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
April 28, 2011
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 2011 to 31
March 2011
28 April 2011
Novo Nordisk increased operating profit by 24% in the first quarter of 2011
Organic sales growth of 15% driven by Victoza®, NovoRapid® and Levemir®
| Sales increased by 15% in Danish kroner and by 11% in local currencies. | |
o | Sales of modern insulins increased by 14% (11% in local currencies). | |
o | Victoza® sales of DKK 1,098 million (growth of 191% in local currencies). | |
o | Sales of NovoSeven® increased by 6% (4% in local currencies). | |
o | Sales in North America increased by 16% (14% in local currencies). | |
o | Sales
in Region China increased by 34% (28% in local currencies). |
|
| Gross
margin improved by 0.3 percentage points in local currencies, reflecting
a favourable product mix development, but due to a negative currency effect,
the gross margin declined by 0.2 percentage points to 80.1% compared to
the first quarter of 2010. |
|
| Reported
operating profit increased by 24% to DKK 5,418 million. Measured in local
currencies, operating profit increased by approximately 20%. |
|
| Net
profit increased by 23% to DKK 4,073 million. Earnings per share (diluted)
increased by 26% to DKK 7.06. |
|
| Novo
Nordisk has completed a pre-specified meta-analysis based on the Degludec
phase 3a trial programme. The meta-analysis confirmed that Degludec is
associated with a lower risk of hypoglycaemia compared to insulin glargine,
both on the total number of confirmed hypoglycaemic events, and on the
number of confirmed nocturnal hypoglycaemic events. Both findings are
statistically significant. |
|
| The 2011 outlook remains unchanged: sales growth of 8-10% and operating profit growth of around 15%, both measured in local currencies. |
Lars Rebien Sørensen, president and CEO, says: We are encouraged by the continued double-digit sales growth driven by Victoza® and modern insulins. It strengthens our confidence in the companys long term growth prospects despite the near-term impact on sales growth from healthcare reforms in the US and other major markets, which is reflected in the 2011 outlook.
Company Announcement no 25 / 2011 |
Page
1 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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 |
Consolidated financial
statement for the first quarter of 2011
The present unaudited interim financial report has been prepared
in accordance with IAS 34 Interim Financial Reporting and accounting
policies set out in the Annual
Report 2010 of Novo Nordisk. Furthermore, the interim financial report
and Managements review are prepared in accordance with additional Danish
disclosure requirements for interim reports of listed companies. Novo Nordisk
has adopted all new, amended or revised accounting standards and interpretations
(IFRSs) endorsed by the EU effective for the accounting period
beginning on 1 January 2011. These IFRSs have not had any significant impact
on the Groups interim financial report.
Amounts in DKK million, except average number of shares outstanding, earnings per share and full-time employees.
%
change
|
||||||
Q1
2010
|
||||||
Profit and loss | Q1 2011 | Q1 2010 | to Q1 2011 | |||
Sales | 15,693 | 13,674 | 15% | |||
Gross profit | 12,576 | 10,984 | 14% | |||
Gross margin | 80.1% | 80.3% | ||||
Sales and distribution costs | 4,260 | 3,984 | 7% | |||
Percent of sales | 27.1% | 29.1% | ||||
Research and development costs | 2,290 | 2,131 | 7% | |||
Percent of sales | 14.6% | 15.6% | ||||
Administrative expenses | 756 | 711 | 6% | |||
Percent of sales | 4.8% | 5.2% | ||||
Licence fees and other operating income | 148 | 224 | (34%) | |||
Operating profit | 5,418 | 4,382 | 24% | |||
Operating margin | 34.5% | 32.0% | ||||
Net financials | (128) | (65) | 97% | |||
Profit before income tax | 5,290 | 4,317 | 23% | |||
Net profit | 4,073 | 3,324 | 23% | |||
Net profit margin | 26.0% | 24.3% | ||||
Other key numbers | ||||||
Depreciation, amortisation and impairment losses | 605 | 581 | 4% | |||
Capital expenditure | 549 | 668 | (18%) | |||
Cash flow from operating activities | 5,108 | 4,231 | 21% | |||
Free cash flow | 4,503 | 3,409 | 32% | |||
Total assets | 59,001 | 54,155 | 9% | |||
Equity | 34,768 | 32,916 | 6% | |||
Equity ratio | 58.9% | 60.8% | ||||
Average number of shares outstanding (million) diluted | 576.7 | 593.0 | (3%) | |||
Diluted earnings per share / ADR (in DKK) | 7.06 | 5.61 | 26% | |||
Full-time employees at the end of the period | 30,867 | 29,154 | 6% |
Company Announcement no 25 / 2011 |
Page
2 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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
Sales increased by 15% in Danish kroner and by 11% measured in
local currencies. All regions contributed to growth measured in local currencies;
North America was the main contributor with 45% share of growth measured in
local currencies, followed by International Operations and Region China, contributing
20% and 18%, respectively. Sales growth was realised within both diabetes
care and biopharmaceuticals, with the majority of growth originating from
Victoza® and the modern
insulins. Sales growth in the first quarter of 2011 was lowered by approximately
three percentage points due to healthcare reforms in the US, major European
markets and Turkey.
Sales
Q1 2011 DKK million |
Growth
as reported |
Growth
in local currencies |
Share
of
growth in local currencies |
|||||
The diabetes care segment | ||||||||
Modern insulins | 6,705 | 14% | 11% | 42% | ||||
NovoRapid® | 2,955 | 13% | 10% | 17% | ||||
NovoMix® | 1,975 | 14% | 10% | 11% | ||||
Levemir® | 1,775 | 17% | 14% | 14% | ||||
Human insulins | 2,655 | (4%) | (8%) | (14%) | ||||
Protein-related products | 639 | 27% | 22% | 7% | ||||
Victoza® | 1,098 | 197% | 191% | 45% | ||||
Oral antidiabetic products | 711 | 10% | 9% | 4% | ||||
Diabetes care total | 11,808 | 16% | 13% | 84% | ||||
The biopharmaceuticals segment | ||||||||
NovoSeven® | 2,032 | 6% | 4% | 5% | ||||
Norditropin® | 1,252 | 16% | 11% | 8% | ||||
Other products | 601 | 15% | 11% | 3% | ||||
Biopharmaceuticals total | 3,885 | 10% | 7% | 16% | ||||
Total sales | 15,693 | 15% | 11% | 100% |
In the following sections, market shares are based on moving annual total (MAT) volume data (unless otherwise noted) from February 2011 by the independent third-party data provider IMS Health.
Diabetes care
sales development
Sales of diabetes care products increased by 16% measured in
Danish kroner to DKK 11,808 million and by 13% in local currencies compared
to the first quarter of 2010. Novo Nordisk is the world leader in diabetes
care and now holds a global value market share of 24% compared to 23% in the
first quarter of 2010.
Modern insulins,
human insulins and protein-related products
In the first quarter of 2011, sales of modern insulins, human
insulins and protein-related products increased by 9% in Danish kroner to
DKK 9,999 million and by 6% measured in local currencies compared to the first
quarter of 2010, with North America and Region China having the highest growth
rates. Sales growth for the global insulin franchise in the first quarter
of 2011 was negatively impacted by approximately three percentage points due
to healthcare reforms.
Company Announcement no 25 / 2011 |
Page
3 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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 of modern insulins increased by 14% in Danish kroner to DKK 6,705 million and by 11% in local currencies compared to the first quarter of 2010, reflecting steady organic sales growth. North America accounted for more than half of the growth, followed by International Operations and Region China. Sales of modern insulin now constitute close to 72% of Novo Nordisks sales of insulin. The decline in human insulin sales reflects a continued conversion of the insulin market from human insulin to modern insulin.
Insulin market shares | Novo Nordisks share of | Novo Nordisks share of | ||||||
(volume, MAT) |
total
insulin market
|
modern
insulin
|
||||||
Geography | Feb 2011 | Feb 2010 | Feb 2011 | Feb 2010 | ||||
Global | 51% | 51% | 46% | 46% | ||||
USA | 42% | 42% | 37% | 35% | ||||
Europe | 53% | 54% | 50% | 51% | ||||
International Operations | 59% | 58% | 56% | 56% | ||||
Japan | 62% | 66% | 56% | 58% | ||||
China | 63% | 62% | 69% | 70% | ||||
Source: IMS, February data |
North America
Sales of modern insulins, human insulins and protein-related
products in North America increased by 10% in Danish kroner and by 8% in local
currencies in the first quarter of 2011, reflecting a continued solid sales
performance of especially Levemir®
and NovoLog® offset
by a decline in human insulin sales and the impact of the healthcare reform
adopted in March 2010. Currently, around 43% of Novo Nordisks modern
insulin volume in the US is being sold in the prefilled device FlexPen®.
Europe
Sales in Europe decreased by 1% measured in Danish kroner and
by 3% in local currencies in the first quarter of 2011. Sales are negatively
impacted by health care reforms that were implemented during 2010, especially
in Germany and Spain. The penetration of the modern insulin portfolio continues,
and consequently human insulin sales are declining. Currently,
around 96% of Novo Nordisks insulin volume in Europe is being sold in
devices.
International
Operations
Sales in International Operations increased by 14% in Danish
kroner and by 11% in local currencies in the first quarter of 2011. The main
contributor to growth was sales of modern insulin, primarily in Russia, Argentina
and Australia. In the first quarter of 2010, the sales to Russia were negatively
impacted by a delay in renewing Novo Nordisks import license. Currently,
around 88% of Novo Nordisks modern insulin volume in International Operations
is being sold in the prefilled device FlexPen®.
Region China
Sales in Region China increased by 26% in Danish kroner and by
20% in local currencies in the first quarter of 2011. The main contributor
to growth was sales of modern insulin especially NovoMix®
- while sales of human insulin continue to add to overall growth in the region.
Currently, around 96% of Novo Nordisks insulin volume in China is being
sold in devices.
Japan & Korea
Sales in Japan & Korea increased by 20% measured in Danish
kroner and by 7% in local currencies in the first quarter of 2011. The sales
development reflects sales growth for all three modern insulins, Levemir®,
NovoRapid® and NovoRapid
Mix® 30, being offset
by a decline in human insulin sales. The device penetration in Japan remains
high with approximately 98% of Novo Nordisks insulin volume being used
in devices, primarily
Company Announcement no 25 / 2011 |
Page
4 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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 |
NovoPen® and FlexPen®. Following the earthquake on 11 March 2011 in Japan, focus has been on ensuring access to Novo Nordisk products for patients in the affected areas and ensuring uninterrupted product supplies. Operations in Japan, including production at the Koriyama factory, resumed to normal within a few weeks. Additional stocking of Novo Nordisk diabetes products has taken place in March throughout the supply chain adding to Novo Nordisk sales growth in Japan in the first quarter of 2011.
Victoza®
(GLP-1 therapy for type 2 diabetes)
Victoza®
sales reached DKK 1,098 million during the first quarter of 2011 reflecting
solid market performance in both Europe and the US. Victoza®
has now reached a global value market share of 39% in the GLP-1 segment (source:
IMS, February MAT value data). As announced on 15 March 2011, Novo Nordisk
has received approval of Victoza®
for the treatment of type 2 diabetes by the State Food and Drug Administration
in China and expects to launch the product in China in the second half of
2011.
NovoNorm®/Prandin®/PrandiMet®
(oral antidiabetic products)
In the first quarter of 2011, sales of oral antidiabetic products
increased by 10% in Danish kroner to DKK 711 million and by 9% measured in
local currencies compared to the first quarter of 2010. The sales development
primarily reflects continued sales growth in China being offset by lower sales
in Europe due to generic competition in several European markets.
Biopharmaceuticals
sales development
In the first quarter of 2011, sales of biopharmaceutical products
increased by 10% measured in Danish kroner to DKK 3,885 million and by 7%
measured in local currencies compared to the first quarter of 2010.
NovoSeven®
(bleeding disorders therapy)
Sales of NovoSeven®
increased by 6% in Danish kroner to DKK 2,032 million and by 4% in local currencies
compared to the first quarter of 2010. Sales growth for NovoSeven®
was primarily driven by International Operations, but also Japan & Korea,
Europe and Region China contributed to the growth. Sales in North America
were unchanged compared to the first quarter of 2010, primarily due to negative
impact from patients transferring to an alternative treatment regimen of immune
tolerance therapy.
Norditropin®
(growth hormone therapy)
Sales of Norditropin®
increased by 16% measured in Danish kroner to DKK 1,252 million and by 11%
measured in local currencies compared to the first quarter of 2010. The sales
growth is driven by International Operations, partly due to tenders being
realised earlier in the year compared to 2010, and by Japan & Korea and
North America. Novo Nordisk is the second-largest company in the global growth
hormone market with a 24% market share measured in volume.
Other products
Sales of other products within biopharmaceuticals, which predominantly
consist of hormone replacement therapy (HRT)-related products, increased by
15% in Danish kroner to DKK 601 million and by 11% measured in local currencies.
This development primarily reflects continued sales progress for Vagifem®
being offset by the impact from generic competition to Activella®
in the US.
Company Announcement no 25 / 2011 |
Page
5 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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 in
costs
The cost of goods sold grew 16% to DKK 3,117 million in the first
quarter of 2011, and thereby providing a gross margin of 80.1% compared to
80.3% in the first quarter of 2010. This primarily reflects a favourable product mix
impact due to increased sales of modern insulins and Victoza®, and
a negative currency impact of 0.5 percentage points. The negative currency
effect arises from first quarter 2011 sales of finished goods in Novo Nordisk
affiliates inventories at the end of 2010. The cost of goods related
to these inventories reflects the higher level of exchange rates prevailing
per 31 December 2010.
In the first quarter of 2011, total non-production-related costs increased by 7% to DKK 7,306 million and by 5% in local currencies compared to the first quarter of 2010.
Sales and distribution costs increased by 7% to DKK 4,260 million, primarily reflecting the promotion costs for Victoza® in Europe and the US, as well as a the expanded field sales forces primarily in China and the US. Novo Nordisk currently expects to increase the Chinese field sales force by approximately 300 additional FTEs during 2011.
Research and development costs increased by 7% to DKK 2,290 million in the first quarter of 2011, primarily reflecting expanding activities in China and early-stage Biopharmaceuticals development activities countered by a lower development activity level for Degludec and DegludecPlus, compared to the first quarter of 2010.
Licence fees and other operating income constituted DKK 148 million in the first quarter of 2011 compared to DKK 224 million in the first quarter of 2010. This development is primarily due to a non-recurring income of approximately DKK 100 million related to a patent settlement during the first quarter of 2010.
Net financials
Net financials showed a net expense of DKK 128 million in the
first quarter of 2011 compared to a net expense of DKK 65 million in the first
quarter of 2010.
For the first quarter of 2011, the foreign exchange result was an expense of DKK 104 million compared to an expense of DKK 137 million in the first quarter of 2010. The foreign exchange result in the first quarter of 2011 reflects losses on foreign exchange hedging contracts, primarily on US dollars, entered into during the fourth quarter of 2009. Foreign exchange hedging gains of around DKK 700 million have been deferred for future income recognition in 2011 and 2012.
In the first quarter of 2010, the result from associated companies was included in net financials with an income of DKK 65 million. After the divestment of shares in ZymoGenetics Inc. and transfer of Innate Pharma S.A. to Other non-current financial assets in the fourth quarter of 2010, the result from investments in associated companies has declined to DKK 0.
Company Announcement no 25 / 2011 |
Page
6 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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 |
Outlook 2011
The current expectations for 2011 are summarised in the table
below:
Expectations are as reported, if not | Current expectations | Previous expectations | ||
otherwise stated | 28 April 2011 | 2 February 2011 | ||
|
|
|
|
|
Sales growth | ||||
- in local currencies |
810%
|
810%
|
||
- as reported | Around 4 percentage points |
Around
1.5 percentage points
|
||
lower |
lower
|
|||
|
|
|
|
|
Operating profit growth |
Around
15%
|
Around
15%
|
||
- in local currencies |
Around
7.5 percentage points
|
Around
2.5 percentage points
|
||
- as reported |
lower
|
lower
|
||
|
|
|
|
|
Income of around DKK 500 |
Expense
of around DKK 100
|
|||
Net financials |
million
|
million
|
||
|
|
|
|
|
Effective tax rate | Around 23% |
Around
23%
|
||
|
|
|
|
|
Capital expenditure | Around DKK 3.5 billion |
Around
DKK 3.5 billion
|
||
|
|
|
|
|
Depreciation, amortisation and | ||||
impairment losses | Around DKK 2.7 billion |
Around
DKK 2.7 billion
|
||
|
|
|
|
|
Free cash flow | More than DKK 16 billion |
More
than DKK 16 billion
|
||
|
|
|
|
Novo Nordisk still expects sales growth in 2011 of 8-10% measured in local currencies. This is based on expectations of continued market penetration for Novo Nordisks key products, as well as expectations of continued intense competition, generic competition to oral antidiabetic products, and an impact from the implementation of healthcare reforms primarily in the US and Europe. Given the current level of exchange rates versus Danish kroner, the reported sales growth is now expected to be around 4 percentage points lower than growth measured in local currencies.
For 2011, growth in operating profit is still expected to be around 15% measured in local currencies. Given the current level of exchange rates versus Danish kroner, the reported operating profit growth is now expected to be 7.5 percentage points lower than growth measured in local currencies.
For 2011, Novo Nordisk now expects a net financial income of around DKK 500 million. The current expectation reflects currency hedging contract gains, primarily related to the US dollar.
The effective tax rate for 2011 is still expected to be around 23%.
Capital expenditure is still expected to be around DKK 3.5 billion in 2011, primarily related to investments in the new insulin formulation and filling plant in China and a new prefilled device production facility in Denmark. Expectations for depreciation, amortisation and impairment losses are still around DKK 2.7 billion and free cash flow is still expected to be more than DKK 16 billion.
All of the above expectations are based on the assumption that the global economic environment will not significantly change business conditions for Novo Nordisk during the remainder of 2011 and that exchange rates, especially the US dollar, will remain at the current level versus the Danish krone during the remainder of 2011. Please refer to appendix 7 for key currency assumptions.
Company Announcement no 25 / 2011 |
Page
7 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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 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
currencies |
Annual
impact on Novo Nordisks operating profit of a 5% movement in currency |
Hedging
period (months) |
|
USD
|
DKK
620 million
|
15
|
|
JPY
|
DKK
155 million
|
15
|
|
CNY
|
DKK
120 million
|
12*
|
|
GBP
|
DKK
85 million
|
10
|
* USD used as proxy when hedging Novo Nordisks CNY currency exposure
The financial impact from foreign exchange hedging is included in Net financials.
Company Announcement no 25 / 2011 |
Page
8 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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:
Insulin and GLP-1
Degludec meta-analysis of hypoglycaemia
Novo Nordisk has completed a pre-specified meta-analysis, investigating
the risk of hypoglycaemia observed in the large patient population studied
in the Degludec phase 3a trial programme. The meta-analysis confirmed the
findings from the individual studies: Degludec administered once daily is
superior to insulin glargine administered once daily in terms of both a lower
rate of overall confirmed hypoglycaemic events and a lower rate of nocturnal
confirmed hypoglycaemic events both findings in the meta-analysis being
statistically significant. A review of the meta-analysis will be provided
in connection with Novo Nordisks capital markets day on 5 May 2011 in
Copenhagen. All sessions of the capital markets day will be webcast live and
a replay will be available on novonordisk.com/investors.
Levemir®
as add-on to Victoza®
phase 3b 12-month data
Novo Nordisk has reviewed
12-month data from a phase 3b study with 988 people with type 2 diabetes.
The study investigated the effect of adding Levemir®
to the patients current treatment with metformin and Victoza®.
The primary endpoints of the study were reached:
| There was a statistically significant improvement in glycaemic control in the Levemir® plus metformin plus Victoza® treatment group compared to the group receiving only metformin plus Victoza®. |
| The initial mean body weight loss of ~3-4 kg, achieved during the 12 week run-in period with Victoza®, was sustained in all treatment groups. |
| No events of major hypoglycaemia and a very low rate of hypoglycaemia (~0.23 events/patient year) were observed in the group receiving Levemir® plus metformin plus Victoza®. |
The study furthermore demonstrated that the profile of Victoza® plus Levemir® co-administered is safe, generally well tolerated and clinically efficacious. Six-month data from the study were communicated on 5 August 2010 and all trial data are intended for label update purposes.
Oral insulin update,
NN1952 and NN1953
Novo Nordisk has completed a phase 1 study with a rapid-acting
insulin analogue, NN1952, designed for oral administration. Due to significant
influence of food-intake on the predictability of the rapid-acting insulin
analogue in current formulation, Novo Nordisk has decided to focus activities
within insulin for oral administration on long-acting insulin. In April 2011
Novo Nordisk progressed a long-acting insulin for oral administration, NN1953,
into phase 1 clinical testing.
Biopharmaceuticals:
Haemostasis
Recombinant FXIII, NN1841, BLA submission in the US for FXIII
congenital deficiency
As communicated on 23 February 2011, Novo Nordisk has submitted
an application for marketing authorisation in the US for NN1841, the first
recombinant factor XIII compound, for patients with congenital factor XIII
deficiency a very rare inherited bleeding disorder. Furthermore, Novo
Nordisk expects to file for marketing authorisation in Europe in the second
quarter of 2011.
Company Announcement no 25 / 2011 |
Page
9 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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 |
Phase II results
for GlycoPegylated rFVIIa, NN7128
The safety and efficacy of GlycoPegylated rFVIIa was tested for
prophylactic effect in a clinical phase 2 trial including 24 haemophilia patients
with inhibitors. Patients were randomised to three dose levels and treated
for three months following a three months observation period. No safety concerns
or immunogenicity were observed. The pharmacokinetic properties of GlycoPegylated
rFVIIa were similar to those observed during phase 1.
In all three dose groups a significant reduction in annualised bleeding rate was observed compared to the observation period. However, a clear dose-response relationship could not be established and further data analyses are planned.
Phase II results
for recombinant FXIII in cardiac surgery, NN1810
The safety and efficacy of recombinant FXIII in avoidance of
transfusion during cardiac surgery was tested in a phase 2 clinical trial
including 409 patients. The results show that for the selected group of patients
there was no effect on transfusion avoidance in any of the dose arms compared
to placebo and no effect on other efficacy endpoints. The trial did not give
rise to any safety concerns. Based on these results, no further investigations
of recombinant FXIII in cardiac surgery will be pursued; however, other indications
currently in nonclinical development are being investigated.
Biopharmaceuticals:
Inflammation
Anti-IL-20, NN8226, for rheumatoid arthritis progresses to
phase 2a
Novo Nordisk has completed a phase 1 rheumatoid arthritis study
for anti-IL-20, a recombinant fully human monoclonal antibody. Anti-IL-20
appeared to have a safe and well- tolerated profile, and no anti-drug antibodies
were observed. Based on the findings, a phase 2a trial in rheumatoid arthritis
has been initiated.
Anti-NKG2D, NN8555,
for Crohns Disease progresses to phase 2a
Novo Nordisk has initiated a phase 2a clinical trial with a recombinant
fully human monoclonal antibody, Anti-NKG2D, in Crohns Disease.
Sustainability
update
The total number of full-time employees was 30,867 as of 31 March
2011 compared to 29,154 as of 31 March 2010. New hiring was led by expansion
in China, the US and countries in the International Operations region.
During the first quarter of 2011, Novo Nordisk introduced a shortened and simplified version of the Novo Nordisk Way, presenting the companys ambitions and values. As Novo Nordisk adds several thousand employees each year, emphasis is on ensuring that the company values are understood and lived by the employees.
Equity
Total equity was DKK 34,768 million at the end of the first quarter
of 2011, equivalent to 58.9% of total assets, compared to 60.8% at the end
of the first quarter of 2010. Please refer to appendix 5 for further elaboration
of changes in equity during the first quarter of 2011.
Reduction of share
capital
The Annual General Meeting of Novo Nordisk A/S, which was held
on 23 March 2011, approved a 3.3% reduction in the total share capital by
cancellation of 20,000,000 treasury B shares of DKK 1 at a nominal value of
DKK 20,000,000. After the legal implementation of the share capital reduction,
which is expected to take place in the beginning of May 2011 after expiry
of
Company Announcement no 25 / 2011 |
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|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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Internet:
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CVR
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the legal notice period, Novo Nordisks share capital will amount to DKK 580,000,000 divided into an A share capital of DKK 107,487,200 and a B share capital of DKK 472,512,800.
Treasury shares
and 2011 share repurchase programme
On 2 February 2011, Novo Nordisk announced a DKK 2 billion share
repurchase programme as part of an overall DKK 10 billion share repurchase
programme for 2011. The purpose of the programme is a reduction of the companys
share capital. Under the programme Novo Nordisk repurchased B shares for an
amount of DKK 2.0 billion in the period from 2 February 2011 to 26 April 2011.
The programme was concluded on 26 April 2011.
As per 26 April 2011, Novo Nordisk A/S and its wholly-owned affiliates owned 30,310,347 of its own B shares, corresponding to 5.1% of the total share capital.
As part of the execution of Novo Nordisk A/S overall DKK 10 billion share repurchase programme for 2011, a new share repurchase programme has now been initiated in accordance with the provisions of the European Commissions regulation no 2273/2003 of 22 December 2003 (The Safe Harbour Regulation). According to this, J.P. Morgan Securities Ltd. as lead manager will repurchase shares on behalf of Novo Nordisk for an amount of up to DKK 2 billion during the trading period from 28 April 2011 to 2 August 2011. A maximum of 152,011 shares can be bought during one single trading day, equal to 20% of the average daily trading volume of Novo Nordisk B shares on NASDAQ OMX Copenhagen during the month of March 2011, and a maximum of 10,032,726 shares in total can be bought during the trading period. At least once every seven trading days, Novo Nordisk will issue an announcement in respect of the transactions made under the repurchase programme.
Legal update
As of 26 April 2011, Novo Nordisk Inc., along with a majority
of the 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 50 individuals
who allege use of a Novo Nordisk hormone therapy product. The 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.). Furthermore, 72 individuals currently allege, in relation
to similar lawsuits against Pfizer Inc., that they have also used a Novo Nordisk
hormone therapy product. Currently, Novo Nordisk does not have any trials
scheduled in 2011. Novo Nordisk does not expect the pending claims to have
a material impact on Novo Nordisk's financial position.
As previously announced, Novo Nordisk is involved in an ongoing patent infringement dispute with Caraco Pharmaceutical Laboratories, Ltd. (Caraco) regarding Caracos application to market a generic version of Prandin® (repaglinide) in the US and the use of repaglinide in combination with metformin. In January 2011, a US District Court ruled that Novo Nordisks US Patent No. 6,677,358, which covers the combination use of repaglinide and metformin for the treatment of type 2 diabetes, was invalid and unenforceable. Novo Nordisk appealed that ruling on 26 January 2011, which is now pending before the Federal Circuit Court of Appeals (CAFC). Furthermore, Caraco has petitioned the Supreme Court for a writ of certiorari after the CAFC allowed Novo Nordisk to retain its current Use Code and then denied Caracos request for a rehearing. If Novo Nordisks current Use Code stands and its patent is held valid and enforceable on appeal, Caraco would be required by the FDA to amend its label to include the repaglinide-metformin combination. Caraco has conceded infringement if the combined use is included in its label pursuant to a stipulation between the parties. On 28 March 2011, the Supreme Court requested the US Solicitor General to provide the view of the United States on
Company Announcement no 25 / 2011 |
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Interim financial report for the period 1 January 2011 to 31 March 2011 |
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Telephone:
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Internet:
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CVR
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the Use Code issue. The Supreme Court will then decide on whether it will review the CAFC Use Code decision by the end of June 2011.
As announced in February 2011, Novo Nordisk was served with a criminal subpoena by the US Attorney in Massachusetts requesting a broad range of documents relating to marketing and promotion practices for NovoLog®, Levemir® and Victoza®. The matter has now been reassigned to the US Attorney in Washington DC and Novo Nordisk is cooperating with the US Attorney in this investigation. Novo Nordisk cannot predict the outcome of this investigation or when the company will be able to provide additional information given the unpredictable nature of these investigations.
Company Announcement no 25 / 2011 |
Page
12 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
Novo
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Investor Relations |
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Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Financial calendar | |
5 May 2011 | Capital Markets Day in Copenhagen, Denmark |
4 August 2011 | Financial statement for the first six months of 2011 |
27 October 2011 | Financial statement for the first nine months of 2011 |
2 February 2012 | Financial statement for 2011 |
Conference call
details
On 28 April 2011 at 13.00 CET, 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.
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 2010
and Form 20-F, both filed with the SEC in February 2011, 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 cooperation 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 regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and |
- | statements regarding the assumptions underlying or relating to such statements. |
In this document, examples of forward-looking statements can be found under the headings Outlook 2011, Research and development update, Equity and Legal 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, 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
Company Announcement no 25 / 2011 |
Page
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Interim financial report for the period 1 January 2011 to 31 March 2011 |
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Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
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 Risk Management on pp 43-45 of the Annual Report 2010 available as of 4 February 2011 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 25 / 2011 |
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Interim financial report for the period 1 January 2011 to 31 March 2011 |
Novo
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Telephone:
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Internet:
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CVR
number:
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Management statement
The Board of Directors and Executive Management have reviewed and approved the interim financial report of Novo Nordisk A/S for the first quarter of 2011. The interim financial report has not been audited or reviewed by the companys independent auditors.
The interim financial report has been prepared in accordance with IAS 34 Interim Financial Reporting and accounting policies set out in the Annual Report 2010 of Novo Nordisk. Furthermore, the interim financial report and Managements Review are prepared in accordance with additional Danish disclosure requirements for interim reports of listed companies.
In our opinion, the accounting policies used are appropriate and the overall presentation of the interim financial report is adequate. Furthermore, in our opinion, Management's Review includes a true and fair account of the development in the operations and financial circumstances, of the results for the period and of the financial position of the Group as well as a description of the most significant risks and elements of uncertainty facing the Group in accordance with Danish disclosure requirements for listed companies.
Bagsværd, 28 April 2011
Executive Management: | ||
Lars
Rebien Sørensen
|
Jesper
Brandgaard
|
|
President and CEO | CFO | |
Lise Kingo | Kåre Schultz | Mads Krogsgaard Thomsen |
COS | COO | CSO |
Board of Directors: | ||
Sten
Scheibye
|
Göran
A Ando
|
Bruno
Angelici
|
Chairman | Vice chairman | |
Henrik Gürtler | Ulrik Hjulmand-Lassen | Thomas Paul Koestler |
Anne Marie Kverneland | Kurt Anker Nielsen | Søren Thuesen Pedersen |
Hannu Ryöppönen | Stig Strøbæk | Jørgen Wedel |
Company Announcement no 25 / 2011 |
Page
15 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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 | Klaus Bülow Davidsen |
Tel: (+45) 4442 3573 | Tel: (+45) 4442 3176 |
mike@novonordisk.com | klda@novonordisk.com |
Jannick Lindegaard | |
Tel: (+45) 4442 4765 | |
jlis@novonordisk.com | |
Frank Daniel Mersebach | |
Tel: (+45) 4442 0604 | |
fdni@novonordisk.com | |
In North America | In North America |
Ken Inchausti | Hans Rommer |
Tel: (+1) 609 786 8316 | Tel: (+1) 609 216 4834 |
kiau@novonordisk.com | hrmm@novonordisk.com |
Further information about Novo Nordisk is available on the companys website novonordisk.com
Company Announcement no 25 / 2011 |
Page
16 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
Novo
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Investor Relations |
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Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
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Appendix 1: Quarterly numbers in DKK
(Amounts in DKK million, except number of employees, earnings per share and number of shares outstanding).
%
change
|
||||||||||||
2011
|
2010
|
Q1 2011 vs | ||||||||||
Q1
|
Q4
|
Q3
|
Q2
|
Q1 | Q1 2010 | |||||||
|
|
|
|
|
|
|
|
|
||||
Sales | 15,693 | 16,124 | 15,584 | 15,394 | 13,674 | 15% | ||||||
Gross profit | 12,576 | 13,039 | 12,648 | 12,425 | 10,984 | 14% | ||||||
Gross margin | 80.1% | 80.9% | 81.2% | 80.7% | 80.3% | |||||||
Sales and distribution costs | 4,260 | 5,274 | 4,573 | 4,364 | 3,984 | 7% | ||||||
Percent of sales | 27.1% | 32.7% | 29.3% | 28.3% | 29.1% | |||||||
Research and development costs | 2,290 | 2,735 | 2,302 | 2,434 | 2,131 | 7% | ||||||
Percent of sales | 14.6% | 17.0% | 14.8% | 15.8% | 15.6% | |||||||
Administrative expenses | 756 | 850 | 759 | 745 | 711 | 6% | ||||||
Percent of sales | 4.8% | 5.3% | 4.9% | 4.8% | 5.2% | |||||||
Licence fees and other operating income (net) | 148 | 164 | 110 | 159 | 224 | (34%) | ||||||
Operating profit | 5,418 | 4,344 | 5,124 | 5,041 | 4,382 | 24% | ||||||
Operating margin | 34.5% | 26.9% | 32.9% | 32.7% | 32.0% | |||||||
Share of profit/(loss) in associated companies | 0 | 1,031 | (22) | (4) | 65 | (100%) | ||||||
Financial income | 84 | 140 | 31 | 146 | 65 | 29% | ||||||
Financial expenses | 212 | 810 | 477 | 575 | 195 | 9% | ||||||
Profit before income taxes | 5,290 | 4,705 | 4,656 | 4,608 | 4,317 | 23% | ||||||
Net profit | 4,073 | 3,946 | 3,585 | 3,548 | 3,324 | 23% | ||||||
Depreciation, amortisation and impairment losses | 605 | 684 | 607 | 595 | 581 | 4% | ||||||
Capital expenditure | 549 | 1,141 | 755 | 744 | 668 | (18%) | ||||||
Cash flow from operating activities | 5,108 | 4,905 | 6,318 | 4,225 | 4,231 | 21% | ||||||
Free cash flow | 4,503 | 4,707 | 5,453 | 3,444 | 3,409 | 32% | ||||||
Total assets | 59,001 | 61,402 | 57,162 | 57,048 | 54,155 | 9% | ||||||
Total equity | 34,768 | 36,965 | 34,264 | 33,635 | 32,916 | 6% | ||||||
Equity ratio | 58.9% | 60.2% | 59.9% | 59.0% | 60.8% | |||||||
Full-time employees at the end of the period | 30,867 | 30,014 | 29,515 | 29,364 | 29,154 | 6% | ||||||
Basic earnings per share (in DKK) | 7.13 | 6.87 | 6.21 | 6.07 | 5.66 | 26% | ||||||
Diluted earnings per share (in DKK) | 7.06 | 6.82 | 6.15 | 6.02 | 5.61 | 26% | ||||||
Average number of shares outstanding (million) | 571.6 | 572.7 | 577.6 | 584.0 | 587.6 | (3%) | ||||||
Average number of shares outstanding incl | ||||||||||||
dilutive effect of options 'in the money' (million) | 576.7 | 577.5 | 582.3 | 588.9 | 593.0 | (3%) | ||||||
Sales by business segments: | ||||||||||||
Modern insulins (insulin analogues) | 6,705 | 7,127 | 6,820 | 6,792 | 5,862 | 14% | ||||||
Human insulins | 2,655 | 2,992 | 2,963 | 3,099 | 2,773 | (4%) | ||||||
Victoza® | 1,098 | 951 | 700 | 296 | 370 | 197% | ||||||
Protein-related products | 639 | 561 | 567 | 583 | 503 | 27% | ||||||
Oral antidiabetic products (OAD) | 711 | 666 | 736 | 704 | 645 | 10% | ||||||
Diabetes care total | 11,808 | 12,297 | 11,786 | 11,474 | 10,153 | 16% | ||||||
NovoSeven® | 2,032 | 1,996 | 1,965 | 2,155 | 1,914 | 6% | ||||||
Norditropin® | 1,252 | 1,242 | 1,233 | 1,245 | 1,083 | 16% | ||||||
Hormone replacement therapy | 492 | 482 | 517 | 450 | 443 | 11% | ||||||
Other products | 109 | 107 | 83 | 70 | 81 | 35% | ||||||
Biopharmaceuticals total | 3,885 | 3,827 | 3,798 | 3,920 | 3,521 | 10% | ||||||
Sales by geographic regions: | ||||||||||||
North America | 6,035 | 6,286 | 6,114 | 5,988 | 5,221 | 16% | ||||||
Europe | 4,595 | 4,886 | 4,675 | 4,671 | 4,432 | 4% | ||||||
International Operations | 2,203 | 2,160 | 2,127 | 2,213 | 1,835 | 20% | ||||||
China | 1,376 | 1,181 | 1,214 | 1,083 | 1,030 | 34% | ||||||
Japan & Korea | 1,484 | 1,611 | 1,454 | 1,439 | 1,156 | 28% | ||||||
Segment operating profit: | ||||||||||||
Diabetes care | 3,115 | 3,096 | 3,419 | 3,033 | 2,554 | 22% | ||||||
Biopharmaceuticals | 2,303 | 1,248 | 1,705 | 2,008 | 1,828 | 26% |
Company Announcement no 25 / 2011 |
Page
17 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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 and Statement of comprehensive income
Q1
|
Q1
|
|||
DKK million | 2011 | 2010 | ||
|
|
|
||
Income statement | ||||
Sales | 15,693 | 13,674 | ||
Cost of goods sold | 3,117 | 2,690 | ||
|
|
|
||
Gross profit | 12,576 | 10,984 | ||
Sales and distribution costs | 4,260 | 3,984 | ||
Research and development costs | 2,290 | 2,131 | ||
Administrative expenses | 756 | 711 | ||
Licence fees and other operating income, net | 148 | 224 | ||
|
|
|
||
Operating profit | 5,418 | 4,382 | ||
Share of profit/(loss) of associated companies, net of tax | - | 65 | ||
Financial income | 84 | 65 | ||
Financial expenses | 212 | 195 | ||
|
|
|
||
Profit before income taxes | 5,290 | 4,317 | ||
Income taxes | 1,217 | 993 | ||
|
|
|
||
NET PROFIT | 4,073 | 3,324 | ||
Basic earnings per share (DKK) | 7.13 | 5.66 | ||
Diluted earnings per share (DKK) | 7.06 | 5.61 | ||
Segment Information | ||||
Segment sales: | ||||
Diabetes care | 11,808 | 10,153 | ||
Biopharmaceuticals | 3,885 | 3,521 | ||
Segment operating profit: | ||||
Diabetes care | 3,115 | 2,554 | ||
Operating margin | 26.4% | 25.2% | ||
Biopharmaceuticals | 2,303 | 1,828 | ||
Operating margin | 59.3% | 51.9% | ||
Total segment operating profit | 5,418 | 4,382 | ||
Statement of comprehensive income | ||||
Net profit for the period | 4,073 | 3,324 | ||
Other comprehensive income: | ||||
Deferred gains/(losses) on cash flow hedges arising during the period | 1,002 | (847) | ||
Transfer of deferred gains/(losses) from previous year of cash flow | ||||
hedges recognised in the Income statement as part of financial | ||||
income/(expenses) | 352 | (247) | ||
Exchange rate adjustment of investments in subsidiaries | (235) | 136 | ||
Share of other comprehensive income of associated comp., net of tax | - | 2 | ||
Gains/(losses) on available-for-sale financial assets (equity investments) | 5 | 5 | ||
Other | (65) | 21 | ||
Tax on other comprehensive income, income/(expense) | (416) | 271 | ||
|
|
|
||
Other comprehensive income for the period, net of tax | 643 | (659) | ||
|
|
|
||
TOTAL COMPREHENSIVE INCOME FOR THE PERIOD | 4,716 | 2,665 |
Company Announcement no 25 / 2011 |
Page
18 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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: Balance sheet
DKK
million
|
31
Mar 2011
|
31
Dec 2010
|
||
|
|
|
||
ASSETS | ||||
Intangible assets | 1,484 | 1,458 | ||
Property, plant and equipment | 20,217 | 20,507 | ||
Investments in associated companies | 43 | 43 | ||
Deferred income tax assets | 1,532 | 1,847 | ||
Other non-current financial assets | 258 | 254 | ||
|
|
|
||
TOTAL NON-CURRENT ASSETS | 23,534 | 24,109 | ||
Inventories | 8,959 | 9,689 | ||
Trade receivables | 9,128 | 8,500 | ||
Tax receivables | 557 | 650 | ||
Other current assets | 2,222 | 2,403 | ||
Marketable securities and financial derivatives | 4,304 | 4,034 | ||
Cash at bank and in hand | 10,297 | 12,017 | ||
|
|
|
||
TOTAL CURRENT ASSETS | 35,467 | 37,293 | ||
|
|
|
||
TOTAL ASSETS | 59,001 | 61,402 | ||
|
|
|
||
EQUITY AND LIABILITIES | ||||
Share capital | 600 | 600 | ||
Treasury shares | (29) | (28) | ||
Retained earnings | 33,258 | 36,097 | ||
Other reserves | 939 | 296 | ||
|
|
|
||
TOTAL EQUITY | 34,768 | 36,965 | ||
Non-current debt | 504 | 504 | ||
Deferred income tax liabilities | 2,981 | 2,865 | ||
Retirement benefit obligations | 562 | 569 | ||
Provisions for other liabilities | 1,933 | 2,023 | ||
|
|
|
||
Total non-current liabilities | 5,980 | 5,961 | ||
Current debt and financial instruments | 1,008 | 1,720 | ||
Trade payables | 2,822 | 2,906 | ||
Tax payables | 1,498 | 1,252 | ||
Other current liabilities | 7,810 | 7,954 | ||
Provisions for other liabilities | 5,115 | 4,644 | ||
|
|
|
||
Total current liabilities | 18,253 | 18,476 | ||
TOTAL LIABILITIES | 24,233 | 24,437 | ||
|
|
|
||
TOTAL EQUITY AND LIABILITIES | 59,001 | 61,402 | ||
|
|
|
||
Company Announcement no 25 / 2011 |
Page
19 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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
|
Q1
2011
|
Q1
2010
|
||
|
|
|
|
|
Net profit | 4,073 | 3,324 | ||
Adjustment for non-cash items: | ||||
Income taxes | 1,217 | 993 | ||
Depreciation, amortisation and impairment losses | 605 | 581 | ||
Interest income and interest expenses | (29) | (7) | ||
Other adjustment | 131 | 680 | ||
Income taxes paid | (956) | (806) | ||
Interest received | 79 | 108 | ||
Interest paid | (6) | (5) | ||
|
|
|
|
|
Cash flow before change in working capital | 5,114 | 4,868 | ||
(Increase)/decrease in trade receivables and other current assets | (447) | (1,187) | ||
(Increase)/decrease in inventories | 730 | (257) | ||
Increase/(decrease) in trade payables and other current liabilities | (228) | 798 | ||
Exchange rate adjustment | (61) | 9 | ||
|
|
|
|
|
Cash flow from operating activities | 5,108 | 4,231 | ||
Purchase of intangible assets and non-current financial assets | (56) | (154) | ||
Proceeds from sale of property, plant and equipment | 3 | 2 | ||
Purchase of property, plant and equipment | (552) | (670) | ||
Net change in marketable securities | 500 | 500 | ||
Dividend received | - | - | ||
|
|
|
|
|
Cash flow from investing activities | (105) | (322) | ||
Repayment of non-current debt | - | - | ||
Purchase of treasury shares | (1,335) | (1,392) | ||
Proceeds from sale of treasury shares | 47 | 252 | ||
Dividends paid to the Company´s owners | (5,700) | (4,400) | ||
|
|
|
|
|
Cash flow from financing activities | (6,988) | (5,540) | ||
NET CASH FLOW | (1,985) | (1,631) | ||
Unrealised gain/(loss) on exchange rates and marketable securities included in cash and cash equivalents | (67) | (80) | ||
|
|
|
|
|
Net change in cash and cash equivalents | (2,052) | (1,711) | ||
Cash and cash equivalents at the beginning of the period | 11,960 | 11,034 | ||
|
|
|
|
|
Cash and cash equivalents at the end of the period | 9,908 | 9,323 | ||
Additional information: | ||||
Cash and cash equivalents at the end of the period | 9,908 | 9,323 | ||
Marketable securities | 3,451 | 530 | ||
Undrawn committed credit facilities | 4,474 | 4,467 | ||
|
|
|
|
|
FINANCIAL RESOURCES AT THE END OF THE PERIOD | 17,833 | 14,320 | ||
Cash flow from operating activities | 5,108 | 4,231 | ||
Cash flow from investing activities | (105) | (322) | ||
Net change in marketable securities | (500) | (500) | ||
|
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|
|
|
FREE CASH FLOW | 4,503 | 3,409 | ||
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|
Company Announcement no 25 / 2011 |
Page
20 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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 |
Tax
and
other adjust- ments |
Total
other reserves |
Total
|
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||
Q1 2011 | |||||||||||||||||
Balance at the beginning of the period |
600
|
(28) | 36,097 | 571 | (672) | 397 | 296 | 36,965 | |||||||||
Profit for the period | 4,073 | 4,073 | |||||||||||||||
Other comprehensive income for the period, net of tax | (235) | 1,354 | (476) | 643 | 643 | ||||||||||||
|
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||
Total comprehensive income for the period | 4,073 | (235) | 1,354 | (476) | 643 | 4,716 | |||||||||||
Transactions with owners, recognised directly in equity: | |||||||||||||||||
Dividends | (5,700) | (5,700) | |||||||||||||||
Share-based payment | 75 | 75 | |||||||||||||||
Purchase of treasury shares | (2) | (1,333) | (1,335) | ||||||||||||||
Sale of treasury shares | 1 | 46 | 47 | ||||||||||||||
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||
Balance at the end of the period |
600
|
(29) | 33,258 | 336 | 682 | (79) | 939 | 34,768 | |||||||||
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||
Other reserves | ||||||||||||||||
|
||||||||||||||||
DKK million |
Share
capital |
Treasury
shares |
Retained
earnings |
Exchange
rate adjust ments |
Deferred
gain/
(loss) on cash flow hedges |
Tax
and
other adjust- ments |
Total
other reserves |
Total
|
||||||||
|
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|
||||||||
Q1 2010 | ||||||||||||||||
Balance at the beginning of the period |
620
|
(32)
|
34,435 | 271 | 393 | 47 | 711 | 35,734 | ||||||||
Profit for the period | 3,324 | 3,324 | ||||||||||||||
Other comprehensive income for the period, net of tax | 136 | (1,094) | 299 | (659) | (659) | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income for the period | 3,324 | 136 | (1,094) | 299 | (659) | 2,665 | ||||||||||
Transactions with owners, recognised directly in equity: | ||||||||||||||||
Dividends | (4,400) | (4,400) | ||||||||||||||
Share-based payment | 57 | 57 | ||||||||||||||
Purchase of treasury shares |
(4)
|
(1,388) | (1,392) | |||||||||||||
Sale of treasury shares |
2
|
250 | 252 | |||||||||||||
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|
|
|
|
|
|
Balance at the end of the period |
620
|
(34)
|
32,278 | 407 | (701) | 346 | 52 | 32,916 | ||||||||
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|
Company Announcement no 25 / 2011 |
Page
21 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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: 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 the average
exchange rate for income statement and the 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.
2011 | 2010 |
%
change
Q1 2011 vs |
|||||||||||
Q1
|
Q4 | Q3 | Q2 | Q1 | Q1 2010 | ||||||||
|
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|
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|
|||||
Sales | 2,105 | 2,163 | 2,092 | 2,069 | 1,837 | 15% | |||||||
Gross profit | 1,687 | 1,750 | 1,698 | 1,669 | 1,476 | 14% | |||||||
Gross margin | 80.1% | 80.9% | 81.2% | 80.7% | 80.3% | ||||||||
Sales and distribution costs | 572 | 707 | 614 | 587 | 535 | 7% | |||||||
Percent of sales | 27.1% | 32.7% | 29.3% | 28.3% | 29.1% | ||||||||
Research and development costs | 307 | 367 | 309 | 327 | 286 | 7% | |||||||
Percent of sales | 14.6% | 17.0% | 14.8% | 15.8% | 15.6% | ||||||||
Administrative expenses | 101 | 114 | 103 | 99 | 96 | 6% | |||||||
Percent of sales | 4.8% | 5.3% | 4.9% | 4.8% | 5.2% | ||||||||
Licence fees and other operating income (net) | 20 | 21 | 16 | 21 | 30 | (34%) | |||||||
Operating profit | 727 | 583 | 688 | 677 | 589 | 24% | |||||||
Operating margin | 34.5% | 26.9% | 32.9% | 32.7% | 32.0% | ||||||||
Share of profit/(loss) in associated companies | 0 | 139 | (3) | (1) | 9 | (100%) | |||||||
Financial income | 11 | 17 | 5 | 19 | 9 | 29% | |||||||
Financial expenses | 28 | 109 | 64 | 76 | 27 | 9% | |||||||
Profit before income taxes | 710 | 630 | 626 | 619 | 580 | 23% | |||||||
Net profit | 546 | 529 | 482 | 476 | 447 | 23% | |||||||
Depreciation, amortisation and impairment losses | 81 | 92 | 81 | 80 | 78 | 4% | |||||||
Capital expenditure | 74 | 153 | 101 | 100 | 90 | (18%) | |||||||
Cash flow from operating activities | 685 | 658 | 848 | 568 | 568 | 21% | |||||||
Free cash flow | 604 | 631 | 732 | 463 | 458 | 32% | |||||||
Total assets | 7,912 | 8,237 | 7,671 | 7,659 | 7,274 | 9% | |||||||
Total equity | 4,663 | 4,959 | 4,598 | 4,515 | 4,421 | 6% | |||||||
Equity ratio | 58.9% | 60.2% | 59.9% | 59.0% | 60.8% | ||||||||
Full-time employees at the end of the period | 30,867 | 30,014 | 29,515 | 29,364 | 29,154 | 6% | |||||||
Basic earnings per share (in EUR) | 0.96 | 0.92 | 0.83 | 0.82 | 0.76 | 26% | |||||||
Diluted earnings per share (in EUR) | 0.95 | 0.91 | 0.83 | 0.81 | 0.75 | 26% | |||||||
Average number of shares outstanding (million) | 571.6 | 572.7 | 577.6 | 584.0 | 587.6 | (3%) | |||||||
Average number of shares outstanding incl | |||||||||||||
dilutive effect of options 'in the money' (million) | 576.7 | 577.5 | 582.3 | 588.9 | 593.0 | (3%) | |||||||
Sales by business segments: | |||||||||||||
Modern insulins (insulin analogues) | 899 | 955 | 917 | 913 | 787 | 14% | |||||||
Human insulins | 356 | 400 | 398 | 418 | 372 | (4%) | |||||||
Victoza® | 147 | 128 | 94 | 39 | 50 | 197% | |||||||
Protein-related products | 86 | 75 | 76 | 78 | 68 | 27% | |||||||
Oral antidiabetic products (OAD) | 95 | 90 | 98 | 94 | 87 | 10% | |||||||
Diabetes care total | 1,583 | 1,648 | 1,583 | 1,542 | 1,364 | 16% | |||||||
NovoSeven® | 273 | 267 | 264 | 290 | 257 | 6% | |||||||
Norditropin® | 168 | 167 | 165 | 168 | 145 | 16% | |||||||
Hormone replacement therapy | 66 | 65 | 69 | 60 | 60 | 11% | |||||||
Other products | 15 | 16 | 11 | 9 | 11 | 35% | |||||||
Biopharmaceuticals total | 522 | 515 | 509 | 527 | 473 | 10% | |||||||
Sales by geographic regions: | |||||||||||||
North America | 809 | 843 | 821 | 804 | 702 | 16% | |||||||
Europe | 616 | 655 | 628 | 628 | 595 | 4% | |||||||
International Operations | 296 | 290 | 285 | 297 | 247 | 20% | |||||||
China | 185 | 159 | 163 | 146 | 138 | 34% | |||||||
Japan & Korea | 199 | 216 | 195 | 194 | 155 | 28% | |||||||
Segment operating profit: | |||||||||||||
Diabetes care | 418 | 415 | 459 | 408 | 343 | 22% | |||||||
Biopharmaceuticals | 309 | 168 | 229 | 269 | 246 | 26% |
Company Announcement no 25 / 2011 |
Page
22 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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: Key currencies assumptions / supplementary information
DKK per 100 | 2010
average exchange rates |
YTD
2011 average exchange rates as of 20 April 2011 |
Current
exchange rate as of 20 April 2011 |
|||
|
|
|
|
|
|
|
USD | 562 | 541 | 514 | |||
JPY | 6.42 | 6.55 | 6.21 | |||
CNY | 83 | 82 | 79 | |||
GBP | 869 | 868 | 841 |
Company Announcement no 25 / 2011 |
Page
23 of 23
|
Interim financial report for the period 1 January 2011 to 31 March 2011 |
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: April 28, 2011 |
NOVO NORDISK A/S Lars Rebien Sørensen, President and Chief Executive Officer |