2,100 |
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11% |
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Equity |
32,173 |
33,046 |
31,251 |
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32,182 |
33,161 |
33,475 |
29,676 |
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-3% |
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Total assets |
48,990 |
48,478 |
47,534 |
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47,731 |
48,423 |
48,300 |
44,742 |
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1% |
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Equity ratio |
65.7% |
68.2% |
65.7% |
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67.4% |
68.5% |
69.3% |
66.3% |
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Full-time
employees
at the end of
the period |
26,360 |
26,060 |
25,765 |
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25,516 |
25,206 |
24,729 |
24,045 |
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5% |
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Basic earnings
per share
(in DKK) |
4.34 |
3.99 |
3.51 |
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1.56 |
3.46 |
5.75 |
2.69 |
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25% |
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Diluted
earnings
per share
(in DKK) |
4.30 |
3.96 |
3.48 |
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1.55 |
3.43 |
5.71 |
2.68 |
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25% |
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Average
number of
shares
outstanding
(million)*** |
614.2 |
618.6 |
620.9 |
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624.4 |
632.0 |
635.8 |
635.0 |
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-3% |
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Average
number of
shares
outstanding
incl |
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dilutive effect
of options
'in the money'
(million)*** |
618.6 |
623.5 |
626.3 |
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629.6 |
636.4 |
640.2 |
639.4 |
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-3% |
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Sales by
business
segments: |
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Modern
insulins
(insulin
analogues) |
4,365 |
4,103 |
3,821 |
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3,911 |
3,568 |
3,464 |
3,065 |
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22% |
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Human
insulins |
2,806 |
2,966 |
2,939 |
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3,116 |
3,098 |
3,222 |
3,136 |
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-9% |
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Insulin-
related sales |
464 |
460 |
443 |
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448 |
445 |
437 |
419 |
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4% |
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Oral
antidiabetic
products
(OAD) |
671 |
478 |
640 |
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512 |
585 |
529 |
523 |
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15% |
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Diabetes
care total |
8,306 |
8,007 |
7,843 |
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7,987 |
7,696 |
7,652 |
7,143 |
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8% |
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NovoSeven® |
1,534 |
1,648 |
1,440 |
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1,519 |
1,427 |
1,508 |
1,411 |
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7% |
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Growth
hormone
therapy |
941 |
986 |
878 |
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925 |
878 |
924 |
784 |
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7% |
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Hormone
replacement
therapy |
394 |
391 |
385 |
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437 |
414 |
411 |
406 |
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-5% |
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Other
products |
71 |
78 |
68 |
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78 |
89 |
68 |
74 |
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-20% |
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Biopharma-
ceuticals total |
2,940 |
3,103 |
2,771 |
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2,959 |
2,808 |
2,911 |
2,675 |
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5% |
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Sales by
geographic
segments: |
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Europe |
4,305 |
4,400 |
4,061 |
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4,348 |
4,036 |
4,035 |
3,931 |
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7% |
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North
America |
3,759 |
3,467 |
3,450 |
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3,608 |
3,500 |
3,424 |
3,214 |
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7% |
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International
Operations |
2,074 |
2,069 |
2,096 |
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1,776 |
1,870 |
1,953 |
1,696 |
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11% |
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Japan &
Oceania |
1,108 |
1,174 |
1,007 |
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1,214 |
1,098 |
1,151 |
977 |
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1% |
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Segment
operating
profit: |
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Diabetes
care |
1,963 |
1,510 |
1,672 |
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(75) |
1,487 |
1,600 |
1,247 |
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32% |
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Diabetes
care (excl.
AERx®)** |
1,913 |
1,665 |
1,892 |
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1,250 |
1,487 |
1,600 |
1,247 |
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29% |
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Biopharma-
ceuticals |
1,361 |
1,336 |
1,157 |
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1,202 |
1,194 |
1,207 |
1,080 |
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14% |
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*) Including costs related to the discontinuation of AERx®
and all other pulmonary diabetes projects. | ||||||||||||||
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**) Excluding costs related to the discontinuation of AERx®
and all other pulmonary diabetes projects. | ||||||||||||||
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***) For Q3 2008 the exact numbers of 'Average number
of shares outstanding' and 'Average number of shares outstanding | ||||||||||||||
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incl dilutive effect of options 'in the money''
are 614,225,888 and 618,666,332 respectively. | ||||||||||||||
Appendix 2: Quarterly numbers in EUR
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(Amounts in EUR million, except number of
employees, earnings per share and number of shares outstanding.) | |||||||||||||
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Key figures are translated into EUR as supplementary information
- the translation is based on average exchange rate | |||||||||||||
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for income statement and exchange rate at the balance sheet
date for balance sheet items. | |||||||||||||
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%
change | |||
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2008 |
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2007 |
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Q3
2008
vs | ||||||||
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Q3 |
Q2 |
Q1 |
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Q4 |
Q3 |
Q2 |
Q1 |
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Q3
2007 | |||
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Sales |
1,508 |
1,489 |
1,424 |
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1,468 |
1,411 |
1,418 |
1,317 |
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7% | |||
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Gross profit |
1,159 |
1,147 |
1,100 |
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1,119 |
1,074 |
1,101 |
1,006 |
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8% | |||
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Gross margin |
76.8% |
77.0% |
77.3% |
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76.2% |
76.1% |
77.7% |
76.4% |
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Sales and distribution
costs |
423 |
426 |
399 |
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432 |
402 |
417 |
409 |
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5% | |||
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Percent of sales |
28.1% |
28.6% |
28.0% |
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29.4% |
28.5% |
29.4% |
31.0% |
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Research and
development costs |
211 |
266 |
249 |
|
458 |
232 |
235 |
221 |
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-8% | |||
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- Hereof costs related
to discontinuation of
all pulmonary
projects* |
7 |
(20) |
(30) |
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(178) |
- |
- |
- |
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Percent of sales |
14.0% |
17.8% |
17.5% |
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31.2% |
16.4% |
16.6% |
16.8% |
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Percent of sales
(excl. AERx®)** |
14.4% |
16.4% |
15.4% |
|
19.1% |
16.4% |
16.6% |
16.8% |
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Administrative
expenses |
85 |
84 |
84 |
|
91 |
84 |
80 |
82 |
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2% | |||
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Percent of sales |
5.6% |
5.6% |
5.9% |
|
6.2% |
5.9% |
5.6% |
6.3% |
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Licence fees and
other operating
income (net) |
7 |
10 |
12 |
|
12 |
4 |
8 |
19 |
|
65% | |||
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|
| |||
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Operating profit |
446 |
381 |
380 |
|
151 |
360 |
377 |
312 |
|
24% | |||
|
Operating margin |
29.6% |
25.6% |
26.7% |
|
10.3% |
25.5% |
26.6% |
23.7% |
|
| |||
|
Operating profit
(excl. AERx®)** |
439 |
401 |
410 |
|
329 |
360 |
377 |
312 |
|
22% | |||
|
Operating margin
(excl. AERx®)** |
29.1% |
27.0% |
28.7% |
|
22.4% |
25.5% |
26.6% |
23.7% |
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Share of profit/(loss)
in associated
companies |
(8) |
0 |
(9) |
|
0 |
(7) |
181 |
(8) |
|
- | |||
|
Financial income |
41 |
57 |
64 |
|
49 |
44 |
40 |
41 |
|
-5% | |||
|
Financial expenses |
9 |
3 |
49 |
|
21 |
12 |
8 |
27 |
|
-27% | |||
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|
| |||
|
Profit before income
taxes |
470 |
436 |
385 |
|
180 |
384 |
589 |
319 |
|
23% | |||
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Net profit |
357 |
332 |
292 |
|
131 |
294 |
490 |
229 |
|
22% | |||
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Depreciation,
amortisation and
impairment losses |
75 |
76 |
76 |
|
188 |
78 |
70 |
68 |
|
-4% | |||
|
Depreciation,
amortisation, etc
(excl. AERx®)** |
75 |
76 |
76 |
|
71 |
78 |
70 |
68 |
|
-4% | |||
|
Capital expenditure |
60 |
44 |
29 |
|
96 |
80 |
68 |
60 |
|
-25% | |||
|
Cash flow from
operating activities |
492 |
391 |
412 |
|
335 |
470 |
193 |
342 |
|
5% | |||
|
Free cash flow |
430 |
347 |
375 |
|
430 |
387 |
111 |
282 |
|
11% | |||
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Equity |
4,312 |
4,431 |
4,191 |
|
4,316 |
4,449 |
4,498 |
3,983 |
|
-3% | |||
|
Total assets |
6,566 |
6,500 |
6,375 |
|
6,401 |
6,496 |
6,490 |
6,005 |
|
1% | |||
|
Equity ratio |
65.7% |
68.2% |
65.7% |
|
67.4% |
68.5% |
69.3% |
66.3% |
|
| |||
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Full-time employees
at the end of the
period |
26,360 |
26,060 |
25,765 |
|
25,516 |
25,206 |
24,729 |
24,045 |
|
5% | |||
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Basic earnings per
share (in EUR) |
0.58 |
0.54 |
0.47 |
|
0.21 |
0.47 |
0.77 |
0.36 |
|
25% | |||
|
Diluted earnings per
share (in EUR) |
0.57 |
0.53 |
0.47 |
|
0.21 |
0.47 |
0.76 |
0.36 |
|
25% | |||
|
Average number of
shares outstanding
(million)*** |
614.2 |
618.6 |
620.9 |
|
624.4 |
632.0 |
635.8 |
635.0 |
|
-3% | |||
|
Average number of
shares outstanding
incl |
|
|
|
|
|
| |||||||
|
dilutive effect of
options 'in the
money' (million)*** |
618.6 |
623.5 |
626.3 |
|
629.6 |
636.4 |
640.2 |
639.4 |
|
-3% | |||
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Sales by business
segments: |
|
|
|
|
|
|
| ||||||
|
Modern insulins
(insulin analogues) |
585 |
550 |
513 |
|
525 |
479 |
465 |
411 |
|
22% | |||
|
Human insulins |
376 |
398 |
394 |
|
418 |
416 |
432 |
421 |
|
-9% | |||
|
Insulin-related
sales |
62 |
62 |
59 |
|
60 |
60 |
59 |
56 |
|
4% | |||
|
Oral antidiabetic
products (OAD) |
90 |
64 |
86 |
|
68 |
79 |
71 |
70 |
|
15% | |||
|
Diabetes care
total |
1,113 |
1,074 |
1,052 |
|
1,071 |
1,034 |
1,027 |
958 |
|
8% | |||
|
|
|
|
|
|
|
|
|
|
|
| |||
|
NovoSeven® |
206 |
221 |
193 |
|
204 |
191 |
203 |
189 |
|
7% | |||
|
Growth hormone
therapy |
126 |
132 |
118 |
|
124 |
118 |
124 |
105 |
|
7% | |||
|
Hormone
replacement therapy |
53 |
52 |
52 |
|
59 |
55 |
56 |
54 |
|
-5% | |||
|
Other products |
9 |
11 |
9 |
|
10 |
12 |
9 |
10 |
|
-20% | |||
|
Biopharmaceuticals
total |
394 |
416 |
372 |
|
397 |
376 |
392 |
358 |
|
5% | |||
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Sales by geographic
segments: |
|
|
|
|
|
|
|
|
|
| |||
|
Europe |
577 |
590 |
545 |
|
583 |
542 |
542 |
527 |
|
7% | |||
|
North America |
504 |
465 |
463 |
|
484 |
470 |
460 |
431 |
|
7% | |||
|
International
Operations |
278 |
278 |
281 |
|
238 |
251 |
262 |
228 |
|
11% | |||
|
Japan & Oceania |
149 |
157 |
135 |
|
163 |
147 |
155 |
131 |
|
1% | |||
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Segment operating
profit: |
|
|
|
|
|
|
|
|
|
| |||
|
Diabetes care |
263 |
203 |
224 |
|
(10) |
200 |
215 |
167 |
|
32% | |||
|
Diabetes care
(excl. AERx®)** |
256 |
223 |
254 |
|
168 |
200 |
215 |
167 |
|
29% | |||
|
Biopharmaceuticals |
183 |
179 |
155 |
|
162 |
160 |
162 |
145 |
|
14% | |||
|
|
|
|
|
|
|
|
|
|
|
| |||
|
*) Including costs related to the discontinuation of AERx®
and all other pulmonary diabetes projects. | |||||||||||||
|
**) Excluding costs related to the discontinuation of AERx®
and all other pulmonary diabetes projects. | |||||||||||||
|
***) For Q3 2008 the exact numbers of 'Average number of
shares outstanding' and 'Average number of shares outstanding | |||||||||||||
|
incl dilutive effect of options 'in the money'' are
614,225,888 and 618,666,332
respectively. | |||||||||||||
Appendix 3: Income statement
|
|
9M |
9M |
|
Q3 |
Q3 | ||
|
DKK million |
2008 |
2007 |
|
2008 |
2007 | ||
|
|
|
|
|
|
| ||
|
|
|
|
|
|
| ||
|
Sales |
32,970 |
30,885 |
|
11,246 |
10,504 | ||
|
Cost of goods sold |
7,573 |
7,192 |
|
2,606 |
2,514 | ||
|
Gross profit |
25,397 |
23,693 |
|
8,640 |
7,990 | ||
|
|
|
|
|
|
| ||
|
Sales and
distribution costs |
9,308 |
9,151 |
|
3,155 |
2,993 | ||
|
Research and
development costs |
5,417 |
5,125 |
|
1,579 |
1,724 | ||
|
- hereof costs
related to
discontinuation of
all pulmonary
projects |
(325) |
- |
|
50 |
- | ||
|
Administrative
expenses |
1,886 |
1,831 |
|
633 |
623 | ||
|
Licence fees and
other operating
income (net) |
213 |
229 |
|
51 |
31 | ||
|
Operating profit |
8,999 |
7,815 |
|
3,324 |
2,681 | ||
|
Operating profit
(excl. costs
related to
discontinuation
of AERx®) |
9,324 |
7,815 |
|
3,274 |
2,681 | ||
|
|
|
|
|
|
| ||
|
Share of
profit/(loss) in
associated
companies |
(128) |
1,233 |
|
(58) |
(57) | ||
|
Financial income |
1,209 |
928 |
|
306 |
322 | ||
|
Financial expenses |
455 |
352 |
|
66 |
90 | ||
|
Profit before
income taxes |
9,625 |
9,624 |
|
3,506 |
2,856 | ||
|
|
|
|
|
|
| ||
|
Income taxes |
2,310 |
2,079 |
|
842 |
672 | ||
|
NET PROFIT |
7,315 |
7,545 |
|
2,664 |
2,184 | ||
|
|
|
|
|
|
| ||
|
|
|
|
|
|
| ||
|
|
|
|
|
|
| ||
|
Basic earnings
per share (DKK) |
11.84 |
11.90 |
|
4.34 |
3.46 | ||
|
Diluted earnings
per share (DKK) |
11.74 |
11.82 |
|
4.30 |
3.43 | ||
|
|
|
|
|
|
| ||
|
|
|
|
|
|
| ||
|
Segment sales: |
|
|
|
|
| ||
|
Diabetes care |
24,156 |
22,491 |
|
8,306 |
7,696 | ||
|
Biopharmaceuticals |
8,814 |
8,394 |
|
2,940 |
2,808 | ||
|
|
|
|
|
|
| ||
|
Segment
operating profit: |
|
|
| ||||
|
Diabetes care |
5,145 |
4,334 |
|
1,963 |
1,487 | ||
|
Operating margin |
21.3% |
19.3% |
|
23.6% |
19.3% | ||
|
Diabetes care
(excl. AERx®)* |
5,470 |
4,334 |
|
1,913 |
1,487 | ||
|
Operating margin
(excl. AERx®)* |
22.6% |
19.3% |
|
23.0% |
19.3% | ||
|
|
|
|
|
|
| ||
|
Biopharmaceuticals |
3,854 |
3,481 |
|
1,361 |
1,194 | ||
|
Operating margin |
43.7% |
41.5% |
|
46.3% |
42.5% | ||
|
|
|
|
|
|
| ||
|
*) Excluding costs related to the
discontinuation of AERx® and all other
pulmonary diabetes projects. | |||||||
Appendix 4: Balance sheet
|
DKK million |
30 Sep
2008 |
31 Dec
2007 |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Intangible assets |
841 |
671 |
|
Property, plant and
equipment |
18,829 |
19,605 |
|
Investments in
associated companies |
192 |
500 |
|
Deferred income tax
assets |
1,774 |
2,522 |
|
Other financial assets |
209 |
131 |
|
TOTAL LONG-TERM
ASSETS |
21,845 |
23,429 |
|
|
|
|
|
Inventories |
9,239 |
9,020 |
|
Trade receivables |
7,034 |
6,092 |
|
Tax receivables |
337 |
319 |
|
Other receivables |
1,740 |
1,493 |
|
Marketable securities
and financial
derivatives |
1,651 |
2,555 |
|
Cash at bank and in
hand |
7,144 |
4,823 |
|
TOTAL CURRENT
ASSETS |
27,145 |
24,302 |
|
|
|
|
|
TOTAL ASSETS |
48,990 |
47,731 |
|
|
|
|
|
|
|
|
|
EQUITY AND LIABILITIES |
| |
|
|
|
|
|
Share capital |
634 |
647 |
|
Treasury shares |
(23) |
(26) |
|
Retained earnings |
31,941 |
30,661 |
|
Other comprehensive
(loss) / income |
(379) |
900 |
|
TOTAL EQUITY |
32,173 |
32,182 |
|
|
|
|
|
Long-term debt |
974 |
961 |
|
Deferred income tax
liabilities |
2,225 |
2,346 |
|
Provision for pensions |
440 |
362 |
|
Other provisions |
862 |
1,239 |
|
Total long-term
liabilities |
4,501 |
4,908 |
|
|
|
|
|
Short-term debt and
financial derivatives |
805 |
405 |
|
Trade payables |
1,519 |
1,947 |
|
Tax payables |
1,265 |
929 |
|
Other liabilities |
5,879 |
4,959 |
|
Other provisions |
2,848 |
2,401 |
|
Total current
liabilities |
12,316 |
10,641 |
|
|
|
|
|
TOTAL LIABILITIES |
16,817 |
15,549 |
|
|
|
|
|
TOTAL EQUITY
AND LIABILITIES |
48,990 |
47,731 |
Appendix 5: Cash flow statement
|
DKK million |
9M 2008 |
9M 2007 |
|
|
|
|
|
|
|
|
|
Net profit |
7,315 |
7,545 |
|
|
|
|
|
Adjustment for non-
cash items |
4,783 |
3,157 |
|
Income taxes paid and
net interest received |
(1,169) |
(1,492) |
|
Cash flow before
change in working
capital |
10,929 |
9,210 |
|
|
|
|
|
Net change in working
capital |
(1,270) |
(1,721) |
|
Cash flow from
operating activities |
9,659 |
7,489 |
|
|
|
|
|
Net investments in
intangible assets and
long-term financial
assets |
(245) |
(126) |
|
Capital expenditure for
property, plant and
equipment |
(990) |
(1,549) |
|
Net change in
marketable securities
(maturity exceeding
three months) |
- |
3 |
|
Received dividend |
170 |
- |
|
Net cash used in
investing activities |
(1,065) |
(1,672) |
|
|
|
|
|
Cash flow from
financing activities |
(6,172) |
(4,746) |
|
|
|
|
|
NET CASH FLOW |
2,422 |
1,071 |
|
|
|
|
|
Unrealised gain/(loss)
on exchange rates and
marketable securities |
| |
|
included in cash and
cash equivalents |
(4) |
(1) |
|
Net change in cash
and cash equivalents |
2,418 |
1,070 |
|
|
|
|
|
Cash and cash
equivalents at the
beginning of the year |
4,617 |
2,985 |
|
Cash and cash
equivalents at the
end of the period |
7,035 |
4,055 |
|
|
|
|
|
Bonds with original
term to maturity
exceeding three months |
1,483 |
994 |
|
Undrawn committed
credit facilities |
7,461 |
7,454 |
|
FINANCIAL
RESOURCES AT THE
END OF THE PERIOD |
15,979 |
12,503 |
|
|
|
|
|
|
|
|
|
Cash flow from
operating activities |
9,659 |
7,489 |
|
+ Net cash used in
investing activities |
(1,065) |
(1,672) |
|
- Net change in
marketable securities
(maturity exceeding
three months) |
- |
3 |
|
FREE CASH FLOW |
8,594 |
5,814 |
Appendix 6: Statement of changes in equity
|
|
|
|
|
|
Other
compre-
hensive
income |
|
|
|
DKK million |
Share
capital |
Treasury
shares |
Re-
tained
earnings |
Exchange
rate
adjust-
ments |
De-
ferred
gain/loss
on cash
flow
hedges |
Other
adjust-
ments |
Total |
|
|
|
|
|
|
|
|
|
|
9M 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at the
beginning
of the
year |
647 |
(26) |
30,661 |
209 |
691 |
- |
32,182 |
|
Exchange
rate
adjust-
ment
of invest-
ments in
subsidiaries |
|
|
|
(120) |
|
|
(120) |
|
Deferred
(gain)/loss
on cash
flow
hedges
at the
beginning
of the
year
recognised
in the
Income
statement
for the
period |
|
|
|
|
(533) |
|
(533) |
|
Changes
of fair
value on
cash flow
hedges
during the
period |
|
|
|
|
(636) |
|
(636) |
|
Fair value
adjust-
ments on
financial
assets
available
for sale |
|
|
|
|
|
|
- |
|
Novo
Nordisk
share of
equity
recognised
by
associated
companies |
|
|
|
|
|
23 |
23 |
|
Other
adjustments |
|
|
|
|
|
(13) |
(13) |
|
Net income
recognised
directly in
equity |
- |
- |
- |
(120) |
(1,169) |
10 |
(1,279) |
|
Net profit
for the
period |
|
|
7,315 |
|
|
|
7,315 |
|
Total
income
for the
period |
- |
- |
7,315 |
(120) |
(1,169) |
10 |
6,036 |
|
Share-
based
payment |
|
|
119 |
|
|
|
119 |
|
Purchase
of treasury
shares |
|
(11) |
117 |
|
|
|
106 |
|
Sale of
treasury
shares |
|
1 |
(3,476) |
|
|
|
(3,475) |
|
Reduction
of the
Bshare
capital |
(13) |
13 |
|
|
|
|
- |
|
Dividends |
|
|
(2,795) |
|
|
|
(2,795) |
|
Balance
at the
end of
the period |
634 |
(23) |
31,941 |
89 |
(478) |
10 |
32,173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9M 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at the
beginning
of the
year |
674 |
(39) |
28,810 |
156 |
420 |
101 |
30,122 |
|
Exchange
rate
adjust-
ment of
invest-
ments
in subsi-
diaries |
|
|
|
24 |
|
|
24 |
|
Deferred
(gain)/loss
on cash
flow
hedges
at the
beginning
of the
year
recognised
in the
Income
statement
for the
period |
|
|
|
|
(420) |
|
(420) |
|
Deferred
gain/
(loss)
on cash
flow
hedges
at the end
of the
period |
|
|
|
|
485 |
|
485 |
|
Other
adjust-
ments |
|
|
|
|
|
30 |
30 |
|
Net income
recognised
directly in
equity |
- |
- |
- |
24 |
65 |
30 |
119 |
|
Net profit
for the
period |
|
|
7,545 |
|
|
|
7,545 |
|
Total
income
for the
period |
- |
- |
7,545 |
24 |
65 |
30 |
7,664 |
|
Share-
based
payment |
|
|
104 |
|
|
|
104 |
|
Purchase
of treasury
shares |
|
(9) |
(2,708) |
|
|
|
(2,717) |
|
Sale of
treasury
shares |
|
1 |
208 |
|
|
|
209 |
|
Reduction
of the B
share
capital |
(27) |
27 |
|
|
|
|
- |
|
Dividends |
|
|
(2,221) |
|
|
|
(2,221) |
|
Balance
at the
end of
the period |
647 |
(20) |
31,738 |
180 |
485 |
131 |
33,161 |
Appendix 7: Assumptions for key currencies and operating profit sensitivity for 2008 and 2009
|
|
YTD average exchange
rates as of
30 September 2008 |
YTD average exchange
rates as of
29 October 2008 |
Current exchange rates
as of 29 October 2008 |
Average exchange
rates used
for 2008 outlook |
|
USD |
491 |
497 |
583 |
512 |
|
JPY |
4.63 |
4.72 |
6.01 |
4.95 |
|
GBP |
955 |
954 |
936 |
951 |
|
CNY |
70 |
71 |
85 |
74 |
|
CAD |
483 |
482 |
463 |
479 |
|
|
Annual impact in 2008 on operating
profit of a 5% movement in currency
(DKK million) |
Annual impact in 2009 on operating
profit of a 5% movement in currency
(DKK million) |
|
USD |
470 |
530 |
|
JPY |
140 |
150 |
|
GBP |
75 |
80 |
|
CNY |
65 |
80 |
|
CAD |
35 |
40 |
Note: The currency sensitivity for 2008 and 2009 is based on the
'Average exchange rates used for 2008 outlook' listed above.
Company Announcement no 68 / 2008