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, 2021
_________________________
NOVO NORDISK A/S
(Exact name of Registrant as specified in its charter)
_________________________
Novo Allé
DK-2880 Bagsværd
Denmark
(Adress 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
o
Indicate by check mark whether the registrant by furnishing the
information contained in this Form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
Yes
o
No
x
If “Yes” is marked, indicate below the file number assigned to the
registrant in connection with Rule
12g-32(b):82-________
Financial report for the period 1 January 2020 to 31 December
2020
3 February 2021
Novo Nordisk's net profit increased
by 8% in 2020
•Sales
increased by 4% in Danish kroner and by 7% at CER to DKK 126.9
billion. Sales in International Operations increased by 7% in
Danish kroner (10% at CER), and sales in North America Operations
increased by 1% in Danish kroner (3% at CER).
Sales growth was negatively impacted by COVID-19, driven by fewer
patients initiating treatment.
•Sales
within Diabetes and Obesity care increased by 5% to DKK 108.0
billion (8% at CER), driven by GLP-1 growth of 26% in Danish kroner
(29% at CER) reflecting the uptake of Ozempic®
and Rybelsus®.
Biopharm sales decreased by 1% in Danish kroner (increased by 1% at
CER).
•The
R&D pipeline progressed with the submissions of new drug
applications for semaglutide 2.4 mg in obesity in the US and the
EU. Furthermore, the phase 3b trial with semaglutide 2.0 mg in
people with type 2 diabetes was successfully
completed.
•As
per end of February 2021, Mads Krogsgaard Thomsen, executive vice
president (EVP) and chief scientific officer (CSO) will retire from
Novo Nordisk and be succeeded by Marcus Schindler, who is promoted
to CSO and EVP for Research & Early Development and Martin
Holst Lange, who is promoted to EVP for Development.
•For
the 2021 outlook, sales growth is expected to be 5-9% at CER, and
operating profit growth is expected to be 4-8% at CER. Growth
reported in DKK is expected to be around 4 and 6 percentage points
lower than at CER for sales and operating profit,
respectively.
•At
the Annual General Meeting on 25 March 2021, the Board of Directors
will propose a final dividend of DKK 5.85
for 2020 per share of DKK 0.20. The expected total dividend for
2020 is DKK 9.10 per share, of which DKK 3.25 was paid as interim
dividend in August 2020. The Board of Directors intends to initiate
a new 12-month share repurchase programme of up to DKK 17
billion.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROFIT AND LOSS |
2020 |
|
2019 |
Growth
as reported |
Growth
at CER* |
DKK million |
|
|
|
|
|
Net sales |
126,946 |
|
|
122,021 |
|
4 |
% |
7 |
% |
Operating profit |
54,126 |
|
|
52,483 |
|
3 |
% |
7 |
% |
|
|
|
|
|
|
Net profit |
42,138 |
|
|
38,951 |
|
8 |
% |
N/A |
Diluted earnings per share (in DKK) |
18.01 |
|
|
16.38 |
|
10 |
% |
N/A |
* CER: Constant exchange rates (average 2019).
Lars Fruergaard Jørgensen, president and CEO:
"We are very satisfied with the progress on our Strategic
Aspirations in 2020
despite the challenges of COVID-19.
This was only possible due to the commitment from all our
employees. The financial results reflect sales growth in both
International Operations and North America Operations driven by
more patients using our GLP-1 treatments. Within R&D, key
milestones in the fourth quarter were the regulatory submissions of
semaglutide 2.4 mg which has the potential to redefine the
treatment of obesity. In 2021, we will continue our focus on
commercial execution while conducting more late-stage clinical
trial programmes than ever to meet the unmet needs of people living
with diabetes and other serious chronic diseases."
On 3 February 2021 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’.
|
|
|
|
|
|
|
|
|
|
|
|
Novo Nordisk A/S
Investor Relations
|
Novo Allé
2880 Bagsværd
Denmark |
Telephone:
+45 4444 8888
www.novonordisk.com |
CVR Number:
24 25 67 90 |
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 2 of 36
|
UPDATE ON COVID-19
During the COVID-19 pandemic, Novo Nordisk's key priorities are to
safeguard employees, continue the supply of lifesaving medicines
and support societies around the world.
Production
Novo Nordisk's manufacturing sites continue to operate and products
are still distributed and made available to patients
worldwide.
R&D
Novo Nordisk continues conduct of all clinical trials already
initiated.
For ongoing trials, recruitment of new patients is still below
pre-COVID-19 levels. Some new trials have been
initiated.
Commercial
Most Novo Nordisk medicines are mainly used for chronic treatment.
However, during the period of social distancing implemented in many
markets, fewer new patients are initiating treatment. This is
especially impacting launch products and products with a short stay
time.
A gradual recovery of patient initiations took place in the fourth
quarter.
In the beginning of the pandemic, stocking mainly at patient level
was seen particularly in the US and Europe and a gradual destocking
at patient level has taken place in the following
quarters.
The COVID-19 pandemic continues to evolve differently across
geographies and operations are running accordingly. In many
markets, sales representatives are working from home using virtual
promotion tools.
Support to society
Novo Nordisk supports societies and local healthcare systems during
the COVID-19 pandemic with contributions in countries across the
world, including patient support, emergency relief donations as
well as protection equipment for medical staff and
hospitals.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 3 of 36
|
STRATEGIC ASPIRATIONS
STRATEGIC ASPIRATIONS 2025
To reflect the broad aspects of Novo Nordisk across therapy areas
and geographies, Novo Nordisk introduced in 2019 a comprehensive
approach describing the future growth aspirations of the company
under the headline Strategic Aspirations 2025.
The strategic aspirations are objectives that Novo Nordisk intends
to work towards and are not a projection of Novo Nordisk's
financial outlook or expected growth. Novo Nordisk intends to
describe how its activities develop in relation to each of the four
dimensions on an ongoing basis.
Performance highlights for 2020:
|
|
|
|
|
|
|
|
|
Purpose and sustainability |
|
Innovation and therapeutic focus |
Adding value to society:
•Launch
of social strategy 'Defeat Diabetes'
•Expansion
of US affordability options
•Societal
contributions during COVID-19 pandemic
•Lowered
ceiling pricing of human insulin as part of Access to Insulin
Commitment in 76 countries
Progress towards zero environmental impact:
•Sourcing
of renewable power for all US operations and 100% renewable power
across all production sites
•Launch
of supplier target aiming at 100% renewable power across all
suppliers by 2030
rog Ensure distinct core capabilities and evolve
culture:
•Progress
on diversity and inclusion agenda as well as digitalisation
capabilities
|
|
Further raise innovation bar for diabetes treatment:
•Semaglutide
high-dose phase 3b trial successfully completed and submitted in
the EU and the US
•Phase
3a trial with once-weekly insulin icodec initiated
•Rybelsus®
approved in the EU and Japan
Develop superior treatment solutions for obesity:
•Semaglutide
2.4 mg in obesity phase 3a programme successfully completed and
submitted in the US and the EU
•Phase
2 monotherapy trial with AM833 phase 1 combination trial of AM833
and semaglutide 2.4 mg successfully completed
Dev Strengthen and progress Biopharm pipeline:
•Mim8
phase 1/2 trials initiated
•Concizumab
phase 3 trial reinitiated
Establish presence in Other serious chronic diseases:
•Ziltivekimab
phase 2b trial in cardiovascular disease successfully
completed
•Semaglutide
in NASH phase 2 trial successfully completed
|
Commercial execution |
|
Financials |
stre
Strengthen diabetes leadership:
•Diabetes
value market share increased by 0.7 percentage point to
29.3%
Sgd
Strengthen obesity leadership and double sales
•Obesity
care sales increased by 3% (CER) to DKK 5.6 billion
Stre
Sec
Secure a sustained growth outlook for Biopharm
•Biopharm
sales increased by 1% (CER)
|
|
Deliver solid sales and operating profit growth:
•Sales
and operating profit growth at 7% (CER)
•Sales
in International Operations grew by 10% (CER)
•In
the US, 48% of sales came from products launched since
2015
Drive
operational efficiencies:
•Gross
margin improvement (CER) driven by productivity gains in Product
Supply
Enable attractive capital allocation to shareholders:
•Free
cash flow of DKK 28.6 billion reflecting acquisitions in
2020
•DKK
37.0 billion returned to shareholders through share buybacks and
dividends
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 4 of 36
|
FINANCIAL PERFORMANCE
CONSOLIDATED FINANCIAL STATEMENT FOR 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROFIT AND LOSS |
2020 |
|
2019 |
2018 |
2017 |
2016 |
|
% change 2020 to 2019 |
(Amounts are in DKK million, except for earnings per share,
dividend per share and employees) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
126,946 |
|
122,021 |
111,831 |
111,696 |
111,780 |
|
4 |
% |
|
|
|
|
|
|
|
|
|
Gross profit |
106,014 |
|
101,933 |
94,214 |
94,064 |
94,597 |
|
4 |
% |
Gross margin |
83.5% |
|
83.5% |
84.2% |
84.2% |
84.6% |
|
|
|
|
|
|
|
|
|
|
|
Sales and distribution costs |
32,928 |
|
31,823 |
29,397 |
28,340 |
28,377 |
|
3 |
% |
Percentage of sales |
25.9% |
|
26.1% |
26.3% |
25.4% |
25.4% |
|
|
|
|
|
|
|
|
|
|
|
Research and development costs |
15,462 |
|
14,220 |
14,805 |
14,014 |
14,563 |
|
9 |
% |
Percentage of sales |
12.2% |
|
11.7% |
13.2% |
12.5% |
13.0% |
|
|
|
|
|
|
|
|
|
|
|
Administrative costs |
3,958 |
|
4,007 |
3,916 |
3,784 |
3,962 |
|
(1 |
%) |
Percentage of sales |
3.1% |
|
3.3% |
3.5% |
3.4% |
3.5% |
|
|
|
|
|
|
|
|
|
|
|
Other operating income, net |
460 |
|
600 |
1,152 |
1,041 |
737 |
|
(23 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating profit |
54,126 |
|
52,483 |
47,248 |
48,967 |
48,432 |
|
3 |
% |
Operating margin |
42.6% |
|
43.0% |
42.2% |
43.8% |
43.3% |
|
|
|
|
|
|
|
|
|
|
|
Financial items (net) |
(996) |
|
(3,930) |
367 |
(287) |
(634) |
|
(75 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit before income taxes |
53,130 |
|
48,553 |
47,615 |
48,680 |
47,798 |
|
9 |
% |
|
|
|
|
|
|
|
|
|
Income taxes |
10,992 |
|
9,602 |
8,987 |
10,550 |
9,873 |
|
14 |
% |
Effective tax rate |
20.7% |
|
19.8% |
18.9% |
21.7% |
20.7% |
|
|
|
|
|
|
|
|
|
|
|
Net profit |
42,138 |
|
38,951 |
38,628 |
38,130 |
37,925 |
|
8 |
% |
Net profit margin |
33.2% |
|
31.9% |
34.5% |
34.1% |
33.9% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER KEY NUMBERS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation, amortisation and impairment losses |
5,753 |
|
5,661 |
3,925 |
3,182 |
3,193 |
|
2 |
% |
Purchase of intangible assets |
16,256 |
|
2,299 |
2,774 |
1,022 |
1,199 |
|
607 |
% |
Capital expenditure1
|
5,825 |
|
8,932 |
9,636 |
7,626 |
7,068 |
|
(35 |
%) |
|
|
|
|
|
|
|
|
|
Net cash generated from operating activities |
51,951 |
|
46,782 |
44,616 |
41,168 |
48,314 |
|
11 |
% |
Free cash flow |
28,565 |
|
34,451 |
32,536 |
32,588 |
39,991 |
|
(17 |
%) |
|
|
|
|
|
|
|
|
|
Total assets |
144,922 |
|
125,612 |
110,769 |
102,355 |
97,539 |
|
15 |
% |
Equity |
63,325 |
|
57,593 |
51,839 |
49,815 |
45,269 |
|
10 |
% |
Equity ratio |
43.7% |
|
45.8% |
46.8% |
48.7% |
46.4% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share / ADR (in DKK) |
18.01 |
|
16.38 |
15.93 |
15.39 |
14.96 |
|
10 |
% |
|
|
|
|
|
|
|
|
|
Total dividend per share
2)
|
9.10 |
|
8.35 |
8.15 |
7.85 |
7.6 |
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payout ratio
3)
|
50.0% |
|
50.5% |
50.6% |
50.4% |
50.2% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1)
Cash-based capital expenditure (purchase of property, plant and
equipment) and intangible assets.
|
2)
Total dividend for the financial year 2020 including proposed final
dividend of DKK 5.85 per share and interim dividend paid in August
2020 of DKK 3.25 per share.
|
3)
Total dividend for the year as a percentage of net
profit.
|
|
|
|
|
|
|
|
|
|
The Board of Directors and Executive Management have approved
the
Annual Report 2020
of Novo Nordisk A/S
including the audited consolidated financial statements. The Board
of Directors and Executive Management also
approved this unaudited financial statement containing condensed
financial information for 2020. This financial
statement is prepared in accordance with the recognition and
measurement requirements of the International
Financial Reporting Standards (IFRS) as issued by IASB and IFRS as
endorsed by the EU.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 5 of 36
|
GEOGRAPHIC SALES DEVELOPMENT
Sales increased by 4% measured in Danish kroner and by 7% at CER to
DKK 126,946 million in 2020. Sales growth was negatively impacted
by COVID-19, driven by fewer patients initiating treatment. Sales
in International Operations increased by 7% measured in Danish
kroner and by 10% at CER. Sales in North America Operations
increased by 1% measured in Danish kroner and by 3% at
CER.
As of April 2020, International Operations was reorganised and
financial reporting has been divided into: EMEA (covering Europe,
the Middle East and Africa), Region China (covering Mainland China,
Hong Kong and Taiwan) and Rest of World (covering all other
countries except for North America). North America Operations was
not impacted by the reorganisation and still includes the US and
Canada. Please see appendix 8 for a breakdown of sales per area in
2019.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales split per geographical area |
Sales 2020
DKK million |
Growth
as reported |
Growth
at CER |
Share of growth
at CER |
|
|
|
|
|
|
|
|
|
|
International Operations |
65,829 |
|
7 |
% |
10 |
% |
77 |
% |
|
- EMEA |
34,297 |
|
6 |
% |
9 |
% |
34 |
% |
|
- Region China |
14,084 |
|
10 |
% |
11 |
% |
18 |
% |
|
- Rest of World |
17,448 |
|
6 |
% |
12 |
% |
25 |
% |
North America Operations |
61,117 |
|
1 |
% |
3 |
% |
23 |
% |
|
- The US |
57,824 |
|
1 |
% |
3 |
% |
18 |
% |
|
|
|
|
|
|
Total sales |
126,946 |
|
4 |
% |
7 |
% |
100 |
% |
International Operations
Sales in International Operations increased by 7% measured in
Danish kroner and by 10% at CER. Sales growth was driven by all
geographical areas, with EMEA growing by 9% (CER), Rest of World
growing by 12% (CER) and Region China growing by 11% (CER). Sales
growth was driven by all therapy areas. Sales growth was negatively
impacted by COVID-19, driven by fewer patients initiating
treatment
EMEA
Sales in EMEA increased by 6% measured in Danish kroner and by 9%
at CER. Sales growth was driven by Diabetes care growing by 10%
(CER) driven by increased GLP-1 and insulin sales. Biopharm sales
increased by 4% (CER) and Obesity care increased by 18%
(CER).
Region China
Sales in Region China increased by 10% measured in Danish kroner
and by 11% at CER. Sales growth was driven by Diabetes care growth
of 11% (CER) due to increased modern and new-generation insulin
sales and Biopharm growing by 33% (CER).
Rest of World
Sales in Rest of World increased by 6% measured in Danish kroner
and by 12% at CER. Sales growth was driven by Diabetes care growing
by 16% (CER) reflecting increased insulin and GLP-1 sales, Biopharm
growing by 5% (CER) and Obesity care growing by 4%
(CER).
North America Operations
Sales in North America Operations increased by 1% measured in
Danish kroner and by 3% at CER. Sales growth was negatively
impacted by COVID-19 due to fewer patients initiating treatment and
increased unemployment in the US,
partially offset by COVID-19-related stocking in the first
quarter.
The sales development reflects Diabetes care GLP-1 sales growing by
28% (CER). This was partially offset by insulin sales declining by
20% (CER) due to
lower realised prices in the US following unfavourable channel mix,
rebate enhancements, affordability programmes and changes in the
coverage gap legislation as well as Biopharm sales declining
by
6% (CER) and Obesity care declining by 1% (CER).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 6 of 36
|
SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
Sales growth in 2020 was 4% measured in Danish kroner and 7% at CER
driven by growth across all therapy areas with Diabetes care sales
growth of 8% (CER), Obesity care sales growth of 3% (CER) and
Biopharm sales growth of 1% (CER). Sales growth was negatively
impacted by COVID-19, driven by fewer patients initiating
treatment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales split per therapy |
Sales 2020
DKK million |
Sales 2019
DKK million |
|
Growth
as reported |
Growth
at CER |
Share of growth
at CER |
Diabetes and Obesity care segment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-acting insulin |
18,439 |
|
20,776 |
|
|
(11 |
%) |
(9 |
%) |
(23 |
%) |
|
- Tresiba®
|
8,968 |
|
9,259 |
|
|
(3 |
%) |
(1 |
%) |
(1 |
%) |
|
- Xultophy®
|
2,444 |
|
2,210 |
|
|
11 |
% |
13 |
% |
3 |
% |
|
- Levemir®
|
7,027 |
|
9,307 |
|
|
(24 |
%) |
(22 |
%) |
(25 |
%) |
|
|
|
|
|
|
|
|
Premix insulin |
10,925 |
|
10,578 |
|
|
3 |
% |
6 |
% |
8 |
% |
|
- Ryzodeg®
|
1,291 |
|
993 |
|
|
30 |
% |
35 |
% |
4 |
% |
|
- NovoMix®
|
9,634 |
|
9,585 |
|
|
1 |
% |
3 |
% |
4 |
% |
|
|
|
|
|
|
|
|
Fast-acting insulin |
18,313 |
|
19,303 |
|
|
(5 |
%) |
(3 |
%) |
(6 |
%) |
|
- Fiasp®
|
1,385 |
|
1,243 |
|
|
11 |
% |
13 |
% |
2 |
% |
|
- NovoRapid®
|
16,928 |
|
18,060 |
|
|
(6 |
%) |
(4 |
%) |
(8 |
%) |
|
|
|
|
|
|
|
|
Human insulin |
8,873 |
|
9,036 |
|
|
(2 |
%) |
2 |
% |
2 |
% |
|
|
|
|
|
|
|
|
Total insulin |
56,550 |
|
59,693 |
|
|
(5 |
%) |
(3 |
%) |
(19 |
%) |
|
|
|
|
|
|
|
|
Victoza®
|
18,747 |
|
21,934 |
|
|
(15 |
%) |
(13 |
%) |
(34 |
%) |
Ozempic®
|
21,211 |
|
11,237 |
|
|
89 |
% |
93 |
% |
128 |
% |
Rybelsus®
|
1,873 |
|
50 |
|
|
— |
— |
23 |
% |
Total GLP-1 |
41,831 |
|
33,221 |
|
|
26 |
% |
29 |
% |
117 |
% |
|
|
|
|
|
|
|
|
Other Diabetes care1
|
4,031 |
|
4,247 |
|
|
(5 |
%) |
(3 |
%) |
(2 |
%) |
|
|
|
|
|
|
|
|
Total Diabetes care |
102,412 |
|
97,161 |
|
|
5 |
% |
8 |
% |
96 |
% |
|
|
|
|
|
|
|
|
Obesity care (Saxenda®)
|
5,608 |
|
5,679 |
|
|
(1 |
%) |
3 |
% |
2 |
% |
|
|
|
|
|
|
|
|
Diabetes and Obesity care total |
108,020 |
|
102,840 |
|
|
5 |
% |
8 |
% |
98 |
% |
|
|
|
|
|
|
|
|
Biopharm segment |
|
|
|
|
|
|
Haemophilia2
|
9,662 |
|
10,281 |
|
|
(6 |
%) |
(4 |
%) |
(5 |
%) |
|
- NovoSeven®
|
7,203 |
|
8,119 |
|
|
(11 |
%) |
(9 |
%) |
(9 |
%) |
|
- NovoEight®
|
1,462 |
|
1,525 |
|
|
(4 |
%) |
(1 |
%) |
0 |
% |
Growth disorders (Norditropin®)
|
7,704 |
|
7,275 |
|
|
6 |
% |
8 |
% |
7 |
% |
Other Biopharm3
|
1,560 |
|
1,625 |
|
|
(4 |
%) |
(2 |
%) |
0 |
% |
Biopharm total |
18,926 |
|
19,181 |
|
|
(1 |
%) |
1 |
% |
2 |
% |
|
|
|
|
|
|
|
|
Total sales |
126,946 |
|
122,021 |
|
|
4 |
% |
7 |
% |
100 |
% |
|
|
|
|
|
|
|
|
1)
Primarily NovoNorm®,
needles and GlucaGen®
HypoKit®.
|
|
|
|
|
2)
Comprises NovoSeven®,
NovoEight®,
Refixia®,
NovoThirteen®
and Esperoct®.
|
|
|
3)
Primarily Vagifem®
and Activelle®.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 7 of 36
|
DIABETES AND OBESITY CARE
Diabetes care, sales development
Sales in Diabetes care increased by 5% measured in Danish kroner
and by 8% at CER to DKK 102,412 million driven by GLP-1 growth.
Novo Nordisk has improved the global diabetes value market share
over the last 12 months from 28.6% to 29.3%, driven by market share
gains in both International Operations and North America
Operations.
In the following sections, unless otherwise noted, market data are
based on moving annual total (MAT) from November 2020 and November
2019 provided by the independent data provider IQVIA.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes care, development per area |
Novo Nordisk’s share of the total diabetes market (value,
MAT) |
Diabetes care, sales development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November |
November |
Sales 2020
DKK million |
Growth
at CER |
|
|
2020 |
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
Global |
29.3 |
% |
28.6 |
% |
102,412 |
|
8 |
% |
International Operations |
23.0 |
% |
22.0 |
% |
52,063 |
|
11 |
% |
|
- EMEA * |
27.6 |
% |
26.9 |
% |
26,488 |
|
10 |
% |
|
- Region China ** |
29.7 |
% |
27.4 |
% |
13,642 |
|
11 |
% |
|
- Rest of World *** |
13.4 |
% |
12.8 |
% |
11,933 |
|
16 |
% |
North America Operations |
31.5 |
% |
31.1 |
% |
50,349 |
|
5 |
% |
|
- The US |
31.6 |
% |
31.3 |
% |
47,857 |
|
4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Source: IQVIA, November 2020 data. *Data for EMEA available for
European markets and seven markets outside Europe representing
approximately 90% of Novo Nordisk Diabetes care sales in the area.
**Data for mainland China, excluding Hong Kong and Taiwan. *** Data
for Rest of World available for seven markets representing
approximately 70% of total Novo Nordisk’s Diabetes care sales in
the area.
Insulin
Sales of insulin decreased by 5% measured in Danish kroner and by
3% at CER to DKK 56,550 million. The sales decrease was driven by
declining sales in the US, partly offset by increased sales in
International Operations.
Sales of long-acting insulin decreased by 11% measured in Danish
kroner and by 9% at CER to DKK 18,439 million. Novo Nordisk has
increased its global volume market share in the long-acting insulin
segment from 32.4% to 32.8% in the last 12 months. The sales
decline measured at CER was driven by declining
Levemir®
and Tresiba®
sales, partially offset by increased sales of
Xultophy®.
Tresiba®
has been launched in 91 countries, while
Xultophy®
has been launched in 42 countries.
Sales of premix insulin increased by 3% measured in Danish kroner
and by 6% at CER to DKK 10,925 million. Novo Nordisk is the market
leader in the premix insulin segment with a global volume market
share of 65.2% compared to 64.2% 12 months ago. The sales increase
was driven by increased sales of both Ryzodeg®
and NovoMix®.
Ryzodeg®
has now been launched in 37 countries.
Sales of fast-acting insulin decreased by 5% measured in Danish
kroner and by 3% at CER to DKK 18,313 million. Novo Nordisk is the
market leader in the fast-acting insulin segment and has increased
its global volume market share to 51.7% from 50.7% in the last 12
months. The sales decrease was driven by
NovoRapid®,
partly offset by increased Fiasp®
sales. Fiasp®
has now been launched in 41 countries.
Sales of human insulin decreased by 2% measured in Danish kroner
and increased by 2% at CER to DKK 8,873 million.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 8 of 36
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Insulin, development per geographical area |
Novo Nordisk’s share of the total insulin market (volume,
MAT) |
Insulin, sales development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November |
November |
Sales 2020
DKK million |
Growth
at CER |
|
|
2020 |
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
Global |
47.2 |
% |
46.5 |
% |
56,550 |
|
(3 |
%) |
International Operations |
50.1 |
% |
49.2 |
% |
38,352 |
|
9 |
% |
|
- EMEA * |
47.5 |
% |
46.5 |
% |
18,364 |
|
5 |
% |
|
- Region China ** |
50.4 |
% |
50.5 |
% |
11,053 |
|
13 |
% |
|
- Rest of World *** |
57.2 |
% |
56.3 |
% |
8,935 |
|
12 |
% |
North America Operations |
39.5 |
% |
39.9 |
% |
18,198 |
|
(20 |
%) |
|
- The US |
39.4 |
% |
40.0 |
% |
17,146 |
|
(22 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
Source: IQVIA, November 2020 data. *Data for EMEA available for
European markets and seven markets outside Europe representing
approximately 90% of Novo Nordisk Diabetes care sales in the area.
**Data for mainland China, excluding Hong Kong and Taiwan. *** Data
for Rest of World available for seven markets representing
approximately 70% of total Novo Nordisk’s Diabetes care sales in
the area.
International Operations
Sales of insulin in International Operations increased by 5%
measured in Danish kroner and by 9% at CER. Sales growth at CER was
driven by all insulin segments.
EMEA
Sales of insulin in EMEA increased by 2% measured in Danish kroner
and by 5% at CER. Sales growth was driven by long-acting and
fast-acting
insulin, partially offset by premix insulin and human
insulin.
Region China
Sales of insulin in Region China increased by 11% measured in
Danish kroner and by 13% at CER. The sales growth was driven by all
insulin products except for human insulin.
Tresiba®
was included on the National Reimbursement Drug List in January
2020 and hospital listings have progressed.
Rest of World
Sales of insulin in Rest of World increased by 6% measured in
Danish kroner and by 12% at CER. The sales growth was driven by
human insulin and the portfolio of modern and new-generation
insulin
.
North America Operations
Sales of insulin in North America Operations decreased by 22%
measured in Danish kroner and by 20% at CER. The sales decline in
the US was driven by
lower realised prices following rebate enhancements, unfavourable
channel mix, changes in the coverage gap legislation and launch of
affordability programmes.
Novo Nordisk has a volume market share of 39.5% of the total
insulin market.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 9 of 36
|
GLP-1 therapy for type 2 diabetes
Sales of GLP-1 products for type 2 diabetes
(Ozempic®,
Victoza®
and Rybelsus®)
increased by 26% measured in Danish kroner and by 29% at CER to DKK
41,831 million. Ozempic®
has now been launched in 52
countries
with sales of DKK 21,211 million, and Rybelsus®
has been launched in nine countries with sales of
DKK 1,873 million.
The GLP-1 segment’s value share of the total diabetes market has
increased to 22.0% compared with 18.0% 12 months ago. Novo Nordisk
continues to be the global market leader in the GLP-1 segment with
a 50.4% value market share, an increase of 2.9 percentage points
compared to 12 months ago. Sales growth was negatively impacted by
COVID-19.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GLP-1, development per geographical area |
Novo Nordisk's share of the diabetes GLP-1 market (value,
MAT) |
GLP-1, sales development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November |
November |
Sales 2020
DKK million |
Growth
at CER |
|
|
2020 |
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
Global |
50.4 |
% |
47.5 |
% |
41,831 |
|
29 |
% |
International Operations |
53.6 |
% |
50.6 |
% |
10,765 |
|
32 |
% |
|
- EMEA * |
55.1 |
% |
52.9 |
% |
7,399 |
|
31 |
% |
|
- Region China ** |
90.5 |
% |
92.8 |
% |
1,043 |
|
18 |
% |
|
- Rest of World *** |
43.6 |
% |
38.8 |
% |
2,323 |
|
41 |
% |
North America Operations |
49.9 |
% |
47.0 |
% |
31,066 |
|
28 |
% |
|
- The US |
49.3 |
% |
46.5 |
% |
29,768 |
|
27 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Source: IQVIA, November 2020 data. *Data for EMEA available for
European markets and seven markets outside Europe representing
approximately 90% of Novo Nordisk Diabetes care sales in the area.
**Data for mainland China, excluding Hong Kong and Taiwan. *** Data
for Rest of World available for seven markets representing
approximately 70% of total Novo Nordisk Diabetes care sales in the
area.
International Operations
Sales of GLP-1 diabetes products in International Operations
increased by 28% measured in Danish kroner and by 32% at CER. Sales
growth is driven by all geographical areas. The value share of the
GLP-1 class of the total diabetes market has increased to 10.8%
from 9.1% 12 months ago. Novo Nordisk is the market leader with a
value market share of 53.6%.
EMEA
Sales in EMEA increased by 30% measured in Danish kroner and by 31%
at CER. The sales growth reflects the uptake of
Ozempic®,
partially offset by lower sales of Victoza®.
Rybelsus®
has now been launched in seven countries in EMEA. Novo Nordisk
remains the market leader in EMEA with a value market share of
55.1%.
Region China
Sales in Region China increased by 16% measured in Danish kroner
and by 18% at CER. The increased sales reflect volume growth,
partly offset by lower realised prices. The GLP-1 class' share of
the overall diabetes market value increased to 3.0% from 2.1% 12
months ago. Victoza®
has a market share of 90.5%.
Rest of World
Sales in Rest of World increased by 28% measured in Danish kroner
and by 41% at CER. The sales growth reflects increased sales of
Ozempic®
and Victoza®.
Novo Nordisk remains the market leader with a value market share of
43.6%.
North America Operations
Sales of GLP-1 diabetes products in North America Operations
increased by 25% measured in Danish kroner and by 28% at CER. Novo
Nordisk is the market leader with a 49.9% value market share
compared to 47.0% 12 months ago. The value market share of the
GLP-1 class of the total North American diabetes market has
increased to 26.0% compared to 21.3% 12 months ago.
Sales growth in the US is driven by a prescription volume growth of
the GLP-1 class of around
30%.
Rybelsus®
has around 90% market access across commercial and Medicare plans
and the weekly new-to-brand market share is
11.5%. The combined Novo Nordisk GLP-1 new-to-brand prescription
market share is now 57.1%. Novo Nordisk is the market
leader measured on total monthly prescriptions for the combined
GLP-1 portfolio.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 10 of 36
|
Sales of GLP-1 in the US increased by 27% at CER. The sales
increase was driven by continued uptake of
Ozempic®
and Rybelsus®,
partially offset by declining Victoza®
sales. GLP-1 sales growth was negatively impacted by rebate
enhancements, unfavourable channel and payer mix as well as changes
in coverage gap legislation.
Obesity care, sales development
Sales of Saxenda®
decreased by 1% measured in Danish kroner and increased by 3% at
CER to DKK 5,608 million. Saxenda®
sales growth at CER was driven by International Operations,
partially offset by North America Operations. Sales growth was
negatively impacted by COVID-19 as fewer patients initiated
treatment. Saxenda®
has now been launched in 55 countries. Novo Nordisk currently has a
value market share of 64.7% of the global obesity prescription drug
market.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Obesity care, development per geographical area |
Obesity care, sales development |
|
|
|
|
|
|
|
|
|
|
Sales 2020
DKK million |
Growth
at CER |
|
|
|
|
|
|
|
|
|
|
Global |
5,608 |
|
3 |
% |
International Operations |
2,118 |
|
11 |
% |
|
- EMEA |
1,124 |
|
18 |
% |
|
- Region China |
10 |
|
11 |
% |
|
- Rest of World |
984 |
|
4 |
% |
North America Operations |
3,490 |
|
(1 |
%) |
|
- The US |
3,230 |
|
(2 |
%) |
|
|
|
|
|
|
|
|
International Operations
Sales of Saxenda®
in International Operations increased by 2% measured in Danish
kroner and by 11% at CER driven by increased sales in EMEA and Rest
of World. Novo Nordisk currently has a value market share of 40.4%
in the obesity prescription drug market. Sales growth was
negatively impacted by fewer patients initiating treatment due to
COVID-19.
EMEA
Sales of Saxenda®
in EMEA increased by 15% measured in Danish kroner and by 18% at
CER. Novo Nordisk currently has a value market share of 67.3% in
the obesity prescription drug market.
Rest of World
Sales of Saxenda®
in Rest of World decreased by 10% measured in Danish kroner and
increased by 4% at CER. Saxenda®
has been launched in 17 countries in Rest of World. Novo Nordisk
currently has a value market share of 31.5% in the obesity
prescription drug market.
North America Operations
Sales of Saxenda®
in North America Operations decreased by 3% measured in Danish
kroner and by 1% at CER. Saxenda®
continues to grow volume and Novo Nordisk now has a value market
share of 80.2% in the obesity prescription drug market in North
America Operations. Sales were negatively impacted by fewer
patients initiating treatment due to COVID-19 as well as
unfavourable channel mix development.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 11 of 36
|
BIOPHARM
Biopharm, sales development
Sales of biopharm products decreased by 1% measured in Danish
kroner and increased by 1% at CER to DKK 18,926 million. The sales
growth at CER was driven by International Operations. Sales growth
was driven by Growth Disorders and
the launches of new haemophilia products, offset by declining sales
of NovoSeven®.
Sales growth was negatively impacted by lower demand due to
COVID-19.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Biopharm, development per geographical area |
Biopharm, sales development |
|
|
|
|
|
|
|
|
|
|
Sales 2020
DKK million |
Growth
at CER |
|
|
|
|
|
|
|
|
|
|
Global |
18,926 |
|
1 |
% |
International Operations |
11,648 |
|
5 |
% |
|
- EMEA |
6,685 |
|
4 |
% |
|
- Region China |
432 |
|
33 |
% |
|
- Rest of World |
4,531 |
|
5 |
% |
North America Operations |
7,278 |
|
(6 |
%) |
|
- The US |
6,737 |
|
(6 |
%) |
|
|
|
|
|
|
|
|
Haemophilia
Sales of haemophilia products decreased by 6% measured in Danish
kroner and by 4% at CER to DKK 9,662 million. The decreasing sales
were driven by declining NovoSeven®
sales, while the haemophilia A and B franchises grew driven by the
continued global roll-out of Esperoct®
and Refixia®.
Sales of NovoSeven®
decreased by 11% measured in Danish kroner and by 9% at CER to DKK
7,203 million. The sales development was driven by declining sales
in North America Operations, Rest of World and EMEA, partially
offset
by increasing sales in Region China, reflecting timing of
shipments.
The
declining sales partly reflect reduced elective surgeries and
bleedings due to COVID-19.
Sales of NovoEight®
decreased by 4% measured in Danish kroner and by 1% at CER to DKK
1,462 million. The decreasing sales were driven by declining sales
in EMEA and the US, partly offset by increased sales in Rest of
World.
The NovoEight®
sales decrease was offset by Esperoct®,
the long-acting haemophilia A treatment, which has now been
launched in 19 countries.
Sales of Refixia®
increased to DKK 518 million. Sales growth was driven by continued
uptake in Rest of World and EMEA as well as continued uptake in
North America Operations. Refixia®
has been launched in 25 countries.
Growth disorders (Norditropin®)
Sales of Norditropin®
increased by 6% measured in Danish kroner and by 8% at CER to DKK
7,704 million. The sales increase was driven by International
Operations increasing by 16%, partially offset by North America
Operations declining by 4% at CER. Novo Nordisk is the leading
company in the global human growth disorder market with a value
market share of 36.0% compared to 33.0% a year ago, driven by new
indications and the global roll-out of the next-generation device.
Sales growth was positively impacted by
additional demand, following supply challenges for competing
products in select countries.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 12 of 36
|
DEVELOPMENT IN COSTS AND OPERATING PROFIT
The
cost of goods sold
increased by 4% measured in Danish kroner and by 5% at CER to DKK
20,932 million, resulting in an unchanged gross margin of 83.5%
measured in Danish kroner compared to 2019. The unchanged gross
margin reflects productivity improvements and a positive product
mix driven by increased GLP-1 sales. This is countered by a
negative impact from lower realised prices in the US and a negative
currency impact of 0.3 percentage point.
Sales and distribution costs
increased by 3% measured in Danish kroner and by 6% at CER to DKK
32,928 million. The increase in costs is driven by North America
Operations reflecting launch activities for
Rybelsus®
and continued promotional activities for Ozempic®,
partly offset by lower promotional spend related to insulin. In
International Operations, promotional spend is related to launch
activities for Ozempic®
and Rybelsus®
as well as the continued roll-out of Saxenda®.
COVID-19 resulted in a reduction of the activity level and delay of
promotional activities.
Research and development costs
increased by 9% measured in Danish kroner and by 10% at CER to DKK
15,462 million. The cost increase is driven by the amortisation of
the priority review voucher for semaglutide 2.4 mg in obesity in
the third quarter of 2020. Increased activities within Other
serious chronic diseases are driving the cost increase following
progression of the early pipeline within cardiovascular disease and
stem cell projects as well as patient recruitment to the ongoing
cardiovascular outcomes trials, SOUL and SELECT.
Administration costs
decreased by 1% measured in Danish kroner and increased by 1% at
CER to DKK 3,958 million, reflecting broadly unchanged spend across
administrative areas.
Other operating income (net)
was DKK 460 million compared with DKK 600 million in 2019 following
reduced royalty income.
Operating profit
increased by 3% measured in Danish kroner and by 7% at CER to DKK
54,126 million.
FINANCIAL ITEMS (NET) AND TAX
Financial
items (net)
showed a net loss of DKK 996 million compared with a net loss of
DKK 3,930 million in 2019.
In line with Novo Nordisk’s treasury policy, the most significant
foreign exchange risks for Novo Nordisk have been hedged, primarily
through foreign exchange forward contracts. The foreign exchange
result was a net loss of DKK 747 million compared with a net loss
of DKK 3,212 million in 2019. This reflects losses on non-hedged
currencies driven by significant depreciations of several emerging
market currencies, partially offset by gains on hedged
currencies.
As per the end of December 2020, a positive market value of
financial contracts of approximately DKK 1.8 billion has been
deferred for recognition in 2021.
The
effective tax rate
is 20.7% in 2020 compared with an effective tax rate of 19.8% in
2019. In 2019, a tax reform was passed in Switzerland which had
positive impact on the effective tax rate, driven by a
non-recurring increase to deferred tax assets.
CAPITAL EXPENDITURE AND FREE CASH FLOW
Capital expenditure for property, plant and equipment was DKK 5.8
billion compared with DKK 8.9 billion in 2019. The lower capital
expenditure was mainly related to lower investments in the new
production facility for diabetes active pharmaceutical ingredients
in Clayton, North Carolina, US, which is now in the final stages of
construction.
Free cash flow of DKK 28.6 billion compared with DKK 34.5 billion
in 2019. The decrease is reflecting purchase of intangible assets
of DKK 16.3 billion, primarily related to the acquisitions of
Corvidia Therapeutics Inc. and Emisphere Technologies
Inc.
Novo Nordisk’s financial reserves were DKK 28.8 billion by end of
December 2020 comprising cash at bank and undrawn credit facilities
less overdrafts and loans repayable within 12 months.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 13 of 36
|
KEY DEVELOPMENTS IN THE FOURTH QUARTER OF 2020
Sales in the fourth quarter of 2020 decreased by 1% measured in
Danish kroner and increased by 5% at CER compared to the same
period in 2019. Operating profit decreased by 6% measured in Danish
kroner and increased by 5% at CER.
The results in Danish kroner were negatively impacted by the
depreciation of the US dollar versus the Danish krone by
5%.
Please refer to appendix 1 for an overview of the quarterly numbers
in DKK and to appendix 6 for additional details on sales in the
fourth quarter of 2020.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales split per geographical area |
Sales Q4 2020
DKK million |
Growth
as reported |
Growth
at CER |
Share of growth
at CER |
|
|
|
|
|
|
|
|
|
|
International Operations |
15,430 |
|
1 |
% |
6 |
% |
54 |
% |
|
- EMEA |
8,138 |
|
(1 |
%) |
3 |
% |
16 |
% |
|
- Region China |
3,248 |
|
8 |
% |
9 |
% |
16 |
% |
|
- Rest of World |
4,044 |
|
(1 |
%) |
10 |
% |
22 |
% |
North America Operations |
16,708 |
|
(2 |
%) |
5 |
% |
46 |
% |
|
- The US |
15,877 |
|
(2 |
%) |
5 |
% |
42 |
% |
|
|
|
|
|
|
Total sales |
32,138 |
|
(1 |
%) |
5 |
% |
100 |
% |
The increased global sales of 5% (CER) were driven by increased
Diabetes and Obesity care sales as increased GLP-1 sales of 27%
(CER) were partially offset by insulin sales declining by 3% (CER)
and Obesity care sales declining by 3% (CER). Biopharm sales
declined 9% (CER). Sales growth was negatively impacted by COVID-19
as fewer patients initiated treatment, unemployment in the US and
COVID-19-related destocking.
International Operations
Sales in International Operations increased by 1% measured in
Danish kroner and by 6% at CER. Sales growth at CER was driven by
all geographical areas. COVID-19 negatively impacted sales growth
driven by fewer patients initiating treatment.
Furthermore, sales growth was negatively impacted by timing of
NovoSeven®
shipments.
Sales growth was driven by Diabetes
care growing by 8% (CER)
driven by increased insulin sales growing by 6%
(CER),
GLP-1 sales growing by 18% (CER) and Obesity care increasing by 21%
(CER). Biopharm sales decreased by 3% (CER) driven by lower
haemophilia sales, reflecting timing of shipments, partially offset
by increased Norditropin®
sales.
North America Operations
Sales in North America Operations decreased by 2% measured in
Danish kroner and increased by 5% at CER. Sales growth was
negatively impacted by COVID-19 as fewer patients initiated
treatment and unemployment increased,
offset by rebate adjustments.
Sales growth was driven by GLP-1 growing by 30% (CER) reflecting
the prescription volume growth, the uptake of
Ozempic®
and the launch of Rybelsus®.
Insulin sales
decreased by 16% (CER) driven by lower realised prices. Obesity
care sales decreased by 13% (CER) reflecting fewer patients
initiating treatment
due to COVID-19 and lower realised prices. Biopharm sales decreased
by 16% (CER) driven by lower Norditropin®
sales, negatively impacted by rebate adjustments.
Costs and operating profit
The gross margin
was 82.5% in the fourth quarter of 2020 compared with 83.2% in the
same period last year. The decline of 0.7 percentage point of the
gross margin reflects positive product mix and productivity,
countered by a negative impact from lower realised prices in the US
and a negative currency impact of 1.3% percentage
points.
Sales and distribution costs
increased by 2% measured in Danish kroner and by 9% at CER compared
with the same period in 2019. The increase was driven by North
America Operations reflecting the launch of
Rybelsus®
and promotional activities related to Ozempic®.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 14 of 36
|
Research and development costs
increased by 2% measured in Danish kroner and by 6% at CER compared
with the same period in 2019. The cost increase is driven by
increased clinical trial activity and patient recruitment to the
ongoing cardiovascular outcome trials, SOUL and SELECT, partly
offset by lower costs following the conclusion of the semaglutide
obesity pivotal phase 3a programme, STEP.
Administrative costs
decreased by 3% measured in Danish kroner and increased by 1% at
CER compared with the same period in 2019.
Other operating income (net)
of DKK 106 million in the fourth quarter of 2020 compared with DKK
43 million in the same period last year reflecting increased
royalty income.
Operating profit
decreased by 6% measured in Danish kroner and increased by 5% at
CER compared with the same period in 2019.
Fnancial items (net)
showed a net gain of DKK 824 million compared with a net loss of
DKK 794 million in the fourth quarter of 2019, mainly reflecting
gains associated with foreign exchange hedging contracts, primarily
related to the US dollar versus the Danish krone.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 15 of 36
|
EQUITY AND CAPITAL ALLOCATION
Total equity was DKK 63,325 million at the end of 2020, equivalent
to 43.7% of total assets, compared with 45.8% at the end of 2019.
Please refer to appendix 5 for further elaboration of changes in
equity.
2020 share repurchase programme
On 3 November 2020, Novo Nordisk announced a share repurchase
programme of up to DKK 2.7 billion to be executed from 4 November
2020 to 1 February 2021, as part of an overall programme of up to
DKK 17 billion to be executed during a 12-month period beginning 5
February 2020. The purpose of the programme was to reduce the
company’s share capital and to meet obligations arising from
share-based incentive programmes. Under the programme, Novo Nordisk
has repurchased 6,368,649 B shares for an amount of DKK 2.7 billion
in the period from 4 November 2020 to 1 February 2021. The
programme was concluded on 1 February 2021.
As of 1 February 2021, Novo Nordisk A/S has repurchased a total of
39,954,171 B shares equal to a transaction value of DKK 17.0
billion under the DKK 17 billion programme beginning 5 February
2020.
As of 1 February 2021, Novo Nordisk and its wholly-owned affiliates
owned 39,892,308 of its own B shares, corresponding to 1.7% of the
total share capital.
Proposed final dividend of DKK 5.85 for each Novo Nordisk A and B
share of DKK 0.20
At the Annual General Meeting on 25 March 2021, the Board of
Directors will propose a final dividend of DKK 5.85
for each Novo Nordisk A and B share of DKK 0.20. The total dividend
for 2020 of DKK 9.10 for each Novo Nordisk A
and B share of DKK 0.20 includes both the interim dividend of DKK
3.25 for each Novo Nordisk A and B share of
DKK 0.20, which was paid in August 2020, and the proposed final
dividend of DKK 5.85 for each Novo Nordisk A
and B share of DKK 0.20 to be paid in March 2021. Hence, the total
dividend is expected to increase by 9.0%
compared with the 2019 dividend of DKK 8.35 for each Novo Nordisk A
and B share of DKK 0.20. The total dividend
for 2020 corresponds to a payout ratio of 50.0%, which is similar
to the payout ratio for Novo Nordisk’s peer group
of comparable pharmaceutical companies in 2019. No dividend will be
paid on the company’s holding of own B
shares.
2021 share repurchase programme
The Board of Directors has approved a new share repurchase
programme of up to DKK 17 billion to be executed
during the coming 12 months. The total programme may be reduced in
size, in case of significant business development transactions
during 2021
As part of the up to DKK 17 billion 2021 share repurchase
programme, Novo Nordisk A/S will initiate a new share
repurchase programme for an amount of up to DKK 3.0 billion in
accordance with Article 5 of Regulation No
596/2014 of the European Parliament and Council of 16 April 2014
(MAR) and the Commission Delegated
Regulation (EU) 2016/1052 of 8 March 2016 (the 'Safe Harbour
Rules'). For that purpose, Novo Nordisk A/S has
appointed Skandinaviska Enskilda Banken, Danmark, filial af
Skandinaviska Enskilda Banken AB (SEB), as lead manager to execute
the programme independently and without influence from Novo Nordisk
A/S. The purpose of the programme is to reduce the company’s share
capital and to meet obligations arising from share-based incentive
programmes. Under the agreement, SEB will repurchase B shares on
behalf of Novo Nordisk A/S during the trading period starting
today, 3 February 2021, and ending on 3 May 2021.
A maximum of 190,000,000 B shares in total can be bought during the
trading period. The maximum number of B
shares that can be repurchased on a single trading day may not
exceed 20% of the average daily trading volume of
Novo Nordisk B shares on the trading venue, on which the purchase
takes place, during the preceding 20 trading
days of the purchase (excluding the day of the purchase), cf
Article 3(3) of the Commission Delegated Regulation
(EU) 2016/1052. At least once every seven trading days, Novo
Nordisk A/S will issue an announcement in respect of
the transactions made under the repurchase programme.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 16 of 36
|
Novo Nordisk’s majority shareholder Novo Holdings 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 year-by-year basis. For 2021, Novo
Nordisk has been informed by Novo Holdings A/S
that it plans to participate in the share repurchase programme.
Novo Holdings A/S has an ownership of 28.1% of
the Novo Nordisk share capital, and Novo Holdings A/S currently
intends to maintain its ownership of the Novo
Nordisk share capital around 28%.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 17 of 36
|
OUTLOOK
OUTLOOK 2021
The current expectations for 2021 are summarised in the table
below:
|
|
|
|
|
|
|
|
|
|
Expectations are as reported, if not otherwise stated |
Expectations
3 February 2021 |
|
|
|
|
Sales growth |
|
at CER |
5% to 9% |
as reported |
Around 4 percentage points lower than at CER |
|
|
|
|
Operating profit growth |
|
at CER |
4% to 8% |
as reported |
Around 6 percentage points lower than at CER |
|
|
|
|
Financial items (net) |
Gain of around DKK 0.7 billion |
|
|
Effective tax rate |
20% to 22% |
|
|
Capital expenditure (PP&E) |
Around DKK
8.0
billion
|
|
|
Depreciation, amortisation and impairment losses |
Around DKK 6 billion |
|
|
Free cash flow |
DKK 36-41 billion |
|
|
|
|
For 2021,
sales growth
is expected to
be 5% to 9% at CER.
The guidance reflects expectations for continued sales growth in
International Operations in line with the strategic aspiration of
6-10% growth as well as growth in North America Operations. The
guidance reflects expectations for sales growth within Diabetes
care, mainly driven by the GLP-1 products
Ozempic®
and Rybelsus®,
as well as growth within Obesity care. Intensifying
competition within both Diabetes care and Biopharm is also
reflected in the guidance. Furthermore, continued pricing pressure
within Diabetes care, especially in the US, is expected to
negatively impact sales development. Given the current exchange
rates versus the Danish krone, growth reported in DKK is expected
to be around
4 percentage points
lower than at CER.
Operating profit growth
is expected to
be 4% to 8%
at CER. The expectation for operating profit growth primarily
reflects the sales growth outlook and continued investments in
current and future growth drivers across the operating units,
including the continued roll-out of Ozempic®
and Rybelsus®
as well as global investments in building an anti-obesity market
and the expected launch of semaglutide 2.4 mg in the US.
Furthermore, resources are allocated to both early and late-stage
pipeline activities, including expected initiations of
several
phase 3a clinical trial programmes in 2021. Given the current
exchange rates versus the Danish krone, growth reported in DKK is
now expected to be around 6 percentage points lower than at CER,
mainly driven by the spot rate of the USD being 615 versus an
average of 654 in 2020.
The current COVID-19 pandemic causes uncertainty to the outlook
regarding the number of patients initiating treatment and societal
impacts such as the
unemployment rate
in the US, which is impacting healthcare insurance coverage. The
outlook is based on a number of assumptions related to the severity
and duration of impacts from COVID-19.
Consequently, volatility in quarterly results should be
expected.
For 2021, Novo Nordisk expects
financial items (net)
to amount to a gain of around DKK 0.7 billion, reflecting the
expected hedging gains of DKK 1.1 billion mainly related to the US
dollar with a hedging period of 11 months and associated hedging
costs.
The
effective tax rate
for 2021 is expected to be in the range
of 20-22%.
Capital expenditure
is expected to be around DKK 8.0 billion in 2021, primarily
relating to investments in additional capacity for active
pharmaceutical ingredient (API) production at existing
manufacturing sites within Diabetes care. The expected increase in
capital expenditure reflects progress of R&D projects based on
the oral technology platform.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 18 of 36
|
Depreciation, amortisation and impairment losses
are expected to be around DKK 6.0 billion. The increase in
depreciation, amortisation and impairment losses in 2021 reflects
depreciation of the new production facility for diabetes active
pharmaceutical ingredients in Clayton, North Carolina, US.
The
free cash flow
is expected to be DKK
36-41
billion. The increase in free cash flow compared to 2020 reflects
the impact from the acquisitions in 2020.
All of the above expectations are based on assumptions that the
global or regional macroeconomic and political environment will not
significantly change business conditions for Novo Nordisk during
2021, including the potential implications from major healthcare
reforms, and that the currency exchange rates, especially the US
dollar, will remain at the current level versus the Danish krone.
Neither does the guidance include the financial implications of
significant business development transactions during the remainder
of 2021.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FX |
Q4 2020 |
Q4 2019 |
% change |
2020 |
2019 |
% change |
Spot rate
28 January 2021 |
|
|
|
|
|
|
|
|
USD |
625 |
|
675 |
|
(7 |
%) |
654 |
|
667 |
|
(2 |
%) |
615 |
|
CNY |
94 |
|
96 |
|
(2 |
%) |
95 |
|
97 |
|
(2 |
%) |
95 |
|
JPY |
5.98 |
|
6.21 |
|
(4 |
%) |
6.13 |
|
6.12 |
|
— |
% |
5.89 |
|
CAD |
479 |
|
511 |
|
(6 |
%) |
488 |
|
503 |
|
(3 |
%) |
478 |
|
GBP |
824 |
|
868 |
|
(5 |
%) |
839 |
|
852 |
|
(2 |
%) |
839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
Impact on Novo Nordisk's operating profit in the next 12 months of
a 5% movement in currency |
Hedging period (months)1
|
|
|
|
|
|
|
USD |
DKK 1,900 million |
11 |
|
CNY2
|
DKK 460 million |
5 |
JPY |
DKK 200 million |
12 |
CAD |
DKK 140 million |
9 |
GBP |
DKK 110 million |
10 |
|
|
|
|
1)
As of 28 January 2021.
2)
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
Financial items (net).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 19 of 36
|
RESEARCH & DEVELOPMENT UPDATE
Diabetes care
Phase 3b trial with high-dose Ozempic®
successfully completed and label expansion applications submitted
in the EU and the US
On 17 November 2020, Novo Nordisk announced the headline results
from the SUSTAIN FORTE trial. SUSTAIN FORTE was a phase 3b,
efficacy and safety trial with once-weekly semaglutide 2.0 mg vs
once-weekly semaglutide 1.0 mg. The trial was a 40-week study in
961 people with type 2 diabetes in need for treatment
intensification. The trial achieved its primary endpoint by
demonstrating a statistically significant and superior reduction in
HbA1c
at week 40 with semaglutide 2.0 mg compared to semaglutide 1.0 mg.
For more information, please read the company announcement here:
www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=34777
(the
contents of the company’s website do not form a part of this Form
6-K).
On 29 December 2020 and 20 January 2021, respectively, Novo Nordisk
announced the submissions of label extension applications to the
European Medicines Agency (EMA) and the US Food and Drug
Administration (FDA) for Ozempic®
to introduce the 2.0 mg dose. For more information, please read the
company announcements at:
https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=40773
(the contents of the company’s website do not form a part of this
Form 6-K) and
https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=43581
(the contents of the company’s website do not form a part of this
Form 6-K).
Phase 3b trial initiated with higher doses of oral semaglutide in
people with type 2 diabetes
In January 2021, Novo Nordisk initiated a phase 3a trial with
higher doses of oral semaglutide than currently marketed. The
objective of the trial is to assess the safety and efficacy of oral
semaglutide 25 mg and 50 mg once daily versus oral semaglutide 14
mg once daily in people with type 2 diabetes. The 68-week trial is
expected to enrol approximately 1,600 people.
Phase 3a development programme initiated with once-weekly insulin
icodec
In December 2020, Novo Nordisk initiated the first phase 3a trial
ONWARDS 1 for insulin icodec. ONWARDS 1 is a 78-week trial
comparing the efficacy and safety of once-weekly insulin icodec
with once-daily insulin glargine U100 both in combination with
non-insulin anti-diabetic treatment in approximately 970
insulin-naïve people with type 2 diabetes.
ONWARDS 1 is the first of six trials from the ONWARDS programme.
The remaining five trials ONWARDS 2-6 are planned to be initiated
in 2021.
ONWARDS 2 is a 26-week trial comparing once-weekly insulin icodec
with once-daily insulin degludec. The objective of the trial is to
assess the efficacy and safety of insulin icodec in people with
type 2 diabetes treated with basal insulin. The trial is expected
to enrol approximately 520 people.
ONWARDS 3 is a 26-week trial comparing once-weekly insulin icodec
with once-daily insulin degludec. The objective of the trial is to
assess the efficacy and safety of insulin icodec in insulin-naïve
people with type 2 diabetes. The trial is expected to enrol
approximately 580 people.
ONWARDS 4 is a 26-week trial comparing once-weekly insulin icodec
with once-daily insulin degludec, both in combination with mealtime
insulin. The objective of the trial is to assess the efficacy and
safety of insulin icodec in people with type 2 diabetes treated
with basal and bolus insulin. The trial is expected to enrol
approximately 580 people.
ONWARDS 5 is a 26-week trial comparing once-weekly insulin icodec
with once-daily basal insulin. The objective of the trial is to
assess the effectiveness and safety of insulin icodec, with an app
providing dosing recommendation, in insulin-naïve people with type
2 diabetes in a clinical practice setting. The trial is expected to
enrol approximately 1,100 people.
ONWARDS 6 is a 52-week trial comparing once-weekly insulin icodec
with once-daily insulin degludec, both in combination with mealtime
insulin. The objective of the trial is to assess the efficacy and
safety of insulin icodec in people with type 1 diabetes. The trial
is expected to enrol approximately 580 people.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 20 of 36
|
Phase 1 trial initiated with Ideal Pump insulin (Insulin
119)
In November 2020, Novo Nordisk initiated the first human dose trial
with Insulin 119. The trial is investigating safety, tolerability,
pharmacokinetics and pharmacodynamics of Insulin 119 compared to
faster-acting insulin aspart in people with type 1
diabetes.
Phase 1 trial initiated with DNA immunotherapy
In December 2020, Novo Nordisk initiated the first human dose trial
with tolerogenic DNA plasmid, a plasmid vector designed to transfer
DNA into cells, where it can re-educate the immune system to halt
the attack on insulin-producing beta cells. The objective of the
trial is to investigate the safety, tolerability, target engagement
and pharmacokinetics of the DNA plasmid administered subcutaneously
once weekly in people diagnosed with type 1 diabetes in the past 48
months.
Obesity care
Submissions of semaglutide 2.4 mg in the US and the EU
On 4 and 18 December, Novo Nordisk submitted regulatory
applications for semaglutide 2.4 mg in obesity to the US FDA and
EMA, respectively. In the US, a priority review voucher was applied
to the new drug application (NDA) and the anticipated review time
is six months from the submission date, according to standard FDA
timelines. The submissions are based on the results from the STEP
phase 3a clinical trial programme, which included more than 4,500
adults with obesity or overweight. For more information, please
read the company announcements
https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=37551
(the contents of the company’s website do not form a part of this
Form 6-K) and
https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=39374
(the contents of the company’s website do not form a part of this
Form 6-K).
Biopharm
Sogroya®
approved in Japan and obtained a positive opinion in the EU for
adults with growth hormone deficiency
In January 2021, once-weekly somapacitan was approved in Japan and
obtained positive opinion in the EU under the brand name
Sogroya®
for substitution of endogenous growth hormone in adults with growth
hormone deficiency (AGHD). The approvals are based on results from
the REAL programme where the global pivotal trial enrolled 301
treatment-naïve adults with growth hormone deficiency.
Sogroya®
administered once-weekly demonstrated superiority over placebo on
the primary endpoint, change in truncal fat
percentage.
NovoEight®
approved in China
In January 2021, turoctocog alfa (NovoEight®)
was approved by the China Center of Drug Evaluation for the
treatment of people with haemophilia A. The approval is based on
the results from the Guardian 7 trial in Chinese people with
haemophilia A. Novo Nordisk expects to launch
NovoEight®
in China in the second half of 2021.
Other serious chronic diseases
Semaglutide in NASH phase 2 proof-of-concept trials in combination
with Gilead successfully completed
In September 2020, Novo Nordisk completed the phase 2
proof-of-concept (PoC) trial investigating combinations of
semaglutide and two small molecule inhibitors from Gilead. The PoC
trial investigated safety and tolerability of semaglutide (2.4 mg)
in combination with the acetyl-CoA carboxylase (ACC) inhibitor,
firsocostat, and/or the selective nonsteroidal farnesoid X receptor
(FXR) agonist, cilofexor, in 108 people with NASH. The trial met
its primary endpoint by demonstrating that in people with NASH and
mild to moderate fibrosis all regimens were well tolerated.
Following the completion of the trial, further clinical development
is now being evaluated. For more information abut the study, please
read the press release
https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=34520
(the contents of the company’s website do not form a part of this
Form 6-K).
Decision to initiate phase 3 development in Alzheimer's disease
with oral semaglutide
On 16 December 2020, Novo Nordisk announced the decision to
initiate a pivotal phase 3a programme with oral semaglutide 14 mg
with approximately 3,700 people with Alzheimer’s disease. The
decision follows evaluation of GLP-1 data from preclinical models,
real-world evidence studies, post-hoc analysis of data from large
cardiovascular outcomes trials, as well as discussions with
regulatory authorities. The programme is planned for initiation in
the first half of 2021 and will investigate the efficacy and safety
of once-daily oral semaglutide, compared to placebo. For more
information, please read the company announcement
https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=39097
(the contents of the company’s website do not form a part of this
Form 6-K).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 21 of 36
|
Technology platforms
Acquisition of Emisphere Technologies Inc.
On 6 November 2020, Novo Nordisk announced that it had entered into
a definitive agreement to acquire Emisphere Technologies Inc.
(Emisphere). Novo Nordisk and Emisphere have collaborated since
2007 and Emisphere’s proprietary drug delivery technology
Eligen®
SNAC is used by Novo Nordisk in the oral formulation of oral
semaglutide, which is marketed and sold under the brand name
Rybelsus®.
With the acquisition, Novo Nordisk eliminates future royalty
obligations and obtains full access to the
Eligen®
SNAC technology platform, thereby enabling Novo Nordisk to expand
the portfolio of oral biologic pipeline assets across therapy
areas. The acquisition was completed on 8 December 2020. For more
information, please read the press releases
https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=33374
(the contents of the company’s website do not form a part of this
Form 6-K) and
https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=38064
(the contents of the company’s website do not form a part of this
Form 6-K).
SUSTAINABILITY UPDATE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ENVIRONMENTAL PERFORMANCE |
2020 |
2019 |
2018 |
2017 |
2016 |
% change
2019 to 2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Resources |
|
|
|
|
|
|
|
|
|
|
|
|
|
Energy consumption for operations (1,000 GJ) |
3,191 |
2,993 |
3.099 |
— |
— |
7 |
% |
Share of renewable power for production
sites |
100% |
76% |
77% |
79% |
78% |
|
Water consumption for production sites (1,000 m3)
|
3,368 |
3,149 |
3,101 |
3,276 |
3,293 |
7 |
% |
|
|
|
|
|
|
|
Emissions and waste |
|
|
|
|
|
|
|
|
|
|
|
|
|
CO2
emissions from operations and transportation (1,000
tonnes)
|
170 |
306 |
278 |
— |
— |
(44 |
%) |
Waste from production sites (1,000 tonnes) |
141 |
124 |
142 |
157 |
153 |
14 |
% |
SOCIAL PERFORMANCE |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patients |
|
|
|
|
|
|
Patients reached with Novo Nordisk's Diabetes care products
(estimate in millions) |
32.8 |
30.0 |
29.2 |
27.7 |
28.0 |
9 |
% |
- Hereof reached via the Novo Nordisk Access to Insulin Commitment
(estimate in millions) |
3.2 |
2.9 |
0.3 |
0.3 |
— |
10 |
% |
Children reached through the Changing Diabetes in Children
programme (CDiC) (cumulative) |
28,296 |
25,695 |
22,876 |
17,638 |
14,648 |
10 |
% |
|
|
|
|
|
|
|
Employees |
|
|
|
|
|
|
Employees (FTE) |
44,723 |
42,703 |
42,672 |
42,076 |
41,971 |
5 |
% |
Employee turnover |
7.9% |
11.4% |
11.7% |
11.0% |
9.7% |
|
GOVERNANCE PERFORMANCE |
|
|
|
|
|
|
|
|
|
|
|
|
|
Relevant employees trained in business ethics |
99% |
99% |
99% |
99% |
99% |
|
Product recalls |
0 |
4 |
3 |
6 |
6 |
|
Failed inspections |
0 |
0 |
0 |
0 |
0 |
|
Company trust (scale 0-100) |
80.6 |
78.2 |
84.5 |
82.2 |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Environment
Resources
Novo Nordisk's ambition is to have zero environmental impact. The
environmental strategy is called Circular for Zero; progress is
measured on use of resources, emissions and waste.
In 2020, the energy consumption from operations was 3,191,000 GJ,
an increase of 7%, compared with 2019, primarily due to a new
production site in North Carolina, US.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 22 of 36
|
The ambition of sourcing 100% renewable power across global
production was achieved when a new solar facility went online
powering our entire US operations. Furthermore, in September 2020,
Novo Nordisk set a target to ensure all direct suppliers supply the
company based on 100% renewable power by 2030.
Water consumption at production sites was 3,368,000 cubic meters,
an increase of 7% compared with 2019 due to the new production site
in North Carolina. Four production locations are in areas subject
to water stress or high seasonal variations, accounting for 11% of
the total water consumption.
Waste
In 2020, total CO2
emissions across our operations and transportation were 170,000
tonnes of CO2,
representing a 44% decrease from 2019, primarily due to the
implementation of renewable energy projects and impacts on travel
due to COVID-19. Production sites had a total of 141,000 tonnes of
waste, an increase of 14% compared to 2019. This increase was due
to increased production in Kalundborg, Denmark. 93% of waste
arising from the production was recycled, converted to biogas or
incinerated in waste-to-energy plants. During 2020, less than 1%
(1,000 tonnes) of waste was sent to landfill.
Social
Patients
In 2020, Novo Nordisk launched a new social responsibility
strategy, Defeat Diabetes. In 2020, Novo Nordisk provided medical
treatment to an estimated total of 32.8 million people living with
diabetes. An increase of 9% from 2019.
Further, Novo Nordisk strengthened the Access to Insulin Commitment
by lowering the ceiling price (the maximum price within the
commitment) from USD 4 to USD 3 per human insulin vial in 76
countries. This covers Least Developed Countries as defined by the
UN, other low-income countries as defined by the World Bank, and
middle-income countries in which large low-income populations lack
sufficient health coverage, as well as selected humanitarian
organisations. An estimated 3.2 million people were treated with
insulin under this commitment in 2020, of whom approximately
200,000 were reached via humanitarian organisations. Beyond this
commitment, Novo Nordisk sold human insulin at or below the ceiling
price in other countries, reaching an estimated 3.1 million people
during 2020. In addition, approximately 1.1 million people were
reached through affordability offerings in the US in
2020.
Novo Nordisk has an ambition that no child should die from type 1
diabetes. To achieve this, the Changing Diabetes in Children
programme was expanded with the aim of reaching 100,000 children by
2030. By 2020, a total of 28,309 children were reached across 14
countries.
Employees
The number of full-time employees at the end of 2020 increased by
4.7% compared to 12 months ago. The total number of employees was
44,893 corresponding to 44,723 full-time positions. The increase in
employees in Novo Nordisk is mainly driven by International
Operations, Product Supply and IT as well as R&D. The turnover
was 7.9% in 2020 compared with 11.4% in 2019.
Governance
In 2020, 99% of employees completed and documented their Business
Ethics training, with the remaining 1% missing mainly due to
employees being on leave.
Novo Nordisk had no product recalls from the market and no failed
inspections in 2020.
The level of trust in Novo Nordisk among key stakeholders – people
with diabetes, general practitioners and diabetes specialists – is
an indicator of the extent to which Novo Nordisk is living up to
stakeholders’ expectations. The trust score, measured on a scale of
0-100, increased to 80.6 in 2020 from 78.2 in 2019.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 23 of 36
|
CORPORATE GOVERNANCE
Changes in Novo Nordisk management
After a distinguished career of more than 30 years with Novo
Nordisk, hereof 20 years as CSO, Mads Krogsgaard Thomsen will
retire from his current position by end of February 2021 and take
up the position as chief executive officer of the Novo Nordisk
Foundation. Consequently, as of 1 March 2021, Research and
Development will be reorganised into two separate
areas:
•Research
& Early Development, headed up by Marcus Schindler, currently
senior vice president (SVP) of Global Drug Discovery, who is
promoted EVP and CSO
•Development,
headed up by Martin Holst Lange, currently SVP of Global
Development, who is promoted to EVP
Before joining Novo Nordisk in 2018, Marcus Schindler held various
leadership roles in the pharmaceutical industry, working both in
international large pharma and biotech companies including Astra
Zeneca and Boehringer Ingelheim. Marcus is a German national and
received his PhD in pharmacology from the University of Cambridge,
UK, and holds a position as adjunct professor of pharmacology at
the University of Gothenburg, Sweden.
Martin Holst Lange joined Novo Nordisk in 2002 as international
medical officer and has since held various positions of increasing
importance and complexity within Development. From 2006-2008, he
worked as senior medical director at Novo Nordisk Inc in the US. In
2018, Martin was promoted to SVP of Global Development in Novo
Nordisk. Martin is a Danish national and received his PhD in
endocrinology from University of Copenhagen, Denmark.
With these changes, Executive Management will have the following
members as of 1 March 2021:
•Lars
Fruergaard Jørgensen, president and CEO
•Monique
Carter, EVP, People & Organisation
•Maziar
Mike Doustdar, EVP, International Operations (based in Zurich,
Switzerland)
•Ludovic
Helfgott, EVP, Biopharm (based in Zurich, Switzerland)
•Karsten
Munk Knudsen, EVP, chief financial officer
•Doug
Langa, EVP, North America Operations (based in Princeton, New
Jersey, US)
•Martin
Holst Lange, EVP, Development
•Marcus
Schindler, EVP, CSO, Research & Early Development
•Camilla
Sylvest, EVP, Commercial Strategy and Corporate
Affairs
•Henrik
Wulff, EVP, Product Supply, Quality & IT
Only Danish-based members of Executive Management are registered
with the Danish Business Authority
Board of Directors and Executive management
remuneration
Long-term incentive programme 2021
The Board of Directors has established a long-term incentive
programme for 2021 covering Executive Management and - in line with
previous years - a number of mid to senior managers (in total
approximately 1,200 employees) with a three-year performance period
(2021-2023). The measures are linked to the Strategic Aspirations
2025. Within Purpose & Sustainability measures are linked to
environmental, social and governance activities and within
Innovation & Therapeutic Focus the measures include key R&D
activities. For Commercial Execution, the measure is sales growth
and for Financials the measure is operating profit
growth.
Around 960,000 Novo Nordisk shares may be allocated at target (at
maximum target achievement the number of shares is around
2,500,000), and the value at launch of the programme will be based
on the average share price for Novo Nordisk B shares on Nasdaq
Copenhagen in the 15 days trading window (3 February to 17 February
2021) following the release of the annual report for 2020. It is
currently estimated that the value at target is approximately DKK
400 million.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 24 of 36
|
Remuneration Report 2020
Novo Nordisk has prepared a separate Remuneration Report describing
the remuneration awarded or due during 2020 to the Board members
and Executives as registered with the Danish Business Authority.
The Remuneration Report will be submitted to the Annual General
Meeting for an advisory vote. The Remuneration Report is available
at:
https://www.novonordisk.com/about/corporate-governance/remuneration.html
(the contents of the company’s website do not form a part of this
Form 6-K).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 25 of 36
|
MANAGEMENT STATEMENT
The Board of Directors and Executive Management have approved the
Annual Report 2020 of Novo Nordisk A/S,
including the audited consolidated financial statements. The Board
of Directors and Executive Management have
also approved this financial statement containing condensed
financial information for 2020.
The consolidated financial statements in the Annual Report 2020
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 2020, including the consolidated financial
statements and management review, is prepared in accordance with
additional Danish disclosure requirements for
listed companies and in accordance with the International
Integrated Reporting Framework.
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 2020 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 2020 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 2021
|
|
|
|
|
|
|
|
|
Executive Management: |
|
|
|
|
|
Lars Fruergaard Jørgensen
President and CEO
|
Karsten Munk Knudsen
CFO
|
Monique Carter |
|
|
|
Camilla Sylvest |
Mads Krogsgaard Thomsen |
Henrik Wulff |
|
|
|
|
|
|
Board of Directors: |
|
|
|
|
|
Helge Lund
Chair
|
Jeppe Christiansen
Vice chair
|
Brian Daniels |
|
|
|
Laurence Debroux |
Andreas Fibig |
Sylvie Grégoire |
|
|
|
Liz Hewitt |
Mette Bøjer Jensen |
Kasim Kutay |
|
|
|
Anne Marie Kverneland |
Martin Mackay |
Thomas Rantzau |
|
|
|
Stig Strøbæk |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 26 of 36
|
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in
1923 and headquartered in Denmark. Our purpose is to drive change
to defeat diabetes and other serious chronic diseases such as
obesity and rare blood and endocrine disorders. We do so by
pioneering scientific breakthroughs, expanding access to our
medicines and working to prevent and ultimately cure disease. Novo
Nordisk employs about
45,000
people in 80 countries and markets its products in around 170
countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen
(Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO).
For more information, visit novonordisk.com, Facebook, Twitter,
LinkedIn, YouTube.
|
|
|
|
|
|
Financial calendar |
|
10 February 2021 |
Deadline for shareholder proposals to the Annual General
Meeting |
25 March 2021 |
Annual General Meeting |
5 May 2021 |
Financial statement for the first three months of 2021 |
5 August 2021 |
Financial statement for the first six months of 2021 |
3 November 2021 |
Financial statement for the first nine months of 2021 |
|
|
|
|
|
|
|
|
|
Contacts for further information |
|
Media: |
|
|
Mette Kruse Danielsen |
+45 3079 3883 |
mkd@novonordisk.com |
Michael Bachner (US) |
+1 609 664 7308 |
mzyb@novonordisk.com |
|
|
|
Investors: |
|
|
Daniel Muusmann Bohsen |
+45 3075 2175 |
dabo@novonordisk.com |
Valdemar Borum Svarrer |
+45 3079 0301 |
jvls@novonordisk.com |
Ann Søndermølle Rendbæk |
+45 3075 2253 |
arnd@novonordisk.com |
Mark Joseph Root |
+45 3079 4211 |
mjhr@novonordisk.com |
Kristoffer Due Berg (US) |
+1 609 235 2989 |
krdb@novonordisk.com |
Further information about Novo Nordisk is available on
novonordisk.com.
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 statutory Annual Report 2020 and Form 20-F both
expected to be filed with the SEC in February 2021 in continuation
of the publication of the Annual Report 2020, 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, and
•statements
regarding the assumptions underlying or relating to such
statements.
In this document, examples of forward-looking statements can be
found under the headings ‘Outlook’, ‘Research and Development
update’ and 'Equity’.
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, failure to maintain a
culture of compliance and epidemics, pandemics or other public
health crises.
For an overview of some, but not all, of the risks that could
adversely affect Novo Nordisk’s results or the accuracy of
forward-looking statements in this document, reference is made to
the overview of risk factors in ‘Risk Management’ of the Annual
Report 2020.
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
|
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 27 of 36
|
APPENDIX 1: QUARTERLY NUMBERS IN DKK
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Amounts in DKK million, except number of full-time equivalent
employees, earnings per share and number of shares
outstanding). |
|
|
|
|
|
|
|
|
|
|
|
% change |
|
2020 |
|
2019 |
|
Q4 2020 vs. |
|
Q4 |
Q3 |
Q2 |
Q1 |
|
Q4 |
Q3 |
Q2 |
Q1 |
|
Q4 2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
32,138 |
30,927 |
30,006 |
33,875 |
|
32,417 |
30,277 |
30,036 |
29,291 |
|
(1 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
26,519 |
25,772 |
25,234 |
28,489 |
|
26,985 |
25,202 |
25,187 |
24,559 |
|
(2 |
%) |
Gross margin |
82.5% |
83.3% |
84.1% |
84.1% |
|
83.2% |
83.2% |
83.9% |
83.8% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and distribution costs |
9,766 |
8,174 |
7,398 |
7,590 |
|
9,536 |
7,761 |
7,580 |
6,946 |
|
2 |
% |
Percentage of sales |
30.4% |
26.4% |
24.7% |
22.4% |
|
29.4% |
25.6% |
25.2% |
23.7% |
|
|
Research and development costs |
4,483 |
3,911 |
3,291 |
3,777 |
|
4,384 |
3,601 |
3,557 |
2,678 |
|
2 |
% |
Percentage of sales |
13.9% |
12.6% |
11.0% |
11.1% |
|
13.5% |
11.9% |
11.8% |
9.1% |
|
|
Administrative costs |
1,198 |
1,006 |
827 |
927 |
|
1,235 |
1,009 |
852 |
911 |
|
(3 |
%) |
Percentage of sales |
3.7% |
3.3% |
2.8% |
2.7% |
|
3.8% |
3.3% |
2.8% |
3.1% |
|
|
Other operating income, net |
106 |
127 |
120 |
107 |
|
43 |
88 |
254 |
215 |
|
147 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Operating profit |
11,178 |
12,808 |
13,838 |
16,302 |
|
11,873 |
12,919 |
13,452 |
14,239 |
|
(6 |
%) |
Operating margin |
34.8% |
41.4% |
46.1% |
48.1% |
|
36.6% |
42.7% |
44.8% |
48.6% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income |
1,352 |
162 |
97 |
17 |
|
20 |
17 |
15 |
13 |
|
N/A |
Financial expenses |
528 |
279 |
519 |
1,298 |
|
814 |
829 |
1,322 |
1,030 |
|
(35 |
%) |
Financial items (net) |
824 |
(117) |
(422) |
(1,281) |
|
(794) |
(812) |
(1,307) |
(1,017) |
|
(204 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
Profit before income taxes |
12,002 |
12,691 |
13,416 |
15,021 |
|
11,079 |
12,107 |
12,145 |
13,222 |
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
2,684 |
2,393 |
2,791 |
3,124 |
|
2,362 |
1,913 |
2,550 |
2,777 |
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Net profit |
9,318 |
10,298 |
10,625 |
11,897 |
|
8,717 |
10,194 |
9,595 |
10,445 |
|
7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation, amortisation and
impairment losses |
1,379 |
2,130 |
1,158 |
1,086 |
|
1,398 |
2,095 |
1,110 |
1,058 |
|
(1 |
%) |
Capital expenditure1
|
1,518 |
1,401 |
1,239 |
1,667 |
|
1,907 |
2,234 |
2,147 |
2,644 |
|
(20 |
%) |
Net cash generated from operating activities |
172 |
17,506 |
24,261 |
10,012 |
|
5,165 |
16,688 |
15,039 |
9,890 |
|
(97 |
%) |
Free cash flow |
(12,994) |
11,224 |
22,666 |
7,669 |
|
1,737 |
14,039 |
12,020 |
6,655 |
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
144,922 |
139,947 |
136,121 |
126,256 |
|
125,612 |
124,908 |
117,909 |
110,135 |
|
15 |
% |
Total equity |
63,325 |
59,573 |
60,054 |
54,399 |
|
57,593 |
52,953 |
53,085 |
47,319 |
|
10 |
% |
Equity ratio |
43.7% |
42.6% |
44.1% |
43.1% |
|
45.8% |
42.4% |
45.0% |
43.0% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Full-time equivalent employees end of period |
44,723 |
44,326 |
43,526 |
43,158 |
|
42,703 |
42,158 |
41,611 |
42,453 |
|
5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share/ADR (in DKK) |
4.02 |
4.42 |
4.54 |
5.07 |
|
3.71 |
4.3 |
4.03 |
4.37 |
|
8 |
% |
Diluted earnings per share/ADR (in DKK) |
4.01 |
4.42 |
4.53 |
5.05 |
|
3.70 |
4.29 |
4.03 |
4.36 |
|
8 |
% |
Average number of shares outstanding (million) |
2,318.9 |
2,329.0 |
2,338.8 |
2,348.8 |
|
2,357.9 |
2,368.8 |
2,380.2 |
2,390.3 |
|
(2 |
%) |
Average number of diluted shares |
|
|
|
|
|
|
|
|
|
|
|
outstanding (million) |
2,325.1 |
2,335.1 |
2,344.9 |
2,354.8 |
|
2,363.3 |
2,373.2 |
2,383.5 |
2,394.6 |
|
(2 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
Sales by business segment: |
|
|
|
|
|
|
|
|
|
|
|
Long-acting insulin |
5,013 |
4,048 |
4,220 |
5,158 |
|
5,102 |
5,019 |
5,411 |
5,244 |
|
(2 |
%) |
Premix insulin |
2,705 |
2,572 |
2,693 |
2,955 |
|
2,665 |
2,596 |
2,560 |
2,757 |
|
2 |
% |
Fast-acting insulin |
4,231 |
4,589 |
4,379 |
5,114 |
|
4,936 |
4,632 |
4,758 |
4,977 |
|
(14 |
%) |
Human insulin |
1,678 |
2,194 |
2,314 |
2,687 |
|
2,204 |
2,237 |
2,180 |
2,415 |
|
(24 |
%) |
Total insulin |
13,627 |
13,403 |
13,606 |
15,914 |
|
14,907 |
14,484 |
14,909 |
15,393 |
|
(9 |
%) |
Total GLP-1 |
11,780 |
10,651 |
9,425 |
9,975 |
|
9,842 |
8,492 |
7,740 |
7,147 |
|
20 |
% |
Other Diabetes care |
975 |
954 |
977 |
1,125 |
|
1,017 |
1,038 |
1,125 |
1,067 |
|
(4 |
%) |
Total Diabetes care |
26,382 |
25,008 |
24,008 |
27,014 |
|
25,766 |
24,014 |
23,774 |
23,607 |
|
2 |
% |
Obesity care (Saxenda®)
|
1,385 |
1,338 |
1,308 |
1,577 |
|
1,564 |
1,442 |
1,462 |
1,211 |
|
(11 |
%) |
Diabetes and Obesity care total |
27,767 |
26,346 |
25,316 |
28,591 |
|
27,330 |
25,456 |
25,236 |
24,818 |
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Haemophilia |
2,140 |
2,311 |
2,401 |
2,810 |
|
2,554 |
2,524 |
2,670 |
2,533 |
|
(16 |
%) |
Growth disorders (Norditropin®)
|
1,832 |
1,890 |
1,952 |
2,030 |
|
2,076 |
1,886 |
1,758 |
1,555 |
|
(12 |
%) |
Other Biopharm |
399 |
380 |
337 |
444 |
|
457 |
411 |
372 |
385 |
|
(13 |
%) |
Biopharm total |
4,371 |
4,581 |
4,690 |
5,284 |
|
5,087 |
4,821 |
4,800 |
4,473 |
|
(14 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
Sales by geographic segment: |
|
|
|
|
|
|
|
|
|
|
|
International Operations2
|
15,430 |
15,988 |
16,115 |
18,296 |
|
15,351 |
15,261 |
15,565 |
15,387 |
|
1 |
% |
- EMEA |
8,138 |
8,318 |
8,167 |
9,674 |
|
8,231 |
7,913 |
8,120 |
7,944 |
|
(1 |
%) |
- Region China |
3,248 |
3,549 |
3,474 |
3,813 |
|
3,019 |
3,258 |
3,192 |
3,375 |
|
8 |
% |
- Rest of World |
4,044 |
4,121 |
4,474 |
4,809 |
|
4,101 |
4,090 |
4,253 |
4,068 |
|
(1 |
%) |
North America Operations |
16,708 |
14,939 |
13,891 |
15,579 |
|
17,066 |
15,016 |
14,471 |
13,904 |
|
(2 |
%) |
- The US |
15,877 |
14,144 |
13,028 |
14,775 |
|
16,252 |
14,256 |
13,767 |
13,211 |
|
(2 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
Segment operating profit: |
|
|
|
|
|
|
|
|
|
|
|
Diabetes and Obesity care |
9,106 |
9,748 |
11,434 |
13,456 |
|
9,013 |
10,403 |
11,393 |
11,828 |
|
1 |
% |
Biopharm |
2,072 |
3,060 |
2,404 |
2,846 |
|
2,860 |
2,516 |
2,059 |
2,411 |
|
(28 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
1)
Cash-based capital expenditure (Purchase of property, plant and
equipment).
2)
Comparatives numbers have been restated following the
re-organisation of International Operations in 2020.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
Legal |
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 28 of 36
|
APPENDIX 2: INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE
INCOME
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DKK million |
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income statement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
126,946 |
|
122,021 |
|
|
|
|
Cost of goods sold |
20,932 |
|
20,088 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
106,014 |
|
101,933 |
|
|
|
|
|
|
|
|
|
|
|
|
Sales and distribution costs |
32,928 |
|
31,823 |
|
|
|
|
Research and development costs |
15,462 |
|
14,220 |
|
|
|
|
Administrative costs |
3,958 |
|
4,007 |
|
|
|
|
Other operating income, net |
460 |
|
600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating profit |
54,126 |
|
52,483 |
|
|
|
|
|
|
|
|
|
|
|
|
Financial income |
1,628 |
|
65 |
|
|
|
|
Financial expenses |
2,624 |
|
3,995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit before income taxes |
53,130 |
|
48,553 |
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
10,992 |
|
9,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET PROFIT |
42,138 |
|
38,951 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share (DKK) |
18.05 |
|
16.41 |
|
|
|
|
Diluted earnings per share (DKK) |
18.01 |
|
16.38 |
|
|
|
|
|
|
|
|
|
|
|
|
Segment Information |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment sales: |
|
|
|
|
|
|
|
Diabetes and Obesity care |
108,020 |
|
102,840 |
|
|
|
|
Biopharm |
18,926 |
|
19,181 |
|
|
|
|
|
|
|
|
|
|
|
|
Segment operating profit: |
|
|
|
|
|
|
|
Diabetes and Obesity care |
43,744 |
|
42,637 |
|
|
|
|
Operating margin |
40.5% |
|
41.5% |
|
|
|
|
|
|
|
|
|
|
|
|
Biopharm |
10,382 |
|
9,846 |
|
|
|
|
Operating margin |
54.9% |
|
51.3% |
|
|
|
|
|
|
|
|
|
|
|
|
Total segment operating profit |
54,126 |
|
52,483 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statement of comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net profit for the period |
42,138 |
|
38,951 |
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
|
|
|
Items that will not subsequently be
reclassified to the Income
statement |
|
|
|
|
|
|
|
Remeasurements on defined benefit
plans |
(67) |
|
(187) |
|
|
|
|
|
|
|
|
|
|
|
|
Items that will be reclassified
subsequently to the Income
statement |
|
|
|
|
|
|
|
Exchange rate adjustments of investments in
subsidiaries |
(1,689) |
|
226 |
|
|
|
|
Cash flow hedges, realisation of previously
deferred (gains)/losses |
329 |
|
1,677 |
|
|
|
|
Cash flow hedges, deferred gains/(losses)
incurred during the period |
1,384 |
|
(329) |
|
|
|
|
Other items |
10 |
|
9 |
|
|
|
|
Tax on other comprehensive income,
income/(expense) |
(577) |
|
(231) |
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income for the period, net of
tax |
(610) |
|
1,165 |
|
|
|
|
TOTAL COMPREHENSIVE INCOME FOR THE PERIOD |
41,528 |
|
40,116 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
Legal |
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 29 of 36
|
APPENDIX 3: CASH FLOW STATEMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DKK million |
2020 |
|
2019 |
|
|
|
|
|
|
|
|
Net profit |
42,138 |
|
|
38,951 |
|
|
|
|
|
Adjustment for non-cash items: |
|
|
|
Income taxes in the Income
Statement |
10,992 |
|
|
9,602 |
|
Depreciation, amortisation and impairment
losses |
5,753 |
|
|
5,661 |
|
Other non-cash items |
7,849 |
|
|
7,032 |
|
Change in working capital |
(4,353) |
|
|
(3,388) |
|
Interest received |
100 |
|
|
64 |
|
Interest paid |
(422) |
|
|
(204) |
|
Income taxes paid |
(10,106) |
|
|
(10,936) |
|
|
|
|
|
|
|
|
|
Net cash generated from operating activities |
51,951 |
|
|
46,782 |
|
|
|
|
|
|
|
|
|
Purchase of intangible assets |
(16,256) |
|
|
(2,299) |
|
Proceeds from sale of property, plant and equipment |
7 |
|
|
4 |
|
Purchase of property, plant and equipment |
(5,825) |
|
|
(8,932) |
|
Proceeds from other financial assets |
12 |
|
|
148 |
|
Purchase of other financial assets |
— |
|
|
(350) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment in associated company |
(392) |
|
|
(97) |
|
Proceeds from the divestment of Group and associated
companies |
— |
|
|
(3) |
|
Dividend received from associated company |
18 |
|
|
20 |
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
(22,436) |
|
|
(11,509) |
|
|
|
|
|
|
|
|
|
Purchase of treasury shares |
(16,855) |
|
|
(15,334) |
|
Dividends paid |
(20,121) |
|
|
(19,409) |
|
Repayment of borrowings |
(950) |
|
|
(822) |
|
Proceeds from borrowings |
5,682 |
|
|
81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in financing activities |
(32,244) |
|
|
(35,484) |
|
|
|
|
|
|
|
|
|
NET CASH GENERATED FROM ACTIVITIES |
(2,729) |
|
|
(211) |
|
|
|
|
|
Cash and cash equivalents at the beginning of the year |
15,411 |
|
|
15,629 |
|
|
|
|
|
Exchange gain/(loss) on cash and cash equivalents |
(456) |
|
|
(7) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at the end of the period |
12,226 |
|
|
15,411 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
Legal |
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 30 of 36
|
APPENDIX 4: BALANCE SHEET
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DKK million |
31 Dec 2020 |
|
31 Dec 2019 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Intangible assets |
20,657 |
|
|
5,835 |
|
Property, plant and equipment |
50,269 |
|
|
50,551 |
|
Investments in associated companies |
582 |
|
|
474 |
|
Deferred income tax assets |
5,865 |
|
|
4,121 |
|
Other receivables and prepayments |
674 |
|
|
841 |
|
Other financial assets |
1,066 |
|
|
1,334 |
|
|
|
|
|
|
|
|
|
TOTAL NON-CURRENT ASSETS |
79,113 |
|
|
63,156 |
|
|
|
|
|
Inventories |
18,536 |
|
|
17,641 |
|
Trade receivables |
27,734 |
|
|
24,912 |
|
Tax receivables |
289 |
|
|
806 |
|
Other receivables and prepayments |
4,161 |
|
|
3,434 |
|
Derivative financial instruments |
2,332 |
|
|
188 |
|
Cash at bank |
12,757 |
|
|
15,475 |
|
|
|
|
|
TOTAL CURRENT ASSETS |
65,809 |
|
|
62,456 |
|
TOTAL ASSETS |
144,922 |
|
|
125,612 |
|
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
|
|
|
|
Share capital |
470 |
|
|
480 |
|
Treasury shares |
(8) |
|
|
(10) |
|
Retained earnings |
63,774 |
|
|
57,817 |
|
Other reserves |
(911) |
|
|
(694) |
|
|
|
|
|
|
|
|
|
TOTAL EQUITY |
63,325 |
|
|
57,593 |
|
|
|
|
|
Borrowings |
2,897 |
|
|
3,009 |
|
Deferred income tax liabilities |
2,502 |
|
|
80 |
|
Retirement benefit obligations |
1,399 |
|
|
1,334 |
|
Provisions |
4,526 |
|
|
4,613 |
|
|
|
|
|
|
|
|
|
Total non-current liabilities |
11,324 |
|
|
9,036 |
|
|
|
|
|
Borrowings |
7,459 |
|
|
1,474 |
|
Trade payables |
5,717 |
|
|
6,358 |
|
Tax payables |
3,913 |
|
|
4,212 |
|
Other liabilities |
17,005 |
|
|
15,085 |
|
Derivative financial instruments |
1,365 |
|
|
734 |
|
Provisions |
34,814 |
|
|
31,120 |
|
|
|
|
|
|
|
|
|
Total current liabilities |
70,273 |
|
|
58,983 |
|
|
|
|
|
TOTAL LIABILITIES |
81,597 |
|
|
68,019 |
|
|
|
|
|
TOTAL EQUITY AND LIABILITIES |
144,922 |
|
|
125,612 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
Strategic aspirations |
Financial
Performance |
Equity and capital allocation |
Outlook |
R&D |
Sustainability |
Corporate governance |
Legal |
Financial Information |
|
|
|
|
|
Company announcement No 6 / 2021 |
|
|
|
|
|
|
Financial report for the period 1 January 2020 to 31 December
2020 |
Page 31 of 36
|
APPENDIX 5: EQUITY STATEMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the beginning of the year |
480 |
|
(10) |
|
57,817 |
|
(839) |
|
(329) |
|
474 |
|
(694) |
|
|
57,593 |
|
Net profit |
|
|
42,138 |
|
|
|
|
|
|
42,138 |
|
Other comprehensive income |
|
|
(67) |
|
(1,689) |
|
1,713 |
|
(567) |
|
(543) |
|
|
(610) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
|
42,071 |
|
(1,689) |
|
1,713 |
|
(567) |
|
(543) |
|
|
41,528 |
|
|
|
|
|
|
|
|
|
|
|
Transfer of cash flow hedge reserve to intangible
assets |
|
|
|
|
418 |
|
(92) |
|
326 |
|
|
326 |
|
Transactions with owners: |
|
|
|
|
|
|
|
|
|
Dividends |
|
|
(20,121) |
|
|
|
|
|
|
(20,121) |
|
Share-based payments |
|
|
823 |
|
|
|
|
|
|
823 |
|
Tax related to restricted stock units |
|
|
31 |
|
|
|
|
|
|
31 |
|
Purchase of treasury shares |
|
(8) |
|
(16,847) |
|
|
|
|
|
|
(16,855) |
|
Reduction of the B share capital |
(10) |
|
10 |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the year |
470 |
|
(8) |
|
|