3rd Quarter Results


  • Reported sales in the first nine months of 2005 increased by 15%
o        Sales of insulin analogues increased by 60%
o        Sales of NovoSeven® increased by 15%
o        Sales in North America increased by 21%
 
  • Operating profit increased by 20% to DKK 6,165 million. Net profit increased by 31% to DKK 4,668 million and earnings per share increased by 35% to DKK 14.13.
 
  • The expectation for sales growth for the full year of 2005 is increased to 13-15%, and the expectation for operating profit growth is increased to 12-15%.
 
  • Lars Rebien Sørensen, president & CEO, said: "We are now seeing the positive effect of having a full portfolio of insulin analogues in our key European markets. With the continued roll-out of Levemir®, our long-acting insulin analogue, we expect to further increase our share of the global insulin analogue market in the years to come."
 
  • Novo Nordisk has decided to conduct a global phase 3 study for the use of NovoSeven® in trauma
o        It is intended to include trauma patients from sites in the US into the ongoing global phase 3 study. 
o        Prior to initiation of the US part of the global study, Novo Nordisk will seek to obtain an exception to the requirement for 'informed consent' in the US to achieve a faster patient enrolment.
o        The global trauma study is now expected to encompass around 1,500 patients and to take close to four years to complete.

Financial statement for the first nine 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 nine months of 2005 increased by 16% measured in local currencies and by 15% in Danish kroner. Growth was realised both within diabetes care and biopharmaceuticals - primarily driven by the insulin analogue products as well as NovoSeven®. Sales of growth hormone therapy products also contributed to growth.
 
 
 
Sales growth was realised in all regions, with the primary growth driver being North America, constituting 28% of total sales.  
 
Diabetes care
Sales of diabetes care products increased by 17% in local currencies compared to the first nine months of 2004 and by 16% in Danish kroner to DKK 17,293 million. Novo Nordisk remains the global market leader in diabetes care (insulin and oral antidiabetic products) with an overall market share of 20%. 
 
Insulin analogues, human insulin and insulin-related products
Sales of insulin analogues, human insulin and insulin-related products increased by 18% measured in Danish kroner and by a similar growth rate in local currencies to DKK 16,039 million. All regions contributed to growth measured in local currencies as well as in Danish kroner.
 
 
Novo Nordisk continues to expand its global leadership position in the insulin market with a total market share of more than 50% and an insulin analogue market share of around 33%, both measured in volume.
 
 
Sales of insulin analogues increased by 61% in local currencies and by 60% in Danish kroner to DKK 5,069 million in the first nine months of 2005. Sales of insulin analogues continue to be the primary growth contributor with 58% of the overall growth in local currencies and constitute close to 32% of Novo Nordisk's total sales of all insulin and insulin-related products, compared to 23% in the first nine months of 2004.
 

North America
Sales in North America increased by 34% in local currencies in the first nine months of 2005 and by 31% 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 37% of the total insulin market and close to 22% of the analogue market, both measured by volume. Sales of human insulin products also increased due to increased volumes as well as higher average prices.
 
 
Novo Nordisk has achieved significant market share gains in the US insulin market during recent years, and the portfolio of marketed insulin analogue products will be further strengthened by the upcoming launch of Levemir®, Novo Nordisk's long-acting insulin analogue. To further solidify the company's market position for the launch, and to also support the continued market penetration of NovoLog® and NovoLog® Mix 70/30, Novo Nordisk has decided to expand the diabetes care sales force in the US by around 400 individuals to a total of more than 1,200. This sales force expansion is expected to be completed around the turn of the year.
 
Europe
Sales in Europe increased by 9% in local currencies and by 10% in Danish kroner, primarily driven by the portfolio of insulin analogues, including Levemir®. Novo Nordisk has now launched Levemir® in most of the European markets, including France, where the product was launched recently. 
 
 
Novo Nordisk continues to consolidate its leadership position in the insulin analogue market, supported by the continued roll-out of Levemir®. The company now holds close to 42% of the European insulin analogue market, measured in volume.
 
 
Japan & Oceania
Sales in Japan & Oceania increased by 11% in local currencies and by 10% in Danish kroner. The growth primarily reflects increased sales of NovoRapid® and NovoRapid® 30 Mix, supported by the continued switch from durable to prefilled devices, which now account for almost two-thirds of the total Japanese insulin market. Novo Nordisk holds close to 60% of the Japanese insulin analogue market.
 
 
International Operations
Sales in International Operations increased by 30% in local currencies and by 31% in Danish kroner. Sales growth in the third quarter of 2005 was positively impacted by timing differences in sales to China, Saudi Arabia and Russia. Compared to the quarterly distribution in previous years, sales in International Operations are expected to be more evenly distributed across quarters in 2005.   
 
 
While sales in International Operations were dominated by human insulin, insulin analogues continue to add to the overall growth in the region. Novo Nordisk is the overall insulin market leader and also holds the leadership position within the insulin analogue segment.
 
Oral antidiabetic products
Sales of oral antidiabetic products increased compared to the same period in 2004 by 2% in local currencies and 1% in Danish kroner to DKK 1,254 million. The development in sales compared to the same period last year was positive both in Europe and International Operations. This was partly offset by lower sales in the US market, reflecting a slightly lower market share for Prandin®.
 
Biopharmaceuticals
Sales of biopharmaceutical products increased by 14% in local currencies compared to the first nine months of 2004 and by 13% in Danish kroner to DKK 7,041 million.
 
NovoSeven®
Sales of NovoSeven® increased by 17% in local currencies compared to the same period last year and by 15% in Danish kroner to DKK 3,674 million. All regions contributed to the sales increase, and North America continued to be the primary growth driver. In Europe, growth in sales resumed during the second and third quarters of 2005.
 
 
The sales growth of NovoSeven® was influenced by several factors during the first nine 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 21% in local currencies and by 20% in Danish kroner to DKK 2,000 million. While all regions contributed to the sales increase compared to the same period last year, North America and Europe were the main growth drivers. Sales have been positively impacted by the penetration of the NordiFlex® prefilled delivery device, and Novo Nordisk has gained market share in all major markets.
 
Other products
Sales of other products within biopharmaceuticals, which predominantly consist of hormone replacement therapy (HRT) related products, were unchanged in local currencies compared to the same period last year and decreased by 1% in Danish kroner to DKK 1,367 million. Whereas European sales of HRT products continue to be negatively impacted by challenging market conditions, sales in the US market increased during the first nine 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 6,653 million, with a gross margin of 72.7%, compared to 72.1% in the first nine months of 2004. The gains from an improved product mix and increased production efficiency were slightly offset by an adverse currency impact, leaving the underlying gross margin improvement at 0.7 percentage points.
 
 
Total non-production-related costs increased by 13% to DKK 11,840 million. The increase in non-production-related costs reflects increased sales and distribution costs. This is primarily a consequence of an increase of the US diabetes care sales force 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 nine months of 2005 were DKK 324 million, compared to DKK 362 million in the same period last year.
 
Net financials
Net financials showed an income of DKK 382 million in the first nine months of 2005 compared to an income of DKK 192 million in the same period in 2004. The result from associated companies was an income of DKK 344 million compared to an expense of DKK 97 million in the first nine months of 2004. This reflects a non-recurring gain in the first quarter of 2005 of around DKK 250 million from the sale of shares in Ferrosan A/S as well as a non-recurring accounting gain of around DKK 200 million from ZymoGenetics' public offering of new shares in August 2005. 
 
 
The foreign exchange gain was DKK 103 million compared to a gain of DKK 287 million in the same period last year. The lower foreign exchange gain reflects losses 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 nine months of 2005 compared to the level prevailing by the end of 2004. In accordance with IFRS, an unrealised loss of DKK 373 million was deferred by the end of September 2005 for profit and loss recognition in the future periods when the hedged operational cash flows occur.   
 
Financial outlook
For 2005, Novo Nordisk now expects to increase sales, measured in Danish kroner, by 13-15%, and a similar level of growth measured in local currencies. The company continues to benefit from the ongoing penetration of Novo Nordisk's insulin analogue portfolio, and also expects increasing sales of NovoSeven® and Norditropin® SimpleXx®.  The higher level of the US dollar and related currencies versus the Danish krone also impacts the company positively.
 
 
Furthermore, Novo Nordisk now expects to report operating profit growth of 12-15% for 2005, compared to the previous expectation of around 10%. This is a consequence of the improved sales expectation, which is only partly offset by additional costs related to the expansion of the US diabetes care sales force. The full-year expectation for growth in underlying operating profit, which excludes the impact from currency movements and non-recurring items, remains unchanged around 15%. This expectation includes the profit and loss impact of the following non-recurring items:
  • In the fourth quarter of 2004, a licence income of DKK 150 million was realised; and
  • in the fourth quarter of 2005, an expected cost of slightly more than DKK 150 million from the employee share offering will be expensed.  
 
 
 
Novo Nordisk still expects the tax rate for 2005 to be slightly below 29%.  
 
 
Capital expenditure is still expected to be close to DKK 4 billion in 2005, and depreciations, amortisation and impairment losses are still expected to be around DKK 1.9 billion, whereas free cash flow is now expected to be close to DKK 4 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 US dollars, Japanese yen and British pounds for 10 months for each of these currencies. In accordance with IFRS, the financial impact from foreign exchange hedging contracts will be included in 'Net financials' as the underlying operational cash flows materialise.  
 
 
With regard to 2006, Novo Nordisk will provide full guidance on expectations in connection with the release of the full-year financial results for 2005, scheduled for 27 January 2006.  Given the present currency exchange rate environment, Novo Nordisk currently expects to achieve at least 10% growth in sales for 2006, and preliminary plans for 2006 indicate an operating profit growth of 10-15%. This reflects Novo Nordisk's intention to invest in the further strengthening of the company's position in the US diabetes care market, including the upcoming launch of Levemir®, and also the expected increase in research and development costs for 2006 as a result of an increased number of late-stage clinical development projects, including the NovoSeven® expansion programme, liraglutide and AERx® iDMS.   
 
Research and development update
 
Diabetes care
At the annual meeting of the European Association for the Study of Diabetes (EASD) in September 2005, Novo Nordisk launched the NovoPen® 4 durable pen device for insulin treatment of patients with diabetes. This is the fourth generation of the NovoPen® range of durable devices, and NovoPen® 4 offers patients a more convenient treatment option, compared to other marketed products.
 
 
In September 2005, the US regulatory authorities (FDA) have extended the marketing authorisation for NovoLog® to include paediatric use. Similarly, in October, the FDA has extended the US marketing authorisation for Levemir® to include paediatric treatment.
 
 
In October 2005, Novo Nordisk received marketing authorisation from the European Commission for the premixed insulin analogue products NovoMix® 50 and NovoMix® 70. Novo Nordisk is now the only company with a complete range of approved insulin analogue products in Europe.
 
 
In the liraglutide phase 2b study, the last patient has recently completed treatment and the phase 3 programme, which is expected to encompass around 3,800 patients with type 2 diabetes, is planned to be initiated in February 2006.
 
 
Finally, Novo Nordisk still expects to file in late 2005 in Japan for marketing approval of Levemir® following the recent successful completion of the phase 3 programme in Japan.
 
In August 2005, the FDA approved the use of NovoSeven® in surgical procedures involving haemophilia patients with inhibitors against their existing factor VIII or factor IX treatment. Furthermore, the FDA has also approved the use of NovoSeven® in patients with factor VII deficiency, a rare hereditary haemorrhagic disease caused by the diminution or absence of this coagulation factor.
 
 
In October 2005, the first patient was dosed in a phase 1 study with rFXIII (recombinant coagulation factor XIII) in patients undergoing cardiac surgery. This phase 1 study is the first of several rFXIII studies planned by Novo Nordisk.
 
 
Novo Nordisk has filed an application with EMEA (the European Medicines Agency) for marketing approval of the use of NovoSeven® in intracerebral haemorrhage (ICH). The filing was based on results obtained from a phase 2b clinical study involving 399 patients and safety data from two smaller phase 2 studies. Furthermore, if requested by EMEA, the filing may be supported around the middle of 2006 by safety information generated from the ongoing global confirmatory phase 3 study.
 
 
Novo Nordisk has recently finalised the discussions with the FDA concerning the design of a US phase 3 clinical study for the use of NovoSeven® in trauma. The study protocol approved by the FDA includes a mortality endpoint as a primary study outcome measure.
 
 
However, before initiation of the US phase 3 study, and in order to accelerate the subsequent completion of the study, Novo Nordisk has decided to pursue an exception to the US 'Informed Consent Requirements', which generally require patients, or alternatively the next of kin, to formally accept inclusion (give consent) in a US clinical study. This may be very challenging to obtain in a trauma setting where patients generally can be physically unable to give such informed consent. Novo Nordisk expects to pursue this exception (a so-called 'Waiver of Informed Consent') via an approval process involving the FDA, US trauma centres and the communities in which these centres are located. This process is currently expected to last up to 18 months, but will - if granted - allow a more rapid enrolment of patients.
 
 
Moreover, Novo Nordisk has decided to merge the US clinical study sites into the global phase 3 study currently in progress outside the US, with initiation of the US sites contingent upon obtaining permission to conduct the study in the US with a waiver of informed consent. The global phase 3 trauma study is expected to include around 1,500 patients. This is expected to provide an improved statistical basis as compared to the previously estimated total enrolment of around 1,000 patients in the ongoing phase 3 study outside the US. Furthermore, the global trauma study is expected to take close to four years to complete, and it will include mortality as a primary study outcome measure.
 
Equity
Total equity was DKK 26,589 million at the end of the first nine months of 2005, equal to 66.2% of total assets, compared to 70.8% at the end of 2004. Please refer to appendix 5 for further specification of changes in equity during 2005.
 
Treasury shares and share repurchase programme
As per 26 October 2005, Novo Nordisk A/S and its wholly-owned affiliates owned 30,970,354 of its own B shares, corresponding to 8.73% of the total share capital.
 
 
In 2005, Novo Nordisk has so far repurchased 8.7 million B shares at a cash value of DKK 2.7 billion. The company still expects to repurchase additional B shares during the remaining part of 2005 equivalent to a cash value of DKK 0.3 billion, thereby completing the current share repurchase programme.
 
Employee share programme
As previously communicated, Novo Nordisk has decided to offer shares to the employees, at a price of DKK 150 per share from the company's holding of treasury shares. The Danish part of this global offering was completed in October, with approximately 0.7 million shares being subscribed, and the international programme is expected to be completed before the end of 2005. The estimated pre-tax cost of the entire offering is slightly more than DKK 150 million, which will be expensed in the fourth quarter of 2005.
 
Legal issues update
 
US hormone therapy litigation
As of 26 October 2005, Novo Nordisk Inc, together with the majority of hormone therapy product manufacturers in the US, is a defendant in product liability lawsuits related to Novo Nordisk's hormone therapy products. These lawsuits currently involve a total of 34 individuals (as compared to 31 individuals by the end of April 2005) who allege to have used Novo Nordisk's hormone therapy products. These products (Activella® and Vagifem®) have been sold and marketed in the US since 2000. Until July 2003, the products were sold and marketed exclusively in the US by Pharmacia & Upjohn Corporation (now Pfizer Inc). According to information received from Pfizer Inc, an additional 16 individuals (as compared to 11 individuals by the end of April 2005) allege, in relation to a similar lawsuit against Pfizer Inc, that they have used Novo Nordisk's hormone therapy products. Currently, it is expected that the first trial will take place in the third quarter of 2006; however, Novo Nordisk is not expecting the claims to impact Novo Nordisk's financial outlook.
 
Patent infringement litigation
On 22 September 2005, Novo Nordisk announced that it filed a patent infringement lawsuit in early September against Sanofi-Aventis alleging that the OptiClik® pen system, marketed by Sanofi-Aventis, infringes one of Novo Nordisk's US patents. The lawsuit was filed against Sanofi-Aventis and certain of its US, German, and Swiss affiliates in the Delaware District Court.
 
Sustainability issues update
 
Employees TakeAction!
Novo Nordisk's corporate volunteer programme, TakeAction!, encourages employees to engage in social causes within the company's areas of expertise. A recent example is the relief assistance provided by US employees to people affected by Hurricane Katrina. Employee donations were matched by Novo Nordisk's US affiliate Novo Nordisk Inc (NNI). Shipping medical supplies free of charge, NNI has so far donated nearly USD 4 million worth of devices, insulin vials and needles to clinics in the affected area, benefiting thousands of people with diabetes.
 
Super Sector Leader
In its 2005 analysis of sustainability leadership, announced in September 2005, the Swiss-based SAM group rates Novo Nordisk a Super Sector Leader. The rating places Novo Nordisk as a healthcare leader on the global Dow Jones Sustainability World Index as well as the pan-European Dow Jones STOXX Sustainability Index.
 
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 for the first nine 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 27 October 2005
 
 

Contacts for further information
 
 
 
Further information on Novo Nordisk is available on the company's internet homepage at the address: novonordisk.com
 
Stock Exchange Announcement No 25 / 2005
 
Appendix 1: Quarterly numbers in DKK