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
January 31, 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]
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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 [ ]
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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 statement for 2013
30 January 2014
Novo
Nordisk increased operating profit in local currencies by 15% in 2013
Sales growth of 12% in local currencies driven by growth
in sales of Victoza®,
NovoRapid® and Levemir®
Sales increased by 12% in local currencies and by 7% to 83.6 billion in Danish kroner. | |
| Sales of modern insulins increased by 14% (10% in Danish kroner). |
| Sales of Victoza® increased by 27% (23% in Danish kroner). |
| Sales of Biopharmaceuticals increased by 12% (6% in Danish kroner). |
| Sales in North America increased by 18% (14% in Danish kroner). |
| Sales in International Operations increased by 17% (8% in Danish kroner). |
| Sales in Region China increased by 13% (12% in Danish kroner). |
Gross margin improved by 0.4 percentage point in Danish kroner to 83.1%, reflecting a favourable price and product mix development partly offset by a 0.3 percentage point negative currency impact.
Operating profit increased by 15% in local currencies and by 7% in Danish kroner to DKK 31.5 billion.
Net profit increased by 18% to DKK 25.2 billion. Diluted earnings per share of DKK 0.20 increased by 20% to DKK 9.35.
In December 2013, Novo Nordisk filed for regulatory approval of a 3 mg dose of liraglutide, the once-daily human GLP-1 analogue, as a treatment for obesity with the regulatory agencies in both the US and in EU.
Kåre Schultz is appointed president & COO, a role in which he will work closely with CEO Lars Rebien Sørensen on matters relevant to the companys senior leadership and the Board of Directors.
For 2014, sales growth measured in local currencies is expected to be 8-11%, whereas operating profit growth measured in local currencies is expected to be around 10%.
At the Annual General Meeting on 20 March 2014, the Board of Directors will propose a 25% increase in dividend to DKK 4.50 per share of DKK 0.20. The Board of Directors has furthermore decided to initiate a new 12 months share repurchase programme of up to DKK 15 billion.
Lars Rebien Sørensen, president and CEO: We are pleased with Novo Nordisks financial performance in 2013, a year which also posed challenges for us. The double-digit sales growth has again in 2013 been driven by robust growth of our portfolio of modern insulins and Victoza®. For Tresiba®, the Complete Response Letter in the US was a disappointment, but in markets where we have launched the product, performance has been encouraging.
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 5 / 2014
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Financial statement for 2012 |
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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 38,000 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
30 January 2014 at 13.00 CET, corresponding to 7.00 am EST, 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
3 February 2014 at 13.30 CET, corresponding to 7.30 am EST, 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 | |
3 February 2014 | PDF version of the Annual Report 2013 |
5 February 2014 | Deadline for the companys receipt of shareholder proposals for the |
Annual General Meeting 2014 | |
14 February 2014 | Printed version of the Annual Report 2013 |
20 March 2014 | Annual General Meeting 2014 |
1 May 2014 | Financial statement for the first three months of 2014 |
7 August 2014 | Financial statement for the first six months of 2014 |
30 October 2014 | Financial statement for the first nine months of 2014 |
30 January 2015 | Financial statement for 2014 |
CONTACTS
FOR FURTHER INFORMATION
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Media:
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Mike
Rulis
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+45
4442 3573
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mike@novonordisk.com
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Ken
Inchausti (US)
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+1
609 514 8316
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kiau@novonordisk.com
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Investors:
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Kasper
Roseeuw Poulsen
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+45
3079 4303
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krop@novonordisk.com
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Frank
Daniel Mersebach
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+45
3079 0604
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fdni@novonordisk.com
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Lars
Borup Jacobsen
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+45
3075 3479
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lbpj@novonordisk.com
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Daniel
Bohsen
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+45
3079 6376
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dabo@novonordisk.com
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Jannick
Lindegaard (US)
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+1
609 235 8567
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jlis@novonordisk.com
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Further information about Novo Nordisk is available on novonordisk.com.
Company announcement No 5 / 2014
Financial statement for 2012 |
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Financial
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CONSOLIDATED FINANCIAL STATEMENT FOR 2013
The Board of Directors and Executive Management have approved the Annual Report 2013 of Novo Nordisk A/S including the audited consolidated financial statements. The Board of Directors and Executive Management also approved this financial statement containing condensed financial information for 2013. This financial statement is prepared in accordance with the recognition and measurement requirements of the International Financial Reporting Standards (IFRS) as issued by IASB, IFRS as endorsed by the EU and the additional Danish disclosure requirements for listed companies. The accounting policies used in this financial statement are consistent with those used in the audited consolidated financial statements in the Annual Report 2013 as well as those applied in the audited consolidated financial statements in the Annual Report 2012.
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PROFIT
AND LOSS
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2013 | 2012 | 2011 | 2010 | 2009 | % change 2012 to 2013 | ||||||
DKK
million
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Sales
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83,572 | 78,026 | 66,346 | 60,776 | 51,078 | 7% | ||||||
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Gross
profit
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69,432 | 64,561 | 53,757 | 49,096 | 40,640 | 8% | ||||||
Gross
margin
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83.1% | 82.7% | 81.0% | 80.8% | 79.6% | |||||||
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Sales
and distribution costs
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23,380 | 21,544 | 19,004 | 18,195 | 15,420 | 9% | ||||||
Percentage
of sales
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28.0% | 27.6% | 28.6% | 29.9% | 30.2% | |||||||
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Research
and development costs
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11,733 | 10,897 | 9,628 | 9,602 | 7,864 | 8% | ||||||
Percentage
of sales
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14.0% | 14.0% | 14.5% | 15.8% | 15.4% | |||||||
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Administrative
costs
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3,508 | 3,312 | 3,245 | 3,065 | 2,764 | 6% | ||||||
Percentage
of sales
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4.2% | 4.2% | 4.9% | 5.0% | 5.4% | |||||||
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Licence
fees and other operating income
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682 | 666 | 494 | 657 | 341 | 2% | ||||||
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Operating
profit
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31,493 | 29,474 | 22,374 | 18,891 | 14,933 | 7% | ||||||
Operating
margin
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37.7% | 37.8% | 33.7% | 31.1% | 29.2% | |||||||
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Net
financials
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1,046 | (1,663) | (449) | (605) | (945) | N/A | ||||||
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Profit
before income taxes
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32,539 | 27,811 | 21,925 | 18,286 | 13,988 | 17% | ||||||
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Income
taxes
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7,355 | 6,379 | 4,828 | 3,883 | 3,220 | 15% | ||||||
Effective
tax rate
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22.6% | 22.9% | 22.0% | 21.2% | 23.0% | |||||||
Net
profit
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25,184 | 21,432 | 17,097 | 14,403 | 10,768 | 18% | ||||||
Net
profit margin
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30.1% | 27.5% | 25.8% | 23.7% | 21.1% | |||||||
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CONSOLIDATED FINANCIAL STATEMENT 2013 CONTINUED
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OTHER KEY NUMBERS | 2013 | 2012 | 2011 | 2010 | 2009 | %
change 2012 to 2013 |
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(Amounts below in DKK million except earnings per share and dividend per share) | ||||||||||||
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Depreciation, amortisation and impairment losses | 2,799 | 2,693 | 2,737 | 2,467 | 2,551 | 4% | ||||||
Capital expenditure | 3,207 | 3,319 | 3,003 | 3,308 | 2,631 | (3%) | ||||||
Net cash generated from operating activities | 25,942 | 22,214 | 21,374 | 19,679 | 15,378 | 17% | ||||||
Free cash flow | 22,358 | 18,645 | 18,112 | 17,013 | 12,332 | 20% | ||||||
Total assets | 70,337 | 65,669 | 64,698 | 61,402 | 54,742 | 7% | ||||||
Equity | 42,569 | 40,632 | 37,448 | 36,965 | 35,734 | 5% | ||||||
Equity ratio | 60.5% | 61.9% | 57.9% | 60.2% | 65.3% | |||||||
Diluted earnings per share / ADR (in DKK) 1) | 9.35 | 7.77 | 6.00 | 4.92 | 3.56 | 20% | ||||||
Dividend per share (in DKK) 1) 2) | 4.50 | 3.60 | 2.80 | 2.00 | 1.50 | 25% | ||||||
Payout ratio 3) | 47.1% | 45.3% | 45.3% | 39.6% | 40.9% |
1) | Comparative figures have been restated to reflect the change in trading unit from DKK 1 to DKK 0.20. |
2) | Proposed dividend for the financial year 2013. |
3) | Dividend for the year as a percentage of net profit. |
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PERFORMANCE VERSUS LONG-TERM FINANCIAL TARGETS
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PERFORMANCE AGAINST LONG-TERM FINANCIAL TARGETS | 2013 | 2012 | 2011 | 2010 | 2009 | Target | ||||||
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Operating profit growth | 6.9% | 31.7% | 18.4% | 26.5% | 20.7% | 15% | ||||||
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Operating profit margin | 37.7% | 37.8% | 33.7% | 31.1% | 29.2% | 40% | ||||||
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Operating profit after tax to net | ||||||||||||
operating assets | 97.2% | 99.0% | 77.9% | 63.6% | 47.3% | 125% | ||||||
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Cash to earnings | 88.8% | 87.0% | 105.9% | 118.1% | 114.5% | |||||||
Cash to earnings (three-years average) | 93.9% | 103.7% | 112.8% | 115.6% | 111.5% | 90% | ||||||
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announcement No 5 / 2014
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SALES
DEVELOPMENT
Sales
increased by 12% measured in local currencies and by 7% in Danish kroner. This
is in line with the latest guidance of 11-13% growth in local currencies
provided in connection with the quarterly announcement in October 2013. North
America was the main contributor with 66% share of growth measured in local
currencies, followed by International Operations and Region China contributing
20% and 9% respectively. Sales growth was realised within both diabetes care
and biopharmaceuticals, with the majority of growth originating from the modern
insulins and Victoza®.
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Sales 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 ® | 16,848 | 7% | 12% | 20% | ||||
- NovoMix ® | 9,759 | 4% | 10% | 10% | ||||
- Levemir ® | 11,546 | 18% | 22% | 24% | ||||
Modern insulins | 38,153 | 10% | 14% | 54% | ||||
Human insulins | 10,869 | (4%) | 0% | 0% | ||||
Victoza® | 11,633 | 23% | 27% | 28% | ||||
Protein-related products | 2,555 | 2% | 9% | 2% | ||||
Oral antidiabetic products | 2,246 | (19%) | (16%) | (5%) | ||||
Diabetes care total | 65,456 | 8% | 12% | 79% | ||||
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The biopharmaceuticals segment | ||||||||
NovoSeven® | 9,256 | 4% | 8% | 7% | ||||
Norditropin® | 6,114 | 7% | 16% | 10% | ||||
Other products | 2,746 | 9% | 15% | 4% | ||||
Biopharmaceuticals total | 18,116 | 6% | 12% | 21% | ||||
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Total sales | 83,572 | 7% | 12% | 100% | ||||
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In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from November 2013 and November 2012 provided by the independent data provider IMS Health.
DIABETES
CARE SALES DEVELOPMENT
Sales
of diabetes care products increased by 12% measured in local currencies and
by 8% in Danish kroner to DKK 65,456 million. Novo Nordisk is the world leader
in diabetes care and now holds a global value market share of 27% compared to
26% at the same time the previous year.
Insulins
and protein-related products
Sales
of insulins and protein-related products increased by 11% in local currencies
and by 6% in Danish kroner to DKK 51,577 million. Measured in local currencies,
sales
Financial
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Financial statement for 2012 |
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growth was driven by North America, International Operations and Region China. Novo Nordisk is the global leader with 48% of the total insulin market and 46% of the market for modern insulin and new-generation insulin, both measured in volume.
The roll-out of Tresiba® (insulin degludec), the once-daily new-generation insulin with an ultra-long duration of action, continues to progress. Launch activities are proceeding as planned and feedback from patients and prescribers is encouraging. Tresiba® has been launched in eight countries with 20 more countries expected to launch during 2014. In the countries where Tresiba® is reimbursed on a similar level as insulin glargine, it has steadily grown its share of the basal insulin market. In these countries, Tresiba® now represents around 10% of the basal insulin market measured in monthly value market share. In the markets where Tresiba® has been launched with restricted market access compared to insulin glargine, market penetration remains modest.
Sales of modern insulins increased by 14% in local currencies and by 10% in Danish kroner to DKK 38,153 million. North America accounted for two-thirds of the growth, followed by International Operations and Region China. Sales of modern insulins now constitute 78% 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 the modern insulin and new-generation insulin market | ||||||
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November 2013 |
November 2012 |
November 2013 |
November 2012 |
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Global | 48% | 49% | 46% | 46% | ||||
USA* | 40% | 41% | 39% | 38% | ||||
Europe | 49% | 50% | 49% | 50% | ||||
International Operations** | 56% | 58% | 53% | 55% | ||||
China*** | 59% | 61% | 64% | 65% | ||||
Japan | 52% | 55% | 48% | 51% | ||||
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Source: IMS, November 2013 data. *: US trend data reflect changes to IMS data collection coverage and methodology **: 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 18% in
local currencies and by 14% in Danish kroner. Sales growth reflects a continued
positive contribution from pricing in the US, solid market penetration of all
three modern insulins, NovoLog®,
Levemir® and NovoLog®
Mix 70/30. 55% 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 remained unchanged in local
currencies and decreased by 1% in Danish kroner. The development reflects that
the declining human insulin sales are offset by the continued progress for Levemir®
and NovoRapid®. Furthermore,
sales are impacted by a low volume growth of the insulin market, around 3%,
as well as the implementation of pricing reforms in several European
Financial
performance |
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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 15% in local currencies and by 6% in Danish kroner. The growth, which is
positively impacted by the timing in tenders and shipments in a number of countries,
is driven by all three modern insulins and a contribution from human insulins.
Currently, 59% 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 15% in
local currencies and by 14% 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 3%
in local currencies and by 22% measured in Danish kroner. The sales development
reflects a stagnant Japanese insulin volume market and the negative impact of
a challenging competitive environment, which is only partly offset by the robust
uptake of Tresiba®.
The device penetration in Japan remains high with 98% of Novo Nordisks
insulin volume being used in devices, primarily FlexPen®.
Victoza®
(GLP-1 therapy for type 2 diabetes)
Victoza®
sales increased by 27% in local currencies and by 23% in Danish kroner to DKK
11,633 million, reflecting robust sales performance driven by North America,
Europe and International Operations. Victoza®
holds the global market share leadership in the GLP-1 segment with a 71% value
market share compared to 68% in 2012. The GLP-1 segments value share of
the total diabetes care market has increased to 6.9% compared to 5.9% 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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November | November | November | November | |||||
2013 | 2012 | 2013 | 2012 | |||||
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Global | 6.9% | 5.9% | 71% | 68% | ||||
USA* | 8.6% | 7.3% | 67% | 62% | ||||
Europe | 7.6% | 6.7% | 78% | 76% | ||||
International Operations** | 2.8% | 3.0% | 75% | 80% | ||||
China*** | 0.6% | 0.5% | 74% | 45% | ||||
Japan | 2.1% | 2.3% | 71% | 77% | ||||
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Source: IMS, November 2013 data. *: US trend data reflect changes to IMS data collection coverage and methodology **: 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.
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North America
Sales
of Victoza®
in North America increased by 31% in local currencies and by 27% in Danish kroner.
This reflects a continued expansion of the GLP-1 class, which represents 8.6%
of the total US diabetes care market in value compared to 7.3% 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 67% value market share compared to 62% a year ago.
Europe
Sales
in Europe increased by 20% in local currencies and by 19% in Danish kroner.
Sales growth is primarily driven by France, the UK, Spain and Italy. In Europe,
the GLP-1 class share of the total diabetes care market in value has increased
to 7.6% compared to 6.7% in 2012. Victoza®
is the GLP-1 market leader with a value market share of 78%.
International
Operations
Sales
in International Operations increased by 31% in local currencies and by 21%
in Danish kroner. Sales growth is primarily driven by a number of Middle Eastern
countries, Brazil and Argentina. The GLP-1 class share of the diabetes
care market in value has contracted to 2.8% compared to 3.0% in 2012. This reflects
a decline in the class share of the total diabetes care market in Brazil
following a strong initial penetration. Outside Brazil, the class continues
to expand. Victoza®
is the GLP-1 market leader across International Operations with a value market
share of 75%.
Region
China
Sales
in Region China increased by 84% in local currencies and by 83% 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 0.5% in 2012. Victoza®
holds a GLP-1 value market share of 74%.
Japan &
Korea
Sales
in Japan & Korea decreased by 8% in local currencies and by 27% in Danish
kroner. In Japan, the GLP-1 class represents 2.1% of the total diabetes care
market value. Victoza®
remains the leader in the class with a value market share of 71%.
NovoNorm®/Prandin®/PrandiMet®
(oral antidiabetic products)
Sales
of oral antidiabetic products decreased by 16% in local currencies and by 19%
in Danish kroner to DKK 2,246 million. The negative sales development reflects
an impact from generic competition in the US and Europe as well as a changed
inventory setup in China.
BIOPHARMACEUTICALS
SALES DEVELOPMENT
Sales
of biopharmaceutical products increased by 12% measured in local currencies
and by 6% in Danish kroner to DKK 18,116 million. Sales growth was primarily
driven by North America and International Operations.
Financial
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NovoSeven®
(bleeding disorders therapy)
Sales
of NovoSeven®
increased by 8% in local currencies and by 4% in Danish kroner to DKK 9,256
million. The market for NovoSeven®
remains volatile, and sales growth is primarily driven by North America and
International Operations.
Norditropin®
(growth hormone therapy)
Sales
of Norditropin®
increased by 16% in local currencies and by 7% in Danish kroner to DKK 6,114
million. The sales growth is primarily driven by contractual wins, the support
programmes that Novo Nordisk offers healthcare professionals and patients as
well as the penetration of the prefilled FlexPro®
device in North America and furthermore by growth in International Operations.
Novo Nordisk is the leading company in the global growth hormone market with
a 28% market share measured in volume.
Other biopharmaceuticals
Sales
of other products within biopharmaceuticals, which predominantly consist of
hormone replacement therapy-related (HRT) products, increased by 15% in local
currencies and by 9% in Danish kroner to DKK 2,746 million. Sales growth is
driven by North America and reflects a positive impact of pricing and non-recurring
adjustments to the provisions for rebates.
DEVELOPMENT
IN COSTS AND OPERATING PROFIT
The
cost of goods sold grew 5% to DKK 14,140 million, resulting in a gross margin
of 83.1% compared to 82.7% 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 negatively impacted by around 0.3 percentage point due
to the depreciation of key invoicing currencies versus the Danish krone compared
to prevailing exchange rates in 2012.
Total non-production-related costs increased by 11% in local currencies and by 8% in Danish kroner to DKK 38,621 million.
Sales and distribution costs increased by 13% in local currencies and by 9% in Danish kroner to DKK 23,380 million. The growth in costs is driven by the expansions of the sales forces and sales and marketing investments in the US, China and selected countries in International Operations as well as costs related to the launch of Tresiba®. The growth percentage for costs has also been impacted by changes to legal provisions in 2012 and 2013.
Research and development costs increased by 9% in local currencies and by 8% in Danish kroner to DKK 11,733 million. Within diabetes care, costs are primarily driven by development costs related to the initiation of the Tresiba® cardiovascular outcome trial, and the ongoing phase 3a trials for both faster-acting insulin aspart and semaglutide, the once-weekly GLP-1 analogue. Within biopharmaceuticals, costs are primarily related to the continued progress of the portfolio of development projects within haemophilia and
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the phase 2 trial for anti-IL-20, a recombinant human monoclonal antibody, in rheumatoid arthritis.
Administrative costs increased by 9% in local currencies and by 6% in Danish kroner to DKK 3,508 million. The increase in costs is primarily driven by back-office infrastructure costs to support the expansions of the sales organisations in North America, China and selected countries in International Operations, non-recurring costs related to new offices in Denmark and the US as well as an impact from a cost refund in 2012 of a previously expensed fine related to an import licence for a major market in International Operations.
Licence income and other operating income constituted DKK 682 million compared to DKK 666 million in 2012.
Operating profit increased by 7% in Danish kroner to DKK 31,493 million. In local currencies, the growth was 15%, which is in line with the latest guidance for operating profit growth measured in local currencies for 2013 of 12-15%.
NET
FINANCIALS AND TAX
Net
financials showed a net income of DKK 1,046 million compared to a net expense
of DKK 1,663 million in 2012. The reported net financial income in 2013 is in
line with the latest guidance of around DKK 1,100 million. As of
31 December 2013, foreign exchange hedging gains of around DKK 1,200 million
have been deferred for recognition in the income statement in 2014.
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. The foreign exchange result was a net income of DKK 1,146 million compared to a net expense of DKK 1,529 million in 2012. This net income reflects gains on foreign exchange hedging involving especially the Japanese yen and the US dollar due to their depreciation versus the Danish krone compared to the prevailing exchange rates in 2012, which has been partly offset by losses on commercial balances, primarily related to non-hedged currencies.
The effective tax rate for 2013 was 22.6%, which is in line with the latest guidance of a tax rate of around 23% for the full year 2013.
CAPITAL
EXPENDITURE AND FREE CASH FLOW
Net
capital expenditure for property, plant and equipment was DKK 3.2 billion compared
to DKK 3.3 billion in 2012. Net capital expenditure was primarily related to
new offices in Denmark, filling capacity in Denmark and Russia, additional GLP-1
manufacturing capacity, new diabetes research facilities in Denmark as well
as device production facilities in the US and Denmark. Net capital expenditure
was in line with previously communicated expectations of around DKK 3.5
billion.
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Free cash flow was DKK 22.4 billion compared to DKK 18.6 billion in 2012, which is in line with the latest guidance of around DKK 22 billion. The increase of 20% compared to 2012 reflects the growth in net profit of 18% and a lower impact from tax payments in 2013 compared to 2012 related to ongoing transfer pricing disputes which was partly offset by earlier payment of rebate liabilities in the US.
KEY
DEVELOPMENTS IN THE FOURTH QUARTER OF 2013
Please
refer to appendix 1 for an overview of the quarterly numbers in DKK and appendix
6 for details on sales in the fourth quarter of 2013.
Sales in the fourth quarter of 2013 increased by 10% in local currencies and by 4% in Danish kroner to 21.7 billion compared to the same period in 2012. The growth, which was driven by the three modern insulins and Victoza®, was partly offset by generic competition to Prandin® in the US. From a geographic perspective, North America, International Operations and Region China represented the majority of total sales growth in local currencies.
The gross margin was 84.3% in the fourth quarter of 2013 compared to 85.0% in the same period last year. The decrease of 0.7 percentage point reflects a negative currency impact of 0.8 percentage point which was partly offset by a positive impact from pricing in the US and a favourable product mix development.
In the fourth quarter of 2013, total non-production-related costs increased by 12% in local currencies and by 7% in Danish kroner to DKK 11,123 million compared to the same period last year.
Sales and distribution costs increased by 11% in local currencies and by 5% in Danish kroner in the fourth quarter of 2013 compared to the same period last year. The growth in costs is driven by expansions of the US and Chinese sales forces, sales and marketing investments in the US, China and selected countries in International Operations.
Research and development costs increased by 14% in local currencies and by 11% in Danish kroner in the fourth quarter of 2013 compared to the same period last year. The cost increase is primarily driven by the continued progress of key development projects within diabetes and biopharmaceuticals including the Tresiba® cardiovascular outcomes trial.
Administrative costs increased by 10% in local currencies and by 8% in Danish kroner in the fourth quarter of 2013 compared to the same period last year. The increase is primarily driven by non-recurring costs related to new offices in Denmark as well as back-office infrastructure costs to support the expansions of the sales organisations in North America, China and selected countries in International Operations.
Operating profit in local currencies increased by 9% and decreased by 3% in Danish kroner in the fourth quarter of 2013 compared to the same period last year.
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OUTLOOK
2014
The
current expectations for 2014 are summarised in the table below:
|
|
Expectations
are as reported,
if not otherwise stated |
Expectations
30 January 2014 |
|
|
Sales
growth
|
|
in
local currencies
|
8-11%
|
as
reported
|
Around
3.5 percentage points lower
|
|
|
Operating
profit growth
|
|
in
local currencies
|
Around
10%
|
as
reported
|
Around
5.5 percentage points lower
|
|
|
Net
financials
|
Income
of around DKK 750 million
|
Effective
tax rate
|
Around
22%
|
Capital
expenditure
|
Around
DKK 4.0 billion
|
Depreciation,
amortisation and impairment losses
|
Around
DKK 2.9 billion
|
Free
cash flow
|
Around
DKK 26 billion
|
|
Sales growth for 2014 is expected to be 8-11% measured in local currencies. This reflects expectations for continued robust performance for the portfolio of modern insulins and Victoza® as well as a modest sales contribution from Tresiba®. These sales drivers are expected to be partly countered by an impact from a more challenging contract environment in the US, generic competition to Prandin® in the US during the first half of 2014, intensifying competition within both diabetes and biopharmaceuticals as well as 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 3.5 percentage points lower than growth measured in local currencies.
For 2014, operating profit growth is expected to be around 10% measured in local currencies. This reflects a significant increase in costs related to the continued progress of key development projects within diabetes and biopharmaceuticals. In addition, significant costs are expected in relation to sales force expansions and sales and marketing investments in the portfolio of modern insulins and Victoza® in the US, China and selected markets in International Operations as well as the launch of Tresiba® outside the US. Given the current level of exchange rates versus the Danish krone, the reported operating profit growth is now expected to be around 5.5 percentage points lower than growth measured in local currencies.
For 2014, Novo Nordisk expects a net financial income of around DKK 750 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 2013.
The effective tax rate for 2014 is expected to be around 22%.
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Capital expenditure is expected to be around DKK 4.0 billion in 2014, primarily related to investments in additional GLP-1 manufacturing capacity, expansion of filling capacity, prefilled device production facilities, construction of new laboratory facilities as well as expansion of protein capacity within the CMC (Chemistry, Manufacturing and Control) organisation. Depreciation, amortisation and impairment losses are expected to be around DKK 2.9 billion. Free cash flow is expected to be around DKK 26 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 2014, and that currency exchange rates, especially 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
1,300 million
|
12
|
|
CNY
|
DKK
220 million
|
12*
|
|
JPY
|
DKK
145 million
|
14
|
|
GBP
|
DKK
85 million
|
12
|
|
CAD
|
DKK
60 million
|
10
|
|
|
|
|
|
* USD used as proxy when hedging Novo Nordisks CNY currency exposure |
The financial impact from foreign exchange hedging is included in Net financials.
DIABETES CARE: INSULIN AND GLP-1
Liraglutide
3 mg filed for regulatory approval in the US and EU as a treatment for obesity
As
announced in December 2013, Novo Nordisk has filed a New Drug Application (NDA)
with the U.S. Food and Drug Administration (FDA) and a Marketing Authorisation
Application (MAA) with the European Medicines Agency (EMA). The submissions
cover the 3 mg dose of liraglutide, a once-daily human GLP-1 analogue, as an
adjunct to a reduced-calorie diet and increased physical activity for chronic
weight management in adults with obesity, or who are overweight and have comorbidities.
DUAL
IV shows benefits of adding IDegLira (NN9068) to sulfonylurea (SU) and metformin
treatment
In
December 2013, Novo Nordisk completed the phase 3b trial DUAL IV with
IDegLira, a combination product of insulin degludec (Tresiba®),
the once-daily new-generation
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basal insulin analogue, with an ultra-long duration of action, and liraglutide (Victoza®), the once-daily human GLP-1 analogue, for the treatment of type 2 diabetes currently under review with EMA.
In DUAL IV, 435 people with type 2 diabetes, inadequately controlled on sulfonylurea (SU) alone, or in combination with metformin, were randomised to 26 weeks of treatment with either IDegLira or placebo added to their existing oral anti-diabetic therapy.
From a baseline HbA1c of 7.9%, people randomised to IDegLira achieved a statistically significantly greater average reduction in HbA1c of 1.4% compared to 0.5% for those treated with placebo. Close to 80% of the people using IDegLira achieved the HbA1c treatment target of <7% recommended by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), and close to 65% reached HbA1c target of ≤6.5% as recommended by the American Association of Clinical Endocrinologists (AACE). The corresponding numbers for placebo were just below 30% for the ADA and EASD targets and just above 10% for the AACE target.
As would be expected from the use of GLP-1 in combination with an SU, the rate of overall confirmed hypoglycaemia was statistically significantly higher among those treated with IDegLira than placebo. The IDegLira arm experienced a modest weight gain of 0.5 kg compared with a weight loss of 1.0 kg among people treated in the placebo group.
The previously reported safety and tolerability profile of IDegLira was reconfirmed and no apparent differences between IDegLira and placebo were observed with respect to adverse events and standard safety parameters.
Two trials
initiated to further document hypoglycaemia profile of Tresiba®
In
January 2014, Novo Nordisk initiated the two 64-week randomised, double-blind,
cross-over trials, announced at the Capital Markets Day in December 2013, comparing
the safety and efficacy of Tresiba® and insulin glargine. The overall purpose
of the trials is to document the hypoglycaemia profile in type 1 diabetes and
type 2 diabetes respectively, compared to insulin glargine. In one trial, BEGIN-SWITCH
1, 450 people with type 1 diabetes will be sequentially treated with Tresiba®
and insulin glargine in combination with insulin aspart in a randomised order.
In the second trial, BEGIN-SWITCH 2, 670 people with type 2 diabetes will
be treated sequentially with Tresiba®
and insulin glargine in combination with metformin in a randomised order.
Recruitment
in SUSTAIN 6 completed and two additional phase 3a trials with semaglutide
(NN9535) initiated
In
December 2013, Novo Nordisk completed recruitment to SUSTAIN 6, a trial
collecting cardiovascular outcome and other long-term diabetes-related endpoints
with semaglutide in more than 3,000 people that had type 2 diabetes and an elevated
cardiovascular risk. Furthermore, as announced at the Capital Markets Day in
December 2013, Novo Nordisk has initiated two additional trials in the phase
3a programme
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SUSTAIN investigating the once-weekly GLP-1 analogue, semaglutide, as a treatment for people with type 2 diabetes. The aim of the trials is to evaluate the efficacy and safety of semaglutide as add-on to oral anti-diabetic drugs for 56 weeks compared to once-weekly exenatide ER (extended release) or once-daily sitagliptin respectively. Novo Nordisk expects to initiate three additional trials in the SUSTAIN programme during 2014.
Phase 3a
pump trial initiated for faster-acting insulin aspart (NN1218)
In
November 2013, Novo Nordisk initiated a 6-week randomised, double-blind trial,
evaluating the compatibility and safety of faster-acting insulin aspart and
insulin aspart, both administered by pumps providing continuous subcutaneous
insulin infusions. The trial is expected to include 40 people with type 1 diabetes.
With this initiation, all four trials in the phase 3a programme, onset,
are ongoing.
Initiation
of phase 3 for LATIN T1D, liraglutide as adjunct therapy to insulin in type
1 diabetes (NN9211)
As
announced at the Capital Markets Day in December 2013, Novo Nordisk has initiated
the first phase 3a trial, ADJUNCT ONE investigating the efficacy and safety
of liraglutide as an adjunct therapy to insulin in people with type 1 diabetes.
ADJUNCT ONE is expected to include 1,400 people with type 1 diabetes who
will be randomised to treatment for 52 weeks with liraglutide or placebo, both
in addition to intensification (treat-to-target concept) of the insulin treatment.
Novo Nordisk expects to initiate the second phase 3a trial, ADJUNCT TWO,
in the first half of 2014.
Initiation
of phase 2 trial for the first oral GLP-1, OG217SC (NN9924)
As
announced at the Capital Markets Day in December 2013, Novo Nordisk has initiated
the first phase 2 trial with an oral GLP-1, OG217SC. The trial will examine
the dose range, dose escalation and efficacy of oral semaglutide administered
over 26 weeks compared with placebo in 600 people with type 2 diabetes.
Novo Nordisk
receives approval for FlexTouch®
in the US
In
November 2013, the US FDA approved the prefilled insulin pens NovoLog®
FlexTouch® and Levemir®
FlexTouch®. FlexTouch® is
Novo Nordisks latest prefilled insulin pen with a spring-loaded push-button
dosing mechanism. FlexTouch®
is expected to be launched in the US in the second half of 2014.
BIOPHARMACEUTICALS: HAEMOPHILIA
NovoEight®
launched in EU and approved in Japan
In
January 2014, following approval by the European Commission in November 2013,
Germany was the first country to launch NovoEight®,
a recombinant coagulation factor VIII product, for the treatment and prophylaxis
of bleeding in patients with haemophilia A.
Furthermore, NovoEight® was approved by the Japanese Ministry of Health, Labor and Welfare in January 2014.
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Novo Nordisk expects to launch NovoEight® in a number of European countries and Japan during 2014.
TRETTEN®
approved in the US for the treatment of congenital factor XIII A-subunit deficiency
In
December 2013, the US FDA approved TRETTEN®,
a recombinant factor XIII compound marketed under
the brand name NovoThirteen®
outside of North America. TRETTEN®
is approved for the routine prophylaxis of bleeding in people with congenital
factor XIII A-subunit deficiency. It is the only recombinant treatment for congenital
FXIII A-subunit deficiency, a rare bleeding disorder with which approximately
1,000 people are diagnosed globally. TRETTEN®
is expected to be available in the US early 2014.
Furthermore, in January 2014, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion to recommend an expansion of the current marketing authorisation for NovoThirteen®, covering adult patients with congenital factor XIII A-subunit deficiency, to also cover paediatric patients under the age of 6 years.
Phase 3a
surgery trial completed with N9-GP (NN7999)
In
January 2014, Novo Nordisk completed the second phase 3 trial with N9-GP, a
glycopegylated recombinant factor IX compound for people with haemophilia B.
The trial (paradigm 3) was open-label, multi-centre and evaluated the
efficacy and safety of N9-GP during surgical procedures in 13 people with haemophilia
B, in line with regulatory guidelines.
In the trial, a single preoperative dose of 80 U/kg of N9-GP prevented bleeding in all participants during major surgeries with 100% success rate. The preoperative dose maintained the level of FIX activity at the normal range and no additional dose was required during the course of surgery. Clinical efficacy evaluated by haemostatic response was reported as excellent or good in all participants.
In addition, postoperative effective haemostatic coverage was achieved by an average of 2 doses of 40 U/kg N9-GP during the first six days after surgery.
In the trial, N9-GP appeared to have a safe and well-tolerated profile and no participants developed inhibitors.
BIOPHARMACEUTICALS: HUMAN GROWTH HORMONE
Multiple
dose trial completed for the once-weekly growth hormone (NN8640) in adults with
growth hormone deficiency
A
phase 1 trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics
of multiple doses of the once-weekly growth hormone derivative, NN8640, in adults
with growth hormone deficiency has been completed. In the trial, NN8640 appeared
to have a safe and well-tolerated profile and no safety concerns were identified.
The trial confirmed the data from a similar trial in healthy adults and supports
the suitability of NN8640 for once-weekly dosing in adults with growth hormone
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deficiency. Based on these results and following consultations with regulatory authorities, Novo Nordisk expects to make a final decision of whether to progress NN8640 into phase 3 development for adult treatment around mid-2014.
BIOPHARMACEUTICALS: INFLAMMATION
Anti-NKG2D
(NN8555) to resume phase 2 development in Crohns Disease
In
December 2012, Novo Nordisk decided to discontinue further development of anti-NKG2D
as a treatment for Crohns disease based on the results from a futility
analysis conducted during the trial. Following completion of the single-dose
trial and analysis of the full data set, Novo Nordisk has now decided to reinitiate
development. In the trial, the primary end-point on effect at week 4 was not
achieved. However, the analysis demonstrated a clear biological and clinical
effect of anti-NKG2D at later time points. In the trial, anti-NKG2D appeared
to be safe and have a well-tolerated profile and Novo Nordisk expects to continue
the phase 2 development of anti-NKG2D for Crohns disease.
Anti-IL-21
(NN8828) discontinued in rheumatoid arthritis
In
January, Novo Nordisk completed a phase 2a trial evaluating the monoclonal antibody
anti-IL-21 as a treatment for rheumatoid arthritis (RA). In the trial, the primary
endpoint of demonstrating a statistically significant change in disease activity
compared to placebo was achieved; however, the magnitude of the treatment effect
did not warrant further development. Consequently, Novo Nordisk has decided
to discontinue further development of anti-IL-21 for RA. In the trial, anti-IL-21
appeared to have a safe and well-tolerated profile. Novo Nordisk will continue
to develop anti-IL-21 as a potential treatment for Crohns disease and
Systemic Lupus Erythematosus (SLE).
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HIGHLIGHTS FROM THE CONSOLIDATED SOCIAL AND ENVIRONMENTAL STATEMENTS FOR 2013
1. According to the UN there are 49 least developed countries in the world
Patients
Novo
Nordisk estimates that the company provides medical treatments for approximately
24.3 million people with diabetes worldwide, showing a 7% increase compared
to 2012. The number is calculated based on WHOs recommended daily doses
for diabetes medicines. The growth is driven by sales of insulin and Victoza®.
Of the 382 million people living with diabetes it is estimated that just over half are diagnosed and many of those diagnosed do not receive medical treatment. Novo Nordisks global access to diabetes care strategy aims to provide better care for those who need it and currently do not have access to proper diabetes care. In 2013, Novo Nordisk sold human insulin according to the companys differential pricing policy in 35 of
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the 49 Least Developed Countries, as defined by the UN. According to this policy, the price should not exceed 20% of the average prices in the Western world; while the number of countries buying insulin in accordance with this policy has been stable for some years, the volume sold increased by 7%.
Employees
At
the end of 2013, the total number of employees was 38,436, corresponding to
37,978 full-time positions, which is an 11% increase compared with 2012. This
growth is driven by expansion of the sales and marketing organisation in the
regions North America and International Operations as well as significant expansion
in Denmark in the research and development organisation and in production.
Employee turnover decreased from 9.1% in 2012 to 8.1%, continuing the positive trend. The average number reflects some geographical variation.
Assurance
Following
the receipt in December 2012 of a Warning Letter from the US Food and Drug Administration
(FDA), a re-inspection was carried out in August 2013. In January 2014, Novo
Nordisk received confirmation from the agency that the violations had been addressed
satisfactorily.
In 2013, Novo Nordisk had six instances of product recalls from the market, which is the same level as the previous year. Among one of these, an internal quality control found that a small percentage (0.14%) of certain batches of the companys prefilled insulin product NovoMix®30 did not meet the specifications for insulin strength. As a result, three million products were recalled from wholesalers, pharmacies and patients in several European markets. The root cause was found to be a production error and has been resolved.
Energy
and water
In
2013, 2,572,000 GJ energy and 2,685,000 m3
water was consumed at production sites around the world. This equals an increase
of 6% and 8% respectively, which is linked to the increased production volume
output and new production capacity.
CO2
In
2013, CO2 emissions from production amounted to a total of 125,000
tons. This equals a 2% increase compared to 2012, which is directly linked
to the increased consumption of energy. The increase in CO2
emission is less than the increase in energy consumption, because part of the
increase in energy consumption happened at sites sourcing less CO2-intensive
energy. At the same time, consumption decreased at sites with coal-based energy
supply. The companys target of a 10% absolute reduction in 10 years is
expected to be met in 2014.
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Total equity was DKK 42,569 million at the end of 2013, equivalent to 60.5% of total assets, compared to 61.9% at the end of 2012. Please refer to appendix 5 for further elaboration of changes in equity.
Five for
one stock split implemented in January 2014
As
announced in October 2013, Novo Nordisks Board of Directors approved a
stock split of the Novo Nordisk B shares listed on NASDAQ OMX Copenhagen and
of the American Depositary Receipts (ADRs) listed on New York Stock Exchange
(NYSE). Consequently, the trading unit of the Novo Nordisk B shares listed on
the stock exchange in Copenhagen was changed from DKK 1 to DKK 0.20. The ratio
of B shares to ADRs listed on NYSE has remained 1:1. The changes in trading
units came into effect on 2 January 2014 for the Novo Nordisk B shares and on
9 January 2014 for the ADRs.
2013 share
repurchase programme
On
31 October, as part of an overall programme of DKK 14 billion to be executed
during a 12-month period beginning 31 January 2013, Novo Nordisk announced a
share repurchase programme of up to DKK 2.8 billion to be executed from 31 October
2013 to 28 January 2014. The purpose of the programme is to reduce the companys
share capital. Under the programme, announced 31 October, Novo Nordisk has repurchased
B shares for an amount of DKK 2.8 billion in the period from 31 October 2013
to 28 January 2014. The programme announced on 31 October 2013 was concluded
on 28 January 2014.
In addition to the DKK 2.8 billion share repurchase programme announced 31 October 2013, Novo Nordisk repurchased 1 million B shares from employees in November 2013. The transaction amounted to DKK 0.2 billion and was related to the general employee share programme outside of Denmark from 2010. The shares in this transaction were not part of the Safe Harbour repurchase programme, but were part of the overall DKK 14 billion repurchase programme.
As of 28 January 2014, Novo Nordisk A/S has repurchased a total of 72,368,270 B shares equal to a transaction value of DKK 14 billion and has thereby completed the DKK 14 billion programme.
Holding
of treasury shares and reduction of share capital
As
of 28 January 2014, Novo Nordisk A/S and its wholly owned affiliates owned 107,640,025
of its own B shares, corresponding to 3.9% of the total share capital.
In order to maintain capital structure flexibility, the Board of Directors will, at the Annual General Meeting in 2014, propose a reduction in the B share capital from DKK 442,512,800 to DKK 422,512,800 by cancelling 100,000,000 B shares of DKK 0.20 from the companys own holdings of B shares at a nominal value of DKK 20,000,000 equivalent to 3.64% of the total share capital. After implementation of the share capital reduction, the companys share capital will amount to DKK 530,000,000; divided into an A share capital of DKK 107,487,200 and a B share capital of DKK 422,512,800.
Financial
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announcement No 5 / 2014
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Financial statement for 2012 |
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Proposed
dividend
At
the Annual General Meeting on 20 March 2014, the Board of Directors will propose
a 25% increase in dividend to DKK 4.50 per share of DKK 0.20, corresponding
to a payout ratio of 47.1%. For 2012, the Novo Nordisk payout ratio was 45.3%,
whereas Novo Nordisks peer group of comparable pharmaceutical companies
operated with a payout ratio around 47%. No dividend will be paid on the companys
holding of treasury shares.
2014 share
repurchase programme
The
Board of Directors has approved a new share repurchase programme of up to DKK
15 billion to be executed during the coming 12 months. As part of the up to
DKK 15 billion share repurchase programme, a new share repurchase programme
has now been initiated in accordance with the provisions of the European Commission's
Regulation No 2273/2003 of 22 December 2003 (The Safe Harbour Regulation). For
that purpose, Novo Nordisk has appointed Skandinaviska Enskilda Banken, Denmark,
as lead manager to execute a part of its share repurchase programme independently
and without influence from Novo Nordisk. The purpose of the programme is to
reduce the company's share capital. Under the agreement, Skandinaviska Enskilda
Banken, Denmark, will repurchase shares on behalf of Novo Nordisk for an amount
of up to DKK 3.6 billion during the trading period starting today, 30 January
and ending on 29 April 2014. A maximum of 583,326 shares can be bought during
one single trading day, equal to 20% of the average daily trading volume of
Novo Nordisk B shares on NASDAQ OMX Copenhagen during the month of December
2013, and a maximum of 35,582,886 shares in total can be bought during the trading
period. At least once every seven trading days, Novo Nordisk will issue an announcement
in respect of the transactions made under the repurchase programme.
In addition to the agreement with Skandinaviska Enskilda Banken of repurchasing shares of an amount of up to DKK 3.6 billion, Novo Nordisk expects to purchase B-shares from employees in January 2014 for approximately DKK 0.1 billion. The repurchase of shares in this transaction is not part of the Safe Harbour programme, but is part of the overall DKK 15 billion share repurchase programme.
Novo Nordisks majority shareholder Novo A/S, a holding company fully owned by the Novo Nordisk Foundation, has informed Novo Nordisk that it intends from 2014 onwards to consider its participation in Novo Nordisks share repurchase programme on a case-by-case basis. This implies that Novo A/S may decide not to participate in a share repurchase programme in any individual year.
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announcement No 5 / 2014
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Financial statement for 2012 |
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Changes
in Novo Nordisks management
Effective
30 January 2014, Chief Operating Officer Kåre Schultz is appointed president
& COO. The promotion is a reflection of the importance and complexity of
Kåre Schultz organisation Operations which he has
led successfully since 2002. Operations is responsible for Novo Nordisks
global sales and product supply organisation. In his role as president, Kåre
Schultz will work closely with CEO Lars Rebien Sørensen and the other
members of Executive Management on matters relevant to the companys senior
leadership and the Board of Directors.
Effective 1 February 2014, Eddie Williams, corporate vice president and head of Biopharmaceuticals in Novo Nordisks US affiliate has been appointed senior vice president and member of the companys global Senior Management Board. The promotion is a reflection of the size and strategic importance of the companys biopharmaceuticals business in the US.
Remuneration
principles for executives
Novo
Nordisks remuneration principles aim to attract, retain and motivate members
of Executive Management. Remuneration levels are designed to be competitive
and to align the interest of the executives with shareholder interests.
Long-term,
share-based incentive programme for senior management
As
from 2004, members of Novo Nordisk's Executive Management (seven in 2013) and
other members of the Senior Management Board (28 in 2013) have participated
in a performance-based incentive programme. In the programme, a proportion of
the calculated economic value added for the calendar year has been allocated
to a joint pool for the participants. For 2013, the joint pool operates with
a yearly maximum allocation per participant equal to nine months fixed
base salary plus pension contribution for members of Executive Management and
a yearly maximum allocation per participant equal to eight months fixed
base salary plus pension contribution for other members of the Senior Management
Board. Once the joint pool has been approved by the Board of Directors, the
total cash amount is converted into Novo Nordisk B shares at market price. The
market price is calculated as the average trading price for Novo Nordisk B shares
on NASDAQ OMX Copenhagen in the open trading window following the release of
the full-year financial results for the year preceding the performance-based
incentive programme. The shares in the joint pool are locked up for a three-year
period before they are transferred to the participants. In the lock-up period,
the Board of Directors may remove shares from the joint pool in the event of
lower than planned value creation in subsequent years.
For 2010, 842,880 shares were allocated to the joint pool and the value at launch of the programme (DKK 64 million) was expensed in 2010. The number of shares in the 2010 joint pool has not subsequently been reduced by the Board of Directors as the financial performance in the following years (20112013) reached specified threshold levels. Hence, the original number of shares allocated to the joint pool will, according to the
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announcement No 5 / 2014
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principles of the scheme, be transferred to 28 current and former members of senior management immediately after the announcement of the 2013 full-year financial results on 30 January 2014.
For 2013, based on an assessment of the economic value generated, the performance of the R&D portfolio and key sustainability projects, the Board of Directors on 29 January 2014 approved the establishment of a joint pool for the financial year of 2013 by allocating a total of 254,417 Novo Nordisk B shares. This allocation amounts to 4.75 months of fixed base salary plus pension contribution per member of Executive Management and 4.2 months of fixed base salary plus pension contribution for senior vice presidents, corresponding to a value at launch of the programme of DKK 51 million, which has been expensed in the 2013 accounts. According to the principles of the programme, the share price used for the conversion of the performance programme to the share pool was the average share price (DKK 202.40 per share of DKK 0.20) for Novo Nordisk B shares on NASDAQ OMX Copenhagen in the 15 days trading window (31 January14 February 2013) following the release of the Annual Report for 2012 when the programme was approved by the Board of Directors. The allocation under the programme reflects that, while Novo Nordisk exceeded the planned financial performance in 2013, the company did not meet its target of having Tresiba® approved in the US due to the Complete Response Letter from the US Food and Drug Administration in February. This event also entailed that the target for the submission of IDegLira for regulatory approval to the US FDA could not be met. As a consequence of these shortcomings the allocation under the long-term incentive programme has been reduced.
Long-term,
share-based incentive programme for corporate vice presidents and vice presidents
As from 2007, a
number of key employees below senior management also participate in a share-based
programme with similar performance criteria as the programme for senior management.
The share-based incentive programme for key employees will, as is the case for
the programme for senior management, be based on an annual calculation of economic
value added compared to the planned performance for the year. The pool will
operate with a maximum contribution per participant equal to four months of
fixed base salary. The shares in the pool are also locked up for a three-year
period before they may be transferred to the participants.
For 2010, 2,744,680 shares were allocated to a share pool for key employees and the value at launch of the programme (DKK 208 million) has been amortised over the period 2010-2013. The number of shares in the 2010 share pool has not subsequently been reduced by the Board of Directors as the financial performance in the following years (20112013) reached specified threshold levels. Hence, 2,475,090 shares will be transferred to 576 employees after the announcement of the 2013 full-year financial results on 30 January 2014. The number of shares to be transferred is lower than the original number of shares allocated to the share pool as some participants have left the company before the release conditions of the programme have been met.
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announcement No 5 / 2014
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Financial statement for 2012 |
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For 2013, based on an assessment similar to the senior management programme, the Board of Directors on 29 January 2014 approved the establishment of a share pool for 2013 for key employees by allocating a total of 622,190 Novo Nordisk B shares. This allocation which is 52.5 % of the maximum according to the terms of the programme corresponds to a value at launch of the programme of DKK 126 million using the same share price mechanism as described for the senior management programme. The value of the programme will be amortised over four years. The number of participants for 2013 is approximately 825.
Product
liability lawsuits related to hormone therapy products
As
of 27 January 2014, 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 two 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,
one individual currently alleges, in relation to similar lawsuits against Pfizer
Inc., that she has also used a Novo Nordisk hormone therapy product. Pfizer
Inc. has publicly announced the settlement of many of its hormone therapy cases.
The continued reduction in pending cases is the result of Pfizer Inc. settling
several cases that also involve Novo Nordisks products. Currently, Novo
Nordisks first trial is scheduled for September 2014. Novo Nordisk does
not expect the pending claims to have a material impact on its financial position,
operating profit and cash flow.
Product
liability lawsuits related to Victoza®
Novo
Nordisk is per 27 January 2014 named in 34 product liability lawsuits seeking
to recover damages for injuries, predominantly related to pancreatic cancer,
allegedly experienced by patients who claim to have been prescribed Victoza®
and other GLP-1/DPP-IV products. Twenty-four of the Novo Nordisk cases include
other defendants, and most cases have been filed in California federal court.
Currently, Novo Nordisk does not have any trials scheduled in 2014. Novo Nordisk
does not expect the pending claims to have a material impact on its financial
position, operating profit and cash flow.
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performance |
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Financial statement for 2012 |
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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 2013 and Form 20-F, both expected to be filed with the SEC in February 2014, 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 update.
These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this document, could cause actual results to differ materially from those contemplated in any forward-looking statements.
Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recalls, 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 Risks to be aware of on pp 42-43 of the Annual Report 2013 available on novonordisk.com on 3 February 2014.
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 approved the Annual Report 2013 of Novo Nordisk A/S including the audited consolidated financial statements. The Board of Directors and Executive Management also approved this financial statement containing condensed financial information for 2013.
The consolidated financial statements in the Annual Report 2013 are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and with the IFRS as endorsed by the EU. Furthermore, the Annual Report 2013, including the consolidated financial statements and management review, is prepared in accordance with additional Danish disclosure requirements for listed companies.
This financial statement has been prepared in accordance with the recognition and measurement requirements in the IFRS, the accounting policies as applied in the audited consolidated financial statements of 2013 and additional Danish disclosure requirements for listed companies.
In our opinion, the accounting policies used are appropriate, and the overall presentation of this financial statement is adequate. Furthermore, in our opinion, this company announcement of the financial statement for 2013 includes a true and fair account of the development in the operations and financial circumstances of the results for the year and of the financial position of the Group as well as a reference to the most significant risks and elements of uncertainty facing the Group in accordance with Danish disclosure requirements for listed companies.
Bagsværd, 30 January 2014
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 |
Financial
performance |
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APPENDIX 1: QUARTERLY NUMBERS IN DKK
|
||||||||||||||||||
(Amounts in DKK million, except number of full-time equivalent employees, earnings per share and number of shares outstanding). | ||||||||||||||||||
%
change
|
||||||||||||||||||
2013
|
2012
|
Q4 2013 vs | ||||||||||||||||
Q4 | Q3 | Q2 | Q1 | Q4 | Q3 | Q2 | Q1 | Q4 2012 | ||||||||||
|
|
|
|
|
|
|
|
|
||||||||||
Sales | 21,698 | 20,511 | 21,380 | 19,983 | 20,962 | 19,845 | 19,468 | 17,751 |
4%
|
|||||||||
Gross profit | 18,298 | 16,986 | 17,774 | 16,374 | 17,809 | 16,360 | 16,044 | 14,348 |
3%
|
|||||||||
Gross margin | 84.3% | 82.8% | 83.1% | 81.9% | 85.0% | 82.4% | 82.4% | 80.8% | ||||||||||
Sales and distribution costs | 6,487 | 5,529 | 5,834 | 5,530 | 6,192 | 5,299 | 5,203 | 4,850 |
5%
|
|||||||||
Percentage of sales | 29.9% | 27.0% | 27.3% | 27.7% | 29.5% | 26.7% | 26.7% | 27.3% | ||||||||||
Research and development costs | 3,566 | 2,795 | 2,715 | 2,657 | 3,210 | 2,617 | 2,563 | 2,507 |
11%
|
|||||||||
Percentage of sales | 16.4% | 13.6% | 12.7% | 13.3% | 15.3% | 13.2% | 13.2% | 14.1% | ||||||||||
Administrative costs | 1,070 | 822 | 815 | 801 | 991 | 766 | 779 | 776 |
8%
|
|||||||||
Percentage of sales | 4.9% | 4.0% | 3.8% | 4.0% | 4.7% | 3.9% | 4.0% | 4.4% | ||||||||||
Licence income and other operating income | 179 | 152 | 175 | 176 | 156 | 186 | 154 | 170 |
15%
|
|||||||||
Operating profit | 7,354 | 7,992 | 8,585 | 7,562 | 7,572 | 7,864 | 7,653 | 6,385 |
(3%)
|
|||||||||
Operating margin | 33.9% | 39.0% | 40.2% | 37.8% | 36.1% | 39.6% | 39.3% | 36.0% | ||||||||||
Financial income | 606 | 418 | 363 | 315 | 17 | (85 | ) | 146 | 47 |
N/A
|
||||||||
Financial expenses | 170 | 111 | 267 | 108 | 137 | 420 | 856 | 375 |
24%
|
|||||||||
Net financials | 436 | 307 | 96 | 207 | (120 | ) | (505 | ) | (710 | ) | (328 | ) |
N/A
|
|||||
Profit before income taxes | 7,790 | 8,299 | 8,681 | 7,769 | 7,452 | 7,359 | 6,943 | 6,057 |
5%
|
|||||||||
Net profit | 6,053 | 6,415 | 6,734 | 5,982 | 5,755 | 5,667 | 5,346 | 4,664 |
5%
|
|||||||||
Depreciation, amortisation and impairment losses | 789 | 643 | 676 | 691 | 755 | 644 | 656 | 638 |
5%
|
|||||||||
Capital expenditure | 739 | 908 | 778 | 782 | 1,006 | 942 | 855 | 516 |
(27%)
|
|||||||||
Net cash generated from operating activities 1) | 5,372 | 6,217 | 7,283 | 7,070 | 1,514 | 7,962 | 7,151 | 5,587 |
255%
|
|||||||||
Free cash flow 1) | 4,538 | 5,219 | 6,423 | 6,178 | 408 | 6,926 | 6,273 | 5,038 |
N/A
|
|||||||||
Total assets | 70,337 | 68,134 | 64,289 | 62,447 | 65,669 | 66,620 | 60,978 | 61,210 |
7%
|
|||||||||
Total equity | 42,569 | 39,125 | 35,357 | 33,801 | 40,632 | 35,660 | 31,334 | 32,358 |
5%
|
|||||||||
Equity ratio | 60.5% | 57.4% | 55.0% | 54.1% | 61.9% | 53.5% | 51.4% | 52.9% | ||||||||||
Full-time equivalent employees end of period | 37,978 | 36,851 | 35,869 | 35,154 | 34,286 | 33,501 | 32,819 | 32,252 |
11%
|
|||||||||
Basic earnings per share/ADR (in DKK) 2) | 2.28 | 2.41 | 2.50 | 2.21 | 2.12 | 2.08 | 1.94 | 1.68 |
8%
|
|||||||||
Diluted earnings per share/ADR (in DKK) 2) | 2.27 | 2.39 | 2.49 | 2.20 | 2.11 | 2.07 | 1.93 | 1.66 |
8%
|
|||||||||
Average number of shares outstanding (million) 2) | 2,653.4 | 2,667.5 | 2,688.5 | 2,708.0 | 2,714.5 | 2,723.0 | 2,745.5 | 2,783.5 |
(2%)
|
|||||||||
Average number of diluted shares | ||||||||||||||||||
outstanding (million) 2) | 2,666.8 | 2,681.5 | 2,702.5 | 2,723.5 | 2,730.0 | 2,739.0 | 2,762.0 | 2,802.5 |
(2%)
|
|||||||||
Sales by business segment: | ||||||||||||||||||
Modern insulins (insulin analogues) | 10,143 | 9,393 | 9,626 | 8,991 | 9,462 | 8,879 | 8,613 | 7,867 |
7%
|
|||||||||
Human insulins | 2,694 | 2,572 | 2,779 | 2,824 | 3,009 | 2,794 | 2,781 | 2,718 |
(10%)
|
|||||||||
Victoza® | 3,231 | 2,847 | 2,877 | 2,678 | 2,709 | 2,503 | 2,293 | 1,990 |
19%
|
|||||||||
Protein-related products | 640 | 666 | 643 | 606 | 621 | 644 | 621 | 625 |
3%
|
|||||||||
Oral antidiabetic products (OAD) | 367 | 504 | 681 | 694 | 670 | 719 | 653 | 716 |
(45%)
|
|||||||||
Diabetes care total | 17,075 | 15,982 | 16,606 | 15,793 | 16,471 | 15,539 | 14,961 | 13,916 |
4%
|
|||||||||
NovoSeven® | 2,259 | 2,428 | 2,542 | 2,027 | 2,420 | 2,153 | 2,451 | 1,909 |
(7%)
|
|||||||||
Norditropin® | 1,662 | 1,436 | 1,479 | 1,537 | 1,461 | 1,451 | 1,440 | 1,346 |
14%
|
|||||||||
Other biopharmaceuticals | 702 | 665 | 753 | 626 | 610 | 702 | 616 | 580 |
15%
|
|||||||||
Biopharmaceuticals total | 4,623 | 4,529 | 4,774 | 4,190 | 4,491 | 4,306 | 4,507 | 3,835 |
3%
|
|||||||||
Sales by geographic segment: | ||||||||||||||||||
North America | 10,214 | 9,763 | 10,038 | 9,009 | 9,559 | 8,981 | 8,356 | 7,324 |
7%
|
|||||||||
Europe | 5,185 | 4,994 | 5,123 | 4,761 | 5,237 | 4,793 | 5,081 | 4,596 |
(1%)
|
|||||||||
International Operations | 3,139 | 2,697 | 3,077 | 3,094 | 2,894 | 2,695 | 2,757 | 2,734 |
8%
|
|||||||||
Japan & Korea | 1,398 | 1,312 | 1,368 | 1,239 | 1,698 | 1,710 | 1,724 | 1,485 |
(18%)
|
|||||||||
Region China | 1,762 | 1,745 | 1,774 | 1,880 | 1,574 | 1,666 | 1,550 | 1,612 |
12%
|
|||||||||
Segment operating profit: | ||||||||||||||||||
Diabetes care | 5,567 | 5,886 | 5,965 | 5,502 | 5,420 | 5,768 | 5,270 | 4,638 |
3%
|
|||||||||
Biopharmaceuticals | 1,787 | 2,106 | 2,620 | 2,060 | 2,152 | 2,096 | 2,383 | 1,747 |
(17%)
|
1) Free
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.
2) Comparative
figures have been restated to reflect the change in trading unit from DKK 1
to DKK 0.20.
Financial
performance |
Outlook
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governance |
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Financial
information |
Company
announcement No 5 / 2014
|
Financial statement for 2013 |
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APPENDIX 2: INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME
|
||||
12M
|
12M
|
|||
DKK million | 2013 | 2012 | ||
|
|
|
|
|
Income statement | ||||
Sales | 83,572 | 78,026 | ||
Cost of goods sold | 14,140 | 13,465 | ||
|
|
|
|
|
Gross profit | 69,432 | 64,561 | ||
Sales and distribution costs | 23,380 | 21,544 | ||
Research and development costs | 11,733 | 10,897 | ||
Administrative costs | 3,508 | 3,312 | ||
Licence income and other operating income, net | 682 | 666 | ||
|
|
|
|
|
Operating profit | 31,493 | 29,474 | ||
Financial income | 1,702 | 125 | ||
Financial expenses | 656 | 1,788 | ||
|
|
|
|
|
Profit before income taxes | 32,539 | 27,811 | ||
Income taxes | 7,355 | 6,379 | ||
|
|
|
|
|
NET PROFIT FOR THE YEAR | 25,184 | 21,432 | ||
|
|
|
|
|
Basic earnings per share (DKK) 1) | 9.40 | 7.82 | ||
Diluted earnings per share (DKK) 1) | 9.35 | 7.77 | ||
Segment information | ||||
|
|
|
|
|
Segment sales: | ||||
Diabetes care | 65,456 | 60,887 | ||
Biopharmaceuticals | 18,116 | 17,139 | ||
Segment operating profit: | ||||
Diabetes care | 22,920 | 21,096 | ||
Operating margin | 35.0% | 34.6% | ||
Biopharmaceuticals | 8,573 | 8,378 | ||
Operating margin | 47.3% | 48.9% | ||
Total segment operating profit | 31,493 | 29,474 | ||
|
|
|
|
|
Statement of comprehensive income | ||||
Net profit for the year | 25,184 | 21,432 | ||
Other comprehensive income | ||||
Items that will not be reclassified subsequently to the Income statement: | ||||
Remeasurements on defined benefit plans | 54 | (281 | ) | |
Items that will be reclassified subsequently to the Income statement, | ||||
when specific conditions are met: | ||||
Exchange rate adjustments of investments in subsidiaries | (435 | ) | (172 | ) |
Cash flow hedges, realisation of previously deferred (gains)/losses | (809 | ) | 1,182 | |
Cash flow hedges, deferred gains/(losses) incurred during the period | 1,195 | 849 | ||
Other items | 75 | 35 | ||
Tax on other comprehensive income, income/(expense) | (211 | ) | (587 | ) |
|
|
|
|
|
Other comprehensive income for the year, net of tax | (131 | ) | 1,026 | |
|
|
|
|
|
TOTAL COMPREHENSIVE INCOME FOR THE YEAR | 25,053 | 22,458 | ||
|
|
|
|
|
1) Comparative figures have been restated to reflect the change in trading unit from DKK 1 to DKK 0.20.
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performance |
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announcement No 5 / 2014
|
Financial statement for 2013 |
Page
30 of 35
|
|
||||
DKK
million
|
31 Dec 2013 | 31 Dec 2012 | ||
|
|
|
|
|
ASSETS | ||||
Intangible assets | 1,615 | 1,495 | ||
Property, plant and equipment | 21,882 | 21,539 | ||
Deferred income tax assets | 4,231 | 2,244 | ||
Other financial assets | 551 | 228 | ||
|
|
|
|
|
TOTAL NON-CURRENT ASSETS | 28,279 | 25,506 | ||
Inventories | 9,552 | 9,543 | ||
Trade receivables | 10,907 | 9,639 | ||
Tax receivables | 3,155 | 1,240 | ||
Other receivables and prepayments | 2,454 | 2,705 | ||
Marketable securities | 3,741 | 4,552 | ||
Derivative financial instruments | 1,521 | 931 | ||
Cash at bank and on hand | 10,728 | 11,553 | ||
|
|
|
|
|
TOTAL CURRENT ASSETS | 42,058 | 40,163 | ||
|
|
|
|
|
TOTAL ASSETS | 70,337 | 65,669 | ||
|
|
|
|
|
EQUITY AND LIABILITIES | ||||
Share capital | 550 | 560 | ||
Treasury shares | (21 | ) | (17 | ) |
Retained earnings | 41,137 | 39,001 | ||
Other reserves | 903 | 1,088 | ||
|
|
|
|
|
TOTAL EQUITY | 42,569 | 40,632 | ||
Deferred income tax liabilities | 672 | 732 | ||
Retirement benefit obligations | 688 | 760 | ||
Provisions | 2,183 | 1,907 | ||
|
|
|
|
|
Total non-current liabilities | 3,543 | 3,399 | ||
Current debt | 215 | 500 | ||
Trade payables | 4,092 | 3,859 | ||
Tax payables | 2,222 | 593 | ||
Other liabilities | 9,386 | 8,982 | ||
Derivative financial instruments | - | 48 | ||
Provisions | 8,310 | 7,656 | ||
|
|
|
|
|
Total current liabilities | 24,225 | 21,638 | ||
TOTAL LIABILITIES | 27,768 | 25,037 | ||
|
|
|
|
|
TOTAL EQUITY AND LIABILITIES | 70,337 | 65,669 | ||
|
|
|
|
Financial
performance |
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|
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|
Financial statement for 2013 |
Page
31 of 35
|
APPENDIX 4: STATEMENT OF CASH FLOWS
|
||||
DKK
million
|
2013
|
2012
|
||
|
|
|
|
|
Net profit for the year | 25,184 | 21,432 | ||
Adjustment for non-cash items | 10,738 | 11,253 | ||
Change in working capital | (265 | ) | 274 | |
Interest received | 131 | 207 | ||
Interest paid | (39 | ) | (61 | ) |
Income taxes paid | (9,807 | ) | (10,891 | ) |
|
|
|
|
|
Net cash generated from operating activities | 25,942 | 22,214 | ||
Proceeds from intangible assets and other financial assets | 29 | - | ||
Purchase of intangible assets and other financial assets | (406 | ) | (250 | ) |
Proceeds from sale of property, plant and equipment | 31 | 53 | ||
Purchase of property, plant and equipment | (3,238 | ) | (3,372 | ) |
Net purchase of marketable securities | 811 | (501 | ) | |
|
|
|
|
|
Net cash used in investing activities | (2,773 | ) | (4,070 | ) |
Repayment of loans | - | (502 | ) | |
Purchase of treasury shares, net | (13,924 | ) | (11,896 | ) |
Dividends paid | (9,715 | ) | (7,742 | ) |
|
|
|
|
|
Net cash used in financing activities | (23,639 | ) | (20,140 | ) |
NET CASH GENERATED FROM ACTIVITIES | (470 | ) | (1,996 | ) |
Cash and cash equivalents at the beginning of the year | 11,053 | 13,057 | ||
Exchange gains/(losses) on cash and cash equivalents | (70 | ) | (8 | ) |
|
|
|
|
|
Cash and cash equivalents at the end of the year | 10,513 | 11,053 |
Financial
performance |
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|
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|
Financial statement for 2013 |
Page
32 of 35
|
APPENDIX 5: STATEMENT OF CHANGES IN EQUITY
|
||||||||||||||||
Other reserves | ||||||||||||||||
|
||||||||||||||||
DKK
million
|
Share
capital |
Treasury
shares |
Retained
earnings |
Exchange
rate adjustment |
Cash
flow
hedges |
Tax
and
other items |
Total
other reserves |
Total
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2013 | ||||||||||||||||
Balance at the beginning of the year | 560 | (17 | ) | 39,001 | 226 | 847 | 15 | 1,088 | 40,632 | |||||||
Net profit for the year | 25,184 | 25,184 | ||||||||||||||
Other comprehensive income for the year | 54 | (435 | ) | 386 | (136 | ) | (185 | ) | (131 | ) | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income for the year | 25,238 | (435 | ) | 386 | (136 | ) | (185 | ) | 25,053 | |||||||
Transactions with owners: | ||||||||||||||||
Dividends | (9,715 | ) | (9,715 | ) | ||||||||||||
Share-based payments | 409 | 409 | ||||||||||||||
Tax credit related to share option scheme | 114 | 114 | ||||||||||||||
Purchase of treasury shares | (15 | ) | (13,974 | ) | (13,989 | ) | ||||||||||
Sale of treasury shares | 1 | 64 | 65 | |||||||||||||
Reduction of the B share capital | (10 | ) | 10 | - | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the year | 550 | (21 | ) | 41,137 | (209 | ) | 1,233 | (121 | ) | 903 | 42,569 | |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At the end of the year proposed dividends (not yet declared) of DKK 11,866 million (4.50 DKK per share of DKK 0.20) are included in Retained earnings. No dividend is declared on treasury shares.
|
||||||||||||||||
Other reserves | ||||||||||||||||
|
||||||||||||||||
DKK
million
|
Share
capital |
Treasury
shares |
Retained
earnings |
Exchange
rate adjustment |
Cash
flow
hedges |
Tax
and
other items |
Total
other reserves |
Total
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2012 | ||||||||||||||||
Balance at the beginning of the year | 580 | (24 | ) | 37,111 | 398 | (1,184 | ) | 567 | (219 | ) | 37,448 | |||||
Net profit for the year | 21,432 | 21,432 | ||||||||||||||
Other comprehensive income for the year | (281 | ) | (172 | ) | 2,031 | (552 | ) | 1,307 | 1,026 | |||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income for the year | 21,151 | (172 | ) | 2,031 | (552 | ) | 1,307 | 22,458 | ||||||||
Transactions with owners: | ||||||||||||||||
Dividends | (7,742 | ) | (7,742 | ) | ||||||||||||
Share-based payments | 308 | 308 | ||||||||||||||
Tax credit related to share option scheme | 56 | 56 | ||||||||||||||
Purchase of treasury shares | (15 | ) | (12,147 | ) | (12,162 | ) | ||||||||||
Sale of treasury shares | 2 | 264 | 266 | |||||||||||||
Reduction of the B share capital | (20 | ) | 20 | - | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the year | 560 | (17 | ) | 39,001 | 226 | 847 | 15 | 1,088 | 40,632 | |||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At the end of the year dividends of DKK 9,715 million (3.60 DKK per share of DKK 0.20) are included in Retained earnings. No dividend is declared on treasury shares.
Financial
performance |
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|
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|
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announcement No 5 / 2014
|
Financial statement for 2013 |
Page
33 of 35
|
APPENDIX 6: REGIONAL SALES SPLIT
|
||||||||||||
Q4 2013 sales split per region | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
DKK million |
Total
|
North
America |
Europe
|
Inter-
national Operations |
Japan
&
Korea |
Region
China
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
The diabetes care segment | ||||||||||||
NovoRapid® | 4,455 | 2,602 | 1,012 | 464 | 253 | 124 | ||||||
% change in local currencies | 10% | 9% | 4% | 36% | 6% | 32% | ||||||
NovoMix® | 2,521 | 668 | 631 | 522 | 198 | 502 | ||||||
% change in local currencies | 9% | 1% | (2% | ) | 29% | (6% | ) | 28% | ||||
Levemir® | 3,167 | 1,938 | 763 | 343 | 66 | 57 | ||||||
% change in local currencies | 24% | 37% | 3% | 27% | (14% | ) | 29% | |||||
Modern insulin | 10,143 | 5,208 | 2,406 | 1,329 | 517 | 683 | ||||||
% change in local currencies | 14% | 16% | 2% | 30% | (2% | ) | 29% | |||||
Human insulin | 2,694 | 561 | 615 | 651 | 120 | 747 | ||||||
% change in local currencies | (5% | ) | (12% | ) | (8% | ) | (5% | ) | (16% | ) | 5% | |
Victoza® | 3,231 | 2,154 | 766 | 195 | 86 | 30 | ||||||
% change in local currencies | 25% | 35% | 9% | 18% | (10% | ) | 48% | |||||
Other diabetes care | 1,007 | 207 | 229 | 159 | 136 | 276 | ||||||
% change in local currencies | (16% | ) | (59% | ) | 0% | 28% | 41% | 11% | ||||
Diabetes care total | 17,075 | 8,130 | 4,016 | 2,334 | 859 | 1,736 | ||||||
% change in local currencies | 10% | 13% | 1% | 17% | 0% | 15% | ||||||
The biopharmaceuticals segment | ||||||||||||
NovoSeven® | 2,259 | 984 | 554 | 521 | 177 | 23 | ||||||
% change in local currencies | (1% | ) | (16% | ) | (4% | ) | 35% | 34% | (8% | ) | ||
Norditropin® | 1,662 | 654 | 445 | 230 | 330 | 3 | ||||||
% change in local currencies | 26% | 59% | (4% | ) | 52% | 12% | 33% | |||||
Other biopharmaceuticals | 702 | 446 | 170 | 54 | 32 | - | ||||||
% change in local currencies | 23% | 48% | (4% | ) | 9% | (20% | ) | 0% | ||||
Biopharmaceuticals total | 4,623 | 2,084 | 1,169 | 805 | 539 | 26 | ||||||
% change in local currencies | 11% | 11% | (4% | ) | 38% | 15% | (3% | ) | ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Total sales | 21,698 | 10,214 | 5,185 | 3,139 | 1,398 | 1,762 | ||||||
% change in local currencies | 10% | 12% | 0% | 22% | 5% | 15% | ||||||
% change as reported | 4% | 7% | (1% | ) | 8% | (18% | ) | 12% | ||||
|
|
|
|
|
|
|
|
|
|
|
|
2013 sales split per region
|
||||||||||||
DKK million |
Total
|
North
America |
Europe
|
Inter-
national Operations |
Japan
&
Korea |
Region
China
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
The diabetes care segment | ||||||||||||
NovoRapid® | 16,848 | 9,953 | 3,819 | 1,639 | 951 | 486 | ||||||
% change in local currencies | 12% | 14% | 4% | 27% | 1% | 32% | ||||||
NovoMix ® | 9,759 | 2,694 | 2,450 | 1,875 | 789 | 1,951 | ||||||
% change in local currencies | 10% | 12% | (3% | ) | 20% | (5% | ) | 25% | ||||
Levemir® | 11,546 | 6,823 | 2,909 | 1,290 | 288 | 236 | ||||||
% change in local currencies | 22% | 33% | 4% | 28% | (8% | ) | 39% | |||||
Modern insulin | 38,153 | 19,470 | 9,178 | 4,804 | 2,028 | 2,673 | ||||||
% change in local currencies | 14% | 20% | 2% | 24% | (3% | ) | 27% | |||||
Human insulin | 10,869 | 1,976 | 2,427 | 2,954 | 490 | 3,022 | ||||||
% change in local currencies | 0% | 4% | (8% | ) | 2% | (20% | ) | 6% | ||||
Victoza® | 11,633 | 7,537 | 2,896 | 741 | 331 | 128 | ||||||
% change in local currencies | 27% | 31% | 20% | 31% | (8% | ) | 84% | |||||
Other diabetes care | 4,801 | 1,590 | 885 | 692 | 471 | 1,163 | ||||||
% change in local currencies | (4% | ) | (18% | ) | (8% | ) | 17% | 19% | 0% | |||
Diabetes care total | 65,456 | 30,573 | 15,386 | 9,191 | 3,320 | 6,986 | ||||||
% change in local currencies | 12% | 18% | 3% | 16% | (4% | ) | 13% | |||||
The biopharmaceuticals segment | ||||||||||||
NovoSeven® | 9,256 | 4,459 | 2,294 | 1,716 | 629 | 158 | ||||||
% change in local currencies | 8% | 5% | 4% | 19% | 17% | 2% | ||||||
Norditropin® | 6,114 | 2,273 | 1,729 | 853 | 1,246 | 13 | ||||||
% change in local currencies | 16% | 36% | 0% | 20% | 8% | 0% | ||||||
Other biopharmaceuticals | 2,746 | 1,719 | 654 | 247 | 122 | 4 | ||||||
% change in local currencies | 15% | 27% | 3% | 18% | (32% | ) | 25% | |||||
Biopharmaceuticals total | 18,116 | 8,451 | 4,677 | 2,816 | 1,997 | 175 | ||||||
% change in local currencies | 12% | 16% | 3% | 19% | 7% | 2% | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Total sales | 83,572 | 39,024 | 20,063 | 12,007 | 5,317 | 7,161 | ||||||
% change in local currencies | 12% | 18% | 3% | 17% | 0% | 13% | ||||||
% change as reported | 7% | 14% | 2% | 8% | (20% | ) | 12% | |||||
|
|
|
|
|
|
|
|
|
|
|
|
Financial
performance |
Outlook
|
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|
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|
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|
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|
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announcement No 5 / 2014
|
Financial statement for 2013 |
Page
34 of 35
|
APPENDIX 7: KEY CURRENCY ASSUMPTIONS
|
|
|
|
|
|
|
|
|
DKK per 100 |
2012
average
exchange rates |
2013
average
exchange rates |
YTD
2014 average
exchange rates as of 27 January 2014 |
Current
exchange rates as of 27 January 2014 |
||||
|
|
|
|
|
|
|
|
|
USD | 579 | 562 | 548 | 546 | ||||
CNY | 91.8 | 91.3 | 90.6 | 90.4 | ||||
JPY | 7.27 | 5.77 | 5.26 | 5.32 | ||||
GBP | 918 | 878 | 901 | 904 | ||||
CAD | 580 | 545 | 504 | 495 |
Financial
performance |
Outlook
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|
Financial statement for 2013 |
Page
35 of 35
|
APPENDIX 8: QUARTERLY NUMBERS IN USD (ADDITIONAL INFORMATION)
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.
|
||||||||||||||||||
(Amounts in USD million, except full-time equivalent employees, earnings per share and number of shares outstanding). | ||||||||||||||||||
%
change
|
||||||||||||||||||
2013 | 2012 |
Q4
2013 vs
|
||||||||||||||||
Q4
|
Q3
|
Q2
|
Q1
|
Q4
|
Q3
|
Q2
|
Q1
|
Q4
2012
|
||||||||||
|
|
|
|
|||||||||||||||
Sales | 3,950 | 3,643 | 3,749 | 3,537 | 3,641 | 3,337 | 3,362 | 3,129 |
4%
|
|||||||||
Gross profit | 3,330 | 3,017 | 3,117 | 2,898 | 3,093 | 2,752 | 2,771 | 2,529 |
3%
|
|||||||||
Gross margin | 84.3% | 82.8% | 83.1% | 81.9% | 85.0% | 82.4% | 82.4% | 80.8% | ||||||||||
Sales and distribution costs | 1,178 | 982 | 1,024 | 978 | 1,075 | 890 | 900 | 854 |
5%
|
|||||||||
Percentage of sales | 29.9% | 27.0% | 27.3% | 27.7% | 29.5% | 26.7% | 26.7% | 27.3% | ||||||||||
Research and development costs | 646 | 497 | 476 | 470 | 557 | 440 | 442 | 442 |
11%
|
|||||||||
Percentage of sales | 16.4% | 13.6% | 12.7% | 13.3% | 15.3% | 13.2% | 13.2% | 14.1% | ||||||||||
Administrative costs | 195 | 145 | 143 | 142 | 172 | 129 | 134 | 137 |
8%
|
|||||||||
Percentage of sales | 4.9% | 4.0% | 3.8% | 4.0% | 4.7% | 3.9% | 4.0% | 4.4% | ||||||||||
Licence income and other operating income | 32 | 27 | 31 | 31 | 27 | 31 | 27 | 30 |
15%
|
|||||||||
Operating profit | 1,343 | 1,420 | 1,505 | 1,339 | 1,316 | 1,324 | 1,322 | 1,126 |
(3%)
|
|||||||||
Operating margin | 33.9% | 39.0% | 40.2% | 37.8% | 36.1% | 39.6% | 39.3% | 36.0% | ||||||||||
Financial income | 110 | 73 | 65 | 55 | 3 | (15 | ) | 26 | 8 |
N/A
|
||||||||
Financial expenses | 31 | 20 | 47 | 19 | 24 | 70 | 149 | 66 |
24%
|
|||||||||
Net financials | 79 | 53 | 18 | 36 | (21 | ) | (85 | ) | (123 | ) | (58 | ) |
N/A
|
|||||
Profit before income taxes | 1,422 | 1,473 | 1,523 | 1,375 | 1,295 | 1,239 | 1,199 | 1,068 |
5%
|
|||||||||
Net profit | 1,105 | 1,139 | 1,181 | 1,059 | 1,000 | 954 | 924 | 822 |
5%
|
|||||||||
Depreciation, amortisation and impairment losses | 143 | 114 | 119 | 122 | 131 | 108 | 114 | 112 |
5%
|
|||||||||
Capital expenditure | 135 | 161 | 137 | 138 | 175 | 159 | 148 | 91 |
(27%)
|
|||||||||
Net cash generated from operating activities 1) | 986 | 1,105 | 1,277 | 1,251 | 270 | 1,343 | 1,237 | 985 |
255%
|
|||||||||
Free cash flow 1) | 834 | 927 | 1,126 | 1,094 | 78 | 1,168 | 1,085 | 888 |
N/A
|
|||||||||
Total assets | 12,995 | 12,338 | 11,274 | 10,698 | 11,604 | 11,554 | 10,328 | 10,988 |
7%
|
|||||||||
Total equity | 7,865 | 7,085 | 6,200 | 5,791 | 7,180 | 6,185 | 5,307 | 5,809 |
5%
|
|||||||||
Equity ratio | 60.5% | 57.4% | 55.0% | 54.1% | 61.9% | 53.5% | 51.4% | 52.9% | ||||||||||
Full-time equivalent employees end of period | 37,978 | 36,851 | 35,869 | 35,154 | 34,286 | 33,501 | 32,819 | 32,252 |
11%
|
|||||||||
Basic earnings per share/ADR (in USD) 2) | 0.41 | 0.43 | 0.44 | 0.39 | 0.37 | 0.35 | 0.33 | 0.30 |
8%
|
|||||||||
Diluted earnings per share/ADR (in USD) 2) | 0.41 | 0.42 | 0.44 | 0.39 | 0.36 | 0.35 | 0.34 | 0.29 |
8%
|
|||||||||
Average number of shares outstanding (million) 2) | 2,653.4 | 2,667.5 | 2,688.5 | 2,708.0 | 2,714.5 | 2,723.0 | 2,745.5 | 2,783.5 |
(2%)
|
|||||||||
Average number of diluted shares | ||||||||||||||||||
outstanding (million) 2) | 2,666.8 | 2,681.5 | 2,702.5 | 2,723.5 | 2,730.0 | 2,739.0 | 2,762.0 | 2,802.5 |
(2%)
|
|||||||||
Sales by business segment: | ||||||||||||||||||
Modern insulins (insulin analogues) | 1,844 | 1,669 | 1,688 | 1,591 | 1,644 | 1,493 | 1,487 | 1,387 |
7%
|
|||||||||
Human insulins | 491 | 457 | 487 | 500 | 523 | 469 | 479 | 479 |
(10%)
|
|||||||||
Victoza® | 587 | 505 | 505 | 474 | 470 | 422 | 396 | 351 |
19%
|
|||||||||
Protein-related products | 117 | 118 | 113 | 107 | 108 | 108 | 107 | 110 |
3%
|
|||||||||
Oral antidiabetic products (OAD) | 68 | 90 | 119 | 123 | 116 | 122 | 113 | 126 |
(45%)
|
|||||||||
Diabetes care total | 3,107 | 2,839 | 2,912 | 2,795 | 2,861 | 2,614 | 2,582 | 2,453 |
4%
|
|||||||||
NovoSeven® | 412 | 431 | 446 | 359 | 420 | 362 | 423 | 337 |
(7%)
|
|||||||||
Norditropin® | 303 | 255 | 259 | 272 | 254 | 244 | 249 | 237 |
14%
|
|||||||||
Other biopharmaceuticals | 128 | 118 | 132 | 111 | 106 | 117 | 108 | 102 |
15%
|
|||||||||
Biopharmaceuticals total | 843 | 804 | 837 | 742 | 780 | 723 | 780 | 676 |
3%
|
|||||||||
Sales by geographic segment: | ||||||||||||||||||
North America | 1,858 | 1,734 | 1,761 | 1,594 | 1,659 | 1,514 | 1,443 | 1,291 |
7%
|
|||||||||
Europe | 944 | 887 | 898 | 843 | 910 | 804 | 878 | 810 |
(1%)
|
|||||||||
International Operations | 572 | 479 | 539 | 548 | 503 | 452 | 476 | 482 |
8%
|
|||||||||
Japan & Korea | 255 | 233 | 240 | 219 | 295 | 287 | 298 | 262 |
(18%)
|
|||||||||
Region China | 321 | 310 | 311 | 333 | 274 | 280 | 267 | 284 |
12%
|
|||||||||
Segment operating profit: | ||||||||||||||||||
Diabetes care | 1,016 | 1,045 | 1,046 | 974 | 942 | 972 | 910 | 818 |
3%
|
|||||||||
Biopharmaceuticals | 327 | 375 | 459 | 365 | 374 | 352 | 412 | 308 |
(17%)
|
1) Free
cash flow for Q1 2012 and Q2 2012 has been reduced by USD 234 million and increased
by USD 234 million, respectively, as withheld dividend tax is now presented
as part of financing activities.
2) Comparative
figures have been restated to reflect the change in trading unit from DKK 1
to DKK 0.20.
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Corporate
governance |
Legal
|
Financial
information |
Company
announcement No 5 / 2014
|
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: January 30, 2014 |
NOVO NORDISK A/S Lars Rebien Sørensen, President and Chief Executive Officer |