UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT
OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange
Act of 1934
OCTOBER 30, 2009
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-_____________________
Company Announcement
Interim financial report for the
period 1 January 2009 to 30 September 2009
29 October 2009
Novo Nordisk increased operating profit by 30% in the first nine months of 2009
| Sales increased by 15% in Danish kroner and by 11% in local currencies. | |
o | Sales of modern insulins increased by 28% (24% in local currencies). | |
o | Sales of NovoSeven® increased by 15% (11% in local currencies). | |
o | Sales of Norditropin® increased by 15% (9% in local currencies). | |
o | Sales in North America increased by 29% (17% in local currencies). | |
o | Sales
in International Operations increased by 18% (16% in local currencies). |
|
| Gross
margin improved by 2.5 percentage points to 79.5% in the first nine months
of 2009, primarily reflecting continued productivity improvements and
a positive currency impact of around 1 percentage point. |
|
| Reported
operating profit increased by 30% to DKK 11,714 million. Adjusted for
the impact from currencies and non-recurring costs in 2008 related to
the discontinuation of all pulmonary delivery projects, underlying operating
profit increased by around 15%. |
|
| Net
profit increased by 15% to DKK 8,445 million. Earnings per share (diluted)
increased by 18% to DKK 13.90. |
|
| Novo
Nordisk continues the constructive dialogue with the United States Food
and Drug Administration (FDA) regarding the regulatory process for liraglutide.
Formal feedback from the FDA regarding liraglutide, a once-daily human
GLP-1 analogue, is still expected in the fourth quarter of 2009. |
|
| For 2009, expectations for growth in operating profit measured in local currencies are increased to around 15% and reported operating profit growth is now expected to be around 3 percentage points higher than the operating profit growth in local currencies. |
Lars Rebien Sørensen, president and CEO, said: The robust sales growth for our portfolio of modern insulins is the key driver of the solid business performance in the first nine months of 2009. The launch of Victoza® in Europe is progressing well and we are seeing strong in-market penetration in the first-wave launch countries, Germany, the United Kingdom and Denmark.
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
1 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Financial highlights
for the first nine months of 2009
The present unaudited interim
financial report for the first nine months of 2009 has been prepared in accordance
with IAS 34 Interim Financial Reporting as issued by IASB and
endorsed by the EU. Furthermore the interim financial report has been prepared
in accordance with the additional Danish disclosure requirements for interim
reports of listed companies. See Accounting policies in appendix
7 for further information.
Amounts in DKK million, except average number of shares outstanding, earnings per share and full-time employees.
%
change
|
||||||
9M
2008
|
||||||
Profit and loss | 9M 2009 | 9M 2008 | to 9M 2009 | |||
Sales | 38,016 | 32,970 | 15% | |||
Gross profit | 30,213 | 25,397 | 19% | |||
Gross margin | 79.5% | 77.0% | ||||
Sales and distribution costs | 11,183 | 9,308 | 20% | |||
Percent of sales | 29.4% | 28.2% | ||||
Research and development costs | 5,477 | 5,417 | 1% | |||
hereof discontinuation costs for pulmonary diabetes projects | - | 325 | - | |||
Percent of sales | 14.4% | 16.4% | ||||
Percent of sales adjusted for pulmonary diabetes projects | 14.4% | 15.4% | ||||
Administrative expenses | 2,038 | 1,886 | 8% | |||
Percent of sales | 5.4% | 5.7% | ||||
Licence fees and other operating income (net) | 199 | 213 | (7%) | |||
Operating profit | 11,714 | 8,999 | 30% | |||
Operating margin | 30.8% | 27.3% | ||||
Net financials | (718 | ) | 626 | (215%) | ||
Profit before tax | 10,996 | 9,625 | 14% | |||
Net profit | 8,445 | 7,315 | 15% | |||
Net profit margin | 22.2% | 22.2% | ||||
Other key numbers | ||||||
Depreciation, amortisation and impairment losses | 1,797 | 1,690 | 6% | |||
Capital expenditure | 1,696 | 990 | 71% | |||
Cash flow from operating activities | 11,795 | 9,659 | 22% | |||
Free cash flow | 9,930 | 8,594 | 16% | |||
Total assets | 52,589 | 48,990 | 7% | |||
Equity | 34,874 | 32,173 | 8% | |||
Equity ratio | 66.3% | 65.7% | ||||
Average number of shares outstanding (million) diluted | 607.4 | 622.8 | (2%) | |||
Diluted earnings per share (in DKK) | 13.90 | 11.74 | 18% | |||
Full-time employees at the end of the period | 28,497 | 26,360 | 8% |
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
2 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Sales development
by segments
Sales increased by 15%
in Danish kroner and by 11% measured in local currencies. Growth was realised
within both diabetes care and biopharmaceuticals; the primary growth contribution
originated from the modern insulins and NovoSeven®.
Sales
|
Growth
|
Growth
|
Share
of
|
|||||
9M
2009
|
as
|
in
local
|
growth
|
|||||
DKK
|
reported
|
currencies
|
in
local
|
|||||
million
|
currencies
|
|||||||
The diabetes care segment | ||||||||
Modern insulins | 15,757 | 28% | 24% | 82% | ||||
NovoRapid® | 7,178 | 29% | 23% | 36% | ||||
NovoMix® | 4,810 | 19% | 17% | 19% | ||||
Levemir® | 3,769 | 39% | 35% | 27% | ||||
Human insulins | 8,630 | (1% | ) | (5% | ) | (12% | ) | |
Protein-related products | 1,495 | 9% | 5% | 2% | ||||
Oral antidiabetic products | 2,016 | 13% | 7% | 4% | ||||
Diabetes care total | 27,898 | 15% | 11% | 76% | ||||
The biopharmaceuticals segment | ||||||||
NovoSeven® | 5,330 | 15% | 11% | 14% | ||||
Norditropin® | 3,230 | 15% | 9% | 7% | ||||
Other products | 1,558 | 12% | 7% | 3% | ||||
Biopharmaceuticals total | 10,118 | 15% | 10% | 24% | ||||
Total sales | 38,016 | 15% | 11% | 100% |
Sales development
by regions
In the first nine months
of 2009, sales growth was realised in all regions. North America was the main
contributor with 51% share of growth measured in local currencies. International
Operations and Europe contributed 29% and 19%, respectively, of the total
sales growth.
Diabetes care
Sales of diabetes care
products increased by 15% measured in Danish kroner to DKK 27,898 million
and by 11% in local currencies compared with the first nine months of 2008.
Modern insulins,
human insulins and protein-related products
In the first nine months
of 2009, sales of modern insulins, human insulins and protein-related products
increased by 16% in Danish kroner to DKK 25,882 million and by 11% measured
in local currencies compared with the same period last year, driven by North
America and International Operations. Novo Nordisk continues to be the global
leader with 51% of the total insulin market and 45% of the modern insulin
market, both measured by volume.
The portfolio of modern insulins is the main contributor to growth and sales increased by 28% in Danish kroner to DKK 15,757 million and by 24% in local currencies compared with the first nine months of 2008. All regions realised solid growth rates, with North America accounting for 52% of the growth followed by Europe and International Operations. Sales of modern insulins now constitute 65% of Novo Nordisks sales of insulin.
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
3 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
North America
Sales in North America
increased by 36% in Danish kroner and by 23% in local currencies in the first
nine months of 2009, reflecting a solid penetration of the modern insulins
Levemir®,
NovoLog®
and NovoLog® Mix 70/30.
Novo Nordisk maintains its leadership position in the US insulin market with
42% of the total insulin market and 34% of the modern insulin market, both
measured by volume. Currently, close to 40% of Novo Nordisks modern
insulin volume in the US is being sold in FlexPen®.
Europe
Sales in Europe were largely
unchanged measured in Danish kroner and increased by 4% in local currencies,
reflecting continued progress for the portfolio of modern insulins but also
declining human insulin sales. Novo Nordisk holds 54% of the total insulin
market and 51% of the modern insulin market, both measured by volume, and
is capturing the main share of growth in the modern insulin market. The device
penetration in Europe remains high with more than 95% of Novo Nordisks
insulin volume being sold in devices, primarily NovoPen®
and FlexPen®.
Victoza®, the first once-daily human GLP-1 analogue, has been launched in Germany, the United Kingdom and Denmark, as previously communicated. Launch activities are progressing well in these markets and in-market penetration is in line with best-in-class launches within diabetes care. In Germany, Victoza® has now obtained more than 1% of the total diabetes care market and more than 40% of the GLP-1 market, both measured in weekly value market shares.
International
Operations
Sales within International
Operations increased by 17% in Danish kroner and by 15% in local currencies.
The main contributor to growth in the first nine months of 2009 was sales
of modern insulins, primarily in China and Turkey. Furthermore, sales of human
insulin, driven by China and India, continue to add to overall growth in the
region. The device penetration in China is high with more than 90% of Novo
Nordisks insulin volume sold in devices, primarily NovoPen®.
Japan & Oceania
Sales in Japan & Oceania
increased by 18% measured in Danish kroner and decreased by 1% in local currencies.
The sales development reflects sales growth for all three modern insulins,
NovoRapid®,
NovoRapid Mix® 30 and
Levemir®, countered
by pressure on the overall Novo Nordisk market share due to intense competition.
Novo Nordisk holds 68% of the total insulin market in Japan and 60% of the
modern insulin market, both measured by volume. The device penetration in
Japan remains high with more than 95% of Novo Nordisks insulin volume
being sold in devices, primarily NovoPen®
and FlexPen®.
Oral antidiabetic
products (NovoNorm®/Prandin®)
In the first nine months
of 2009, sales of oral antidiabetic products increased by 13% in Danish kroner
to DKK 2,016 million and by 7% in local currencies compared with the same
period in 2008.
Biopharmaceuticals
In the first nine months
of 2009, sales of biopharmaceutical products increased by 15% measured in
Danish kroner to DKK 10,118 million and by 10% measured in local currencies
compared with the first nine months of 2008.
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
4 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
NovoSeven®
Sales of NovoSeven®
increased by 15% in Danish kroner to DKK 5,330 million and by 11% in local
currencies compared with the first nine months of 2008. Sales growth for NovoSeven®
was primarily realised in Europe and International Operations. The sales growth
for NovoSeven® primarily
reflected increased sales within the congenital bleeding disorder segments
as well as within acquired haemophilia. Treatment of spontaneous bleeds for
congenital inhibitor patients remains the largest area of use.
Norditropin®
Sales of Norditropin®
(ie growth hormone in a liquid, ready-to-use formulation) increased by 15%
measured in Danish kroner to DKK 3,230 million and by 9% measured in local
currencies compared with the first nine months of 2008. North America and
Europe were the main contributors to growth measured in local currencies.
Novo Nordisk is the second-largest company in the global growth hormone market
with 23% 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 12% in Danish kroner to DKK 1,558
million and by 7% in local currencies. This development primarily reflects
continued sales progress for Vagifem®,
a topical oestrogen product, countered by generic competition in the US for
Activella® (Activelle®
outside the US), Novo Nordisks continuous-combined HRT product. The
low-dose version of Activelle®
was launched in Europe in April 2009 and has been available in the US since
2007.
Development in
gross margin and costs
The gross margin increased
to 79.5% compared with 77.0% in the same period of 2008.
This improvement reflects improved production efficiency,
higher average selling prices in the US and a positive product mix effect.
The gross margin was positively impacted by around 1 percentage point from
a positive currency development, primarily the higher value of the US dollar
and the Japanese yen versus the Danish krone compared with the first nine
months of 2008.
In the first nine months of 2009, total non-production-related costs increased by 13% to DKK 18,698 million compared with the same period last year. Around one-third of the increase in non-production-related costs, or around 4 percentage points, reflects the higher value of key currencies versus the Danish krone in the first nine months of 2009 compared with the first nine months of 2008. The underlying development in non-production-related costs relates to the expanded sales force in especially the US, the UK, Germany, Japan and China countered by limited growth in research and development costs. The development in research and development costs primarily reflects the timing of phase 3 clinical trial programmes as well as the non-recurring costs of DKK 325 million in the first nine months of 2008 related to the discontinuation of pulmonary diabetes projects.
Net financials
Net financials showed a
net expense of DKK 718 million in the first nine months of 2009 compared with
a net income of DKK 626 million in the same period of 2008.
For the first nine months of 2009, the foreign exchange result was an expense of DKK 617 million compared with an income of DKK 671 million in the first nine months of 2008. This
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
5 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
development reflects losses on foreign exchange hedging of especially US dollars and Japanese yen primarily due to the appreciation of these currencies versus Danish kroner in the first six months of 2009 compared to the exchange rate level prevailing in 2008.
Included in net financials is the result from associated companies with an expense of DKK 53 million, primarily related to Novo Nordisks share of losses in ZymoGenetics, Inc. In the same period of 2008, the result from associated companies was an expense of DKK 128 million.
Outlook
The current expectations
for 2009 are summarised and compared to the previous expectations in the table
below (changes highlighted in bold and italic):
Expectations are as reported, if not |
Current
expectations
|
Previous
expectations
|
otherwise stated |
29
October 2009
|
6
August 2009
|
|
||
Sales growth | ||
- in local currencies |
At
the level of 10%
|
At
the level of 10%
|
- as reported |
Around
1.5 percentage
|
Around
2 percentage points
|
points
higher
|
higher
|
|
|
||
Operating profit growth | ||
- in local currencies |
Around
15%
|
1214%
|
- as reported |
Around
3 percentage points
|
Around
4 percentage points
|
higher
|
higher
|
|
|
||
Net financial expense |
Around
DKK 750 million
|
Around
DKK 900 million
|
|
||
Effective tax rate |
Approximately
23%
|
Approximately
23%
|
Capital expenditure |
Around
DKK 2.5 billion
|
Around
DKK 3.0 billion
|
|
||
Depreciation, amortisation and impairment losses |
Around
DKK 2.6 billion
|
Around
DKK 2.6 billion
|
|
||
Free cash flow |
At
least DKK 11 billion
|
More
than DKK 10 billion
|
|
||
Novo Nordisk still expects sales growth in 2009 at the level of 10% measured in local currencies. This is based on expectations of continued market penetration for Novo Nordisks key strategic products within diabetes care and biopharmaceuticals as well as expectations of continued intense competition. Given the current level of exchange rates versus Danish kroner, the reported sales growth is now expected to be around 1.5 percentage points higher than the growth rate measured in local currencies.
For 2009, growth in operating profit is now expected to be around 15% measured in local currencies. The increased expectations primarily reflect further improvement of the gross margin and slightly lower expected research and development costs for 2009 due to timing of phase 3 clinical trial programmes. Given the current level of exchange rates versus Danish kroner, the reported operating profit growth is now expected to be around 3 percentage points higher than the growth rate measured in local currencies.
For 2009, Novo Nordisk now expects a net financial expense of around DKK 750 million. The current expectation reflects significant foreign exchange hedging losses, primarily related to the US dollar and the Japanese yen.
The effective tax rate for 2009 is still expected to be around 23%.
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
6 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Capital expenditure is now expected to be around DKK 2.5 billion in 2009, primarily reflecting timing of activities in relation to the new insulin formulation and filling plant in China. Expectations for depreciations, amortisation and impairment losses of around DKK 2.6 billion are unchanged, whereas free cash flow is expected to be at least DKK 11 billion, primarily reflecting the lower level of capital expenditure.
With regard to the financial outlook for 2010 it is Novo Nordisks intention to provide detailed guidance on expectations in connection with the full-year release of financial results for 2009 scheduled for 2 February 2010. At present, the preliminary plans for 2010 indicate 510% sales growth and more than 5% growth in operating profit, both measured in local currencies. Due to an expected negative currency impact following the recent significant depreciation of Novo Nordisks main invoicing currencies the reported sales growth for 2010 is expected to be around 3.5 percentage points lower than the growth measured in local currencies, whereas the reported operating profit growth is expected to be around 7 percentage points lower than the growth measured in local currencies. The preliminary plans reflect expectations for continued solid penetration of the portfolio of modern insulins, continued global roll-out of Victoza® and progress for key products within biopharmaceuticals. The preliminary plans also reflect expected generic competition for oral antidiabetic products, impact from a potential US healthcare reform, and a continued intense competition within both diabetes care and biopharmaceuticals.
All of the above expectations are based on the assumption that the global economic downturn will not significantly change the business environment for Novo Nordisk during the remainder of 2009 and in 2010. In addition, the above expectations are provided that currency exchange rates, especially the US dollar, remain at the current level versus the Danish krone during the remaining part of 2009 and in 2010 (see appendix 6). 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 Nordisks operating profit as outlined in the table below.
Key
invoicing
|
Annual
impact on Novo Nordisks
|
Hedging
period
|
currencies
|
operating
profit of a 5%
|
(months)
|
movement
in currency
|
||
USD
|
DKK
580 million
|
16
|
JPY
|
DKK
150 million
|
15
|
CNY
|
DKK
100 million
|
16*
|
GBP
|
DKK
80 million
|
12
|
CAD
|
DKK
40 million
|
7
|
*USD used as proxy when hedging Novo Nordisks CNY currency exposure
The financial impact from foreign exchange hedging is included in Net financials and at present it is expected that the significant negative currency impact on reported operating profit in 2010 will be offset by a similar significant foreign exchange hedging gain of approximately DKK 1 billion, again provided that key currency exchange rates remain at the current level versus the Danish krone during the remaining part of 2009 and in 2010.
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
7 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Research and development update
Diabetes care
Novo Nordisk continues
the constructive dialogue with the United States Food and Drug Administration
(FDA) regarding the regulatory process for liraglutide. Formal feedback from
the FDA regarding liraglutide, a once-daily human GLP-1 analogue, is still
expected in the fourth quarter of 2009.
At the annual meeting of the European Association for the Study of Diabetes (EASD) held in Vienna, Austria, from 30 September to 2 October this year, Novo Nordisk presented results from a new meta-analysis on the safety of Novo Nordisks long-acting modern insulin Levemir®. The meta-analysis assessed the relative risk of a cancer diagnosis during clinical treatment with Levemir®. It covered a total of approximately 9,000 patients in 21 randomised, controlled trials and compared the incidence of cancer in patients treated with Levemir® to that of patients treated with either human insulin (NPH insulin) or insulin glargine. The studies comparing Levemir® to NPH insulin revealed that treatment with Levemir® was associated with a statistically significant lower incidence of cancer than with NPH insulin treatment (0.36 events per 100 patient years in the Levemir® group versus 0.92 events in the NPH insulin group; p<0.05). The meta-analysis has recently been published online in Diabetologia, the journal of the EASD.
During the annual meeting of the EASD, Novo Nordisk also presented new experimental studies on the molecular safety of Levemir® and other insulins. These studies assessed comparative IGF-1 and insulin receptor subtype binding, as well as the potential of the insulins to induce cell growth (mitogenicity). Regarding the balance between insulin receptor and IGF-1 receptor binding, Levemir® was found to possess a profile very similar to that of human insulin, and when mitogenicity was studied in a number of different cell lines, it was found that Levemir® exhibited a similar or lower mitogenicity than human insulin.
The new generation of insulins, SIBA and SIAC, have now both entered phase 3 clinical development with the trial programmes named BEGIN and BOOST, respectively. The large trial programmes with around 10,000 patients in total are executed in a sequence of four waves. The first wave for both programmes has been initiated and the first trials have completed recruitment; the second wave is expected to be initiated during the fourth quarter of 2009. In the BEGIN programme the second wave consists of one trial comparing the use of SIBA once daily in two different regimens to insulin glargine once daily in insulin naïve type 2 diabetes patients. In the BOOST programme, the trial in the second wave will investigate intensified use of SIAC compared to treatment with NovoMix® 30 in people with type 2 diabetes previously treated with premixed insulin. The final two waves are expected to be initiated during the first half of 2010.
In Japan, NovoRapid Mix® 50 and NovoRapid Mix® 70 have recently been approved by the Ministry of Health, Labor and Welfare. Both products have been approved for the treatment of adult type 1 and type 2 diabetes patients. Novo Nordisk expects to launch both NovoRapid Mix® 50 and NovoRapid Mix® 70 in 2010 in Japan when reimbursement discussions are finalised.
The results of the Treating to Target in Type 2 Diabetes (4-T) study conducted by the Diabetes Trials Unit at the Oxford Centre for Diabetes, Endocrinology and Metabolism were recently published in the New England Journal of Medicine. The study, which was supported by
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
8 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Novo Nordisk and Diabetes UK, was a three-year randomised, controlled, multicentre trial, in which 708 patients with suboptimal HbA1c levels on metformin and sulphonylurea therapy were assigned to receive NovoMix® 30 (biphasic insulin aspart) twice daily, mealtime NovoRapid® (insulin aspart) three times daily, or Levemir® (insulin detemir) once daily. Among the outcome measures after three years were mean HbA1c, the proportion of patients with an HbA1c level of 7% or less, the rate of hypoglycaemia and weight gain. The design of the 4-T trial made it possible to report differences between three different initiation and intensification regimens, all with insulin analogues, over the longest randomised treat-to-target comparison of insulin therapies yet published.
The 4-T study showed that at three years, the mean HbA1c level did not differ between groups. The proportion of patients achieving an HbA1c level of 7% or less was high, and similar in the NovoRapid® (67%) and Levemir® (63%) initiation groups, but somewhat lower in the NovoMix® (51%) group. In the NovoMix® group, however, fewer patients received intensification with a second insulin preparation during the three-year treatment period. The median numbers of hypoglycaemic events per patient per year were relatively low, but highest for the NovoRapid® initiation group: 1.7 for the Levemir®, 3.0 for NovoMix® and 5.5 for NovoRapid® initiation groups, and the mean weight gains were 3.6 kg, 5.7 kg and 6.4 kg respectively. Thus, the group initiated on once-daily Levemir® therapy statistically significantly experienced the lowest weight gain despite being intensified to a basal bolus therapy with NovoRapid®. More than 80% of randomised patients completed the three-year trial during which the rates of adverse events were similar among all groups. Overall, the 4-T study in type 2 diabetes has shown that initiation of insulin treatment with once-daily Levemir® or twice-daily NovoMix® 30, followed by intensification with NovoRapid® when needed, is well-tolerated and associated with similar, strong HbA1c lowering, in the presence of low levels of hypoglycaemia.
Biopharmaceuticals
In the area of haemophilia,
and in line with previous communication, Novo Nordisk has initiated a phase
1 study with a long-acting rFIX derivative, a phase 1 study with a long-acting
rFVIIa derivative for subcutaneous administration as well as a phase 2 study
with a long-acting rFVIIa derivative for intravenous administration.
Novo Nordisk now expects to complete the ongoing phase 2 trial with NN1731 in the second quarter of 2010. NN1731 is a rFVIIa analogue designed to provide faster and more efficient haemostasis in haemophilia patients with inhibitors. The extended duration of the trial is due to a lower than anticipated number of bleeding events.
Novo Nordisk officially opened the new inflammation research centre based in Seattle, Washington, USA, in September this year. The research centre will leverage Novo Nordisks strong knowledge within the field of proteins in order to further build the companys clinical pipeline of products for the treatment of chronic inflammatory diseases.
Equity
Total equity was DKK 34,874
million at the end of the first nine months of 2009, equal to 66.3% of total
assets, compared with 65.2% at the end of 2008. Please refer to appendix 5
for further elaboration of changes in equity during the first nine months
of 2009.
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
9 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Treasury shares
and share repurchase programme
As per 28 October 2009,
Novo Nordisk A/S and its wholly-owned affiliates owned 29,264,308 of its own
B shares, corresponding to 4.7% of the total share capital.
In 2009, Novo Nordisk repurchased 18,667,682 B shares equal to a cash value of DKK 5.5 billion. Novo Nordisk still expects to finalise the share repurchase programme of DKK 19.0 billion before the end of 2009 implying that Novo Nordisk expects to repurchase B shares equal to a cash value of around DKK 6.5 billion in 2009 in total. In the period from 2006 to 2008 Novo Nordisk repurchased B shares equal to a cash value of DKK 12.5 billion in total.
Sustainability
issues update
CO2
emissions below 2004 baseline
In the run-up to the UN
Climate Summit in Copenhagen in December, Novo Nordisk is well on its
way to achieving the companys climate strategy target: a 10% absolute
reduction of CO2 emissions from production in the period 20042014.
Growth in CO2 emissions has been gradually
decoupled from business growth since 2004. In 2008, the emissions curve broke,
and by mid-year 2009, emissions reached the level of the 2004 baseline year
210,000 tons annually.
The energy-saving programme in production has resulted in a 25,000 tons reduction in CO2 emissions corresponding to a more than 10% reduction of the annual energy consumption since 2005. Half of the energy-saving projects implemented globally since 2007 are paid back within less than one year.
Since May 2007, energy savings in Denmark have been earmarked to purchase of electricity from the new offshore wind farm at Horns Rev, Denmark. More than 100 energy-saving projects have been implemented under this programme. A total saving of more than 30 million KWh has been achieved, which will secure a 100% green electricity supply once the offshore wind farm is in full operation in 2010. Switching to electricity from the wind farm will result in an annual CO2 reduction of 100,000 tons.
Legal issues update
US hormone therapy
litigation
As of 28 October 2009,
Novo Nordisk Inc., as well as the majority of hormone therapy product manufacturers
in the US, is a defendant in product liability lawsuits related to hormone
therapy products. These lawsuits currently involve a total of 52 individuals
who allege use of a Novo Nordisk hormone therapy product. These products (Activella®
and Vagifem®) have
been sold and marketed in the US since 2000. Until July 2003, the products
were sold and marketed exclusively in the US by Pharmacia & Upjohn Company
(now Pfizer Inc.). Further 62 individuals currently allege, in relation to
similar lawsuits against Pfizer Inc., that they have also used a Novo Nordisk
hormone therapy product. Currently, the first court trial is expected in the
first quarter of 2010. Novo Nordisk does not expect the pending claims to
impact Novo Nordisks financial outlook.
Financial calendar
for 2010
2 February | Financial statement for 2009 |
4 February | PDF version of the Annual Report 2009 available on novonordisk.com |
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
10 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
10 February | Deadline for the companys receipt of shareholder proposals for the |
Annual General Meeting 2010 | |
18 February | Printed version of the Annual Report 2009 |
24 March | Annual General Meeting 2010 |
27 April | Financial statement for the first three months of 2010 |
5 August | Financial statement for the first six months of 2010 |
27 October | Financial statement for the first nine months of 2010 |
Conference call
details
At 1.00 pm 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. Presentation
material for the conference call will be made available on the same page approximately
one hour before.
Forward-looking statements
Novo Nordisks reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document as well as the companys Annual Report 2008 and Form 20-F, both filed with the SEC in February 2009, 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 Nordisks products, product research, product development, product introductions and product approvals as well as cooperations 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 of future economic performance, future actions and outcome of contingencies such as legal proceedings, and |
- | statements of the assumptions underlying or relating to such statements. |
In this document, examples of forward-looking statements can be found under the headings Outlook 2009, Research and development update, Equity and Legal issues update.
These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those 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 Nordisks products, introduction of competing products, reliance on information technology,
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
11 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Novo Nordisks 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 Managing Risks on pp 2425 of the Annual Report 2008 available on the companys 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 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
12 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Management statement
Today, the Board of Directors and Executive Management approved the interim financial report of Novo Nordisk A/S for the first nine months of 2009.
The interim financial report has been prepared in accordance with IAS 34 Interim Financial Reporting as issued by the International Accounting Standard Board (IASB) and endorsed by the EU. Furthermore, the interim financial report has been prepared in accordance with the additional Danish disclosure requirements for interim reports of listed companies. The interim financial report has not been audited or reviewed by the companys auditors.
In our opinion the accounting policies used are appropriate and the overall presentation of the interim financial report gives a true and fair view of the Groups assets and liabilities as of 30 September 2009 and the results and cash flows for the first nine month of 2009. Furthermore, in our opinion, the interim financial report includes a fair view of the development and performance of the business and the financial position of the Group, as well as an overview of the material risks and uncertainties the Group faces.
Bagsværd 29 October 2009
Executive Management
Lars
Rebien Sørensen
|
Jesper
Brandgaard
|
|
President and CEO | CFO | |
Lise Kingo | Kåre Schultz | Mads Krogsgaard Thomsen |
Board of Directors: | ||
Sten Scheibye | Göran A Ando | |
Chairman | Vice chairman | |
Henrik Gürtler | Johnny Henriksen | Pamela J Kirby |
Anne Marie Kverneland | Kurt Anker Nielsen | Søren Thuesen Pedersen |
Hannu Ryöppönen | Stig Strøbæk | Jørgen Wedel |
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
13 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Contacts for further information
Media: |
Investors:
|
Mike Rulis | Mads Veggerby Lausten |
Tel: (+45) 4442 3573 | Tel: (+45) 4443 7919 |
E-mail: mike@novonordisk.com | E-mail: mlau@novonordisk.com |
Kasper Roseeuw Poulsen | |
Tel: (+45) 4442 4471 | |
E-mail: krop@novonordisk.com | |
In North America: | |
Sean Clements | Hans Rommer |
Tel: (+1) 609 514 8316 | Tel: (+1) 609 919 7937 |
E-mail: secl@novonordisk.com | E-mail: hrmm@novonordisk.com |
Further information on Novo Nordisk is available on the companys internet homepage at the address: novonordisk.com
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
14 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Appendix 1: Quarterly numbers in DKK
(Amounts in DKK million, except number of employees, earnings per share and number of shares outstanding).
%
change
|
||||||||||||||||
2009 | 2008 | Q3 2009 vs | ||||||||||||||
Q3
|
Q2
|
Q1
|
Q4
|
Q3
|
Q2
|
Q1
|
Q3 2008 | |||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Sales | 12,517 | 13,001 | 12,498 | 12,583 | 11,246 | 11,110 | 10,614 | 11% | ||||||||
Gross profit | 9,832 | 10,391 | 9,990 | 10,047 | 8,640 | 8,556 | 8,201 | 14% | ||||||||
Gross margin | 78.5% | 79.9% | 79.9% | 79.8% | 76.8% | 77.0% | 77.3% | |||||||||
Sales and distribution costs | 3,502 | 3,837 | 3,844 | 3,558 | 3,155 | 3,178 | 2,975 | 11% | ||||||||
Percent of sales | 28.0% | 29.5% | 30.8% | 28.3% | 28.1% | 28.6% | 28.0% | |||||||||
Research and development costs | 1,884 | 1,849 | 1,744 | 2,439 | 1,579 | 1,980 | 1,858 | 19% | ||||||||
- Hereof costs related to AERx ®* | - | - | - | - | 50 | (155 | ) | (220 | ) | |||||||
Percent of sales | 15.1% | 14.2% | 14.0% | 19.4% | 14.0% | 17.8% | 17.5% | |||||||||
Percent of sales (excl AERx ®* ) | 15.1% | 14.2% | 14.0% | 19.4% | 14.5% | 16.4% | 15.4% | |||||||||
Administrative expenses | 666 | 693 | 679 | 749 | 633 | 626 | 627 | 5% | ||||||||
Percent of sales | 5.3% | 5.3% | 5.4% | 6.0% | 5.6% | 5.6% | 5.9% | |||||||||
Licence fees and other operating income (net) | 34 | 78 | 87 | 73 | 51 | 74 | 88 | (33% | ) | |||||||
Operating profit | 3,814 | 4,090 | 3,810 | 3,374 | 3,324 | 2,846 | 2,829 | 15% | ||||||||
Operating margin | 30.5% | 31.5% | 30.5% | 26.8% | 29.6% | 25.6% | 26.7% | |||||||||
Operating profit (excl AERx®*) | 3,814 | 4,090 | 3,810 | 3,374 | 3,274 | 3,001 | 3,049 | 16% | ||||||||
Operating margin (excl AERx ®* ) | 30.5% | 31.5% | 30.5% | 26.8% | 29.1% | 27.0% | 28.7% | |||||||||
Share of profit/(loss) in associated companies | (7 | ) | (11 | ) | (35 | ) | 4 | (58 | ) | (3 | ) | (67 | ) | (88% | ) | |
Financial income | 9 | 166 | 142 | (82 | ) | 306 | 429 | 474 | (97% | ) | ||||||
Financial expenses | 209 | 361 | 412 | 226 | 66 | 21 | 368 | 217% | ||||||||
Profit before income taxes | 3,607 | 3,884 | 3,505 | 3,070 | 3,506 | 3,251 | 2,868 | 3% | ||||||||
Net profit | 2,755 | 2,991 | 2,699 | 2,330 | 2,664 | 2,471 | 2,180 | 3% | ||||||||
Depreciation, amortisation and impairment losses | 657 | 533 | 607 | 752 | 560 | 567 | 563 | 17% | ||||||||
Capital expenditure | 726 | 557 | 413 | 764 | 448 | 328 | 214 | 62% | ||||||||
Cash flow from operating activities | 5,039 | 2,608 | 4,148 | 3,204 | 3,673 | 2,916 | 3,070 | 37% | ||||||||
Free cash flow | 4,242 | 2,062 | 3,626 | 2,421 | 3,210 | 2,589 | 2,795 | 32% | ||||||||
Equity | 34,874 | 34,086 | 31,345 | 32,979 | 32,173 | 33,046 | 31,251 | 8% | ||||||||
Total assets | 52,589 | 51,246 | 50,205 | 50,603 | 48,990 | 48,478 | 47,534 | 7% | ||||||||
Equity ratio | 66.3% | 66.5% | 62.4% | 65.2% | 65.7% | 68.2% | 65.7% | |||||||||
Full-time employees at the end of the period | 28,497 | 27,998 | 27,429 | 26,575 | 26,360 | 26,060 | 25,765 | 8% | ||||||||
Basic earnings per share (in DKK) | 4.62 | 4.96 | 4.44 | 3.82 | 4.34 | 3.99 | 3.51 | 6% | ||||||||
Diluted earnings per share (in DKK) | 4.58 | 4.91 | 4.41 | 3.80 | 4.30 | 3.96 | 3.48 | 7% | ||||||||
Average number of shares outstanding (million) | 596.4 | 603.1 | 607.4 | 609.3 | 614.2 | 618.6 | 620.9 | (3% | ) | |||||||
Average number of shares outstanding incl | ||||||||||||||||
dilutive effect of options 'in the money' (million) | 601.4 | 607.9 | 612.7 | 614.4 | 618.6 | 623.5 | 626.3 | (3% | ) | |||||||
Sales by business segments: | ||||||||||||||||
Modern insulins (insulin analogues) | 5,353 | 5,414 | 4,990 | 5,028 | 4,365 | 4,103 | 3,821 | 23% | ||||||||
Human insulins | 2,747 | 2,879 | 3,004 | 3,093 | 2,806 | 2,966 | 2,939 | (2% | ) | |||||||
Protein-related sales | 519 | 492 | 484 | 477 | 464 | 460 | 443 | 12% | ||||||||
Oral antidiabetic products (OAD) | 650 | 675 | 691 | 602 | 671 | 478 | 640 | (3% | ) | |||||||
Diabetes care total | 9,269 | 9,460 | 9,169 | 9,200 | 8,306 | 8,007 | 7,843 | 12% | ||||||||
NovoSeven® | 1,651 | 1,874 | 1,805 | 1,774 | 1,534 | 1,648 | 1,440 | 8% | ||||||||
Norditropin® | 1,074 | 1,122 | 1,034 | 1,060 | 941 | 986 | 878 | 14% | ||||||||
Hormone replacement therapy | 440 | 435 | 409 | 442 | 394 | 391 | 385 | 12% | ||||||||
Other products | 83 | 110 | 81 | 107 | 71 | 78 | 68 | 17% | ||||||||
Biopharmaceuticals total | 3,248 | 3,541 | 3,329 | 3,383 | 2,940 | 3,103 | 2,771 | 10% | ||||||||
Sales by geographic regions: | ||||||||||||||||
North America | 4,527 | 4,710 | 4,532 | 4,478 | 3,759 | 3,467 | 3,450 | 20% | ||||||||
Europe | 4,376 | 4,375 | 4,195 | 4,453 | 4,305 | 4,400 | 4,061 | 2% | ||||||||
International Operations | 2,288 | 2,532 | 2,513 | 2,186 | 2,074 | 2,069 | 2,096 | 10% | ||||||||
Japan & Oceania | 1,326 | 1,384 | 1,258 | 1,466 | 1,108 | 1,174 | 1,007 | 20% | ||||||||
Segment operating profit: | ||||||||||||||||
Diabetes care | 2,286 | 2,333 | 2,171 | 2,424 | 1,963 | 1,510 | 1,672 | 16% | ||||||||
Diabetes care (excl AERx®*) | 2,286 | 2,333 | 2,171 | 2,424 | 1,913 | 1,665 | 1,892 | 19% | ||||||||
Biopharmaceuticals | 1,528 | 1,757 | 1,639 | 950 | 1,361 | 1,336 | 1,157 | 12% |
*) Costs related to the discontinuation of all pulmonary diabetes projects.
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
15 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Appendix 2: Income Statement
9M
|
9M
|
Q3
|
Q3
|
|||||
DKK million | 2009 | 2008 | 2009 | 2008 | ||||
|
|
|
|
|
|
|
|
|
Sales | 38,016 | 32,970 | 12,517 | 11,246 | ||||
Cost of goods sold | 7,803 | 7,573 | 2,685 | 2,606 | ||||
|
|
|
|
|
|
|
||
Gross profit | 30,213 | 25,397 | 9,832 | 8,640 | ||||
Sales and distribution costs | 11,183 | 9,308 | 3,502 | 3,155 | ||||
Research and development costs | 5,477 | 5,417 | 1,884 | 1,579 | ||||
- hereof costs related to AERx ® * | - | (325 | ) | - | 50 | |||
Administrative expenses | 2,038 | 1,886 | 666 | 633 | ||||
Licence fees and other operating income (net) | 199 | 213 | 34 | 51 | ||||
|
|
|
|
|
|
|
||
Operating profit | 11,714 | 8,999 | 3,814 | 3,324 | ||||
Operating profit (excl AERx ® *) | 11,714 | 9,324 | 3,814 | 3,274 | ||||
Share of profit/(loss) in associated companies | (53 | ) | (128 | ) | (7 | ) | (58 | ) |
Financial income | 317 | 1,209 | 9 | 306 | ||||
Financial expenses | 982 | 455 | 209 | 66 | ||||
|
|
|
|
|
|
|
||
Profit before income taxes | 10,996 | 9,625 | 3,607 | 3,506 | ||||
Income taxes | 2,551 | 2,310 | 852 | 842 | ||||
|
|
|
|
|
|
|
||
NET PROFIT | 8,445 | 7,315 | 2,755 | 2,664 | ||||
|
|
|
|
|
|
|
||
Basic earnings per share (DKK) | 14.02 | 11.84 | 4.62 | 4.34 | ||||
Diluted earnings per share (DKK) | 13.90 | 11.74 | 4.58 | 4.30 | ||||
Segment Information | ||||||||
|
|
|
|
|
|
|
|
|
Segment sales: | ||||||||
Diabetes care | 27,898 | 24,156 | 9,269 | 8,306 | ||||
Biopharmaceuticals | 10,118 | 8,814 | 3,248 | 2,940 | ||||
Segment operating profit**): | ||||||||
Diabetes care | 6,790 | 5,145 | 2,286 | 1,963 | ||||
Operating margin | 24.3% | 21.3% | 24.7% | 23.6% | ||||
Biopharmaceuticals | 4,924 | 3,854 | 1,528 | 1,361 | ||||
Operating margin | 48.7% | 43.7% | 47.0% | 46.3% | ||||
Total segment operating profit | 11,714 | 8,999 | 3,814 | 3,324 | ||||
|
|
|
|
|
|
|
|
|
Statement of comprehensive income | ||||||||
Net profit for the period | 8,445 | 7,315 | 2,755 | 2,664 | ||||
Other comprehensive income: | ||||||||
Exchange rate adjustment of investments in subsidiaries | 430 | (120 | ) | 102 | (244 | ) | ||
Novo Nordisk share of equity recognised by associated companies | 8 | 23 | (1 | ) | 9 | |||
Deferred (gain)/loss on cash flow hedges at the beginning of the year | ||||||||
recognised in the Income statement for the period | 596 | (533 | ) | 263 | (52 | ) | ||
Fair value adjustments on financial instruments | 775 | (638 | ) | 221 | (1,346 | ) | ||
Tax on fair value adjustments on financial instruments | 3 | 2 | 2 | 2 | ||||
Other adjustments | 14 | (50 | ) | 29 | (123 | ) | ||
Tax on other adjustments | (47 | ) | 37 | (16 | ) | 98 | ||
|
|
|
|
|
|
|
||
Other comprehensive income for the period, net of tax | 1,779 | (1,279 | ) | 600 | (1,656 | ) | ||
TOTAL COMPREHENSIVE INCOME FOR THE PERIOD | 10,224 | 6,036 | 3,355 | 1,008 | ||||
|
|
|
|
|
|
|
||
*) Excluding costs related
to the discontinuation of AERx®
and all other pulmonary diabetes projects.
**) Group financing (including
financial expense and financial income) and income taxes are managed on a
group basis and are not allocated to operating segments.
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
16 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Appendix 3: Statement of financial position
DKK
million
|
30 Sep 2009 | 31 Dec 2008 | ||
|
|
|
|
|
ASSETS | ||||
Intangible assets | 999 | 788 | ||
Property, plant and equipment | 18,845 | 18,639 | ||
Investments in associated companies | 163 | 222 | ||
Deferred income tax assets | 1,388 | 1,696 | ||
Other financial assets | 186 | 194 | ||
|
|
|
|
|
TOTAL NON-CURRENT ASSETS | 21,581 | 21,539 | ||
Inventories | 9,748 | 9,611 | ||
Trade receivables | 6,893 | 6,581 | ||
Tax receivables | 513 | 1,010 | ||
Other receivables | 1,991 | 1,704 | ||
Marketable securities and financial derivatives | 1,635 | 1,377 | ||
Cash at bank and in hand | 10,228 | 8,781 | ||
|
|
|
|
|
TOTAL CURRENT ASSETS | 31,008 | 29,064 | ||
|
|
|
|
|
TOTAL ASSETS | 52,589 | 50,603 | ||
|
|
|
|
|
EQUITY AND LIABILITIES | ||||
Share capital | 620 | 634 | ||
Treasury shares | (28 | ) | (26 | ) |
Retained earnings | 33,565 | 33,433 | ||
Other comprehensive (loss) / income | 717 | (1,062 | ) | |
|
|
|
|
|
TOTAL EQUITY | 34,874 | 32,979 | ||
Long-term debt | 963 | 980 | ||
Deferred income tax liabilities | 2,388 | 2,404 | ||
Provision for pensions | 457 | 419 | ||
Other provisions | 972 | 863 | ||
|
|
|
|
|
Total non-current liabilities | 4,780 | 4,666 | ||
Short-term debt and financial derivatives | 229 | 1,334 | ||
Trade payables | 1,537 | 2,281 | ||
Tax payables | 1,133 | 567 | ||
Other liabilities | 7,078 | 5,853 | ||
Other provisions | 2,958 | 2,923 | ||
|
|
|
|
|
Total current liabilities | 12,935 | 12,958 | ||
TOTAL LIABILITIES | 17,715 | 17,624 | ||
|
|
|
|
|
TOTAL EQUITY AND LIABILITIES | 52,589 | 50,603 | ||
|
|
|
|
|
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
17 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Appendix 4: Statement of cash flows
DKK
million
|
9M
2009
|
9M
2008
|
||
|
|
|
|
|
Net profit | 8,445 | 7,315 | ||
Adjustment for non-cash items | 4,811 | 4,783 | ||
Income taxes paid and net interest received | (985 | ) | (1,169 | ) |
|
|
|
|
|
Cash flow before change in working capital | 12,271 | 10,929 | ||
Net change in working capital | (476 | ) | (1,270 | ) |
|
|
|
|
|
Cash flow from operating activities | 11,795 | 9,659 | ||
Net investments in intangible assets and long-term financial assets | (187 | ) | (245 | ) |
Capital expenditure for property, plant and equipment | (1,696 | ) | (990 | ) |
Net change in marketable securities (maturity exceeding three months) | - | - | ||
Received dividend | 18 | 170 | ||
|
|
|
|
|
Net cash used in investing activities | (1,865 | ) | (1,065 | ) |
Cash flow from financing activities | (8,515 | ) | (6,172 | ) |
NET CASH FLOW | 1,415 | 2,422 | ||
Unrealised gain/(loss) on exchange rates and marketable securities | ||||
included in cash and cash equivalents | 21 | (4 | ) | |
|
|
|
|
|
Net change in cash and cash equivalents | 1,436 | 2,418 | ||
Cash and cash equivalents at the beginning of the year | 8,726 | 4,617 | ||
|
|
|
|
|
Cash and cash equivalents at the end of the period | 10,162 | 7,035 | ||
Bonds with original term to maturity exceeding three months | 1,017 | 1,483 | ||
Undrawn committed credit facilities | 7,444 | 7,461 | ||
|
|
|
|
|
FINANCIAL RESOURCES AT THE END OF THE PERIOD | 18,623 | 15,979 | ||
Cash flow from operating activities | 11,795 | 9,659 | ||
+ Net cash used in investing activities | (1,865 | ) | (1,065 | ) |
- Net change in marketable securities (maturity exceeding three months) | - | - | ||
|
|
|
|
|
FREE CASH FLOW | 9,930 | 8,594 | ||
|
|
|
|
|
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
18 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
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
|
Other
adjust-
ments
|
Total
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9M 2009 | ||||||||||||||
Balance at the beginning of the period | 634 | (26 | ) | 33,433 | (256 | ) | (859 | ) | 53 | 32,979 | ||||
Total comprehensive income for the period | 8,445 | 430 | 1,374 | (25 | ) | 10,224 | ||||||||
Dividends | (3,650 | ) | (3,650 | ) | ||||||||||
Share-based payment | 186 | 186 | ||||||||||||
Reduction of the B share capital | (14 | ) | 14 | |||||||||||
Purchase of treasury shares | (17 | ) | (4,948 | ) | (4,965 | ) | ||||||||
Sale of treasury shares | 1 | 99 | 100 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period | 620 | (28 | ) | 33,565 | 174 | 515 | 28 | 34,874 | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At the end of the year proposed dividends (declared in 2009) of DKK 3,650 million (6.00 DKK per share) are included in Retained earnings. No dividend is declared on treasury shares.
Other
reserves
|
||||||||||||||
|
||||||||||||||
Exchange
|
Deferred
gain/
|
|||||||||||||
Share
|
Treasury
|
Retained
|
rate
|
loss
on cash
|
Other
|
|||||||||
DKK
million
|
capital
|
shares
|
earnings
|
adjustments
|
flow
hedges
|
adjustments
|
Total
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9M 2008 | ||||||||||||||
Balance at the beginning of the period | 647 | (26 | ) | 30,661 | 209 | 678 | 13 | 32,182 | ||||||
Total comprehensive income for the period | 7,315 | (120 | ) | (1,169 | ) | 10 | 6,036 | |||||||
Dividends | (2,795 | ) | (2,795 | ) | ||||||||||
Share-based payment | 119 | 119 | ||||||||||||
Reduction of the B share capital | (13 | ) | 13 | |||||||||||
Purchase of treasury shares | (11 | ) | (3,464 | ) | (3,475 | ) | ||||||||
Sale of treasury shares | 1 | 105 | 106 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period | 634 | (23 | ) | 31,941 | 89 | (491 | ) | 23 | 32,173 | |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At the end of the year proposed dividends (declared in 2008) of DKK 2,795 million (4.50 DKK per share) are included in Retained earnings. No dividend is declared on treasury shares.
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
19 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Appendix 6: Assumptions for key currencies
DKK per 100 | 2008 average |
YTD
2009 average
|
Current exchange rate | |||
exchange
rates
|
exchange
rates as of
|
as
of 26 October 2009
|
||||
26
October 2009
|
||||||
|
|
|
|
|
|
|
USD | 509 | 543 | 496 | |||
JPY | 4.96 | 5.75 | 5.39 | |||
GBP | 938 | 838 | 810 | |||
CNY | 73 | 79 | 73 | |||
CAD | 479 | 468 | 469 |
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
20 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Appendix 7: Accounting policies
The unaudited interim financial report for the first nine months of 2009 has been prepared in accordance with IAS 34 Interim Financial Reporting as issued by IASB and endorsed by the EU. Furthermore the interim financial report has been prepared in accordance with the additional Danish disclosure requirements for interim reports of listed companies.
The following standards relevant to Novo Nordisk have been adopted by the EU and were implemented with effective date 1 January 2009 as described in the Annual Report 2008:
| IAS 1 (Revised) Presentation of financial statements. |
| IAS 23 (Amendment) Borrowing costs. |
| IFRS 2 (Amendment) Share-based payment. |
| IAS 28 (Amendment) Investment in associates (and consequential amendments to IAS 32, Financial Instruments: Disclosure and Presentation. |
| IAS 36 (Amendment) Impairment of assets. |
| IAS 38 (Amendment) Intangible assets. |
| IAS 19 (Amendment) Employee benefits. |
| Minor amendments to IFRS 7, IAS 1, IAS 8, IAS 10, IAS 18, IAS 34 and IAS 39. |
| IFRIC 16 Hedges of net investment in a foreign operation. |
The adoption of these standards has not affected recognition and measurement in Novo Nordisks interim financial report for the first nine months of 2009. Except for the above-mentioned implemented standards, the interim financial report has been prepared using the same accounting policies as in the Annual Report 2008.
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
21 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Appendix 8: 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 average exchange rate for income statement and 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
|
||||||||||||||||
2009 |
2008
|
Q3 2009 vs | ||||||||||||||
Q3
|
Q2
|
Q1
|
Q4
|
Q3
|
Q2
|
Q1
|
Q3 2008 | |||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Sales | 1,681 | 1,746 | 1,677 | 1,688 | 1,508 | 1,489 | 1,424 | 11% | ||||||||
Gross profit | 1,321 | 1,395 | 1,341 | 1,348 | 1,159 | 1,147 | 1,100 | 14% | ||||||||
Gross margin | 78.5% | 79.9% | 79.9% | 79.8% | 76.8% | 77.0% | 77.3% | |||||||||
Sales and distribution costs | 471 | 515 | 516 | 478 | 423 | 426 | 399 | 11% | ||||||||
Percent of sales | 28.0% | 29.5% | 30.8% | 28.3% | 28.1% | 28.6% | 28.0% | |||||||||
Research and development costs | 253 | 248 | 234 | 327 | 211 | 266 | 249 | 19% | ||||||||
- Hereof costs related to AERx ®* | - | - | - | - | 7 | (20 | ) | (30 | ) | |||||||
Percent of sales | 15.1% | 14.2% | 14.0% | 19.4% | 14.0% | 17.8% | 17.5% | |||||||||
Percent of sales (excl AERx ®* ) | 15.1% | 14.2% | 14.0% | 19.4% | 14.4% | 16.4% | 15.4% | |||||||||
Administrative expenses | 90 | 93 | 91 | 100 | 85 | 84 | 84 | 5% | ||||||||
Percent of sales | 5.3% | 5.3% | 5.4% | 6.0% | 5.6% | 5.6% | 5.9% | |||||||||
Licence fees and other operating income (net) | 5 | 10 | 12 | 10 | 7 | 10 | 12 | (33% | ) | |||||||
Operating profit | 512 | 549 | 512 | 453 | 446 | 381 | 380 | 15% | ||||||||
Operating margin | 30.5% | 31.5% | 30.5% | 26.8% | 29.6% | 25.6% | 26.7% | |||||||||
Operating profit (excl AERx®*) | 512 | 549 | 512 | 453 | 439 | 401 | 410 | 16% | ||||||||
Operating margin (excl AERx ®* ) | 30.5% | 31.5% | 30.5% | 26.8% | 29.1% | 27.0% | 28.7% | |||||||||
Share of profit/(loss) in associated companies | (1 | ) | (1 | ) | (5 | ) | 2 | (8 | ) | 0 | (9 | ) | (88% | ) | ||
Financial income | 2 | 22 | 19 | 8 | 41 | 57 | 64 | (97% | ) | |||||||
Financial expenses | 28 | 49 | 55 | 50 | 9 | 3 | 49 | 217% | ||||||||
Profit before income taxes | 485 | 521 | 471 | 413 | 470 | 436 | 385 | 3% | ||||||||
Net profit | 370 | 402 | 362 | 313 | 357 | 332 | 292 | 3% | ||||||||
Depreciation, amortisation and impairment losses | 88 | 72 | 81 | 101 | 75 | 76 | 76 | 17% | ||||||||
Capital expenditure | 98 | 75 | 55 | 102 | 60 | 44 | 29 | 62% | ||||||||
Cash flow from operating activities | 677 | 350 | 557 | 429 | 492 | 391 | 412 | 37% | ||||||||
Free cash flow | 569 | 277 | 487 | 325 | 430 | 347 | 375 | 32% | ||||||||
Equity | 4,685 | 4,577 | 4,208 | 4,426 | 4,312 | 4,431 | 4,191 | 8% | ||||||||
Total assets | 7,064 | 6,881 | 6,741 | 6,792 | 6,566 | 6,500 | 6,375 | 7% | ||||||||
Equity ratio | 66.3% | 66.5% | 62.4% | 65.2% | 65.7% | 68.2% | 65.7% | |||||||||
Full-time employees at the end of the period | 28,497 | 27,998 | 27,429 | 26,575 | 26,360 | 26,060 | 25,765 | 8% | ||||||||
Basic earnings per share (in EUR) | 0.62 | 0.66 | 0.60 | 0.51 | 0.58 | 0.54 | 0.47 | 6% | ||||||||
Diluted earnings per share (in EUR) | 0.62 | 0.66 | 0.59 | 0.51 | 0.57 | 0.53 | 0.47 | 7% | ||||||||
Average number of shares outstanding (million) | 596.4 | 603.1 | 607.4 | 609.3 | 614.2 | 618.6 | 620.9 | (3% | ) | |||||||
Average number of shares outstanding incl | ||||||||||||||||
dilutive effect of options 'in the money' (million) | 601.4 | 607.9 | 612.7 | 614.4 | 618.6 | 623.5 | 626.3 | (3% | ) | |||||||
Sales by business segments: | ||||||||||||||||
Modern insulins (insulin analogues) | 719 | 727 | 670 | 675 | 585 | 550 | 513 | 23% | ||||||||
Human insulins | 369 | 387 | 403 | 415 | 376 | 398 | 394 | (2% | ) | |||||||
Protein-related sales | 70 | 66 | 65 | 64 | 62 | 62 | 59 | 12% | ||||||||
Oral antidiabetic products (OAD) | 87 | 90 | 93 | 81 | 90 | 64 | 86 | (3% | ) | |||||||
Diabetes care total | 1,245 | 1,270 | 1,231 | 1,235 | 1,113 | 1,074 | 1,052 | 12% | ||||||||
NovoSeven® | 222 | 252 | 242 | 238 | 206 | 221 | 193 | 8% | ||||||||
Norditropin® | 144 | 150 | 139 | 142 | 126 | 132 | 118 | 14% | ||||||||
Hormone replacement therapy | 59 | 58 | 55 | 59 | 53 | 52 | 52 | 12% | ||||||||
Other products | 11 | 16 | 10 | 14 | 9 | 11 | 9 | 17% | ||||||||
Biopharmaceuticals total | 436 | 476 | 446 | 453 | 394 | 416 | 372 | 10% | ||||||||
Sales by geographic regions: | ||||||||||||||||
North America | 607 | 633 | 608 | 601 | 504 | 465 | 463 | 20% | ||||||||
Europe | 588 | 587 | 563 | 597 | 577 | 590 | 545 | 2% | ||||||||
International Operations | 308 | 340 | 337 | 293 | 278 | 278 | 281 | 10% | ||||||||
Japan & Oceania | 178 | 186 | 169 | 197 | 149 | 157 | 135 | 20% | ||||||||
Segment operating profit: | ||||||||||||||||
Diabetes care | 307 | 314 | 291 | 325 | 263 | 203 | 224 | 16% | ||||||||
Diabetes care (excl AERx®*) | 307 | 314 | 291 | 325 | 256 | 223 | 254 | 19% | ||||||||
Biopharmaceuticals | 205 | 235 | 221 | 127 | 183 | 179 | 155 | 12% | ||||||||
*) Costs related to the discontinuation of all pulmonary diabetes projects.
Company Announcement
no 63 / 2009 Interim financial report for the period 1 January 2009 to 30 September 2009 |
Page
22 of 22
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
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 30, 2009 |
NOVO NORDISK A/S Lars Rebien Sørensen, President and Chief Executive Officer |