UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT
OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
MAY 01, 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 31 March 2009
30 April 2009
Novo Nordisk increased
sales by 18% in the first quarter of 2009
Operating
profit increased by 35% supported by continued gross margin improvement
| • | Sales in Danish kroner increased by 18% and by 11% in local currencies. | |
| o | Sales of modern insulins increased by 31% (25% in local currencies). | |
| o | Sales of NovoSeven® increased by 25% (18% in local currencies). | |
| o | Sales of Norditropin® increased by 18% (9% in local currencies). | |
| o | Sales in North America increased by 31% (16% in local currencies). | |
| o | Sales in International Operations increased by 20% (16% in local currencies). | |
| • | Gross margin improved by 2.6 percentage points to 79.9% in the first three months of 2009, primarily reflecting continued productivity improvements and a positive currency impact of around 1.0 percentage points. |
| • | Reported operating profit increased by 35% to DKK 3,810 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 24% to DKK 2,699 million. Earnings per share (diluted) increased by 27% to DKK 4.41. |
| • | In Europe, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMEA) adopted a positive opinion for Victoza® (liraglutide) and Novo Nordisk expects to receive the European Marketing Authorisation from the European Commission within approximately two months. |
| • | In the US, following the Advisory Committee meeting on 2 April, Novo Nordisk is working with the United States Food and Drug Administration (FDA) as it completes the review of the liraglutide application. |
| • | For 2009, operating profit measured in local currencies is now expected to grow by at least 10% and reported operating profit growth to be around 8 percentage points higher. |
Lars Rebien Sørensen, president and CEO, said: “We are satisfied with the financial performance during the first quarter of 2009 which is driven by solid sales growth for the modern insulins and gross margin improvements. Following the positive opinion in Europe for Victoza®, we now look forward to launching Victoza® in the first European markets this summer.”
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
1 of 20
|
|
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 statement
for the first three months of 2009
The present
interim financial report for the first quarter of 2009 has been prepared in
accordance with IAS 34 Interim Financial Reporting, as issued by IASB and adopted
by the EU, and the additional Danish disclosure requirements applying to listed
companies’ interim reports. The interim financial report has not been audited.
See ‘Accounting policies’ on page 10 for further information.
Amounts in DKK million, except average number of shares outstanding, earnings per share and full-time employees.
|
%
change
|
|||||||
|
Q1
2008
|
|||||||
| Profit and loss |
Q1
2009
|
Q1
2008
|
to
Q1 2009
|
||||
| Sales | 12,498 | 10,614 | 18% | ||||
| Gross profit |
9,990
|
8,201
|
22%
|
||||
| Gross margin |
79.9%
|
77.3%
|
|||||
| Sales and distribution costs |
3,844
|
2,975
|
29%
|
||||
| Percent of sales |
30.8%
|
28.0%
|
|||||
| Research and development costs |
1,744
|
1,858
|
(6%
|
)
|
|||
| - hereof discontinuationcosts for pulmonary diabetes projects |
-
|
220
|
-
|
||||
| Percent of sales |
14.0%
|
17.5%
|
|||||
| Percent of sales adjusted for pulmonary diabetes projects |
14.0%
|
15.4%
|
|||||
| Administrative expenses |
679
|
627
|
8%
|
||||
| Percent of sales |
5.4%
|
5.9%
|
|||||
| Licence fees and other operating income |
87
|
88
|
(1%
|
)
|
|||
| Operating profit |
3,810
|
2,829
|
35%
|
||||
| Operating margin |
30.5%
|
26.7%
|
|||||
| Net financials |
(305
|
)
|
39
|
-
|
|||
| Profit before tax |
3,505
|
2,868
|
22%
|
||||
| Net profit |
2,699
|
2,180
|
24%
|
||||
| Net profit margin |
21.6%
|
20.5%
|
|||||
| Other key numbers | |||||||
| Depreciation, amortisation and impairment losses |
607
|
563
|
8%
|
||||
| Capital expenditure |
413
|
214
|
93%
|
||||
| Cash flow from operating activities |
4,148
|
3,070
|
35%
|
||||
| Free cash flow |
3,626
|
2,795
|
30%
|
||||
| Total assets |
50,205
|
47,534
|
6%
|
||||
| Equity |
31,345
|
31,251
|
0%
|
||||
| Equity ratio |
62.4%
|
65.7%
|
|||||
| Average number of shares outstanding (million) – diluted |
612.7
|
626.3
|
(2%
|
)
|
|||
| Diluted earnings per share (in DKK) |
4.41
|
3.48
|
27%
|
||||
| Full-time employees at the end of the period |
27,429
|
25,765
|
6%
|
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
2 of 20
|
|
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 18% in Danish kroner and by 11% measured in local currencies. While growth
was realised within both diabetes care and biopharmaceuticals, the primary growth
contribution originated from the modern insulins.
|
Sales
|
Growth
|
Growth
|
Share
of
|
||||||
|
Q1
2009
|
as
|
in
local
|
growth
|
||||||
|
DKK
|
reported
|
currencies
|
in
local
|
||||||
|
million
|
currencies
|
||||||||
| The diabetes care segment | |||||||||
| Modern insulins |
4,990
|
31%
|
25%
|
77%
|
|||||
| - Levemir® |
1,161
|
42%
|
37%
|
25%
|
|||||
| - NovoMix® |
1,553
|
25%
|
21%
|
22%
|
|||||
| - NovoRapid® |
2,276
|
29%
|
21%
|
30%
|
|||||
| Human insulins |
3,004
|
2%
|
(4%
|
)
|
(9%
|
)
|
|||
| Insulin-related products |
484
|
9%
|
5%
|
2%
|
|||||
| Oral antidiabetic products |
691
|
8%
|
1%
|
0%
|
|||||
| Diabetes care – total |
9,169
|
17%
|
11%
|
70%
|
|||||
| The biopharmaceuticals segment | |||||||||
| NovoSeven® |
1,805
|
25%
|
18%
|
22%
|
|||||
| Growth hormone therapy (Norditropin®) |
1,034
|
18%
|
9%
|
7%
|
|||||
| Other products |
490
|
8%
|
3%
|
1%
|
|||||
| Biopharmaceuticals – total |
3,329
|
20%
|
13%
|
30%
|
|||||
| Total sales |
12,498
|
18%
|
11%
|
100%
|
Sales development
by regions
In the first
three months of 2009, sales growth was realised in all regions. North America
was the main contributor to growth with 44% share of growth measured in local
currencies and now constitutes the largest sales region for Novo Nordisk. International
Operations and Europe contributed 28% and 26%, respectively, of the total sales
growth, whereas Japan and Oceania accounted for 2% of the growth.
Diabetes care
Sales of diabetes
care products increased by 17% measured in Danish kroner to DKK 9,169 million
and by 11% in local currencies compared to the first three months of 2008.
Modern insulins,
human insulins and insulin-related products
In the first
three months of 2009, sales of modern insulins, human insulins and insulin-related
products increased by 18% in Danish kroner to DKK 8,478 million and by 12% measured
in local currencies compared with the same period last year. All regions contributed
to growth measured in local currencies, with North America and International
Operations having the highest growth rates. Novo Nordisk continues to be the
global leader with 52% of the total insulin market and 45% of the modern insulin
market, both measured by volume.
The sales growth is driven by the portfolio of modern insulins exhibiting a steady sales growth globally. Sales of modern insulins increased by 31% in Danish kroner to DKK 4,990 million and by 25% in local currencies compared with the first three months of 2008. All regions realised
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
3 of 20
|
|
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 |
solid growth rates, with North America accounting for more than half of the growth followed by Europe and International Operations. Sales of modern insulins now constitute 62% of Novo Nordisk’s sales of insulin.
North America
Sales in North
America increased by 39% in Danish kroner and by 22% in local currencies in
the first three 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 33%
of the modern insulin market, both measured by volume. Currently, around 38%
of Novo Nordisk’s modern insulin volume in the US is being sold in FlexPen®.
Europe
Sales in Europe
decreased by 1% measured in Danish kroner and increased by 3% in local currencies,
reflecting continued progress for the portfolio of modern insulins but also
declining human insulin sales. Novo Nordisk holds 55% 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 Nordisk’s insulin volume
being sold in devices, primarily NovoPen®
and FlexPen®.
International
Operations
Sales within
International Operations increased by 22% in Danish kroner and by 19% in local
currencies. The main contributor to growth in the first three months of 2009
was sales of modern insulins, primarily in Turkey and China. Furthermore, sales
of human insulins continue to add to overall growth in the region, also driven
by China.
Japan &
Oceania
Sales in Japan
& Oceania increased by 23% measured in Danish kroner and by 1% in local
currencies. The sales development reflects sales growth for all three modern
insulins NovoRapid®,
NovoRapid Mix®
30 and Levemir®. Novo Nordisk holds 71% of the total
insulin market in Japan and 63% of the modern insulin market, both measured
by volume. The device penetration in Japan remains high with more than 95% of
Novo Nordisk’s insulin volume being sold in devices, primarily NovoPen®
and FlexPen®.
Oral antidiabetic
products (NovoNorm®/Prandin®)
In the first
three months of 2009, sales of oral antidiabetic products increased by 8% in
Danish kroner to DKK 691 million and by 1% in local currencies compared to the
same period in 2008. The sales development reflects increased sales in Europe
countered by lower sales in China in the first quarter of 2009 compared to the
same period last year due to the timing of sales in China in 2008.
Biopharmaceuticals
In the first
three months of 2009, sales of biopharmaceutical products increased by 20% measured
in Danish kroner to DKK 3,329 million and by 13% measured in local currencies
compared to the first three months of 2008.
NovoSeven®
Sales
of NovoSeven®
increased by 25% in Danish kroner to DKK 1,805 million and by 18% in local currencies
compared with the first three months of 2008. Sales growth for NovoSeven® was primarily realised in Europe and
International Operations and is positively impacted by
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
4 of 20
|
|
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 |
timing of sales in these regions. The sales growth for NovoSeven® primarily reflected increased sales within the congenital bleeding disorder segments. Treatment of spontaneous bleeds for congenital inhibitor patients remains the largest area of use.
Growth hormone
therapy (Norditropin®)
Sales of Norditropin®
(ie growth hormone in a liquid, ready-to-use formulation) increased by 18% measured
in Danish kroner to DKK 1,034 million and by 9% measured in local currencies
compared with the first three months of 2008. North America and Europe were
the main contributors to growth measured in local currencies. Novo Nordisk remains
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 8% in Danish kroner to DKK 490
million and by 3% in local currencies. This development primarily reflects continued
sales progress for Vagifem®,
a topical oestrogen product, partly due to a US price increase countered by
generic competition in the US with Activella® (Activelle®
outside the US), Novo Nordisk’s 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.
Costs, licence
fees and other operating income
The cost of
goods sold was DKK 2,508 million in the first three months of 2009 representing
a gross margin of 79.9% compared with 77.3% in the same period of 2008. This
improvement reflects improved production efficiency and higher average selling
prices in the US. The gross margin was positively impacted by around 1.0 percentage
point due to a positive currency development, primarily the higher value of
the US dollar and the Japanese yen versus the Danish krone compared with the
first three months of 2008.
In the first three months of 2009, total non-production-related costs increased by 15% to DKK 6,267 million compared with the same period last year. Slightly more than half of the increase in non-production-related costs, or around 8 percentage points, reflect the higher value of key currencies versus the Danish krone in the first three months of 2009 compared with the first three months of 2008. The underlying development in non-production-related costs relate to the expanded sales force in certain key markets like US, UK, Germany and China countered by lower research and development costs, primarily reflecting timing with regard to the initiation of phase 3 clinical trial programmes as well as the non-recurring costs of DKK 220 million in the first quarter of 2008 related to the discontinuation of pulmonary diabetes projects.
Licence fees and other operating income were DKK 87 million in the first three months of 2009 compared with DKK 88 million in the same period of 2008.
Net financials
Net financials
showed a net expense of DKK 305 million in the first three months of 2009 compared
with a net income of DKK 39 million in the same period of 2008.
Included in net financials is the result from associated companies with an expense of DKK 35 million, primarily related to Novo Nordisk’s share of losses in ZymoGenetics, Inc. In the same period of 2008, the result from associated companies was an expense of 67 DKK million.
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
5 of 20
|
|
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 |
For the first three months of 2009, the foreign exchange result was an expense of DKK 327 million compared with an income of DKK 70 million in the first three months of 2008. This development reflects losses on foreign exchange hedging of especially US dollars and Japanese yen due to the significant appreciation of these versus Danish kroner. Foreign exchange hedging losses of around DKK 900 million have been deferred for future income recognition.
Outlook 2009
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 |
30
April 2009
|
29
January 2009
|
|
|
|
|
| Sales growth | ||
| - in local currencies |
At
the level of 10%
|
At
the level of 10%
|
| - as reported |
Around
4.5 percentage
|
Around
5 percentage
|
|
points
higher
|
points
higher
|
|
|
|
|
|
| Operating profit growth | ||
| - underlying |
At
least 10%
|
At
the level of 10%
|
| - as reported |
Around
8 percentage
|
Around
9 percentage
|
|
points
higher
|
points
higher
|
|
|
|
|
|
| Net financial expense |
Around
DKK 1.5 billion
|
Around
DKK 1.6 billion
|
|
|
|
|
| Effective tax rate |
Approximately
23%
|
Approximately
24%
|
|
|
|
|
| Capital expenditure |
Around
DKK 3 billion
|
Around
DKK 3 billion
|
|
|
|
|
| Depreciation, amortisation | ||
| and impairment losses |
Around
DKK 2.6 billion
|
Around
DKK 2.6 billion
|
|
|
|
|
| Free cash flow |
Around
DKK 10 billion
|
At
least DKK 9 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 Nordisk’s key strategic products within diabetes care and biopharmaceuticals as well as expectations of continued intense competition during 2009. Given the current level of exchange rates versus Danish kroner, the reported sales growth is now expected to be around 4.5 percentage points higher than the growth rate measured in local currencies.
For 2009, growth in operating profit is now expected to be at least 10% measured in local currencies. The increase reflects lower expected research and development costs for 2009 due to timing of phase 3 clinical trial programmes. Furthermore, the forecast is based on assumptions of a continued improvement of the gross margin and increased spending for sales and distribution relative to sales due to the increase in Novo Nordisk’s global sales force. Given the current level of exchange rates versus Danish kroner, the reported operating profit growth is now expected to be around 8 percentage points higher than the growth rate measured in local currencies.
For 2009, Novo Nordisk now expects a net financial expense of DKK 1.5 billion. 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 now expected to be around 23%.
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
6 of 20
|
|
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 still expected to be around DKK 3 billion in 2009. Expectations for depreciations, amortisation and impairment losses of around DKK 2.6 billion are unchanged, and free cash flow is now expected to be around DKK 10 billion.
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 2009. In addition, all of the above expectations are provided that currency exchange rates, especially the US dollar, remain at the current level versus the Danish krone for the rest of 2009 (see appendix 7). Novo Nordisk has hedged expected net cash flows in key invoicing currencies and, all other things being equal, movements in key invoicing currencies will impact Novo Nordisk’s operating profit as outlined in the below table.
|
Key
invoicing
|
Annual
impact on Novo Nordisk’s
|
Hedging
period
|
|
currencies
|
operating
profit of a 5%
|
(months)
|
|
movement
in currency
|
||
|
USD
|
DKK
530 million
|
15
|
|
JPY
|
DKK
150 million
|
14
|
|
GBP
|
DKK
80 million
|
13
|
|
CNY
|
DKK
80 million
|
15*
|
|
CAD
|
DKK
40 million
|
5
|
*USD used as proxy when hedging Novo Nordisk’s CNY currency exposure
The financial impact from foreign exchange hedging is included in ‘Net financials’.
Research and development update
Diabetes care
In Europe,
the Committee for Medicinal Products for Human Use (CHMP) under the European
Medicines Agency (EMEA) on 23 April adopted a positive opinion for Victoza®
for the treatment of type 2 diabetes. Victoza®
is the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed
for the treatment of type 2 diabetes. The positive opinion for Victoza®
covers the expected indications of: combination treatment with metformin or
a sulphonylurea in patients with insufficient glycaemic control despite maximal
tolerated dose of monotherapy with metformin or sulphonylurea and combination
treatment with metformin and a sulphonylurea or metformin and a thiazolidinedione
in patients with insufficient glycaemic control despite dual therapy. Novo Nordisk
expects to receive the European Marketing Authorisation from the European Commission
within approximately two months.
The regulatory process for liraglutide in Japan is progressing according to plans and a decision by the Japanese regulatory authorities is expected in 2010.
On 2 April and as previously communicated, the Endocrinologic and Metabolic Drug Advisory Committee of the United States Food and Drug Administration (FDA) discussed questions related to liraglutide, Novo Nordisk’s once-daily human GLP-1 analogue which was filed for regulatory approval in the US in May 2008. The Advisory Committee voted on four questions related to the risk profile of liraglutide. A majority of Advisory Committee members supported that appropriate evidence of cardiovascular safety had been provided to rule out excess cardiovascular risk of liraglutide relative to comparators. Novo Nordisk has committed to do a large post-approval cardiovascular outcome study.
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
7 of 20
|
|
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 |
A majority of Advisory Committee members voted no to the question on whether the data available with the regulatory submission on thyroid C-cell tumours showed that this finding is not relevant to humans. However, the Advisory Committee was split on the FDA question related to whether the available data on C-cell tumours permitted approvability. Finally, the Advisory Committee unanimously dismissed any risk of papillary thyroid cancer related to liraglutide. Following the meeting, Novo Nordisk will be discussing next steps with the FDA to resolve the issues raised at the Advisory Committee meeting. US approval of liraglutide, and the timing thereof, will depend on the completion of the FDA's review of the application.
Novo Nordisk recently obtained two-year data from the liraglutide plus metformin combination study (LEAD™ 2). On a background of metformin therapy three different doses of liraglutide were compared to glimepiride treatment and placebo in people with type 2 diabetes. In total 880 people with diabetes completed the initial first six months of the study and 529 completed two years. People treated with liraglutide achieved statistically significant reductions in HbA1ccompared to placebo after two years. Furthermore, significantly more people treated with the highest dose of liraglutide were below 7% HbA1c, the American Diabetes Association (ADA) target for good glycaemic control, compared to treatment with glimepiride. Finally, the favourable benefit to risk profile of liraglutide was confirmed in this study.
At the annual meeting of the American Diabetes Association (ADA) to be held in New Orleans on 5–9 June 2009, Novo Nordisk expects to present further detailed results from the global liraglutide clinical development programme.
Novo Nordisk very recently finalised a phase 2 study investigating safety and efficacy of five doses of semaglutide (NN9535), a once-weekly human GLP-1 analogue, versus placebo and open-label liraglutide add-on therapy in people with type 2 diabetes. At study start, patients were treated with metformin or controlled with diet and exercise. The 12-week multi-centre, multinational, double-blind, placebo-controlled, randomised dose-finding trial, which included a little more than 400 patients, demonstrated that clinical efficacy and safety of semaglutide was broadly in line with liraglutide. Semaglutide was generally well tolerated and was not associated with an increase in injection site reactions, antibody formation or calcitonin levels. After more detailed analysis of the dose-response findings on efficacy and safety, Novo Nordisk will discuss the future plans for semaglutide development with regulatory authorities before initiation of phase 3 development.
Novo Nordisk is preparing initiation of phase 3 programmes for the new generation of insulins, known as NN5401 and NN1250, in the second half of 2009 and good progress has been made with regulatory agencies around the world. The first phase 3 trials with NN1250 and NN5401 are expected to be initiated in the third and fourth quarters of 2009, respectively. Novo Nordisk expects to give a more detailed update on expected timelines and design of the phase 3 programmes in connection with the release of financial results for the first half of 2009 on 6 August 2009.
Biopharmaceuticals
In April 2009,
Novo Nordisk initiated a phase 3 trial of a recombinant factor VIII compound
in patients with haemophilia A. The trial is conducted as a multi-centre, open-label,
non-controlled trial and evaluates the efficacy and safety in both prevention
and on-demand treatment of haemophilia A bleeding episodes. A sub-trial investigates
efficacy and safety of the recombinant factor VIII compound in patients undergoing
major or minor elective surgery requiring factor VIII replenishment. Novo Nordisk
expects to enrol a total of 140 patients in the phase 3 programme.
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
8 of 20
|
|
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 recently received approval from the Japanese Pharmaceuticals and Medical Devices Agency for an expansion of the Norditropin® label to include treatment of growth hormone deficiency in adults. Growth hormone deficiency in adults is an approved indication for Norditropin® in both Europe and the US.
As previously communicated, Novo Nordisk initiated a phase 3 study with recombinant FXIII in congenital factor XIII deficiency in August 2008. All 41 patients have now been recruited and entered into the one-year treatment period of this trial.
Equity
Total equity
was DKK 31,345 million at the end of the first three months of 2009, equal to
62.4% of total assets, compared with 65.2% at the end of 2008. Please refer
to appendix 6 for further elaboration of changes in equity during the first
three months of 2009.
Reduction of
share capital
The Annual
General Meeting of Novo Nordisk A/S, which was held on 18 March 2009, approved
a 2.2% reduction in the total share capital by cancellation of 14,000,000 treasury
B shares of DKK 1 at a nominal value of DKK 14,000,000. After the legal implementation
of the share capital reduction, which is expected to take place after expiry
of the legal notice period in June 2009, Novo Nordisk’s share capital will
amount to DKK 620,000,000 divided into an A share capital of DKK 107,487,200
and a B share capital of DKK 512,512,800.
Treasury shares
and share repurchase programme
Novo Nordisk’s
ongoing share repurchase programme is conducted in accordance with the provisions
of the European Commission’s regulation no 2273/2003 of 22 December 2003,
also known as ‘Safe Harbour Regulation’, with J.P. Morgan Securities
Ltd. as lead manager. According to this, J.P. Morgan Securities Ltd. will repurchase
shares on behalf of Novo Nordisk for up to DKK 3.0 billion during the trading
period that started on 29 January 2009 and will end on 5 August 2009. A maximum
of 159,541 shares can be bought during one single trading day, equal to 15%
of the average daily trading volume of Novo Nordisk B shares on NASDAQ OMX Copenhagen
during the month of December 2008, and a maximum of 20,580,773 shares in total
can be bought during the trading period.
As per 29 April 2009, Novo Nordisk A/S and its wholly-owned affiliates owned 29,940.023 of its own B shares, corresponding to 4.7% of the total share capital.
The overall DKK 18.5 billion share repurchase programme initiated in 2006 is still expected to be finalised before the end of 2009. In 2006, 2007 and 2008 Novo Nordisk repurchased B shares equal to a cash value of DKK 12.5 billion and Novo Nordisk still expects to repurchase B shares equal to a cash value of around DKK 6 billion in 2009.
Sustainability issues update
Expanding access
to treatment
In the first
quarter of 2009, Novo Nordisk made progress towards its ambitious plan to expand
access to treatment for children in Africa with type 1 diabetes. Software was
installed and training provided to begin patient registries in four countries,
and collaboration was initiated with Ministries of Health on treatment strategies
in all of the five pilot countries, Cameroon, the Democratic Republic of Congo,
Guinea-Conakry, Tanzania and Uganda. The objective of
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
9 of 20
|
|
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 |
the programme is to reduce child mortality due to lack of or insufficient diabetes care in the world’s poorest countries. It will offer free insulin, treatment and diabetes education for children and their families, and the goal is to reach 10,000 children on a five-year horizon.
Legal issues update
US hormone
therapy litigation
As of 29 April
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 53
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.). A further 63 individuals currently allege, in relation to
similar lawsuits against Pfizer Inc., that they have also used a Novo Nordisk
hormone therapy product. Novo Nordisk does not currently have any court trials
scheduled for 2009. Novo Nordisk does not expect the pending claims to impact
Novo Nordisk’s financial outlook.
Conference
call details
At 13.00 CET
today, corresponding to 7.00 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 approximately one hour
before on the same page.
Accounting
policies
The present
interim financial report for the first quarter of 2009 has been prepared in
accordance with IAS 34 Interim Financial Reporting, as issued by IASB and adopted
by the EU, and the additional Danish disclosure requirements applying to listed
companies’ interim reports.
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 2008 Annual Report:
|
•
|
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 Nordisk’s interim financial report for the first quarter of 2009. Except for the above-mentioned implemented standards, the interim financial report has been prepared using the same accounting policies as the Annual Report for 2008.
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
10 of 20
|
|
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 |
Forward-looking
statement
Novo Nordisk’s
reports filed with or furnished to the US Securities and Exchange Commission
(SEC), including this document as well as the company’s Annual Report 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 Nordisk’s
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 Nordisk’s products, introduction of competing products, reliance on information technology, Novo Nordisk’s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees and failure to maintain a culture of compliance.
Please also refer to the overview of risk factors in ‘Managing Risks’ on pp 24–25 of the Annual Report 2008 available on the company’s website (novonordisk.com).
Unless required by law Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this document, whether as a result of new information, future events or otherwise.
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
11 of 20
|
|
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 reviewed and approved the interim
report and accounts of Novo Nordisk A/S for the first three months of 2009.
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.
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 include a fair review 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 30 April 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 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
12 of 20
|
|
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 company’s internet homepage at the address: novonordisk.com
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
13 of 20
|
|
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
|
Q1
2009 vs
|
|||||||||||
| Q1 | Q4 | Q3 | Q2 | Q1 |
Q1
2008
|
||||||||
|
|
|
|
|
|
|
|
|
|
|||||
| Sales | 12,498 | 12,583 | 11,246 | 11,110 | 10,614 |
18%
|
|||||||
| Gross profit | 9,990 | 10,047 | 8,640 | 8,556 | 8,201 |
22%
|
|||||||
| Gross margin | 79.9% | 79.8% | 76.8% | 77.0% | 77.3% | ||||||||
| Sales and distribution costs | 3,844 | 3,558 | 3,155 | 3,178 | 2,975 |
29%
|
|||||||
| Percent of sales | 30.8% | 28.3% | 28.1% | 28.6% | 28.0% | ||||||||
| Research and development costs | 1,744 | 2,439 | 1,579 | 1,980 | 1,858 |
(6%
|
) | ||||||
| - Hereof costs related to AERx®* | - | - | 50 | (155 | ) | (220 | ) | ||||||
| Percent of sales | 14.0% | 19.4% | 14.0% | 17.8% | 17.5% | ||||||||
| Percent of sales (excl AERx®* ) | 14.0% | 19.4% | 14.5% | 16.4% | 15.4% | ||||||||
| Administrative expenses | 679 | 749 | 633 | 626 | 627 |
8%
|
|||||||
| Percent of sales | 5.4% | 6.0% | 5.6% | 5.6% | 5.9% | ||||||||
| Licence fees and other operating income (net) | 87 | 73 | 51 | 74 | 88 |
(1%
|
) | ||||||
| Operating profit | 3,810 | 3,374 | 3,324 | 2,846 | 2,829 |
35%
|
|||||||
| Operating margin | 30.5% | 26.8% | 29.6% | 25.6% | 26.7% | ||||||||
| Operating profit (excl AERx®*) | 3,810 | 3,374 | 3,274 | 3,001 | 3,049 |
25%
|
|||||||
| Operating margin (excl AERx®*) | 30.5% | 26.8% | 29.1% | 27.0% | 28.7% | ||||||||
| Share of profit/(loss) in associated companies | (35 | ) | 4 | (58 | ) | (3 | ) | (67 | ) |
(48%
|
) | ||
| Financial income | 142 | (82 | ) | 306 | 429 | 474 |
(70%
|
) | |||||
| Financial expenses | 412 | 226 | 66 | 21 | 368 |
12%
|
|||||||
| Profit before income taxes | 3,505 | 3,070 | 3,506 | 3,251 | 2,868 |
22%
|
|||||||
| Net profit | 2,699 | 2,330 | 2,664 | 2,471 | 2,180 |
24%
|
|||||||
| Depreciation, amortisation and impairment losses | 607 | 752 | 560 | 567 | 563 |
8%
|
|||||||
| Capital expenditure | 413 | 764 | 448 | 328 | 214 |
93%
|
|||||||
| Cash flow from operating activities | 4,148 | 3,204 | 3,673 | 2,916 | 3,070 |
35%
|
|||||||
| Free cash flow | 3,626 | 2,421 | 3,210 | 2,589 | 2,795 |
30%
|
|||||||
| Equity | 31,345 | 32,979 | 32,173 | 33,046 | 31,251 |
0%
|
|||||||
| Total assets | 50,205 | 50,603 | 48,990 | 48,478 | 47,534 |
6%
|
|||||||
| Equity ratio | 62.4% | 65.2% | 65.7% | 68.2% | 65.7% | ||||||||
| Full-time employees at the end of the period | 27,429 | 26,575 | 26,360 | 26,060 | 25,765 |
6%
|
|||||||
| Basic earnings per share (in DKK) | 4.44 | 3.82 | 4.34 | 3.99 | 3.51 |
26%
|
|||||||
| Diluted earnings per share (in DKK) | 4.41 | 3.80 | 4.30 | 3.96 | 3.48 |
27%
|
|||||||
| Average number of shares outstanding (million) | 607.4 | 609.3 | 614.2 | 618.6 | 620.9 |
(2%
|
) | ||||||
| Average number of shares outstanding incl | |||||||||||||
| dilutive effect of options 'in the money' (million) | 612.7 | 614.4 | 618.6 | 623.5 | 626.3 |
(2%
|
) | ||||||
| Sales by business segments: | |||||||||||||
| Modern insulins (insulin analogues) | 4,990 | 5,028 | 4,365 | 4,103 | 3,821 |
31%
|
|||||||
| Human insulins | 3,004 | 3,093 | 2,806 | 2,966 | 2,939 |
2%
|
|||||||
| Insulin-related sales | 484 | 477 | 464 | 460 | 443 |
9%
|
|||||||
| Oral antidiabetic products (OAD) | 691 | 602 | 671 | 478 | 640 |
8%
|
|||||||
| Diabetes care total | 9,169 | 9,200 | 8,306 | 8,007 | 7,843 |
17%
|
|||||||
| NovoSeven® | 1,805 | 1,774 | 1,534 | 1,648 | 1,440 |
25%
|
|||||||
| Growth hormone therapy | 1,034 | 1,060 | 941 | 986 | 878 |
18%
|
|||||||
| Hormone replacement therapy | 409 | 442 | 394 | 391 | 385 |
6%
|
|||||||
| Other products | 81 | 107 | 71 | 78 | 68 |
19%
|
|||||||
| Biopharmaceuticals total | 3,329 | 3,383 | 2,940 | 3,103 | 2,771 |
20%
|
|||||||
| Sales by geographic regions: | |||||||||||||
| Europe | 4,195 | 4,453 | 4,305 | 4,400 | 4,061 |
3%
|
|||||||
| North America | 4,532 | 4,478 | 3,759 | 3,467 | 3,450 |
31%
|
|||||||
| International Operations | 2,513 | 2,186 | 2,074 | 2,069 | 2,096 |
20%
|
|||||||
| Japan & Oceania | 1,258 | 1,466 | 1,108 | 1,174 | 1,007 |
25%
|
|||||||
| Segment operating profit: | |||||||||||||
| Diabetes care | 2,171 | 2,424 | 1,963 | 1,510 | 1,672 |
30%
|
|||||||
| Diabetes care (excl AERx®*) | 2,171 | 2,424 | 1,913 | 1,665 | 1,892 |
15%
|
|||||||
| Biopharmaceuticals | 1,639 | 950 | 1,361 | 1,336 | 1,157 |
42%
|
|||||||
*) Costs related to the discontinuation of all pulmonary diabetes projects.
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
14 of 20
|
|
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: Quarterly numbers in EUR
(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.
|
%
change
|
|||||||||||||
|
2009
|
2008
|
Q1
2009 vs
|
|||||||||||
|
Q1
|
Q4
|
Q3
|
Q2
|
Q1
|
Q1
2008
|
||||||||
|
|
|
|
|
|
|
||||||||
| Sales |
1,677
|
1,688
|
1,508
|
1,489
|
1,424
|
18%
|
|||||||
| Gross profit |
1,341
|
1,348
|
1,159
|
1,147
|
1,100
|
22%
|
|||||||
| Gross margin |
79.9%
|
79.8%
|
76.8%
|
77.0%
|
77.3%
|
||||||||
| Sales and distribution costs |
516
|
478
|
423
|
426
|
399
|
29%
|
|||||||
| Percent of sales |
30.8%
|
28.3%
|
28.1%
|
28.6%
|
28.0%
|
||||||||
| Research and development costs |
234
|
327
|
211
|
266
|
249
|
(6%
|
) | ||||||
| - Hereof costs related to AERx®* |
-
|
-
|
7
|
(20
|
) |
(30
|
) | ||||||
| Percent of sales |
14.0%
|
19.4%
|
14.0%
|
17.8%
|
17.5%
|
||||||||
| Percent of sales (excl AERx®* ) |
14.0%
|
19.4%
|
14.4%
|
16.4%
|
15.4%
|
||||||||
| Administrative expenses |
91
|
100
|
85
|
84
|
84
|
8%
|
|||||||
| Percent of sales |
5.4%
|
6.0%
|
5.6%
|
5.6%
|
5.9%
|
||||||||
| Licence fees and other operating income (net) |
12
|
10
|
7
|
10
|
12
|
(1%
|
) | ||||||
| Operating profit |
512
|
453
|
446
|
381
|
380
|
35%
|
|||||||
| Operating margin |
30.5%
|
26.8%
|
29.6%
|
25.6%
|
26.7%
|
||||||||
| Operating profit (excl AERx®*) |
512
|
453
|
439
|
401
|
410
|
25%
|
|||||||
| Operating margin (excl AERx®*) |
30.5%
|
26.8%
|
29.1%
|
27.0%
|
28.7%
|
||||||||
| Share of profit/(loss) in associated companies |
(5
|
) |
2
|
(8
|
) |
0
|
(9
|
) |
(48%
|
) | |||
| Financial income |
19
|
8
|
41
|
57
|
64
|
(70%
|
) | ||||||
| Financial expenses |
55
|
50
|
9
|
3
|
49
|
12%
|
|||||||
| Profit before income taxes |
471
|
413
|
470
|
436
|
385
|
22%
|
|||||||
| Net profit |
362
|
313
|
357
|
332
|
292
|
24%
|
|||||||
| Depreciation, amortisation and impairment losses |
81
|
101
|
75
|
76
|
76
|
8%
|
|||||||
| Capital expenditure |
55
|
102
|
60
|
44
|
29
|
93%
|
|||||||
| Cash flow from operating activities |
557
|
429
|
492
|
391
|
412
|
35%
|
|||||||
| Free cash flow |
487
|
325
|
430
|
347
|
375
|
30%
|
|||||||
| Equity |
4,208
|
4,426
|
4,312
|
4,431
|
4,191
|
0%
|
|||||||
| Total assets |
6,741
|
6,792
|
6,566
|
6,500
|
6,375
|
6%
|
|||||||
| Equity ratio |
62.4%
|
65.2%
|
65.7%
|
68.2%
|
65.7%
|
||||||||
| Full-time employees at the end of the period |
27,429
|
26,575
|
26,360
|
26,060
|
25,765
|
6%
|
|||||||
| Basic earnings per share (in EUR) |
0.60
|
0.51
|
0.58
|
0.54
|
0.47
|
26%
|
|||||||
| Diluted earnings per share (in EUR) |
0.59
|
0.51
|
0.57
|
0.53
|
0.47
|
27%
|
|||||||
| Average number of shares outstanding (million) |
607.4
|
609.3
|
614.2
|
618.6
|
620.9
|
(2%
|
) | ||||||
| Average number of shares outstanding incl | |||||||||||||
| dilutive effect of options 'in the money' (million) |
612.7
|
614.4
|
618.6
|
623.5
|
626.3
|
(2%
|
) | ||||||
| Sales by business segments: | |||||||||||||
| Modern insulins (insulin analogues) |
670
|
675
|
585
|
550
|
513
|
31%
|
|||||||
| Human insulins |
403
|
415
|
376
|
398
|
394
|
2%
|
|||||||
| Insulin-related sales |
65
|
64
|
62
|
62
|
59
|
9%
|
|||||||
| Oral antidiabetic products (OAD) |
93
|
81
|
90
|
64
|
86
|
8%
|
|||||||
| Diabetes care total |
1,231
|
1,235
|
1,113
|
1,074
|
1,052
|
17%
|
|||||||
| NovoSeven® |
242
|
238
|
206
|
221
|
193
|
25%
|
|||||||
| Growth hormone therapy |
139
|
142
|
126
|
132
|
118
|
18%
|
|||||||
| Hormone replacement therapy |
55
|
59
|
53
|
52
|
52
|
6%
|
|||||||
| Other products |
10
|
14
|
9
|
11
|
9
|
19%
|
|||||||
| Biopharmaceuticals total |
446
|
453
|
394
|
416
|
372
|
20%
|
|||||||
| Sales by geographic regions: | |||||||||||||
| Europe |
563
|
597
|
577
|
590
|
545
|
3%
|
|||||||
| North America |
608
|
601
|
504
|
465
|
463
|
31%
|
|||||||
| International Operations |
337
|
293
|
278
|
278
|
281
|
20%
|
|||||||
| Japan & Oceania |
169
|
197
|
149
|
157
|
135
|
25%
|
|||||||
| Segment operating profit: | |||||||||||||
| Diabetes care |
291
|
325
|
263
|
203
|
224
|
30%
|
|||||||
| Diabetes care (excl AERx®*) |
291
|
325
|
256
|
223
|
254
|
15%
|
|||||||
| Biopharmaceuticals |
221
|
127
|
183
|
179
|
155
|
42%
|
*) Costs related to the discontinuation of all pulmonary diabetes projects.
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
15 of 20
|
|
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: Income statement
|
Q1
|
Q1
|
||||
| DKK million |
2009
|
2008
|
|||
|
|
|
|
|
|
|
| Sales |
12,498
|
10,614
|
|||
| Cost of goods sold |
2,508
|
2,413
|
|||
|
|
|
|
|
|
|
| Gross profit |
9,990
|
8,201
|
|||
| Sales and distribution costs |
3,844
|
2,975
|
|||
| Research and development costs |
1,744
|
1,858
|
|||
| - hereof costs related to AERx®* |
-
|
(220
|
) | ||
| Administrative expenses |
679
|
627
|
|||
| Licence fees and other operating income (net) |
87
|
88
|
|||
|
|
|
|
|
|
|
| Operating profit |
3,810
|
2,829
|
|||
| Operating profit (excl AERx ®*) |
3,810
|
3,049
|
|||
| Share of profit/(loss) in associated companies |
(35
|
) |
(67
|
) | |
| Financial income |
142
|
474
|
|||
| Financial expenses |
412
|
368
|
|||
|
|
|
|
|
|
|
| Profit before income taxes |
3,505
|
2,868
|
|||
| Income taxes |
806
|
688
|
|||
|
|
|
|
|
|
|
| NET PROFIT |
2,699
|
2,180
|
|||
| Basic earnings per share (DKK) |
4.44
|
3.51
|
|||
| Diluted earnings per share (DKK) |
4.41
|
3.48
|
|||
| Segment Information | |||||
|
|
|
|
|
|
|
| Segment sales: | |||||
| Diabetes care |
9,169
|
7,843
|
|||
| Biopharmaceuticals |
3,329
|
2,771
|
|||
| Segment operating profit: | |||||
| Diabetes care |
2,171
|
1,672
|
|||
| Operating margin |
23.7%
|
21.3%
|
|||
| Biopharmaceuticals |
1,639
|
1,157
|
|||
| Operating margin |
49.2%
|
41.8%
|
|||
| Total segment operating profit |
3,810
|
2,829
|
|||
|
|
|
|
|
|
|
| Statement of comprehensive income | |||||
| Net profit for the period |
2,699
|
2,180
|
|||
| Other comprehensive income: | |||||
| Exchange rate adjustment of investments in subsidiaries |
163
|
(109
|
) | ||
| Novo Nordisk share of equity recognised by associated companies |
8
|
9
|
|||
| Deferred (gain)/loss on cash flow hedges at the beginning of the year | |||||
| recognised in the Income statement for the period |
113
|
(208
|
) | ||
| Fair value adjustments on financial instruments |
(181
|
) |
572
|
||
| Tax on fair value adjustments on financial instruments |
4
|
-
|
|||
| Other adjustments |
(14
|
) |
(38
|
) | |
| Tax on other adjustments |
17
|
-
|
|||
|
|
|
|
|
|
|
| Other comprehensive income for the period, net of tax |
110
|
226
|
|||
|
|
|
|
|
|
|
| TOTAL COMPREHENSIVE INCOME FOR THE PERIOD |
2,809
|
2,406
|
*) Excluding costs related to discontinuation of pulmonary diabetes projects
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
16 of 20
|
|
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: Balance sheet
|
DKK
million
|
31
Mar 2009
|
31
Dec 2008
|
|||
|
|
|
|
|
|
|
| ASSETS | |||||
| Intangible assets |
912
|
788
|
|||
| Property, plant and equipment |
18,684
|
18,639
|
|||
| Investments in associated companies |
162
|
222
|
|||
| Deferred income tax assets |
1,572
|
1,696
|
|||
| Other financial assets |
212
|
194
|
|||
| TOTAL LONG-TERM ASSETS |
21,542
|
21,539
|
|||
| Inventories |
9,930
|
9,611
|
|||
| Trade receivables |
6,677
|
6,581
|
|||
| Tax receivables |
948
|
1,010
|
|||
| Other receivables |
1,795
|
1,704
|
|||
| Marketable securities and financial derivatives |
1,264
|
1,377
|
|||
| Cash at bank and in hand |
8,049
|
8,781
|
|||
| TOTAL CURRENT ASSETS |
28,663
|
29,064
|
|||
|
|
|
|
|
|
|
| TOTAL ASSETS |
50,205
|
50,603
|
|||
|
|
|
|
|
|
|
| EQUITY AND LIABILITIES | |||||
| Share capital |
634
|
634
|
|||
| Treasury shares |
(28
|
) |
(26
|
) | |
| Retained earnings |
31,691
|
33,433
|
|||
| Other comprehensive income |
(952
|
) |
(1,062
|
) | |
| TOTAL EQUITY |
31,345
|
32,979
|
|||
| Long-term debt |
1,010
|
980
|
|||
| Deferred income tax liabilities |
2,357
|
2,404
|
|||
| Provision for pensions |
441
|
419
|
|||
| Other provisions |
911
|
863
|
|||
|
|
|
|
|
|
|
| Total long-term liabilities |
4,719
|
4,666
|
|||
| Short-term debt and financial derivatives |
1,451
|
1,334
|
|||
| Trade payables |
1,744
|
2,281
|
|||
| Tax payables |
354
|
567
|
|||
| Other liabilities |
7,556
|
5,853
|
|||
| Other provisions |
3,036
|
2,923
|
|||
|
|
|
|
|
|
|
| Total current liabilities |
14,141
|
12,958
|
|||
| TOTAL LIABILITIES |
18,860
|
17,624
|
|||
|
|
|
|
|
|
|
| TOTAL EQUITY AND LIABILITIES |
50,205
|
50,603
|
|||
|
|
|
|
|
|
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
17 of 20
|
|
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: Cash flow statement
|
DKK
million
|
Q1
2009
|
Q1
2008
|
|||
|
|
|
|
|
|
|
| Net profit |
2,699
|
2,180
|
|||
| Adjustment for non-cash items |
1,482
|
1,435
|
|||
| Income taxes paid and net interest received |
(756
|
) |
(359
|
) | |
|
|
|
|
|
|
|
| Cash flow before change in working capital |
3,425
|
3,256
|
|||
| Net change in working capital |
723
|
(186
|
) | ||
|
|
|
|
|
|
|
| Cash flow from operating activities |
4,148
|
3,070
|
|||
| Net investments in intangible assets and long-term financial assets |
(127
|
) |
(61
|
) | |
| Capital expenditure for property, plant and equipment |
(413
|
) |
(214
|
) | |
| Net change in marketable securities (maturity exceeding three months) |
-
|
4
|
|||
| Received dividend |
18
|
-
|
|||
|
|
|
|
|
|
|
| Net cash used in investing activities |
(522
|
) |
(271
|
) | |
| Cash flow from financing activities |
(4,488
|
) |
(3,371
|
) | |
| NET CASH FLOW |
(862
|
) |
(572
|
) | |
| Unrealised gain/(loss) on exchange rates and marketable securities | |||||
| included in cash and cash equivalents |
10
|
(23
|
) | ||
|
|
|
|
|
|
|
| Net change in cash and cash equivalents |
(852
|
) |
(595
|
) | |
| Cash and cash equivalents at the beginning of the year |
8,726
|
4,617
|
|||
|
|
|
|
|
|
|
| Cash and cash equivalents at the end of the period |
7,874
|
4,022
|
|||
| Bonds with original term to maturity exceeding three months |
1,015
|
1,490
|
|||
| Undrawn committed credit facilities |
7,448
|
7,451
|
|||
|
|
|
|
|
|
|
| FINANCIAL RESOURCES AT THE END OF THE PERIOD |
16,337
|
12,963
|
|||
| Cash flow from operating activities |
4,148
|
3,070
|
|||
| + Net cash used in investing activities |
(522
|
) |
(271
|
) | |
| - Net change in marketable securities (maturity exceeding three months) |
-
|
4
|
|||
| FREE CASH FLOW |
3,626
|
2,795
|
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
18 of 20
|
|
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: Statement of changes in equity
|
Other
reserves
|
|||||||||||||||
|
|
|||||||||||||||
|
DKK
million
|
Share
capital
|
Treasury shares
|
Retained
earnings
|
Exchange
rate adjustments
|
Deferred
gain/loss on cash flow hedges
|
Other
adjustments
|
Total
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Q1 2009 | |||||||||||||||
| Balance at the beginning of the period |
634
|
(26
|
) |
33,433
|
(256
|
) |
(859
|
) |
53
|
32,979
|
|||||
| Total comprehensive income for the period |
2,699
|
163
|
(64
|
) |
11
|
2,809
|
|||||||||
| Dividends |
(3,650
|
) |
(3,650
|
) | |||||||||||
| Share-based payment |
53
|
53
|
|||||||||||||
| Purchase of treasury shares |
(3
|
) |
(907
|
) |
(910
|
) | |||||||||
| Sale of treasury shares |
1
|
63
|
64
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Balance at the end of the period |
634
|
(28
|
) |
31,691
|
(93
|
) |
(923
|
) |
64
|
31,345
|
|||||
| 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
|
|||||||||||||||
|
|
|||||||||||||||
|
DKK
million
|
Share
capital
|
Treasury shares
|
Retained
earnings
|
Exchange
rate adjustments
|
Deferred
gain/loss on cash flow hedges
|
Other
adjustments
|
Total
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Q1 2008 | |||||||||||||||
| Balance at the beginning of the period |
647
|
(26
|
) |
30,661
|
209
|
678
|
13
|
32,182
|
|||||||
| Total comprehensive income for the period |
2,180
|
(109
|
) |
364
|
(29
|
) |
2,406
|
||||||||
| Dividends |
(2,795
|
) |
(2,795
|
) | |||||||||||
| Share-based payment |
34
|
34
|
|||||||||||||
| Purchase of treasury shares |
(2
|
) |
(620
|
) |
(622
|
) | |||||||||
| Sale of treasury shares |
1
|
45
|
46
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Balance at the end of the period |
647
|
(27
|
) |
29,505
|
100
|
1,042
|
(16
|
) |
31,251
|
||||||
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 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
19 of 20
|
|
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: Assumptions for key currencies
| DKK per 100 |
2008
average
|
YTD
2009 average
|
Current
exchange rate
|
||||
|
exchange
rates
|
exchange
rates
|
as
of
|
|||||
|
as
of
|
27
April 2009
|
||||||
|
27
April 2009
|
|||||||
|
|
|
|
|
|
|
|
|
| USD |
509
|
570
|
568
|
||||
|
|
|
|
|
|
|
|
|
| JPY |
4.96
|
6.02
|
5.87
|
||||
|
|
|
|
|
|
|
|
|
| GBP |
938
|
822
|
827
|
||||
|
|
|
|
|
|
|
|
|
| CNY |
73
|
83
|
83
|
||||
|
|
|
|
|
|
|
|
|
| CAD |
479
|
459
|
467
|
||||
|
|
|
|
|
|
|
|
|
| Company Announcement
no 25 / 2009 Interim financial report for the period 1 January 2009 to 31 March 2009 |
Page
20 of 20
|
|
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 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
| Date: MAY 01, 2009 |
NOVO NORDISK A/S Lars Rebien Sørensen, President and Chief Executive Officer |