Interim Results


Novo Nordisk increased sales by 14% in the first half of 2005
Expectation for operating profit growth increased to around 10% for 2005
 
  • In local currencies sales in the first half of 2005 increased by 15%
o        Sales of insulin analogues increased by 67%
o        Sales of NovoSeven® increased by 14%
o        Sales in North America increased by 28%
 
  • Operating profit increased by 14% to DKK 3,853 million. Adjusted for the impact from currencies and changes in the level of non-recurring income, underlying operating profit increased by more than 15%.
 
  • Net profit increased by 25% to DKK 2,916 million and earnings per share (diluted) increased by 28% to DKK 8.78.
 
  • The expectation for operating profit growth is increased from around 5% to around 10% for the full year of 2005.
 
  • The continued consultations with the European regulatory authorities (EMEA) have led Novo Nordisk to withdraw the phase 2-based registration file for NovoSeven® in trauma. It is expected that results from a confirmatory clinical study will enable a subsequent, updated European filing.
 
  • Positive opinion has been received from EMEA on NovoMix® 50 and NovoMix® 70 filings in Europe. NovoLog® Mix 50/50 and NovoLog® Mix 30/70 have been filed for approval in the US.
 
  • Lars Rebien Sørensen, president & CEO, said: "We are encouraged by the continued market success of our strategic products, in particular the full range of insulin analogues and NovoSeven®.  Moreover, the performance in our North American business has increased our confidence in the future growth potential for Novo Nordisk in the world's largest pharmaceutical market."

Financial statement for the first six months of 2005


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 2004, which includes the expense impact of share-based payment schemes. The interim report has not been audited.
Amounts in DKK million, except average number of shares outstanding, earnings per share and full-time employees.
 

Sales development by segments
Sales in the first six months of 2005 increased by 15% measured in local currencies and by 14% in Danish kroner. Growth was realised both within diabetes care and biopharmaceuticals - primarily driven by strategically important products such as the insulin analogues as well as NovoSeven®. Furthermore, sales of growth hormone therapy products also contributed to growth.
 
 
 
Sales growth was realised in all regions and North America now constitutes 28% of total sales.  
 
Diabetes care
Sales of diabetes care products increased by 16% in local currencies compared to the first six months of 2004 and by 15% in Danish kroner to DKK 11,006 million.
 
Insulin analogues, human insulin and insulin-related products
Sales of insulin analogues, human insulin and insulin-related products increased by 18% measured in local currencies and by 17% to DKK 10,239 million in Danish kroner. All regions contributed to growth measured in local currencies as well as in Danish kroner.
 
Novo Nordisk continues to be the global leader in the insulin market with a total market share of 50% and an insulin analogue market share of more than 30%, measured in volume.
 
Sales of insulin analogues increased by 67% in local currencies and by 63% in Danish kroner to DKK 3,140 million in the first six months of 2005. Sales of insulin analogues contributed with 62% of the overall growth in local currencies and constitute more than 30% of Novo Nordisk's total sales of all insulin and insulin-related products.
 
North America
Sales in North America increased by 45% in local currencies in the first six months of 2005 and by 39% in Danish kroner, reflecting solid penetration of the insulin analogues NovoLog® and NovoLog® Mix 70/30. In the US market, Novo Nordisk now holds more than 36% of the total insulin market and over 20% of the analogue market, measured by volume. Sales of human insulin products also increased due to increased volumes and higher average prices.
 
Europe
Sales in Europe increased by 8% in local currencies and by 9% in Danish kroner, with growth primarily driven by the portfolio of insulin analogues, including Levemir®, which has now been introduced in 11 European countries.
 
Japan & Oceania
Sales in Japan & Oceania increased by 13% in local currencies and by 11% in Danish kroner, with growth primarily reflecting sales of NovoRapid® and NovoRapid® Mix 30, supported by the continued switch from durable to prefilled devices.
 
International Operations
Sales in International Operations increased by 21% in local currencies and by 19% in Danish kroner. Sales were dominated by human insulin but insulin analogues continue to add to overall growth in the region. China was the primary growth driver and contributed more than 15% of total sales in International Operations in the first six months of 2005.  
 
Oral antidiabetic products
Sales of oral antidiabetic products decreased compared to the same period in 2004 by 2% in local currencies and 4% in Danish kroner to DKK 767 million. While the sales development was positive both in Europe and International Operations, the overall decrease in sales compared to the same period last year mainly reflects lower sales to wholesalers in the US market during the first six months of 2005.
 
Biopharmaceuticals
Sales of biopharmaceutical products increased by 12% in local currencies compared to the first six months of 2004 and by 10% in Danish kroner to DKK 4,535 million.
 
NovoSeven®
Sales of NovoSeven® increased by 14% in local currencies compared to the same period last year and by 11% in Danish kroner to DKK 2,338 million, with sales growth primarily driven by North America, but also International Operations and Japan & Oceania contributed to growth. In Europe, sales growth resumed during the second quarter of 2005.  
 
The sales growth of NovoSeven® was influenced by several factors during the first six months of 2005. Due to the high penetration within spontaneous bleeds in congenital inhibitor patients, the predominant part of the growth within the inhibitor segment has been generated by treatment of acquired haemophilia patients and usage of NovoSeven® in connection with elective surgery. Treatment of spontaneous bleeds for congenital inhibitor patients remains the largest area of use. In addition, sales are perceived to have been positively affected by increased investigational use of NovoSeven®.  
 
Growth hormone therapy (Norditropin® and Norditropin® SimpleXx®)
Sales of growth hormone therapy products increased by 19% in local currencies and by 17% in Danish kroner to DKK 1,300 million. All regions contributed to the sales increase compared to the same period last year, with North America and Europe as the main growth drivers. Sales have been positively impacted by the NordiFlex® prefilled delivery device.
 
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 1% in Danish kroner to DKK 897 million. While total sales of HRT products continue to be negatively impacted by challenging market conditions, sales in the US increased during the first six months due to higher market share and higher average prices.
 
Costs, licence fees and other operating income
The cost of goods sold increased by 13% to DKK 4,295 million, leaving the gross margin at 72.4%, compared to 72.2% in the first six months of 2004. The gains from an improved product mix and increased productivity were partially offset by an adverse currency impact, leaving the underlying gross margin improvement at 0.4 percentage point. The gross margin was negatively impacted by a write-down on inventories of animal insulin crystals, which has been included in the cost of goods sold.
 
Total non-production-related costs increased by 13% to DKK 7,662 million. The increase in non-production-related costs reflects especially costs related to sales and distribution, which increased in line with sales. This reflects the increase in the US diabetes care sales force implemented during the second quarter of 2004 as well as costs related to the launch of Levemir® in the European market.
 
Licence fees and other operating income in the first six months of 2005 were DKK 269 million, compared to DKK 303 million in the same period last year. In the second quarter of 2005 a non-recurring income of around DKK 100 million was realised from a sale-and-leaseback transaction involving certain office buildings in Denmark.  
 
Net financials
Net financials showed an income of DKK 278 million in the first six months of 2005 compared to an income of DKK 107 million in the same period in 2004. A non-recurring gain of around DKK 250 million was recorded in the first quarter of 2005 from the sale of shares in Ferrosan A/S.
 
The foreign exchange gains were DKK 135 million compared to a gain of DKK 195 million in the same period last year. The lower level of foreign exchange gains mainly reflects lower income from foreign exchange hedging activities, which include forward contracts and foreign exchange options. The effect of these hedging activities has been negatively impacted by the higher level of the US dollar versus the Danish krone in the first six months of 2005 compared to the level prevailing in 2004. At the end of June 2005, an unrealised loss of DKK 386 million has, in accordance with IFRS, been deferred for profit and loss recognition in the period when hedged cash flows occur.   
 
Outlook 2005
Reflecting the continued appreciation of the US dollar and related currencies, Novo Nordisk now expects to report Danish kroner sales growth in 2005 of 12-15%, and a similar level of growth measured in local currencies.
 
The expectation for reported operating profit growth is increased from around 5% to around 10%. This reflects the improved exchange rate environment as well as the non-recurring income from the sale-and-leaseback transaction and also the expected costs related to a planned employee share offering during the fourth quarter of 2005 - as further described below under 'Employee share programme'. Excluding the impact from currency movements and non-recurring items, underlying operating profit is still expected to grow by around 15%.  
 
 
Novo Nordisk now expects the tax rate for 2005 to be slightly below 29% as a consequence of the reduction in the Danish corporate income tax rate from 30% to 28%, effective for the income year 2005, which was formally approved by the Danish parliament (Folketinget) in June 2005.
 
As previously communicated, the expected tax rate for 2005 is reduced by close to two percentage points by two factors of a non-recurring nature, each of which account for close to one percentage-point reduction in the tax rate:
  • the tax-exempt status of the capital gain on the sale of shares in Ferrosan A/S; and
  • the re-evaluation of the company's deferred tax liabilities as a consequence of the reduction of the Danish corporate income tax rate.    
 
Furthermore, the tax-exempt status of the accounting gain related to ZymoGenetics' public offering of new shares will reduce the expected tax rate for 2005 by around half a percentage point on a non-recurring basis.
 
Novo Nordisk still expects capital expenditure of close to DKK 4 billion in 2005. Depreciations, amortisation and impairment losses are still expected to be around DKK 1.9 billion, whereas free cash flow is now expected to be around DKK 3 billion.
 
All of the above expectations are provided that currency exchange rates remain at the current level for the rest of 2005.
 
Novo Nordisk has hedged expected net cash flows in relation to US dollars, Japanese yen and British pounds for 10, 9 and 9 months, respectively. In accordance with IFRS, the financial impact from foreign exchange hedging contracts will be included in 'Net financials' as the underlying future operational cash flow materialises.  
 
Research and development update
 
Diabetes care
As previously communicated, Levemir® was approved by the US Food and Drug Administration (FDA) in June 2005, and Novo Nordisk is thereby the only company with a complete range of insulin analogues approved in the US, encompassing rapid-acting NovoLog®, premixed NovoLog® Mix 70/30 and now also the long-acting analogue Levemir®. Novo Nordisk expects to launch Levemir® in the US market within 12 months following the approval.
 
In June 2005, Novo Nordisk received a positive opinion from the European regulatory authorities' Committee for Medicinal Products for Human Use (CHMP) for the premixed analogue insulin products NovoMix® 50 and NovoMix® 70. Following the positive opinion from CHMP, Novo Nordisk expects to receive marketing authorisation from the European Commission for NovoMix® 50 and NovoMix® 70 in the second half of 2005.
 
In June 2005, Novo Nordisk filed an application with the FDA for marketing approval of NovoLog® Mix 50/50 and NovoLog® Mix 30/70 (the US trade names for NovoMix® 50 and NovoMix® 70).
 
As previously communicated, Novo Nordisk filed an application with EMEA (The European Medicines Agency) in January 2005 for marketing approval for the use of NovoSeven® in blunt trauma. The filing was based on results obtained from a phase 2 clinical study. As a consequence of subsequent feedback from EMEA, Novo Nordisk has, however, decided to voluntarily withdraw the registration file.
 
To support an updated European filing at a later stage, Novo Nordisk has, as previously announced, initiated a confirmatory phase 3 study in the EU and other countries outside the US. This study is now expected to encompass around 1,000 patients.
 
In the US, the current FDA-guided phase 3 study design for the use of NovoSeven® in trauma is being evaluated in terms of implied patient benefits versus potential number of patients in the study and related timelines. An update on the US clinical strategy is expected to be provided in connection with the release of financial results for the first nine months of 2005.
 
Novo Nordisk still expects to file an application in Europe for marketing approval for the use of NovoSeven® in connection with intracerebral haemorrhage (ICH). The filing, which will be based on clinical data from phase 2 studies, is now expected to take place during the fourth quarter of 2005. The filing may, as previously announced, be supported by additional safety data from the ongoing global confirmatory phase 3 study. 
 
This phase 3 study has been initiated both in Europe and the US. It is now expected to encompass around 675 patients in clinical centres located in the US, Europe, South America and Asia. The clinical results from the study will be pivotal to the future filing with the FDA for US marketing approval for the use of NovoSeven® in connection with ICH.
 
Within HRT Novo Nordisk has completed a successful phase 3 study and, based on this, expects to file in the fourth quarter of 2005 for marketing approval with EMEA and the FDA of an ultra-low dose version of Activelle® (Activella® in the US), Novo Nordisk's continuous-combined HRT product. This is expected to support the move towards even lower-dose versions of HRT products.
 
Equity
Total equity was DKK 25,620 million at the end of the first six months of 2005, equal to 67.9% of total assets, compared to 70.8% at the end of 2004. Please refer to appendix 5 for further elaboration of changes in equity during 2005.
 
Treasury shares and share repurchase programme
As per 10 August 2005, Novo Nordisk A/S and its wholly-owned affiliates owned 28,268,127 of its own B shares, corresponding to 7.97% of the total share capital.
 
In 2005, Novo Nordisk has so far repurchased 5.9 million B shares at a cash value of DKK 1.8 billion, and the company still expects to repurchase additional B shares during the remaining part of 2005 equivalent to a cash value of DKK 1.2 billion.
 
Employee share programme
To stimulate the ownership interest in the company and to give an incentive to the employees, the Board of Directors has approved a global offering of shares to the employees in the autumn of 2005. The offering is expected to include approximately 1 million B shares (equivalent to around 0.3% of the total share capital), which will be sold from the company's holding of treasury shares at a price of DKK 150 per share. The shares in the programme will generally have a minimum restricted period of five years for employees in Denmark and three years for employees outside Denmark.
 
The accounting impact of the offering will be calculated based on the average market price in the offering period. The estimated pre-tax cost of the offering will be in the range of DKK 150-200 million.
 
Sustainability issues update
 
Clinical trials information
During the second half of 2004 there was an increasing demand from medical journals, industry associations and general media for investigators and pharmaceutical companies to ensure public access to clinical trial data. This includes information on study protocols for clinical trials to be initiated or presently ongoing and, furthermore, providing public access to results from all trials that have been executed for products marketed in at least one country.
 
Novo Nordisk has decided to fulfil these requirements by submitting the data to two external databases; www.clinicaltrials.gov and www.clinicalstudyresults.org.
 
Novo Nordisk posted the first clinical trial results in April 2005 and expects to achieve full compliance by 1 October 2005. All hypothesis testing clinical trials to be initiated after 1 July 2005 are being registered prior to patient enrolment, and registration of currently ongoing trials will be fully implemented by the deadline set by the ICMJE (International Committee of Medical Journal Editors) of 13 September 2005.
 
Conference call details
At 14.00 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 - Conference calls'. Presentation material for the conference call will be made available approximately one hour before on the same page.
 
Forward-looking statement
The above sections contain forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of 1995. Forward-looking statements provide current expectations or forecasts of events such as new product introductions, product approvals and financial performance.
 
Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk's products, introduction of competing products, Novo Nordisk's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses. 
 
Risks and uncertainties are further described in reports filed by Novo Nordisk with the US Securities and Exchange Commission (SEC) including the company's Form 20-F, which was filed on 21 February 2005. Please also refer to the section 'Risk Management' in the Annual Report 2004. Novo Nordisk is under no duty to update any of the forward-looking statements or to conform such statements to actual results, unless required by law.
 
 
 
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 six months of 2005.

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. The interim report has not been audited.

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 interim report and accounts give a true and fair view of the Group's assets, liabilities, financial position and of the results of the operations and consolidated cash flows for the period under review.
 
Bagsværd 11 August 2005
 
 
 
Contacts for further information:
 
 
 
Further information on Novo Nordisk is available on the company's internet homepage at the address: novonordisk.com
 
 
Appendix 1:
 
Appendix 2:
 
Appendix 3:
Appendix 5:
 
Appendix 6:
 
Stock Exchange Announcement No 20 / 2005