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
MAY 1, 2013
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 [ ]
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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]
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If Yes is marked, indicate below the file number assigned to the registrant in connection with Rule 12g-32(b):82-_____________________
Financial report for the period 1 January 2013 to 31 March 2013
1 May 2013
Novo Nordisk
increased operating profit by 18% in the first
quarter of 2013
Sales growth of
13% driven by Victoza®,
NovoRapid® and Levemir®
Sales increased by 14% in local currencies and by 13% to 20.0 billion in Danish kroner. | |
| Sales of modern insulins increased by 16% (14% in Danish kroner). |
| Sales of Victoza® increased by 36% (35% in Danish kroner). |
| Sales in North America increased by 24% (23% in Danish kroner). |
| Sales in International Operations increased by 17% (13% in Danish kroner). |
Gross margin improved by 1.1 percentage points in Danish kroner to 81.9%, reflecting a favourable price and product mix development.
Reported operating profit increased by 21% in local currencies and by 18% in Danish kroner to DKK 7.6 billion.
Net profit increased by 28% to DKK 6.0 billion. Diluted earnings per share increased by 32% to DKK 10.98.
Tresiba®, the new-generation insulin with an ultra-long duration of action, has been launched in the UK, Denmark and Japan. In the US, Novo Nordisk received a Complete Response Letter from the FDA regarding the New Drug Applications for Tresiba® and Ryzodeg® in February 2013. In the letter, the FDA requests that Novo Nordisk conducts a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed.
For 2013, sales growth measured in local currencies is now expected to be 9-11%, whereas operating profit growth measured in local currencies is still expected to be around 10%.
Lars Rebien Sørensen, president and CEO: We are pleased with the strong sales in the first quarter of 2013 driven by our portfolio of modern insulins and Victoza®. We have launched Tresiba®, the new-generation insulin with an ultra-long duration of action, in a number of countries and are encouraged by the early feedback from patients and doctors. In the US, we are in a constructive dialogue with the FDA on how to resolve the issues raised in the Complete Response Letter for Tresiba® and Ryzodeg®.
Novo Nordisk
A/S Investor Relations |
Novo
Allé
2880
Bagsværd
Denmark |
Telephone:
+45
4444 8888
www.novonordisk.com |
CVR
No:
24
25 67 90
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Company
announcement No 32 / 2013
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Financial report for the period 1 January 2013 to 31 March 2013 |
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ABOUT NOVO NORDISK
Novo Nordisk is a global
healthcare company with 90 years of innovation and leadership in diabetes
care. The company also has leading positions within haemophilia care, growth
hormone therapy and hormone replacement therapy. Headquartered in Denmark,
Novo Nordisk employs approximately 35,000 employees in 75 countries, and markets
its products in more than 180 countries. Novo Nordisks B shares are
listed on NASDAQ OMX Copenhagen (Novo-B) and its ADRs are listed on the New
York Stock Exchange (NVO).
CONFERENCE CALL
DETAILS
On 1 May 2013 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 available approximately one hour
before on the same page.
WEB CAST DETAILS
On 2 May 2013 at 10.00
CEST, corresponding to 4.00 am EDT, management will give a presentation to
institutional investors and sell side-analysts in London. A webcast of the
presentation can be followed via a link on novonordisk.com,
which can be found under Investors Download centre. Presentation
material for the conference call will be made available on the same page.
FINANCIAL CALENDAR | |
22 June 2013 | ADA investor presentation |
8 August 2013 | Financial statement for the first six months of 2013 |
31 October 2013 | Financial statement for the first nine months of 2013 |
30 January 2014 | Financial statement for 2013 |
CONTACTS FOR FURTHER INFORMATION | ||
Media: | ||
Mike Rulis |
+45
4442 3573
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mike@novonordisk.com
|
Ken Inchausti (US) |
+1
609 514 8316
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kiau@novonordisk.com
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Investors: | ||
Kasper Roseeuw Poulsen | +45 4442 4303 |
krop@novonordisk.com
|
Frank Daniel Mersebach | +45 4442 0604 |
fdni@novonordisk.com
|
Lars Borup Jacobsen | +45 3075 3479 |
lbpj@novonordisk.com
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Jannick Lindegaard (US) | +1 609 786 4575 |
jlis@novonordisk.com
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Further information about Novo Nordisk is available on the companys website novonordisk.com.
Company announcement No 32 / 2013
Financial report for the period 1 January 2013 to 31 March 2013 |
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Financial
performance |
Outlook
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R&D
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Sustainability
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Equity
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Corporate
governance |
Legal
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Financial
information |
Company announcement No 32 / 2013
Financial report for the period 1 January 2013 to 31 March 2013 |
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CONSOLIDATED
FINANCIAL STATEMENT FOR THE FIRST QUARTER OF 2013
These unaudited consolidated
financial statements for the first three months of 2013 have been prepared
in accordance with IAS 34 Interim Financial Reporting and on the
basis of the same accounting policies as were applied in the Annual Report
2012 of Novo Nordisk. Furthermore, the financial report including the consolidated
financial statements for the first three months of 2013 and Managements
review have been 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)
as published by the IASB, and also those that are endorsed by the EU effective
for the accounting period beginning on 1 January 2013. These IFRSs have not
had a significant impact on the consolidated financial statements for the
first three months of 2013.
Amounts in DKK million, except number of shares, earnings per share and full-time equivalent employees.
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PROFIT AND LOSS |
Q1
2013
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Q1
2012
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%
change
Q1 2012 to Q1 2013 |
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DKK million | ||||||
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Sales | 19,983 | 17,751 | 13% | |||
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Gross profit | 16,374 | 14,348 | 14% | |||
Gross margin | 81.9% | 80.8% | ||||
Sales and distribution costs | 5,530 | 4,850 | 14% | |||
Percent of sales | 27.7% | 27.3% | ||||
Research and development costs | 2,657 | 2,507 | 6% | |||
Percent of sales | 13.3% | 14.1% | ||||
Administrative costs | 801 | 776 | 3% | |||
Percent of sales | 4.0% | 4.4% | ||||
Licence fees and other operating income | 176 | 170 | 4% | |||
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Operating profit | 7,562 | 6,385 | 18% | |||
Operating margin | 37.8% | 36.0% | ||||
Net financials | 207 | (328 | ) |
N/A
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Profit before income taxes | 7,769 | 6,057 | 28% | |||
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Net profit | 5,982 | 4,664 | 28% | |||
Net profit margin | 29.9% | 26.3% | ||||
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OTHER KEY NUMBERS | ||||||
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Depreciation, amortisation and impairment losses | 691 | 638 | 8% | |||
Capital expenditure | 782 | 516 | 52% | |||
Net cash generated from operating activities1 | 7,070 | 5,587 | 27% | |||
Free cash flow1 | 6,178 | 5,038 | 23% | |||
Total assets | 62,447 | 61,210 | 2% | |||
Equity | 33,801 | 32,358 | 4% | |||
Equity ratio | 54.1% | 52.9% | ||||
Average number of diluted shares outstanding (million) | 544.7 | 560.5 | (3% | ) | ||
Diluted earnings per share / ADR (in DKK) | 10.98 | 8.32 | 32% | |||
Full-time equivalent employees end of period | 35,154 | 32,252 | 9% |
1Free
cash flow for Q1 2012 has been reduced by DKK 1,328 million as withheld dividend
tax is now presented as part of financing activities.
Financial
performance |
Outlook
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R&D
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Sustainability
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Equity
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Corporate
governance |
Legal
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Financial
information |
Financial report for the period 1 January 2013 to 31 March 2013 |
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SALES
DEVELOPMENT
Sales increased by 14%
measured in local currencies and by 13% in Danish kroner. North America was
the main contributor with 68% share of growth measured in local currencies,
followed by International Operations, Region China and Europe, contributing
19%, 10% and 6% respectively. Sales growth was realised within both diabetes
care and biopharmaceuticals, with the majority of growth originating from
the modern insulins and Victoza®.
Sales growth was positively impacted by a number of non-recurring events including
timing in shipments in the US and International Operations, extraordinary
sales in International Operations as well as a modest level of sales for NovoSeven®
in the first quarter of 2012.
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Sales
Q1 2013 DKK million |
Growth
as reported |
Growth
in local currencies |
Share
of
growth in local currencies |
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The diabetes care segment | ||||||||
- NovoRapid ® | 4,017 | 14% | 16% | 22% | ||||
- NovoMix ® | 2,400 | 12% | 14% | 12% | ||||
- Levemir ® | 2,574 | 17% | 19% | 16% | ||||
Modern insulins | 8,991 | 14% | 16% | 50% | ||||
Human insulins | 2,824 | 4% | 5% | 6% | ||||
Victoza® | 2,678 | 35% | 36% | 28% | ||||
Protein-related products | 606 | (3% | ) | 0% | (1% | ) | ||
Oral antidiabetic products (OAD) | 694 | (3% | ) | (3% | ) | (1% | ) | |
Diabetes care total | 15,793 | 13% | 15% | 82% | ||||
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The biopharmaceuticals segment | ||||||||
NovoSeven® | 2,027 | 6% | 7% | 6% | ||||
Norditropin® | 1,537 | 14% | 18% | 10% | ||||
Other biopharmaceuticals | 626 | 8% | 9% | 2% | ||||
Biopharmaceuticals total | 4,190 | 9% | 12% | 18% | ||||
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Total sales | 19,983 | 13% | 14% | 100% | ||||
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In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from January 2013 and January 2012 provided by the independent data provider IMS Health.
DIABETES
CARE SALES DEVELOPMENT
Sales of diabetes care
products increased by 15% measured in local currencies and by 13% in Danish
kroner to DKK 15,793 million. Novo Nordisk is the world leader in diabetes
care and now holds a global value market share of 26% compared to 24% at the
same time the year before.
Insulins and protein-related
products
Sales of modern insulins,
human insulins and protein-related products increased by 13% in local currencies
and by 11% in Danish kroner to DKK 12,421 million. In local currencies, sales
growth was driven by North America, International Operations and
Financial
performance |
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information |
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Region China. Novo Nordisk is the global leader with 49% of the total insulin market and 46% of the modern insulin market, both measured in volume.
Tresiba® (insulin degludec), the once-daily new-generation insulin with an ultra-long duration of action, was commercially launched in the UK and Denmark on 4 March and in Japan on 7 March. In the UK and Denmark reimbursement is restricted whereas Tresiba® is broadly reimbursed in Japan. Launch activities are progressing as planned in all three markets and early feedback from patients and prescribers is encouraging.
Sales of modern insulins increased by 16% in local currencies and by 14% in Danish kroner to DKK 8,991 million. North America accounted for more than half of the growth, followed by International Operations and Region China. Sales of modern insulins now constitute 76% of Novo Nordisks sales of insulin.
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INSULIN MARKET
SHARES (volume, MAT) |
Novo
Nordisks share of total insulin market |
Novo
Nordisks share of modern insulin market |
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January 2013 |
January 2012 |
January 2013 |
January 2012 |
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Global | 49% | 50% | 46% | 46% | ||||
USA | 41% | 40% | 38% | 36% | ||||
Europe | 50% | 51% | 50% | 50% | ||||
International Operations* | 57% | 58% | 54% | 56% | ||||
China** | 60% | 62% | 64% | 66% | ||||
Japan | 55% | 59% | 50% | 53% | ||||
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Source: IMS, January 2013 data. *: Data for 12 selected markets representing approximately 60% of Novo Nordisks diabetes sales in the region. **: Data for mainland China, excluding Hong Kong and Taiwan.
North America
Sales of insulins and protein-related
products in North America increased by 21% in both local currencies and Danish
kroner. Sales growth reflects continued solid market penetration of all three
modern insulins, NovoLog®,
Levemir® and NovoLog®
Mix 70/30 and human insulin sales growth as well as a positive contribution
from US pricing. In the US, sales were slightly positively impacted by changes
in inventories at wholesaler level. 51% of Novo Nordisks modern insulin
volume in the US is used in the prefilled device FlexPen®.
Europe
Sales of insulins and protein-related
products in Europe were unchanged both in local currencies and Danish kroner.
Sales in Europe reflect continued progress for Levemir®
and NovoRapid®, countered
by declining human insulin sales. Sales growth in Europe is negatively impacted
by a continued low insulin volume growth, below 2%, and by the implementation
of pricing reforms in several European markets. The device penetration in
Europe remains high with 96% of Novo Nordisks insulin volume being used
in devices, primarily NovoPen®
and FlexPen®.
International
Operations
Sales of insulins and protein-related
products in International Operations increased by 18% in local currencies
and by 13% in Danish kroner. The growth, which is positively impacted by extraordinary
sales and the timing of shipments in a number of countries, is driven by all
three modern insulins and a solid contribution from human insulins.
Financial
performance |
Outlook
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R&D
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Sustainability
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Equity
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Corporate
governance |
Legal
|
Financial
information |
Company announcement No 32 / 2013
Financial report for the period 1 January 2013 to 31 March 2013 |
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Currently, 58% of Novo Nordisks insulin volume in the major private markets is used in devices.
Region China
Sales of insulins and protein-related
products in Region China increased by 19% in local currencies and by 20% in
Danish kroner. The sales growth was driven by all three modern insulins, while
sales of human insulins only grew modestly. Currently, 97% of Novo Nordisks
insulin volume in China is used in devices, primarily the durable device NovoPen®.
Japan & Korea
Sales of insulins and protein-related
products in Japan & Korea decreased by 6% in local currencies and by 19%
measured in Danish kroner. Sales development is impacted negatively by a very
low volume growth in the Japanese insulin market and a challenging competitive
environment. The device penetration in Japan remains high with 98% of Novo
Nordisks insulin volume being used in devices, primarily the FlexPen®.
Victoza®
(GLP-1 therapy for type 2 diabetes)
Victoza®
sales increased by 36% in local currencies and by 35% in Danish kroner to
DKK 2,678 million, reflecting robust sales performance driven by North America,
Europe and International Operations. Victoza®
holds the global market share leadership with a 68% value market share in
the GLP-1 segment compared to 61% in 2012. The GLP-1 segments value
share of the total diabetes care market has increased to 6.2% compared to
4.8% in 2012.
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GLP-1 MARKET SHARES
(value, MAT) |
GLP-1
share of total diabetes care market |
Victoza®
share of GLP-1 market |
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January 2013 |
January 2012 |
January 2013 |
January 2012 |
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Global | 6.2% | 4.8% | 68% | 61% | ||||
USA | 7.6% | 6.0% | 63% | 55% | ||||
Europe | 6.9% | 5.3% | 77% | 70% | ||||
International Operations* | 3.0% | 1.7% | 79% | 72% | ||||
China** | 0.6% | 0.3% | 50% | 9% | ||||
Japan | 2.3% | 1.8% | 76% | 85% | ||||
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Source: IMS, January 2013 data. *: Data for 12 selected markets representing approximately 60% of Novo Nordisks diabetes sales in the region. **: Data for mainland China, excluding Hong Kong and Taiwan.
North America
Sales of Victoza®
in North America increased by 41% in both local currencies and in Danish kroner.
This reflects a continued expansion of the GLP-1 class, which represents 7.6%
of the total US diabetes care market in value compared to 6.0% in 2012. Despite
the launch of a competing product in 2012, Victoza®
continues to drive the US GLP-1 market expansion and is the GLP-1 market leader,
now with a 63% value market share compared to 55% a year ago.
Europe
Sales in Europe increased
by 26% in both local currencies and in Danish kroner. Sales growth is primarily
driven by France, the UK, Italy and Spain. In Europe, the GLP-1 class
share of the total diabetes care market in value has increased to 6.9% compared
to 5.3% in 2012. Victoza®
is the GLP-1 market leader with a value market share of 77%.
Financial
performance |
Outlook
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R&D
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Sustainability
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Equity
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Corporate
governance |
Legal
|
Financial
information |
Company announcement No 32 / 2013
Financial report for the period 1 January 2013 to 31 March 2013 |
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International Operations
Sales in International
Operations increased by 44% in local currencies and by 35% in Danish kroner.
This reflects continued market penetration, driven by a number of Middle Eastern
countries and Brazil as well as timing of shipments. The GLP-1 class is expanding
in International Operations and represents 3.0% of the total diabetes care
market in value compared to 1.7% in 2012. Victoza®
is the GLP-1 market leader across International Operations with a value market
share of 79%.
Region China
Sales in Region China increased
by 131% in local currencies and by 138% in Danish kroner. The GLP-1 class
in China is not reimbursed and relatively modest in size. However, its share
of the total diabetes care market in value has expanded to 0.6% compared to
0.3% in 2012. Victoza®
holds a GLP-1 value market share of 50%.
Japan & Korea
Sales in Japan & Korea
were unchanged in local currencies and decreased by 15% in Danish kroner.
In Japan, the GLP-1 class is gradually expanding and now represents 2.3% of
the total diabetes care market in value compared to 1.8% in 2012. Victoza®
remains the leader in the Japanese GLP-1 class with a value market share of
76%, but it has lost some market share to a competitor product.
NovoNorm®/Prandin®/PrandiMet®
(oral antidiabetic products)
Sales of oral antidiabetic
products decreased by 3% both in local currencies and in Danish kroner to
DKK 694 million. The sales development reflects a decrease in sales in Europe
and Region China where generic competition is negatively impacting overall
sales in several markets.
BIOPHARMACEUTICALS
SALES DEVELOPMENT
Sales of biopharmaceutical
products increased by 12% measured in local currencies and by 9% in Danish
kroner to DKK 4,190 million. Sales growth was primarily driven by North America
and International Operations.
NovoSeven®
(bleeding disorders therapy)
Sales of NovoSeven®
increased by 7% in local currencies and by 6% in Danish kroner to DKK 2,027
million compared to a relatively low level of sales in the first quarter of
2012. The sales development reflects a strong performance in North America
and Europe countered by lower sales in International Operations. The market
for NovoSeven® is volatile
and remains negatively impacted by stricter budgetary controls, inhibitor
patients participating in clinical trials and patients transferring to an
alternative treatment regimen of immune tolerance therapy.
Norditropin®
(growth hormone therapy)
Sales of Norditropin®
increased by 18% in local currencies and by 14% in Danish kroner to DKK 1,537
million. The sales growth is primarily driven by North America and by International
Operations, where performance is positively impacted by extraordinary sales
and timing of shipments in a number of Middle Eastern countries. Novo Nordisk
is the leading company in the global growth hormone market with a 24% market
share measured by volume.
Other biopharmaceuticals
Sales of other products
within biopharmaceuticals, which predominantly consist of hormone replacement
therapy (HRT)-related products, increased by 9% in local
Financial
performance |
Outlook
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R&D
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Corporate
governance |
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Financial
information |
Company announcement No 32 / 2013
Financial report for the period 1 January 2013 to 31 March 2013 |
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currencies and by 8% in Danish kroner to DKK 626 million. This development primarily reflects a positive impact of pricing in the US for Vagifem®, which is partly countered by competition from generic HRT products.
DEVELOPMENT
IN COSTS AND OPERATING PROFIT
The cost of goods sold
grew 6% to DKK 3,609 million, resulting in a gross margin of 81.9% compared
to 80.8% in 2012. This development primarily reflects an underlying improvement
driven by favourable price development in North America and a positive net
impact from product mix due to increased sales of modern insulins and Victoza®.
The gross margin was positively impacted from currencies by around 0.1 percentage
points primarily as a result of depreciation of the Brazilian real versus
the Danish krone compared to prevailing exchange rates in 2012.
Total non-production-related costs increased by 11% in both local currencies and in Danish kroner to DKK 8,988 million.
Sales and distribution costs increased by 15% in local currencies and by 14% in Danish kroner to DKK 5,530 million. The growth in costs is driven by the expansion of the US sales force in the second half of 2012, costs related to the launch of Tresiba® in Europe and Japan as well as an impact from the reversals of legal provisions in 2012.
Research and development costs increased by 6% in both local currencies and Danish kroner to DKK 2,657 million. The modest cost increase reflects timing of clinical trial activity and is primarily driven by development costs related to the ongoing phase 3a trials for the once-weekly GLP-1 analogue semaglutide and liraglutide in obesity. Within biopharmaceuticals, costs are primarily related to the continued progress of the portfolio of development projects within haemophilia and the phase 2 trial for anti-IL-20, a recombinant human monoclonal antibody, in rheumatoid arthritis.
Administration costs increased by 5% in local currencies and by 3% in Danish kroner to DKK 801 million. The increase in cost is primarily driven by back-office infrastructure costs to support the expansion of the sales organisation in North America and International Operations as well as refurbishment costs in relation to a new regional office in the US.
Licence fees and other operating income constituted DKK 176 million compared to DKK 170 million in 2012.
Operating profit in local currencies increased by 21% and by 18% in Danish kroner to DKK 7,562 million.
NET
FINANCIALS
Net financials showed a
net income of DKK 207 million compared to a net expense of DKK 328 million
in 2012.
In line with Novo Nordisks
treasury policy, the most significant foreign exchange risks for the group
have been hedged primarily through foreign exchange forward contracts. Reflecting
the portfolio of foreign exchange hedging contracts, the foreign exchange
result was an income of DKK 226 million compared to an expense of DKK 309
million in 2012. This development reflects gains on foreign exchange hedging
involving especially the Japanese yen due to its depreciation versus the Danish
krone compared to the prevailing exchange rates in the beginning of 2012.
Financial
performance |
Outlook
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R&D
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Sustainability
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Equity
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Corporate
governance |
Legal
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Financial
information |
Company announcement No 32 / 2013
Financial report for the period 1 January 2013 to 31 March 2013 |
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CAPITAL
EXPENDITURE AND FREE CASH FLOW
Net capital expenditure
for property, plant and equipment was DKK 0.8 billion compared to DKK 0.5
billion in 2012. Net capital expenditure was primarily related to filling
capacity in Denmark and Russia, new office buildings in Denmark, new diabetes
research facilities in Denmark as well as device production facilities in
the US and Denmark.
Free cash flow was DKK 6.2 billion compared to DKK 5.0 billion in 2012. The increase of 23% compared to 2012 reflects the growth in net profit of 28% countered by an increase in capital expenditure.
OUTLOOK 2013
The current expectations
for 2013 are summarised in the table below:
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Expectations are
as reported, if not otherwise stated |
Current
expectations
1 May 2013 |
Previous
expectations
31 January 2013 |
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Sales growth | ||
in local currencies | 9-11% | 811% |
as reported | Around 3 percentage points lower | Around 4.5 percentage points lower |
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Operating profit growth | ||
in local currencies | Around 10% | Around 10% |
as reported | Around 5 percentage points lower | Around 7 percentage points lower |
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Net financials | Income of around DKK 900 million | Income of around DKK 1,400 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 3.0 billion | Around DKK 3.0 billion |
Free cash flow | Around DKK 22 billion | Around DKK 22 billion |
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Novo Nordisk now expects sales growth in 2013 of 9-11% measured in local currencies. This reflects expectations for continued robust penetration for the portfolio of modern insulins, a continued steady Victoza® performance and a modest sales contribution from Tresiba®, primarily in the EU and Japan. These sales drivers are partly expected to be countered by an impact from the challenging pricing environments in major markets, generic competition to oral antidiabetic products, intensifying competition within diabetes care as well as biopharmaceuticals and the macroeconomic conditions in a number of markets in International Operations. Given the current level of exchange rates versus the Danish krone, the reported sales growth is now expected to be around 3 percentage points lower than growth measured in local currencies.
For 2013, operating
profit growth is still expected to be around 10% measured
in local currencies. This reflects significant costs related to the expanded
sales force and sales and marketing investments in the portfolio of modern
insulins and Victoza®
in the US, the launch of Tresiba®
outside the US as well as sales and marketing investments
in China and in a selected number of countries in International Operations.
Given the current level
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of exchange rates versus the Danish krone, the reported operating profit growth is now expected to be around 5 percentage points lower than growth measured in local currencies.
For 2013, Novo Nordisk expects a net financial income of around DKK 900 million. The current expectation primarily reflects gains associated with foreign exchange hedging contracts following the depreciation of the Japanese yen and the US dollar versus the Danish krone compared to the average prevailing exchange rates in 2012.
The effective tax rate for 2013 is still expected to be around 23%.
Capital expenditure is still expected to be around DKK 3.5 billion in 2013, primarily related to investments in filling capacity and prefilled device production facilities and new office buildings in Denmark. Depreciation, amortisation and impairment losses are still expected to be around DKK 3.0 billion. Free cash flow is still expected to be around DKK 22 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 2013, and that currency exchange rates, especially for the US dollar, will remain at the current level versus the Danish krone. 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
currencies |
Annual
impact on Novo Nordisks
operating profit of a 5% movement in currency |
Hedging
period
(months) |
|
|
|
USD |
DKK
1,100 million
|
12
|
JPY |
DKK
200 million
|
14
|
CNY |
DKK
170 million
|
12*
|
GBP |
DKK
85 million
|
12
|
CAD |
DKK
55 million
|
8
|
|
|
|
* USD used as proxy when hedging Novo Nordisks CNY currency exposure
The financial impact
from foreign exchange hedging is included in Net financials.
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DIABETES CARE: INSULIN AND GLP-1
Tresiba®
and Ryzodeg® regulatory update
As previously announced,
Novo Nordisk received a Complete Response Letter from the US Food and Drug
Administration (FDA) regarding the New Drug Applications for Tresiba®
and Ryzodeg® in February 2013. In the letter, the FDA requests
additional cardiovascular data from a dedicated cardiovascular outcomes trial
before the review of the New Drug Applications can be completed.
Novo Nordisk is currently in a dialogue with the agency to agree on the design of the trial to generate the requested data. The Tresiba® trial is expected to be double-blinded and use insulin glargine as comparator. Duration of the trial is expected to be dependent on the occurrence of cardiovascular events. It is expected that the basis for resubmission will be an interim analysis of the cardiovascular events in the trial. In addition, it is expected that Novo Nordisk will be required to continue the trial in order to make a definitive assessment of the cardiovascular safety of Tresiba®. Novo Nordisk expects to initiate the trial within one year and that data to support the interim analysis will be available around two to three years after trial initiation. Completion of the cardiovascular outcomes trial is expected around four to six years after initiation.
Second phase 3a obesity
trial completed for liraglutide 3 mg (NN8022)
As announced in March,
SCALE Diabetes, the second of four phase 3a obesity trials with liraglutide
3 mg has been completed.
The trial included 846 overweight and obese people with type 2 diabetes, a population which in prior obesity trials has shown a more modest weight response to treatment than non-diabetic populations. The participants had a mean baseline weight of 106 kg and a BMI of 37. During the trial, the weight loss for people treated with liraglutide 3 mg and liraglutide 1.8 mg after 56 weeks was 6% and 5% respectively, compared to a 2% weight loss for people treated with placebo. The proportion of people achieving a weight loss of at least 5% or 10% was 50% and 22% for liraglutide 3 mg, and 35% and 13% for liraglutide 1.8 mg and 13% and 4% for placebo treatment. All differences for both doses of liraglutide were statistically significantly different from placebo and the trial met all three co-primary endpoints.
Starting from a baseline HbA1C of 8.0%, 69%, 67% and 27% of people treated with liraglutide 3 mg, liraglutide 1.8 mg and placebo respectively achieved the HbA1c
treatment target of 7% recommended by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). The rate of hypoglycaemia was comparable to that observed in previous trials with liraglutide.
Liraglutide was generally
well tolerated and the 56-week completion rate was 77%, 78% and 66% for liraglutide
3 mg, liraglutide 1.8 mg and placebo respectively. Withdrawals
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due to adverse events were below 10% in all treatment groups. In line with previous liraglutide trials, the most common adverse events were related to the gastrointestinal system and diminished over time. No other apparent differences between the treatment groups were observed with respect to adverse events and standard safety parameters.
Novo Nordisk expects to complete the two remaining phase 3a trials in the SCALE programme by mid-2013.
IDegLira (NN9068)
completes 26-week extension of DUAL I
In February, a 26-week
extension of the phase 3a trial DUAL I with IDegLira, a fixed-ratio
combination of insulin degludec (Tresiba®) and the once-daily
human GLP-1 analogue, liraglutide (Victoza®), was completed.
In the core trial more than 1,600 people with type 2 diabetes, previously
inadequately controlled on one or two oral anti-diabetic drugs (OADs), were
randomised to 26 weeks of once-daily treatment with either IDegLira, Tresiba®
or Victoza®. More than 1,300 trial participants entered into
the extension phase where they continued with the treatment they had been
randomised to at the start of the trial.
The results of the 26-week extension were in line with the results of the first 26 weeks, which were announced in August 2012, and people randomised to IDegLira also experienced a statistically significant greater reduction in HbA1c compared to those randomised to Tresiba® or Victoza® after 52 weeks. Starting from a baseline HbA1c of 8.3%, 78% of people using IDegLira achieved the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) HbA1c treatment target of 7% after 52 weeks, compared to 81% after 26 weeks. The corresponding numbers for Tresiba® and Victoza® were 62% and 57% after 52 weeks, compared to 65% and 60% respectively after 26 weeks.
The rates of hypoglycaemia after 52 weeks were also consistent with those observed after 26 weeks of treatment, and the greater HbA1c reduction in patients treated with IDegLira remained associated with a statistically significant lower rate of confirmed hypoglycaemia, compared to treatment with Tresiba® alone.
After 52 weeks of treatment, people treated with IDegLira and Victoza® sustained the weight losses achieved during the first 26 weeks of around 0.5 kg and 3 kg respectively. People treated with Tresiba® experienced a weight gain of around 2.5 kg after 52 weeks compared to the weight gain of 1.5 kg after 26 weeks.
Tresiba® and Victoza® both confirmed previous safety and tolerability profiles, and no apparent differences between the three treatment groups were observed with respect to adverse events and standard safety parameters during the 52 weeks of treatment.
The DUAL I extension phase results confirm that the level of glycaemic control obtained after 26 weeks of treatment, as well as the favourable effects observed on hypoglycaemia and weight, were sustained up to 52 weeks for IDegLira.
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Novo Nordisk is planning regulatory filing for IDegLira in the EU during the second quarter of 2013. In the US, filing is expected to be contingent upon the regulatory dialogue related to Tresiba®.
Semaglutide (NN9535)
initiates first phase 3a trial as planned
In February, Novo Nordisk
initiated the first phase 3a trial with semaglutide, a once-weekly GLP-1 analogue.
The randomised, double-blind, placebo-controlled, multinational trial will
evaluate cardiovascular outcomes and other long-term diabetes-related endpoints
with semaglutide in around 3,000 subjects with type 2 diabetes. The trial
is expected to be completed in 2016.
Novo Nordisk plans to initiate more phase 3a trials in the SUSTAIN programme, the global clinical development programme for semaglutide, during the second half of 2013 and in 2014.
New oral insulin,
OI287GT (NN1956), starts phase 1
In March, Novo Nordisk
initiated the first phase 1 trial for OI287GT. The phase 1 trial will investigate
safety, tolerability and pharmacokinetics of single doses of OI287GT in healthy
volunteers.
BIOPHARMACEUTICALS: HAEMOPHILIA
New administration
system for NovoSeven® launched
Novo Nordisk has launched
a new pre-filled solvent syringe for intravenous infusion of NovoSeven®
in Germany. The pre-filled solvent syringe makes administration more convenient
by reducing the number of steps patients have to go through. Novo Nordisk
expects to launch NovoSeven® with the pre-filled solvent syringe
in more countries in Europe and in the US, where the product will be marketed
as NovoSeven®RT with MixPro, throughout 2013.
N8-GP (NN7088) initiates
pivotal paediatric trial
In March, Novo Nordisk
initiated a paediatric trial for N8-GP. The trial will investigate safety,
efficacy and pharmacokinetics in around 50 previously treated paediatric patients
with severe haemophilia A.
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BIOPHARMACEUTICALS: INFLAMMATION
Phase 2a initiated
with Anti-IL-21 in Crohns Disease (NN8828)
In March, Novo Nordisk
initiated a phase 2a trial with anti-IL-21 investigating efficacy and safety
in people with moderately to severely active Crohns disease. The trial
is planned to include around 110 people. This is the third indication being
investigated with anti-IL-21, which is currently also being studied in phase
2a for rheumatoid arthritis (RA) and in phase 1 for systemic lupus erythematosus
(SLE).
SUSTAINABILITY & ASSURANCE UPDATE
Number of full-time
equivalent employees
The number of full-time
equivalent employees was 35,154 as of 31 March 2013 compared to 32,252 as
of 31 March 2012. New hiring was led by expansion in the US, countries in
the International Operations region, Research & Development and Product
Supply.
Novo Nordisk ranked
as the fifth most sustainable company in the world
During the first quarter
of 2013 in connection with the World Economic Forum in Davos, Corporate
Knights released its Global 100 Most Sustainable Corporations in
the World index. Novo Nordisk was ranked fifth in the index across sectors
and was the highest ranked company in the pharmaceuticals and biotechnology
industry.
The Global 100 Most Sustainable Corporations in the World index is a data-driven corporate sustainability assessment, which screens all companies with a market capitalisation in excess of USD 2 billion. The selection of the top100 is based on 12 performance indicators including environmental productivity, innovation capacity, tax rate, safety and leadership diversity.
First diabetes forum
held in Mexico
In early April, the first
Diabetes Forum in Mexico took place to address the challenges posed to the
country by the diabetes burden. It is estimated that 10.6 million people in
Mexico have diabetes. This corresponds to around 15% of the adult population.
The Forum was hosted by the Ministry of Health of the Government of Mexico City and the National Institute of Medical Science and Nutrition, supported by diabetes patient organisations and with Novo Nordisk servicing as facilitator. At the Forum, the Federal Health Secretary announced the development of a national diabetes and obesity strategy to prevent the diabetes and its most costly complications as well as the intent to host the first Latin American Diabetes Leadership Forum with participations from other Latin American nations.
FDA feedback on response
to Warning Letter dated 12 December 2012
In March, Novo Nordisk
received FDAs reply to the response provided by Novo Nordisk in December
2012 to the previously announced Warning Letter received from the FDA following
a current Good Manufacturing Practice (cGMP) inspection of an aseptic filling
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facility in Bagsværd, Denmark. In its response the FDA acknowledges that the corrective actions proposed by Novo Nordisk should adequately address the violations cited in the Warning Letter and that a follow-up inspection of the facility is needed to verify that the corrective actions have been appropriately implemented.
Total equity was DKK 33,801 million at the end of the first quarter of 2013, equivalent to 54.1% of total assets, compared to 52.9% at the end of the first quarter of 2012. Please refer to appendix 5 for further elaboration of changes in equity.
Reduction in share
capital
The Annual General Meeting
of Novo Nordisk A/S, which was held on 20 March 2013, approved a 1.8% reduction
in the total share capital by cancellation of 10,000,000 treasury B shares
of DKK 1 at a nominal value of DKK 10,000,000. After the legal implementation
of the share capital reduction on 22 April 2013, Novo Nordisks share
capital now amounts to DKK 550,000,000 divided into an A share capital of
DKK 107,487,200 and a B share capital of DKK 442,512,800.
2013 share repurchase
programme
On 31 January 2013, Novo
Nordisk announced a share repurchase programme of up to DKK 3.0 billion to
be executed from 31 January 2013 to 29 April 2013, as part of an overall programme
of up to DKK 14 billion to be executed during a 12-month period. The purpose
of the programme is to reduce the companys share capital. Under the
programme, Novo Nordisk has repurchased B shares for an amount of DKK 3.0
billion in the period from 31 January 2013 to 29 April 2013. The programme
was concluded on 29 April 2013.
As per 29 April 2013, Novo Nordisk A/S and its wholly-owned affiliates owned 10,645,508 of its own B shares, corresponding to 1.9% of the total share capital.
Share repurchases under the overall programme of up to DKK 14 billion in the period February 2013 to January 2014 is expected to be resumed shortly.
Establishment of Nomination
Committee by the Board of Directors
In order to enhance the
process for nominating members to the Board of Directors of Novo Nordisk A/S,
the Board has established a Nomination Committee. The Nomination Committee
will assist the Board of Directors with the oversight of the competence profile
and composition of the Board, nomination of members of the Board and nomination
of members of Board committees all of which has previously been the responsibility
of the Chairmanship. The Board elected Göran Ando as the chairman and
Bruno Angelici, Liz Hewitt and Anne Marie Kverneland as members of the committee.
New composition of
Audit Committee
Further, the Board of Directors
elected Stig Strøbæk as member of the Audit Committee. The Audit
Committee now consists of Hannu Ryöppönen as chairman and Liz Hewitt
and Stig Strøbæk as members. Hannu Ryöppönen and Liz
Hewitt were both designated by the Board as financial experts and independent,
as defined by the US Securities and
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Exchange Commission (SEC). Under Danish law, the Board also designated both Hannu Ryöppönen and Liz Hewitt as financial experts and independent.
Product liability
lawsuits related to hormone therapy products
As of 29 April 2013, 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 24 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.). In addition, 36 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 Nordisks products. Currently, Novo Nordisk does
not have any trials scheduled in 2013. Novo Nordisk does not expect the pending
claims to have a material impact on its financial position, operating profit
and cash flow.
Patent infringement
lawsuits related to Prandin®
In the ongoing patent infringement
lawsuit against Caraco Pharmaceutical Laboratories, Ltd. (Caraco) regarding
Caracos abbreviated new drug application (ANDA) for a generic version
of Prandin® (repaglinide), the U.S. Court of Appeals for the
Federal Circuit appeal of a 2011 decision of patent invalidity and unenforceability
is underway. Oral argument was held 4 March, with a decision expected Q2 2013.
A companion case appeal involving Paddock Laboratories also had its oral argument
heard before The U.S. Court of Appeals for the Federal Circuit on 4 March,
likewise with a decision expected Q2 2013. Related patent infringement cases
involving Aurobindo Pharma Ltd., Lupin Ltd., and Sandoz Inc. are stayed pending
the outcome of the appeal in the Caraco case. Also stayed pending the appeal
is a consolidated class action where a putative class of direct purchasers
of Prandin® allege Novo Nordisk has violated US antitrust laws
in delaying the entry of generic versions of Prandin®.
Product liability
lawsuits related to Victoza®
Novo Nordisk is per 29
April 2013 named as one of several defendants in five single-plaintiff lawsuits
primarily seeking to recover damages for pancreatic cancer experienced by
patients who allege to have been prescribed Victoza® and other
GLP-1/DPP-IV products. Three of these cases have been filed in California
federal court and the other two in California state court. Novo Nordisk believes
these claims, as presented, are without substance and merit.
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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 2012 and
Form 20-F, both filed with the SEC in February 2013, 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 targets, 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, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures |
| statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings |
| 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, Research and Development update, Equity and Legal matters.
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 the Risk overview on p 43 of the Annual Report 2012 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.
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The Board of Directors and Executive Management have reviewed and approved the financial report of Novo Nordisk A/S for the first quarter of 2013. The financial report has not been audited or reviewed by the companys 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 2012 of Novo Nordisk. Furthermore, the first quarter 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 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, 1 May 2013
Executive Management: | ||
Lars Rebien Sørensen |
Jesper
Brandgaard
|
Lars
Fruergaard Jørgensen
|
President and CEO | CFO | |
Lise Kingo | Jakob Riis | Kåre Schultz |
Mads Krogsgaard Thomsen | ||
Board of Directors: | ||
Göran Ando |
Jeppe
Christiansen
|
Bruno
Angelici
|
Chairman |
Vice
chairman
|
|
Henrik Gürtler |
Liz
Hewitt
|
Ulrik
Hjulmand-Lassen
|
Thomas Paul Koestler |
Anne
Marie Kverneland
|
Søren
Thuesen Pedersen
|
Hannu Ryöppönen |
Stig
Strøbæk
|
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APPENDIX 1: QUARTERLY NUMBERS IN DKK
%
change
|
||||||||||||
2013
|
2012
|
Q1 2013 vs | ||||||||||
Q1
|
Q4
|
Q3
|
Q2
|
Q1
|
Q1 2012 | |||||||
|
|
|
|
|
|
|
|
|
|
|||
Sales | 19,983 | 20,962 | 19,845 | 19,468 | 17,751 | 13% | ||||||
Gross profit | 16,374 | 17,809 | 16,360 | 16,044 | 14,348 | 14% | ||||||
Gross margin | 81.9% | 85.0% | 82.4% | 82.4% | 80.8% | |||||||
Sales and distribution costs | 5,530 | 6,192 | 5,299 | 5,203 | 4,850 | 14% | ||||||
Percentage of sales | 27.7% | 29.5% | 26.7% | 26.7% | 27.3% | |||||||
Research and development costs | 2,657 | 3,210 | 2,617 | 2,563 | 2,507 | 6% | ||||||
Percentage of sales | 13.3% | 15.3% | 13.2% | 13.2% | 14.1% | |||||||
Administrative costs | 801 | 991 | 766 | 779 | 776 | 3% | ||||||
Percentage of sales | 4.0% | 4.7% | 3.9% | 4.0% | 4.4% | |||||||
Licence fees and other operating income (net) | 176 | 156 | 186 | 154 | 170 | 4% | ||||||
Operating profit | 7,562 | 7,572 | 7,864 | 7,653 | 6,385 | 18% | ||||||
Operating margin | 37.8% | 36.1% | 39.6% | 39.3% | 36.0% | |||||||
Financial income | 315 | 17 | (85 | ) | 146 | 47 |
N/A
|
|||||
Financial expenses | 108 | 137 | 420 | 856 | 375 |
N/A
|
||||||
Net financials | 207 | (120 | ) | (505 | ) | (710 | ) | (328 | ) |
N/A
|
||
Profit before income taxes | 7,769 | 7,452 | 7,359 | 6,943 | 6,057 | 28% | ||||||
Net profit | 5,982 | 5,755 | 5,667 | 5,346 | 4,664 | 28% | ||||||
Depreciation, amortisation and impairment losses | 691 | 755 | 644 | 656 | 638 | 8% | ||||||
Capital expenditure | 782 | 1,006 | 942 | 855 | 516 | 52% | ||||||
Net cash generated from operating activities1 | 7,070 | 1,514 | 7,962 | 7,151 | 5,587 | 27% | ||||||
Free cash flow1 | 6,178 | 408 | 6,926 | 6,273 | 5,038 | 23% | ||||||
Total assets | 62,447 | 65,669 | 66,620 | 60,978 | 61,210 | 2% | ||||||
Total equity | 33,801 | 40,632 | 35,660 | 31,334 | 32,358 | 4% | ||||||
Equity ratio | 54.1% | 61.9% | 53.5% | 51.4% | 52.9% | |||||||
Full-time equivalent employees end of period | 35,154 | 34,286 | 33,501 | 32,819 | 32,252 | 9% | ||||||
Basic earnings per share/ADR (in DKK) | 11.04 | 10.59 | 10.40 | 9.72 | 8.38 | 32% | ||||||
Diluted earnings per share/ADR (in DKK) | 10.98 | 10.53 | 10.33 | 9.67 | 8.32 | 32% | ||||||
Average number of shares outstanding (million) | 541.6 | 542.9 | 544.6 | 549.1 | 556.7 | (3% | ) | |||||
Average number of diluted shares | ||||||||||||
outstanding (million) | 544.7 | 546.0 | 547.8 | 552.4 | 560.5 | (3% | ) | |||||
Sales by business segment: | ||||||||||||
Modern insulins (insulin analogues) | 8,991 | 9,462 | 8,879 | 8,613 | 7,867 | 14% | ||||||
Human insulins | 2,824 | 3,009 | 2,794 | 2,781 | 2,718 | 4% | ||||||
Victoza® | 2,678 | 2,709 | 2,503 | 2,293 | 1,990 | 35% | ||||||
Protein-related products | 606 | 621 | 644 | 621 | 625 | (3% | ) | |||||
Oral antidiabetic products (OAD) | 694 | 670 | 719 | 653 | 716 | (3% | ) | |||||
Diabetes care total | 15,793 | 16,471 | 15,539 | 14,961 | 13,916 | 13% | ||||||
NovoSeven® | 2,027 | 2,420 | 2,153 | 2,451 | 1,909 | 6% | ||||||
Norditropin® | 1,537 | 1,461 | 1,451 | 1,440 | 1,346 | 14% | ||||||
Other biopharmaceuticals | 626 | 610 | 702 | 616 | 580 | 8% | ||||||
Biopharmaceuticals total | 4,190 | 4,491 | 4,306 | 4,507 | 3,835 | 9% | ||||||
Sales by geographic segment: | ||||||||||||
North America | 9,009 | 9,559 | 8,981 | 8,356 | 7,324 | 23% | ||||||
Europe | 4,761 | 5,237 | 4,793 | 5,081 | 4,596 | 4% | ||||||
International Operations | 3,094 | 2,894 | 2,695 | 2,757 | 2,734 | 13% | ||||||
Japan & Korea | 1,239 | 1,698 | 1,710 | 1,724 | 1,485 | (17% | ) | |||||
Region China | 1,880 | 1,574 | 1,666 | 1,550 | 1,612 | 17% | ||||||
Segment operating profit: | ||||||||||||
Diabetes care | 5,502 | 5,420 | 5,768 | 5,270 | 4,638 | 19% | ||||||
Biopharmaceuticals | 2,060 | 2,152 | 2,096 | 2,383 | 1,747 | 18% |
1Free cash flow for Q1 2012 and Q2 2012 has been reduced by DKK 1,328 million and increased by DKK 1,328 million, respectively, as withheld dividend tax is now presented as part of financing activities.
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Corporate
governance |
Legal
|
Financial
information |
Financial report for the period 1 January 2013 to 31 March 2013 |
Page
21 of 27
|
APPENDIX 2: INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME
|
|
|
|
|
Q1
|
Q1
|
|||
DKK million | 2013 | 2012 | ||
|
|
|
||
Income statement | ||||
Sales | 19,983 | 17,751 | ||
Cost of goods sold | 3,609 | 3,403 | ||
|
|
|
||
Gross profit | 16,374 | 14,348 | ||
Sales and distribution costs | 5,530 | 4,850 | ||
Research and development costs | 2,657 | 2,507 | ||
Administrative costs | 801 | 776 | ||
Licence fees and other operating income, net | 176 | 170 | ||
|
|
|
||
Operating profit | 7,562 | 6,385 | ||
Financial income | 315 | 47 | ||
Financial expenses | 108 | 375 | ||
|
|
|
||
Profit before income taxes | 7,769 | 6,057 | ||
Income taxes | 1,787 | 1,393 | ||
|
|
|
||
NET PROFIT | 5,982 | 4,664 | ||
|
|
|
||
Basic earnings per share (DKK) | 11.04 | 8.38 | ||
Diluted earnings per share (DKK) | 10.98 | 8.32 | ||
Segment Information | ||||
Segment sales: | ||||
Diabetes care | 15,793 | 13,916 | ||
Biopharmaceuticals | 4,190 | 3,835 | ||
Segment operating profit: | ||||
Diabetes care | 5,502 | 4,638 | ||
Operating margin | 34.8% | 33.3% | ||
Biopharmaceuticals | 2,060 | 1,747 | ||
Operating margin | 49.2% | 45.6% | ||
Total segment operating profit | 7,562 | 6,385 | ||
Statement of comprehensive income | ||||
Net profit for the period | 5,982 | 4,664 | ||
Other comprehensive income | ||||
Items that will not be reclassified subsequently to the Income | ||||
statement: | ||||
Remeasurements on defined benefit plans | - | - | ||
Items that will be reclassified subsequently to the Income statement, | ||||
when specific conditions are met: | ||||
Exchange rate adjustments of investments in subsidiaries | 157 | 26 | ||
Cash flow hedges, realisation of previously deferred (gains)/losses | (185 | ) | 397 | |
Cash flow hedges, deferred gains/(losses) incurred during the period | (483 | ) | 587 | |
Other items | (3 | ) | 49 | |
Tax on other comprehensive income, income/(expense) | 178 | (322 | ) | |
|
|
|
||
Other comprehensive income for the period, net of tax | (336 | ) | 737 | |
|
|
|
||
TOTAL COMPREHENSIVE INCOME FOR THE PERIOD | 5,646 | 5,401 | ||
|
|
|
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Corporate
governance |
Legal
|
Financial
information |
Financial report for the period 1 January 2013 to 31 March 2013 |
Page
22 of 27
|
|
||||
DKK
million
|
31
Mar 2013
|
31
Dec 2012
|
||
|
|
|
|
|
ASSETS | ||||
Intangible assets | 1,565 | 1,495 | ||
Property, plant and equipment | 21,838 | 21,539 | ||
Deferred income tax assets | 3,002 | 2,244 | ||
Other financial assets | 243 | 228 | ||
|
|
|
|
|
TOTAL NON-CURRENT ASSETS | 26,648 | 25,506 | ||
Inventories | 9,593 | 9,543 | ||
Trade receivables | 10,580 | 9,639 | ||
Tax receivables | 830 | 1,240 | ||
Other receivables and prepayments | 3,015 | 2,705 | ||
Marketable securities | 4,039 | 4,552 | ||
Derivative financial instruments | 558 | 931 | ||
Cash at bank and on hand | 7,184 | 11,553 | ||
|
|
|
|
|
TOTAL CURRENT ASSETS | 35,799 | 40,163 | ||
|
|
|
|
|
TOTAL ASSETS | 62,447 | 65,669 | ||
|
|
|
|
|
EQUITY AND LIABILITIES | ||||
Share capital | 560 | 560 | ||
Treasury shares | (19 | ) | (17 | ) |
Retained earnings | 32,508 | 39,001 | ||
Other reserves | 752 | 1,088 | ||
|
|
|
|
|
TOTAL EQUITY | 33,801 | 40,632 | ||
Deferred income tax liabilities | 410 | 732 | ||
Retirement benefit obligations | 770 | 760 | ||
Provisions | 1,840 | 1,907 | ||
|
|
|
|
|
Total non-current liabilities | 3,020 | 3,399 | ||
Current debt | 300 | 500 | ||
Trade payables | 3,079 | 3,859 | ||
Tax payables | 2,096 | 593 | ||
Other liabilities | 11,039 | 8,982 | ||
Derivative financial instruments | 386 | 48 | ||
Provisions | 8,726 | 7,656 | ||
|
|
|
|
|
Total current liabilities | 25,626 | 21,638 | ||
TOTAL LIABILITIES | 28,646 | 25,037 | ||
|
|
|
|
|
TOTAL EQUITY AND LIABILITIES | 62,447 | 65,669 | ||
|
|
|
|
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Corporate
governance |
Legal
|
Financial
information |
Financial report for the period 1 January 2013 to 31 March 2013 |
Page
23 of 27
|
APPENDIX 4: STATEMENT OF CASH FLOWS
|
|
|
|
|
DKK
million
|
Q1
2013
|
Q1
2012
|
||
|
|
|
|
|
Net profit | 5,982 | 4,664 | ||
Adjustment for non-cash items | 3,592 | 3,745 | ||
Change in working capital1 | (1,824 | ) | (1,906 | ) |
Interest received | 55 | 75 | ||
Interest paid | (9 | ) | (8 | ) |
Income taxes paid | (726 | ) | (983 | ) |
|
|
|
|
|
Net cash generated from operating activities | 7,070 | 5,587 | ||
|
|
|
|
|
Purchase of intangible assets and other financial assets | (110 | ) | (33 | ) |
Proceeds from sale of property, plant and equipment | 4 | 12 | ||
Purchase of property, plant and equipment | (786 | ) | (528 | ) |
Net purchase of marketable securities | 499 | (800 | ) | |
|
|
|
|
|
Net cash used in investing activities | (393 | ) | (1,349 | ) |
|
|
|
|
|
Purchase of treasury shares, net | (2,865 | ) | (2,828 | ) |
Dividends paid | (9,715 | ) | (7,742 | ) |
Withheld dividend tax1 | 1,721 | 1,328 | ||
|
|
|
|
|
Net cash used in financing activities | (10,859 | ) | (9,242 | ) |
|
|
|
|
|
NET CASH GENERATED FROM ACTIVITIES | (4,182 | ) | (5,004 | ) |
Cash and cash equivalents at the beginning of the year | 11,053 | 13,057 | ||
Exchange gain/(loss) on cash and cash equivalents | 13 | (3 | ) | |
|
|
|
|
|
Cash and cash equivalents at the end of the period | 6,884 | 8,050 | ||
|
|
|
|
|
Additional information: | ||||
Cash and cash equivalents at the end of the period | 6,884 | 8,050 | ||
Marketable securities at the end of the period | 4,039 | 4,871 | ||
Undrawn committed credit facilities | 4,844 | 4,836 | ||
|
|
|
|
|
FINANCIAL RESOURCES AT THE END OF THE PERIOD | 15,767 | 17,757 | ||
|
|
|
|
|
Net cash generated from operating activities | 7,070 | 5,587 | ||
Net cash used in investing activities | (393 | ) | (1,349 | ) |
Net change of marketable securities | (499 | ) | 800 | |
|
|
|
|
|
FREE CASH FLOW1 | 6,178 | 5,038 | ||
|
|
|
|
1Free cash flow for Q1 2012 has been reduced by DKK 1,328 million as withheld dividend tax is now presented as part of financing activities.
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Corporate
governance |
Legal
|
Financial
information |
Financial report for the period 1 January 2013 to 31 March 2013 |
Page
24 of 27
|
APPENDIX 5: STATEMENT OF CHANGES IN EQUITY
|
||||||||||||||||
Other reserves | ||||||||||||||||
|
||||||||||||||||
DKK million |
Share
capital |
Treasury
shares |
Retained
earnings |
Exchange
rate adjustments |
Cash
flow
hedges |
Tax
and
other items |
Total
other reserves |
Total
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1 2013 | ||||||||||||||||
Balance at the beginning of the period |
560
|
(17 | ) | 39,001 | 226 | 847 | 15 | 1,088 | 40,632 | |||||||
Net profit for the period | 5,982 | 5,982 | ||||||||||||||
Other comprehensive income for the period | 157 | (668 | ) | 175 | (336 | ) | (336 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income for the period | 5,982 | 157 | (668 | ) | 175 | (336 | ) | 5,646 | ||||||||
Transactions with owners, recognised directly in equity: | ||||||||||||||||
Dividends | (9,715 | ) | (9,715 | ) | ||||||||||||
Share-based payment | 103 | 103 | ||||||||||||||
Purchase of treasury shares | (3 | ) | (2,888 | ) | (2,891 | ) | ||||||||||
Sale of treasury shares | 1 | 25 | 26 | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period |
560
|
(19 | ) | 32,508 | 383 | 179 | 190 | 752 | 33,801 | |||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other reserves | ||||||||||||||||
|
||||||||||||||||
DKK million |
Share
capital |
Treasury
shares |
Retained
earnings |
Exchange
rate adjustments |
Cash
flow
hedges |
Tax
and
other items |
Total
other reserves |
Total
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Q1 2012 | ||||||||||||||||
Balance at the beginning of the period |
580
|
(24 | ) | 37,111 | 398 | (1,184 | ) | 567 | (219 | ) | 37,448 | |||||
Net profit for the period | 4,664 | 4,664 | ||||||||||||||
Other comprehensive income for the period | 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 | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Corporate
governance |
Legal
|
Financial
information |
Financial report for the period 1 January 2013 to 31 March 2013 |
Page
25 of 27
|
APPENDIX 6: FIRST QUARTER OF 2013 REGIONAL SALES SPLIT
|
||||||||||||
DKK million | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
North
America |
Europe
|
International
Operations |
Japan
&
Korea |
Region
China
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
The diabetes care segment | ||||||||||||
NovoRapid ® | 4,017 | 2,373 | 901 | 403 | 224 | 116 | ||||||
% change in local currencies | 16% | 20% | 4% | 27% | (2% | ) | 42% | |||||
NovoMix ® | 2,400 | 659 | 603 | 480 | 197 | 461 | ||||||
% change in local currencies | 14% | 22% | (2% | ) | 20% | (2% | ) | 31% | ||||
Levemir ® | 2,574 | 1,437 | 691 | 319 | 75 | 52 | ||||||
% change in local currencies | 19% | 23% | 7% | 32% | 0% | 49% | ||||||
Modern insulin | 8,991 | 4,469 | 2,195 | 1,202 | 496 | 629 | ||||||
% change in local currencies | 16% | 21% | 3% | 25% | (2% | ) | 34% | |||||
Human insulin | 2,824 | 446 | 597 | 833 | 123 | 825 | ||||||
% change in local currencies | 5% | 27% | (10% | ) | 12% | (24% | ) | 10% | ||||
Victoza® | 2,678 | 1,720 | 637 | 208 | 82 | 31 | ||||||
% change in local currencies | 36% | 41% | 26% | 44% | 0% | 131% | ||||||
Other diabetes care | 1,300 | 490 | 209 | 166 | 100 | 335 | ||||||
% change in local currencies | (2% | ) | 8% | (19% | ) | 1% | (5% | ) | 0% | |||
Diabetes care total | 15,793 | 7,125 | 3,638 | 2,409 | 801 | 1,820 | ||||||
% change in local currencies | 15% | 25% | 2% | 20% | (6% | ) | 16% | |||||
The biopharmaceuticals segment | ||||||||||||
NovoSeven® | 2,027 | 1,031 | 530 | 296 | 114 | 56 | ||||||
% change in local currencies | 7% | 18% | 10% | (16% | ) | (6% | ) | 12% | ||||
Norditropin® | 1,537 | 488 | 425 | 329 | 292 | 3 | ||||||
% change in local currencies | 18% | 31% | 2% | 48% | 5% | 0% | ||||||
Other biopharmaceuticals | 626 | 365 | 168 | 60 | 32 | 1 | ||||||
% change in local currencies | 9% | 8% | 13% | 22% | (3% | ) | 0% | |||||
Biopharmaceuticals total | 4,190 | 1,884 | 1,123 | 685 | 438 | 60 | ||||||
% change in local currencies | 12% | 19% | 7% | 10% | 1% | 11% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Total sales | 19,983 | 9,009 | 4,761 | 3,094 | 1,239 | 1,880 | ||||||
% change in local currencies | 14% | 24% | 3% | 17% | (4% | ) | 16% | |||||
|
|
|
|
|
|
|
|
|
|
|
|
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Corporate
governance |
Legal
|
Financial
information |
Financial report for the period 1 January 2013 to 31 March 2013 |
Page
26 of 27
|
APPENDIX 7: KEY CURRENCY ASSUMPTIONS
|
||||||
DKK per 100 |
2012
average
exchange rates |
YTD
2013 average
exchange rates as of 25 April 2013 |
Current
exchange rate
as of 25 April 2013 |
|||
|
|
|
|
|
|
|
USD | 579 | 566 | 570 | |||
JPY | 7.27 | 6.07 | 5.75 | |||
CNY | 92 | 91 | 92 | |||
GBP | 918 | 876 | 882 | |||
CAD | 580 | 561 | 557 |
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Corporate
governance |
Legal
|
Financial
information |
Financial report for the period 1 January 2013 to 31 March 2013 |
Page
27 of 27
|
APPENDIX 8: QUARTERLY NUMBERS IN USD (ADDITIONAL INFORMATION)
(Amounts in USD million, except number of full-time equivalent employees, earnings per share and number of shares outstanding). Key figures are translated into USD as additional 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
|
||||||||||||
2013
|
2012
|
Q1 2013 vs | ||||||||||
Q1
|
Q4
|
Q3
|
Q2
|
Q1
|
Q1 2012 | |||||||
|
|
|
|
|
|
|
|
|
||||
Sales | 3,537 | 3,641 | 3,337 | 3,362 | 3,129 | 13% | ||||||
Gross profit | 2,898 | 3,093 | 2,752 | 2,771 | 2,529 | 14% | ||||||
Gross margin | 81.9% | 85.0% | 82.4% | 82.4% | 80.8% | |||||||
Sales and distribution costs | 978 | 1,075 | 890 | 900 | 854 | 14% | ||||||
Percentage of sales | 27.7% | 29.5% | 26.7% | 26.7% | 27.3% | |||||||
Research and development costs | 470 | 557 | 440 | 442 | 442 | 6% | ||||||
Percentage of sales | 13.3% | 15.3% | 13.2% | 13.2% | 14.1% | |||||||
Administrative costs | 142 | 172 | 129 | 134 | 137 | 3% | ||||||
Percentage of sales | 4.0% | 4.7% | 3.9% | 4.0% | 4.4% | |||||||
Licence fees and other operating income (net) | 31 | 27 | 31 | 27 | 30 | 4% | ||||||
Operating profit | 1,339 | 1,316 | 1,324 | 1,322 | 1,126 | 18% | ||||||
Operating margin | 37.8% | 36.1% | 39.6% | 39.3% | 36.0% | |||||||
Financial income | 55 | 3 | (15 | ) | 26 | 8 |
N/A
|
|||||
Financial expenses | 19 | 24 | 70 | 149 | 66 |
N/A
|
||||||
Net financials | 36 | (21 | ) | (85 | ) | (123 | ) | (58 | ) |
N/A
|
||
Profit before income taxes | 1,375 | 1,295 | 1,239 | 1,199 | 1,068 | 28% | ||||||
Net profit | 1,059 | 1,000 | 954 | 924 | 822 | 28% | ||||||
Depreciation, amortisation and impairment losses | 122 | 131 | 108 | 114 | 112 | 8% | ||||||
Capital expenditure | 138 | 175 | 159 | 148 | 91 | 52% | ||||||
Net cash generated from operating activities1 | 1,251 | 270 | 1,343 | 1,237 | 985 | 27% | ||||||
Free cash flow1 | 1,094 | 78 | 1,168 | 1,085 | 888 | 23% | ||||||
Total assets | 10,698 | 11,604 | 11,554 | 10,328 | 10,988 | 2% | ||||||
Total equity | 5,791 | 7,180 | 6,185 | 5,307 | 5,809 | 4% | ||||||
Equity ratio | 54.1% | 61.9% | 53.5% | 51.4% | 52.9% | |||||||
Full-time equivalent employees end of period | 35,154 | 34,286 | 33,501 | 32,819 | 32,252 | 9% | ||||||
Basic earnings per share/ADR (in EUR) | 1.95 | 1.84 | 1.75 | 1.68 | 1.48 | 32% | ||||||
Diluted earnings per share/ADR (in EUR) | 1.94 | 1.83 | 1.74 | 1.67 | 1.47 | 32% | ||||||
Average number of shares outstanding (million) | 541.6 | 542.9 | 544.6 | 549.1 | 556.7 | (3% | ) | |||||
Average number of diluted shares outstanding (million) | 544.7 | 546.0 | 547.8 | 552.4 | 560.5 | (3% | ) | |||||
Sales by business segment: | ||||||||||||
Modern insulins (insulin analogues) | 1,591 | 1,644 | 1,493 | 1,487 | 1,387 | 14% | ||||||
Human insulins | 500 | 523 | 469 | 479 | 479 | 4% | ||||||
Victoza® | 474 | 470 | 422 | 396 | 351 | 35% | ||||||
Protein-related products | 107 | 108 | 108 | 107 | 110 | (3% | ) | |||||
Oral antidiabetic products (OAD) | 123 | 116 | 122 | 113 | 126 | (3% | ) | |||||
Diabetes care total | 2,795 | 2,861 | 2,614 | 2,582 | 2,453 | 13% | ||||||
NovoSeven® | 359 | 420 | 362 | 423 | 337 | 6% | ||||||
Norditropin® | 272 | 254 | 244 | 249 | 237 | 14% | ||||||
Other biopharmaceuticals | 111 | 106 | 117 | 108 | 102 | 8% | ||||||
Biopharmaceuticals total | 742 | 780 | 723 | 780 | 676 | 9% | ||||||
Sales by geographic segment: | ||||||||||||
North America | 1,594 | 1,659 | 1,514 | 1,443 | 1,291 | 23% | ||||||
Europe | 843 | 910 | 804 | 878 | 810 | 4% | ||||||
International Operations | 548 | 503 | 452 | 476 | 482 | 13% | ||||||
Japan & Korea | 219 | 295 | 287 | 298 | 262 | (17% | ) | |||||
Region China | 333 | 274 | 280 | 267 | 284 | 17% | ||||||
Segment operating profit: | ||||||||||||
Diabetes care | 974 | 942 | 972 | 910 | 818 | 19% | ||||||
Biopharmaceuticals | 365 | 374 | 352 | 412 | 308 | 18% |
1Free cash flow for Q1 2012 and Q2 2012 has been reduced by USD 234 million and increased by DKK 234 million, respectively, as withheld dividend tax is now presented as part of financing activities.
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Corporate
governance |
Legal
|
Financial
information |
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
Date: MAY 1, 2013 |
NOVO NORDISK A/S Lars Rebien Sørensen, President and Chief Executive Officer |