Performance in the first half of 2001
Sales in the first half of 2001 increased by 17% to DKK 11,351 million. The sales increase measured in local currencies was also 17%, reflecting a balanced net currency effect.
Sales in the first half of 2001 increased by 17% to DKK 11,351 million. The sales increase measured in local currencies was also 17%, reflecting a balanced net currency effect.
Total costs, excluding net finance and tax, rose by 15% to DKK 9,068 million. Production costs grew in line with sales, whereas administration costs were stable compared to the first half of 2000. The progress of important research and development projects within diabetes care and the trials initiated regarding new clinical indications for NovoSeven® led to cost increase in research and development at a rate similar to the growth in sales. Sales and distribution costs grew more than sales, partly reflecting the build-up of the Novo Nordisk sales force in the US and partly reflecting the introduction and launch of new products. Included in the total costs are depreciation and amortisation of DKK 538 million, an increase of 5%.
Total licence fees and other income, including the income of close to DKK 250 million related to the settlement of a patent dispute with Aventis in January 2001, amounted to DKK 457 million in the first half of 2001 compared to DKK 460 million in the first half of 2000.
Operating profit was realised at DKK 2,740 million, which represents an increase of 21%. Adjusted for non-recurring items such as Seroxat® licence income and one-off income from patent settlement with Eli Lilly last year and Aventis this year, the increase in operating profit was 26%.
Profit before tax in the first half of 2001 rose by 31% to DKK 2,981 million, impacted by the increase in net financials for the first half of the year from DKK 6 million in 2000 to DKK 241 million. This development reflects the positive contribution in 2001 of hedging currency exposure, especially from the JPY.
The tax rate for the first half was 36.0%, down from 37.6% in the first half of 2000, and net profit hence increased by 34% to DKK 1,908 million, up from DKK 1,420 million in the first half of last year.
Outlook for 2001
Assuming that the currency exchange rates remain at the current level for the rest of the year, Novo Nordisk still expects to meet its long-term financial target of 15% growth in operating profit in 2001. This forecast includes the effect of the planned outlicensing of NN622 in North America in July 2001 to Novartis.
Assuming that the currency exchange rates remain at the current level for the rest of the year, Novo Nordisk still expects to meet its long-term financial target of 15% growth in operating profit in 2001. This forecast includes the effect of the planned outlicensing of NN622 in North America in July 2001 to Novartis.
Novo Nordisk hedges the foreign exchange exposure in its major currencies, and the instruments used are forward contracts and options. At the current interest rates and exchange rates, Novo Nordisk still expects net financial income for the full year to amount to approximately DKK 300 million. Likewise, the expectation for the income tax rate is unchanged at the level of 36%.
As indicated in the press release for the first quarter the company will realise a relatively high investment level in 2001. Currently Novo Nordisk expects the investment level for 2001 to be approx DKK 3.5 billion. Also for the next couple of years the investment level is expected to be elevated due to the positive underlying development in the business and the expected commercial potential of late stage development projects and products not yet commercialised. Even with these elevated investment levels Novo Nordisk expects to realise positive free cash flows.
Sales development
Sales growth was realised within all key business areas in the first half of 2001, where especially diabetes care and coagulation disorders were drivers of growth. Solid growth rates were realised worldwide with the exception of Japan, where sales were flat compared to the first half of 2000.
Sales growth was realised within all key business areas in the first half of 2001, where especially diabetes care and coagulation disorders were drivers of growth. Solid growth rates were realised worldwide with the exception of Japan, where sales were flat compared to the first half of 2000.
Diabetes care
Sales of diabetes care products rose by 16% to DKK 7,938 million in the first half of 2001 compared to the first half of 2000.
Sales of diabetes care products rose by 16% to DKK 7,938 million in the first half of 2001 compared to the first half of 2000.
Excluding NovoNorm®/Prandin® sales of diabetes care products grew by 13%, and on a geographical basis high growth was realised in Europe and in the US, whereas the sales development in Japan was flat.
In the US market, diabetes care products excluding Prandin® increased by 29% measured in DKK and by 22% measured in local currency. This development was primarily driven by the co-marketing agreement with Wal-Mart launched in August 2000, but also by sales of PenFill® and NovoLet(TM). Novo Nordisk expects to launch the rapid-acting insulin analogue NovoLog® in the US later this year, supported by a sales force of approximately 600 fully integrated Novo Nordisk employees.
Sales of NovoNorm®/Prandin® increased by 50% to DKK 769 million and growth in sales was realised in all major markets. In the first half of 2001 growth in the US reflected the stable underlying market performance, however sales are to some extent reflecting inventory build-up. Sales of NovoNorm® in Europe also contributed to growth and the product is now launched in all major European markets. Growth was also seen outside the US and Europe, where especially a contract with the Russian Ministry of Health contributed positively.
InnoLet® has now been introduced in several European countries and Japan and launch of this innovative disposable doser will continue into next year.
In the second quarter InDuo(TM), the world's first combined insulin doser and blood glucose measurement device, was introduced at the American Diabetes Association annual conference. InDuo(TM), which was developed in collaboration with LifeScan (a Johnson & Johnson subsidiary), is expected to be launched in the US later this year.
On 19 July 2001 Novo Nordisk and Novartis announced a partnership on the commercialisation of the dual-acting sensitiser, NN622, for the North American market. NN622 is currently in Phase 2 and Novo Nordisk expects to finish the proof of concept trials later this year.
Coagulation disorders
Sales of NovoSeven® increased by 45% to DKK 1,499 million, supported by continued strong growth in the US and increasing sales in Europe.
Sales of NovoSeven® increased by 45% to DKK 1,499 million, supported by continued strong growth in the US and increasing sales in Europe.
Several factors contributed to the sales growth of NovoSeven® in the first half of 2001. As confidence in the use of NovoSeven® in connection with surgical procedures in haemophilia patients increases so does the use of NovoSeven®. Also NovoSeven® is increasingly being used for the treatment of acquired haemophilia. During the first half of 2001 there has been a temporary limitation of recombinant FVIII products for use in certain segments of the inhibitor patient group, which has impacted sales positively. Finally sales are also perceived to have been positively affected by increased investigational use of NovoSeven®.
A Phase 2 study for the use of NovoSeven® in patients with chronic liver disease undergoing liver resection surgery has been initiated. The clinical expansion programme is progressing and Novo Nordisk still expects to have initiated studies within all selected clinical areas by year-end.
Human growth hormone
Sales of human growth hormone products rose by 6% to DKK 1,011 million in the first half of 2001. Sales in Europe have been driving growth through the continued launch of Norditropin® SimpleXx®. In Japan sales in the first half of 2001 were negatively impacted by inventory adjustments at wholesalers in the fourth quarter of 2000. In addition, the depreciation of the JPY compared to first half 2000 has influenced reported sales negatively.
Sales of human growth hormone products rose by 6% to DKK 1,011 million in the first half of 2001. Sales in Europe have been driving growth through the continued launch of Norditropin® SimpleXx®. In Japan sales in the first half of 2001 were negatively impacted by inventory adjustments at wholesalers in the fourth quarter of 2000. In addition, the depreciation of the JPY compared to first half 2000 has influenced reported sales negatively.
Hormone replacement therapy
Sales of hormone replacement therapy products rose by 15% to DKK 692 million in the first half of 2001. In Europe, especially sales of Activelle(TM) and Vagifem® contributed to the sales growth. US also contributed positively to growth following the launch by Pharmacia of Activella(TM), Vagifem® and Innofem® in the US during the second and third quarters of 2000.
Sales of hormone replacement therapy products rose by 15% to DKK 692 million in the first half of 2001. In Europe, especially sales of Activelle(TM) and Vagifem® contributed to the sales growth. US also contributed positively to growth following the launch by Pharmacia of Activella(TM), Vagifem® and Innofem® in the US during the second and third quarters of 2000.
Net financials
In the first half of 2001, Novo Nordisk had net financial income of DKK 241 million compared to a net financial income of DKK 6 million in the first half of 2000. Foreign exchange gains in the first half of 2001 were DKK 189 million compared to a loss of DKK 41 million in the first half of 2000. The gains primarily relates to the hedging of JPY.
In the first half of 2001, Novo Nordisk had net financial income of DKK 241 million compared to a net financial income of DKK 6 million in the first half of 2000. Foreign exchange gains in the first half of 2001 were DKK 189 million compared to a loss of DKK 41 million in the first half of 2000. The gains primarily relates to the hedging of JPY.
Shareholders' funds
Development in shareholders' funds
Development in shareholders' funds
Shareholders' funds increased by DKK 2,015 million to DKK 17,753, primarily due to the positive net profit of DKK 1,908 million.
|
Shareholders' funds at 31 December 2000 |
DKK |
15,738 |
million |
|
Net profit for the period |
- |
1,908 |
- |
|
Repurchase of own shares |
- |
(24) |
- |
|
Sale of own shares |
- |
31 |
- |
|
Other adjustments |
- |
100 |
- |
|
Shareholders' funds at 30 June 2001 |
DKK |
17,753 |
million |
Reduction in share capital
At the Annual General Meeting in March 2001 it was decided to reduce the B share capital by cancellation of nominally DKK 45 million of own B shares. Registration of the cancellation, which corresponds to approximately 6% of the total share capital, is being completed and will be effective in August 2001.
Holding of own shares
As at the end of the first half of 2001, Novo Nordisk A/S (NYSE:NVO) and its wholly-owned affiliates owned 31,516,705 of its own B shares corresponding to a total nominal value of DKK 63,033,410 or 8.36% of the total share capital.
At the Annual General Meeting in March 2001 it was decided to reduce the B share capital by cancellation of nominally DKK 45 million of own B shares. Registration of the cancellation, which corresponds to approximately 6% of the total share capital, is being completed and will be effective in August 2001.
Holding of own shares
As at the end of the first half of 2001, Novo Nordisk A/S (NYSE:NVO) and its wholly-owned affiliates owned 31,516,705 of its own B shares corresponding to a total nominal value of DKK 63,033,410 or 8.36% of the total share capital.
Share transactions by Board of Directors and Executive Committee
The insiders trading rules for Novo Nordisk only permit trading in Novo Nordisk shares and ADSs by members of the Board of Directors and Management in the 15 calendar days' period following both each quarterly announcement and the Annual General Meeting ('the open windows'). It has been decided by the Board of Directors to announce movements in the shareholding and option portfolio of the Board of Directors and Executive Committee, as a group, after each 'open window'.
The insiders trading rules for Novo Nordisk only permit trading in Novo Nordisk shares and ADSs by members of the Board of Directors and Management in the 15 calendar days' period following both each quarterly announcement and the Annual General Meeting ('the open windows'). It has been decided by the Board of Directors to announce movements in the shareholding and option portfolio of the Board of Directors and Executive Committee, as a group, after each 'open window'.
In the future the information will be announced on Novo Nordisk's homepage www.novonordisk.com under 'Investors - Insiders trading' at 08:00 CET 21 calendar days after each quarterly announcement and the Annual General Meeting. Following the closure of the 'open window' related to results for the first half of 2001, the information will be available on www.novonordisk.com on 28 August 2001 at 08:00 CET.
Conference call
At 16:00 CET today, corresponding to 10.00 am New York time, a conference call will be held. Investors will be able to listen in via a link on www.novonordisk.com, which can be found under 'Investors - Conference call'. Presentation material for the conference call will be made available approximately one hour before on the same page.
At 16:00 CET today, corresponding to 10.00 am New York time, a conference call will be held. Investors will be able to listen in via a link on www.novonordisk.com, which can be found under 'Investors - Conference call'. 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. The forward-looking statements include statements regarding Novo Nordisk's expected growth rates.
The above sections contain forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of 1995. The forward-looking statements include statements regarding Novo Nordisk's expected growth rates.
Such forward-looking statements are subject to risk and uncertainties that may cause actual results to differ materially from expectations, including unexpected developments in the international currency exchange and securities markets, delay or failure of development projects, production problems, government-mandated or market-driven price decreases for Novo Nordisk's products in the company's major markets and the introduction of competing products within Novo Nordisk's core businesses.
These and other 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 28 April 2001.
Novo Nordisk is under no duty to update any of the forward-looking statements after the date of this report or to confirm such statements to actual results, unless required by law.
Further information
Media:
Outside North America:
Karsten Madsen
Phone (direct): (+45) 4442 4137
In North America:
Susan Jackson
Phone (direct): (+1) 212 867 0123
Susan Jackson
Phone (direct): (+1) 212 867 0123
Investors:
Outside North America:
Peter Haahr
Phone (direct): (+45) 4442 1207
Outside North America:
Peter Haahr
Phone (direct): (+45) 4442 1207
Palle Holm Olesen
Phone (direct): (+45) 4442 6175
Phone (direct): (+45) 4442 6175
In North America
Rasmus Jorgensen
Phone (direct): (+1) 212 878 9607
Rasmus Jorgensen
Phone (direct): (+1) 212 878 9607
Further information about Novo Nordisk is available on the company's Internet homepage at the address: www.novonordisk.com.
Bagsværd, 7 August 2001
Board of Directors
Novo Nordisk A/S
Appendix: Q2 2001, Q1 2001 and 2000
(click here to see tables)
Board of Directors
Novo Nordisk A/S
Appendix: Q2 2001, Q1 2001 and 2000
(click here to see tables)
Stock Exchange Announcement No 12 / 2001