UNITED
STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT
OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange
Act of 1934
APRIL 30, 2012
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
Financial report for the period 1 January 2012 to 31 March 2012
27 April 2012
Operating profit increased by 18% in the first quarter of 2012
Sales growth of 13% driven by Victoza®, NovoRapid® and Levemir®
| · | Sales increased by 13% to 17.8 billion in Danish kroner and by 10% in local currencies. | |
| o | Sales of modern insulins increased by 17% (14% in local currencies). | |
| o | Sales of Victoza® increased by 81% (76% in local currencies). | |
| o | Sales in North America increased by 21% (17% in local currencies). | |
| o |
Sales in International
Operations increased by 24% (24% in local currencies). |
|
| · | Gross
margin improved by 0.7 percentage points in Danish kroner to 80.8% in
the first quarter of 2012, reflecting a favourable price and product mix
development. |
|
| · | Reported
operating profit increased by 18% to DKK 6,385 million. Measured in local
currencies, operating profit increased by approximately 13%. |
|
| · | Net
profit increased by 15% to DKK 4,664 million. Earnings per share (diluted)
increased by 18% to DKK 8.32. |
|
| · | The
regulatory reviews of the new ultra-long-acting insulins Degludec and
DegludecPlus continue to progress in the major markets. The intended global
brand name for Degludec is Tresiba®
and
the intended global brand name for DegludecPlus is Ryzodeg®. |
|
| · | Novo
Nordisk has initiated a phase 3a programme for the long-acting recombinant
factor VIII compound N8-GP for the treatment of haemophilia A. |
|
| · | For 2012, sales growth measured in local currencies is now expected to be 8-11% (previously 7-11%), and operating profit growth measured in local currencies is now expected to be at least 10% (previously around 10%). | |
Lars Rebien Sørensen, president and CEO: “We are satisfied with the solid sales growth during the first quarter of 2012 – still driven by the modern insulins NovoRapid® and Levemir® as well as our once-daily human GLP-1 Victoza®. Furthermore, the regulatory reviews for Tresiba® and Ryzodeg®, our new generation of insulins, continue to progress well in the major markets.”
| Company Announcement no 28 / 2012 |
Page
1 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 2012
The present unaudited first quarter financial report has been prepared in accordance with IAS 34 ‘Interim Financial Reporting’ and accounting policies set out in the Annual Report 2011 of Novo Nordisk. Furthermore, the first quarter financial report and Management’s 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 2012. These IFRSs have not had a significant impact on the Group’s first quarter financial report.
Amounts in DKK million, except average number of shares outstanding, earnings per share and full-time employees.
|
%
change
|
||||||
|
Q1
2011
|
||||||
| Profit and loss | Q1 2012 | Q1 2011 |
to
Q1 2012
|
|||
| Sales | 17,751 | 15,693 |
13%
|
|||
| Gross profit | 14,348 | 12,576 |
14%
|
|||
| Gross margin | 80.8% | 80.1% | ||||
| Sales and distribution costs | 4,850 | 4,260 |
14%
|
|||
| Percentage of sales | 27.3% | 27.1% | ||||
| Research and development costs | 2,507 | 2,290 |
9%
|
|||
| Percentage of sales | 14.1% | 14.6% | ||||
| Administrative expenses | 776 | 756 |
3%
|
|||
| Percentage of sales | 4.4% | 4.8% | ||||
| Licence fees and other operating income | 170 | 148 |
15%
|
|||
| Operating profit | 6,385 | 5,418 |
18%
|
|||
| Operating margin | 36.0% | 34.5% | ||||
| Net financials | (328 | ) | (128 | ) |
156%
|
|
| Profit before income tax | 6,057 | 5,290 |
14%
|
|||
| Net profit | 4,664 | 4,073 |
15%
|
|||
| Net profit margin | 26.3% | 26.0% | ||||
| Other key numbers | ||||||
| Depreciation, amortisation and impairment losses | 638 | 605 |
5%
|
|||
| Capital expenditure | 516 | 549 |
(6%
|
) | ||
| Net cash generated from operating activities | 6,915 | 5,108 |
35%
|
|||
| Free cash flow | 6,366 | 4,503 |
41%
|
|||
| Total assets | 61,210 | 59,001 |
4%
|
|||
| Equity | 32,358 | 34,768 |
(7%
|
) | ||
| Equity ratio | 52.9% | 58.9% | ||||
| Average number of shares outstanding (million) – diluted | 560.5 | 576.7 |
(3%
|
) | ||
| Diluted earnings per share / ADR (in DKK) | 8.32 | 7.06 |
18%
|
|||
| Full-time employees at the end of the period | 32,252 | 30,867 |
4%
|
| Company Announcement no 28 / 2012 |
Page
2 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 13% in Danish kroner and by 10% measured in local currencies. North America was the main contributor to growth with 64% share of growth measured in local currencies, followed by International Operations and Region China, contributing 34% and 8%, respectively. The majority of growth originated from the modern insulins and Victoza®. Sales growth in the first quarter of 2012 was reduced by approximately 1.5 percentage points due to the impact of healthcare and pricing reforms in several European markets, the US, International Operations and China.
|
Sales
|
Growth
|
Growth
|
Share
of
|
||||||
|
Q1
2012
|
as
|
in
local
|
growth
|
||||||
|
DKK
|
reported
|
currencies
|
in
local
|
||||||
|
million
|
currencies
|
||||||||
| The diabetes care segment | |||||||||
| Modern insulins |
7,867
|
17%
|
14%
|
61%
|
|||||
| – NovoRapid® |
3,518
|
19%
|
|
16%
|
|
29%
|
|
||
| – NovoMix® |
2,151
|
9%
|
|
6%
|
|
8%
|
|
||
| – Levemir® |
2,198
|
24%
|
|
21%
|
|
24%
|
|
||
| Human insulins |
2,718
|
2%
|
(1%
|
)
|
(1%
|
)
|
|||
| Protein-related products |
625
|
(2%
|
)
|
(4%
|
)
|
(2%
|
)
|
||
| Victoza® |
1,990
|
81%
|
76%
|
53%
|
|||||
| Oral antidiabetic products |
716
|
1%
|
(3%
|
)
|
(1%
|
)
|
|||
| Diabetes care total |
13,916
|
18%
|
|
15%
|
|
110%
|
|
||
| The biopharmaceuticals segment | |||||||||
| NovoSeven® |
1,909
|
(6%
|
)
|
(8%
|
)
|
(11%
|
)
|
||
| Norditropin® |
1,346
|
8%
|
4%
|
3%
|
|||||
| Other products |
580
|
(3%
|
)
|
(6%
|
)
|
(2%
|
)
|
||
| Biopharmaceuticals total |
3,835
|
(1%
|
)
|
(4%
|
)
|
(10%
|
)
|
||
| Total sales |
17,751
|
13%
|
|
10%
|
|
100%
|
|
In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) volume data from February 2012 provided by the independent data provider IMS Health.
Diabetes
care sales development
Sales of
diabetes care products increased by 18% measured in Danish kroner to DKK 13,916
million and by 15% in local currencies compared to the first quarter of 2011.
Novo Nordisk is the world leader in diabetes care and now holds a global value
market share of 25% compared to 24% at the same point in time last year.
Modern insulins,
human insulins and protein-related products
In the first
quarter of 2012, sales of modern insulins, human insulins and protein-related
products increased by 12% in Danish kroner to DKK 11,210 million and by 9%
measured in local currencies compared to the first quarter of 2011, with International
Operations and North America having the highest growth rates. Novo Nordisk
is the global leader with 50% of the total insulin market and 46% of the modern
insulin market.
Sales of modern insulins increased by 17% in Danish kroner to DKK 7,867 million and by 14% in local currencies compared to the first quarter of 2011. North America accounted for more than half of the growth, followed by International Operations and Europe. Sales of modern insulins now constitute more than 74% of Novo Nordisk s sales of insulin.
| Company Announcement no 28 / 2012 |
Page
3 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 |
| Insulin market shares |
Novo
Nordisk’s share of
|
Novo
Nordisk’s share of
|
|||||||
| (volume, MAT) |
total
insulin market
|
modern
insulin market
|
|||||||
|
February
2012
|
February
2011
|
February
2012
|
February
2011
|
||||||
| Global |
50%
|
|
51%
|
|
46%
|
|
46%
|
|
|
| USA |
41%
|
42%
|
37%
|
37%
|
|||||
| Europe |
51%
|
53%
|
50%
|
50%
|
|||||
| International Operations* |
59%
|
59%
|
56%
|
56%
|
|||||
| Japan |
58%
|
62%
|
53%
|
56%
|
|||||
| China** |
62%
|
63%
|
66%
|
69%
|
|||||
| Source: IMS, February 2012 data. | |||||||||
| *: Data for the 11 major countries in IO, **: 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 21% in Danish kroner and by 17% in local currencies in the first quarter
of 2012, reflecting a continued solid market penetration of the modern insulins,
NovoLog®, Levemir®
and NovoLog®
Mix 70/30, offset by a slight decline in human insulin sales. Currently, around
47%
of Novo Nordisk’s modern insulin volume in the US is being sold in the
prefilled
device FlexPen®
compared to around 43% in 2011.
Europe
Sales of modern
insulins, human insulins and protein-related products in Europe remained stable
in Danish kroner and increased by 1% in local currencies in the first quarter
of 2012, reflecting continued progress for NovoRapid®
and Levemir® as
well as declining human insulin sales. The growth of the insulin volume market
in Europe is currently low, ie below 3%, and Novo
Nordisk’s insulin sales
are negatively impacted by market share
losses, and by healthcare reforms implemented in a number of European markets,
most recently Poland. The
device penetration in Europe remains high with more than 96% of Novo Nordisk’s
insulin being
used in devices, primarily NovoPen®
and FlexPen®.
International
Operations
Sales of modern
insulins, human insulins and protein-related products in International Operations
increased by 24% in Danish kroner and by 25% in local currencies in the first
quarter of 2012. The growth is driven by all three modern insulins and with
solid contribution from human insulin, which is positively impacted by timing
in shipments to markets in Northern Africa. Currently, around 58% of Novo Nordisk’s insulin volume
of International Operations’
major non-tender markets is being sold for
use in devices.
China
Sales
of modern insulins,
human insulins and protein-related products in Region China increased by 17%
in Danish kroner and by 8% in local currencies in the first quarter of 2012.
The sales growth was driven by the portfolio of modern insulins, while sales
of human insulin were at the same level as in the first quarter of 2011. Currently,
around 96% of Novo Nordisk’s
insulin volume in China is being sold
for use in
devices, primarily Penfill® for use in the durable device NovoPen®.
Japan &
Korea
Sales
of modern insulins,
human insulins and protein-related products in Japan & Korea declined
by 9% measured in Danish kroner and by 16% in local currencies in the first
quarter of 2012. The sales growth development reflects wholesaler destocking
prior to mandatory price reductions taking effect 1 April 2012, whereas the
first quarter of 2011 were positively
| Company Announcement no 28 / 2012 |
Page
4 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 |
impacted by supply chain stocking following the earthquake in March 2011. Furthermore, continuous low market growth in Japan, ie below 3%, is impacting overall growth and in a continuously challenging competitive environment, Novo Nordisk now holds 58% of the total insulin market in Japan and 53% of the modern insulin market. The device penetration in Japan remains high with more than 98% of Novo Nordisk’s insulin volume being used in devices, primarily NovoPen® and FlexPen®.
Victoza®
(GLP-1 therapy for type 2 diabetes)
Victoza®
sales reached DKK 1,990 million during the first quarter of 2012, reflecting
solid sales performance in all regions. The global roll-out is continuing, now
with 53 countries having launched Victoza®, most recently Armenia, Estonia,
Iceland, Sri Lanka, Bangladesh and South Africa. Victoza® holds a global market share leadership
with 62% value market share in the GLP-1 segment in February 2012 compared to
39% in February 2011. The GLP-1 class’ volume share
of the total diabetes care market increased to 4.8% in February 2012 compared
to 3.4% in February 2011.
North America
Sales of Victoza®
in North America increased by 74% in Danish kroner and by 68% measured in local
currencies in the first quarter of 2012 compared to 2011. This reflects continuous
GLP-1 market expansion driven by Victoza®
with the GLP-1
class’ value share of total diabetes care market increasing to 6.0% in February
2012 compared to 4.6% in February 2011. The GLP-1 market expansion in 2012 also
reflects the launch of a competitive product. Victoza®
retains the GLP-1 value market leadership position with 56% share in February
2012 compared to 33% share in February 2011.
Europe
Sales in Europe
increased by 59% in Danish kroner and by 59% measured in local currencies in
the first quarter of 2012 compared to the first quarter of 2011. This reflects
continued roll-out across Europe and in particular sales growth in France, the
UK and Italy. In Europe, the GLP-1
class’ value share of the total diabetes care has increased to 5.4% in February 2012
compared to 3.8% in February 2011.
International
Operations
Sales in
International Operations increased by 418% in Danish kroner and by 427% measured
in local currencies in the first quarter of 2012 compared to the first quarter
of 2011. This reflects a very modest comparison base in 2011 and continued
solid performance particularly in Brazil and certain Middle-Eastern countries.
Region
China
Victoza®
was launched in China during the fourth quarter of 2011, and although initial
market feedback is positive and hospital listings are growing satisfactorily,
actual sales remain limited. The new drug application for Victoza®
in Hong Kong was approved in March 2012, allowing for the product to be commercially
launched later in 2012.
Japan &
Korea
Sales in
Japan & Korea increased by 94% in Danish kroner and by 79% measured in
local currencies in the first quarter of 2012 compared to the first quarter
of 2011.
NovoNorm®/Prandin®/PrandiMet®
(oral antidiabetic products)
In the first
quarter of 2012, sales of oral antidiabetic products increased by 1% in Danish
kroner to DKK 716 million but decreased by 3% measured in local currencies
compared to the
| Company Announcement no 28 / 2012 |
Page
5 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 |
first quarter of 2011. The sales development reflects modest sales growth in all regions, except Europe where generic competition in several markets is negatively impacting overall sales.
Biopharmaceuticals
sales development
In the first
quarter of 2012, sales of biopharmaceutical products decreased by 1% measured
in Danish kroner to DKK 3,835 million and by 4% measured in local currencies
compared to the first quarter of 2011 primarily driven by lower sales in Europe
and North America.
NovoSeven®
(bleeding disorders therapy)
Sales of
NovoSeven®
decreased by 6% in Danish kroner to DKK 1,909 million and by 8% in local currencies
compared to the first quarter of 2011. In Europe and North America, the sales
development primarily reflects a low level of surgeries involving NovoSeven®
treatment, stricter budgetary controls in hospitals, a low level of acquired
haemophilia cases and also an increase in inhibitor patients participating
in clinical trials.
Norditropin®
(growth hormone therapy)
Sales of
Norditropin®
increased by 8% measured in Danish kroner to DKK 1,346 million and by 4% measured
in local currencies compared to the first quarter of 2011. The sales growth
is primarily driven by International Operations and North America. Novo Nordisk
is the second-largest company in the global growth hormone market with a 24%
market share measured by volume.
Other products
Sales of
other products within biopharmaceuticals, which predominantly consist of hormone
replacement therapy (HRT)-related products, decreased by 3% in Danish kroner
to DKK 580 million and by 6% measured in local currencies compared to the
first quarter of 2011. This development primarily reflects the impact from
generic competition to Activella® being
partly offset by continued sales progress for Vagifem®
in the US.
Development
in costs
The cost
of goods sold grew 9% to DKK 3,403 million in the first quarter of 2012, resulting
in a gross margin of 80.8% compared to 80.1% in the first quarter of 2011. This
improvement primarily reflects a favourable price development in North America
and a favourable product mix impact due to increased sales of modern insulins
and Victoza®.
In the first quarter of 2012, total non-production-related costs increased by 11% to DKK 8,133 million and by 9% in local currencies compared to the first quarter of 2011.
Sales and distribution costs increased by 14% to DKK 4,850 million driven by marketing investments in the US and the sales force expansion of approximately 300 sales representatives in China mid-2011.
Research and development costs increased by 9% to DKK 2,507 million primarily driven by phase 3 trials for IdegLira, the fixed combination product of insulin degludec and liraglutide (the active ingredient in Victoza®), and the two ongoing phase 3 trials for liraglutide in obesity. Biopharm development costs were impacted by the ongoing phase 3 trials for vatreptacog alfa, a fast-acting recombinant factor VIIa analogue, and N9-GP, a long-acting recombinant factor IX, as well as phase 2 trial costs related to anti-IL-20, a monoclonal antibody, in rheumatoid arthritis. Finally, the ongoing phase 3b trials for Tresiba® and Ryzodeg® impacted diabetes development costs.
| Company Announcement no 28 / 2012 |
Page
6 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 |
Licence fees and other operating income constituted DKK 170 million in the first quarter of 2012 compared to DKK 148 million in the first quarter of 2011.
Net financials
Net financials
showed a net expense of DKK 328 million in the first quarter of 2012 compared
to a net expense of DKK 128 million in the first quarter of 2011.
For the first quarter of 2012, the foreign exchange result was an expense of DKK 309 million compared to an expense of DKK 104 million in the first quarter of 2011. This development reflects losses on foreign exchange hedging of especially US dollars due to the appreciation versus Danish kroner in the first quarter of 2012 compared to the exchange rate level prevailing towards the end of 2010 and in the early part of 2011.
Outlook 2012
The current
expectations for 2012 are summarised in the table below:
| Expectations are as reported, if not |
Current
expectations
|
Previous
expectations
|
| otherwise stated |
27
April 2012
|
2
February 2012
|
|
|
||
| Sales growth | ||
| - in local currencies |
8-11%
|
7-11%
|
| - as reported |
Around
4 percentage points
|
Around
4 percentage points
|
|
higher
|
higher
|
|
|
|
||
| Operating profit growth |
|
|
| - in local currencies |
At
least 10%
|
Around
10%
|
| - as reported |
Around
6.5 percentage points
|
Around
7 percentage points
|
|
higher
|
higher
|
|
|
|
||
| Net financials |
Expense
of around DKK 800
|
Expense
of around DKK 1,000
|
|
million
|
million
|
|
|
|
||
| Effective tax rate |
Around
23%
|
Around
22-23%
|
|
|
||
| Capital expenditure |
Around
DKK 3.5 billion
|
Around
DKK 3.5 billion
|
|
|
||
| Depreciation, amortisation and | ||
| impairment losses |
Around
DKK 2.9 billion
|
Around
DKK 2.9 billion
|
|
|
|
|
| Free cash flow |
Around
DKK 18 billion
|
Around
DKK 18 billion
|
|
|
||
Novo Nordisk now expects sales growth in 2012 of 8-11% measured in local currencies. This is based on expectations of continued market penetration for Novo Nordisk’s key products, as well as expectations for continued intense competition, generic competition to oral antidiabetic products, and impact from the implementation of healthcare reforms primarily in the US, Europe and China. Given the current level of exchange rates versus Danish kroner, the reported sales growth is now expected to be around 4 percentage points higher than growth measured in local currencies.
For 2012, growth in operating profit is now expected to be at least 10% measured in local currencies. The expectation for operating profit growth reflects significant investments in sales and marketing including costs related to an expansion of the US sales force in the middle of 2012. Given the current level of exchange rates versus Danish kroner, the reported operating profit growth is now expected to be 6.5 percentage points higher than growth measured in local currencies.
For 2012, Novo Nordisk now expects a net financial expense of around DKK 800 million. The current expectation primarily reflects losses associated with currency hedging contracts
| Company Announcement no 28 / 2012 |
Page
7 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 |
following the appreciation of the US dollar and Japanese yen vs Danish kroner compared to the exchange rates prevailing in 2011.
The effective tax rate for 2012 is now expected to be around 23% which reflects settlements of tax cases and a reassessment of tax liabilities.
Capital expenditure is still expected to be around DKK 3.5 billion in 2012, primarily related to investments in filling capacity and a prefilled device production facility in Denmark. Expectations for depreciation, amortisation and impairment losses are still expected to be around DKK 2.9 billion, and free cash flow is still expected to be around DKK 18 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 2012 and that currency exchange rates, especially the US dollar, will remain at the current level versus the Danish krone during the remainder of 2012. 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 Nordisk’s operating profit as outlined in the table below.
|
Key
invoicing
|
Annual
impact on Novo Nordisk’s
|
Hedging
period
|
|
currencies
|
operating
profit of a 5%
|
(months)
|
|
movement
in currency
|
||
|
USD
|
DKK
775 million
|
11
|
|
JPY
|
DKK
170 million
|
12
|
|
CNY
|
DKK
100 million
|
12*
|
|
GBP
|
DKK
75 million
|
11
|
* USD used as proxy when hedging Novo Nordisk’s CNY currency exposure
The financial impact from foreign exchange hedging is included in ‘Net financials’.
Research and development update
Diabetes
care: Insulin and GLP-1
Tresiba®
and Ryzodeg®
regulatory update
Global brand
names for the new generation of insulins have been selected: Degludec is intended
to be marketed as Tresiba®
and DegludecPlus is intended to be marketed as Ryzodeg®.
The regulatory reviews for Tresiba® and Ryzodeg® continue to progress. Novo Nordisk has now submitted Tresiba® and Ryzodeg® for regulatory review in the US, Europe, Japan, Switzerland, Canada, South Africa, India, Australia, Brazil and Mexico. Further, Tresiba® has also been submitted in Russia.
Initial phase
1 results for novel faster-acting formulations of insulin aspart, NN1218
Novo Nordisk has successfully
concluded an initial phase 1 trial for a range of novel faster-acting insulin
aspart formulations, NN1218. Confirmatory phase 1 trial activities will proceed
during 2012, potentially allowing for selection of the formulation to be developed
in phase 3.
| Company Announcement no 28 / 2012 |
Page
8 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 |
Victoza®
label expansions and updates
On 28 February
2012, the European Commission approved the inclusion of a study comparing
Victoza® once-daily vs exenatide twice-daily
results in the European Victoza® product label. The label now reflects
that Victoza®
is statistically superior to exenatide treatment in reducing blood sugar levels.
As communicated on 6 April 2012, the Food and Drug Administration (FDA) in the US has approved an update of the product label for Victoza®. The label now includes data showing superior blood sugar control and weight reduction when compared to the DPP-IV inhibitor sitagliptin and also data demonstrating the safety and efficacy of co-usage of basal insulin and Victoza®.
On 23 April 2012, the European Commission approved inclusion of the Victoza® vs sitagliptin trial results in the European product label, demonstrating superior blood sugar control and weight reduction when compared to the DPP-IV inhibitor sitagliptin.
LEADER®,
a cardiovascular outcomes trial for Victoza®,
completes enrolment
The cardiovascular
outcomes trial, LEADER®,
for Victoza®
has completed enrolment in February 2012 as planned. As part of a post-approval
commitment given to the FDA and the European Medicines Agency (EMA), more
than 9,000 patients have been enrolled globally with the objective to assess
the cardiovascular risk and benefit profile of Victoza®
in type 2 diabetes. The trial is expected to conclude in 2016.
Phase 1
trial investigating liraglutide as adjunct therapy to insulin in type 1 diabetes
initiated
Novo Nordisk
has initiated a phase 1 trial to explore the efficacy and safety of liraglutide,
the active ingredient in the once-daily human GLP-1 analogue Victoza®,
as an adjunct to insulin in type 1 diabetes.
Biopharmaceuticals:
Haemophilia
Phase
3 programme for long-acting recombinant factor VIII compound, N8-GP, initiated
In February
2012, Novo Nordisk initiated the phase 3 programme for a novel long-acting
recombinant factor VIII compound for the treatment of haemophilia A.
Biopharmaceuticals:
Inflammation
Phase
2a trial results for anti-NKG2D in rheumatoid arthritis
Anti-NKG2D
is a monoclonal antibody in clinical development. The phase 2a study in rheumatoid
arthritis proved that the drug had a safe profile but did
not demonstrate an effect on disease activity (as measured by DAS28-CRP, Disease
Activity Score) which served as the primary endpoint. As a consequence, Novo
Nordisk has decided not to pursue further development of the compound within
rheumatoid arthritis.
Sustainability
update
The number
of full-time employees was 32,252 as of 31 March 2012 compared to 30,867 as
of 31 March 2011. New hiring was led by expansion in China, countries in the
International Operations region and within Research and Development in Denmark,
India and the US.
As part of the Changing Diabetes® in Children programme, Novo Nordisk inaugurated its third clinic in Dhaka, Bangladesh. More than 1,000 children with diabetes will be cared for at this clinic. Bangladesh has been singled out as a focus country for this effort, since it is estimated by the International Diabetes Federation (IDF) to host more than a third of all people with diabetes in the world’s 49 least developed countries as defined by the UN.
| Company Announcement no 28 / 2012 |
Page
9 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
The number of children enrolled at this clinic is expected to reach 1,500 by the end of the year. To date more than 50 clinics have been established in nine countries under this dedicated programme, reaching 5,300 children and providing diabetes training for more than 1,100 healthcare professionals.
Equity
Total equity
was DKK 32,358 million at the end of the first quarter of 2012, equivalent
to 52.9% of total assets, compared to 58.9% at the end of the first quarter
of 2011. The development in equity ratio is primarily driven by the increased
dividend payments and the ongoing share repurchase programme – lowering
retained earnings – while the liabilities grow in line with operations.
Please refer to appendix 5 for further elaboration of changes in equity during
the first quarter of 2012.
Reduction
of share capital
The Annual
General Meeting of Novo Nordisk A/S, which was held on 21 March 2012, approved
a 3.4% 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 on 23 April 2012, Novo
Nordisk’s share capital now amounts to DKK 560,000,000 divided
into an A share capital of DKK 107,487,200 and a B share capital of DKK 452,512,800.
Treasury
shares and 2012 share repurchase programme
On 2 February
2012, Novo Nordisk announced a DKK 2.5 billion share repurchase programme as
part of an overall DKK 12 billion programme to be executed during a 12-month
period. The purpose of the programme is to reduce the
company’s
share capital. Under the programme Novo
Nordisk has repurchased B shares for an amount of DKK 2.5 billion in the period
from 2 February 2012 to 25 April 2012. The programme was concluded on 25 April
2012.
As per 25 April 2012, Novo Nordisk A/S and its wholly-owned affiliates owned 8,101,726 of its own B shares, corresponding to 1.4% of the total share capital.
Share repurchases under the overall DKK 12 billion programme will be resumed shortly.
Legal update
As of 26 April
2012, 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 48
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, 64 individuals currently allege, in relation
to similar lawsuits against Pfizer Inc., that they have also used a Novo Nordisk
hormone therapy product. Pfizer Inc. has publicly announced the settlement of
many of its hormone therapy cases. The reduction in pending cases is the result
of Pfizer Inc.
settling several cases that also
involve Novo Nordisk’s products. Currently, Novo
Nordisk’s
first trial is scheduled for September 2012. Novo Nordisk does not expect the
pending claims to have a material impact on its financial position, operating
profit and cash flow.
On 17 April 2012, the US Supreme Court reversed the US Court of Appeals for the Federal Circuit s (CAFC) April 2010 decision, which dismissed generic manufacturer Caraco
| Company Announcement no 28 / 2012 |
Page
10 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 |
Pharmaceutical’s right to claim a change to NN’s use code in FDA’s Orange Book. The use code includes a description of the scope of Novo Nordisk’s patents relevant to the combination use of repaglinide (marketed as Prandin® in the US) and metformin for the treatment of type 2 diabetes. Caraco had at CAFC argued that the use code description was too broad and therefore prevented any generic from entering the market. It had therefore raised a counterclaim to challenge the description. The US Supreme Court concluded that Caraco may pursue a claim to seek correction of Novo Nordisk’s use code, and referred the case for further proceedings on such a claim at the CAFC.
| Financial calendar | ||
| 9 August 2012 | Financial statement for the first six months of 2012 | |
| 31 October 2012 | Financial statement for the first nine months of 2012 | |
| 31 January 2013 | Financial statement for 2012 |
Conference call
details
At 13.00 CET today, corresponding to 7.00 am EDT, a conference call will be
held. Investors will be able to listen in via a link on novonordisk.com,
which can be found under ‘Investors – Download centre’ (http://www.novonordisk.com/investors/default.asp).
Presentation material for the conference call will be available approximately
one hour prior to the start of the conference call on the same page.
Forward-looking statements
Novo Nordisk’s reports filed with or furnished to US Securities and Exchange Commission (SEC), including this document as well as the company’s Annual Report 2011 and Form 20-F, both filed with the SEC in February 2012, and written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as ‘believe’, ‘expect’, ‘may, ‘will’, ‘plan’, ‘strategy’, ‘prospect’, ‘foresee’, ‘estimate’, ‘project’, ‘anticipate’, ‘can’, ‘intend’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to:
| – | statements of plans, objectives or goals for future operations, including those related to Novo Nordisk’s products, product research, product development, product introductions and product approvals as well as 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 of the assumptions underlying or relating to such statements. |
In this document, examples of forward-looking statements can be found under the headings ‘Outlook 2012’, ‘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.
| Company Announcement no 28 / 2012 |
Page
11 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 |
Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recall, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk’s products, introduction of competing products, reliance on information technology, Novo Nordisk’s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees and failure to maintain a culture of compliance.
Please also refer to the overview of risk factors in ‘Risk Management’ on pp22-24 of the Annual Report 2011 available on the company’s website novonordisk.com.
Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this document, whether as a result of new information, future events or otherwise.
| Company Announcement no 28 / 2012 |
Page
12 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Management statement
The Board of Directors and Executive Management have reviewed and approved the financial report of Novo Nordisk A/S for the first quarter of 2012. The financial report has not been audited or reviewed by the company’s independent auditors.
The first quarter financial report has been prepared in accordance with IAS 34 ‘Interim Financial Reporting’ and accounting policies set out in the Annual Report 2011 of Novo Nordisk. Furthermore, the first quarter financial report and Management’s 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 first quarter 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, 27 April 2012
|
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
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
|
Liz
Hewitt
|
| Company Announcement no 28 / 2012 |
Page
13 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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
|
|
Lars
Borup Jacobsen
|
|
|
Tel:
(+45) 3075 3479
|
|
|
lbpj@novonordisk.com
|
|
|
Frank
Daniel Mersebach
|
|
|
Tel:
(+45) 4442 0604
|
|
|
fdni@novonordisk.com
|
|
|
In
North America:
|
In
North America
|
|
Ken
Inchausti
|
Jannick
Lindegaard
|
|
Tel:
(+1) 609 786 8316
|
Tel:
(+1) 609 786 4575
|
|
kiau@novonordisk.com
|
jlis@novonordisk.com
|
Further information about Novo Nordisk is available on the company’s website novonordisk.com
| Company Announcement no 28 / 2012 |
Page
14 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
Appendix
1: Quarterly numbers in DKK
(Amounts
in DKK million, except number of employees, earnings per share and number
of shares outstanding).
|
%
change
|
||||||||||||||
|
2012
|
2011
|
Q1
2012 vs
|
||||||||||||
|
Q1
|
|
Q4
|
|
Q3
|
Q2
|
|
Q1
|
|
Q1
2011
|
|||||
|
|
|
|
|
|
|
|||||||||
| Sales |
17,751
|
18,120
|
16,532
|
16,001
|
15,693
|
13%
|
||||||||
| Gross profit |
14,348
|
14,998
|
13,281
|
12,902
|
12,576
|
14%
|
||||||||
| Gross margin |
80.8%
|
82.8%
|
80.3%
|
80.6%
|
80.1%
|
|||||||||
| Sales and distribution costs |
4,850
|
5,387
|
4,724
|
4,633
|
4,260
|
14%
|
||||||||
| Percent of sales |
27.3%
|
29.7%
|
28.6%
|
29.0%
|
27.1%
|
|||||||||
| Research and development costs |
2,507
|
2,752
|
2,263
|
2,323
|
2,290
|
9%
|
||||||||
| Percent of sales |
14.1%
|
15.2%
|
13.7%
|
14.5%
|
14.6%
|
|||||||||
| Administrative expenses |
776
|
|
923
|
|
788
|
|
778
|
|
756
|
|
3%
|
|||
| Percent of sales |
4.4%
|
5.1%
|
4.8%
|
4.9%
|
4.8%
|
|||||||||
| Licence fees and other operating income (net) |
170
|
|
145
|
|
104
|
|
97
|
|
148
|
|
15%
|
|||
| Operating profit |
6,385
|
6,081
|
5,610
|
5,265
|
5,418
|
18%
|
||||||||
| Operating margin |
36.0%
|
33.6%
|
33.9%
|
32.9%
|
34.5%
|
|||||||||
| Share of profit/(loss) in associated companies |
–
|
(4
|
)
|
–
|
–
|
–
|
N/A
|
|||||||
| Financial income |
47
|
|
6
|
|
154
|
|
270
|
|
84
|
|
(44%
|
)
|
||
| Financial expenses |
375
|
|
272
|
|
308
|
|
167
|
|
212
|
|
77%
|
|||
| Profit before income taxes |
6,057
|
5,811
|
5,456
|
5,368
|
5,290
|
14%
|
||||||||
| Net profit |
4,664
|
4,689
|
4,201
|
4,134
|
4,073
|
15%
|
||||||||
| Depreciation, amortisation and impairment losses |
638
|
|
692
|
|
615
|
|
825
|
|
605
|
|
5%
|
|||
| Capital expenditure |
516
|
|
1,182
|
645
|
|
627
|
|
549
|
|
(6%
|
)
|
|||
| Net cash generated from operating activities |
6,915
|
3,981
|
7,754
|
4,531
|
5,108
|
35%
|
||||||||
| Free cash flow |
6,366
|
2,751
|
7,066
|
3,792
|
4,503
|
41%
|
||||||||
| Total assets |
61,210
|
64,698
|
62,013
|
61,528
|
59,001
|
4%
|
||||||||
| Total equity |
32,358
|
37,448
|
35,428
|
36,966
|
34,768
|
(7%
|
)
|
|||||||
| Equity ratio |
52.9%
|
57.9%
|
57.1%
|
60.1%
|
58.9%
|
|||||||||
| Full-time employees at the end of the period |
32,252
|
32,136
|
32,016
|
31,549
|
30,867
|
4%
|
||||||||
| Basic earnings per share/ADR (in DKK) |
8.38
|
8.40
|
7.45
|
7.26
|
7.13
|
18%
|
||||||||
| Diluted earnings per share/ADR (in DKK) |
8.32
|
8.33
|
7.39
|
7.21
|
7.06
|
18%
|
||||||||
| Average number of shares outstanding (million) |
556.7
|
557.6
|
563.5
|
569.1
|
571.6
|
(3%
|
)
|
|||||||
| Average number of shares outstanding incl | ||||||||||||||
| dilutive effect of options ‘in the money’ (million) |
560.5
|
561.9
|
568.1
|
573.8
|
576.7
|
(3%
|
)
|
|||||||
| Sales by business segment: | ||||||||||||||
| Modern insulins (insulin analogues) |
7,867
|
7,856
|
7,232
|
6,972
|
6,705
|
17%
|
||||||||
| Human insulins |
2,718
|
2,790
|
2,698
|
2,642
|
2,655
|
2%
|
||||||||
| Victoza® |
1,990
|
2,096
|
1,547
|
1,250
|
1,098
|
81%
|
||||||||
| Protein-related products |
625
|
|
569
|
|
574
|
|
527
|
|
639
|
|
(2%
|
)
|
||
| Oral antidiabetic products (OAD) |
716
|
|
649
|
|
562
|
|
653
|
|
711
|
|
1%
|
|||
| Diabetes care total |
13,916
|
13,960
|
12,613
|
12,044
|
11,808
|
18%
|
||||||||
| NovoSeven® |
1,909
|
2,131
|
2,044
|
2,140
|
2,032
|
(6%
|
)
|
|||||||
| Norditropin® |
1,346
|
1,340
|
1,275
|
1,180
|
1,252
|
8%
|
||||||||
| Hormone replacement therapy |
500
|
|
548
|
|
501
|
|
513
|
|
492
|
|
2%
|
|||
| Other products |
80
|
|
141
|
|
99
|
|
124
|
|
109
|
|
(27%
|
)
|
||
| Biopharmaceuticals total |
3,835
|
4,160
|
3,919
|
3,957
|
3,885
|
(1%
|
)
|
|||||||
| Sales by geographic segment: | ||||||||||||||
| North America |
7,324
|
7,582
|
6,804
|
6,165
|
6,035
|
21%
|
||||||||
| Europe |
4,596
|
4,998
|
4,728
|
4,847
|
4,595
|
0%
|
||||||||
| International Operations |
2,734
|
2,463
|
2,286
|
2,415
|
2,203
|
24%
|
||||||||
| Region China |
1,612
|
1,300
|
1,175
|
1,151
|
1,376
|
17%
|
||||||||
| Japan & Korea |
1,485
|
1,777
|
1,539
|
1,423
|
1,484
|
0%
|
||||||||
| Segment operating profit: | ||||||||||||||
| Diabetes care |
4,638
|
4,419
|
3,636
|
3,415
|
3,115
|
49%
|
||||||||
| Biopharmaceuticals |
1,747
|
1,662
|
1,974
|
1,850
|
2,303
|
(24%
|
)
|
|||||||
| Company Announcement no 28 / 2012 |
Page
15 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 |
2012
|
2011
|
||||
|
|
|
|
|
|
|
|
| Income statement | ||||||
| Sales |
17,751
|
15,693
|
||||
| Cost of goods sold |
3,403
|
3,117
|
||||
|
|
|
|
|
|
|
|
| Gross profit |
14,348
|
12,576
|
||||
| Sales and distribution costs |
4,850
|
4,260
|
||||
| Research and development costs |
2,507
|
2,290
|
||||
| Administrative expenses |
776
|
|
756
|
|
||
| Licence fees and other operating income, net |
170
|
|
148
|
|
||
|
|
|
|
|
|
|
|
| Operating profit |
6,385
|
5,418
|
||||
| Financial income |
47
|
|
84
|
|
||
| Financial expenses |
375
|
|
212
|
|
||
|
|
|
|
|
|
|
|
| Profit before income taxes |
6,057
|
5,290
|
||||
| Income taxes |
1,393
|
1,217
|
||||
|
|
|
|
|
|
|
|
| NET PROFIT |
4,664
|
4,073
|
||||
| Basic earnings per share (DKK) |
8.38
|
7.13
|
||||
| Diluted earnings per share (DKK) |
8.32
|
7.06
|
||||
| Segment Information | ||||||
|
|
|
|
|
|
|
|
| Segment sales: | ||||||
| Diabetes care |
13,916
|
11,808
|
||||
| Biopharmaceuticals |
3,835
|
3,885
|
||||
| Segment operating profit: | ||||||
| Diabetes care |
4,638
|
3,115
|
||||
| Operating margin |
33.3%
|
26.4%
|
||||
| Biopharmaceuticals |
1,747
|
2,303
|
||||
| Operating margin |
45.6%
|
59.3%
|
||||
| Total segment operating profit |
6,385
|
5,418
|
||||
|
|
|
|
|
|
|
|
| Statement of comprehensive income | ||||||
| Net profit for the period |
4,664
|
4,073
|
||||
| Other comprehensive income: | ||||||
| Realisation of previously deferred (gains)/losses on cash flow hedges to | ||||||
| income statement |
397
|
|
352
|
|
||
| Deferred gains/(losses) on cash flow hedges arising during the period |
587
|
|
1,002
|
|||
| Exchange rate adjustments of investments in subsidiaries |
26
|
|
(235
|
)
|
||
| Deferred gains/(losses) on equity investments |
37
|
|
5
|
|
||
| Other |
12
|
|
(65
|
)
|
||
| Tax on other comprehensive income, income/(expense) |
(322
|
)
|
(416
|
)
|
||
|
|
|
|
|
|
|
|
| Other comprehensive income for the period, net of tax |
737
|
|
643
|
|
||
|
|
|
|
|
|
|
|
| TOTAL COMPREHENSIVE INCOME FOR THE PERIOD |
5,401
|
4,716
|
| Company Announcement no 28 / 2012 |
Page
16 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 2012
|
31
Dec 2011
|
||||
|
|
|
|
|
|
|
|
| ASSETS | ||||||
| Intangible assets | 1,470 | 1,489 | ||||
| Property, plant and equipment | 20,731 | 20,931 | ||||
| Investments in associated companies | 40 | 39 | ||||
| Deferred income tax assets | 2,353 | 2,414 | ||||
| Other financial assets | 263 | 234 | ||||
|
|
|
|
|
|
|
|
| TOTAL NON-CURRENT ASSETS | 24,857 | 25,107 | ||||
| Inventories | 9,546 | 9,433 | ||||
| Trade receivables | 9,578 | 9,349 | ||||
| Tax receivables | 1,227 | 883 | ||||
| Other receivables and prepayments | 2,612 | 2,376 | ||||
| Marketable securities | 4,871 | 4,094 | ||||
| Derivative financial instruments | 87 | 48 | ||||
| Cash at bank and in hand | 8,432 | 13,408 | ||||
|
|
|
|
|
|
|
|
| TOTAL CURRENT ASSETS | 36,353 | 39,591 | ||||
|
|
|
|
|
|
|
|
| TOTAL ASSETS | 61,210 | 64,698 | ||||
|
|
|
|
|
|
|
|
| EQUITY AND LIABILITIES | ||||||
| Share capital | 580 | 580 | ||||
| Treasury shares | (27 | ) | (24 | ) | ||
| Retained earnings | 31,287 | 37,111 | ||||
| Other reserves | 518 | (219 | ) | |||
|
|
|
|
|
|
|
|
| TOTAL EQUITY | 32,358 | 37,448 | ||||
| Loans | 511 | 502 | ||||
| Deferred income tax liabilities | 3,779 | 3,206 | ||||
| Retirement benefit obligations | 440 | 439 | ||||
| Provisions | 2,129 | 2,324 | ||||
|
|
|
|
|
|
|
|
| Total non-current liabilities | 6,859 | 6,471 | ||||
| Current debt | 383 | 351 | ||||
| Trade payables | 2,560 | 3,291 | ||||
| Tax payables | 2,435 | 1,171 | ||||
| Other liabilities | 9,178 | 8,534 | ||||
| Derivative financial instruments | 570 | 1,492 | ||||
| Provisions | 6,867 | 5,940 | ||||
|
|
|
|
|
|
|
|
| Total current liabilities | 21,993 | 20,779 | ||||
| TOTAL LIABILITIES | 28,852 | 27,250 | ||||
|
|
|
|
|
|
|
|
| TOTAL EQUITY AND LIABILITIES | 61,210 | 64,698 | ||||
|
|
|
|
|
|
|
| Company Announcement no 28 / 2012 |
Page
17 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 2012 | Q1 2011 | ||||
|
|
|
|
|
|
|
|
| Net profit | 4,664 | 4,073 | ||||
| Adjustment for non-cash items | 3,745 | 1,924 | ||||
| Change in working capital | (578 | ) | (6 | ) | ||
| Interest received | 75 | 79 | ||||
| Interest paid | (8 | ) | (6 | ) | ||
| Income taxes paid | (983 | ) | (956 | ) | ||
|
|
|
|
|
|
|
|
| Net cash generated from operating activities | 6,915 | 5,108 | ||||
| Purchase of intangible assets and other financial assets | (33 | ) | (56 | ) | ||
| Proceeds from sale of property, plant and equipment | 12 | 3 | ||||
| Purchase of property, plant and equipment | (528 | ) | (552 | ) | ||
| Net change in marketable securities | (800 | ) |
500 |
|||
|
|
|
|
|
|
|
|
| Net cash used in investing activities | (1,349 | ) | (105 | ) | ||
| Purchase of treasury shares, net | (2,828 | ) | (1,288 | ) | ||
| Dividends paid | (7,742 | ) | (5,700 | ) | ||
|
|
|
|
|
|
|
|
| Net cash used in financing activities | (10,570 | ) | (6,988 | ) | ||
| NET CASH GENERATED FROM ACTIVITIES | (5,004 | ) | (1,985 | ) | ||
| Cash and cash equivalents at the beginning of the year | 13,057 | 11,960 | ||||
| Exchange gain/(loss) on cash and cash equivalents | (3 | ) | (67 | ) | ||
|
|
|
|
|
|
|
|
| Cash and cash equivalents at the end of the period | 8,050 | 9,908 | ||||
| Additional information: | ||||||
| Cash and cash equivalents at the end of the period | 8,050 | 9,908 | ||||
| Marketable securities at the end of the period | 4,871 | 3,451 | ||||
| Undrawn committed credit facilities | 4,836 | 4,474 | ||||
|
|
|
|
|
|
|
|
| FINANCIAL RESOURCES AT THE END OF THE PERIOD | 17,757 | 17,833 | ||||
| Net cash generated from operating activities | 6,915 | 5,108 | ||||
| Net cash used in investing activities | (1,349 | ) | (105 | ) | ||
| Net change in marketable securities | 800 | (500 | ) | |||
|
|
|
|
|
|
|
|
| FREE CASH FLOW | 6,366 | 4,503 | ||||
|
|
|
|
|
|
|
| Company Announcement no 28 / 2012 |
Page
18 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 adjustments
|
Deferred
gain/
(loss)
on cash
flow
hedges
|
Tax
and other
adjustments
|
Total
other
reserves
|
Total
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Q1 2012 | |||||||||||||||||
| Balance at the beginning of the period |
580
|
(24
|
)
|
37,111
|
398
|
(1,184
|
)
|
567
|
(219
|
)
|
37,448
|
||||||
| Profit for the period |
4,664
|
4,664
|
|||||||||||||||
| Other comprehensive income for the period, net of tax |
26
|
|
984
|
(273
|
)
|
737
|
|
737
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Total comprehensive income for the period |
4,664
|
26
|
|
984
|
(273
|
)
|
737
|
|
5,401
|
||||||||
| Transactions with owners, recognised directly in equity: | |||||||||||||||||
| Dividends |
(7,742
|
)
|
(7,742
|
) | |||||||||||||
| Share-based payment |
79
|
|
79
|
||||||||||||||
| Purchase of treasury shares |
(4
|
)
|
(2,882
|
)
|
(2,886
|
) | |||||||||||
| Sale of treasury shares |
1
|
|
57
|
|
58
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Balance at the end of the period |
580
|
(27
|
)
|
31,287
|
424
|
(200
|
)
|
294
|
518
|
32,358
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
reserves
|
|||||||||||||||||
|
|
|
||||||||||||||||
| DKK million |
Share
capital
|
Treasury
shares
|
Retained
earnings
|
Exchange
rate
adjustments |
Deferred
gain/
(loss)
on cash
flow
hedges
|
Tax
and
other
adjustments
|
Total
other
reserves
|
Total
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 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
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 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
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Balance at the end of the period |
600
|
(29
|
)
|
33,258
|
336
|
682
|
(79
|
)
|
939
|
34,768
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Company Announcement no 28 / 2012 |
Page
19 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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.
|
%
change
|
||||||||||||||||||||
| 2012 | 2011 |
Q1
2012 vs
|
||||||||||||||||||
|
Q1
|
Q4
|
Q3
|
Q2
|
Q1
|
Q1
2011
|
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
| Sales | 2,388 | 2,435 | 2,219 | 2,146 | 2,105 |
13%
|
||||||||||||||
| Gross profit | 1,930 | 2,015 | 1,783 | 1,730 | 1,687 |
14%
|
||||||||||||||
| Gross margin | 80.8% | 82.8% | 80.3% | 80.6% | 80.1% | |||||||||||||||
| Sales and distribution costs | 653 | 722 | 636 | 620 | 572 |
14%
|
||||||||||||||
| Percent of sales | 27.3% | 29.7% | 28.6% | 29.0% | 27.1% | |||||||||||||||
| Research and development costs | 337 | 370 | 303 | 312 | 307 |
9%
|
||||||||||||||
| Percent of sales | 14.1% | 15.2% | 13.7% | 14.5% | 14.6% | |||||||||||||||
| Administrative expenses | 104 | 125 | 105 | 105 | 101 |
3%
|
||||||||||||||
| Percent of sales | 4.4% | 5.1% | 4.8% | 4.9% | 4.8% | |||||||||||||||
| Licence fees and other operating income (net) | 23 | 19 | 14 | 13 | 20 |
15%
|
||||||||||||||
| Operating profit | 859 | 817 | 753 | 706 | 727 |
18%
|
||||||||||||||
| Operating margin | 36.0% | 33.6% | 33.9% | 32.9% | 34.5% | |||||||||||||||
| Share of profit/(loss) in associated companies | - | (1 |
)
|
- | - | - |
N/A
|
|||||||||||||
| Financial income | 6 | 1 | 21 | 36 | 11 |
(44%
|
) | |||||||||||||
| Financial expenses | 50 | 36 | 41 | 23 | 28 |
77%
|
||||||||||||||
| Profit before income taxes | 815 | 781 | 733 | 719 | 710 |
14%
|
||||||||||||||
| Net profit | 627 | 630 | 564 | 555 | 546 |
15%
|
||||||||||||||
| Depreciation, amortisation and impairment losses | 86 | 93 | 82 | 111 | 81 |
5%
|
||||||||||||||
| Capital expenditure | 69 | 159 | 86 | 84 | 74 |
(6%
|
) | |||||||||||||
| Net cash generated from operating activities | 930 | 536 | 1,040 | 608 | 685 |
35%
|
||||||||||||||
| Free cash flow | 856 | 370 | 948 | 509 | 604 |
41%
|
||||||||||||||
| Total assets | 8,227 | 8,703 | 8,333 | 8,249 | 7,912 |
4%
|
||||||||||||||
| Total equity | 4,349 | 5,037 | 4,761 | 4,956 | 4,663 |
(7%
|
) | |||||||||||||
| Equity ratio | 52.9% | 57.9% | 57.1% | 60.1% | 58.9% | |||||||||||||||
| Full-time employees at the end of the period | 32,252 | 32,136 | 32,016 | 31,549 | 30,867 |
4%
|
||||||||||||||
| Basic earnings per share/ADR (in EUR) | 1.13 | 1.13 | 1.00 | 0.97 | 0.96 |
18%
|
||||||||||||||
| Diluted earnings per share/ADR (in EUR) | 1.12 | 1.12 | 1.00 | 0.96 | 0.95 |
18%
|
||||||||||||||
| Average number of shares outstanding (million) | 556.7 | 557.6 | 563.5 | 569.1 | 571.6 |
(3%
|
) | |||||||||||||
| Average number of shares outstanding incl | ||||||||||||||||||||
| dilutive effect of options ‘in the money’ (million) | 560.5 | 561.9 | 568.1 | 573.8 | 576.7 |
(3%
|
) | |||||||||||||
| Sales by business segment: | ||||||||||||||||||||
| Modern insulins (insulin analogues) | 1,058 | 1,056 | 971 | 935 | 899 |
17%
|
||||||||||||||
| Human insulins | 366 | 375 | 363 | 354 | 356 |
2%
|
||||||||||||||
| Victoza® | 268 | 281 | 208 | 168 | 147 |
81%
|
||||||||||||||
| Protein-related products | 84 | 77 | 77 | 70 | 86 |
(2%
|
) | |||||||||||||
| Oral antidiabetic products (OAD) | 96 | 88 | 75 | 88 | 95 |
1%
|
||||||||||||||
| Diabetes care total | 1,872 | 1,877 | 1,694 | 1,615 | 1,583 |
18%
|
||||||||||||||
| NovoSeven® | 257 | 286 | 274 | 287 | 273 |
(6%
|
) | |||||||||||||
| Norditropin® | 181 | 180 | 171 | 158 | 168 |
8%
|
||||||||||||||
| Hormone replacement therapy | 67 | 74 | 67 | 69 | 66 |
2%
|
||||||||||||||
| Other products | 11 | 18 | 13 | 17 | 15 |
(27%
|
) | |||||||||||||
| Biopharmaceuticals total | 516 | 558 | 525 | 531 | 522 |
(1%
|
) | |||||||||||||
| Sales by geographic segment: | ||||||||||||||||||||
| North America | 985 | 1,019 | 914 | 827 | 809 |
21%
|
||||||||||||||
| Europe | 618 | 672 | 634 | 651 | 616 |
0%
|
||||||||||||||
| International Operations | 368 | 331 | 307 | 323 | 296 |
24%
|
||||||||||||||
| Region China | 217 | 174 | 158 | 154 | 185 |
17%
|
||||||||||||||
| Japan & Korea | 200 | 239 | 206 | 191 | 199 |
0%
|
||||||||||||||
| Segment operating profit: | ||||||||||||||||||||
| Diabetes care | 624 | 594 | 488 | 458 | 418 |
49%
|
||||||||||||||
| Biopharmaceuticals | 235 | 223 | 265 | 248 | 309 |
(24%
|
) | |||||||||||||
| Company Announcement no 28 / 2012 |
Page
20 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
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 |
2011
average exchange
rates
|
|
YTD
2012 average exchange
rates
as of 24 April 2012
|
|
Current
exchange rate as of
24
April 2012
|
||
|
|
|
||||||
|
|
|
|
|
|
|
|
|
| USD |
536
|
567
|
565
|
||||
| JPY |
6.73
|
7.12
|
6.96
|
||||
| CNY |
83
|
90
|
90
|
||||
| GBP |
859
|
893
|
912
|
| Company Announcement no 28 / 2012 |
Page
21 of 21
|
| Financial report for the period 1 January 2012 to 31 March 2012 |
|
Novo
Nordisk A/S
Investor Relations |
Novo
Allé
2880 Bagsværd Denmark |
Telephone:
+45 4444 8888 Telefax: +45 4444 6626 |
Internet:
novonordisk.com |
CVR
number:
24256790 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
| Date: April 30, 2012 |
NOVO NORDISK A/S Lars Rebien Sørensen, President and Chief Executive Officer |