6-K 1 c107509.htm Prepared by Imprima de Bussy

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION


Washington, D.C. 20549


FORM 6-K


REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934

OCTOBER 31, 2012


        NOVO NORDISK A/S       
(Exact name of Registrant as specified in its charter)

Novo Allé
DK- 2880, Bagsvaerd
Denmark

(Address of principal executive offices)


Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F

Form 20-F [X]     
     Form 40-F [  ]

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes [  ]     
      No [X]

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g-32(b):82-_____________________

 


 

FINANCIAL REPORT FOR THE PERIOD 1 JANUARY 2012 TO 30 SEPTEMBER 2012

31 October 2012

Novo Nordisk increased operating profit by 34% in the first nine months of 2012

Sales grew 18% driven by Victoza®, NovoRapid® and Levemir®

Sales grew 18% to 57.1 billion in Danish kroner and by 11% in local currencies.

  Sales of modern insulins increased by 21% (14% in local currencies).
  Sales of Victoza® increased by 74% (64% in local currencies).
  Sales in North America increased by 30% (19% in local currencies).
  Sales in International Operations increased by 19% (16% in local currencies).

Reported gross margin improved by 1.5 percentage points to 81.9%.

Reported operating profit increased by 34% to DKK 21,902 million. Measured in local currencies, operating profit increased by 21%.

Net profit increased by 26% to DKK 15,677 million. Earnings per share (diluted) increased by 31% to DKK 28.32.

The regulatory process for the new generation insulins, with the intended brand names Tresiba® and Ryzodeg®, continues to progress in the major markets. In Japan, Tresiba® has now been approved and in Europe, CHMP has issued positive opinions for Tresiba® and Ryzodeg®. In the US, the FDA has disclosed that the Advisory Committee meeting to discuss the new drug applications on 8 November 2012 will focus on the benefits associated with a lower risk of hypoglycaemia and the cardiovascular risk profiles of the two products.

For 2012, sales growth measured in local currencies is now expected to be 10-12% (previously 9-12%), and operating profit growth measured in local currencies is now expected to be 16-18% (previously around 15%).

The preliminary outlook for 2013 indicates high single-digit sales and operating profit growth, both measured in local currencies. The outlook includes an expected positive sales contribution from Tresiba®, primarily in the US, EU and Japan, countered by an impact from the challenging operating environment in major markets. In addition, the outlook for operating profit reflects significant costs related to the expected launch of Tresiba®.

Lars Rebien Sørensen, president and CEO: “Continued strong sales of our modern insulins and Victoza® have led to a robust financial performance in the first nine months of 2012. The approval of Tresiba® in Japan and the positive CHMP opinions in Europe for Tresiba® and Ryzodeg® constitute two significant milestones in the process of bringing this new generation of insulin to the market.”


Company announcement No 70 / 2012
   

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


CONSOLIDATED FINANCIAL STATEMENTS FOR THE FIRST NINE MONTHS OF 2012
The present unaudited consolidated financial statements for the first nine months of 2012 have been prepared in accordance with IAS 34 ‘Interim Financial Reporting’ and on the basis of the same accounting policies as applied in the Annual Report 2011 of Novo Nordisk. Furthermore, the financial report, including the consolidated financial statements for the first nine months of 2012 and management’s review, has been prepared in accordance with additional Danish disclosure requirements for interim reports of listed companies. Novo Nordisk has adopted all new, amended or revised accounting standards and interpretations endorsed by the EU effective for the accounting period beginning on 1 January 2012. Adoption of these standards and interpretations has not had a significant impact on the consolidated financial statements for the first nine months of 2012.

Amounts in DKK million, except number of shares, earnings per share and full-time employees.







 
PROFIT AND LOSS
9M 2012
9M 2011
% change
 
 
9M 2011
 
 
to 9M 2012
 






 
             
Sales
57,064
48,226
18%
 






 
Gross profit
46,752
38,759
21%
 
Gross margin 81.9%   80.4%      
             
Sales and distribution costs 15,352   13,617   13%  
Percentage of sales 26.9%   28.2%      
             
Research and development costs 7,687   6,876   12%  
Percentage of sales 13.5%   14.3%      
             
Administrative expenses 2,321   2,322   (0% )
Percentage of sales 4.1%   4.8%      
             
Licence fees and other operating income 510   349   46%  






 
Operating profit 21,902   16,293   34%  
Operating margin 38.4%   33.8%      
             
Net financials (1,543 ) (179 ) 762%  






 
Profit before income taxes 20,359   16,114   26%  






 
Net profit 15,677   12,408   26%  
Net profit margin 27.5%   25.7%      






 
OTHER KEY NUMBERS            






 
Depreciation, amortisation and impairment losses 1,938   2,045   (5% )
Capital expenditure 2,313   1,821   27%  
             
Net cash generated from operating activities 20,700   17,393   19%  
Free cash flow 18,237   15,361   19%  
             
Total assets 66,620   62,013   7%  
Equity 35,660   35,428   1%  
Equity ratio 53.5%   57.1%      
             
Average number of shares outstanding (million) - diluted            
  553.5   572.9   (3% )
Diluted earnings per share / ADR (in DKK) 28.32   21.66   31%  
             
Full-time employees at the end of the period 33,501   32,016   5%  






 



Company announcement No 70 / 2012
Page 2 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


SALES DEVELOPMENT
Sales increased by 18% in Danish kroner and by 11% measured in local currencies compared to the first nine months of 2011. North America was the main contributor to growth with 64% share of growth measured in local currencies, followed by International Operations and Region China, contributing 20% and 11%, respectively. The majority of growth originated from the modern insulins and Victoza®. Sales growth was negatively impacted by around 1.5 percentage points due to healthcare and pricing reforms in several European markets, the US, China and International Operations.









 
 
Sales
9M 2012
DKK million
 
Growth
as reported
 
Growth
in local
currencies
 
Share of
growth
in local
currencies
 








 
The diabetes care segment
 
 
 
 
Modern insulins
25,359
 
21%
 
14%
 
54%
 
   - NovoRapid ®
11,400
 
23%
 
15%
 
26%
 
   - NovoMix ®
6,862
 
13%
 
7%
 
7%
 
   - Levemir ®
7,097
 
28%
 
21%
 
21%
 
Human insulins
8,293
 
4%
 
(2%
)
(3%
)
Protein-related products
1,890
 
9%
 
2%
 
1%
 
Victoza®
6,786
 
74%
 
64%
 
45%
 
Oral antidiabetic products
2,088
 
8%
 
1%
 
0%
 
 
 
 
 
 
Diabetes care total
44,416
 
22%
 
15%
 
97%
 








 
The biopharmaceuticals segment
 
 
 
 
NovoSeven®
6,513
 
5%
 
(1%
)
(1%
)
Norditropin®
4,237
 
14%
 
8%
 
5%
 
Other products
1,898
 
3%
 
(3%
)
(1%
)
 
 
 
 
 
Biopharmaceuticals total
12,648
 
8%
 
1%
 
3%
 








 
Total sales
57,064
 
18%
 
11%
 
100%
 








 

In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from August 2012 and August 2011 provided by the independent data provider IMS Health.

DIABETES CARE SALES DEVELOPMENT
Sales of diabetes care products increased by 22% measured in Danish kroner to DKK 44,416 million and by 15% in local currencies. Novo Nordisk is the world leader in diabetes care and now holds a global value market share of 25% compared to 24% at the same point in time last year.

Modern insulins, human insulins and protein-related products
Sales of modern insulins, human insulins and protein-related products increased by 16% in Danish kroner to DKK 35,542 million and by 9% measured in local currencies, with North America, International Operations and Region China having the highest growth rates. Novo Nordisk is the global leader with 49% of the total insulin market and 46% of the modern insulin market.




Company announcement No 70 / 2012
Page 3 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


Sales of modern insulins increased by 21% in Danish kroner to DKK 25,359 million and by 14% in local currencies. North America accounted for more than half of the growth, followed by International Operations and Region China. Sales of modern insulins now constitute 75% of Novo Nordisk’s sales of insulin.





 
INSULIN MARKET SHARES
(volume, MAT)
Novo Nordisk’s share
of total insulin market
Novo Nordisk’s share
of modern insulin market
 








 
 
August 2012
August 2011
August 2012
August 2011
 








 
Global 49%   50%   46%   46%  
USA 41%   41%   38%   36%  
Europe 51%   52%   50%   50%  
International Operations* 58%   58%   55%   56%  
Japan 56%   60%   51%   54%  
China** 61%   62%   66%   68%  








 

Source: IMS, August 2012 data. *: Data for 12 selected markets representing approximately 60% of diabetes sales in the region. **: Data for mainland China, excluding Hong Kong and Taiwan.

North America
Sales of modern insulins, human insulins and protein-related products in North America increased by 28% in Danish kroner and by 17% in local currencies. This reflects a continued solid market penetration of the modern insulins, NovoLog®, Levemir® and NovoLog® Mix 70/30, partly countered by a continued decline in human insulin sales. Currently, 50% of Novo Nordisk’s modern insulin volume in the US is used in the prefilled device FlexPen® compared to 45% in 2011.

Europe
Sales of modern insulins, human insulins and protein-related products in Europe remained unchanged both in Danish kroner and in local currencies. Sales in Europe reflect continued progress for NovoRapid® and Levemir®, partly countered by declining human insulin sales. Sales growth in Europe is negatively impacted by a continued low insulin volume growth, below 3%, and by the implementation of healthcare and pricing reforms in several European markets. The device penetration in Europe remains high with 96% of Novo Nordisk’s insulin volume being used in devices, primarily NovoPen® and FlexPen®.

International Operations
Sales of modern insulins, human insulins and protein-related products in International Operations increased by 18% in Danish kroner and by 15% in local currencies. The growth is driven by all three modern insulins and with robust contribution from human insulin. Currently, 58% of Novo Nordisk’s insulin volume in the major private markets is used in devices.

Japan & Korea
Sales of modern insulins, human insulins and protein-related products in Japan & Korea increased by 4% measured in Danish kroner but declined by 6% in local currencies. Sales growth is negatively impacted by a volume decline in the Japanese market and a continuously challenging competitive environment. The device penetration in Japan remains high with 98% of Novo Nordisk’s insulin volume being used in devices, primarily the FlexPen®.




Company announcement No 70 / 2012
Page 4 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


Region China
Sales of modern insulins, human insulins and protein-related products in Region China increased by 29% in Danish kroner and by 15% in local currencies. The sales growth was driven by all three modern insulins, while sales of human insulin only grew modestly. Currently, 97% of Novo Nordisk’s insulin volume in China is used in devices, primarily the durable device NovoPen®.

Victoza® (GLP-1 therapy for type 2 diabetes)
Victoza® sales increased by 74% in Danish kroner to DKK 6,786 million and by 64% in local currencies, reflecting robust sales performance in all regions. The global roll-out is continuing, with 57 countries having launched Victoza® by the end of September 2012. The most recent countries to launch were Australia, Mauritius and Libya and more than five countries are preparing to launch during the remainder of 2012. Victoza® holds the global market share leadership with a 66% market share in the GLP-1 segment compared to 53% in 2011. The GLP-1 class’ share of the total diabetes care market has increased to 5.6% compared to 4.2% in 2011.





 
GLP-1 MARKET SHARES
GLP-1 share of total
 
Victoza® share
 
(value, MAT)
diabetes care market
 
of GLP-1 market
 








 
 
August 2012
 
August 2011
 
August 2012
 
August 2011
 








 
Global
5.6%
  4.2%   66%   53%  
USA
6.7%
  5.4%   60%   47%  
Europe
6.3%
  4.7%   75%   64%  
International Operations*
3.0%
  0.6%   81%   34%  
Japan
2.2%
  1.2%   79%   90%  
China**
0.4%
  0.2%   32%   0%  








 

Source: IMS, August 2012 data. *: Data for 12 selected markets representing approximately 60% of diabetes sales in the region. **: Data for mainland China, excluding Hong Kong and Taiwan.

North America
Sales of Victoza® in North America increased by 75% in Danish kroner and by 60% measured in local currencies. This reflects a continued expansion of the GLP-1 class, which represents 6.7% of the total US diabetes care market compared to 5.4% in 2011. Despite the launch of a competitive product, Victoza® continues to drive the US GLP-1 market expansion and is the GLP-1 market leader with a 60% market share.

Europe
Sales in Europe increased by 55% in Danish kroner and by 54% measured in local currencies. Sales growth is primarily driven by France, Italy, Spain and the UK. In Europe, the GLP-1 class’ share of the total diabetes care market has increased to 6.3% compared to 4.7% in 2011. Victoza® is the GLP-1 market leader with a market share of 75%.

International Operations
Sales in International Operations increased by 195% in Danish kroner and by 206% measured in local currencies. This reflects continued strong performance, driven by Brazil and certain Middle Eastern countries, and a modest comparator in 2011. The GLP-1 class is expanding in International Operations and represents 3.0% of the total diabetes care market compared to 0.6% in 2011. The significant expansion of the GLP-1 class is




Company announcement No 70 / 2012
Page 5 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


primarily driven by a strong uptake in Brazil. Victoza® is the GLP-1 market leader across International Operations, with a market share of 81%.

Japan & Korea
Sales in Japan & Korea increased by 55% in Danish kroner and by 39% measured in local currencies. In Japan, the GLP-1 market is growing and represents 2.2% of the total diabetes care market compared to 1.2% in 2011. Victoza® is the leader in the Japanese GLP-1 class with a market share of 79%.

Region China
Victoza® was launched in China during the fourth quarter of 2011. Early market feedback is positive and hospital listings are developing satisfactorily. The GLP-1 class in China is relatively modest in size, but its share of the total diabetes care market has expanded to 0.4% compared to 0.2% in 2011. Victoza® holds a GLP-1 market share of 32%.

NovoNorm®/Prandin®/PrandiMet® (oral antidiabetic products)
Sales of oral antidiabetic products increased by 8% in Danish kroner to DKK 2,088 million and by 1% measured in local currencies. The sales development reflects modest sales growth in all regions except Europe where generic competition is negatively impacting overall sales in several markets.

BIOPHARMACEUTICALS SALES DEVELOPMENT
Sales of biopharmaceutical products increased by 8% measured in Danish kroner to DKK 12,648 million and by 1% measured in local currencies primarily driven by higher sales in the US, partly countered by lower sales in Europe.

NovoSeven® (bleeding disorders therapy)
Sales of NovoSeven® increased by 5% in Danish kroner to DKK 6,513 million and decreased by 1% in local currencies. The market for NovoSeven® remains negatively impacted by stricter budgetary controls and an increased number of inhibitor patients participating in clinical trials. In local currencies, the sales development reflects a strong performance in Japan countered by lower sales in Europe.

Norditropin® (growth hormone therapy)
Sales of Norditropin® increased by 14% measured in Danish kroner to DKK 4,237 million and by 8% measured in local currencies. The sales growth is primarily driven by North America and International Operations. Novo Nordisk is the second-largest company in the global growth hormone market with a 24% market share measured by volume.

Other products
Sales of other products within biopharmaceuticals, which predominantly consist of hormone replacement therapy (HRT)-related products, increased by 3% in Danish kroner to DKK 1,898 million and decreased by 3% measured in local currencies. This development primarily reflects continued sales progress for Vagifem®, partly countered by an impact from generic competition to Activella® in the US and a decline in the total glucagon market for diagnostic purposes in Japan.

DEVELOPMENT IN COSTS
The cost of goods sold grew 9% to DKK 10,312 million, resulting in a gross margin of 81.9% compared to 80.4% in 2011. This development primarily reflects an underlying improvement driven by favourable price development in North America and a positive net




Company announcement No 70 / 2012
Page 6 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


impact from product mix due to increased sales of modern insulins and Victoza®. The gross margin was positively impacted from currencies by around 0.8 percentage point as a result of the appreciation of primarily the US dollar and the Japanese yen versus the Danish krone compared to 2011.

Total non-production-related costs increased by 11% to DKK 25,360 million and by 7% in local currencies.

Sales and distribution costs increased by 13% to DKK 15,352 million and by 7% in local currencies. The cost increase is driven by the expansion of the US sales force and other costs to prepare for the global launch of Tresiba®. Furthermore, costs increased due to sales and marketing investments in selected countries in International Operations as well as the Chinese sales force expansion in mid-2011. Growth in sales and distribution costs is being partly offset by a reversal of provisions for legal disputes.

Research and development costs increased by 12% to DKK 7,687 million and by 9% in local currencies. The cost increase is primarily driven by development costs related to the on-going phase 3 trials for liraglutide in obesity and the phase 3a trials for IDegLira, a fixed-ratio combination of insulin degludec and liraglutide. Within biopharmaceuticals, costs are primarily related to the continued progress of the portfolio of development projects within haemophilia and the phase 2 trial for anti-IL-20, a recombinant human monoclonal antibody, in rheumatoid arthritis.

Administration costs stayed flat at DKK 2,321 million and decreased by 3% in local currencies. The decrease in local currencies reflects items of a non-recurring nature in 2011 and 2012.

Licence fees and other operating income constituted DKK 510 million compared to DKK 349 million in 2011. This development reflects a higher level of recurring royalty income.

NET FINANCIALS
Net financials showed a net expense of DKK 1,543 million compared to a net expense of DKK 179 million in 2011.

In line with Novo Nordisk’s treasury policy, the most significant foreign exchange risks for the group have been hedged primarily through forward currency contracts. Reflecting the portfolio of foreign currency exchange hedging contracts, the foreign exchange result was an expense of DKK 1,455 million compared to an expense of DKK 109 million in 2011. This development reflects losses on foreign exchange hedging involving especially the US dollar and the Japanese yen due to their appreciation versus Danish kroner compared to the exchange rate level prevailing in 2011.

KEY DEVELOPMENTS IN THE THIRD QUARTER OF 2012
Please refer to appendix 1 for an overview of the quarterly numbers in DKK.

Sales in the third quarter of 2012 increased by 20% to DKK 19,845 million and by 11% in local currencies compared to the same period in 2011. The growth was driven by the three modern insulins and Victoza®. Victoza® sales of DKK 2,503 million in the third quarter of 2012 were primarily driven by the US and Europe. From a geographic perspective, North America and International Operations represented the majority of total sales growth.




Company announcement No 70 / 2012
Page 7 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


The gross margin increased to 82.4% in the third quarter of 2012 compared to 80.3% in the same period last year. The underlying increase was driven by a positive impact from pricing in the US and a favourable product mix development. The reported gross margin was further improved by a positive currency impact of 1.6 percentage points.

In the third quarter of 2012, total non-production-related costs increased by 12% to DKK 8,682 million and by 6% in local currencies compared to the same period last year.

Sales and distribution costs in Danish kroner increased by 12% as reported and by 4% in local currencies in the third quarter of 2012 compared to the same period last year. The cost increase is driven by the expansion of the US sales force and sales and marketing investments in selected countries in International Operations. Growth in sales and distribution costs is being partly offset by a reversal of provisions for legal disputes.

Research and development costs in Danish kroner increased by 16% as reported and by 12% in local currencies in the third quarter of 2012 compared to the same period last year. The development primarily reflects the continued progress of key development projects and the expansion of Novo Nordisk’s global research activities in the US and China.

Administration costs in Danish kroner declined by 3% as reported and by 6% in local currencies in the third quarter of 2012 compared to the same period last year. The decrease in local currencies reflects items of a non-recurring nature in 2011 and 2012.

Reported operating profit increased by 40% in the third quarter of 2012 compared to the same period last year and by 21% in local currencies. This primarily reflects the sales growth, the improvement in gross margin as well as modest growth levels for costs relative to sales.

OUTLOOK 2012
The current expectations for 2012 are summarised in the table below:




 
Expectations are as reported,
Current expectations
Previous expectations
 
if not otherwise stated
31 October 2012
9 August 2012
 



 
Sales growth
 
   - in local currencies
10-12%
9–12%
 
   - as reported
Around 6 percentage
Around 7 percentage
 
 
points higher
points higher
 



 
Operating profit growth
 
   - in local currencies
16-18%
Around 15%
 
   - as reported
Around 11 percentage
Around 12 percentage
 
 
points higher
points higher
 



 
Net financials
Expense of around
Expense of around
 
 
DKK 1,700 million
DKK 1,950 million
 
Effective tax rate
Around 23%
Around 23%
 
Capital expenditure
Around DKK 3.5 billion
Around DKK 3.5 billion
 
Depreciation, amortisation
Around DKK 2.9 billion
Around DKK 2.9 billion
 
and impairment losses
 
Free cash flow
Around DKK 19 billion
Around DKK 19 billion
 



 



Company announcement No 70 / 2012
Page 8 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


Novo Nordisk now expects sales growth in 2012 of 10-12% measured in local currencies. This is based on expectations of continued market penetration of Novo Nordisk’s key products, as well as expectations of continued intense competition and impact from the implementation of healthcare and pricing reforms. Given the current level of exchange rates versus Danish kroner, the reported sales growth is now expected to be around 6 percentage points higher than the growth measured in local currencies.

For 2012, operating profit growth is now expected to be 16-18% measured in local currencies. This reflects a significant increase in costs in the fourth quarter of 2012 driven by launch preparations for Tresiba®, the expanded US sales force as well as sales and marketing investments in China and a selected number of countries in International Operations. Given the current level of exchange rates versus Danish kroner, the reported operating profit growth is now expected to be around 11 percentage points higher than growth measured in local currencies.

For 2012, Novo Nordisk now expects a net financial expense of around DKK 1,700 million. The current expectation primarily reflects losses associated with currency hedging contracts following the appreciation of the US dollar and the Japanese yen versus Danish kroner compared to the exchange rates prevailing in 2011. The expectations for losses related to currency hedging contracts are more than offset by the expected significant positive net impact on reported operating profit from the appreciation of invoicing currencies versus Danish kroner.

The effective tax rate for 2012 is still expected to be around 23%.

Capital expenditure is still expected to be around DKK 3.5 billion in 2012, primarily related to investments in filling capacity and prefilled device production facilities. Expectations for depreciation, amortisation and impairment losses are still expected to be around DKK 2.9 billion. Free cash flow is still expected to be around DKK 19 billion reflecting significant tax payments in the fourth quarter of 2012.

With regard to the financial outlook for 2013, Novo Nordisk expects to provide detailed guidance on expectations in connection with the release of full-year financial results for 2012 on 31 January 2013. At present, the preliminary plans for 2013 indicate high single-digit percentage-point growth in sales and operating profit, both measured in local currencies. The outlook reflects expectations for continued penetration of the portfolio of modern insulins, continued growth for the Victoza® franchise and a positive sales contribution from Tresiba®, primarily in the US, EU and Japan. These sales drivers will be partly countered by the impact from a challenging pricing environment in major markets, generic competition to oral antidiabetic products, intensifying competition within both diabetes care and biopharmaceuticals as well as the macroeconomic conditions in a number of markets in International Operations. In addition, the outlook for operating profit reflects significant costs related to the expected global launch of Tresiba®. At the current exchange rates, reported growth in sales and operating profit is expected to be in line with the growth measured in local currencies.

All of the above expectations are based on the assumption that the global economic environment will not significantly change business conditions for Novo Nordisk during the remainder of 2012 and in 2013, and that currency exchange rates, especially the US dollar, will remain at the current level versus the Danish krone. Please refer to appendix 7 for key currency assumptions.




Company announcement No 70 / 2012
Page 9 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


Novo Nordisk has hedged expected net cash flows in a number of invoicing currencies and, all other things being equal, movements in key invoicing currencies will impact Novo Nordisk’s operating profit as outlined in the table below.




 
Key invoicing
currencies
Annual impact on Novo Nordisk’s
operating profit of a 5%
movement in currency
Hedging period
(months)
 
 
 



 
USD
DKK 875 million
11
 
JPY
DKK 200 million
12
 
CNY
DKK 110 million
11*
 
GBP
DKK 80 million
11
 



 
* USD used as proxy when hedging Novo Nordisk’s CNY currency exposure      

The financial impact from foreign exchange hedging is included in ‘Net financials’.

RESEARCH AND DEVELOPMENT UPDATE

Diabetes care: Insulin and GLP-1

Tresiba® and Ryzodeg® regulatory update
The regulatory reviews for Tresiba®
(the intended brand name for insulin degludec) and Ryzodeg® (the intended brand name for insulin degludec/insulin aspart) continue to progress. As previously announced, Novo Nordisk has submitted Tresiba® and Ryzodeg® for regulatory review in the US, EU, Japan, Switzerland, Canada, South Africa, India, Australia, Brazil, Mexico and Russia.

In Japan, the Ministry of Health, Labour and Welfare approved Tresiba® for the treatment of diabetes on 28 September. Launch of Tresiba® is expected as soon as price negotiations have been completed. On 18 October, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) published their assessment report of Tresiba® which is the first extensive review of the data in the New Drug Application (NDA) for Tresiba®.

In Europe, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted positive opinions recommending marketing authorisations for Tresiba® and Ryzodeg® for the treatment of diabetes on 18 October. Novo Nordisk expects to receive final marketing authorisations from the European Commission within approximately two months.

In Mexico, the Federal Commission for the protection against sanitary risk (COFEPRIS) approved Tresiba® and Ryzodeg® for the treatment of diabetes on 25 October. Novo Nordisk expects to launch Tresiba® following pricing and reimbursement negotiations. Ryzodeg® is currently expected to be launched approximately one year after Tresiba®

In the US, the Food and Drug Administration (FDA) has confirmed that the Advisory Committee meeting to discuss the safety and efficacy of the New Drug Applications (NDA) for Tresiba® and Ryzodeg® will take place on 8 November. On 25 October, the FDA disclosed that the focus of discussion at the meeting will be benefits associated with a lower risk of hypoglycaemia and cardiovascular risk profile of the two products.




Company announcement No 70 / 2012
Page 10 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


Annual meeting of the European Association for the study of Diabetes (EASD)
In October, at the annual meeting of the European Association for the study of Diabetes (ESAD) held in Berlin, Germany, Novo Nordisk presented results from the company’s broad diabetes research and development activities. Novo Nordisk had a solid scientific presence with 57 accepted abstracts comprising 12 orals and 45 posters. Key presentations by Novo Nordisk focused on Tresiba® but also included phase 2 data for semaglutide, a once-weekly human GLP-1 (Glucagon-Like Peptide-1) analogue. The phase 2 data, which were previously announced as headline data in April 2009, showed that semaglutide, dose-dependently reduced HbA1c and body weight over 12 weeks, with higher doses being more effective than liraglutide on both parameters. In the phase 2 study, semaglutide demonstrated a good safety and tolerability profile.

A phase 3b trial comparing Victoza® and NovoRapid® as add-on therapy to Tresiba® completed
In September, Novo Nordisk completed a 26-week treat-to-target extension study, NN1250-3643, in patients with type 2 diabetes. The study evaluated the efficacy and safety of adding one daily injection of Victoza® or NovoRapid® to once-daily Tresiba® treatment as well as the durability of Tresiba® plus metformin treatment. Patients in the trial were in their third year of treatment and had previously participated in the NN1250-3579 study and in its subsequent 1 year extension.

In the extension trial, patients whose HbA1c was above 7.0% were randomised to intensification with Victoza® or NovoRapid® with their main meal, respectively. Patients who had an HbA1c below 7.0% continued Tresiba® treatment in combination with metformin in a non-randomised arm.

From a baseline HbA1c of 7.7% in both randomised treatment arms, patients randomised to Victoza® achieved a significantly lower end-of-trial HbA1c of 7.0% compared to 7.3% for patients treated with once-daily NovoRapid® taken with the main meal. Patients treated with Victoza® experienced a significantly lower rate of both overall and nocturnal hypoglycaemia compared to patients treated with NovoRapid®. With regard to body weight, patients treated with Victoza® achieved a weight loss of 2 kg whereas the patients treated with NovoRapid® experienced a weight increase of around 1 kg.

From a baseline HbA1c of 6.4%, patients continuing Tresiba® treatment in combination with metformin in the non-randomised treatment arm experienced a stable HbA1c throughout the treatment period, ending with an HbA1c of 6.5%. Rates of overall and nocturnal hypoglycaemia were low and comparable to those observed in the phase 3a programme for Tresiba®, and the patients experienced no change in body weight during the trial.

In general, safety and tolerability profiles of Tresiba®, Victoza® and NovoRapid® were confirmed.

New oral GLP-1, OG987SC (NN9927), starts phase 1
In October, Novo Nordisk initiated the first phase 1 trial for OG987SC, the fourth oral GLP-1 project brought into clinical development by Novo Nordisk. The phase 1 trial will investigate safety, tolerability, and pharmacokinetics of single doses of OG987SC in healthy volunteers.




Company announcement No 70 / 2012
Page 11 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


Biopharmaceuticals: Haemostasis

NovoThirteen® approved in the EU and Switzerland
During the last two months, both the European Commission and the Swiss Agency for Therapeutic Products, Swissmedic, approved NovoThirteen®, a recombinant factor XIII product. The product was approved for once-monthly prophylactic treatment of congenital FXIII A-subunit deficiency in patients above the age of six years. NovoThirteen® will be the only recombinant treatment option for this rare disease, affecting approximately 900 people worldwide. Novo Nordisk expects to launch NovoThirteen® in the first European countries towards the end of 2012.

Turoctocog alfa (NN7008) regulatory application submitted in the US and in Europe
In October, Novo Nordisk submitted the regulatory application for turoctocog alfa to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Turoctocog alfa is a third-generation recombinant coagulation factor VIII intended for the prevention and treatment of bleeding in people with haemophilia A.

Vatreptacog alfa (NN1713) discontinued following analysis of phase 3 data
In September, Novo Nordisk announced the decision to discontinue the development of vatreptacog alfa, a fast-acting recombinant factor VIIa analogue for haemophilia patients with inhibitors. The decision follows analysis of the data from the phase 3a trial adeptTM 2 where a few patients developed anti-drug antibodies to vatreptacog alfa, one patient with a potentially neutralising effect. None of the antibodies were inhibitory and the patients responded well to treatment during the course of the trial.

New administration system for NovoSeven® approved in Europe
In October, the European Commission granted marketing authorisation for a new administration system for intravenous infusion of NovoSeven®. The administration system improves convenience by reducing the number of dosing steps that patients have to go through. Novo Nordisk expects the first launches in Europe to take place in the beginning of 2013.

Biopharmaceuticals: Inflammation

rFXIII initiates phase 2a in ulcerative colitis (NN8717)
In October, Novo Nordisk initiated a phase 2a trial with rFXIII for the treatment of ulcerative colitis. In the trial, rFXIII will be administered to people with mild to moderate active ulcerative colitis. rFXIII is at present solely approved for congenital FXIII A-subunit deficiency in the EU, Canada and Switzerland.

Phase 2a initiated with anti-IL-21 (NN8828) in rheumatoid arthritis
In September, Novo Nordisk initiated the first phase 2a trial with anti-IL-21 for the treatment of rheumatoid arthritis. The trial will evaluate the effect of anti-IL-21 compared to placebo in patients with active rheumatoid arthritis on a background of methotrexate therapy.

Phase 1 initiated with anti-IL-21 (NN8828) in systemic lupus erythematosus
In October, Novo Nordisk initiated the first phase 1 trial with anti-IL-21 for the treatment of systemic lupus erythematosus. The trial will evaluate the safety and tolerability of anti-IL-21 in patients with systemic lupus erythematosus.




Company announcement No 70 / 2012
Page 12 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


SUSTAINABILITY UPDATE

Development in number of employees
The number of full-time employees was 33,501 as of 30 September 2012 compared to 32,016 of 30 September 2011. New hiring was led by expansion in the US, countries in the International Operations region and within Research & Development.

HERO initiative strengthens market proposition in haemophilia
During the third quarter, Novo Nordisk announced the first results from the HERO study (Haemophilia Experiences, Results and Opportunities), the largest, multi-country study aiming to improve the understanding of life with haemophilia, seen from the perspective of people with haemophilia, their families and their healthcare providers.

The study comprised responses from questionnaires with 1,236 persons with haemophilia and their parents from 10 countries. The study revealed an unmet need for psychological and psychiatric services to help people with haemophilia address daily challenges related to employment, forming adult relationships, and dependency on others as well as insufficient knowledge among professional caretakers and school teachers of how to help care for a child with haemophilia.

HERO is an initiative under the Changing Possibilities in Haemophilia® programme and represents Novo Nordisk’s commitment to mitigate the social and economic consequences of haemophilia and rare bleeding disorders. This is an integrated part of Novo Nordisk’s strategic objective to achieve leadership in haemophilia by improving the efficacy of prevention and treatment of bleeding episodes for all patients with haemophilia and rare bleeding disorders.

EQUITY
Total equity was DKK 35,660 million at the end of the first nine months of 2012, equivalent to 53.5% of total assets, compared to 57.1% at the end of the first nine months of 2011. The development in equity ratio is primarily driven by the increased dividend payments and the ongoing share repurchase programme – lowering retained earnings – while the liabilities grow in line with operations. Please refer to appendix 5 for further elaboration of changes in equity.

Treasury shares and 2012 share repurchase programme
On 9 August 2012, Novo Nordisk announced a DKK 2.0 billion share repurchase programme as part of the overall DKK 12 billion programme to be executed during a 12-month period starting 2 February 2012. The purpose of the programme is to reduce the company’s share capital. Under the programme announced 9 August, Novo Nordisk has repurchased B shares for an amount of DKK 2.0 billion in the period from 9 August 2012 to 29 October 2012 when the programme was concluded. As of 29 October 2012, Novo Nordisk has repurchased 12,513,460 shares corresponding to a total value of DKK 10.5 billion under the DKK 12 billion programme.

As per 29 October 2012, Novo Nordisk A/S and its wholly-owned affiliates owned 17,189,296 of its own B shares, corresponding to 3.1% of the total share capital.

Share repurchases under the overall DKK 12 billion programme will be resumed shortly.




Company announcement No 70 / 2012
Page 13 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


LEGAL UPDATE
As of 26 October 2012, Novo Nordisk Inc., along with a majority of the 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 41 individuals who allege use of a Novo Nordisk hormone therapy product. The 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.). In addition, 50 individuals currently allege, in relation to similar lawsuits against Pfizer Inc., that they have also used a Novo Nordisk hormone therapy product. Pfizer Inc. has publicly announced the settlement of many of its hormone therapy cases. The reduction in pending cases is the result of Pfizer Inc. settling several cases that also involve Novo Nordisk’s products. Currently, Novo Nordisk does not have any trials scheduled in 2012. Novo Nordisk does not expect the pending claims to have a material impact on its financial position, operating profit and cash flow.

FINANCIAL CALENDAR
31 January 2013 Financial statement for 2012
4 February 2013 PDF version of the Annual Report 2012
5 February 2013 Deadline for the company’s receipt of shareholder proposals for the
  Annual General Meeting 2013
22 February 2013 Printed version of the Annual Report 2012
20 March 2013 Annual General Meeting 2013
1 May 2013 Financial statement for the first three months of 2013
8 August 2013 Financial statement for the first six months of 2013
31 October 2013 Financial statement for the first nine months of 2013

CONFERENCE CALL DETAILS
At 13.00 CET today, corresponding to 8.00 am EDT, 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’ (http://www.novonordisk.com/investors/download-centre/default.asp). Presentation material for the conference call will be available approximately one hour prior to the start of the conference call on the same page.

FORWARD-LOOKING STATEMENTS
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 2011 and Form 20-F, both filed with the SEC in February 2012, and written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as ‘believe’, ‘expect’, ‘may’, ‘will’, ‘plan’, ‘strategy’, ‘prospect’, ‘foresee’, ‘estimate’, ‘project’, ‘anticipate’, ‘can’, ‘intend’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to:

statements of plans, objectives or goals for future operations, including those related to Novo Nordisk’s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto
statements containing projections of or targets for revenues, income (or loss), earnings per share, capital expenditures, dividends, capital structure or other net financials
statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and
statements of the assumptions underlying or relating to such statements.




Company announcement No 70 / 2012
Page 14 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


In this document, examples of forward-looking statements can be found under the headings ‘Outlook 2012’, ‘Research and development update’, ‘Equity’ and ‘Legal 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 described in this document, could cause actual results to differ materially from those contemplated in any forward-looking statements.

Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, 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 the overview of risk factors in ‘Risk Management’ on pp 22-24 of the Annual Report 2011 available on the company’s 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.




Company announcement No 70 / 2012
Page 15 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


MANAGEMENT STATEMENT
The Board of Directors and Executive Management have reviewed and approved the financial report of Novo Nordisk A/S for the first nine months of 2012. The financial report has not been audited or reviewed by the company’s independent auditors.

The consolidated financial statements for the first nine months of 2012 have been prepared in accordance with IAS 34 ‘Interim Financial Reporting’ and on the basis of the same accounting policies as applied in the Annual Report 2011 of Novo Nordisk. Furthermore, the financial report, including the consolidated financial statements for the first nine months of 2012 and management’s review, has been prepared in accordance with additional Danish disclosure requirements for interim reports of listed companies.

In our opinion, the accounting policies used are appropriate and the overall presentation of the consolidated financial statements for the first nine months of 2012 is adequate. Furthermore, in our opinion, management's review includes a true and fair account of the development in the operations and financial circumstances, of the results for the period and of the financial position of the Group as well as a description of the most significant risks and elements of uncertainty facing the Group in accordance with Danish disclosure requirements for listed companies.

Bagsværd, 31 October 2012

Executive Management:    
Lars Rebien Sørensen
Jesper Brandgaard
 
President and CEO CFO  
     
Lise Kingo Kåre Schultz Mads Krogsgaard Thomsen
COS COO CSO
     
Board of Directors:    
Sten Scheibye Göran Ando Bruno Angelici
Chairman Vice chairman  
     
Henrik Gürtler Ulrik Hjulmand-Lassen Thomas Paul Koestler
     
Anne Marie Kverneland Kurt Anker Nielsen Søren Thuesen Pedersen
     
Hannu Ryöppönen Stig Strøbæk Liz Hewitt



Company announcement No 70 / 2012
Page 16 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


CONTACTS FOR FURTHER INFORMATION  
Media:      
Mike Rulis
+
45 4442 3573
mike@novonordisk.com
Ken Inchausti (US)
+
1 609 514 8316
kiau@novonordisk.com
   
Investors:  
Kasper Roseeuw Poulsen +
45 4442 4303
krop@novonordisk.com
Frank Daniel Mersebach +
45 4442 0604
fdni@novonordisk.com
Lars Borup Jacobsen +
45 3075 3479
lbpj@novonordisk.com
Jannick Lindegaard (US) +
1 609 786 4575
jlis@novonordisk.com

Further information about Novo Nordisk is available on the company’s website novonordisk.com


Company announcement No 70 / 2012
Page 17 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


APPENDIX 1:
QUARTERLY NUMBERS IN DKK

 


(Amounts in DKK million, except number of employees, earnings per share and number of shares outstanding).  
                             
% change
 
 
2012
 
2011
  Q3 2012 vs  
 
Q3
Q2
Q1
Q4
Q3
Q2
Q1
  Q3 2011  
 
 
 

Sales 19,845   19,468   17,751   18,120   16,532   16,001   15,693   20%  
Gross profit 16,360   16,044   14,348   14,998   13,281   12,902   12,576   23%  
Gross margin 82.4%   82.4%   80.8%   82.8%   80.3%   80.6%   80.1%      
Sales and distribution costs 5,299   5,203   4,850   5,387   4,724   4,633   4,260   12%  
Percentage of sales 26.7%   26.7%   27.3%   29.7%   28.6%   29.0%   27.1%      
Research and development costs 2,617   2,563   2,507   2,752   2,263   2,323   2,290   16%  
Percentage of sales 13.2%   13.2%   14.1%   15.2%   13.7%   14.5%   14.6%      
Administrative expenses 766   779   776   923   788   778   756   (3%)
Percentage of sales 3.9%   4.0%   4.4%   5.1%   4.8%   4.9%   4.8%      
Licence fees and other operating income (net) 186   154   170   145   104   97   148   79%  
Operating profit 7,864   7,653   6,385   6,081   5,610   5,265   5,418   40%  
Operating margin 39.6%   39.3%   36.0%   33.6%   33.9%   32.9%   34.5%      
Share of profit/(loss) in associated companies -   -   -   (4 ) -   -   -  
N/A
 
Financial income (85 ) 146   47   6   154   270   84   (155%)
Financial expenses 420   856   375   272   308   167   212   36%  
Net financials (505 ) (710 ) (328 ) (270 ) (154 ) 103   (128 ) 228%  
Profit before income taxes 7,359   6,943   6,057   5,811   5,456   5,368   5,290   35%  
Net profit 5,667   5,346   4,664   4,689   4,201   4,134   4,073   35%  
Depreciation, amortisation and impairment losses 644   656   638   692   615   825   605   5%  
Capital expenditure 942   855   516   1,182   645   627   549   46%  
Net cash generated from operating activities 7,962   5,823   6,915   3,981   7,754   4,531   5,108   3%  
Free cash flow 6,926   4,945   6,366   2,751   7,066   3,792   4,503   (2%)
Total assets 66,620   60,978   61,210   64,698   62,013   61,528   59,001   7%  
Total equity 35,660   31,334   32,358   37,448   35,428   36,966   34,768   1%  
Equity ratio 53.5%   51.4%   52.9%   57.9%   57.1%   60.1%   58.9%      
Full-time employees at the end of the period 33,501   32,819   32,252   32,136   32,016   31,549   30,867   5%  
Basic earnings per share/ADR (in DKK) 10.40   9.72   8.38   8.40   7.45   7.26   7.13   40%  
Diluted earnings per share/ADR (in DKK) 10.33   9.67   8.32   8.33   7.39   7.21   7.06   40%  
Average number of shares outstanding (million) 544.6   549.1   556.7   557.6   563.5   569.1   571.6   (3%)
Average number of shares outstanding incl                                
dilutive effect of options 'in the money' (million) 547.8   552.4   560.5   561.9   568.1   573.8   576.7   (4%)
Sales by business segment:                                
   Modern insulins (insulin analogues) 8,879   8,613   7,867   7,856   7,232   6,972   6,705   23%  
   Human insulins 2,794   2,781   2,718   2,790   2,698   2,642   2,655   4%  
   Protein-related products 644   621   625   569   574   527   639   12%  
   Victoza® 2,503   2,293   1,990   2,096   1,547   1,250   1,098   62%  
   Oral antidiabetic products (OAD) 719   653   716   649   562   653   711   28%  
   Diabetes care total 15,539   14,961   13,916   13,960   12,613   12,044   11,808   23%  
   NovoSeven® 2,153   2,451   1,909   2,131   2,044   2,140   2,032   5%  
   Norditropin® 1,451   1,440   1,346   1,340   1,275   1,180   1,252   14%  
   Hormone replacement therapy 600   530   500   548   501   513   492   20%  
   Other products 102   86   80   141   99   124   109   3%  
   Biopharmaceuticals total 4,306   4,507   3,835   4,160   3,919   3,957   3,885   10%  
Sales by geographic segment:                                
   North America 8,981   8,356   7,324   7,582   6,804   6,165   6,035   32%  
   Europe 4,793   5,081   4,596   4,998   4,728   4,847   4,595   1%  
   International Operations 2,695   2,757   2,734   2,463   2,286   2,415   2,203   18%  
   Region China 1,666   1,550   1,612   1,300   1,175   1,151   1,376   42%  
   Japan & Korea 1,710   1,724   1,485   1,777   1,539   1,423   1,484   11%  
Segment operating profit:                                
   Diabetes care 5,768   5,270   4,638   4,419   3,636   3,415   3,115   59%  
   Biopharmaceuticals 2,096   2,383   1,747   1,662   1,974   1,850   2,303   6%  



Company announcement No 70 / 2012
Page 18 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


APPENDIX 2:
INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME









 
 
9M
9M
Q3
 
Q3
 
DKK million
2012
 
2011
 
2012
 
2011
 








 
Income statement
 
 
 
 
                 
Sales
57,064
 
48,226
 
19,845
 
16,532
 
Cost of goods sold
10,312
 
9,467
 
3,485
 
3,251
 




 


 
Gross profit
46,752
 
38,759
 
16,360
 
13,281
 
 
 
 
 
 
Sales and distribution costs
15,352
 
13,617
 
5,299
 
4,724
 
Research and development costs
7,687
 
6,876
 
2,617
 
2,263
 
Administrative expenses
2,321
 
2,322
 
766
 
788
 
Licence fees and other operating income (net)
510
 
349
 
186
 
104
 








 
Operating profit
21,902
 
16,293
 
7,864
 
5,610
 
 
 
 
 
 
Financial income
108
 
508
 
(85
)
154
 
Financial expenses
1,651
 
687
 
420
 
308
 








 
Profit before income taxes
20,359
 
16,114
 
7,359
 
5,456
 
 
 
 
 
 
Income taxes
4,682
 
3,706
 
1,692
 
1,255
 








 
Net profit
15,677
 
12,408
 
5,667
 
4,201
 








 
 
 
 
 
 
Basic earnings per share (DKK)
28.50
 
21.84
 
10.40
 
7.45
 
Diluted earnings per share (DKK)
28.32
 
21.66
 
10.33
 
7.39
 
 
 
 
 
 
                 
Segment Information
 
 
 
 








 
Segment sales:
 
 
 
 
   Diabetes care
44,416
 
36,465
 
15,539
 
12,613
 
   Biopharmaceuticals
12,648
 
11,761
 
4,306
 
3,919
 
                 
Segment operating profit:
 
 
 
 
   Diabetes care
15,676
 
10,166
 
5,768
 
3,636
 
   Operating margin
35.3%
 
27.9%
 
37.1%
 
28.8%
 
   Biopharmaceuticals
6,226
 
6,127
 
2,096
 
1,974
 
   Operating margin
49.2%
 
52.1%
 
48.7%
 
50.4%
 
 
 
 
 
 
Total segment operating profit
21,902
 
16,293
 
7,864
 
5,610
 








 
 
 
 
 
 
 
 
 
 
 
Statement of comprehensive income
 
 
 
 
Net profit for the period
15,677
 
12,408
 
5,667
 
4,201
 
      Other comprehensive income:
 
 
 
 
      Realisation of previously deferred (gains)/losses on cash flow hedges to
 
 
 
 
      income statement
1,090
 
599
 
252
 
103
 
      Deferred gains/(losses) on cash flow hedges arising during the period
34
 
(483
)
562
 
(1,379
)
      Exchange rate adjustments of investments in subsidiaries
(137
)
(343
)
(28
)
(131
)
      Deferred gains/(losses) on equity investments
26
 
11
 
3
 
8
 
      Other
(3
)
(8
)
2
 
49
 
      Tax on other comprehensive income, income/(expense)
(282
)
(58
)
(231
)
406
 








 
      Other comprehensive income for the period, net of tax
728
 
(282
)
560
 
(944
)








 
Total comprehensive income for the period
16,405
 
12,126
 
6,227
 
3,257
 








 



Company announcement No 70 / 2012
Page 19 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


APPENDIX 3:
BALANCE SHEET





 
DKK million
30 Sep 2012
31 Dec 2011
 




 
         
ASSETS        
         
Intangible assets 1,472   1,489  
Property, plant and equipment 21,323   20,931  
Investments in associated companies 41   39  
Deferred income tax assets 2,669   2,414  
Other financial assets 220   234  




 
Total non-current assets 25,725   25,107  
         
Inventories 9,414   9,433  
Trade receivables 9,691   9,349  
Tax receivables 1,227   883  
Other receivables and prepayments 2,913   2,376  
Marketable securities 4,063   4,094  
Derivative financial instruments 105   48  
Cash at bank and in hand 13,482   13,408  




 
Total current assets 40,895   39,591  
         




 
Total assets 66,620   64,698  




 
         
         
EQUITY AND LIABILITIES        
         
Share capital 560   580  
Treasury shares (16 ) (24 )
Retained earnings 34,607   37,111  
Other reserves 509   (219 )




 
Total equity 35,660   37,448  
         
Loans 503   502  
Deferred income tax liabilities 1,824   3,206  
Retirement benefit obligations 481   439  
Provisions 1,926   2,324  




 
Total non-current liabilities 4,734   6,471  
         
Current debt 588   351  
Trade payables 2,689   3,291  
Tax payables 5,359   1,171  
Other liabilities 9,130   8,534  
Derivative financial instruments 601   1,492  
Provisions 7,859   5,940  




 
Total current liabilities 26,226   20,779  
         
Total liabilities 30,960   27,250  
         




 
Total equity and liabilities 66,620   64,698  




 



Company announcement No 70 / 2012
Page 20 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


APPENDIX 4:
STATEMENT OF CASH FLOWS





 
DKK million
9M 2012
 
9M 2011
 




 
         
Net profit 15,677   12,408  
         
Adjustment for non-cash items 9,019   7,021  
Change in working capital (666 ) (195 )
Interest received 192   211  
Interest paid (32 ) (31 )
Income taxes paid (3,490 ) (2,021 )




 
Net cash generated from operating activities 20,700   17,393  
         
Purchase of intangible assets and other financial assets (150 ) (211 )
Proceeds from sale of property, plant and equipment 17   8  
Purchase of property, plant and equipment (2,330 ) (1,829 )
Net change in marketable securities 10   1,105  




 
Net cash used in investing activities (2,453 ) (927 )
         
Purchase of treasury shares, net (10,690 ) (8,143 )
Dividends paid (7,742 ) (5,700 )




 
Net cash used in financing activities (18,432 ) (13,843 )
         
Net cash generated from activities (185 ) 2,623  
         
Cash and cash equivalents at the beginning of the period 13,057   11,960  
Exchange gain/(loss) on cash and cash equivalents 23   (27 )




 
Cash and cash equivalents at the end of the period 12,895   14,556  
         
Additional information:        
Cash and cash equivalents at the end of the period 12,895   14,556  
Marketable securities at the end of the period 4,063   2,835  
Undrawn committed credit facilities 4,846   4,465  




 
Financial resources at the end of the period 21,804   21,856  
         
Net cash generated from operating activities 20,700   17,393  
Net cash used in investing activities (2,453 ) (927 )
Net change in marketable securities (10 ) (1,105 )




 
Free cash flow 18,237   15,361  




 



Company announcement No 70 / 2012
Page 21 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


APPENDIX 5:
STATEMENT OF CHANGES IN EQUITY


 
              Other reserves      
             
     
DKK million
Share
capital
Treasury
shares
Retained
earnings
Exchange
rate adjust
ments
Deferred gain/
loss on cash flow
hedges
Tax and
other
adjust-
ments
Total
other
reserves
Total
 
















 
9M 2012                                
Balance at the beginning of the period 580   (24 ) 37,111   398   (1,184 ) 567   (219 ) 37,448  
Profit for the period         15,677                   15,677  
Other comprehensive income for the period, net of tax             (137 ) 1,124   (259 ) 728   728  
















 
Total comprehensive income for the period 580   (24 ) 52,788   261   (60 ) 308   509   53,853  
                                 
Transactions with owners, recognised directly in equity:                                
Dividends         (7,742 )                 (7,742 )
Share-based payment         239                   239  
Reduction of the B share capital (20 ) 20                       -  
Purchase of treasury shares     (13 ) (10,774 )                 (10,787 )
Sale of treasury shares     1   96                   97  
















 
Balance at the end of the period 560   (16 ) 34,607   261   (60 ) 308   509   35,660  
















 
 
Other reserves
 
 

 
DKK million
Share
capital
Treasury
shares
Retained
earnings
Exchange
rate adjust
ments
Deferred gain/
loss on cash flow
hedges
Tax and
other
adjust-
ments
Total
other
reserves
Total
 
















 
9M 2011                                
Balance at the beginning of the period 600   (28 ) 36,097   571   (672 ) 397   296   36,965  
Profit for the period         12,408                   12,408  
Other comprehensive income for the period, net of tax             (343 ) 116   (55 ) (282 ) (282 )
















 
Total comprehensive income for the period 600   (28 ) 48,505   228   (556 ) 342   14   49,091  
                                 
Transactions with owners, recognised directly in equity:                                
Dividends         (5,700 )                 (5,700 )
Share-based payment         180                   180  
Reduction of the B share capital (20 ) 20                       -  
Purchase of treasury shares     (14 ) (8,193 )                 (8,207 )
Sale of treasury shares     1   63                   64  
















 
Balance at the end of the period 580   (21 ) 34,855   228   (556 ) 342   14   35,428  
















 



Company announcement No 70 / 2012
Page 22 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


APPENDIX 6:
QUARTERLY NUMBERS IN EUR / SUPPLEMENTARY INFORMATION

(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 the average exchange rate for income statement and the exchange rate at the balance sheet date for balance sheet items.
The specified percent changes are based on the changes in the 'Quarterly numbers in DKK', see appendix 1.


 
                             
% change
 
 
2012
2011
  Q3 2012 vs  
 
Q3
 
Q2
 
Q1
 
Q4
 
Q3
 
Q2
 
Q1
  Q3 2011  
 




 






 
 
Sales 2,665   2,618   2,388   2,435   2,219   2,146   2,105   20%  
Gross profit 2,198   2,157   1,930   2,015   1,783   1,730   1,687   23%  
Gross margin 82.4%   82.4%   80.8%   82.8%   80.3%   80.6%   80.1%      
Sales and distribution costs 713   699   653   722   636   620   572   12%  
Percentage of sales 26.7%   26.7%   27.3%   29.7%   28.6%   29.0%   27.1%      
Research and development costs 351   345   337   370   303   312   307   16%  
Percentage of sales 13.2%   13.2%   14.1%   15.2%   13.7%   14.5%   14.6%      
Administrative expenses 103   105   104   125   105   105   101   (3% )
Percentage of sales 3.9%   4.0%   4.4%   5.1%   4.8%   4.9%   4.8%      
Licence fees and other operating income (net) 25   21   23   19   14   13   20   79%  
Operating profit 1,056   1,029   859   817   753   706   727   40%  
Operating margin 39.6%   39.3%   36.0%   33.6%   33.9%   32.9%   34.5%      
Share of profit/(loss) in associated companies -   -   -   (1 ) -   -   -  
N/A
 
Financial income (11 ) 20   6   1   21   36   11   (155%)
Financial expenses 56   116   50   36   41   23   28   36%  
Net financials (67 ) (96 ) (44 ) (36 ) (20 ) 13   (17 ) 228%  
Profit before income taxes 989   933   815   781   733   719   710   35%  
Net profit 761   719   627   630   564   555   546   35%  
Depreciation, amortisation and impairment losses 87   88   86   93   82   111   81   5%  
Capital expenditure 127   115   69   159   86   84   74   46%  
Net cash generated from operating activities 1,070   783   930   536   1,040   608   685   3%  
Free cash flow 931   665   856   370   948   509   604   (2%)
Total assets 8,936   8,203   8,227   8,703   8,333   8,249   7,912   7%  
Total equity 4,783   4,215   4,349   5,037   4,761   4,956   4,663   1%  
Equity ratio 53.5%   51.4%   52.9%   57.9%   57.1%   60.1%   58.9%      
Full-time employees at the end of the period 33,501   32,819   32,252   32,136   32,016   31,549   30,867   5%  
Basic earnings per share/ADR (in EUR) 1.40   1.30   1.13   1.13   1.00   0.97   0.96   40%  
Diluted earnings per share/ADR (in EUR) 1.39   1.30   1.12   1.12   1.00   0.96   0.95   40%  
Average number of shares outstanding (million) 544.6   549.1   556.7   557.6   563.5   569.1   571.6   (3%)
Average number of shares outstanding incl                                
dilutive effect of options 'in the money' (million) 547.8   552.4   560.5   561.9   568.1   573.8   576.7   (4%)
Sales by business segment:                                
   Modern insulins (insulin analogues) 1,192   1,158   1,058   1,056   971   935   899   23%  
   Human insulins 375   374   366   375   363   354   356   4%  
   Protein-related products 86   84   84   77   77   70   86   12%  
   Victoza® 336   308   268   281   208   168   147   62%  
   Oral antidiabetic products (OAD) 97   88   96   88   75   88   95   28%  
   Diabetes care total 2,086   2,012   1,872   1,877   1,694   1,615   1,583   23%  
   NovoSeven® 290   329   257   286   274   287   273   5%  
   Norditropin® 195   194   181   180   171   158   168   14%  
   Hormone replacement therapy 80   72   67   74   67   69   66   20%  
   Other products 14   11   11   18   13   17   15   3%  
   Biopharmaceuticals total 579   606   516   558   525   531   522   10%  
Sales by geographic segment:                                
   North America 1,208   1,123   985   1,019   914   827   809   32%  
   Europe 643   684   618   672   634   651   616   1%  
   International Operations 361   371   368   331   307   323   296   18%  
   Region China 224   208   217   174   158   154   185   42%  
   Japan & Korea 229   232   200   239   206   191   199   11%  
Segment operating profit:                                
   Diabetes care 774   709   624   594   488   458   418   59%  
   Biopharmaceuticals 282   320   235   223   265   248   309   6%  



Company announcement No 70 / 2012
Page 23 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax:
+45 4444 2314
Internet:
www.novonordisk.com
CVR no:
24256790
 

 


APPENDIX 7:
KEY CURRENCIES ASSUMPTIONS / SUPPLEMENTARY INFORMATION


 
DKK per 100
2011 average
 
YTD 2012 average exchange
 
Current exchange rate
 
 
exchange rates
 
rates as of 26 October 2012
 
as of 26 October 2012
 






 
USD
536
 
580
 
578
 
JPY
6.73
 
7.32
 
7.23
 
CNY
83
 
92
 
92
 
GBP
859
 
917
 
931
 



Company announcement No 70 / 2012
Page 24 of 24
Financial report for the period 1 January 2012 to 30 September 2012  

Novo Nordisk A/S

Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Telefax: +45 4444 2314
Internet: www.novonordisk.com
CVR no:
24256790
 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.

Date: OCTOBER 31, 2012

NOVO NORDISK A/S


Lars Rebien Sørensen, President and Chief Executive Officer