UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________
FORM 6-K
________________
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
February 3, 2016
________________
NOVO NORDISK A/S
(Exact name
of Registrant as specified in its charter)
Novo Allé
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
________________
Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F
Form 20-F [X] |
Form 40-F [ ] |
Indicate by check mark whether the registrant by furnishing the information contained
in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
If “Yes” is marked, indicate below the file number assigned to the registrant
in connection with Rule 12g-32(b):82-________
Financial statement for 2015
3 February 2016
Novo
Nordisk increased operating profit by 43% in 2015 to DKK 49.4 billion
14% local currency operating profit growth adjusted for
NNIT divestment
Sales increased by 22% in Danish kroner and by 8% in local currencies to 107.9
billion.
| • Sales of modern and new-generation insulin increased by 22% (9% in local currencies). |
| • Sales of Victoza® increased by 34% (18% in local currencies). |
| • Sales in North America increased by 32% (11% in local currencies). |
| • Sales in International Operations increased by 19% (15% in local currencies). |
| • Sales in Region China increased by 22% (4% in local currencies). |
Operating profit increased by 43% in Danish kroner and by 21% in local
currencies to DKK 49.4 billion. Adjusted for the DKK 2.4 billion non-recurring income related to the partial divestment of NNIT,
the operating margin was 43.6% corresponding to an increase in operating profit in local currencies of 14%.
Net profit increased by 32% to DKK 34.9 billion. Diluted earnings per
share increased by 34% to DKK 13.52. Adjusted for the partial divestment of NNIT, net profit and diluted earnings per share increased
by 22% and 25% respectively.
In 2015, Novo Nordisk achieved its four long-term
financial targets established in January 2013 and consequently, the Board of Directors has approved three updated long-term financial
targets to guide Novo Nordisk’s performance. The target for operating profit growth has now been set at 10%, whereas no target
for operating margin development has been established, as the operating margin is expected to stay at the current level around
44%. The targets for operating profit after tax to net operating assets and cash to earnings remain unchanged at 125% and 90% respectively.
For 2016, sales growth is expected to be 5-9% measured in local currencies.
Growth in operating profit is also expected to be 5-9% measured in local currencies, adjusted for the non-recurring impact of the
partial divestment of NNIT and the income related to the out-licensing of assets for inflammatory disorders, both in 2015. Growth
reported in DKK, for both items, is expected to be around 1 percentage point lower than the local currency levels.
At the Annual General Meeting on 18 March 2016, the Board of Directors
will propose a 28% increase in dividend to DKK 6.40 per share of DKK 0.20 and intends to initiate a new 12-months share repurchase
programme of up to DKK 14 billion.
Lars Rebien Sørensen, president and CEO: “We are very pleased
with Novo Nordisk’s performance in 2015 and the achievement of our four long-term financial targets. In 2016 we will continue
to focus on the global launch of Tresiba® and we are encouraged by the recent SWITCH 2
data, which further demonstrate the ability of Tresiba® to reduce the risk of hypoglycaemia
in people with type 2 diabetes on basal insulin therapy.”
Novo Nordisk A/S
Investor Relations |
Novo Allé
2880 Bagsværd
Denmark |
Telephone:
+45 4444 8888
www.novonordisk.com
|
CVR no:
24 25 67 90 |
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 2 of 40 |
ABOUT NOVO NORDISK
Novo Nordisk is a global healthcare company with more than 90 years of
innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help
people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk
employs approximately 41,000 people in 75 countries and markets its products in more than 180 countries. Novo Nordisk's B shares
are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO).
CONFERENCE CALL DETAILS
On 3 February 2016 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’. Presentation material for the conference call will
be available approximately one hour before on the same page.
WEB CAST DETAILS
On 4 February 2016 at 14.15 CET, corresponding to 8.15 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’.
Presentation material for the webcast will be made available on the same page.
4 February 2016 Deadline for the company’s receipts of shareholder proposals for the Annual General Meeting 2016 8 February 2016 PDF Version of Annual Report 2015 23 February 2016 Printed version of the Annual Report 2015 18 March 2016 Annual General Meeting 2016 29 April 2016 Financial Statement for first three months of 2016 5 August 2016 Financial Statement for first six months of 2016 28 October 2016 Financial Statement for first nine months of 2016
FINANCIAL CALENDAR
4 February 2016 |
Deadline for the company’s receipts of shareholder proposals for the Annual General Meeting 2016 |
8 February 2016 |
PDF Version of Annual Report 2015 |
23 February 2016 |
Printed version of the Annual Report 2015 |
18 March 2016 |
Annual General Meeting 2016 |
29 April 2016 |
Financial Statement for first three months of 2016 |
5 August 2016 |
Financial Statement for first six months of 2016 |
28 October 2016 |
Financial Statement for first nine months of 2016 |
CONTACTS FOR FURTHER INFORMATION
Media: |
Katrine Sperling |
+45 3079 6718 |
krsp@novonordisk.com |
Ken Inchausti (US) |
+1 267 809 7552 |
kiau@novonordisk.com |
|
|
|
Investors: |
Peter Hugreffe Ankersen |
+45 3075 9085 |
phak@novonordisk.com |
Daniel Bohsen |
+45 3079 6376 |
dabo@novonordisk.com |
Melanie Raouzeos |
+45 3075 3479 |
mrz@novonordisk.com |
Kasper Veje |
+45 3075 8519 |
kpvj@novonordisk.com |
Further information about Novo Nordisk is available
on novonordisk.com.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 3 of 40 |
LIST OF CONTENTS |
|
FINANCIAL PERFORMANCE |
4 |
|
Consolidated financial statement for 2015 |
4 |
|
Performance versus long-term financial targets |
5 |
|
Sales development |
6 |
|
Development in costs and operating profit |
11 |
|
net financials and tax |
11 |
|
Capital expenditure and free cash flow |
12 |
|
Key developments in the fourth quarter of 2015 |
12 |
OUTLOOK |
14 |
LONG-TERM FINANCIAL TARGETS UPDATE |
15 |
RESEARCH & DEVELOPMENT UPDATE |
17 |
|
Diabetes |
17 |
|
Biopharmaceuticals |
20 |
|
Other |
21 |
SUSTAINABILITY |
22 |
|
Highlights from the Consolidated social and environmental statements for 2015 |
22 |
|
Social performance |
22 |
EQUITY |
24 |
CORPORATE GOVERNANCE |
26 |
LEGAL UPDATE |
28 |
MANAGEMENT STATEMENT |
31 |
FINANCIAL INFORMATION |
32 |
|
Appendix 1: |
Quarterly numbers in DKK (unaudited) |
32 |
|
Appendix 2: |
Income statement and statement of comprehensive income |
33 |
|
Appendix 3: |
Balance sheet |
34 |
|
Appendix 4: |
Statement of cash flows |
35 |
|
Appendix 5: |
Statement of changes in equity |
36 |
|
Appendix 6: |
Regional sales split |
37 |
|
Appendix 7: |
Key currency assumptions |
38 |
|
Appendix 8: |
Quarterly numbers in USD (additional information - unaudited) |
39 |
|
Appendix 9: |
new regional sales split as per 1 january 2016 |
40 |
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 4 of 40 |
FINANCIAL PERFORMANCE
CONSOLIDATED FINANCIAL STATEMENT FOR 2015
The Board of Directors and Executive Management have approved the Annual
Report 2015 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 2015. 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 2015 as well as those applied in the audited consolidated financial statements in the Annual Report
2014.
PROFIT AND LOSS
DKK million |
2015 |
2014 |
2013 |
2012 |
2011 |
% change
2014 to
2015 |
Net sales |
107,927 |
88,806 |
83,572 |
78,026 |
66,346 |
22% |
Gross profit |
91,739 |
74,244 |
69,432 |
64,561 |
53,757 |
24% |
Gross margin |
85.0% |
83.6% |
83.1% |
82.7% |
81.0% |
|
|
|
|
|
|
|
|
Sales and distribution costs |
28,312 |
23,223 |
23,380 |
21,544 |
19,004 |
22% |
Percentage of sales |
26.2% |
26.2% |
28.0% |
27.6% |
28.6% |
|
|
|
|
|
|
|
|
Research and development costs |
13,608 |
13,762 |
11,733 |
10,897 |
9,628 |
(1%) |
Percentage of sales |
12.6% |
15.5% |
14.0% |
14.0% |
14.5% |
|
|
|
|
|
|
|
|
Administrative costs |
3,857 |
3,537 |
3,508 |
3,312 |
3,245 |
9% |
Percentage of sales |
3.6% |
4.0% |
4.2% |
4.2% |
4.9% |
|
|
|
|
|
|
|
|
Other operating income, net |
3,482 |
770 |
682 |
666 |
494 |
N/A |
- Non-recurring income from the partial divestment
of NNIT A/S |
2,376 |
- |
- |
- |
- |
|
Operating profit |
49,444 |
34,492 |
31,493 |
29,474 |
22,374 |
43% |
Operating margin |
45.8% |
38.8% |
37.7% |
37.8% |
33.7% |
|
Operating margin adjusted for the partial divestment of NNIT A/S |
43.6% |
38.8% |
37.7% |
37.8% |
33.7% |
|
|
|
|
|
|
|
|
Net financials |
(5,961) |
(396) |
1,046 |
(1,663) |
(449) |
N/A |
Profit before income taxes |
43,483 |
34,096 |
32,539 |
27,811 |
21,925 |
28% |
|
|
|
|
|
|
|
Income taxes |
8,623 |
7,615 |
7,355 |
6,379 |
4,828 |
13% |
Effective tax rate |
19.8% |
22.3% |
22.6% |
22.9% |
22.0% |
|
|
|
|
|
|
|
|
Net profit |
34,860 |
26,481 |
25,184 |
21,432 |
17,097 |
32% |
Net profit margin |
32.3% |
29.8% |
30.1% |
27.5% |
25.8% |
|
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 5 of 40 |
CONSOLIDATED FINANCIAL STATEMENT 2015 –
CONTINUED
OTHER KEY NUMBERS
(Amounts below in DKK million except
earnings per
share and dividend per share)
|
2015 |
2014 |
2013 |
2012 |
2011 |
% change
2014 to
2015 |
Depreciation, amortisation and impairment losses 1) |
2,959 |
3,435 |
2,799 |
2,693 |
2,737 |
(14%) |
Capital expenditure (tangible assets) |
5,209 |
3,986 |
3,207 |
3,319 |
3,003 |
31% |
|
|
|
|
|
|
|
Net cash generated from operating |
|
|
|
|
|
|
activities |
38,287 |
31,692 |
25,942 |
22,214 |
21,374 |
21% |
Free cash flow |
34,222 |
27,396 |
22,358 |
18,645 |
18,112 |
25% |
|
|
|
|
|
|
|
Total assets |
91,799 |
77,062 |
70,337 |
65,669 |
64,698 |
19% |
Equity |
46,969 |
40,294 |
42,569 |
40,632 |
37,448 |
17% |
Equity ratio |
51.2% |
52.3% |
60.5% |
61.9% |
57.9% |
|
|
|
|
|
|
|
|
Diluted earnings per share / ADR |
|
|
|
|
|
|
(in DKK) |
13.52 |
10.07 |
9.35 |
7.77 |
6.00 |
34% |
Diluted earnings per share / ADR adjusted for |
|
|
|
|
|
|
non-recurring income from the partial |
12.58 |
10.07 |
9.35 |
7.77 |
6.00 |
25% |
divestment of NNIT A/S (in DKK) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividend per share (in DKK) 2) |
6.40 |
5.00 |
4.50 |
3.60 |
2.80 |
28% |
|
|
|
|
|
|
|
Payout ratio 3) |
46.6% |
48.7% |
47.1% |
45.3% |
45.3% |
|
Payout ratio adjusted for the partial divestment of NNIT A/S 4) |
50.0% |
48.7% |
47.1% |
45.3% |
45.3% |
|
1) |
Including impairments
of around DKK 480 million in 2014 related to discontinuation of activities within inflammatory disorders. |
2) |
Proposed dividend for the
financial year 2015. |
3) |
Proposed dividend for the
year as a percentage of net profit. |
4) |
The net profit impact from
the partial divestment of NNIT A/S was returned to Novo Nordisk shareholders through a DKK 2.5 billion increase in the share
repurchase programme announced in April 2015. |
PERFORMANCE
VERSUS LONG-TERM FINANCIAL TARGETS
PERFORMANCE
AGAINST LONG- TERM FINANCIAL TARGETS
|
2015 |
2014 |
2013 |
2012 |
2011 |
Target |
Operating profit growth |
43.3% |
9.5% |
6.9% |
31.7% |
18.4% |
15% |
Growth in local currencies |
20.6% |
12.7% |
14.6% |
20.2% |
22.1% |
|
|
|
|
|
|
|
|
Operating profit margin |
45.8% |
38.8% |
37.7% |
37.8% |
33.7% |
40% |
|
|
|
|
|
|
|
Operating profit after tax to net operating assets |
148.7% |
101.0% |
97.2% |
99.0% |
77.9% |
125% |
|
|
|
|
|
|
|
Cash to earnings |
98.2% |
103.5% |
88.8% |
87.0% |
105.9% |
|
Cash to earnings (three-years average) |
96.8% |
93.1% |
93.9% |
103.7% |
112.8% |
90% |
|
|
|
|
|
|
|
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 6 of 40 |
SALES DEVELOPMENT
Sales increased by 22% measured in Danish kroner and by 8% in local currencies.
This is in line with the latest guidance of ‘7–9% growth in local currencies’ provided in connection with the
quarterly announcement in October 2015. North America was the main contributor with 62% share of growth measured in local currencies,
followed by International Operations with 26%. Sales growth was realised within both diabetes care and biopharmaceuticals, with
the majority of growth originating from modern insulin and Victoza®.
The diabetes and obesity care segment |
Sales
2015
DKK
million |
Growth
as reported |
Growth
in local
currencies |
Share of
growth
in local
currencies |
New-generation insulin 1) |
1,438 |
119% |
109% |
10% |
Modern insulin |
50,164 |
21% |
7% |
41% |
- NovoRapid ® |
20,720 |
19% |
6% |
13% |
- NovoMix ® |
11,144 |
13% |
2% |
3% |
- Levemir ® |
18,300 |
29% |
13% |
25% |
Human insulin |
11,231 |
9% |
(1%) |
(1%) |
Victoza® |
18,027 |
34% |
18% |
32% |
Other diabetes and obesity care 2) |
4,730 |
16% |
5% |
3% |
Diabetes and obesity care total |
85,590 |
22% |
9% |
85% |
The biopharmaceuticals segment |
10,647 |
14% |
3% |
3% |
Haemophilia 3) |
|
|
|
|
- NovoSeven ® |
10,064 |
10% |
(1%) |
(2%) |
Norditropin® |
7,820 |
20% |
8% |
7% |
Other biopharmaceuticals 4) |
3,870 |
28% |
13% |
5% |
Biopharmaceuticals total |
22,337 |
19% |
6% |
15% |
Total sales |
107,927 |
22% |
8% |
100% |
1) |
Comprises Tresiba®,
Ryzodeg® and Xultophy®. |
2) |
Primarily NovoNorm®,
needles and Saxenda®. |
3) |
Comprises NovoSeven®,
NovoEight® and NovoThirteen®. |
4) |
Primarily Vagifem®
and Activelle®. |
In the following sections, unless otherwise noted, market data are based
on moving annual total (MAT) from November 2015 and November 2014 provided by the independent data provider IMS Health.
DIABETES AND OBESITY CARE, SALES DEVELOPMENT
Sales of diabetes and obesity care products increased by 22% measured
in Danish kroner and by 9% in local currencies to DKK 85,590 million. Novo Nordisk is the world leader in diabetes care and holds
a global value market share of 28% compared to 27% at the same time last year.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 7 of 40 |
Insulin
Sales of insulin increased by 20% in Danish kroner and by 7% in local
currencies to DKK 62,833 million. Measured in local currencies, sales growth was driven by North America, International Operations
and Region China. Novo Nordisk is the global leader with 47% of the total insulin market and 46% of the market for modern insulin
and new-generation insulin, both measured in volume.
Sales of new-generation insulin (Tresiba®,
Ryzodeg® and Xultophy®) reached DKK 1,438 million
compared with DKK 658 million in 2014.
The roll-out of Tresiba® (insulin
degludec), the once-daily new-generation basal insulin, continues and the product has now been launched in 39 countries including
Spain and the US with initial encouraging market access. In Japan, where Tresiba® was
launched in March 2013 with the same level of reimbursement as insulin glargine, its share of the basal insulin market has grown
steadily, and Tresiba® has captured 33% of the market measured in monthly value market
share. Similarly, Tresiba® has shown solid penetration in other markets with reimbursement
at a similar level to insulin glargine, whereas penetration remains modest in markets with restricted market access compared with
insulin glargine. Novo Nordisk has ceased distribution of Tresiba® in Germany in January
2016 as a result of the negative outcome from price negotiations with the National Association of Statutory Health Insurance Funds
(GKV-SV).
Ryzodeg®, a soluble formulation
of insulin degludec and insulin aspart, was recently launched in Japan as the third market following launches in Mexico and India.
Launch activities are progressing as planned and early feedback from patients and prescribers is encouraging.
Xultophy®, a once-daily single-injection
combination of insulin degludec (Tresiba®) and liraglutide (Victoza®),
has been marketed in Switzerland, Germany, the UK and Sweden. Launch activities are progressing as planned, and also here, early
feedback from patients and prescribers is encouraging.
Sales of modern insulin increased by 21% in Danish kroner and by 7%
in local currencies to DKK 50,164 million. North America accounted for 66% of the growth, followed by International Operations
and Region China. Sales of modern insulin and new-generation insulin now constitute 82% of Novo Nordisk’s sales of insulin.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 8 of 40 |
INSULIN MARKET SHARES
(volume, MAT)
|
Novo Nordisk’s share
of total insulin market
|
|
Novo
Nordisk’s share
of the modern insulin and
new-generation insulin market
|
|
|
November
2015 |
|
November
2014 |
|
November
2015 |
|
November
2014 |
|
Global |
47% |
|
47% |
|
46% |
|
45% |
|
USA |
37% |
|
36% |
|
39% |
|
38% |
|
Europe |
47% |
|
48% |
|
47% |
|
47% |
|
International Operations* |
55% |
|
55% |
|
52% |
|
52% |
|
China** |
55% |
|
58% |
|
62% |
|
64% |
|
Japan |
52% |
|
52% |
|
50% |
|
49% |
|
Source: IMS, November
2015 data. *: Data for 13 selected markets representing approximately 70% of Novo Nordisk’s diabetes sales in the region.
**: Data for mainland China, excluding Hong Kong and Taiwan.
North America
Sales of insulin in North America increased by 28% in Danish kroner and
by 8% in local currencies. Sales growth is driven by the market share gains for Levemir® and
NovoLog® as well as a positive contribution from the underlying volume growth of the insulin
market, partly offset by a contracting premix insulin segment. 54% of Novo Nordisk’s modern insulin volume in the US is used
in the prefilled devices FlexPen® and FlexTouch®.
Europe
Sales of insulin in Europe increased by 2% in Danish kroner and were unchanged
in local currencies. Sales growth is driven by the penetration of Tresiba®, the continued
progress of NovoRapid® as well as a positive contribution from Xultophy®,
offset by a contracting premix insulin segment and declining human insulin sales. Furthermore, sales are affected by a net negative
impact from the implementation of pricing reforms in several European countries. The device penetration in Europe is high, and
96% of Novo Nordisk’s insulin volume is being used in devices, primarily NovoPen® and
FlexPen®.
International Operations
Sales of insulin in International Operations increased by 21% in Danish
kroner and by 18% in local currencies. The growth in local currencies is driven by human insulin and the three modern insulins
as well as Tresiba®. Currently, 58% of Novo Nordisk’s insulin volume in the major
private markets is used in devices.
Region China
Sales of insulin in Region China increased by 24%
in Danish kroner and by 5% in local currencies. The modest sales growth is driven by the continued market penetration of the three
modern insulins but partially offset by a lower growth rate for the overall diabetes care market. This is reflecting cost containment
measures in the healthcare system including restrictions on access to healthcare professionals and an impact from intensified local
competition. Currently, 98% of Novo Nordisk’s insulin volume in China is used in devices, primarily the durable device NovoPen®.
Japan & Korea
Sales of insulin in Japan & Korea increased by 6% in Danish kroner
and by 1% in local currencies. The sales development reflects the continued strong uptake of Tresiba®
in the
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 9 of 40 |
Japanese market which is partly offset by a declining Japanese insulin
volume market. The device penetration in Japan remains high with 98% of Novo Nordisk’s insulin volume being used in devices,
primarily FlexPen® and FlexTouch®.
Victoza®
(GLP-1 therapy for type 2 diabetes)
Victoza® sales increased by 34%
in Danish kroner and by 18% in local currencies to DKK 18,027 million. Sales growth is driven by North America as well as positive
contribution from Europe, Japan & Korea and International Operations. The GLP-1 segment’s value share of the total diabetes
care market has increased to 7.8% compared with 7.0% in 2014. Victoza® is the market leader
in the GLP-1 segment with a 67% value market share.
GLP-1 MARKET SHARES
(value, MAT)
|
GLP-1 share of total
diabetes care market |
Victoza® share
of GLP-1 market |
|
November
2015 |
|
November
2014 |
|
November
2015 |
|
November
2014 |
|
Global |
7.8% |
|
7.0% |
|
67% |
|
72% |
|
USA |
9.0% |
|
8.4% |
|
65% |
|
69% |
|
Europe |
8.9% |
|
8.2% |
|
75% |
|
78% |
|
International Operations* |
2.2% |
|
2.4% |
|
77% |
|
76% |
|
China** |
0.8% |
|
0.7% |
|
54% |
|
58% |
|
Japan |
3.7% |
|
2.1% |
|
69% |
|
60% |
|
Source: IMS, November
2015 data. *: Data for 13 selected markets representing approximately 70% of Novo Nordisk’s diabetes sales in the region.
**: Data for mainland China, excluding Hong Kong and Taiwan.
North America
Sales of Victoza® in North America
increased by 44% in Danish kroner and by 21% in local currencies. Sales growth is driven by an underlying prescription volume growth
of the GLP-1 class of more than 20% in the US. The value share of the GLP-1 class of the total US diabetes care market has increased
to 9.0%. The growth of the GLP-1 market continues to be driven by Victoza® and the launch
of competing products. Victoza® is the market leader with a 65% value market share.
Europe
Sales in Europe increased by 8% in Danish kroner
and by 7% in local currencies. Sales growth is primarily driven by Germany, France and Spain while partly offset by the UK. In
Europe, the share of the GLP-1 class of the total diabetes care market in value has increased to 8.9%. Victoza®
is the GLP-1 market leader with a value market share of 75%.
International Operations
Sales in International Operations increased by 17% in Danish kroner and
by 17% in local currencies. Sales growth is primarily driven by a number of countries in the Middle East and Latin America. The
value share of the GLP-1 class of the total diabetes care market has declined slightly to 2.2% primarily due to stagnating GLP-1
sales in Brazil. Victoza® is the GLP-1 market leader across International Operations with
a value market share of 77%.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 10 of 40 |
Region China
Sales in Region China increased by 25% in Danish kroner and by 6% in
local currencies. The modest increase in sales measured in local currencies reflects intensified competition and the declining
growth rate for the overall diabetes care market. In China, the GLP-1 class, which represents 0.8% of the total diabetes care market
in value, is generally not reimbursed and relatively modest in size. Victoza® holds a
GLP-1 value market share of 54%.
Japan & Korea
Sales in Japan & Korea increased by 68% in Danish kroner and by 60%
in local currencies. The sales growth reflects a positive impact of an improved product label in Japan in September 2014. In Japan,
the GLP-1 class now represents 3.7% of the total diabetes care market value compared with 2.1% in 2014. Victoza®
remains the leader in the class with a value market share of 69%.
Other diabetes and obesity care
Sales of other diabetes and obesity care products, which predominantly
consist of oral antidiabetic products, needles and Saxenda®, increased by 16% in Danish
kroner and by 5% in local currencies to DKK 4,730 million. This reflects a significant positive contribution from the US launch
of Saxenda®, liraglutide 3 mg for weight management, in May 2015. In the US, Saxenda®
has broad market access in the commercial segment, launch activities are progressing as planned and feedback from patients
and prescribers is encouraging. Declining sales of needles in Europe and oral anti-diabetics in North America and International
Operations partly offset sales growth.
BIOPHARMACEUTICALS SALES DEVELOPMENT
Sales of biopharmaceutical products increased by 19% measured in Danish
kroner and by 6% in local currencies to DKK 22,337 million. Sales growth is primarily driven by North America, International Operations
and Europe.
Haemophilia
Sales of haemophilia products increased by 14% in Danish kroner and by
3% in local currencies to DKK 10,647 million. The growth in local currencies is primarily driven by the roll-out of NovoEight®
in Europe, Japan and the US as well as by NovoSeven® in International Operations
partly offset by lower NovoSeven® sales in the US and Japan.
Norditropin® (growth
hormone therapy)
Sales of Norditropin® increased
by 20% in Danish kroner and by 8% in local currencies to DKK 7,820 million. The sales growth is primarily derived from North America
reflecting favourable pricing and increased demand driven by the prefilled FlexPro® device
as well as Latin American and Middle East markets in International Operations. Novo Nordisk is the leading company in the global
growth hormone market with a 32% 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 28% in Danish
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 11 of 40 |
kroner and by 13% in local currencies to DKK 3,870 million. Sales growth
is driven by a positive impact from pricing of Vagifem® in the US.
DEVELOPMENT IN COSTS AND OPERATING PROFIT
The cost of goods sold increased by 11% to DKK 16,188 million, resulting
in a gross margin of 85.0% compared with 83.6% in 2014. This reflects a positive currency impact of 1.5 percentage points and a
positive impact from the product mix primarily due to increased sales of Victoza® and
modern insulin. This is countered by ramp-up costs for new manufacturing capacity.
Sales and distribution costs increased by 22% in Danish kroner and by
9% in local currencies to DKK 28,312 million. The increase in costs is driven by US launch costs related to Saxenda®
and NovoEight® and by preparations for the Tresiba®
launch in the US, sales force investments in selected countries in International Operations as well as adjustments to legal
provisions.
Research and development costs decreased by 1% in Danish kroner and by
6% in local currencies to DKK 13,608 million. Excluding all costs related to inflammatory disorders, an area which Novo Nordisk
exited in September 2014, research and development costs increased by 8% compared to 2014. The increase in underlying costs reflects
the progression of the late-stage diabetes care portfolio and is primarily driven by the cardiovascular outcomes trial DEVOTE for
insulin degludec and the phase 3a programme SUSTAIN for the once-weekly GLP-1 analogue semaglutide. The increase in costs is partly
offset by lower costs related to faster-acting insulin aspart following the completion of the phase 3a development programme, onset,
in August 2015.
Administration costs increased by 9% in Danish kroner and by 4% in local
currencies to DKK 3,857 million.
Other operating income (net) was DKK 3,482 million compared with DKK
770 million in 2014. The increase is driven by the DKK 2,376 million non-recurring income from the partial divestment of NNIT,
an IT service and consultancy company, in connection with the Initial Public Offering on Nasdaq Copenhagen under the symbol ‘NNIT’
(ISIN DK0060580512) as well as the DKK 449 million non-recurring income related to the out- licensing of assets for inflammatory
disorders.
Operating profit increased by 43% in Danish kroner to DKK 49,444 million.
In local currencies the growth was 21%, which is slightly higher than the latest guidance for operating profit growth measured
in local currencies for 2015 of ‘around 20%’. Adjusted for the income related to the partial divestment of NNIT, the
growth in operating profit was 14% measured in local currencies.
NET FINANCIALS AND TAX
Net financials showed a net loss of DKK 5,961 million compared with a
net loss of DKK 396 million in 2014. The reported net financial loss in 2015 is larger than the latest guidance of ‘around
DKK 5.6 billion’ primarily reflecting higher than expected losses on
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 12 of 40 |
commercial balances following the depreciation of the Argentine peso
in December 2015 as well as an effect from the depreciation of the Russian rouble and the Brazilian real during the fourth quarter
of 2015.
In line with Novo Nordisk’s 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 loss of DKK 5,898 million compared with a loss of DKK 381 million in 2014. This development reflects losses on foreign
exchange hedging involving especially the US dollar due to its appreciation versus the Danish krone compared with the prevailing
exchange rates in 2014. As of 31 December 2015, foreign exchange hedging losses of around DKK 700 million have been deferred for
recognition in the income statement in 2016.
The effective tax rate for 2015 was 19.8%, which is in line with the latest
guidance of a tax rate of ‘around 20%’ for the full year 2015. The lower tax rate compared with the 2014 level of 22.3%
primarily reflects the tax-free gain from the partial divestment of NNIT, the gradual reduction of the corporate income tax rate
in Denmark from 24.5% in 2014 to 23.5% in 2015 as well as changes in provisions related to international tax cases.
CAPITAL EXPENDITURE AND FREE CASH FLOW
Net capital expenditure for property, plant and equipment
was DKK 5.2 billion compared with DKK 4.0 billion in 2014, which is in line with the latest guidance of ‘around DKK 5.0 billion’.
Net capital expenditure was primarily related to investments in additional insulin filling capacity, expansion of the manufacturing
capacity for biopharmaceutical products and the construction of new research facilities.
Free cash flow was DKK 34.2 billion compared with
DKK 27.4 billion in 2014, which is in line with the latest guidance of DKK 33-35 billion. The increase of 25% compared with 2014
primarily reflects the increased cash flow from operating activities as well as the non-recurring proceeds from the partial divestment
of NNIT.
KEY DEVELOPMENTS IN THE FOURTH QUARTER OF 2015
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 2015.
Sales in the fourth quarter of 2015
increased by 17% in Danish kroner and by 8% in local currencies compared with the same period in 2014. The growth was
primarily driven by the three modern insulins and Victoza® but also with a notable
contribution from Tresiba® and Saxenda®.
From a geographic perspective, sales growth in local currencies was driven by North America and International Operations
representing 78% and 22% of the growth, respectively. Growth in North America was driven by Levemir, which gained market
share in the growing basal insulin segment, as well as Victoza®, which benefits from
the growing GLP-1 market partly offset by a modest market share decline. International Operations delivered solid growth,
with contribution from Brazil and Argentina due to positive impact from tender business and improved pricing.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 13 of 40 |
The gross margin was 84.0% in the fourth quarter of 2015 compared with
83.7% in the same period last year. The increase of 0.3 percentage point reflects an underlying positive currency impact of 0.8
percentage point countered by ramp-up costs for new manufacturing capacity.
Sales and distribution costs increased by 20% in Danish kroner and by
11% in local currencies in the fourth quarter of 2015 compared with the same period last year. The increase in costs was driven
by launch costs related to Saxenda® and preparations for the Tresiba®
launch in the US and sales force investments in selected countries in International Operations as well as increased provisions
related to legal cases.
Research and development costs increased by 4% in Danish kroner and were
unchanged in local currencies in the fourth quarter of 2015 compared with the same period last year. The costs were impacted by
continued expansion of the early diabetes and obesity pipeline which was countered by the gradual finalisation of the SUSTAIN development
programme for semaglutide.
Administrative costs increased by 9% in Danish
kroner and by 5% in local currencies in the fourth quarter of 2015 compared with the same period last year.
Other operating income (net) was DKK 94 million in the fourth quarter
of 2015 compared with DKK 182 million in the same period last year. The lower income compared with the same period last year reflects
reduced royalty income.
Operating profit in Danish kroner increased by 21% and by 7% in local
currencies in the fourth quarter of 2015 compared with the same period last year.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 14 of 40 |
OUTLOOK
OUTLOOK 2016
The current expectations for 2016 are summarised in the table below:
Expectations are as reported,
if not otherwise stated |
Expectations 3 February 2016 |
Sales growth |
|
in local currencies |
5-9% |
as reported |
Around 1 percentage point lower |
Operating profit growth* |
|
in local currencies |
5-9% |
as reported |
Around 1 percentage point lower |
Net financials |
Loss of around DKK 1.3 billion |
Effective tax rate |
20-22% |
Capital expenditure |
Around DKK 7.0 billion |
Depreciation, amortisation and impairment losses |
Around DKK 3.0 billion |
Free cash flow |
DKK 36-39 billion |
* Adjusted DKK 2,376 million for the partial divestment
of NNIT and DKK 449 million for the income related to the out-licensing of assets for inflammatory disorders, both in 2015.
Sales growth for 2016 is expected to be 5–9% measured in local
currencies. This reflects expectations for continued robust performance for the portfolio of modern insulin, Victoza®
and Tresiba® as well as a contribution from Saxenda®
and Xultophy®. These sales drivers are expected to be partly countered by an impact
from a contract loss in the US, healthcare reforms, the loss of exclusivity for products within hormone replacement therapy, intensifying
competition within diabetes and biopharmaceuticals as well as macroeconomic conditions in China and a number of markets in International
Operations. Given the current level of exchange rates versus the Danish krone, growth reported in DKK is expected to be around
1 percentage point lower than the local currency level.
For 2016, operating profit growth is expected to be 5–9% measured
in local currencies, adjusted by DKK 2,376 million for the partial divestment of NNIT and by DKK 449 million for the income related
to the out-licensing of assets for inflammatory disorders, both in 2015. The expectations for operating profit growth reflect growth
in selling and distribution costs to support continued launch activities as well as in research and development costs to support
the progress of Novo Nordisk’s pipeline. Given the current level of exchange rates versus the Danish krone, growth reported
in DKK is expected to be around 1 percentage point lower than the local currency level.
For 2016, Novo Nordisk expects a net financial loss of around DKK
1.3 billion. The current expectation primarily reflects losses associated with foreign exchange hedging contracts, mainly related
to the appreciation of the US dollar versus the Danish krone compared to the prevailing exchange rates in 2015.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 15 of 40 |
The effective tax rate for 2016 is expected to be in the range of 20–22%.
Capital expenditure is expected to be around DKK 7.0 billion in 2016,
primarily related to investments in an expansion of the manufacturing capacity for biopharmaceutical products, additional capacity
for active pharmaceutical ingredient production within diabetes care, an expansion of the insulin filling capacity and construction
of new research facilities. Depreciation, amortisation and impairment losses are expected to be around DKK 3.0 billion.
Free cash flow is expected to be DKK 36-39 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 2016, 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 Nordisk’s operating
profit as outlined in the table below.
Key invoicing
Currencies |
Annual impact on Novo Nordisk’s operat
ing profit of a 5%
movement in currency
|
Hedging period
(months) |
USD |
DKK 2,000 million |
12 |
CNY |
DKK 300 million |
11* |
JPY |
DKK 150 million |
12 |
GBP |
DKK 85 million |
11 |
CAD |
DKK 70 million |
11 |
* USD and Chinese
Yuan traded offshore (CNH) used as proxy when hedging Novo Nordisk’s CNY currency exposure
The financial impact from foreign exchange hedging is included in ‘Net
financials’.
LONG-TERM FINANCIAL TARGETS UPDATE
Novo Nordisk introduced four long-term financial targets in 1996 to balance
short- and long-term considerations thereby ensuring a focus on shareholder value creation. The targets were subsequently revised
and updated on several occasions most recently in connection with the annual results for 2012 released in January 2013.
In 2015, Novo Nordisk reached these four long-term financial targets and
consequently, the Board of Directors has approved three updated long-term financial targets to guide Novo Nordisk’s performance.
The targets have been revised based on an assumption of a continuation of the current business environment. Significant changes
to the business environment, including the structure of the US healthcare system, regulatory requirements, pricing and market access
environment, competitive environment, healthcare reforms, exchange rates and changes to accounting standards may significantly
impact the time horizon for achieving the long-term targets or require them to be revised.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 16 of 40 |
PERFORMANCE AGAINST
LONG-TERM FINANCIAL TARGETS
|
Result 2015 |
Average
2012-2015* |
Previous
target |
Updated
target |
Operating profit growth |
43% |
23% |
15% |
10% |
Operating margin |
46% |
40% |
40% |
N/A** |
Operating profit after tax to net operating assets |
149% |
111% |
125% |
125% |
Cash to earnings |
98% |
|
|
|
Cash to earnings
(three-year average) |
97% |
97% |
90% |
90% |
* Calculated as
a simple average
** A new target
has not been established, as operating margin is expected to remain around 44%
The target level for long-term operating profit growth has been set at
10%, reflecting the current outlook for organic sales growth and opportunities for operating margin leverage.
Novo Nordisk’s current operating margin level
of 43.6% (adjusted for the effect of the partial divestment of NNIT) has been achieved by continuous improvement in manufacturing
efficiency, positive pricing impact, sales and distribution leverage, reprioritisation of focus areas within research and development
as well as administrative efficiencies. It is a strategic priority to continue to invest in future organic sales growth, and as
a consequence operating margin improvement is not expected to be a major contributor to operating profit growth. This expectation
reflects an expanded product portfolio, a significant number of product launches and continued investments within research and
development. Consequently, no target for operating margin has been established, as the operating margin is expected to remain at
the current level around 44%.
The target level for operating profit after tax to net operating assets
is unchanged at 125%. The target reflects the expectation of a continued robust operating profit growth combined with a stable
effective tax rate and gradual increase in net operating assets, partly related to an expanded fixed asset investment to sales
ratio to accommodate future sales growth primarily within diabetes care.
The target level for the cash to earnings ratio is maintained at 90%,
as expected continued growth in International Operations and expanding investment priorities will gradually impact net operating
assets. As previously and given the inherent volatility in this ratio, the target will be pursued looking at the average over a
three-year period.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 17 of 40 |
RESEARCH &
DEVELOPMENT UPDATE
DIABETES
Tresiba® demonstrates significantly
lower rate of hypoglycaemia than insulin glargine in the SWITCH 2 blinded phase 3b trial in people with type 2 diabetes
In January 2016, Novo Nordisk announced the headline results from SWITCH
2, the first of two 2x32-weeks randomised, double-blind, cross-over, treat-to-target trials, comparing the safety and efficacy
of Tresiba® (insulin degludec) and insulin glargine. The overall purpose of the trial
was to compare the hypoglycaemia occurrence in people with type 2 diabetes treated with Tresiba®
or insulin glargine.
In the trial, 721 people with type 2 diabetes were randomised to cross-over
treatment with Tresiba® and insulin glargine in combination with metformin. The timing
of the daily injections of both Tresiba® and insulin glargine was randomised equally to
take place either in the morning or evening. The primary end-point of the trial was the number of treatment emergent severe or
blood glucose confirmed symptomatic hypoglycaemia episodes during the maintenance period (ie after 16 weeks of treatment) in each
treatment period.
From a mean baseline of 7.6%, the trial showed
non-inferiority in HbA1c reduction of Tresiba® compared
to insulin glargine, thus fulfilling the requirements for objectively comparing hypoglycaemia rates between the two treatments.
Likewise, the end-of-trial insulin doses were similar at the end of treatment in the two treatment periods.
The observed rate of severe or blood glucose confirmed symptomatic hypoglycemia
was 186 events per 100 patient years exposed to Tresiba® and 265 events per 100 patient
years exposed to insulin glargine during the maintenance period. This reduction was statistically significant, and the trial thus
met its primary endpoint by demonstrating a reduction of 30% when people were treated with Tresiba®
compared to insulin glargine.
The observed rate of severe or blood glucose symptomatic nocturnal confirmed
hypoglycaemia in the maintenance period was 55 events per 100 patient years exposed to Tresiba®
and 94 events per 100 patient years exposed to insulin glargine, corresponding to a 42% reduction with Tresiba®
compared to insulin glargine and showing statistical significance on this confirmatory secondary end-point.
The confirmatory secondary endpoint of proportions of subjects experiencing
severe hypoglycaemia during the maintenance period did not reach statistical significance. However, the supportive end-point, rate
of severe hypoglycaemia, showed a 46% reduction with Tresiba® in the maintenance period
and a statistically significant reduction of 51% with Tresiba® in the full treatment period.
In the trial, Tresiba® appeared
to have a safe and well-tolerated profile. Adverse events were comparable between the two treatment arms. The most common adverse
events were nasopharyngitis and upper respiratory tract infections.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 18 of 40 |
Phase 3b trial initiated comparing Xultophy®
(IDegLira) (NN9068) with insulin glargine
In January 2016, Novo Nordisk initiated DUAL VIII, a 104-week, open-label,
phase 3b trial investigating the long-term glycaemic control of Xultophy® versus insulin
glargine, in about 1,000 adults with type 2 diabetes mellitus, who are insulin naïve and inadequately controlled with oral
anti-diabetics.
Novo Nordisk files for regulatory approval of faster-acting insulin
aspart (NN1218) in the EU and the US for the treatment of type 1 and 2 diabetes
In December 2015, Novo Nordisk announced the submissions of the Marketing
Authorisation Application (MAA) to the European Medicines Agency (EMA) and the New Drug Application (NDA) to the US Food and Drug
Administration (FDA) for faster-acting insulin aspart. Faster-acting insulin aspart is a mealtime insulin for improved control
of postprandial glucose excursions and has been developed for the treatment of people with type 1 and type 2 diabetes.
The filing of faster-acting insulin aspart
is based on the results from the 'onset' clinical trial programme which involved around 2,100 people with type 1 and 2
diabetes. In the onset programme, people treated with faster-acting insulin aspart achieved improvements in postprandial
control versus NovoRapid® and an HbA1c reduction
on par with NovoRapid®. For people with type 1 diabetes, faster-acting insulin
aspart results from the double-blinded onset 1 trial showed statistically significantly greater HbA1c reduction
when dosed at mealtime or similar HbA1c reduction when dosed 20 minutes after a meal
compared to NovoRapid®. Across the onset trials, faster-acting insulin aspart had a
safe and well tolerated profile, with the most common adverse event being hypoglycaemia, similar to the levels observed with
NovoRapid®.
Phase 1 trial initiated with a liver-preferential mealtime insulin (NN1406)
In November 2015, Novo Nordisk initiated the first phase 1 trial with
a liver-preferential mealtime insulin. The trial will investigate safety, tolerability, pharmacokinetics and pharmacodynamics of
single doses of the drug in around 50 male adults with type 1 diabetes.
Novo Nordisk successfully completes SUSTAIN 4 trial comparing once-weekly
subcutaneous administration of the GLP-1 analogue semaglutide (NN9535) with once- daily insulin glargine
In November 2015, Novo Nordisk announced the results for SUSTAIN 4, the
third phase 3a trial for semaglutide which included a total of 1,089 people with type 2 diabetes previously treated with metformin
with or without sulfonylurea.
From a mean baseline, HbA1c of 8.2%,
people treated once-weekly with doses of 0.5 mg and 1.0 mg semaglutide achieved statistically significant and superior improvements
in HbA1c of 1.2% and 1.6%, respectively, compared to 0.8% with insulin glargine after 30 weeks
of treatment. The mean daily insulin glargine dose was 29 units. 58% of the people treated with 0.5 mg semaglutide and 73% of the
people treated with 1.0 mg semaglutide achieved the American Diabetes Association (ADA) and the European
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 19 of 40 |
Association for the Study of Diabetes (EASD) treatment target of HbA1c
below 7% compared with 38% of the people treated with insulin glargine.
Furthermore, from a mean baseline body
weight of 93 kg, people treated with 0.5 mg and 1.0 mg semaglutide experienced statistically significant and superior weight
loss of 3.5 kg and 5.2 kg, respectively, compared with a weight gain of 1.2 kg with insulin glargine.
In the trial, semaglutide appeared to have a safe and well-tolerated
profile. The most common adverse event was nausea which diminished over time. Nausea was reported by up to 22% of people treated
with semaglutide compared with 4% of people treated with insulin glargine. Severe or blood glucose-confirmed symptomatic hypoglycaemia
was experienced by 4% and 6% of people treated with 0.5 mg or 1.0 mg once-weekly semaglutide, respectively, compared with 11% in
the insulin glargine group. The discontinuation rate due to adverse events was 6% and 8% for people treated with 0.5 mg semaglutide
and 1.0 mg semaglutide respectively, compared to 1% for people treated with insulin glargine.
Novo Nordisk successfully completes SUSTAIN 2 trial comparing once-weekly
subcutaneous administration of the GLP-1 analogue semaglutide (NN9535) with once- daily 100 mg sitagliptin
In December 2015, Novo Nordisk announced the headline results from the
fourth phase 3a trial for semaglutide, SUSTAIN 2. The double-blinded trial investigated the efficacy and safety of 0.5 mg and 1.0
mg semaglutide compared with 100 mg sitagliptin, a once- daily DPP-IV inhibitor, after 56 weeks of treatment in 1,231 people with
type 2 diabetes, where both drugs were added on to metformin, thiazolidinedione (TZD) or a combination of metformin and TZD.
The trial successfully achieved its objective by demonstrating that,
from a mean baseline HbA1c of 8.1%, people treated with 0.5 mg or 1.0 mg semaglutide achieved
a statistically significant and superior improvement in HbA1c of 1.3% and 1.6% respectively,
compared to an improvement in HbA1c of 0.5% with 100 mg sitagliptin. 69% of the people treated
with 0.5 mg semaglutide and 78% of the people treated with 1.0 mg semaglutide achieved the American Diabetes Association (ADA)
and the European Association for the Study of Diabetes (EASD) treatment target of HbA1c below
7% compared with 36% of the people treated with 100 mg sitagliptin.
Furthermore, from a mean baseline body
weight of 89 kg, people treated with 0.5 mg and 1.0 mg semaglutide experienced a statistically significant and superior
weight loss of 4.3 kg and 6.1 kg respectively, compared with a weight loss of 1.9 kg for people treated with 100 mg
sitagliptin.
In the trial, semaglutide appeared to have a safe and well-tolerated
profile. The most common adverse event was nausea which diminished over time. Nausea was reported by 18% of the people treated
with 0.5 mg semaglutide and by 18% of the people treated with 1.0 mg semaglutide, compared with 7% of people treated with 100 mg
sitagliptin.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 20 of 40 |
The discontinuation rate due to adverse
events was 8% and 10% for people treated with 0.5 mg semaglutide and 1.0 mg semaglutide respectively, compared to 3% for
people treated with 100 mg sitagliptin.
LATIN T1D, liraglutide as adjunct therapy to insulin in type 1 diabetes
(NN9211) discontinued in phase 3 development
In January 2016, Novo Nordisk decided to discontinue the further development
of liraglutide as adjunct therapy to insulin for people with type 1 diabetes as the overall benefit/risk profile emerging from
the ADJUNCT ONE™ and ADJUNCT TWO™ phase 3a trial results did not support the regulatory filing for a label extension
for Victoza®.
Initiation of phase 2 trial with Anti-IL-21 and liraglutide in people
with recent onset type 1 diabetes (NN9828)
In November 2015, Novo Nordisk initiated the phase 2 trial investigating
the potential of Anti-IL-21 and liraglutide 1.8 mg, alone or as combination treatment, to preserve insulin- producing beta cells
in people with newly diagnosed type 1 diabetes. The trial is a four- arm randomised, double-blinded, double-dummy, placebo-controlled
trial including approximately 300 newly diagnosed adults with type 1 diabetes. Trial subjects will be treated for a period of 54
weeks with a subsequent follow-up period of 26 weeks.
OG987GT (NN9926) and OG987SC (NN9927) discontinued in phase 1 development
In January 2016, Novo Nordisk decided to discontinue the further development
of the oral GLP-1 projects OG987GT and OG987SC in phase 1 as a consequence of the decision to initiate phase 3a development with
OG217SC (oral semaglutide) during the first quarter of 2016 as announced in August 2015.
BIOPHARMACEUTICALS
Novo Nordisk completes 3b extension trial mentor 2 with rFXIII, NovoThirteen®
In December 2015, Novo Nordisk received additional
data from the mentor 2 phase 3b extension trial with NovoThirteen® in around 60 people
who were treated for a planned minimum of 52 weeks and up to 276 weeks for the longest treated person. All were treated with a
monthly prophylaxis dose of 35IU/kg of rFXIII. In line with previous results, the reported data showed that the monthly recombinant
factor XIII, NovoThirteen®, appeared to have a safe and well-tolerated profile with no
subjects developing antibodies against rFXIII. The annualised bleeding rate (ABR) was 0.04 over 186.5 patient years.
Novo Nordisk completes first part of the pathfinder 2 extension trial
with N8-GP (NN7088)
In November 2015, Novo Nordisk announced the results from the completion
of the first part of the pathfinder 2 extension trial. In line with previous results, the reported data showed that the long-acting
recombinant factor VIII, N8-GP (turoctocog alfa pegol), appeared to have a safe and well-tolerated profile, and that 95% of mild
to moderate bleeds could be managed with 1-2 infusions.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 21 of 40 |
Additionally, a subset of 55 patients, who experienced up to 2 bleeds
during 6 months on every four days prophylaxis, were in the extension phase randomised to either every four days (50 IU/kg) or
once-weekly (75 IU/kg) treatment. During the 180-day observation period of this sub-study, the median annualised bleeding rate
(ABR) was 0 (zero) for patients in both treatment arms.
Novo Nordisk files for regulatory approval of long-acting factor IX,
N9-GP (NN7999) in the EU for the treatment of haemophilia B
In January 2016, Novo Nordisk announced the submission of the MAA to
the EMA for the approval of long-acting factor IX, nonacog beta pegol. Nonacog beta pegol is a glycopegylated recombinant factor
IX with a significantly improved pharmacokinetic (PK) profile, developed for patients with haemophilia B. Novo Nordisk expects
to file the Biologics License Application (BLA) for nonacog beta pegol to the FDA during first half of 2016.
The filing of nonacog beta pegol is based
on the results from the paradigm clinical trial programme, which involved 115 patients with severe or moderately severe
haemophilia B. Nonacog beta pegol was found to be efficacious in routine prophylaxis, treatment of bleeding episodes and
surgery for adults, adolescents and children. Furthermore, nonacog beta pegol appeared to be well-tolerated and no safety
concerns were identified.
Compared to standard factor IX products, nonacog beta pegol has a five times
longer half-life. Patients in the paradigm study achieved a higher level of factor IX in the blood despite less frequent dosing
of nonacog beta pegol. In the phase 3 trials, once-weekly administration of 40 IU/kg nonacog beta pegol maintained factor IX activity
levels above 15%, reduced the median annualised bleeding rate (ABR) to 1.0 and showed a potential to prevent bleeds in target joints.
Furthermore, these patients reported an improvement in quality of life during the trial.
OTHER
NASH phase 2 clinical programme with semaglutide to be initiated in 2016
Novo Nordisk plans to initiate a phase 2
clinical programme with once-daily semaglutide for treatment of non-alcoholic steatohepatitis (NASH) in 2016. The plans are
based on the positive results from a study conducted by independent researchers with liraglutide 1.8 mg for NASH. Novo
Nordisk is currently preparing for discussions with relevant regulatory authorities prior to initiating the trial.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 22 of 40 |
SUSTAINABILITY
HIGHLIGHTS FROM THE CONSOLIDATED SOCIAL AND ENVIRONMENTAL STATEMENTS
FOR 2015
SOCIAL PERFORMANCE |
2015 |
2014 |
2013 |
2012 |
2011 |
%
change
2014 to
2015 |
Patients |
|
|
|
|
|
|
Patients reached with diabetes careproducts (estimate in millions) |
26.8 |
24.4 |
24.3 |
22.8 |
20.9 |
10% |
Least developed countries where Novo
Nordisk sells insulin according to the
differential pricing policy1) |
23 |
32 |
35 |
35 |
36 |
-28% |
|
|
|
|
|
|
|
Employees |
|
|
|
|
|
|
Employees (FTEs)2) |
40.638 |
40.957 |
37.978 |
34.286 |
32.136 |
-1% |
Employee turnover |
9.2% |
9.0% |
8.1% |
9.1% |
9.8% |
|
Gender in Management (men/women) |
59%/41% |
60%/40% |
61%/39% |
61%/39% |
63%/37% |
|
|
|
|
|
|
|
|
Assurance |
|
|
|
|
|
|
Relevant employees trained in business ethics |
98% |
98% |
97% |
99% |
99% |
|
Product recalls |
2 |
2 |
6 |
6 |
5 |
- |
Failed inspections |
0 |
0 |
0 |
1 |
0 |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ENVIRONMENTAL PERFORMANCE |
|
|
|
|
|
|
Resources |
|
|
|
|
|
|
Energy consumption (1,000 GJ) |
2.778 |
2.556 |
2.572 |
2.433 |
2.187 |
9% |
Water consumption (1,000 m3) |
3.131 |
2.959 |
2.685 |
2.475 |
2.136 |
6% |
Emissions and waste |
|
|
|
|
|
|
CO2 emissions from energy consumption (1,000 tons) |
107 |
120 |
125 |
122 |
94 |
-11% |
1) According to the UN there are 48 least developed
countries in the world
2)
2015 data exclude employees in NNIT, which was divested in 2015 (approximately 2,400
employees in NNIT in 2014)
SOCIAL PERFORMANCE
Patients
In 2015, Novo Nordisk provided medical treatments to an estimated 26.8
million patients with diabetes worldwide, compared with 24.4 million in 2014, calculated based on WHO’s recommended daily
doses for diabetes medicines. The number reflects an overall increase in the number of patients treated with Novo Nordisk’s
insulin products and was driven by human insulin in International Operations (1.2 million patients) and modern and new-generation
insulins globally (0.9 million patients). Novo Nordisk focuses on enhancing quality of care through product innovation, while remaining
committed to expand access to medical treatment and care for patients with diabetes throughout the world. The company has several
programmes specifically targeting people in low- and middle-income countries who have limited access to health services.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 23 of 40 |
Novo Nordisk sold human insulin according to the company’s
differential pricing policy in 23 of the world’s 48 poorest countries (the Least Developed Countries – LDC),
compared with 32 countries in 2014. According to this policy the price should not exceed 20% of the average insulin price in
the western world (defined as the EU, Norway, Switzerland, the US, Canada and Japan). In 2015 the LDC ceiling price for
insulin treatment per patient per day was USD 0.19, while the average realised price for insulin sold under the programme was
USD 0.15, corresponding to USD 3.85 per vial. The decline in number of countries is attributed to fewer insulin tenders in
2015, and lack of response from governments or private wholesalers and other partners to Novo Nordisk’s offer. The
total number of patients treated with insulin sold at or below ceiling price was approximately 411,000 in 2015, which is a
slight decrease compared with approximately 431,000 in 2014. Beyond this scheme, Novo Nordisk sells human insulin at similar
prices in low-income countries. In 2015, an estimated 5.5 million patients have been treated with insulin for USD 0.19 per
day or less, corresponding to a price per vial of USD 4.81 or less. In comparison an estimated 4.3 million patients were
treated with insulin at or below the ceiling price in 2014.
Employees
At the end of 2015, the total number of employees was 41,122, corresponding
to 40,638 full-time positions, which is a 1% decrease compared with 2014 due to the divestment of NNIT in March 2015. The underlying
growth (5%) is primarily driven by expansion within the sales region International Operations and in Denmark, primarily within
research & development and production.
Employee turnover increased from 9.0% in 2014 to 9.2% and was primarily
driven by Region China. In previous years, the turnover rates have been 8-10%.
To ensure a robust pipeline of talent for management positions, a new
aspiration has been set that strives for enhanced diversity in all management teams, including entry- level and middle management.
By the end of 2015 the gender diversity among managers was 59% men and 41% women. Of the newly promoted managers 44% were women.
Tragically, a sales representative in
India died in a traffic accident while on duty in 2015. The 2015 average frequency rate of occupational accidents with
absence decreased to 3.0 per million working hours, compared with 3.2 in 2014. Novo Nordisk is working with a zero-injury
mindset, and the long-term commitment is to continuously improve performance. Focus is on strengthening risk awareness and
preventing occupational accidents for all employees.
ENVIRONMENTAL PERFORMANCE
Energy and water
In 2015, 2,778,000 GJ energy and 3,131,000 m3 water were used at production
sites around the world. In spite of a high focus on process optimisation, the energy consumption increased by 9% and the water
consumption by 6%. This development reflects increased production and capacity as well as increased activities within research
and development. Of the water used at production sites, 14% is in water scarce regions
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 24 of 40 |
in Brazil and China, and these sites have particular focus on good water stewardship.
CO2 emissions
While the main focus of Novo Nordisk’s climate action programme
has been to reduce CO2 emissions from production as well as emissions from distribution of
products, Novo Nordisk is now extending the scope of the climate programme to encompass indirect emissions from relevant business
activities. The initial focus is on the supply chain, and emissions from company cars and business travel.
The CO2 emissions related to consumption
of energy at the production facilities decreased by 11% despite the increase in energy use of 9%. The production plant in Tianjin,
China has started sourcing wind power from a windfarm in Inner Mongolia and the Danish production facilities are now sourcing bio-natural
gas. This is biogas produced from liquid manure, food waste and organic waste from the industry. The biogas is upgraded to meet
the quality requirements of natural gas and feeds into the natural gas distribution system.
CO2 emissions
from transport (product distribution) decreased significantly by 25% compared with 2014. This is mainly due to an increase
in the volume of products distributed via sea from 72% in 2014 to 83% in 2015. In 2015, CO2 emissions
from sea freight accounted for 16%, transport via trucks accounted for 5% and air transport accounted for 79% of total
emissions. Distributing as many products as possible by sea is a priority for Novo Nordisk, as it reduces both CO2 emissions
and costs.
EQUITY
Total equity was DKK 46,969 million at the end of the fourth quarter of
2015, equivalent to 51.2% of total assets, compared with 52.3% at the end of the fourth quarter of 2014. The decrease in equity
as a percentage of total assets reflects the sustained policy of returning excess capital to the company’s shareholders while
the underlying operating activities have continued to expand and in addition been impacted by currencies primarily related to the
appreciation of the US dollar versus the Danish krone.
On 29 October 2015, Novo Nordisk announced a share repurchase programme
of up to DKK 4.5 billion to be executed from 29 October 2015 to 1 February 2016, as part of an overall 2015 programme of up to
DKK 17.5 billion to be executed during a 12-month period beginning 30 January 2015. The purpose of the programme is to reduce the
company’s share capital. Under the programme announced 29 October 2015, Novo Nordisk has repurchased 11,835,964 B shares
for an amount of DKK 4.5 billion in the period. The programme was concluded 1 February 2016.
As of 2 February 2016, Novo Nordisk A/S has repurchased a total of 47,739,215
B shares equal to a transaction value of DKK 17.5 billion under the up to DKK 17.5 billion programme beginning 30 January 2015.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 25 of 40 |
Holding of treasury shares and reduction of share capital
As of 2 February 2016, Novo Nordisk A/S and its wholly-owned affiliates
owned 56,325,667 of its own B shares, corresponding to 2.2% of the total share capital.
In order to maintain capital structure flexibility, the Board of Directors
will, at the Annual General Meeting in 2016, propose a reduction in the B share capital from DKK 520,000,000 to DKK 510,000,000
by cancelling 50,000,000 B shares of DKK 0.20 from the company’s own holdings of B shares at a nominal value of DKK 10,000,000
equivalent to 1.92% of the total share capital. After implementation of the share capital reduction, the company’s share
capital will amount to DKK 510,000,000; divided into an A share capital of DKK 107,487,200 and a B share capital of DKK 402,512,800
Proposed dividend and introduction of interim dividend
At the Annual General Meeting on 18 March 2016, the Board of Directors
will propose a 28% increase in dividend to DKK 6.40 per share of DKK 0.20, corresponding to a payout ratio of 46.6%. Adjusting
for the impact from the divestment of shares in NNIT A/S, where the related cash flow was returned to shareholders via an expansion
of the 2015 share repurchase programme, the payout ratio will be 50.0%. For 2014, the Novo Nordisk payout ratio was 48.7%, whereas
Novo Nordisk’s peer group of comparable pharmaceutical companies operated with a payout ratio around 54%. No dividend will
be paid on the company’s holding of treasury shares.
At the Annual General Meeting in March 2015, the Board was granted an
authorisation to distribute extraordinary dividends. Hence the Board of Directors has been given authority to pay biannual dividends
without obtaining specific approval from the Annual General Meeting. Subject to final approval, Novo Nordisk intends to introduce
the first interim dividend in August 2016.
2016 share repurchase programme
The Board of Directors has approved a new share repurchase programme
of up to DKK 14 billion to be executed during the coming 12 months. As part of the up to DKK 14 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 Nordea Bank Danmark
A/S as lead manager to execute the programme independently and without influence from Novo Nordisk. The purpose of the programme
is to reduce the company's share capital. Under the agreement, Nordea Bank Danmark A/S will repurchase shares on behalf of Novo
Nordisk for an amount of up to DKK 3.3 billion during the trading period starting today, 3 February and ending on 27 April 2016.
A maximum of 519,896 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 Copenhagen during the month of January 2016, and a maximum of 29,634,072 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.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 26 of 40 |
As announced in January 2014, Novo Nordisk’s majority shareholder
Novo A/S, a holding company fully owned by the Novo Nordisk Foundation, has informed Novo Nordisk that it intends to consider its
participation in the Novo Nordisk share repurchase programme on a case by case basis. For 2016, Novo A/S has informed Novo Nordisk
that it does not plan to participate in the share repurchase programme.
CORPORATE GOVERNANCE
Remuneration principles for executives
Novo Nordisk’s remuneration principles aim to attract, retain and
motivate members of Executive Management. Remuneration levels are designed to be competitive and to align the interests of the
executives with shareholder interests.
Long-term, share-based incentive programme for senior management
As of 2004, members of Novo Nordisk's Executive
Management (nine in 2015) and other members of the Senior Management Board (28 in 2015) participated in a performance- based incentive
programme. In the programme, a proportion of the calculated economic value creation for the calendar year has been allocated to
a joint pool for the participants. For 2015, the joint pool operates with a yearly maximum allocation equal to 12 months’
fixed base salary plus pension contribution for the CEO, nine months’ fixed base salary plus pension contribution for the
other 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 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 2012, 487,730 shares were allocated to the joint pool and the
value at launch of the programme (DKK 73 million) was expensed in 2012. The number of shares in the 2012 joint pool has not
subsequently been reduced by the Board of Directors as the financial performance in the following years (2013–2015)
reached specified threshold levels. Hence, the original number of shares allocated to the joint pool will, according to the
principles of the scheme, be transferred to 30 current and former members of senior management immediately after the
announcement of the 2015 full-year financial results on 3 February 2016.
For 2015, based on an assessment of the economic value creation, the
sales growth obtained, the quality and compliance status, the performance of the R&D portfolio and key sustainability projects,
the Board of Directors on 2 February 2016 approved the establishment of a joint pool for the financial year of 2015 by allocating
a total of 378,943 Novo Nordisk B shares. This allocation amounts to 12 months of fixed base
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 27 of 40 |
salary plus pension contribution for the CEO and 9 months of fixed base
salary plus pension contribution for the other members of Executive Management as per 1 March 2015 and 8 months of fixed base salary
plus pension contribution for senior vice presidents as per 1 March 2015, corresponding to a value at launch of the programme of
DKK 108 million, which has been expensed in the 2015 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 285 per share of DKK 0.20) for
Novo Nordisk B shares on Nasdaq Copenhagen in the 15 days trading window (30 January–13 February 2015) following the release
of the Annual Report for 2014 when the programme was approved by the Board of Directors. The allocation under the programme
reflects that Novo Nordisk exceeded the planned target for economic value creation in 2015 and it met the threshold for the achievement
of the non-financial targets established for 2015.
Long-term, share-based incentive programme for
corporate vice presidents and vice presidents
As of 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 creation compared to the planned performance for the year. At the beginning of each year, the Board of Directors
defines a maximum number of shares per participant targeting around three 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 2012, 1,559,235 shares were allocated to a share pool for key employees,
and the value at launch of the programme (DKK 234 million) has been amortised over the period 2012–2015. The number of shares
in the 2012 share pool has not subsequently been reduced by the Board of Directors as the financial performance in the following
years (2013–2015) reached specified threshold levels. 1,355,153 shares will be transferred to 635 employees after the announcement
of the 2015 full-year financial results on 3 February 2016. 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.
For 2015, based on an assessment similar to the senior management programme,
the Board of Directors on 2 February 2016 approved the establishment of a share pool for 2015 for key employees by allocating a
total of 879,988 Novo Nordisk B shares. This allocation – which is the maximum according to the terms of the programme –
corresponds to a value at launch of the programme of DKK 251 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 2015
is approximately 920.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 28 of 40 |
As the long-term share-based incentive programmes for both senior management
and other key employees are evaluated by the Board of Directors to have worked successfully in 2015, it is planned to continue
in 2016 with a similar structure.
Restricted stock units to employees (2013 programme)
Following the 90th anniversary in
2013, all employees in the company (excluding NNE Pharmaplan) were offered 100 restricted stock units. A restricted stock unit
gives the right to receive one Novo Nordisk B share free of charge on 1 April 2016 subject to continued employment and average
sales growth of at least 5% per year measured in DKK in the period 2012–2015. The cost of the DKK 440 million programme is
amortised over the period 2013–2016 at an annual amount of DKK 135 million. As the sales growth has been achieved –
the shares will be granted to the employees on 1 April 2016
Restricted stock units to employees (2016 programme)
To commemorate that the sales of Novo Nordisk passed DKK 100 billion
for the first time in 2015, all employees in the company (excluding NNE Pharmaplan and Steno Diabetes Center) will be offered 50
restricted stock units. A restricted stock unit gives the right to receive one Novo Nordisk B share free of charge in February
2019 subject to continued employment. The cost of the DKK 540 million programme will be amortised over the pLeegriaold
2016–2018 at an annual amount of DKK 180 million.
LEGAL UPDATE
Product liability lawsuits related to Victoza®
As of 22 January 2016, Novo Nordisk, along with the majority of incretin-based
product manufacturers in the US, is a defendant in product liability lawsuits related to use of incretin-based medications. To
date, 194 plaintiffs have named Novo Nordisk in product liability lawsuits, predominantly claiming damages for pancreatic cancer
that allegedly developed as a result of using Victoza® and other GLP-1/DPP-IV products.
134 of the Novo Nordisk plaintiffs have also named other defendants in their lawsuits. Most Novo Nordisk plaintiffs have filed
suit in California federal and state courts.
In November 2015, the California federal
and state courts overseeing the vast majority of cases in the incretin-based products liability litigation issued an order
granting the defendants’ motion for summary judgment on federal pre-emption in all pancreatic cancer cases before those
courts as of mid-Q4 2015. These rulings will result in the dismissal of the vast majority of pancreatic cancer cases naming
Novo Nordisk and our co-defendants in the litigation. Plaintiffs are pursuing appeals of the summary judgment rulings in both
state and federal court. Currently, Novo Nordisk does not have any individual trials scheduled in 2016. Novo Nordisk does not
expect the pending claims to have a material impact on its financial position, operating profit and cash flow.
Update on subpoena from US Attorney
In October 2014, the office of the US Attorney for the District of Massachusetts
served Novo Nordisk with a subpoena calling for the production of documents regarding potential manufacturing issues within certain
production units located in Kalundborg, Denmark.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 29 of 40 |
Novo Nordisk has been fully cooperating with the US Attorney in this investigation.
The US Attorney has recently informed Novo Nordisk that it is unlikely to pursue the investigation further. Novo Nordisk does not
expect the investigation to have a material impact on Novo Nordisk’s financial position, operating profit or cash flow.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 30 of 40 |
FORWARD-LOOKING STATEMENTS
Novo Nordisk’s reports filed with or furnished to the US Securities
and Exchange Commission (SEC), including this document as well as the company’s Annual Report 2015 and Form 20-F,
both expected to be filed with the SEC in February 2016, 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 Nordisk’s products, product research, product development, product introductions and product approvals as well as
cooperation in relation thereto |
| • | statements containing projections of or targets for revenues, 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 Nordisk’s
products, introduction of competing products, reliance on information technology, Novo Nordisk’s ability to successfully
market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental
laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on
testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments
in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the
right employees, and failure to maintain a culture of compliance.
Please also refer to the overview of risk factors in ‘Managing risks’
on pp 42-43 of the
Annual Report 2015 available on novonordisk.com on 8 February 2016.
Unless required by law, Novo Nordisk is under no
duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this document, whether
as a result of new information, future events or otherwise.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 31 of 40 |
MANAGEMENT STATEMENT
The Board of Directors and Executive Management have approved the Annual
Report 2015 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 2015.
The consolidated financial statements in the Annual Report 2015 have
been 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 2015, 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
2015 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 2015 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, 3 February 2016
Executive Management: |
Lars Rebien Sørensen
CEO |
Jesper Brandgaard
CFO |
Lars Fruergaard Jørgensen |
Jakob Riis |
Mads Krogsgaard Thomsen |
|
Board of Directors: |
Göran Ando
Chairman |
Jeppe Christiansen
Vice chairman |
Bruno Angelici |
Sylvie Grégoire |
Liz Hewitt |
Liselotte Hyveled |
Thomas Paul Koestler |
Eivind Kolding |
Anne Marie Kverneland |
Søren Thuesen Pedersen |
Stig Strøbæk |
Mary Szela |
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 32 of 40 |
FINANCIAL
INFORMATION
APPENDIX
1: QUARTERLY NUMBERS IN DKK (UNAUDITED)
(Amounts
in DKK million, except number of full-time equivalent employees, earnings per share and number of shares outstanding).
| |
2015 | |
2014 | |
% change Q4 2015 vs |
| |
Q4 | |
Q3 | |
Q2 | |
Q1 | |
Q4 | |
Q3 | |
Q2 | |
Q1 | |
Q4
2014 |
Net sales | |
| 28,876 | | |
| 26,792 | | |
| 27,059 | | |
| 25,200 | | |
| 24,585 | | |
| 22,249 | | |
| 21,629 | | |
| 20,343 | | |
| 17 | % |
Gross profit | |
| 24,268 | | |
| 22,945 | | |
| 23,200 | | |
| 21,326 | | |
| 20,586 | | |
| 18,823 | | |
| 17,958 | | |
| 16,877 | | |
| 18 | % |
Gross margin | |
| 84.0 | % | |
| 85.6 | % | |
| 85.7 | % | |
| 84.6 | % | |
| 83.7 | % | |
| 84.6 | % | |
| 83.0 | % | |
| 83.0 | % | |
| | |
Sales and distribution costs | |
| 8,039 | | |
| 6,951 | | |
| 7,175 | | |
| 6,147 | | |
| 6,679 | | |
| 5,899 | | |
| 5,559 | | |
| 5,086 | | |
| 20 | % |
Percentage of sales | |
| 27.8 | % | |
| 25.9 | % | |
| 26.5 | % | |
| 24.4 | % | |
| 27.2 | % | |
| 26.5 | % | |
| 25.7 | % | |
| 25.0 | % | |
| | |
Research and development costs | |
| 4,034 | | |
| 3,289 | | |
| 3,035 | | |
| 3,250 | | |
| 3,865 | | |
| 3,654 | | |
| 3,075 | | |
| 3,168 | | |
| 4 | % |
Costs related to discontinuation of activities within inflammatory disorders | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 600 | | |
| - | | |
| - | | |
| N/A | |
Percentage of sales | |
| 14.0 | % | |
| 12.3 | % | |
| 11.2 | % | |
| 12.9 | % | |
| 15.7 | % | |
| 16.4 | % | |
| 14.2 | % | |
| 15.6 | % | |
| | |
Administrative costs | |
| 1,164 | | |
| 952 | | |
| 887 | | |
| 854 | | |
| 1,067 | | |
| 870 | | |
| 795 | | |
| 805 | | |
| 9 | % |
Percentage of sales | |
| 4.0 | % | |
| 3.6 | % | |
| 3.3 | % | |
| 3.4 | % | |
| 4.3 | % | |
| 3.9 | % | |
| 3.7 | % | |
| 4.0 | % | |
| | |
Other operating income, net | |
| 94 | | |
| 227 | | |
| 379 | | |
| 2,782 | | |
| 182 | | |
| 169 | | |
| 204 | | |
| 215 | | |
| (48 | %) |
- Non-recurring income from the partial divestment of NNIT A/S | |
| | | |
| - | | |
| - | | |
| 2,376 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| N/A | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Operating profit | |
| 11,125 | | |
| 11,980 | | |
| 12,482 | | |
| 13,857 | | |
| 9,157 | | |
| 8,569 | | |
| 8,733 | | |
| 8,033 | | |
| 21 | % |
Operating margin | |
| 38.5 | % | |
| 44.7 | % | |
| 46.1 | % | |
| 55.0 | % | |
| 37.2 | % | |
| 38.5 | % | |
| 40.4 | % | |
| 39.5 | % | |
| | |
Financial income | |
| 18 | | |
| 9 | | |
| (227 | ) | |
| 285 | | |
| (1,141 | ) | |
| 326 | | |
| 396 | | |
| 586 | | |
| N/A | |
Financial expenses | |
| 829 | | |
| 1,853 | | |
| 1,707 | | |
| 1,657 | | |
| (336 | ) | |
| 441 | | |
| 140 | | |
| 318 | | |
| N/A | |
Net financials | |
| (811 | ) | |
| (1,844 | ) | |
| (1,934 | ) | |
| (1,372 | ) | |
| (805 | ) | |
| (115 | ) | |
| 256 | | |
| 268 | | |
| 1 | % |
Profit before income taxes | |
| 10,314 | | |
| 10,136 | | |
| 10,548 | | |
| 12,485 | | |
| 8,352 | | |
| 8,454 | | |
| 8,989 | | |
| 8,301 | | |
| 23 | % |
Income taxes | |
| 2,056 | | |
| 1,753 | | |
| 2,205 | | |
| 2,609 | | |
| 1,823 | | |
| 1,954 | | |
| 1,995 | | |
| 1,843 | | |
| 13 | % |
Net profit | |
| 8,258 | | |
| 8,383 | | |
| 8,343 | | |
| 9,876 | | |
| 6,529 | | |
| 6,500 | | |
| 6,994 | | |
| 6,458 | | |
| 26 | % |
Depreciation, amortisation and impairment losses 1) | |
| 1,015 | | |
| 633 | | |
| 648 | | |
| 663 | | |
| 928 | | |
| 1,183 | | |
| 667 | | |
| 657 | | |
| 9 | % |
Capital expenditure | |
| 2,181 | | |
| 1,246 | | |
| 1,018 | | |
| 764 | | |
| 1,505 | | |
| 986 | | |
| 802 | | |
| 693 | | |
| 45 | % |
Net cash generated from operating activities | |
| 10,119 | | |
| 12,088 | | |
| 11,974 | | |
| 4,106 | | |
| 7,301 | | |
| 12,197 | | |
| 8,125 | | |
| 4,069 | | |
| 39 | % |
Free cash flow | |
| 6,942 | | |
| 10,807 | | |
| 10,830 | | |
| 5,643 | | |
| 5,717 | | |
| 11,157 | | |
| 7,250 | | |
| 3,272 | | |
| 21 | % |
Total assets | |
| 91,799 | | |
| 85,195 | | |
| 81,313 | | |
| 77,457 | | |
| 77,062 | | |
| 71,283 | | |
| 63,681 | | |
| 63,241 | | |
| 19 | % |
Total equity | |
| 46,969 | | |
| 43,109 | | |
| 39,111 | | |
| 32,108 | | |
| 40,294 | | |
| 37,967 | | |
| 36,661 | | |
| 33,583 | | |
| 17 | % |
Equity ratio | |
| 51.2 | % | |
| 50.6 | % | |
| 48.1 | % | |
| 41.5 | % | |
| 52.3 | % | |
| 53.3 | % | |
| 57.6 | % | |
| 53.1 | % | |
| | |
Full-time equivalent employees end of period | |
| 40,638 | | |
| 40,261 | | |
| 39,658 | | |
| 39,062 | | |
| 40,957 | | |
| 40,700 | | |
| 40,226 | | |
| 39,579 | | |
| (1 | %) |
Basic earnings per share/ADR (in DKK) | |
| 3.25 | | |
| 3.27 | | |
| 3.24 | | |
| 3.8 | | |
| 2.51 | | |
| 2.49 | | |
| 2.66 | | |
| 2.44 | | |
| 29 | % |
Diluted earnings per share/ADR (in DKK) | |
| 3.24 | | |
| 3.26 | | |
| 3.23 | | |
| 3.79 | | |
| 2.51 | | |
| 2.47 | | |
| 2.66 | | |
| 2.43 | | |
| 29 | % |
Average number of shares outstanding (million) | |
| 2,553.2 | | |
| 2,571.9 | | |
| 2,578.1 | | |
| 2,596.7 | | |
| 2,599.7 | | |
| 2,613.9 | | |
| 2,628.9 | | |
| 2,642.4 | | |
| (2 | %) |
Average number of diluted shares outstanding (million) | |
| 2,559.7 | | |
| 2,571.8 | | |
| 2,584.1 | | |
| 2,604.2 | | |
| 2,608.2 | | |
| 2,622.2 | | |
| 2,637.3 | | |
| 2,653.1 | | |
| (2 | %) |
Sales by business segment: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
New-generation insulin | |
| 461 | | |
| 376 | | |
| 330 | | |
| 271 | | |
| 262 | | |
| 175 | | |
| 141 | | |
| 80 | | |
| 76 | % |
Modern insulin (insulin analogues) | |
| 13,562 | | |
| 12,500 | | |
| 12,604 | | |
| 11,498 | | |
| 11,168 | | |
| 10,641 | | |
| 10,351 | | |
| 9,377 | | |
| 21 | % |
Human insulin | |
| 2,778 | | |
| 2,772 | | |
| 2,784 | | |
| 2,897 | | |
| 2,772 | | |
| 2,478 | | |
| 2,475 | | |
| 2,573 | | |
| 0 | % |
Victoza® | |
| 4,904 | | |
| 4,680 | | |
| 4,486 | | |
| 3,957 | | |
| 4,010 | | |
| 3,441 | | |
| 3,059 | | |
| 2,916 | | |
| 22 | % |
Other diabetes and obesity care | |
| 1,237 | | |
| 1,223 | | |
| 1,075 | | |
| 1,195 | | |
| 1,064 | | |
| 953 | | |
| 1,031 | | |
| 1,013 | | |
| 16 | % |
Diabetes and obesity care total | |
| 22,942 | | |
| 21,551 | | |
| 21,279 | | |
| 19,818 | | |
| 19,276 | | |
| 17,688 | | |
| 17,057 | | |
| 15,959 | | |
| 19 | % |
Haemophilia | |
| 2,785 | | |
| 2,371 | | |
| 2,757 | | |
| 2,734 | | |
| 2,610 | | |
| 2,112 | | |
| 2,327 | | |
| 2,255 | | |
| 7 | % |
Norditropin® | |
| 2,065 | | |
| 1,842 | | |
| 2,083 | | |
| 1,830 | | |
| 1,811 | | |
| 1,686 | | |
| 1,509 | | |
| 1,500 | | |
| 14 | % |
Other biopharmaceuticals 2) | |
| 1,084 | | |
| 1,028 | | |
| 940 | | |
| 818 | | |
| 888 | | |
| 763 | | |
| 736 | | |
| 629 | | |
| 22 | % |
Biopharmaceuticals total | |
| 5,934 | | |
| 5,241 | | |
| 5,780 | | |
| 5,382 | | |
| 5,309 | | |
| 4,561 | | |
| 4,572 | | |
| 4,384 | | |
| 12 | % |
Sales by geographic segment: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
North America | |
| 15,662 | | |
| 14,415 | | |
| 14,325 | | |
| 12,455 | | |
| 12,164 | | |
| 11,133 | | |
| 10,561 | | |
| 9,265 | | |
| 29 | % |
Europe | |
| 5,399 | | |
| 5,200 | | |
| 5,222 | | |
| 4,977 | | |
| 5,413 | | |
| 5,045 | | |
| 4,989 | | |
| 4,703 | | |
| 0 | % |
International Operations | |
| 3,992 | | |
| 3,406 | | |
| 3,884 | | |
| 3,684 | | |
| 3,602 | | |
| 2,938 | | |
| 2,968 | | |
| 3,032 | | |
| 11 | % |
Region China | |
| 2,325 | | |
| 2,415 | | |
| 2,284 | | |
| 2,847 | | |
| 2,089 | | |
| 1,881 | | |
| 1,947 | | |
| 2,171 | | |
| 11 | % |
Japan & Korea | |
| 1,498 | | |
| 1,356 | | |
| 1,344 | | |
| 1,237 | | |
| 1,317 | | |
| 1,252 | | |
| 1,164 | | |
| 1,172 | | |
| 14 | % |
Segment operating profit: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Diabetes and obesity care | |
| 8,153 | | |
| 9,085 | | |
| 8,713 | | |
| 7,950 | | |
| 6,383 | | |
| 6,989 | | |
| 6,376 | | |
| 5,785 | | |
| 28 | % |
Biopharmaceuticals | |
| 2,972 | | |
| 2,895 | | |
| 3,769 | | |
| 3,531 | | |
| 2,774 | | |
| 1,580 | | |
| 2,357 | | |
| 2,248 | | |
| 7 | % |
Income from the initial public offering of NNIT A/S (unallocated to segments) | |
| - | | |
| - | | |
| | | |
| 2,376 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| N/A | |
1)
Including impairments of around DKK 480 million in Q3 and Q4 2014 related to discontinuation of activities within inflammatory
disorders.
2)
Comparative figures have been restated as NovoEight® and NovoThirteen® are now reported as Haemophilia together
with NovoSeven®.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 33 of 40 |
APPENDIX
2: INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME
DKK million | |
|
2015 |
| |
|
2014 |
|
| |
| |
|
Income statement | |
| |
|
| |
| |
|
Net sales | |
| 107,927 | | |
| 88,806 | |
Cost of goods sold | |
| 16,188 | | |
| 14,562 | |
Gross profit | |
| 91,739 | | |
| 74,244 | |
| |
| | | |
| | |
Sales and distribution costs | |
| 28,312 | | |
| 23,223 | |
Research and development costs | |
| 13,608 | | |
| 13,762 | |
Administrative costs | |
| 3,857 | | |
| 3,537 | |
Other operating income, net | |
| 3,482 | | |
| 770 | |
- Non-recurring income from the partial divestment of NNIT A/S | |
| 2,376 | | |
| - | |
Operating profit | |
| 49,444 | | |
| 34,492 | |
| |
| | | |
| | |
Financial income | |
| 85 | | |
| 167 | |
Financial expenses | |
| 6,046 | | |
| 563 | |
Profit before income taxes | |
| 43,483 | | |
| 34,096 | |
| |
| | | |
| | |
Income taxes | |
| 8,623 | | |
| 7,615 | |
NET PROFIT | |
| 34,860 | | |
| 26,481 | |
| |
| | | |
| | |
Basic earnings per share (DKK) | |
| 13.56 | | |
| 10.10 | |
Diluted earnings per share (DKK) | |
| 13.52 | | |
| 10.07 | |
Segment
Information
Segment sales: | |
| | | |
| | |
Diabetes and obesity care | |
| 85,590 | | |
| 69,980 | |
Biopharmaceuticals | |
| 22,337 | | |
| 18,826 | |
| |
| | | |
| | |
Segment operating profit: | |
| | | |
| | |
Diabetes and obesity care | |
| 33,901 | | |
| 25,533 | |
Operating
margin | |
| 39.6 | % | |
| 36.5 | % |
Biopharmaceuticals | |
| 13,167 | | |
| 8,959 | |
Operating
margin | |
| 58.9 | % | |
| 47.6 | % |
| |
| | | |
| | |
Income from the initial public offering of NNIT A/S (unallocated to segments) | |
| 2,376 | | |
| - | |
| |
| | | |
| | |
Total segment operating profit | |
| 49,444 | | |
| 34,492 | |
Statement of comprehensive income | |
| |
|
| |
| |
|
Net profit for the year | |
| 34,860 | | |
| 26,481 | |
| |
| | | |
| | |
Other comprehensive income | |
| | | |
| | |
| |
| | | |
| | |
Exchange rate adjustments of investments in subsidiaries | |
| (669 | ) | |
| (39 | ) |
Cash flow hedges, realisation of previously deferred (gains)/losses | |
| 2,216 | | |
| (1,229 | ) |
Cash flow hedges, deferred gains/(losses) incurred during the period | |
| (681 | ) | |
| (2,225 | ) |
Other items | |
| 366 | | |
| 111 | |
Items that will be reclassified subsequently to the Income statement, when specific conditions are met | |
| 1,232 | | |
| (3,382 | ) |
| |
| | | |
| | |
Remeasurements on defined benefit plans | |
| (37 | ) | |
| (247 | ) |
Items that will not subsequently be reclassified to the Income statement | |
| (37 | ) | |
| (247 | ) |
| |
| | | |
| | |
Other comprehensive income before tax | |
| 1,195 | | |
| (3,629 | ) |
| |
| | | |
| | |
Tax on other comprehensive income, income/(expense) | |
| (87 | ) | |
| 977 | |
Other comprehensive income for the year, net of tax | |
| 1,108 | | |
| (2,652 | ) |
| |
| | | |
| | |
TOTAL COMPREHENSIVE INCOME FOR THE YEAR | |
| 35,968 | | |
| 23,829 | |
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 34 of 40 |
APPENDIX 3: BALANCE SHEET
DKK million | |
|
31
Dec 2015 |
| |
|
31
Dec 2014 |
|
| |
| |
|
ASSETS | |
| | | |
| | |
| |
| | | |
| | |
| |
| | | |
| | |
Intangible assets | |
| 2,158 | | |
| 1,378 | |
Property, plant and equipment | |
| 25,545 | | |
| 23,136 | |
Investment in associated company | |
| 811 | | |
| - | |
Deferred income tax assets | |
| 6,806 | | |
| 5,399 | |
Other financial assets | |
| 1,339 | | |
| 856 | |
TOTAL NON-CURRENT ASSETS | |
| 36,659 | | |
| 30,769 | |
| |
| | | |
| | |
Inventories | |
| 12,758 | | |
| 11,357 | |
Trade receivables | |
| 15,485 | | |
| 13,041 | |
Tax receivables | |
| 3,871 | | |
| 3,210 | |
Other receivables and prepayments | |
| 2,257 | | |
| 2,750 | |
Marketable securities | |
| 3,542 | | |
| 1,509 | |
Derivative financial instruments | |
| 304 | | |
| 30 | |
Cash at bank and on hand | |
| 16,923 | | |
| 14,396 | |
TOTAL CURRENT ASSETS | |
| 55,140 | | |
| 46,293 | |
| |
| | | |
| | |
TOTAL ASSETS | |
| 91,799 | | |
| 77,062 | |
EQUITY AND LIABILITIES | |
| |
|
| |
| |
|
Share capital | |
| 520 | | |
| 530 | |
Treasury shares | |
| (10 | ) | |
| (11 | ) |
Retained earnings | |
| 46,816 | | |
| 41,277 | |
Other reserves | |
| (357 | ) | |
| (1,502 | ) |
TOTAL EQUITY | |
| 46,969 | | |
| 40,294 | |
| |
| | | |
| | |
Deferred income tax liabilities | |
| 6 | | |
| 7 | |
Retirement benefit obligations | |
| 1,186 | | |
| 1,031 | |
Provisions | |
| 2,765 | | |
| 2,041 | |
Total non-current liabilities | |
| 3,957 | | |
| 3,079 | |
| |
| | | |
| | |
Current debt | |
| 1,073 | | |
| 720 | |
Trade payables | |
| 4,927 | | |
| 4,950 | |
Tax payables | |
| 3,777 | | |
| 2,771 | |
Other liabilities | |
| 12,655 | | |
| 11,051 | |
Derivative financial instruments | |
| 1,382 | | |
| 2,607 | |
Provisions | |
| 17,059 | | |
| 11,590 | |
Total current liabilities | |
| 40,873 | | |
| 33,689 | |
| |
| | | |
| | |
TOTAL LIABILITIES | |
| 44,830 | | |
| 36,768 | |
| |
| | | |
| | |
TOTAL EQUITY AND LIABILITIES | |
| 91,799 | | |
| 77,062 | |
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 35 of 40 |
APPENDIX
4: STATEMENT OF CASH FLOWS
DKK
million | |
| 2015 | | |
| 2014 | |
| |
| | | |
| | |
Net profit for the year | |
| 34,860 | | |
| 26,481 | |
| |
| | | |
| | |
Adjustment for non-cash items: | |
| | | |
| | |
Income taxes in the Income Statement | |
| 8,623 | | |
| 7,615 | |
Depreciation, amortisation and impairment losses | |
| 2,959 | | |
| 3,435 | |
NNIT non-recurring income included in 'other operating income' | |
| (2,526 | ) | |
| - | |
Other non-cash items | |
| 5,908 | | |
| 4,163 | |
Change in working capital | |
| (2,157 | ) | |
| (2,148 | ) |
Interest received | |
| 55 | | |
| 131 | |
Interest paid | |
| (61 | ) | |
| (78 | ) |
Income taxes paid | |
| (9,374 | ) | |
| (7,907 | ) |
Net cash generated from operating activities | |
| 38,287 | | |
| 31,692 | |
| |
| | | |
| | |
Proceeds from the partial divestment of NNIT A/S | |
| 2,303 | | |
| - | |
Purchase of intangible assets | |
| (1,182 | ) | |
| (321 | ) |
Proceeds from sale of property, plant and equipment | |
| 15 | | |
| 4 | |
Purchase of property, plant and equipment | |
| (5,224 | ) | |
| (3,990 | ) |
Proceeds from other financial assets | |
| 32 | | |
| 35 | |
Purchase of other financial assets | |
| (9 | ) | |
| (24 | ) |
Sale of marketable securities | |
| 1,500 | | |
| 2,232 | |
Purchase of marketable securities | |
| (3,533 | ) | |
| - | |
Net cash used in investing activities | |
| (6,098 | ) | |
| (2,064 | ) |
| |
| | | |
| | |
Purchase of treasury shares, net | |
| (17,196 | ) | |
| (14,667 | ) |
Dividends paid | |
| (12,905 | ) | |
| (11,866 | ) |
Net cash used in financing activities | |
| (30,101 | ) | |
| (26,533 | ) |
| |
| | | |
| | |
NET CASH GENERATED FROM ACTIVITIES | |
| 2,088 | | |
| 3,095 | |
| |
| | | |
| | |
Cash and cash equivalents at the beginning of the year | |
| 13,676 | | |
| 10,513 | |
Exchange gain/(loss) on cash and cash equivalents | |
| 86 | | |
| 68 | |
Cash and cash equivalents at the end of the year | |
| 15,850 | | |
| 13,676 | |
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 36 of 40 |
APPENDIX
5: STATEMENT OF CHANGES IN EQUITY
| |
| | | |
| | | |
| | | |
| Other reserves | | |
| | |
DKK million | |
| Share capital | | |
| Treasury shares | | |
| Retained earnings | | |
| Exchange rate adjust- ments | | |
| Cash flow hedges | | |
| Tax and other adjust- ments | | |
| Total other reserves | | |
| Total | |
2015 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at the beginning of the year | |
| 530 | | |
| (11 | ) | |
| 41,277 | | |
| (248 | ) | |
| (2,221 | ) | |
| 967 | | |
| (1,502 | ) | |
| 40,294 | |
Net profit for the year | |
| | | |
| | | |
| 34,860 | | |
| | | |
| | | |
| | | |
| | | |
| 34,860 | |
Other comprehensive income for the year | |
| | | |
| | | |
| (37 | ) | |
| (669 | ) | |
| 1,535 | | |
| 279 | | |
| 1,145 | | |
| 1,108 | |
Total comprehensive income for the year | |
| | | |
| | | |
| 34,823 | | |
| (669 | ) | |
| 1,535 | | |
| 279 | | |
| 1,145 | | |
| 35,968 | |
Transactions with owners: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Dividends | |
| | | |
| | | |
| (12,905 | ) | |
| | | |
| | | |
| | | |
| | | |
| (12,905 | ) |
Share-based payments | |
| | | |
| | | |
| 442 | | |
| | | |
| | | |
| | | |
| | | |
| 442 | |
Tax credit related to restricted stock units | |
| | | |
| | | |
| 366 | | |
| | | |
| | | |
| | | |
| | | |
| 366 | |
Purchase of treasury shares | |
| | | |
| (10 | ) | |
| (17,219 | ) | |
| | | |
| | | |
| | | |
| | | |
| (17,229 | ) |
Sale of treasury shares | |
| | | |
| 1 | | |
| 32 | | |
| | | |
| | | |
| | | |
| | | |
| 33 | |
Reduction of the B share capital | |
| (10 | ) | |
| 10 | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| - | |
Balance at the end of the year | |
| 520 | | |
| (10 | ) | |
| 46,816 | | |
| (917 | ) | |
| (686 | ) | |
| 1,246 | | |
| (357 | ) | |
| 46,969 | |
At the end of the year proposed dividends (not yet declared) of DKK 16,230
million (6.40 DKK per share of DKK 0.20) are included in Retained earnings. No dividend is declared on treasury shares.
| |
| | | |
| | | |
| | | |
| Other reserves | | |
| | |
| |
| Share
capital | | |
| Treasury
shares | | |
| Retained
earnings | | |
| Exchange
rate adjust-
ments | | |
| Cash flow
hedges | | |
| Tax and
other
adjust-
ments | | |
| Total other
reserves | | |
| Total | |
2014 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at the beginning of the year | |
| 550 | | |
| (21 | ) | |
| 41,137 | | |
| (209 | ) | |
| 1,233 | | |
| (121 | ) | |
| 903 | | |
| 42,569 | |
Net profit for the year | |
| | | |
| | | |
| 26,481 | | |
| | | |
| | | |
| | | |
| | | |
| 26,481 | |
Other comprehensive income for the year | |
| | | |
| | | |
| (247 | ) | |
| (39 | ) | |
| (3,454 | ) | |
| 1,088 | | |
| (2,405 | ) | |
| (2,652 | ) |
Total comprehensive income for the year | |
| | | |
| | | |
| 26,234 | | |
| (39 | ) | |
| (3,454 | ) | |
| 1,088 | | |
| (2,405 | ) | |
| 23,829 | |
Transactions with owners: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Dividends | |
| | | |
| | | |
| (11,866 | ) | |
| | | |
| | | |
| | | |
| | | |
| (11,866 | ) |
Share-based payments | |
| | | |
| | | |
| 371 | | |
| | | |
| | | |
| | | |
| | | |
| 371 | |
Tax credit related to restricted stock units | |
| | | |
| | | |
| 58 | | |
| | | |
| | | |
| | | |
| | | |
| 58 | |
Purchase of treasury shares | |
| | | |
| (11 | ) | |
| (14,717 | ) | |
| | | |
| | | |
| | | |
| | | |
| (14,728 | ) |
Sale of treasury shares | |
| | | |
| 1 | | |
| 60 | | |
| | | |
| | | |
| | | |
| | | |
| 61 | |
Reduction of the B share capital | |
| (20 | ) | |
| 20 | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| - | |
Balance at the end of the year | |
| 530 | | |
| (11 | ) | |
| 41,277 | | |
| (248 | ) | |
| (2,221 | ) | |
| 967 | | |
| (1,502 | ) | |
| 40,294 | |
At the end of the year proposed dividends of DKK 12,905 million (5.00
DKK per share of DKK 0.20) are included in Retained earnings. No dividend is declared on treasury shares.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 37 of 40 |
APPENDIX 6: REGIONAL SALES SPLIT
Q4 2015 sales split per region
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
DKK million | |
| Total | | |
| North
America | | |
| Europe | | |
| Inter-
national
Operations | | |
| Region
China | | |
| Japan &
Korea | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
The diabetes and obesity care segment | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Modern insulin | |
| 13,562 | | |
| 8,003 | | |
| 2,441 | | |
| 1,626 | | |
| 1,040 | | |
| 452 | |
% change in
local currencies | |
| 11 | % | |
| 17 | % | |
| (2 | %) | |
| 15 | % | |
| 10 | % | |
| (4 | %) |
NovoRapid ® | |
| 5,689 | | |
| 3,548 | | |
| 1,126 | | |
| 561 | | |
| 214 | | |
| 240 | |
% change in
local currencies | |
| 8 | % | |
| 9 | % | |
| 4 | % | |
| 12 | % | |
| 15 | % | |
| 0 | % |
NovoMix ® | |
| 2,832 | | |
| 733 | | |
| 547 | | |
| 661 | | |
| 728 | | |
| 163 | |
% change in
local currencies | |
| 3 | % | |
| 1 | % | |
| (11 | %) | |
| 16 | % | |
| 10 | % | |
| (9 | %) |
Levemir ® | |
| 5,041 | | |
| 3,722 | | |
| 768 | | |
| 404 | | |
| 98 | | |
| 49 | |
% change in
local currencies | |
| 22 | % | |
| 31 | % | |
| (3 | %) | |
| 18 | % | |
| 2 | % | |
| (8 | %) |
Human insulin | |
| 2,778 | | |
| 551 | | |
| 509 | | |
| 780 | | |
| 854 | | |
| 84 | |
% change in
local currencies | |
| (5 | %) | |
| (21 | %) | |
| (11 | %) | |
| 14 | % | |
| (4 | %) | |
| (15 | %) |
Victoza® | |
| 4,904 | | |
| 3,632 | | |
| 840 | | |
| 244 | | |
| 47 | | |
| 141 | |
% change in
local currencies | |
| 10 | % | |
| 14 | % | |
| (3 | %) | |
| 5 | % | |
| 2 | % | |
| 45 | % |
Other diabetes and obesity care 1) | |
| 1,698 | | |
| 506 | | |
| 326 | | |
| 276 | | |
| 339 | | |
| 251 | |
% change in
local currencies | |
| 20 | % | |
| 78 | % | |
| 9 | % | |
| 14 | % | |
| (6 | %) | |
| 13 | % |
Diabetes and obesity care total | |
| 22,942 | | |
| 12,692 | | |
| 4,116 | | |
| 2,926 | | |
| 2,280 | | |
| 928 | |
% change in local currencies | |
| 9 | % | |
| 15 | % | |
| (3 | %) | |
| 14 | % | |
| 2 | % | |
| 4 | % |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
The biopharmaceuticals
segment | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Haemophilia | |
| 2,785 | | |
| 1,265 | | |
| 653 | | |
| 647 | | |
| 40 | | |
| 180 | |
%
change in local currencies | |
| (1 | %) | |
| (4 | %) | |
| 2 | % | |
| (2 | %) | |
| (8 | % | |
| 18 | % |
Norditropin® | |
| 2,065 | | |
| 915 | | |
| 429 | | |
| 346 | | |
| 4 | | |
| 371 | |
%
change in local currencies | |
| 5 | % | |
| 2 | % | |
| 1 | % | |
| 20 | % | |
| (25 | % | |
| 6 | % |
Other biopharmaceuticals | |
| 1,084 | | |
| 790 | | |
| 201 | | |
| 73 | | |
| 1 | | |
| 19 | |
%
change in local currencies | |
| 11 | % | |
| 12 | % | |
| 4 | % | |
| 25 | % | |
| 50 | % | |
| (23 | %) |
Biopharmaceuticals total | |
| 5,934 | | |
| 2,970 | | |
| 1,283 | | |
| 1,066 | | |
| 45 | | |
| 570 | |
%
change in local currencies | |
| 3 | % | |
| 1 | % | |
| 2 | % | |
| 6 | % | |
| (7 | %) | |
| 9 | % |
Total sales | |
| 28,876 | | |
| 15,662 | | |
| 5,399 | | |
| 3,992 | | |
| 2,325 | | |
| 1,498 | |
%
change in local currencies | |
| 8 | % | |
| 13 | % | |
| (2 | %) | |
| 12 | % | |
| 1 | % | |
| 6 | % |
% change as reported | |
| 17 | % | |
| 29 | % | |
| 0 | % | |
| 11 | % | |
| 11 | % | |
| 14 | % |
Share
of growth | |
| 100 | % | |
| 78 | % | |
| (5 | %) | |
| 22 | % | |
| 1 | % | |
| 4 | % |
12M 2015 sales split per region
| |
|
|
| |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
DKK million | |
|
Total |
| |
|
North America |
| |
|
Europe | |
|
Inter-
national Operations | |
|
Region China | |
|
Japan & Korea |
|
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
The diabetes and obesity care segment | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Modern insulin | |
| 50,164 | | |
| 28,708 | | |
| 9,349 | | |
| 6,082 | | |
| 4,312 | | |
| 1,713 | |
%
change in local currencies | |
| 7 | % | |
| 9 | % | |
| (1 | %) | |
| 15 | % | |
| 12 | % | |
| (5 | %) |
NovoRapid
® | |
| 20,720 | | |
| 12,576 | | |
| 4,239 | | |
| 2,151 | | |
| 866 | | |
| 888 | |
%
change in local currencies | |
| 6 | % | |
| 4 | % | |
| 4 | % | |
| 19 | % | |
| 19 | % | |
| 1 | % |
NovoMix
® | |
| 11,144 | | |
| 2,837 | | |
| 2,181 | | |
| 2,458 | | |
| 3,036 | | |
| 632 | |
%
change in local currencies | |
| 2 | % | |
| (4 | %) | |
| (8 | %) | |
| 14 | % | |
| 11 | % | |
| (9 | %) |
Levemir
® | |
| 18,300 | | |
| 13,295 | | |
| 2,929 | | |
| 1,473 | | |
| 410 | | |
| 193 | |
%
change in local currencies | |
| 13 | % | |
| 19 | % | |
| (2 | %) | |
| 11 | % | |
| 5 | % | |
| (15 | %) |
Human insulin | |
| 11,231 | | |
| 2,094 | | |
| 2,014 | | |
| 3,262 | | |
| 3,537 | | |
| 324 | |
%
change in local currencies | |
| (1 | %) | |
| (11 | %) | |
| (9 | %) | |
| 17 | % | |
| (1 | %) | |
| (16 | %) |
Victoza® | |
| 18,027 | | |
| 13,014 | | |
| 3,394 | | |
| 937 | | |
| 213 | | |
| 469 | |
%
change in local currencies | |
| 18 | % | |
| 21 | % | |
| 7 | % | |
| 17 | % | |
| 6 | % | |
| 60 | % |
Other diabetes and obesity care 1) | |
| 6,168 | | |
| 1,442 | | |
| 1,225 | | |
| 1,058 | | |
| 1,594 | | |
| 849 | |
%
change in local currencies | |
| 19 | % | |
| 45 | % | |
| 18 | % | |
| 27 | % | |
| (2 | %) | |
| 23 | % |
Diabetes and obesity care total | |
| 85,590 | | |
| 45,258 | | |
| 15,982 | | |
| 11,339 | | |
| 9,656 | | |
| 3,355 | |
%
change in local currencies | |
| 9 | % | |
| 12 | % | |
| 1 | % | |
| 17 | % | |
| 4 | % | |
| 6 | % |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
The biopharmaceuticals segment | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Haemophilia | |
| 10,647 | | |
| 5,208 | | |
| 2,405 | | |
| 2,196 | | |
| 195 | | |
| 643 | |
%
change in local currencies | |
| 3 | % | |
| (2 | %) | |
| 9 | % | |
| 8 | % | |
| (2 | %) | |
| 0 | % |
Norditropin® | |
| 7,820 | | |
| 3,626 | | |
| 1,675 | | |
| 1,165 | | |
| 15 | | |
| 1,339 | |
%
change in local currencies | |
| 8 | % | |
| 10 | % | |
| (1 | %) | |
| 22 | % | |
| 0 | % | |
| 7 | % |
Other biopharmaceuticals | |
| 3,870 | | |
| 2,765 | | |
| 736 | | |
| 266 | | |
| 5 | | |
| 98 | |
%
change in local currencies | |
| 13 | % | |
| 18 | % | |
| 5 | % | |
| 5 | % | |
| 25 | % | |
| (8 | %) |
Biopharmaceuticals
total | |
| 22,337 | | |
| 11,599 | | |
| 4,816 | | |
| 3,627 | | |
| 215 | | |
| 2,080 | |
%
change in local currencies | |
| 6 | % | |
| 6 | % | |
| 5 | % | |
| 12 | % | |
| (2 | %) | |
| 4 | % |
Total sales | |
| 107,927 | | |
| 56,857 | | |
| 20,798 | | |
| 14,966 | | |
| 9,871 | | |
| 5,435 | |
%
change in local currencies | |
| 8 | % | |
| 11 | % | |
| 2 | % | |
| 15 | % | |
| 4 | % | |
| 5 | % |
%
change as reported | |
| 22 | % | |
| 32 | % | |
| 3 | % | |
| 19 | % | |
| 22 | % | |
| 11 | % |
Share
of growth | |
| 100 | % | |
| 62 | % | |
| 4 | % | |
| 26 | % | |
| 4 | % | |
| 4 | % |
1) Other diabetes and obesity care also includes new-generation insulin.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 38 of 40 |
APPENDIX 7: KEY CURRENCY ASSUMPTIONS
| |
| |
| |
| |
|
DKK per 100 | |
|
2014 average
exchange rates |
| |
| 2015 average exchange rates |
| |
YTD 2016 average
exchange rates as of 1 February 2016 |
|
| |
Current
exchange rates as of 1 February 2016 |
|
USD | |
| 562 | | |
| 673 | | |
| 687 | | |
| 686 | |
| |
| | | |
| | | |
| | | |
| | |
CNY | |
| 91.2 | | |
| 107.0 | | |
| 104.5 | | |
| 104.2 | |
| |
| | | |
| | | |
| | | |
| | |
JPY | |
| 5.32 | | |
| 5.56 | | |
| 5.81 | | |
| 5.65 | |
| |
| | | |
| | | |
| | | |
| | |
GBP | |
| 925 | | |
| 1,028 | | |
| 989 | | |
| 981 | |
| |
| | | |
| | | |
| | | |
| | |
CAD | |
| 509 | | |
| 526 | | |
| 483 | | |
| 489 | |
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 39 of 40 |
APPENDIX 8: QUARTERLY NUMBERS IN USD (ADDITIONAL
INFORMATION - UNAUDITED)
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. The specified percentage changes in USD is calculated as a development in USD
numbers in this appendix.
(Amounts in USD million, except full-time equivalent employees, earnings per
share and number of shares outstanding).
| |
| 2015 | |
| 2014 | | |
| %
change
Q4 2015 vs | | |
| %
change
Q4 2015 vs | |
| |
| Q4 | |
| Q3 | | |
| Q2 | | |
| Q1 | | |
| Q4 | | |
| Q3 | | |
| Q2 | | |
| Q1 | | |
| Q4
2014 in USD | | |
| Q4
2014 in DKK | |
Net sales | |
| 4,240 | | |
| 3,991 | | |
| 4,004 | | |
| 3,808 | | |
| 4,143 | | |
| 3,957 | | |
| 3,975 | | |
| 3,734 | | |
| 2 | % | |
| 17 | % |
Gross profit | |
| 3,562 | | |
| 3,418 | | |
| 3,434 | | |
| 3,222 | | |
| 3,469 | | |
| 3,349 | | |
| 3,301 | | |
| 3,097 | | |
| 3 | % | |
| 18 | % |
Gross margin | |
| 84.0 | % | |
| 85.6 | % | |
| 85.7 | % | |
| 84.6 | % | |
| 83.7 | % | |
| 84.6 | % | |
| 83.0 | % | |
| 83.0 | % | |
| | | |
| | |
Sales and distribution costs | |
| 1,181 | | |
| 1,035 | | |
| 1,064 | | |
| 928 | | |
| 1,128 | | |
| 1,051 | | |
| 1,021 | | |
| 933 | | |
| 5 | % | |
| 20 | % |
Percentage of sales | |
| 27.8 | % | |
| 25.9 | % | |
| 26.5 | % | |
| 24.4 | % | |
| 27.2 | % | |
| 26.5 | % | |
| 25.7 | % | |
| 25.0 | % | |
| | | |
| | |
Research and development costs | |
| 593 | | |
| 491 | | |
| 448 | | |
| 491 | | |
| 652 | | |
| 651 | | |
| 566 | | |
| 581 | | |
| (9 | %) | |
| 4 | % |
Costs
related to discontinuation of activities within inflammatory disorders | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 109 | | |
| - | | |
| - | | |
| N/A | | |
| N/A | |
Percentage of sales | |
| 14.0 | % | |
| 12.3 | % | |
| 11.2 | % | |
| 12.9 | % | |
| 15.7 | % | |
| 16.4 | % | |
| 14.2 | % | |
| 15.6 | % | |
| | | |
| | |
Administrative costs | |
| 171 | | |
| 142 | | |
| 131 | | |
| 129 | | |
| 181 | | |
| 155 | | |
| 146 | | |
| 148 | | |
| (6 | %) | |
| 9 | % |
Percentage of sales | |
| 4.0 | % | |
| 3.6 | % | |
| 3.3 | % | |
| 3.4 | % | |
| 4.3 | % | |
| 3.9 | % | |
| 3.7 | % | |
| 4.0 | % | |
| | | |
| | |
Other operating income, net | |
| 12 | | |
| 34 | | |
| 52 | | |
| 420 | | |
| 30 | | |
| 30 | | |
| 38 | | |
| 39 | | |
| (60 | %) | |
| (48 | %) |
- Non-recurring income from
the partial divestment of NNIT A/S | |
| - | | |
| - | | |
| - | | |
| 359 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| N/A | | |
| N/A | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Operating profit | |
| 1,629 | | |
| 1,784 | | |
| 1,843 | | |
| 2,094 | | |
| 1,538 | | |
| 1,522 | | |
| 1,606 | | |
| 1,474 | | |
| 6 | % | |
| 21 | % |
Operating margin | |
| 38.5 | % | |
| 44.7 | % | |
| 46.1 | % | |
| 55.0 | % | |
| 37.2 | % | |
| 38.5 | % | |
| 40.4 | % | |
| 39.5 | % | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Financial income | |
| 3 | | |
| 1 | | |
| (34 | ) | |
| 43 | | |
| (208 | ) | |
| 58 | | |
| 72 | | |
| 108 | | |
| N/A | | |
| N/A | |
Financial expenses | |
| 121 | | |
| 276 | | |
| 252 | | |
| 251 | | |
| (63 | ) | |
| 79 | | |
| 26 | | |
| 58 | | |
| N/A | | |
| N/A | |
Net financials | |
| (118 | ) | |
| (275 | ) | |
| (286 | ) | |
| (208 | ) | |
| (145 | ) | |
| (21 | ) | |
| 46 | | |
| 50 | | |
| (19 | %) | |
| 1 | % |
Income taxes | |
| 1,511 | | |
| 1,509 | | |
| 1,557 | | |
| 1,886 | | |
| 1,393 | | |
| 1,501 | | |
| 1,652 | | |
| 1,524 | | |
| 8 | % | |
| 23 | % |
Profit before income taxes | |
| 301 | | |
| 260 | | |
| 326 | | |
| 394 | | |
| 303 | | |
| 348 | | |
| 366 | | |
| 339 | | |
| (1 | %) | |
| 13 | % |
Net profit | |
| 1,210 | | |
| 1,249 | | |
| 1,231 | | |
| 1,492 | | |
| 1,090 | | |
| 1,153 | | |
| 1,286 | | |
| 1,185 | | |
| 11 | % | |
| 26 | % |
Depreciation,
amortisation and impairment losses 1) | |
| 150 | | |
| 94 | | |
| 96 | | |
| 100 | | |
| 156 | | |
| 212 | | |
| 122 | | |
| 121 | | |
| (4 | %) | |
| 9 | % |
Capital expenditure | |
| 322 | | |
| 186 | | |
| 151 | | |
| 115 | | |
| 259 | | |
| 176 | | |
| 148 | | |
| 127 | | |
| 24 | % | |
| 45 | % |
Net cash generated from operating activities | |
| 1,485 | | |
| 1,802 | | |
| 1,784 | | |
| 620 | | |
| 1,211 | | |
| 2,191 | | |
| 1,493 | | |
| 747 | | |
| 23 | % | |
| 39 | % |
Free cash flow | |
| 1,014 | | |
| 1,611 | | |
| 1,609 | | |
| 853 | | |
| 939 | | |
| 2,005 | | |
| 1,332 | | |
| 601 | | |
| 8 | % | |
| 21 | % |
Total assets | |
| 13,441 | | |
| 12,794 | | |
| 12,195 | | |
| 11,157 | | |
| 12,589 | | |
| 12,051 | | |
| 11,666 | | |
| 11,679 | | |
| 7 | % | |
| 19 | % |
Total equity | |
| 6,877 | | |
| 6,474 | | |
| 5,866 | | |
| 4,625 | | |
| 6,582 | | |
| 6,419 | | |
| 6,716 | | |
| 6,202 | | |
| 4 | % | |
| 17 | % |
Equity ratio | |
| 51.2 | % | |
| 50.6 | % | |
| 48.1 | % | |
| 41.5 | % | |
| 52.3 | % | |
| 53.3 | % | |
| 57.6 | % | |
| 53.1 | % | |
| | | |
| | |
Full-time equivalent employees end of period | |
| 40,638 | | |
| 40,261 | | |
| 39,658 | | |
| 39,062 | | |
| 40,957 | | |
| 40,700 | | |
| 40,226 | | |
| 39,579 | | |
| (1 | %) | |
| (1 | %) |
Basic earnings per share/ADR (in USD) | |
| 0.48 | | |
| 0.49 | | |
| 0.48 | | |
| 0.57 | | |
| 0.42 | | |
| 0.44 | | |
| 0.49 | | |
| 0.45 | | |
| 14 | % | |
| 29 | % |
Diluted earnings per share/ADR (in USD) | |
| 0.48 | | |
| 0.48 | | |
| 0.48 | | |
| 0.57 | | |
| 0.42 | | |
| 0.44 | | |
| 0.48 | | |
| 0.45 | | |
| 14 | % | |
| 29 | % |
Average number of shares outstanding (million) | |
| 2,553.20 | | |
| 2,565.90 | | |
| 2,578.10 | | |
| 2,596.70 | | |
| 2,599.70 | | |
| 2,613.90 | | |
| 2,628.90 | | |
| 2,642.40 | | |
| (2 | %) | |
| (2 | %) |
Average number of diluted shares outstanding (million) | |
| 2,559.70 | | |
| 2,571.80 | | |
| 2,584.10 | | |
| 2,604.20 | | |
| 2,608.20 | | |
| 2,622.20 | | |
| 2,637.30 | | |
| 2,653.10 | | |
| (2 | %) | |
| (2 | %) |
Sales by business segment: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
New-generation insulin | |
| 68 | | |
| 56 | | |
| 49 | | |
| 41 | | |
| 45 | | |
| 31 | | |
| 26 | | |
| 15 | | |
| 51 | % | |
| 76 | % |
Modern insulin (insulin analogues) | |
| 1,992 | | |
| 1,862 | | |
| 1,867 | | |
| 1,736 | | |
| 1,879 | | |
| 1,893 | | |
| 1,902 | | |
| 1,721 | | |
| 6 | % | |
| 21 | % |
Human insulin | |
| 407 | | |
| 413 | | |
| 411 | | |
| 438 | | |
| 466 | | |
| 440 | | |
| 455 | | |
| 472 | | |
| (13 | %) | |
| 0 | % |
Victoza® | |
| 721 | | |
| 697 | | |
| 664 | | |
| 598 | | |
| 679 | | |
| 614 | | |
| 562 | | |
| 535 | | |
| 6 | % | |
| 22 | % |
Other diabetes and obesity care | |
| 181 | | |
| 183 | | |
| 158 | | |
| 181 | | |
| 178 | | |
| 170 | | |
| 189 | | |
| 186 | | |
| 2 | % | |
| 16 | % |
Diabetes and obesity care total | |
| 3,369 | | |
| 3,211 | | |
| 3,149 | | |
| 2,994 | | |
| 3,247 | | |
| 3,148 | | |
| 3,134 | | |
| 2,929 | | |
| 4 | % | |
| 19 | % |
Haemophilia | |
| 409 | | |
| 353 | | |
| 408 | | |
| 413 | | |
| 441 | | |
| 373 | | |
| 427 | | |
| 415 | | |
| (7 | %) | |
| 7 | % |
Norditropin® | |
| 303 | | |
| 274 | | |
| 308 | | |
| 277 | | |
| 305 | | |
| 300 | | |
| 278 | | |
| 275 | | |
| (1 | %) | |
| 14 | % |
Other biopharmaceuticals
2) | |
| 159 | | |
| 153 | | |
| 139 | | |
| 124 | | |
| 150 | | |
| 136 | | |
| 136 | | |
| 115 | | |
| 6 | % | |
| 22 | % |
Biopharmaceutical
total | |
| 871 | | |
| 780 | | |
| 855 | | |
| 814 | | |
| 896 | | |
| 809 | | |
| 841 | | |
| 805 | | |
| (3 | %) | |
| 12 | % |
Sales by geographic segment: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
North America | |
| 2,302 | | |
| 2,147 | | |
| 2,121 | | |
| 1,882 | | |
| 2,054 | | |
| 1,981 | | |
| 1,940 | | |
| 1,702 | | |
| 12 | % | |
| 29 | % |
Europe | |
| 792 | | |
| 774 | | |
| 773 | | |
| 752 | | |
| 910 | | |
| 897 | | |
| 917 | | |
| 863 | | |
| (13 | %) | |
| 0 | % |
International Operations | |
| 586 | | |
| 508 | | |
| 574 | | |
| 557 | | |
| 608 | | |
| 522 | | |
| 546 | | |
| 556 | | |
| (4 | %) | |
| 11 | % |
Region China | |
| 340 | | |
| 360 | | |
| 337 | | |
| 430 | | |
| 350 | | |
| 334 | | |
| 358 | | |
| 398 | | |
| (3 | %) | |
| 11 | % |
Japan & Korea | |
| 220 | | |
| 202 | | |
| 199 | | |
| 187 | | |
| 221 | | |
| 223 | | |
| 214 | | |
| 215 | | |
| 0 | % | |
| 14 | % |
Segment operating profit: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Diabetes and obesity care | |
| 1,194 | | |
| 1,353 | | |
| 1,290 | | |
| 1,201 | | |
| 1,067 | | |
| 1,244 | | |
| 1,173 | | |
| 1,061 | | |
| 12 | % | |
| 28 | % |
Biopharmaceuticals | |
| 435 | | |
| 431 | | |
| 557 | | |
| 534 | | |
| 471 | | |
| 278 | | |
| 433 | | |
| 413 | | |
| (8 | %) | |
| 7 | % |
Income from the initial public offering of NNIT
A/S (unallocated to segments) | |
| - | | |
| - | | |
| - | | |
| 359 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| N/A | | |
| N/A | |
1) Including impairments of around USD 85 million in Q3
and Q4 2014 related to discontinuation of activities within inflammatory disorders.
2) Comparative figures have been restated as NovoEight®
and NovoThirteen® are now reported as Haemophilia together with NovoSeven®.
Company announcement No 8 / 2016 |
Financial Statement for 2015 | Page 40 of 40 |
APPENDIX 9: NEW REGIONAL SALES SPLIT AS PER 1 JANUARY
2016
As per 1 January 2016, Novo Nordisk will change reporting structure for
its regional sales split, including the introduction of ‘Region Pacific’ comprising Japan, Korea, Australasia and Canada.
| |
| |
|
Q1 to Q4 2015 sales split - new regions as per
1 January 2016 | |
| |
|
Q1 2015 sales split per region - DKK million | |
| Total | | |
| USA | | |
| Europe | | |
| Inter-
national Operations | | |
| Region
China | | |
| Region
Pacific | |
The diabetes and obesity care segment | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Modern insulin
| |
| 11,498 | | |
| 6,053 | | |
| 2,229 | | |
| 1,308 | | |
| 1,184 | | |
| 724 | |
NovoRapid ® | |
| 4,682 | | |
| 2,669 | | |
| 995 | | |
| 420 | | |
| 229 | | |
| 369 | |
NovoMix ® | |
| 2,744 | | |
| 596 | | |
| 540 | | |
| 547 | | |
| 845 | | |
| 216 | |
Levemir ® | |
| 4,072 | | |
| 2,788 | | |
| 694 | | |
| 341 | | |
| 110 | | |
| 139 | |
Human
insulin | |
| 2,897 | | |
| 447 | | |
| 501 | | |
| 771 | | |
| 1,027 | | |
| 151 | |
Victoza® | |
| 3,957 | | |
| 2,671 | | |
| 805 | | |
| 228 | | |
| 58 | | |
| 195 | |
Other diabetes and obesity care 1) | |
| 1,466 | | |
| 184 | | |
| 292 | | |
| 244 | | |
| 512 | | |
| 234 | |
Diabetes and obesity care total | |
| 19,818 | | |
| 9,355 | | |
| 3,827 | | |
| 2,551 | | |
| 2,781 | | |
| 1,304 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
The biopharmaceuticals segment | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Haemophilia | |
| 2,734 | | |
| 1,274 | | |
| 557 | | |
| 611 | | |
| 60 | | |
| 232 | |
Norditropin® | |
| 1,830 | | |
| 870 | | |
| 422 | | |
| 222 | | |
| 4 | | |
| 312 | |
Other biopharmaceuticals | |
| 818 | | |
| 512 | | |
| 171 | | |
| 39 | | |
| 2 | | |
| 94 | |
Biopharmaceuticals total | |
| 5,382 | | |
| 2,656 | | |
| 1,150 | | |
| 872 | | |
| 66 | | |
| 638 | |
Total sales | |
| 25,200 | | |
| 12,011 | | |
| 4,977 | | |
| 3,423 | | |
| 2,847 | | |
| 1,942 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Q2 2015 sales split per region - DKK million | |
| Total | | |
| US | | |
| Europe | | |
| Inter-
national Operations | | |
| Region
China | | |
| Region
Pacific | |
The diabetes and obesity care segment | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Modern insulin | |
| 12,604 | | |
| 6,987 | | |
| 2,334 | | |
| 1,462 | | |
| 1,033 | | |
| 788 | |
NovoRapid ® | |
| 5,230 | | |
| 3,053 | | |
| 1,052 | | |
| 522 | | |
| 201 | | |
| 402 | |
NovoMix ® | |
| 2,852 | | |
| 762 | | |
| 548 | | |
| 569 | | |
| 737 | | |
| 236 | |
Levemir ® | |
| 4,522 | | |
| 3,172 | | |
| 734 | | |
| 371 | | |
| 95 | | |
| 150 | |
Human
insulin | |
| 2,784 | | |
| 440 | | |
| 505 | | |
| 894 | | |
| 781 | | |
| 164 | |
Victoza® | |
| 4,486 | | |
| 3,068 | | |
| 880 | | |
| 254 | | |
| 50 | | |
| 234 | |
Other diabetes and obesity care 1) | |
| 1,405 | | |
| 261 | | |
| 288 | | |
| 242 | | |
| 354 | | |
| 260 | |
Diabetes and obesity care total | |
| 21,279 | | |
| 10,756 | | |
| 4,007 | | |
| 2,852 | | |
| 2,218 | | |
| 1,446 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
The biopharmaceuticals segment | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Haemophilia | |
| 2,757 | | |
| 1,419 | | |
| 619 | | |
| 419 | | |
| 63 | | |
| 237 | |
Norditropin® | |
| 2,083 | | |
| 1,034 | | |
| 414 | | |
| 279 | | |
| 3 | | |
| 353 | |
Other biopharmaceuticals | |
| 940 | | |
| 611 | | |
| 182 | | |
| 46 | | |
| - | | |
| 101 | |
Biopharmaceuticals total | |
| 5,780 | | |
| 3,064 | | |
| 1,215 | | |
| 744 | | |
| 66 | | |
| 691 | |
Total sales | |
| 27,059 | | |
| 13,820 | | |
| 5,222 | | |
| 3,596 | | |
| 2,284 | | |
| 2,137 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Q3 2015 sales split per region - DKK million | |
| Total | | |
| US | | |
| Europe | | |
| Inter-
national Operations | | |
| Region
China | | |
| Region
Pacific | |
The diabetes and obesity care segment | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Modern insulin | |
| 12,500 | | |
| 7,092 | | |
| 2,345 | | |
| 1,249 | | |
| 1,055 | | |
| 759 | |
NovoRapid ® | |
| 5,119 | | |
| 3,013 | | |
| 1,066 | | |
| 432 | | |
| 222 | | |
| 386 | |
NovoMix ® | |
| 2,716 | | |
| 702 | | |
| 546 | | |
| 518 | | |
| 726 | | |
| 224 | |
Levemir ® | |
| 4,665 | | |
| 3,377 | | |
| 733 | | |
| 299 | | |
| 107 | | |
| 149 | |
Human
insulin | |
| 2,772 | | |
| 497 | | |
| 499 | | |
| 750 | | |
| 875 | | |
| 151 | |
Victoza® | |
| 4,680 | | |
| 3,314 | | |
| 869 | | |
| 204 | | |
| 58 | | |
| 235 | |
Other diabetes and obesity care 1) | |
| 1,599 | | |
| 370 | | |
| 319 | | |
| 243 | | |
| 389 | | |
| 278 | |
Diabetes and obesity care total | |
| 21,551 | | |
| 11,273 | | |
| 4,032 | | |
| 2,446 | | |
| 2,377 | | |
| 1,423 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
The biopharmaceuticals segment | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Haemophilia | |
| 2,371 | | |
| 1,157 | | |
| 576 | | |
| 369 | | |
| 32 | | |
| 237 | |
Norditropin® | |
| 1,842 | | |
| 806 | | |
| 410 | | |
| 266 | | |
| 4 | | |
| 356 | |
Other biopharmaceuticals | |
| 1,028 | | |
| 703 | | |
| 182 | | |
| 30 | | |
| 2 | | |
| 111 | |
Biopharmaceuticals total | |
| 5,241 | | |
| 2,666 | | |
| 1,168 | | |
| 665 | | |
| 38 | | |
| 704 | |
Total sales | |
| 26,792 | | |
| 13,939 | | |
| 5,200 | | |
| 3,111 | | |
| 2,415 | | |
| 2,127 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Q4 2015 sales split per region - DKK million | |
| Total | | |
| US | | |
| Europe | | |
| Inter-
national Operations | | |
| Region
China | | |
| Region
Pacific | |
The diabetes and obesity care segment | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Modern insulin
| |
| 13,562 | | |
| 7,813 | | |
| 2,441 | | |
| 1,451 | | |
| 1,040 | | |
| 817 | |
NovoRapid ® | |
| 5,689 | | |
| 3,449 | | |
| 1,126 | | |
| 478 | | |
| 214 | | |
| 422 | |
NovoMix ® | |
| 2,832 | | |
| 719 | | |
| 547 | | |
| 593 | | |
| 728 | | |
| 245 | |
Levemir ® | |
| 5,041 | | |
| 3,645 | | |
| 768 | | |
| 380 | | |
| 98 | | |
| 150 | |
Human
insulin | |
| 2,778 | | |
| 500 | | |
| 509 | | |
| 757 | | |
| 854 | | |
| 158 | |
Victoza® | |
| 4,904 | | |
| 3,517 | | |
| 840 | | |
| 240 | | |
| 47 | | |
| 260 | |
Other diabetes and obesity care 1) | |
| 1,698 | | |
| 455 | | |
| 326 | | |
| 256 | | |
| 339 | | |
| 322 | |
Diabetes and obesity care total | |
| 22,942 | | |
| 12,285 | | |
| 4,116 | | |
| 2,704 | | |
| 2,280 | | |
| 1,557 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
The biopharmaceuticals segment | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Haemophilia | |
| 2,785 | | |
| 1,236 | | |
| 653 | | |
| 599 | | |
| 40 | | |
| 257 | |
Norditropin® | |
| 2,065 | | |
| 915 | | |
| 429 | | |
| 340 | | |
| 4 | | |
| 377 | |
Other biopharmaceuticals | |
| 1,084 | | |
| 733 | | |
| 201 | | |
| 38 | | |
| 1 | | |
| 111 | |
Biopharmaceuticals total | |
| 5,934 | | |
| 2,884 | | |
| 1,283 | | |
| 977 | | |
| 45 | | |
| 745 | |
Total sales | |
| 28,876 | | |
| 15,169 | | |
| 5,399 | | |
| 3,681 | | |
| 2,325 | | |
| 2,302 | |
1) Other diabetes and obesity care also includes new-generation insulin.
Company
announcement No 8 / 2016
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
Date: February 3, 2016 |
NOVO NORDISK A/S
Lars Rebien Sørensen,
Chief Executive Officer |
Novo Nordisk (NYSE:NVO)
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