SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
Sales growth in the first
six
months of 2019 of
9%
measured in Danish kroner and
5%
at CER was driven by solid growth across all therapy areas including Diabetes sales growth of
4%
(CER), Obesity sales growth of
56%
(CER) and Biopharmaceuticals sales growth of
3%
(CER).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales split per therapy
|
Sales H1 2019
DKK million
|
|
Sales H1 2018 DKK million
|
|
Growth
as reported
|
|
Growth
at CER
|
|
Share of growth
at CER
|
|
Diabetes and obesity segment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-acting insulin
|
10,655
|
|
10,230
|
|
4
|
%
|
0
|
%
|
0
|
%
|
|
- Tresiba
®
|
4,642
|
|
3,707
|
|
25
|
%
|
19
|
%
|
25
|
%
|
|
- Xultophy
®
|
1,051
|
|
720
|
|
46
|
%
|
42
|
%
|
10
|
%
|
|
- Levemir
®
|
4,962
|
|
5,803
|
|
(14
|
%)
|
(18
|
%)
|
(35
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
Premix insulin
|
5,317
|
|
5,229
|
|
2
|
%
|
1
|
%
|
1
|
%
|
|
- Ryzodeg
®
|
469
|
|
320
|
|
47
|
%
|
45
|
%
|
5
|
%
|
|
- NovoMix
®
|
4,848
|
|
4,909
|
|
(1
|
%)
|
(2
|
%)
|
(4
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
Fast-acting insulin
|
9,735
|
|
9,714
|
|
0
|
%
|
(3
|
%)
|
(10
|
%)
|
|
- Fiasp
®
|
503
|
|
220
|
|
129
|
%
|
122
|
%
|
9
|
%
|
|
- NovoRapid
®
|
9,232
|
|
9,494
|
|
(3
|
%)
|
(6
|
%)
|
(19
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
Human insulin
|
4,595
|
|
4,701
|
|
(2
|
%)
|
(4
|
%)
|
(6
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
Total insulin
|
30,302
|
|
29,874
|
|
1
|
%
|
(1
|
%)
|
(15
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
Victoza
®
|
11,137
|
|
11,718
|
|
(5
|
%)
|
(9
|
%)
|
(38
|
%)
|
Ozempic
®
|
3,750
|
|
264
|
|
-
|
|
-
|
|
112
|
%
|
Total GLP-1
|
14,887
|
|
11,982
|
|
24
|
%
|
18
|
%
|
74
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Other diabetes
1)
|
2,192
|
|
2,132
|
|
3
|
%
|
1
|
%
|
0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Total diabetes
|
47,381
|
|
43,988
|
|
8
|
%
|
4
|
%
|
59
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Obesity (Saxenda
®
)
|
2,673
|
|
1,653
|
|
62
|
%
|
56
|
%
|
32
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes and obesity total
|
50,054
|
|
45,641
|
|
10
|
%
|
6
|
%
|
91
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Biopharmaceuticals segment
|
|
|
|
|
|
Haemophilia
2)
|
5,203
|
|
4,797
|
|
8
|
%
|
5
|
%
|
8
|
%
|
|
- NovoSeven
®
|
4,175
|
|
4,040
|
|
3
|
%
|
(1
|
%)
|
(1
|
%)
|
|
- NovoEight
®
|
762
|
|
635
|
|
20
|
%
|
17
|
%
|
4
|
%
|
Growth disorders (Norditropin
®
)
|
3,313
|
|
3,184
|
|
4
|
%
|
0
|
%
|
0
|
%
|
Other biopharmaceuticals
3)
|
757
|
|
715
|
|
6
|
%
|
5
|
%
|
1
|
%
|
Biopharmaceuticals total
|
9,273
|
|
8,696
|
|
7
|
%
|
3
|
%
|
9
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Total sales
|
59,327
|
|
54,337
|
|
9
|
%
|
5
|
%
|
100
|
%
|
|
|
|
|
|
|
|
1)
Primarily oral antidiabetic products, needles and GlucaGen
®
HypoKit
®
.
|
|
|
|
2)
Comprises NovoSeven
®
, NovoEight
®
, NovoThirteen
®
and Refixia
®
.
|
3)
Primarily Vagifem
®
and Activelle
®
.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
Performance
|
Equity
|
Outlook
|
R&D
|
Sustainability
|
Corporate Governance
|
Legal
|
Financial Information
|
|
|
|
|
|
|
Company announcement No 46 / 2019
|
|
|
|
Financial report for the period 1 January 2019 to 30 June 2019
|
Page
5
of 30
|
DIABETES AND OBESITY
Diabetes, sales development
Sales in Diabetes
increased by 8% measured in Danish kroner and by 4% at CER
to DKK
47,381 million
driven by solid GLP-1 growth, partly offset by declining insulin sales. Novo Nordisk has improved its global diabetes value market share over the last 12 months from 27.5% to 28.3%, driven by improved global insulin market share and growth of the GLP-1 segment, partly offset by declining GLP-1 market share.
In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from May 2019 and May 2018 provided by the independent data provider IQVIA.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes, regional development
|
Novo Nordisk’s share
of the total diabetes market (value, MAT)
|
Diabetes, sales development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May
|
|
May
|
|
Sales H1 2019
DKK million
|
|
Growth
at CER
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Global
|
28.3
|
%
|
27.5
|
%
|
47,381
|
|
4
|
%
|
International Operations
|
21.9
|
%
|
22.2
|
%
|
24,183
|
|
12
|
%
|
|
- Region Europe
|
26.8
|
%
|
26.9
|
%
|
8,750
|
|
8
|
%
|
|
- Region AAMEO *
|
21.6
|
%
|
22.2
|
%
|
5,716
|
|
17
|
%
|
|
- Region China **
|
27.8
|
%
|
29.6
|
%
|
6,397
|
|
12
|
%
|
|
- Region Japan & Korea
|
9.7
|
%
|
10.2
|
%
|
1,825
|
|
2
|
%
|
|
- Region Latin America ***
|
16.7
|
%
|
16.0
|
%
|
1,495
|
|
30
|
%
|
North America Operations
|
30.6
|
%
|
29.6
|
%
|
23,198
|
|
(3
|
%)
|
|
- USA
|
30.9
|
%
|
29.9
|
%
|
22,220
|
|
(4
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
Source: IQVIA, May 2019 data. * Data available for 9 private markets representing approximately 60% of total Novo Nordisk diabetes sales in the region. ** Data for mainland China, excluding Hong Kong and Taiwan. *** Data available for three private markets representing approximately 70% of total Novo Nordisk’s diabetes sales in the region.
Insulin
Sales of insulin
increased by 1% measured in Danish kroner and decreased by 1% at CER
to DKK
30,302
million. Sales decline was driven by declining sales in the USA, partly offset by increased sales in International Operations.
Sales of long-acting insulin
increased by 4% measured in Danish kroner, and remained unchanged at CER,
to DKK
10,655 million
. Novo Nordisk has improved its global volume market share in the long-acting insulin segment from 31.2% to 32.2% in the last 12 months. Sales were driven by Tresiba
®
and Xultophy
®
, partly offset by Levemir
®
. Tresiba
®
has now been launched in 83 countries, while Xultophy
®
has been launched in 32 countries.
Sales of premix insulin
increased by 2% measured in Danish kroner and by 1% at CER
to DKK
5,317 million
. Novo Nordisk is market leader in the segment and has improved its global volume market share in the premix insulin segment from 63.7% to 64.0% in the last 12 months. The increase in sales was driven by Ryzodeg
®
while sales of NovoMix
®
declined. Ryzodeg
®
has now been launched in 27 countries.
Sales of fast-acting insulin
remained unchanged in Danish kroner and decreased by 3% at CER
to DKK
9,735 million
.
Novo Nordisk is market leader in the fast-acting insulin segment with a global volume market share of 51.1%, which has been broadly unchanged over the past 12 months. The decreased sales measured at CER were positively impacted by Fiasp
®
, offset by declining sales of NovoRapid
®
. Fiasp
®
has now been launched in 29 countries.
Sales of human insulin
decreased by 2% measured in Danish kroner and by 4% at CER
to DKK
4,595 million
.
|
|
|
|
|
|
|
|
|
Financial
Performance
|
Equity
|
Outlook
|
R&D
|
Sustainability
|
Corporate Governance
|
Legal
|
Financial Information
|
|
|
|
|
|
|
Company announcement No 46 / 2019
|
|
|
|
Financial report for the period 1 January 2019 to 30 June 2019
|
Page
6
of 30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Insulin, regional development
|
Novo Nordisk’s share
of the total insulin market (volume, MAT)
|
Insulin, sales development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May
|
|
May
|
|
Sales H1 2019
DKK million
|
|
Growth
at CER
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Global
|
46.8
|
%
|
46.5
|
%
|
30,302
|
|
(1
|
%)
|
International Operations
|
49.7
|
%
|
49.5
|
%
|
18,439
|
|
9
|
%
|
|
- Region Europe
|
44.0
|
%
|
44.3
|
%
|
6,195
|
|
3
|
%
|
|
- Region AAMEO *
|
58.9
|
%
|
58.3
|
%
|
4,831
|
|
18
|
%
|
|
- Region China **
|
49.9
|
%
|
51.8
|
%
|
5,076
|
|
11
|
%
|
|
- Region Japan & Korea
|
50.4
|
%
|
50.0
|
%
|
1,266
|
|
(2
|
%)
|
|
- Region Latin America ***
|
49.8
|
%
|
43.2
|
%
|
1,071
|
|
21
|
%
|
North America Operations
|
40.0
|
%
|
39.5
|
%
|
11,863
|
|
(15
|
%)
|
|
- USA
|
40.3
|
%
|
39.9
|
%
|
11,379
|
|
(16
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
Source: IQVIA, May 2019 data. * Data available for 9 private markets representing approximately 60% of total Novo Nordisk diabetes sales in the region. ** Data for mainland China, excluding Hong Kong and Taiwan. *** Data available for three private markets representing approximately 70% of total Novo Nordisk’s diabetes sales in the region.
International Operations
Sales of insulin in International Operations
increased by 10% measured in Danish kroner and by 9% at CER
. Sales growth at CER was driven by long-acting, fast-acting and premix insulin as well as increasing human insulin sales.
Region Europe
Sales of insulin in Region Europe
increased by 3% in both Danish kroner and at CER
. Sales growth was driven by the penetration of Tresiba
®
, Xultophy
®
and Fiasp
®
across the region, partly offset by contracting Levemir
®
sales, reflecting the continued roll-out of Tresiba
®
as well as declining human insulin and NovoMix
®
sales.
Region AAMEO
Sales of insulin in Region AAMEO
increased by 18% in both Danish kroner and at CER
. The sales growth was driven by increased sales in all insulin categories.
Region China
Sales of insulin in Region China
increased by 12% measured in Danish kroner and by 11% at CER
. The sales growth was driven by NovoMix
®
, NovoRapid
®
and Levemir
®
, partly offset by lower human insulin sales.
Region Japan & Korea
Sales of insulin in Region Japan & Korea
increased by 4% measured in Danish kroner and decreased by 2% at CER
. The decline in sales at CER was driven by NovoMix
®
and
NovoRapid
®
, as both products reached the 15-year price protection limit 1 April 2018 in Japan, leading to significant mandatory price reductions as well as lower human insulin sales, partly offset by positive contribution from market share gains for Ryzodeg
®
in both Japan and Korea.
Region Latin America
Sales of insulin in Region Latin America
increased by 15% measured in Danish kroner and by 21% at CER
. The sales growth was driven by growth of the overall diabetes market, market share gains and increased sales of human insulin, Xultophy
®
, NovoRapid
®
and Tresiba
®
.
North America Operations
Sales of insulin in North America Operations
decreased by 9% measured in Danish kroner and by 15% at CER
. The decline in sales in the USA was driven by lower realised prices due to higher rebate rates across the insulin portfolio, the changes in the coverage gap legislation, rebate adjustments related to prior periods as well as inventory reductions in the first quarter of 2019. Novo Nordisk has expanded its volume market share from 39.9% to 40.3% in the last 12 months, and the expansion was driven by continued market share gains in the basal insulin segment.
|
|
|
|
|
|
|
|
|
Financial
Performance
|
Equity
|
Outlook
|
R&D
|
Sustainability
|
Corporate Governance
|
Legal
|
Financial Information
|
|
|
|
|
|
|
Company announcement No 46 / 2019
|
|
|
|
Financial report for the period 1 January 2019 to 30 June 2019
|
Page
7
of 30
|
GLP-1 therapy for type 2 diabetes
Sales of GLP-1 products for type 2 diabetes (Victoza
®
and Ozempic
®
)
increased by 24% measured in Danish kroner and by 18% at CER
to DKK
14,887 million
. Ozempic
®
has now been launched in 21 countries in North America Operations, Region Europe and Region Latin America. Sales growth was driven by both North America Operations and International Operations. The GLP-1 segment’s value share of the total diabetes market has increased to 16.2% compared with 13.0% 12 months ago. Novo Nordisk continues to be the global market leader in the GLP-1 segment with a 46.4% value market share.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GLP-1, regional development
|
Novo Nordisk's share of the diabetes GLP-1 market (value, MAT)*
|
GLP-1, sales development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May
|
|
May
|
|
Sales H1 2019
DKK million
|
|
Growth
at CER
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Global
|
46.4
|
%
|
47.2
|
%
|
14,887
|
|
18
|
%
|
International Operations
|
50.4
|
%
|
53.8
|
%
|
3,952
|
|
28
|
%
|
|
- Region Europe
|
53.1
|
%
|
56.3
|
%
|
2,268
|
|
24
|
%
|
|
- Region AAMEO **
|
38.1
|
%
|
44.5
|
%
|
526
|
|
13
|
%
|
|
- Region China ***
|
91.5
|
%
|
77.8
|
%
|
428
|
|
75
|
%
|
|
- Region Japan & Korea
|
30.6
|
%
|
36.0
|
%
|
334
|
|
11
|
%
|
|
- Region Latin America ****
|
66.4
|
%
|
70.4
|
%
|
396
|
|
66
|
%
|
North America Operations
|
45.7
|
%
|
46.0
|
%
|
10,935
|
|
14
|
%
|
|
- USA
|
45.3
|
%
|
45.6
|
%
|
10,510
|
|
13
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Source: IQVIA, May 2019 data MAT. * Novo Nordisk's GLP-1 diabetes products comprise Victoza
®
and Ozempic
®
** Data for 9 selected private markets representing approximately 60% of Novo Nordisk total diabetes sales in the region. *** Data for mainland China, excluding Hong Kong and Taiwan. **** Data for three selected private markets representing approximately 70% of Novo Nordisk’s total diabetes sales in the region.
International Operations
Sales of GLP-1 in International Operations
increased by 29% measured in Danish kroner and by 28% at CER
. Sales growth is driven by all regions. The value share of the GLP-1 class of the total diabetes market has increased to 8.4% from 7.1% 12 months ago. Novo Nordisk is the market leader with a 50.4% value market share.
Region Europe
Sales in Region Europe
increased by 24% in both Danish kroner and at CER
. The sales development reflects the positive impact from the introduction of Ozempic
®
in 18 countries and the cardiovascular indication for Victoza
®
, partly offset by the impact from a competing once-weekly product. The initial feedback from the launch of Ozempic
®
has been positive and leading to a stabilisation of the market share in launch markets. Novo Nordisk remains the market leader in Region Europe with a 53.1% value market share.
Region AAMEO
Sales in Region AAMEO
increased by 17% measured in Danish kroner and by 13% at CER
. The value share of the GLP-1 class of the total diabetes market remains low and Novo Nordisk is the GLP-1 market leader across Region AAMEO with a value market share of 38.1%.
Region China
Sales in Region China
increased by 77% measured in Danish kroner and by 75% at CER
. The increase in sales reflects
broad market access and continued commercial investments, which have driven the expansion of the GLP-1 class and increased the Victoza
®
GLP-1 value market share to 91.5%. The share of the GLP-1 class of the total diabetes market remains low.
Region Japan & Korea
Sales in Region Japan & Korea
increased by 17% measured in Danish kroner and by 11% at CER
. The sales growth reflects the continued expansion of the GLP-1 market in Japan, partly offset by intensified competition from a once-weekly product. Novo Nordisk currently holds a value market share of 30.6%.
|
|
|
|
|
|
|
|
|
Financial
Performance
|
Equity
|
Outlook
|
R&D
|
Sustainability
|
Corporate Governance
|
Legal
|
Financial Information
|
|
|
|
|
|
|
Company announcement No 46 / 2019
|
|
|
|
Financial report for the period 1 January 2019 to 30 June 2019
|
Page
8
of 30
|
Region Latin America
Sales in Region Latin America
increased by 55% measured in Danish kroner and by 66% at CER
. The sales growth reflects the continued expansion of the GLP-1 markets across the region and the introduction of Ozempic
®
in Brazil. Novo Nordisk remains the market leader in the region with a value market share of 66.4%.
North America Operations
Sales of Novo Nordisk's GLP-1 diabetes products in North America Operations
increased by 23% measured in Danish kroner and by 14% at CER
. Novo Nordisk is the market leader with a 45.7% value market share. The value share of the GLP-1 class of the total North American diabetes market has increased to 19.0%.
Sales growth in the USA is driven by an underlying prescription volume growth of the GLP-1 class of around 30%, primarily driven by the once-weekly GLP-1 products. In February 2018, Novo Nordisk launched Ozempic
®
in the USA and broad formulary coverage has been obtained. The weekly new-to-brand prescription market share for Ozempic
®
has now reached 35% bringing Novo Nordisk's combined GLP-1 new-to-brand prescription market share to 53%, consequently the decline in the Novo Nordisk GLP-1 market share has stabilised measured on monthly prescriptions.
Sales of GLP-1 in the USA increased by
13%
at CER. The increase in sales was driven by continued uptake of Ozempic
®
, partly offset by declining sales of Victoza
®
. The declining sales of Victoza
®
reflects a negative impact from changes in the channel and payer mix and the changes in the coverage gap legislation, impacting average realised prices negatively, as well as inventory reductions in the first quarter of 2019. Rebate adjustments for Victoza
®
related to prior periods were of a similar magnitude in the second quarter of 2019 and the second quarter of 2018, respectively. Furthermore, sales of Victoza
®
were negatively impacted by the launch of Ozempic
®
and a competing once-weekly product.
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Financial
Performance
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Equity
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Outlook
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R&D
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Sustainability
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Corporate Governance
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Legal
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Financial Information
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Company announcement No 46 / 2019
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Financial report for the period 1 January 2019 to 30 June 2019
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Page
9
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Obesity, sales development
Sales of Saxenda
®
increased by 62% measured in Danish kroner and by 56% at CER
to DKK
2,673 million
.
Sales growth of Saxenda
®
was driven by both International Operations and North America Operations. Saxenda
®
has now been launched in 43 countries.
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Obesity, regional development
|
Obesity, sales development
|
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Sales H1 2019
DKK million
|
|
Growth
at CER
|
|
|
|
|
|
|
|
|
|
|
|
Global
|
2,673
|
|
56
|
%
|
International Operations
|
1,097
|
|
121
|
%
|
|
- Region Europe
|
150
|
|
66
|
%
|
|
- Region AAMEO
|
463
|
|
111
|
%
|
|
- Region China
|
4
|
|
—
|
|
|
- Region Japan & Korea
|
151
|
|
—
|
|
|
- Region Latin America
|
329
|
|
92
|
%
|
North America Operations
|
1,576
|
|
28
|
%
|
|
- USA
|
1,458
|
|
29
|
%
|
|
|
|
|
|
|
|
|
International Operations
Sales of Saxenda
®
in International Operations
increased by 119% measured in Danish kroner and by 121% at CER
driven by increased sales in all regions. Novo Nordisk currently has a value market share of 38% in the Obesity market in International Operations.
Region Europe
Sales of Saxenda
®
in Region Europe
increased by 67% measured in Danish kroner and by 66% at CER
. Saxenda
®
has now been launched in 18 countries in Region Europe. Novo Nordisk currently has a value market share of 50% in the obesity market in Region Europe.
Region AAMEO
Sales of Saxenda
®
in Region AAMEO
increased by 116% measured in Danish kroner and by 111% at CER
. Saxenda
®
has now been launched in 16 countries in Region AAMEO. Novo Nordisk currently has a value market share of 35% in the obesity market in Region AAMEO.
Region Japan & Korea
Sales of Saxenda
®
in Region Japan & Korea were driven by Korea following the launch in early 2018.
Region Latin America
Sales of Saxenda
®
in Region Latin America
increased by 81% measured in Danish kroner and by 92% at CER
. Saxenda
®
has now been launched in 5 countries in Region Latin America. Novo Nordisk currently has a value market share of 34% in the obesity market in Region Latin America.
North America Operations
Sales of Saxenda
®
in North America Operations
increased by 37% measured in Danish kroner and by 28% at CER
and were driven by increased sales in both the USA and Canada. Sales in the USA were
negatively impacted by inventory reductions.
Novo Nordisk currently has a value market share of 68% in the obesity market in North America Operations.
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Financial
Performance
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Equity
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Outlook
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R&D
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Sustainability
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Corporate Governance
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Legal
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Financial Information
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Company announcement No 46 / 2019
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Financial report for the period 1 January 2019 to 30 June 2019
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Page
10
of 30
|
BIOPHARMACEUTICALS
Biopharmaceuticals, sales development
Sales of biopharmaceutical products
increased by 7% measured in Danish kroner and by 3% at CER
to DKK
9,273 million
. The sales development was driven by sales growth in Region AAMEO, Region Latin America, Region China and Region Japan & Korea partly offset by declining sales in the USA as well as Region Europe.
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Biopharmaceuticals, regional development
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Biopharmaceuticals, sales development
|
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Sales H1 2019
DKK million
|
|
Growth
at CER
|
|
|
|
|
|
|
|
|
|
|
|
Global
|
9,273
|
|
3
|
%
|
International Operations
|
5,672
|
|
5
|
%
|
|
- Region Europe
|
2,467
|
|
(1
|
%)
|
|
- Region AAMEO
|
1,106
|
|
10
|
%
|
|
- Region China
|
166
|
|
45
|
%
|
|
- Region Japan & Korea
|
1,146
|
|
5
|
%
|
|
- Region Latin America
|
787
|
|
15
|
%
|
North America Operations
|
3,601
|
|
0
|
%
|
|
- USA
|
3,300
|
|
(2
|
%)
|
|
|
|
|
|
|
|
|
Haemophilia
Sales of haemophilia products
increased by 8% measured in Danish kroner and by 5% at CER
to DKK
5,203 million
. Increased sales were driven by the continued global rollout of NovoEight
®
and Refixia
®
, partly offset by lower NovoSeven
®
sales. Novo Nordisk continues to expand its broad global haemophilia presence.
Sales of NovoSeven
®
increased by 3% measured in Danish kroner and decreased by 1% at CER
to DKK
4,175 million
, reflecting the solid position of NovoSeven
®
as a haemostatic agent in critical treatment settings in an increasingly competitive environment. The development in sales is driven by declining sales in Region Europe, Region Japan & Korea as well as Region AAMEO, partly offset by increased sales in Region Latin America and North America Operations. NovoSeven
®
sales in the USA were positively impacted by rebate adjustments related to prior periods.
Sales of NovoEight
®
increased by 20% measured in Danish kroner and by 17% at CER
to DKK
762 million
. Sales growth was driven by Region AAMEO and Region Europe. NovoEight
®
has now been launched in 49 countries.
Sales of Refixia
®
increased to DKK
147 million
. Sales growth was driven by the product launches in North America Operations, Region Europe and Region Japan & Korea. Refixia
®
has been launched in 14 countries.
Growth disorders (Norditropin
®
)
Sales of growth disorder products
increased by 4% measured in Danish kroner, and remained unchanged at CER,
to DKK
3,313 million
. The unchanged sales measured at CER were driven by positive contribution from International Operations increasing sales by
5%
at CER, offset by declining sales in North America Operations declining by
7%
at CER impacted by inventory reductions in the first quarter of 2019 in the USA. Sales in the USA were positively impacted by rebate adjustments related to prior periods. Novo Nordisk is the leading company in the global human growth disorder market with a market share measured in value of around 33% and focusing on continued expansion of the presence in the market driven by new indications and the introduction of the next-generation device.
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Financial
Performance
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Equity
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Outlook
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R&D
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Sustainability
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Corporate Governance
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Legal
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Financial Information
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Company announcement No 46 / 2019
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Financial report for the period 1 January 2019 to 30 June 2019
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Page
11
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DEVELOPMENT IN COSTS AND OPERATING PROFIT
The
cost of goods sold
increased
by
12%
measured in both Danish kroner and at CER to DKK
9,581 million
, resulting in a gross margin of
83.9%
measured in Danish kroner, compared with
84.3%
in
2018
.
The decrease in gross margin reflects a negative impact from lower prices in the USA and growth of lower margin insulin products partly countered by a positive currency impact of
0.6
percentage point.
Sales and distribution
costs
increased
by
7%
measured
in Danish kroner and by
4%
at CER to DKK
14,526 million
. The increase in sales and distribution costs was driven by International Operations reflecting resource allocation to growth markets and promotional activities for Victoza
®
and Saxenda
®
as well as launch activities for Ozempic
®
. In the USA, promotional activities are focusing on Ozempic
®
and Saxenda
®
.
Research and development
costs
decreased
by
6%
measured
in Danish kroner and by
7%
at CER to DKK
6,235 million
, reflecting reversal of write-downs on clinical prelaunch inventory in first quarter of 2019 following the filing of oral semaglutide to the US FDA. Adjusted for the reversal of write-downs, research and development costs were broadly unchanged. The development in costs is driven by the completion of the oral semaglutide phase 3a development programme and the completion of the head-to-head study between Tresiba
®
and insulin glargine U300, offset by increasing costs for the semaglutide in obesity clinical programmes STEP and SELECT.
Administration costs
increased
by
3%
measured in Danish kroner and by
2%
at CER to DKK
1,763 million
, reflecting growth across the regions in International Operations.
Other operating income (net)
was DKK
469 million
compared with DKK
737 million
in
2018
. In 2018, Novo Nordisk received milestone payments from partners related to out-licensed clinical assets, and Novo Nordisk recorded a net gain of DKK 122 million following the disposal of 2 million shares in NNIT A/S to Novo Holdings A/S.
Operating profit
increased
by
12%
in Danish kroner and by
6%
at CER to DKK
27,691 million
.
FINANCIAL ITEMS (NET) AND TAX
Financial items (net) showed a net loss of DKK
2,324 million
compared with a net gain of DKK
1,455 million
in
2018
.
In line with Novo Nordisk’s treasury policy, the most significant foreign exchange risks for the Group have been hedged, primarily through foreign exchange forward contracts. The foreign exchange result was a loss of DKK
1,984 million
compared with a gain of DKK
1,495 million
in
2018
. This development reflects a loss on foreign exchange hedging, especially related to the US dollar versus the Danish krone.
As per the end of
June
2019
, a negative market value of financial contracts of approximately DKK
0.6 billion
has been deferred for recognition later in
2019
and
2020
.
The effective tax was 21.0% in the first half of 2019 compared with an effective tax rate of 19.2% in 2018. The higher effective tax rate reflects the non-recurring change in tax provisions related to settlement of international tax cases in 2018.
CAPITAL EXPENDITURE AND FREE CASH FLOW
Net capital expenditure for property, plant and equipment was DKK
4.2 billion
compared with DKK
3.9 billion
in
2018
.
Net capital expenditure was primarily related to investments in a new production facility for diabetes active pharmaceutical ingredients in Clayton, North Carolina, USA, expansion of production facilities in Chartres, France and a new diabetes filling capacity in Hillerød, Denmark.
Free cash flow was DKK
18.7 billion
compared with DKK
20.5 billion
in
2018
. The decrease of
9%
compared with
2018
primarily reflects lower net profit in the first half of 2019, a negative development in working capital, investment in intangible assets reflecting a recent acquisition of a priority review voucher, increased capital expenditure and proceeds from the the partial divestment of NNIT A/S shares in the first quarter of 2018, partly offset by the timing of rebate payments in the USA.
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Financial
Performance
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Equity
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Outlook
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R&D
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Sustainability
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Corporate Governance
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Legal
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Financial Information
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Company announcement No 46 / 2019
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Financial report for the period 1 January 2019 to 30 June 2019
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Page
12
of 30
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KEY DEVELOPMENTS IN THE SECOND QUARTER OF 2019
Please refer to appendix 1 for an overview of the quarterly numbers in DKK and to appendix 6 for details on sales in the second quarter of 2019.
Sales in the second quarter of 2019 increased by
10%
in Danish kroner and by
6%
at CER compared with the same period in 2018. Sales growth in International Operations measured at CER was
12%
and sales remained unchanged measured at CER in North America Operations. The sales
growth was driven by Diabetes derived from increased GLP-1 sales offset by declining insulin sales, as well as increased Obesity and Biopharmaceuticals sales.
The gross margin was
83.9%
in the second quarter of 2019 compared with
84.1%
in the same period last year. The
decline
of
0.2
percentage point of the gross margin reflects a negative impact from lower prices in the USA partly countered by a positive currency impact of
0.5
percentage point.
Sales and distribution costs
increased
by
7%
in Danish kroner and by
5%
at CER compared with the same period in 2018. The
increase in sales and distribution costs was driven by International Operations reflecting resource allocation to growth markets and promotional activities for Saxenda
®
as well as launch activities for Ozempic
®
. In the USA, promotional activities are focusing on Ozempic
®
and Saxenda
®
.
Research and development costs
increased
by
8%
in Danish kroner and by
7%
at CER compared with the same period in 2018.
The development in costs is driven by increasing costs for the semaglutide in obesity clinical programmes STEP and SELECT, partly offset by the completion of the oral semaglutide phase 3a development programme.
Administrative costs remained unchanged both measured in Danish kroner and at CER compared with the same period in 2018.
Other operating income (net) was DKK
254 million
in the second quarter of 2019 compared with DKK
386 million
in the same period last year.
Operating profit
increased
by
10%
in Danish kroner and by
4%
at CER compared with the same period in 2018.
EQUITY
Total equity was DKK
53,085 million
at the end of the first
six
months of
2019
, equivalent to
45.0%
of total assets, compared with
47.5%
at the end of the first
six
months of
2018
. Please refer to appendix 5 for further elaboration of changes in equity.
Interim dividend
The Board of Directors has decided to pay out interim dividend for 2019 of DKK 3.00 for each Novo Nordisk A and B share of DKK 0.20, which will be paid in August 2019. The ex-dividend date for the interim dividend will be 16 August 2019. The record date will be 19 August 2019 for the A and B shares as well as ADRs. The payment date for
the A and B shares will be 20 August 2019, while the payment date for the ADRs will be 27 August 2019. No
dividend will be paid on the company’s holding of B shares.
2019 share repurchase programme
On 7 May 2019, Novo Nordisk announced a share repurchase programme of up to DKK 2.7 billion to be executed from 8 May to 7 August 2019, as part of an overall programme of up to DKK 15 billion to be executed during a 12-month period from February 2019 to January 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 8,224,508 B shares for an amount of DKK 2.7 billion in the period from 8 May to 7 August 2019. The programme was concluded on 7 August 2019. As of 7 August 2019, Novo Nordisk A/S has repurchased a total of 23,401,012 B shares equal to a transaction value of DKK 7.635 billion under the DKK 15 billion programme beginning 1 February 2019.
As of 7 August 2019, Novo Nordisk and its wholly-owned affiliates owned 30,568,156 of its own B shares, corresponding to 1.3% of the total share capital.
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Financial
Performance
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Equity
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Outlook
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R&D
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Sustainability
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Corporate Governance
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Legal
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Financial Information
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Company announcement No 46 / 2019
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Financial report for the period 1 January 2019 to 30 June 2019
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Page
13
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|
The execution of Novo Nordisk’s 2019 share repurchase programme of DKK 15 billion to be executed during a 12-month period from February 2019 to January 2020 continues, and a new share repurchase programme will be initiated 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 Nordea Danmark, Filial af Nordea Bank Abp, 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, Nordea Danmark, Filial af Nordea Bank Abp, will repurchase B shares on behalf of Novo Nordisk A/S during the trading period starting today, 9 August, and ending on 30 October 2019.
A maximum of 209,431,844 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.
As announced in February 2019, 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 2019, 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 28.3% 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%.
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Financial
Performance
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Equity
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Outlook
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R&D
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Sustainability
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Corporate Governance
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Legal
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Financial Information
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Company announcement No 46 / 2019
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Financial report for the period 1 January 2019 to 30 June 2019
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Page
14
of 30
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OUTLOOK
OUTLOOK 2019
The current expectations for 2019 are summarised in the table below:
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|
Expectations are as reported, if not otherwise stated
|
Expectations
9 August 2019
|
Expectations
3 May 2019
|
|
|
|
|
|
|
Sales growth
|
|
|
at CER
|
4% to 6%
|
2% to 5%
|
as reported
|
Around 3%-points higher than at CER
|
Around 3%-points higher than at CER
|
|
|
|
|
|
|
Operating profit growth
|
|
|
at CER
|
4% to 6%
|
2% to 6%
|
as reported
|
Around 5%-points higher than at CER
|
Around 5%-points higher than at CER
|
|
|
|
|
|
|
Financial items (net)
|
Loss of around DKK 3.5 billion
|
Loss of around DKK 3.3 billion
|
|
|
|
Effective tax rate
|
20% to 22%
|
20% to 22%
|
|
|
|
Capital expenditure (PP&E)
|
Around DKK 9 billion
|
Around DKK 9 billion
|
|
|
|
Depreciation, amortisation and impairment losses
|
Around DKK 4.5 billion
|
Around DKK 4.5 billion
|
|
|
|
Free cash flow
|
DKK 30-34 billion
|
DKK 29-34 billion
|
|
|
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|
|
For 2019,
sales growth
is now expected to be 4% to 6%, measured at CER. This guidance reflects expectations for robust performance for the GLP-1-based diabetes products Victoza
®
and Ozempic
®
and the obesity product Saxenda
®
as well as the portfolio of new-generation insulin. The guidance also reflects intensifying competition both within Diabetes and Biopharmaceuticals, especially within the haemophilia inhibitor segment. Furthermore, continued pricing pressure within Diabetes is expected, especially in the USA. This includes the previously communicated funding of the Medicare Part D coverage gap, which has been changed based on new legislation with effect from 2019, and with an expected negative impact of approximately DKK 2 billion. Given the current exchange rates versus the Danish krone, growth reported in DKK is expected to be around 3 percentage points higher than at CER.
For 2019,
operating profit growth
is now expected to be 4% to 6%, measured at CER. The expectation for operating profit growth primarily reflects the sales growth outlook and continued focus on cost control. Operating profit growth is negatively impacted due to the changes in the funding of the coverage gap. Furthermore, growth in operating profit is positively impacted by the costs for the priority review voucher, which was expensed in fourth quarter of 2018. Given the current exchange rates versus the Danish krone, growth reported in DKK is expected to be around 5 percentage points higher than at CER.
For 2019, Novo Nordisk now expects
financial items (net)
to amount to a loss of around DKK 3.5 billion, offsetting the positive currency impact on operating profit. The current expectation for 2019 primarily reflects losses associated with foreign exchange hedging contracts, mainly related to the US dollar versus the Danish krone.
The effective tax rate for 2019 is expected to be in the range of 20-22%. A potential impact on the effective tax rate from the Swiss tax reform is not included until the legislative process in Canton Zurich has been finalised.
Capital expenditure
is expected to be around DKK 9 billion in 2019, primarily related to investments in additional capacity for active pharmaceutical ingredient production within diabetes and an expansion of the diabetes filling capacity.
Depreciation, amortisation and impairment losses
are expected to be around DKK 4.5 billion. The increased level of depreciation, amortisation and impairment losses in 2019 reflects the inclusion of depreciation of lease assets following the adoption of IFRS 16.
Free cash flow
is now expected to be DKK 30-34 billion.
All of the above expectations are based on assumptions that the global economic and political environment will not significantly change business conditions for Novo Nordisk during 2019, including the potential implications from Brexit, 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 in case of a significant bolt-on acquisition during 2019. Please refer to the table below for the key currency assumptions.
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Financial
Performance
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Equity
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Outlook
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R&D
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Sustainability
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Corporate Governance
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Legal
|
Financial Information
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Company announcement No 46 / 2019
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Financial report for the period 1 January 2019 to 30 June 2019
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Page
15
of 30
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FX
|
Q2 2019
|
|
Q2 2018
|
|
% change
|
|
H1 2019
|
|
H1 2018
|
|
% change
|
|
Spot rate
5 August 2019
|
|
|
|
|
|
|
|
|
|
USD
|
664
|
|
625
|
|
6
|
%
|
661
|
|
615
|
|
7
|
%
|
668
|
|
CNY
|
97
|
|
98
|
|
(1
|
%)
|
97
|
|
97
|
|
1
|
%
|
95
|
|
JPY
|
6.04
|
|
5.73
|
|
5
|
%
|
6.00
|
|
5.66
|
|
6
|
%
|
6.30
|
|
GBP
|
855
|
|
850
|
|
1
|
%
|
855
|
|
846
|
|
1
|
%
|
812
|
|
CAD
|
497
|
|
484
|
|
3
|
%
|
495
|
|
482
|
|
3
|
%
|
505
|
|
|
|
|
|
|
|
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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.
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Key invoicing currencies
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Impact on Novo Nordisk's operating profit in the next 12 months of a 5% immediate movement in currency
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Hedging period (months)
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USD
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DKK 2,100 million
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9
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CNY
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DKK 375 million
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7*
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JPY
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DKK 170 million
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12
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CAD
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DKK 100 million
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9
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GBP
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DKK 80 million
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11
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* 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).
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Financial
Performance
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Outlook
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R&D
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Corporate Governance
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Financial Information
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Company announcement No 46 / 2019
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Financial report for the period 1 January 2019 to 30 June 2019
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Page
16
of 30
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RESEARCH & DEVELOPMENT UPDATE
Diabetes
Oral semaglutide filed for regulatory review in Japan
In July 2019, Novo Nordisk submitted the New Drug Application to the Japanese Authorities (PMDA) for oral semaglutide. The submission is based on the results from PIONEER phase 3a programme with oral semaglutide in adults with type 2 diabetes. In the PIONEER programme, people treated with oral semaglutide demonstrated greater HbA
1c
reductions and weight loss in all completed head-to-head trials versus sitagliptin, empagliflozin, liraglutide and dulaglutide, at the end of the trials. Across the PIONEER trials, oral semaglutide had a safe and well-tolerated profile consistent with the GLP-1 class; the most common adverse event being gastrointestinal-related adverse events reported at, or below, levels previously observed for injectable GLP-1 products.
Label update with paediatric data for Victoza
®
approved in the USA and positive CHMP opinion in EU based on data from the Ellipse trial
In May 2019, the FDA (US Food and Drug Administration) confirmed that six months of paediatric exclusivity had been granted and added to the patents for Victoza
®
listed in the Orange Book, effective 1 May 2019. Furthermore, in June 2019, the FDA approved the use of Victoza
®
, as an adjunct to diet and exercise, to improve glycaemic control in children and adolescents (10 years and above) with type 2 diabetes.
In June 2019, the Committee for Medicinal Products for Human Use (CHMP) recommended that Victoza
®
, as an adjunct to diet and exercise, is indicated for the treatment of children and adolescents (10 years and above) with insufficiently controlled type 2 diabetes. Once CHMP’s recommendation has been endorsed by the European Commission, Novo Nordisk can apply for 6 months of paediatric extension to the Victoza
®
supplementary patent certificate.
Xultophy
®
approved in Japan
In June 2019, Xultophy
®
was approved in Japan for the treatment of people with type 2 diabetes requiring insulin therapy. The approval was based on the results from the two DUAL trials, including more than 1,000 adults from Japan. The approval follows the approval of Victoza
®
1.8 mg in Japan earlier this year.
Ryzodeg
®
approved in China
In May 2019, Ryzodeg
®
was approved in China for the treatment of adults with type 2 diabetes. In September 2018, Ryzodeg
®
was included on the fast-track review list, which accelerated the approval process and Ryzodeg
®
was approved after only 14 months review.
Positive phase 2 results with anti-IL-21 and liraglutide in people with newly diagnosed type 1 diabetes
In May 2019, Novo Nordisk completed the phase 2 trial with the combination of anti-IL-21 and liraglutide. The phase 2 trial was a multinational, randomised, parallel group, placebo-controlled proof of principle trial in people with newly diagnosed type 1 diabetes. The primary objective was to evaluate the preservation of beta cell function after treatment with anti-IL-21 and liraglutide for 54 weeks, followed by a 26 weeks observation period without treatment.
The trial demonstrated statistically significantly better beta cell function for the combination of anti-IL-21 and liraglutide after 54 weeks compared to placebo. Furthermore, there was an improvement in glycaemic parameters and a reduction in use of insulin after 54 weeks of treatment for the combination of anti-IL-21 and liraglutide. At the end of the trial, ie after the 26 weeks observation period without treatment, the beta cell function for people treated with the combination of anti-IL-21 and liraglutide appeared similar to placebo. No safety or tolerability concerns associated with the treatment of the combination of anti-IL-21 and liraglutide were observed during the trial. Novo Nordisk is now engaging with regulatory authorities to evaluate next steps.
Three phase 3b trials initiated with subcutaneous semaglutide
In May 2019, the FOCUS trial was initiated. The objective of the trial is to assess the long-term effects of semaglutide on diabetic retinopathy in people with type 2 diabetes. The trial is expected to enrol 1,500 people from 17 countries. The five-year trial seeks to demonstrate a long-term benefit of semaglutide on eyesight - as assessed by the ETDRS score - driven by superior glucose control.
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Company announcement No 46 / 2019
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Financial report for the period 1 January 2019 to 30 June 2019
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Page
17
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In June 2019, the SUSTAIN FORTE trial was initiated. The objective of the trial is to assess efficacy and safety of semaglutide 2 mg subcutaneous once-weekly compared to semaglutide 1 mg subcutaneous once-weekly in people with type 2 diabetes. The trial is expected to enrol approximately 1,000 people from 10 countries.
In June 2019, the FLOW trial was initiated. The objective of the trial is to assess the effect of semaglutide versus placebo on the progression of renal impairment in people with type 2 diabetes and chronic kidney disease. The trial is expected to enrol more than 3,000 people from 28 countries.
Initiation of SOUL, a cardiovascular outcomes trial with oral semaglutide
In June 2019, the SOUL trial was initiated. SOUL is a dedicated diabetes cardiovascular outcomes trial (CVOT), aiming to confirm oral semaglutide's cardiovascular risk reduction and expand the scientific evidence base about the cardiovascular benefits of semaglutide. The trial is expected to enrol approximately 9,600 people in 34 countries.
Phase 1 trial initiated with FSI965, investigating the safety, tolerability and pharmacokinetics of single doses in healthy male subjects
In June 2019, the first human dose trial for FSI965, a next-generation basal insulin was initiated. The trial is a single-centre, randomised, double-blinded, single-dose, dose-escalation trial. The trial is designed to investigate the safety, tolerability and pharmacokinetics of FSI965.
Obesity
Phase 1 initiated with LA-GDF15
In July 2019, the first human dose trial with LA-GDF15 was initiated including both single and multiple ascending doses. Human GDF15 (Growth Differentiation Factor 15, also known as MIC-1), is a stress-induced cytokine with multiple effects, one being appetite regulation leading to weight loss. LA-GDF15 is a long-acting version of human GDF15.
Biopharmaceuticals
Esperoct
®
(turoctocog alfa pegol, N8-GP) approved in the EU
In June 2019, Novo Nordisk announced that the European Commission has granted marketing authorisation for Esperoct
®
for the treatment of patients 12 years and above with haemophilia A. The authorisation covers all 28 European Union member states. Esperoct
®
is the brand name for turoctocog alfa pegol, N8-GP. Esperoct
®
is indicated for prophylaxis and on-demand treatment of bleeding as well as for surgical procedures for patients 12 years and above with haemophilia A (congenital factor VIII deficiency). The efficacy and safety evaluation was based on the results from the largest pre-registration clinical programme conducted in haemophilia A, with inclusion of 270 previously treated people with severe haemophilia A and more than 5 years of clinical exposure. The marketing authorisation follows the positive opinion from the CHMP, under the European Medicines Agency, provided 26 April 2019.
NovoEight
®
submitted for regulatory approval in China
In July 2019, the Chinese Regulatory Authority accepted the marketing authorisation application for NovoEight
®
, which was submitted in May 2019.
Phase 3 trial (REAL 4) initiated with somapacitan in children with growth hormone deficiency
In May 2019, Novo Nordisk initiated the phase 3 programme (REAL 4) for somapacitan in children with growth hormone deficiency. REAL 4 is a global trial programme and expected to enrol approximately 200 children.
Other Serious Chronic Diseases
Phase 2 initiated with semaglutide in combination with Gilead Science's cilofexor and firsocostat for treatment of NASH
In July 2019, Gilead Sciences and Novo Nordisk initiated a phase 2 proof-of-concept study combining Novo Nordisk's semaglutide (GLP-1 analogue) and Gilead's cilofexor (FXR agonist) and firsocostat (ACC inhibitor) for the treatment of patients with nonalcoholic steatohepatitis (NASH).
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Financial Information
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Company announcement No 46 / 2019
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Financial report for the period 1 January 2019 to 30 June 2019
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Page
18
of 30
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SUSTAINABILITY UPDATE
The number of employees in Novo Nordisk decreased by 3.5%
The number of full-time employees at the end of the first
six
months of
2019
decreased by 3.5% compared to 12 months ago. The total number of employees was 42,154, corresponding to
41,611
full-time positions. This reflects a decline in Research & Development and North America Operations, countered by an increase in the global service centre in Bangalore, India, Product Supply and International Operations.
Novo Nordisk bans single-use plastics globally
As part of the company’s Circular for Zero strategy, Novo Nordisk bans single-use plastics across the global organisation. By the end of 2019, all use of single-use plastic items will be phased out. The initiative covers products made of 100% plastic where sustainable alternatives are available, such as bottles, cups, food packaging, cutlery and straws. Exempted are products used for purposes subject to regulation and laboratory equipment.
CORPORATE GOVERNANCE
Executive Vice President of Business Service & Compliance, Lars Green has decided to resign to take up an executive position outside Novo Nordisk. Monique Carter has been promoted to executive vice president of People & Organisation
In August 2019, Executive Vice President (EVP) of Business Services & Compliance Lars Green decided to resign from his position by the end of August 2019 to take up an executive position outside of Novo Nordisk. Lars Green joined Novo Nordisk in 1992 and he has in the period between 1992 to 2017 taken up several positions across the global finance function. In July 2017, Lars Green was promoted to executive vice president and member of Executive Management in Novo Nordisk.
Following Lars Green’s resignation, Monique Carter has been promoted to EVP of People & Organisation and member of Novo Nordisk’s Executive Management. Monique Carter joined Novo Nordisk in November 2018 as senior vice president for Global People & Organisation. Prior to joining Novo Nordisk, Monique Carter was Group HR director and member of the Executive Committee at GKN plc, UK. Monique Carter worked in the chemicals industry from 2005 to 2014 starting with ICI plc, UK (which later became part of Akzo Nobel, the Netherlands) and held several HR positions in the UK, Singapore and the Netherlands. Monique Carter is a British and Irish national and holds a postgraduate education in Human Resource Management.
With these changes, Executive Management will have the following members:
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•
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Lars Fruergaard Jørgensen, president and CEO
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•
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Monique Carter, EVP, People & Organisation
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•
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Maziar Mike Doustdar, EVP, International Operations (based in Zurich, Switzerland)
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•
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Lars Green, EVP (until the end of August 2019)
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•
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Ludovic Helfgott, EVP, Biopharm (based in Zurich, Switzerland)
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•
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Karsten Munk Knudsen, EVP, chief financial officer
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Doug Langa, EVP, North America Operations (based in Princeton, New Jersey, USA)
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Camilla Sylvest, EVP, Commercial Strategy & Corporate Affairs
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•
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Mads Krogsgaard Thomsen, EVP, chief science officer
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•
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Henrik Wulff, EVP, Product Supply, Quality & IT
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Only Danish-based members of Executive Management are registered with the Danish Business Authority.
Restricted stock units to employees (2019 programme)
To appreciate the efforts of the employees during the latest years, all employees will be offered 75 restricted stock units. A restricted stock unit gives the right to receive one Novo Nordisk B share free of charge in February 2023 subject to continued employment. The DKK 660 million cost of the programme will be amortised over the period 2019-2023 at an annual amount of DKK 189 million.
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Company announcement No 46 / 2019
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Financial report for the period 1 January 2019 to 30 June 2019
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Page
19
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LEGAL MATTERS
Product liability lawsuits related to Victoza
®
Novo Nordisk, along with the majority of incretin-based product manufacturers in the USA, is a defendant in product liability lawsuits related to use of incretin-based medications. As of 5 August 2019, 312 plaintiffs have named Novo Nordisk in product liability lawsuits, predominantly claiming damages for pancreatic cancer that allegedly developed as a result of using Victoza
®
and other GLP-1/DPP-IV incretin-based products. 200 of the Novo Nordisk plaintiffs have also named other defendants in their lawsuits. Most Novo Nordisk plaintiffs have filed suit in California federal and state courts. In November 2015, all pancreatic cancer cases pending in the California federal and state courts were dismissed on federal pre-emption grounds. Plaintiffs subsequently appealed these rulings to the federal and California state appeals courts. In November 2017, the U.S. Court of Appeals for the Ninth Circuit reversed and vacated the Federal District Court Judge’s ruling, thereby reinstating the dismissed federal lawsuits and sending them back to the Federal District Court in California for further proceedings. In November 2018, the California Court of Appeal issued a similar ruling, thus sending the California state court cases back to state trial court for further proceedings. Currently, Novo Nordisk does not have any individual trials scheduled in 2019. Novo Nordisk does not expect the pending claims to have a material impact on its financial position, operating profit or cash flow.
Mylan has filed an Abbreviated New Drug Application for liraglutide with the US FDA
In July 2019, Mylan notified Novo Nordisk that it had filed an Abbreviated New Drug Application (ANDA) for
liraglutide with the US FDA. According to Mylan, the ANDA contains Paragraph IV certifications to obtain approval
to engage in the commercial manufacture, use or sale of liraglutide before the expiration of seven patents currently listed for liraglutide in the Orange Book with expiration dates ranging from July 2021 until March 2033, including the drug substance patent expiring February 2023 (all dates including a six month paediatric extension). Novo Nordisk is currently assessing its legal options, which could lead to litigation against Mylan. Novo Nordisk does not expect the matter to have a material impact on Novo Nordisk’s financial position, operating profit or cash flow.
Subpoena from New York State Attorney General’s office calling for information related to practices for Novo Nordisk’s insulin products
In July 2019, the New York State Attorney General’s office served Novo Nordisk Inc. with a subpoena calling for the production of documents and information relating to pricing and trade practices for Novo Nordisk’s insulin products from 1 July 2013 through the present. Novo Nordisk is cooperating with the New York State Attorney General in this investigation. Novo Nordisk does not expect the investigation to have a material impact on Novo Nordisk’s financial position, operating profit or cash flow.
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Company announcement No 46 / 2019
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Financial report for the period 1 January 2019 to 30 June 2019
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MANAGEMENT STATEMENT
The Board of Directors and Executive Management have reviewed and approved the financial report of Novo Nordisk A/S for the first
six
months of
2019
. The financial report has not been audited or reviewed by the company’s independent auditors.
The financial report for the first
six
months of
2019
has been prepared in accordance with IAS 34 'Interim Financial Reporting’. The accounting policies adopted in the preparation are consistent with those applied in the
Annual Report
2018
of Novo Nordisk, except for the adoption of new, amended or revised standards and interpretations (IFRSs) as published by the IASB that are endorsed by the EU effective as of 1 January
2019
. This includes IFRS 16 'Leases' applied modified retrospectively. Furthermore, the financial report for the first
six
months of
2019
and Management’s Review are prepared in accordance with additional Danish disclosure requirements for interim reports of listed companies.
In our opinion, the accounting policies used are appropriate and the overall presentation of the financial report for the first
six
months of
2019
is adequate. Furthermore, in our opinion, Management’s Review includes a true and fair account of the development in the operations and financial circumstances of the results for the period and of the financial position of the Group as well as a description of the most significant risks and elements of uncertainty facing the Group in accordance with Danish disclosure requirements for listed companies.
Besides what has been disclosed in the quarterly financial report, no changes in the Group’s most significant risks and uncertainties have occurred relative to what was disclosed in the consolidated annual report for
2018
.
Bagsværd, 9 August 2019
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Executive Management:
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Lars Fruergaard Jørgensen
President and CEO
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Karsten Munk Knudsen
CFO
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Lars Green
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Camilla Sylvest
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Mads Krogsgaard Thomsen
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Henrik Wulff
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Board of Directors:
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Helge Lund
Chair
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Jeppe Christiansen
Vice chair
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Brian Daniels
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Laurence Debroux
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Andreas Fibig
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Sylvie Grégoire
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Liz Hewitt
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Mette Bøjer Jensen
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Kasim Kutay
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Anne Marie Kverneland
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Martin Mackay
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Thomas Rantzau
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Stig Strøbæk
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Financial
Performance
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Corporate Governance
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Financial Information
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Company announcement No 46 / 2019
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