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
AUGUST 4, 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 30 June 2011
4 August 2011
Novo Nordisk increased operating profit by 13% in the first six months of 2011
Sales growth of 11% in local currencies driven by Victoza®, NovoRapid® and Levemir®
| Sales increased by 11% in local currencies and by 9% in Danish kroner. | |
o | Sales of modern insulins increased by 10% (8% in Danish kroner). | |
o | Victoza® sales of DKK 2,348 million (growth of 253% in Danish kroner). | |
o | Sales of NovoSeven® increased by 5% (3% in Danish kroner). | |
o | Sales in North America increased by 15% (9% in Danish kroner). | |
o | Sales
in Region China increased by 22% (20% in Danish kroner). |
|
| Gross
margin improved by 0.3 percentage points in local currencies, reflecting
a favourable product mix development due to increased sales of modern
insulin versus lower human insulin sales. Measured in Danish kroner, the
gross margin declined slightly with 0.1 percentage point to 80.4%. |
|
| Reported
operating profit increased by 13% to DKK 10,683 million. In local currencies,
operating profit increased by approximately 17%. |
|
| Net
profit increased by 19% to DKK 8,207 million. Earnings per share (diluted)
increased by 23% to DKK 14.27. |
|
| Significant
progress has been achieved for the clinical development pipeline. Phase
3a programmes have been initiated for the following three product candidates:
a fixed-ratio insulin/GLP-1 combination for type 2 diabetes, a fast-acting
recombinant factor VIIa analogue for haemophilia patients with inhibitors,
and a long-acting recombinant factor IX for haemophilia B. Further, two
phase 3a trials investigating liraglutide for obesity have been initiated. |
|
| The outlook for 2011 has improved: sales growth measured in local currencies is now expected to be 911% (previously 8-10%), and operating profit growth measured in local currencies is now expected to be 15-19% (previously around 15%). |
Lars Rebien Sørensen, president and CEO: We are satisfied with the results of the first six months with 11% underlying sales growth driven by Victoza® and our modern insulins. This leads us to raise the outlook for the full year results.
Company Announcement no 46 / 2011 |
Page
1 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Consolidated financial statement for the first six months of 2011
The present unaudited interim financial report has been prepared in accordance with IAS 34 Interim Financial Reporting and the 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
|
||||||
H1
2010
|
||||||
Profit and loss | H1 2011 | H1 2010 | to H1 2011 | |||
Sales | 31,694 | 29,068 | 9% | |||
Gross profit | 25,478 | 23,409 | 9% | |||
Gross margin | 80.4% | 80.5% | ||||
Sales and distribution costs | 8,893 | 8,348 | 7% | |||
Percent of sales | 28.1% | 28.7% | ||||
Research and development costs | 4,613 | 4,565 | 1% | |||
Percent of sales | 14.6% | 15.7% | ||||
Administrative expenses | 1,534 | 1,456 | 5% | |||
Percent of sales | 4.8% | 5.0% | ||||
Licence fees and other operating income | 245 | 383 | (36%) | |||
Operating profit | 10,683 | 9,423 | 13% | |||
Operating margin | 33.7% | 32.4% | ||||
Net financials | (25 | ) | (498 | ) | (95%) | |
Profit before income tax | 10,658 | 8,925 | 19% | |||
Net profit | 8,207 | 6,872 | 19% | |||
Net profit margin | 25.9% | 23.6% | ||||
Other key numbers | ||||||
Depreciation, amortisation and impairment losses | 1,430 | 1,176 | 22% | |||
Capital expenditure | 1,176 | 1,412 | (17%) | |||
Cash flow from operating activities | 9,639 | 8,456 | 14% | |||
Free cash flow | 8,295 | 6,853 | 21% | |||
Total assets | 61,528 | 57,048 | 8% | |||
Equity | 36,966 | 33,635 | 10% | |||
Equity ratio | 60.1% | 59.0% | ||||
Average number of shares outstanding (million) diluted | 575.3 | 591.0 | (3%) | |||
Diluted earnings per share / ADR (in DKK) | 14.27 | 11.63 | 23% | |||
Full-time employees at the end of the period | 31,549 | 29,364 | 7% |
Company Announcement no 46 / 2011 |
Page
2 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Sales development
Sales increased by 11%
measured in local currencies and by 9% in Danish kroner during the first six
months of 2011 compared to the same period last year. All regions contributed
to growth; North America was the main contributor with 51% share of growth
measured in local currencies, followed by International Operations and Region
China, contributing 22% and 14%, 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 six months of 2011 was
reduced by approximately three percentage points due to healthcare reforms
in the US, several European markets and Turkey.
Sales
H1
2011
DKK
million
|
Growth
as
reported
|
Growth
in
local
currencies
|
Share
of
growth
in
local
currencies
|
|||||
The diabetes care segment | ||||||||
Modern insulins | 13,677 | 8% | 10% | 41% | ||||
NovoRapid® | 6,033 | 7% | 9% | 16% | ||||
NovoMix® | 4,005 | 8% | 9% | 11% | ||||
Levemir® | 3,639 | 11% | 14% | 14% | ||||
Human insulins | 5,297 | (10% | ) | (9% | ) | (17% | ) | |
Protein-related products | 1,166 | 7% | 8% | 3% | ||||
Victoza® | 2,348 | 253% | 263% | 55% | ||||
Oral antidiabetic products | 1,364 | 1% | 5% | 2% | ||||
Diabetes care total | 23,852 | 10% | 12% | 84% | ||||
The biopharmaceuticals segment | ||||||||
NovoSeven® | 4,172 | 3% | 5% | 7% | ||||
Norditropin® | 2,432 | 4% | 4% | 3% | ||||
Other products | 1,238 | 19% | 20% | 6% | ||||
Biopharmaceuticals total | 7,842 | 5% | 7% | 16% | ||||
Total sales | 31,694 | 9% | 11% | 100% |
In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) volume data from May 2011 provided by the independent data provider IMS Health.
Diabetes care
sales development
Sales of diabetes care
products increased by 12% measured in local currencies and by 10% in Danish
kroner to DKK 23,852 million compared to the first six months 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 six months of 2010.
Modern insulins,
human insulins and protein-related products
In the first six months
of 2011, sales of modern insulins, human insulins and protein-related products
increased by 4% measured in local currencies and by 3% in Danish kroner to
DKK 20,140 million compared to the first six months of 2010, driven by North
America, International Operations and Region China. Sales growth for the global
insulin franchise was in the first six months of 2011 negatively impacted
by healthcare reforms and a decline in human insulin sales especially in Europe
and North America.
Company Announcement no 46 / 2011 |
Page
3 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Sales of modern insulins increased by 10% in local currencies and by 8% in Danish kroner to DKK 13,677 million compared to the first six months of 2010, reflecting steady organic sales growth. North America, International Operations and Region China were the main contributors to the growth. Sales of modern insulin now constitute more than 72% of Novo Nordisks sales of insulin.
Insulin market
shares (volume, MAT) |
Novo
Nordisks share of
total
insulin market
|
Novo
Nordisks share of
modern
insulin market
|
||||||
May 2011 | May 2010 | May 2011 | May 2010 | |||||
Global | 51% | 51% | 46% | 46% | ||||
USA | 41% | 42% | 37% | 36% | ||||
Europe | 52% | 54% | 50% | 51% | ||||
International Operations | 59% | 59% | 56% | 56% | ||||
Japan | 61% | 65% | 55% | 57% | ||||
China* | 63% | 63% | 68% | 70% | ||||
Source: IMS, May 2011 data. *: Data for mainland China, excluding Hong Kong and Taiwan |
North America
Sales of modern insulins,
human insulins and protein-related products in North America increased by
6% in local currencies and were unchanged measured in Danish kroner in the
first six months of 2011. This reflects continued solid sales performance
of especially NovoRapid®
and Levemir® offset by a decline in human insulin sales
and an approximate 6 percentage points negative impact of the US healthcare
reform adopted in March 2010. Currently, around 44% of Novo Nordisks
modern insulin volume in the US is being sold in the prefilled device FlexPen®
compared to around 41% for the same period last year.
Europe
Sales in Europe decreased
by 2% in local currencies and by 1% measured in Danish kroner in the first
six months of 2011. The insulin volume market growth in Europe is currently
low, ie below 3%, and Novo Nordisk insulin sales are negatively impacted by
market share losses, especially in the UK, and the healthcare reforms implemented
during 2010. 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 11% in local currencies and by 8% in Danish kroner
in the first six months of 2011. The sales growth in the first six months
of 2011 is driven by modern insulins whereas human insulin sales are unchanged
compared to the first six months of 2010. Currently, around 57% of Novo Nordisks
insulin volume in International Operations non-tender markets is being sold
in devices.
Region China
Sales in Region China increased
by 17% in local currencies and by 15% in Danish kroner in the first six months
of 2011. The main contributor to growth was sales of modern insulin with the
entire portfolio growing strongly 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
decreased by 2% in local currencies and increased by 3% measured in Danish
kroner in the first six months 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
Company Announcement no 46 / 2011 |
Page
4 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
approximately 98% of Novo Nordisks insulin volume being used in devices, primarily NovoPen® and FlexPen®. The sales impact in the first half of 2011 of the earthquake on 11 March 2011 in Japan is estimated to have been neutral with an immediate supply chain stocking in March being followed by normalisation of inventory levels in the second quarter of 2011.
Victoza®
(GLP-1 therapy for type 2 diabetes)
Victoza®
sales reached DKK 2,348 million during the first six months of 2011 reflecting
solid market performance in both the US and Europe. Victoza®
has now reached a global value market share of 47% in the GLP-1 segment primarily
driven by a value market share of 41% in the US and 59% in Europe.
The launch of Victoza® has accelerated the growth of the overall GLP-1 market value: The MAT value of the global GLP-1 market has grown 62% during the last 12 months, compared to 15% growth during the preceding 12 months. The global roll-out of Victoza® continues and is now launched in 36 countries, now including Brazil, Philippines, Singapore and Slovenia.
NovoNorm®/Prandin®/PrandiMet®
(oral antidiabetic products)
In the first six months
of 2011, sales of oral antidiabetic products increased by 5% measured in local
currencies and by 1% in Danish kroner to DKK 1,364 million compared to the
first six months 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 six months
of 2011, sales of biopharmaceutical products increased by 7% measured in local
currencies and by 5% measured in Danish kroner to DKK 7,842 million compared
to the first six months of 2010 with all regions contributing to the growth.
NovoSeven®
(bleeding disorders therapy)
Sales of NovoSeven®
increased by 5% in local currencies and by 3% in Danish kroner to DKK 4,172
million compared to the first six months of 2010. Sales growth for NovoSeven®
was primarily driven by International Operations and Europe. Sales in North
America declined slightly compared to the first six months of 2010 due to
market dynamics and the impact of the US healthcare reform.
Norditropin®
(growth hormone therapy)
Sales of Norditropin®
increased by 4% measured in local currencies and by 4% measured in Danish
kroner to DKK 2,432 million compared to the first six months of 2010. The
sales growth was driven by International Operations and Japan & Korea.
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 20% measured in local currencies
and by 19% in Danish kroner to DKK 1,238 million compared to the first six
months of 2010. This development primarily reflects continued sales progress
for Vagifem®
10 mcg being partly offset by the impact from generic competition to Activella®
in the US.
Company Announcement no 46 / 2011 |
Page
5 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Development in
costs
The cost of goods sold
grew 10% to DKK 6,216 million in the first six months of 2011. The gross margin
measured in local currencies increased 0.3 percentage points in the first
six months of 2011.
This primarily reflects a product mix impact with
the upgrade from human insulins to modern insulins. Reported gross margin
was 80.4% compared to 80.5% for the same period last year due to negative
currency impact of 0.4 percentage points.
In the first six months of 2011, total non-production-related costs increased by 6% in local currencies and by 5% in Danish kroner to DKK 15,040 million compared to the first six months of 2010.
Sales and distribution costs increased by 7% to DKK 8,893 million primarily as a result of the expanded field sales forces in the US and China.
Research and development costs increased by 1% to DKK 4,613 million in the first six months of 2011. Compared to the same period last year, this primarily reflects expanding research activities and initiation of pivotal trials offset by the completion of the phase 3a programme for Degludec and DegludecPlus.
Licence fees and other operating income constituted DKK 245 million in the first six months of 2011 compared to DKK 383 million in the first six months of 2010. This development is primarily due to a non-recurring income related to a patent settlement during the first quarter of 2010.
Net financials
Net financials showed a
net expense of DKK 25 million in the first six months of 2011 compared to
a net expense of DKK 498 million in the first six months of 2010.
For the first six months of 2011, the foreign exchange result was an income of DKK 32 million compared to an expense of DKK 460 million in the first six months of 2010. The foreign exchange gain in the first six months of 2011 reflects gains on foreign exchange hedging contracts in US dollars due to the depreciation of US dollars versus the Danish kroner in 2011 compared to the exchange rate level prevailing in 2010. This positive effect is partly offset by losses on foreign exchange hedging contracts in Japanese yen due to the appreciation versus the Danish kroner in 2011 compared to the exchange rate level prevailing in 2010. Further, the foreign exchange result is negatively affected by losses on commercial balances primarily in non-hedged currencies.
As of 30 June 2011, foreign exchange hedging gains of around DKK 700 million have been deferred for future income recognition in 2011 and 2012.
In the first six months of 2010, the result from associated companies was included in net financials with an income of DKK 61 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.
Key developments
in the second quarter of 2011
Please refer to appendix
1 for an overview of the quarterly numbers in DKK.
Company Announcement no 46 / 2011 |
Page
6 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
The sales in the second quarter of 2011 increased by 11% in local currencies and by 4% in Danish kroner to DKK 16,001 million compared to the same period in 2010. The growth is primarily driven by Victoza® and modern insulins offset by a decline in human insulin sales. North America, International Operations and Region China all exhibit double-digit growth and represent the majority of the sales increase. Victoza® sales growth rate in the second quarter of 2011 in North America also reflects the lower sales in the second quarter of 2010 following the initial supply chain filling in the first quarter of 2010.
The gross margin measured in local currencies increased 0.3 percentage points in the second quarter of 2011 compared to the same period last year primarily caused by a positive product mix impact.
Sales and distribution costs increased by 6% for the second quarter of 2011 compared to the same period last year, primarily driven by expanded field forces in the US and China. The US settlements announced 10 June 2011, and summarised in Legal update, did not significantly impact costs in the second quarter of 2011.
Research and development costs decreased by 5% in the second quarter of 2011 compared to the same period last year due to the completion of Degludec and DegludecPlus phase 3a trials. The development costs in the second quarter of 2011 include non-recurring impairment charges related to tangible and intangible assets.
Reported operating profit increased by 4% in the second quarter of 2011 compared to the same period last year, and by 15% in local currencies. This primarily reflects the steady operating performance countered by a negative currency impact.
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 | 4 August 2011 | 28 April 2011 | |
|
|
|
|
Sales growth | |||
- in local currencies |
9-11%
|
810%
|
|
- as reported |
Around
3 percentage points
lower
|
Around
4 percentage points
|
|
lower
|
|||
|
|
|
|
Operating profit growth | |||
- in local currencies |
15-19%
Around
5.5 percentage points
|
Around
15%
Around
7.5 percentage points
|
|
- as reported |
lower
|
lower
|
|
|
|
|
|
Net financials |
Income
of around DKK 150
million
|
Income
of around DKK 500
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 now expects sales growth in 2011 of 9-11% measured in local currencies. This is based on expectations for continued market penetration of Novo Nordisks key products, as well as expectations for continued intense competition, generic competition to oral antidiabetic products, and negative 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
Company Announcement no 46 / 2011 |
Page
7 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
sales growth is now expected to be around 3 percentage points lower than growth measured in local currencies.
For 2011, growth in operating profit is now expected to be 15-19% measured in local currencies. Given the current level of exchange rates versus Danish kroner, the reported operating profit growth is now expected to be around 5.5 percentage points lower than growth measured in local currencies.
For 2011, Novo Nordisk now expects a net financial income of around DKK 150 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.
Novo Nordisk has hedged expected net cash flows in a number of invoicing currencies and, all other things being equal, movements in key invoicing currencies will impact Novo Nordisks operating profit as outlined in the table below.
Key
invoicing
|
Annual
impact on Novo Nordisks
|
Hedging
period
|
|
currencies
|
operating
profit of a 5%
|
(months)
|
|
movement
in currency
|
|||
USD
|
DKK
700 million
|
14
|
|
JPY
|
DKK
155 million
|
13
|
|
CNY
|
DKK
120 million
|
12*
|
|
GBP
|
DKK
85 million
|
11
|
|
* USD used as proxy when hedging Novo Nordisks CNY currency exposure |
The financial impact from foreign exchange hedging is included in Net financials.
Research and development update
Diabetes care:
Insulin and GLP-1
American Diabetes
Association (ADA) meeting 24-28 June 2011 in San Diego, USA
At the annual meeting of
the American Diabetes Association (ADA) held in San Diego, Novo Nordisk presented
the results from the companys broad diabetes research and development
activities including 58 abstracts, 38 posters, and three oral presentations.
Key presentations included detailed results of two 52-weeks basal-bolus studies comparing the ultra-long acting basal insulin Degludec with insulin glargine in people with type 1 and type 2 diabetes. Both studies had previously been announced in headline form in December 2010,
Company Announcement no 46 / 2011 |
Page
8 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
and the detailed presentations showed Degludecs ability to control blood sugar levels with a statistically significant lower risk of nocturnal hypoglycaemia.
Further, poster presentations - including details of clinical clamp studies comparing Degludec and insulin glargine - showed that Degludec has a half-life twice as long as insulin glargine and a consistently lower within-patient variability when compared to insulin glargine.
EU approval for
FlexTouch® - a new
prefilled insulin pen
As published on 14 July
2011, Novo Nordisk has been granted approval by the European Commission for
the new prefilled insulin pen FlexTouch®.
The approval covers FlexTouch®
with the insulins NovoRapid®
and Levemir®. The ergonomic
pen offers patients a number of innovative features; eg the actual drug injection
is based on a new mechanism that requires a very low force to inject the insulin,
and the pen gives an audible click when the insulin dose has been injected.
The device has now also been submitted for marketing authorisation with the
insulins NovoLog® and
Levemir® in the US.
Phase 3a for IDegLira,
the fixed-ratio Degludec-liraglutide combination, initiated
In May 2011, Novo Nordisk
initiated the first of two phase 3a trials for IDegLira, the fixed-ratio combination
of Degludec and liraglutide, a potential first-in-class product combining
a basal insulin and a long-acting GLP-1 product. The trial is expected to
randomise 1,660 participants with type 2 diabetes in a 26-weeks trial to three
separate treatment-arms comparing IDegLira, Degludec and Victoza®
as stand-alone therapies.
Two phase 3a trials
to support regulatory filing for the use of liraglutide in obesity initiated
Two phase 3a trials investigating
the use of liraglutide in obesity were initiated in June 2011. Around 4,400
subjects are expected to be enrolled in these 56-weeks treatment trials. As
communicated in October 2010, the first of the phase 3a trials, a 56-weeks
maintenance trial investigated prevention of weight regain and demonstrated
weight loss of 6.1% above placebo (after an initial 5% diet-related weight
loss, ie in total 12 kg after one year) in the 422 randomised, obese, non-diabetic
participants.
Biopharmaceuticals:
Haemostasis
Phase 3a for a fast-acting
rFVIIa, vatreptacog alfa, initiated
In July 2011 Novo Nordisk
initiated the pivotal phase 3a trial for vatreptacog alfa (formerly referred
to as NN1731), a fast-acting bypassing agent. The trial will investigate efficacy
and safety of home-treatment of acute bleeding episodes for vatreptacog alfa
in 60 patients with congenital haemophilia and inhibitors. Hereby, Novo Nordisk
now has ongoing phase 3a trials in all major haemophilia segments: haemophilia
A, haemophilia B, and haemophilia with inhibitors.
Phase 1 trial
results for a long-acting rFVIII, N8-GP
Novo Nordisk has successfully
concluded a phase 1 study with a long-acting recombinant factor VIII compound,
N8-GP, for treatment of people with haemophilia A. The study showed that the
compound was well tolerated, with a half-life potentially enabling less frequent
administration than currently available treatment options. Pending discussions
with regulatory authorities, Novo Nordisk expects to initiate a phase 3 trial
programme in 2012.
Biopharmaceuticals:
Inflammation
Anti-NKG2a (NN8765-3658)
for rheumatoid arthritis enters clinical development
In May 2011 Novo Nordisk
initiated a phase 1 clinical trial with anti-NKG2a for rheumatoid arthritis.
The trial is expected to enrol 52 patients.
Company Announcement no 46 / 2011 |
Page
9 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Sustainability
update
The total number of full-time
employees was 31,549 as of 30 June 2011 compared to 29,364 as of 30 June 2010.
New hiring was led by expansion in China, the US and countries in the International
Operations region.
Novo Nordisk has launched the IMPACT project in France in May to test the effect of a targeted community information campaign towards 900 women with gestational diabetes to prevent them and their children from getting diabetes later in life. Novo Nordisks gestational diabetes screening, detection and management programme, Changing Diabetes in Pregnancy, also includes local public-private partnerships in India, Colombia and Nicaragua to identify cost-effective ways of reducing the burden of diabetes-related diseases.
Equity
Total equity was DKK 36,966
million at the end of the first six months of 2011, equivalent to 60.1% of
total assets, compared to 59.0% at the end of the first six months of 2010.
Please refer to appendix 5 for further elaboration of changes in equity during
the first six months 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. The reduction was executed
on 2 May 2011, and Novo Nordisks share capital now amounts 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 28 April 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 28 April 2011 to 2 August 2011. The programme was concluded
on 2 August 2011. Novo Nordisk has now repurchased 6,172,053 shares corresponding
to a total value of DKK 4.0 billion as part of the overall DKK 10 billion
share repurchase programme for 2011.
As per 2 August 2011, Novo Nordisk A/S and its wholly-owned affiliates owned 13,343,054 of its own B shares, corresponding to 2.3% of the total share capital.
Legal update
As of 2 August 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 49 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.
Company Announcement no 46 / 2011 |
Page
10 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
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 Court of Appeals for the Federal Circuit (CAFC).
Meanwhile, Caraco petitioned the US Supreme Court to review an earlier CAFC decision allowing Novo Nordisk to retain its current FDA use code. If Novo Nordisks current Use Code stands, Caraco will be unable to carve-out the the repaglinide-metformin combination information from the approved label. Caraco has conceded infringement if the combined use is included in its label (pursuant to a stipulation between the parties). On 27 June 2011, the Supreme Court announced that it will review the CAFC use code decision. A hearing date has not been set for the Supreme Court appeal, but a decision is expected in the first half of 2012. The CAFC appeal on the validity and enforceability of the patent will resume following the outcome of the Supreme Court appeal.
As announced on 10 June 2011, Novo Nordisk reached an agreement with the US Department of Justice and two individuals to settle an investigation and civil lawsuit related to alleged improper marketing practices in the United States regarding NovoSeven®. The agreement involves a payment from Novo Nordisk of USD 25 million to the settling parties and Novo Nordisk Inc. (Novo Nordisks US affiliate) has entered into a five-year Corporate Integrity Agreement with the Office of the Inspector General of the U.S. Department of Health and Human Services. Under that agreement, Novo Nordisk Inc. will add additional reporting and other procedures to its compliance programme. Further, Novo Nordisk announced the settlement relating to an investigation initiated in 2005 into certain elements of the companys US marketing and promotional practices for its insulin products. The settlement agreement involves a payment from Novo Nordisk of USD 1.75 million. In both cases, Novo Nordisk is not admitting to any wrongdoing as part of agreeing to settle the matter.
Financial calendar | |
27 October 2011 | Financial statement for the first nine months of 2011 |
14 November 2011 | 30th anniversary celebration as listed company at NYSE |
2 February 2012 | Financial statement for 2011 |
Conference
call details
On 4 August 2011 at 13.00
CEST, 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
Company Announcement no 46 / 2011 |
Page
11 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
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 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 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 46 / 2011 |
Page
12 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
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 six months 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, 4 August 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 46 / 2011 |
Page
13 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 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 | |
Ken Inchausti | Lars Borup Jacobsen |
Tel: (+1) 609 786 8316 | Tel: (+45) 3075 3479 |
kiau@novonordisk.com | lbpj@novonordisk.com |
Further information about Novo Nordisk is available on the companys website novonordisk.com
Company Announcement no 46 / 2011 |
Page
14 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 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
|
||||||||||||||
2011
|
2010
|
Q2 2011 vs | ||||||||||||
Q2
|
Q1
|
Q4
|
Q3
|
Q2
|
Q1
|
Q2 2010 | ||||||||
|
|
|
|
|
|
|
|
|
|
|
||||
Sales | 16,001 | 15,693 | 16,124 | 15,584 | 15,394 | 13,674 | 4% | |||||||
Gross profit | 12,902 | 12,576 | 13,039 | 12,648 | 12,425 | 10,984 | 4% | |||||||
Gross margin | 80.6% | 80.1% | 80.9% | 81.2% | 80.7% | 80.3% | ||||||||
Sales and distribution costs | 4,633 | 4,260 | 5,274 | 4,573 | 4,364 | 3,984 | 6% | |||||||
Percent of sales | 29.0% | 27.1% | 32.7% | 29.3% | 28.3% | 29.1% | ||||||||
Research and development costs | 2,323 | 2,290 | 2,735 | 2,302 | 2,434 | 2,131 | (5%) | |||||||
Percent of sales | 14.5% | 14.6% | 17.0% | 14.8% | 15.8% | 15.6% | ||||||||
Administrative expenses | 778 | 756 | 850 | 759 | 745 | 711 | 4% | |||||||
Percent of sales | 4.9% | 4.8% | 5.3% | 4.9% | 4.8% | 5.2% | ||||||||
Licence fees and other operating income (net) | 97 | 148 | 164 | 110 | 159 | 224 | (39%) | |||||||
Operating profit | 5,265 | 5,418 | 4,344 | 5,124 | 5,041 | 4,382 | 4% | |||||||
Operating margin | 32.9% | 34.5% | 26.9% | 32.9% | 32.7% | 32.0% | ||||||||
Share of profit/(loss) in associated companies | 0 | 0 | 1,031 | (22 | ) | (4 | ) | 65 | (100%) | |||||
Financial income | 270 | 84 | 140 | 31 | 146 | 65 | 85% | |||||||
Financial expenses | 167 | 212 | 810 | 477 | 575 | 195 | (71%) | |||||||
Profit before income taxes | 5,368 | 5,290 | 4,705 | 4,656 | 4,608 | 4,317 | 16% | |||||||
Net profit | 4,134 | 4,073 | 3,946 | 3,585 | 3,548 | 3,324 | 17% | |||||||
Depreciation, amortisation and impairment losses | 825 | 605 | 684 | 607 | 595 | 581 | 39% | |||||||
Capital expenditure | 627 | 549 | 1,141 | 755 | 744 | 668 | (16%) | |||||||
Cash flow from operating activities | 4,531 | 5,108 | 4,905 | 6,318 | 4,225 | 4,231 | 7% | |||||||
Free cash flow | 3,792 | 4,503 | 4,707 | 5,453 | 3,444 | 3,409 | 10% | |||||||
Total assets | 61,528 | 59,001 | 61,402 | 57,162 | 57,048 | 54,155 | 8% | |||||||
Total equity | 36,966 | 34,768 | 36,965 | 34,264 | 33,635 | 32,916 | 10% | |||||||
Equity ratio | 60.1% | 58.9% | 60.2% | 59.9% | 59.0% | 60.8% | ||||||||
Full-time employees at the end of the period | 31,549 | 30,867 | 30,014 | 29,515 | 29,364 | 29,154 | 7% | |||||||
Basic earnings per share (in DKK) | 7.26 | 7.13 | 6.87 | 6.21 | 6.07 | 5.66 | 20% | |||||||
Diluted earnings per share (in DKK) | 7.21 | 7.06 | 6.82 | 6.15 | 6.02 | 5.61 | 20% | |||||||
Average number of shares outstanding (million) | 569.1 | 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) | 573.8 | 576.7 | 577.5 | 582.3 | 588.9 | 593.0 | (3%) | |||||||
Sales by business segments: | ||||||||||||||
Modern insulins (insulin analogues) | 6,972 | 6,705 | 7,127 | 6,820 | 6,792 | 5,862 | 3% | |||||||
Human insulins | 2,642 | 2,655 | 2,992 | 2,963 | 3,099 | 2,773 | (15%) | |||||||
Victoza® | 1,250 | 1,098 | 951 | 700 | 296 | 370 | 322% | |||||||
Protein-related products | 527 | 639 | 561 | 567 | 583 | 503 | (10%) | |||||||
Oral antidiabetic products (OAD) | 653 | 711 | 666 | 736 | 704 | 645 | (7%) | |||||||
Diabetes care total | 12,044 | 11,808 | 12,297 | 11,786 | 11,474 | 10,153 | 5% | |||||||
NovoSeven® | 2,140 | 2,032 | 1,996 | 1,965 | 2,155 | 1,914 | (1%) | |||||||
Norditropin® | 1,180 | 1,252 | 1,242 | 1,233 | 1,245 | 1,083 | (5%) | |||||||
Hormone replacement therapy | 513 | 492 | 482 | 517 | 450 | 443 | 14% | |||||||
Other products | 124 | 109 | 107 | 83 | 70 | 81 | 77% | |||||||
Biopharmaceuticals total | 3,957 | 3,885 | 3,827 | 3,798 | 3,920 | 3,521 | 1% | |||||||
Sales by geographic regions: | ||||||||||||||
North America | 6,165 | 6,035 | 6,286 | 6,114 | 5,988 | 5,221 | 3% | |||||||
Europe | 4,847 | 4,595 | 4,886 | 4,675 | 4,671 | 4,432 | 4% | |||||||
International Operations | 2,415 | 2,203 | 2,160 | 2,127 | 2,213 | 1,835 | 9% | |||||||
China | 1,151 | 1,376 | 1,181 | 1,214 | 1,083 | 1,030 | 6% | |||||||
Japan & Korea | 1,423 | 1,484 | 1,611 | 1,454 | 1,439 | 1,156 | (1%) | |||||||
Segment operating profit: | ||||||||||||||
Diabetes care | 3,415 | 3,115 | 3,096 | 3,419 | 3,033 | 2,554 | 13% | |||||||
Biopharmaceuticals | 1,850 | 2,303 | 1,248 | 1,705 | 2,008 | 1,828 | (8%) |
Company Announcement no 46 / 2011 |
Page
15 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Appendix 2: Income statement and Statement of comprehensive income
H1
|
H1
|
Q2
|
Q2
|
|||||
DKK million |
2011
|
2010 | 2011 | 2010 | ||||
|
|
|
|
|
|
|
||
Income statement | ||||||||
Sales | 31,694 | 29,068 | 16,001 | 15,394 | ||||
Cost of goods sold | 6,216 | 5,659 | 3,099 | 2,969 | ||||
|
|
|
|
|
|
|
||
Gross profit | 25,478 | 23,409 | 12,902 | 12,425 | ||||
Sales and distribution costs | 8,893 | 8,348 | 4,633 | 4,364 | ||||
Research and development costs | 4,613 | 4,565 | 2,323 | 2,434 | ||||
Administrative expenses | 1,534 | 1,456 | 778 | 745 | ||||
Licence fees and other operating income (net) | 245 | 383 | 97 | 159 | ||||
|
|
|
|
|
|
|
||
Operating profit | 10,683 | 9,423 | 5,265 | 5,041 | ||||
Share of profit or loss of associated companies, net of tax | 0 | 61 | 0 | (4 | ) | |||
Financial income | 354 | 211 | 270 | 146 | ||||
Financial expenses | 379 | 770 | 167 | 575 | ||||
|
|
|
|
|
|
|
||
Profit before income taxes | 10,658 | 8,925 | 5,368 | 4,608 | ||||
Income taxes | 2,451 | 2,053 | 1,234 | 1,060 | ||||
|
|
|
|
|
|
|
||
NET PROFIT | 8,207 | 6,872 | 4,134 | 3,548 | ||||
Basic earnings per share (DKK) | 14.39 | 11.73 | 7.26 | 6.07 | ||||
Diluted earnings per share (DKK) | 14.27 | 11.63 | 7.21 | 6.02 | ||||
Segment Information | ||||||||
Segment sales: | ||||||||
Diabetes care | 23,852 | 21,627 | 12,044 | 11,474 | ||||
Biopharmaceuticals | 7,842 | 7,441 | 3,957 | 3,920 | ||||
Segment operating profit: | ||||||||
Diabetes care | 6,530 | 5,587 | 3,415 | 3,033 | ||||
Operating margin | 27.4% | 25.8% | 28.4% | 26.4% | ||||
Biopharmaceuticals | 4,153 | 3,836 | 1,850 | 2,008 | ||||
Operating margin | 53.0% | 51.6% | 46.8% | 51.2% | ||||
Total segment operating profit | 10,683 | 9,423 | 5,265 | 5,041 | ||||
Statement of comprehensive income | ||||||||
Net profit for the period | 8,207 | 6,872 | 4,134 | 3,548 | ||||
Other comprehensive income: | ||||||||
Deferred gains/(losses) on cash flow hedges arising during the period | 896 | (2,315 | ) | (106 | ) | (1,468 | ) | |
Transfer of deferred gains/(losses) from previous year of cash flow | ||||||||
hedges recognised in the Income statement as part of financial | ||||||||
income/(expenses) | 496 | (495 | ) | 144 | (248 | ) | ||
Exchange rate adjustment of investments in subsidiaries | (212 | ) | 413 | 23 | 277 | |||
Share of other comprehensive income of associated comp., net of tax | 0 | 8 | 0 | 6 | ||||
Gains/(losses) on available-for-sale financial assets (equity investments) | 3 | 5 | (2 | ) | 0 | |||
Other | (57 | ) | (12 | ) | 8 | (33 | ) | |
Tax on other comprehensive income, income/(expense) | (464 | ) | 851 | (48 | ) | 580 | ||
|
|
|
|
|
|
|
||
Other comprehensive income for the period, net of tax | 662 | (1,545 | ) | 19 | (886 | ) | ||
|
|
|
|
|
|
|
||
TOTAL COMPREHENSIVE INCOME FOR THE PERIOD | 8,869 | 5,327 | 4,153 | 2,662 |
Company Announcement no 46 / 2011 |
Page
16 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Appendix
3: Balance sheet
|
||||
DKK
million
|
30
Jun 2011
|
31
Dec 2010
|
||
|
|
|
|
|
ASSETS | ||||
Intangible assets | 1,479 | 1,458 | ||
Property, plant and equipment | 20,175 | 20,507 | ||
Investments in associated companies | 43 | 43 | ||
Deferred income tax assets | 1,704 | 1,847 | ||
Other non-current financial assets | 252 | 254 | ||
|
|
|
|
|
TOTAL NON-CURRENT ASSETS | 23,653 | 24,109 | ||
Inventories | 8,992 | 9,689 | ||
Trade receivables | 9,437 | 8,500 | ||
Tax receivables | 660 | 650 | ||
Other current assets | 2,293 | 2,403 | ||
Marketable securities and financial derivatives | 3,921 | 4,034 | ||
Cash at bank and in hand | 12,572 | 12,017 | ||
|
|
|
|
|
TOTAL CURRENT ASSETS | 37,875 | 37,293 | ||
|
|
|
|
|
TOTAL ASSETS | 61,528 | 61,402 | ||
|
|
|
|
|
EQUITY AND LIABILITIES | ||||
Share capital | 580 | 600 | ||
Treasury shares | (12 | ) | (28 | ) |
Retained earnings | 35,440 | 36,097 | ||
Other reserves | 958 | 296 | ||
|
|
|
|
|
TOTAL EQUITY | 36,966 | 36,965 | ||
Non-current debt | 504 | 504 | ||
Deferred income tax liabilities | 3,095 | 2,865 | ||
Retirement benefit obligations | 564 | 569 | ||
Provisions for other liabilities | 1,799 | 2,023 | ||
|
|
|
|
|
Total non-current liabilities | 5,962 | 5,961 | ||
Current debt and financial instruments | 885 | 1,720 | ||
Trade payables | 2,662 | 2,906 | ||
Tax payables | 2,229 | 1,252 | ||
Other current liabilities | 7,373 | 7,954 | ||
Provisions for other liabilities | 5,451 | 4,644 | ||
|
|
|
|
|
Total current liabilities | 18,600 | 18,476 | ||
TOTAL LIABILITIES | 24,562 | 24,437 | ||
|
|
|
|
|
TOTAL EQUITY AND LIABILITIES | 61,528 | 61,402 | ||
|
|
|
|
|
Company Announcement no 46 / 2011 |
Page
17 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Appendix
4: Statement of cash flows
|
||||
DKK
million
|
H1
2011
|
H1
2010
|
||
|
|
|
|
|
Net profit | 8,207 | 6,872 | ||
Adjustment for non-cash items: | ||||
Income taxes | 2,451 | 2,053 | ||
Depreciation, amortisation and impairment losses | 1,430 | 1,176 | ||
Interest income and interest expenses | (37 | ) | 76 | |
Other adjustment | (101 | ) | 1,416 | |
Income taxes paid | (1,584 | ) | (1,782 | ) |
Interest received | 154 | 142 | ||
Interest paid | (22 | ) | (199 | ) |
|
|
|
|
|
Cash flow before change in working capital | 10,498 | 9,754 | ||
(Increase)/decrease in trade receivables and other current assets | (827 | ) | (2,075 | ) |
(Increase)/decrease in inventories | 697 | (30 | ) | |
Increase/(decrease) in trade payables and other current liabilities | (825 | ) | 728 | |
Exchange rate adjustment | 96 | 79 | ||
|
|
|
|
|
Cash flow from operating activities | 9,639 | 8,456 | ||
Purchase of intangible assets and non-current financial assets | (168 | ) | (191 | ) |
Proceeds from sale of property, plant and equipment | - | 2 | ||
Purchase of property, plant and equipment | (1,176 | ) | (1,414 | ) |
Net change in marketable securities (maturity exceeding three months) | 1,019 | 500 | ||
Dividend received | - | - | ||
|
|
|
|
|
Cash flow from investing activities | (325 | ) | (1,103 | ) |
Repayment of non-current debt | - | - | ||
Purchase of treasury shares | (3,330 | ) | (3,464 | ) |
Proceeds from sale of treasury shares | 57 | 314 | ||
Dividends paid to the Company´s owners | (5,700 | ) | (4,400 | ) |
|
|
|
|
|
Cash flow from financing activities | (8,973 | ) | (7,550 | ) |
NET CASH FLOW | 341 | (197 | ) | |
Unrealised gain/(loss) on exchange rates and marketable securities | ||||
included in cash and cash equivalents | (36 | ) | 80 | |
|
|
|
|
|
Net change in cash and cash equivalents | 305 | (117 | ) | |
Cash and cash equivalents at the beginning of the period | 11,960 | 11,034 | ||
|
|
|
|
|
Cash and cash equivalents at the end of the period | 12,265 | 10,917 | ||
Additional information: | ||||
Cash and cash equivalents at the end of the period | 12,265 | 10,917 | ||
Bonds with original term to maturity exceeding three months | 2,908 | 522 | ||
Undrawn committed credit facilities | 4,475 | 4,469 | ||
|
|
|
|
|
FINANCIAL RESOURCES AT THE END OF THE PERIOD | 19,648 | 15,908 | ||
Cash flow from operating activities | 9,639 | 8,456 | ||
+ Cash flow from investing activities | (325 | ) | (1,103 | ) |
Net change in marketable securities | (1,019 | ) | (500 | ) |
|
|
|
|
|
FREE CASH FLOW | 8,295 | 6,853 | ||
|
|
|
|
|
Company Announcement no 46 / 2011 |
Page
18 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H1 2011 | ||||||||||||||||
Balance at the beginning of the period | 600 | (28 | ) | 36,097 | 571 | (672 | ) | 397 | 296 | 36,965 | ||||||
Profit for the period | 8,207 | 8,207 | ||||||||||||||
Other comprehensive income for the period, net of tax | (212 | ) | 1,392 | (518 | ) | 662 | 662 | |||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income for the period | 600 | (28 | ) | 44,304 | 359 | 720 | (121 | ) | 958 | 45,834 | ||||||
Transactions with owners, recognised directly in equity: | ||||||||||||||||
Dividends | (5,700 | ) | (5,700 | ) | ||||||||||||
Share-based payment | 105 | 105 | ||||||||||||||
Reduction of the B share capital | (20 | ) | 20 | - | ||||||||||||
Purchase of treasury shares | (5 | ) | (3,325 | ) | (3,330 | ) | ||||||||||
Sale of treasury shares | 1 | 56 | 57 | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period | 580 | (12 | ) | 35,440 | 359 | 720 | (121 | ) | 958 | 36,966 | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H1 2010 | ||||||||||||||||
Balance at the beginning of the period | 620 | (32 | ) | 34,435 | 271 | 393 | 47 | 711 | 35,734 | |||||||
Profit for the period | 6,872 | 6,872 | ||||||||||||||
Other comprehensive income for the period, net of tax | 413 | (2,810 | ) | 852 | (1,545 | ) | (1,545 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income for the period | 620 | (32 | ) | 41,307 | 684 | (2,417 | ) | 899 | (834 | ) | 41,061 | |||||
Transactions with owners, recognised directly in equity: | ||||||||||||||||
Dividends | (4,400 | ) | (4,400 | ) | ||||||||||||
Share-based payment | 124 | 124 | ||||||||||||||
Reduction of the B share capital | (20 | ) | 20 | - | ||||||||||||
Purchase of treasury shares | (8 | ) | (3,456 | ) | (3,464 | ) | ||||||||||
Sale of treasury shares | 2 | 312 | 314 | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period | 600 | (18 | ) | 33,887 | 684 | (2,417 | ) | 899 | (834 | ) | 33,635 | |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Company Announcement no 46 / 2011 |
Page
19 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 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.
%
change
|
||||||||||||||
2011
|
2010
|
Q2 2011 vs | ||||||||||||
Q2 | Q1 | Q4 | Q3 | Q2 | Q1 | Q2 2010 | ||||||||
|
|
|
|
|
|
|
|
|
|
|
||||
Sales | 2,146 | 2,105 | 2,163 | 2,092 | 2,069 | 1,837 | 4% | |||||||
Gross profit | 1,730 | 1,687 | 1,750 | 1,698 | 1,669 | 1,476 | 4% | |||||||
Gross margin | 80.6% | 80.1% | 80.9% | 81.2% | 80.7% | 80.3% | ||||||||
Sales and distribution costs | 620 | 572 | 707 | 614 | 587 | 535 | 6% | |||||||
Percent of sales | 29.0% | 27.1% | 32.7% | 29.3% | 28.3% | 29.1% | ||||||||
Research and development costs | 312 | 307 | 367 | 309 | 327 | 286 | (5%) | |||||||
Percent of sales | 14.5% | 14.6% | 17.0% | 14.8% | 15.8% | 15.6% | ||||||||
Administrative expenses | 105 | 101 | 114 | 103 | 99 | 96 | 4% | |||||||
Percent of sales | 4.9% | 4.8% | 5.3% | 4.9% | 4.8% | 5.2% | ||||||||
Licence fees and other operating income (net) | 13 | 20 | 21 | 16 | 21 | 30 | (39%) | |||||||
Operating profit | 706 | 727 | 583 | 688 | 677 | 589 | 4% | |||||||
Operating margin | 32.9% | 34.5% | 26.9% | 32.9% | 32.7% | 32.0% | ||||||||
Share of profit/(loss) in associated companies | 0 | 0 | 139 | (3 | ) | (1 | ) | 9 | (100%) | |||||
Financial income | 36 | 11 | 17 | 5 | 19 | 9 | 85% | |||||||
Financial expenses | 23 | 28 | 109 | 64 | 76 | 27 | (71%) | |||||||
Profit before income taxes | 719 | 710 | 630 | 626 | 619 | 580 | 16% | |||||||
Net profit | 555 | 546 | 529 | 482 | 476 | 447 | 17% | |||||||
Depreciation, amortisation and impairment losses | 111 | 81 | 92 | 81 | 80 | 78 | 39% | |||||||
Capital expenditure | 84 | 74 | 153 | 101 | 100 | 90 | (16%) | |||||||
Cash flow from operating activities | 608 | 685 | 658 | 848 | 568 | 568 | 7% | |||||||
Free cash flow | 509 | 604 | 631 | 732 | 463 | 458 | 10% | |||||||
Total assets | 8,249 | 7,912 | 8,237 | 7,671 | 7,659 | 7,274 | 8% | |||||||
Total equity | 4,956 | 4,663 | 4,959 | 4,598 | 4,515 | 4,421 | 10% | |||||||
Equity ratio | 60.1% | 58.9% | 60.2% | 59.9% | 59.0% | 60.8% | ||||||||
Full-time employees at the end of the period | 31,549 | 30,867 | 30,014 | 29,515 | 29,364 | 29,154 | 7% | |||||||
Basic earnings per share (in EUR) | 0.97 | 0.96 | 0.92 | 0.83 | 0.82 | 0.76 | 20% | |||||||
Diluted earnings per share (in EUR) | 0.96 | 0.95 | 0.91 | 0.83 | 0.81 | 0.75 | 20% | |||||||
Average number of shares outstanding (million) | 569.1 | 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) | 573.8 | 576.7 | 577.5 | 582.3 | 588.9 | 593.0 | (3%) | |||||||
Sales by business segments: | ||||||||||||||
Modern insulins (insulin analogues) | 935 | 899 | 955 | 917 | 913 | 787 | 3% | |||||||
Human insulins | 354 | 356 | 400 | 398 | 418 | 372 | (15%) | |||||||
Victoza® | 168 | 147 | 128 | 94 | 39 | 50 | 322% | |||||||
Protein-related products | 70 | 86 | 75 | 76 | 78 | 68 | (10%) | |||||||
Oral antidiabetic products (OAD) | 88 | 95 | 90 | 98 | 94 | 87 | (7%) | |||||||
Diabetes care total | 1,615 | 1,583 | 1,648 | 1,583 | 1,542 | 1,364 | 5% | |||||||
NovoSeven® | 287 | 273 | 267 | 264 | 290 | 257 | (1%) | |||||||
Norditropin® | 158 | 168 | 167 | 165 | 168 | 145 | (5%) | |||||||
Hormone replacement therapy | 69 | 66 | 65 | 69 | 60 | 60 | 14% | |||||||
Other products | 17 | 15 | 16 | 11 | 9 | 11 | 77% | |||||||
Biopharmaceuticals total | 531 | 522 | 515 | 509 | 527 | 473 | 1% | |||||||
Sales by geographic regions: | ||||||||||||||
North America | 827 | 809 | 843 | 821 | 804 | 702 | 3% | |||||||
Europe | 651 | 616 | 655 | 628 | 628 | 595 | 4% | |||||||
International Operations | 323 | 296 | 290 | 285 | 297 | 247 | 9% | |||||||
China | 154 | 185 | 159 | 163 | 146 | 138 | 6% | |||||||
Japan & Korea | 191 | 199 | 216 | 195 | 194 | 155 | (1%) | |||||||
Segment operating profit: | ||||||||||||||
Diabetes care | 458 | 418 | 415 | 459 | 408 | 343 | 13% | |||||||
Biopharmaceuticals | 248 | 309 | 168 | 229 | 269 | 246 | (8%) |
Company Announcement no 46 / 2011 |
Page
20 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Appendix
7: Key currencies assumptions / supplementary information |
||||||||
DKK per | 2010 average | Exchange rates as of | YTD 2011 average | Current exchange | ||||
100 | exchange rates | 30 June 2011 | exchange rates as of | rate as of 29 July | ||||
29 July 2011 | 2011 | |||||||
|
|
|
|
|
|
|
|
|
USD | 562 | 516 | 531 | 522 | ||||
JPY | 6.42 | 6.42 | 6.50 | 6.74 | ||||
CNY | 83 | 80 | 81 | 80 | ||||
GBP | 869 | 826 | 857 | 852 |
Company Announcement no 46 / 2011 |
Page
21 of 21
|
Interim financial report for the period 1 January 2011 to 30 June 2011 |
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4443 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: AUGUST 4, 2011 |
NOVO NORDISK A/S Lars Rebien Sørensen, President and Chief Executive Officer |