|
1) Investment in tangible assets |
2) Full-time equivalent employees in Q1 2014 in NNIT A/S was 2,190 |
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Sales increased by 24% measured in Danish kroner and by 9% in local currencies. North America was the main contributor with 56% share of growth measured in local currencies, followed by International Operations and Region China contributing 20% and 13% respectively. Sales growth was realised within both diabetes care and biopharmaceuticals, with the majority of growth originating from modern insulin and Victoza®.
The diabetes care segment
|
|
Sales Q1 2015
DKK
million
|
|
|
Growth
as reported
|
|
|
Growth
in local
currencies
|
|
|
Share of
growth
in local
currencies
|
|
New-generation insulin 1)
|
|
|
271 |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
10 |
% |
Modern insulin
|
|
|
11,498 |
|
|
|
23 |
% |
|
|
8 |
% |
|
|
39 |
% |
- NovoRapid ®
|
|
|
4,682 |
|
|
|
20 |
% |
|
|
6 |
% |
|
|
12 |
% |
- NovoMix ®
|
|
|
2,744 |
|
|
|
16 |
% |
|
|
3 |
% |
|
|
4 |
% |
- Levemir ®
|
|
|
4,072 |
|
|
|
31 |
% |
|
|
13 |
% |
|
|
23 |
% |
Human insulin
|
|
|
2,897 |
|
|
|
13 |
% |
|
|
0 |
% |
|
|
0 |
% |
Victoza®
|
|
|
3,957 |
|
|
|
36 |
% |
|
|
18 |
% |
|
|
28 |
% |
Other diabetes care
|
|
|
1,195 |
|
|
|
18 |
% |
|
|
6 |
% |
|
|
3 |
% |
Diabetes care total
|
|
|
19,818 |
|
|
|
24 |
% |
|
|
9 |
% |
|
|
80 |
% |
The biopharmaceuticals segment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemophilia
|
|
|
2,734 |
|
|
|
21 |
% |
|
|
6 |
% |
|
|
8 |
% |
- Hereof NovoSeven ®
|
|
|
2,647 |
|
|
|
18 |
% |
|
|
3 |
% |
|
|
4 |
% |
Norditropin®
|
|
|
1,830 |
|
|
|
22 |
% |
|
|
9 |
% |
|
|
7 |
% |
Other biopharmaceuticals
|
|
|
818 |
|
|
|
30 |
% |
|
|
14 |
% |
|
|
5 |
% |
Biopharmaceuticals total
|
|
|
5,382 |
|
|
|
23 |
% |
|
|
8 |
% |
|
|
20 |
% |
Total sales
|
|
|
25,200 |
|
|
|
24 |
% |
|
|
9 |
% |
|
|
100 |
% |
1) Comprises Tresiba®, Ryzodeg® and Xultophy®.
Please refer to appendix 6 for further details on sales in the first quarter of 2015.
In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from February 2015 and February 2014 provided by the independent data provider IMS Health.
Sales of diabetes care products increased by 24% measured in Danish kroner and by 9% in local currencies to DKK 19,818 million. Novo Nordisk is the world leader in diabetes care and now holds a global value market share of 27% compared with 28% at the same time the year before.
Insulin
Sales of insulin increased by 22% measured in Danish kroner and by 8% in local currencies to DKK 14,666 million. Measured in local currencies, sales growth was driven
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Page 6 of 29
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by North America, Region China and International Operations. Novo Nordisk is the global leader with 47% of the total insulin market and 45% of the market for modern insulin and new-generation insulin, both measured in volume.
Sales of new-generation insulin (Tresiba®, Ryzodeg® and Xultophy®) reached DKK 271 million compared with DKK 80 million in 2014.
The roll-out of Tresiba® (insulin degludec), the once-daily new-generation insulin with an ultra-long duration of action, continues and the product has now been launched in 27 countries, most recently in Colombia, Libya, Finland and the United Arab Emirates. In Japan, where Tresiba® was launched in March 2013 with the same level of reimbursement as insulin glargine, its share of the basal insulin market has grown steadily, and Tresiba® has now captured 27% of the basal insulin market measured in monthly value market share. Similarly, Tresiba® has shown solid penetration in other markets with reimbursement at a similar level to insulin glargine, whereas penetration remains modest in markets with restricted market access compared with insulin glargine.
Ryzodeg®, a soluble formulation of insulin degludec and insulin aspart, marketed in Mexico and India, has now also been launched in Bangladesh. Launch activities are progressing as planned and early feedback from patients and prescribers is encouraging.
In January, Switzerland was the first country to launch Xultophy®, a once-daily single- injection combination of insulin degludec (Tresiba®) and liraglutide (Victoza®). The early feedback from patients and prescribers in Switzerland is very encouraging.
Sales of modern insulin increased by 23% in Danish kroner and by 8% in local currencies to DKK 11,498 million. North America accounted for 52% of the growth, followed by International Operations and Region China. Sales of modern insulin and new-generation insulin now constitute 80% of Novo Nordisk’s sales of insulin measured in value.
INSULIN MARKET SHARES
(volume, MAT)
|
|
Novo Nordisk’s share
of total insulin market
|
|
|
Novo Nordisk’s share
of the modern insulin and
new-generation insulin market
|
|
|
|
February
2015
|
|
|
February
2014
|
|
|
February
2015
|
|
|
February
2014
|
|
Global
|
|
|
47 |
% |
|
|
47 |
% |
|
|
45 |
% |
|
|
46 |
% |
USA
|
|
|
36 |
% |
|
|
37 |
% |
|
|
38 |
% |
|
|
38 |
% |
Europe
|
|
|
47 |
% |
|
|
48 |
% |
|
|
47 |
% |
|
|
48 |
% |
International Operations*
|
|
|
55 |
% |
|
|
55 |
% |
|
|
52 |
% |
|
|
53 |
% |
China**
|
|
|
57 |
% |
|
|
58 |
% |
|
|
63 |
% |
|
|
64 |
% |
Japan
|
|
|
52 |
% |
|
|
52 |
% |
|
|
50 |
% |
|
|
48 |
% |
Source: IMS, February 2015 data. *: Data for 13 selected markets representing approximately 70% of Novo Nordisk’s diabetes sales in the region. **: Data for mainland China, excluding Hong Kong and Taiwan.
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North America
Sales of insulin in North America increased by 30% in Danish kroner and by 8% in local currencies. Sales growth is primarily driven by the underlying volume growth of the insulin market and continued market share gains for Levemir®. 59% of Novo Nordisk’s modern insulin volume in the US is used in the prefilled devices FlexPen® and FlexTouch®.
Europe
Sales of insulin in Europe increased by 5% in Danish kroner and by 3% in local currencies. Sales growth is primarily driven by the penetration of Tresiba® and the continued progress of NovoRapid® which are only partly offset by a contracting premix insulin segment and declining human insulin sales. Furthermore, sales are affected by a net negative impact from the implementation of pricing reforms in several European countries. The device penetration in Europe remains high with 96% of Novo Nordisk’s insulin volume being used in devices, primarily NovoPen® and FlexPen®.
International Operations
Sales of insulin in International Operations increased by 25% in Danish kroner and by 17% in local currencies reflecting a significant appreciation of key invoicing currencies, primarily the Saudi Arabian riyal, the Indian rupee and the Turkish lira against the Danish krone compared with the exchange rates in 2014. The growth in local currencies is driven by the two modern insulins NovoRapid® and NovoMix® and positively impacted by sales growth of human insulin and Tresiba®. Currently, 61% of Novo Nordisk’s insulin volume in the major private markets is used in devices.
Region China
Sales of insulin in Region China increased by 29% in Danish kroner and by 9% in local currencies. The sales growth reflects the continued market penetration of the three modern insulins which were partly offset by slightly declining human insulin sales.
Currently, 98% of Novo Nordisk’s insulin volume in China is used in devices, primarily the durable device NovoPen®.
Japan & Korea
Sales of insulin in Japan & Korea decreased by 2% in Danish kroner and by 7% measured in local currencies. The sales development reflects a declining Japanese insulin volume market and the impact of increased wholesaler inventory levels in the first quarter of 2014 due to an increase in the Japanese consumption tax. The negative impact of these factors is partly offset by the strong uptake of Tresiba®. The device penetration in Japan remains high with 98% of Novo Nordisk’s insulin volume being used in devices, primarily FlexPen® and FlexTouch®.
Victoza® (GLP-1 therapy for type 2 diabetes)
Victoza® sales increased by 36% in Danish kroner and by 18% in local currencies to DKK 3,957 million. Sales growth is driven by North America and Europe. The GLP-1 segment’s value share of the total diabetes care market has increased to 7.0% compared with 6.8% in 2014. Victoza® is market leader in the GLP-1 segment with a 71% value market share.
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Financial report for the period 1 January 2015 to 31 March 2015
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Page 8 of 29
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GLP-1 MARKET SHARES
(value, MAT)
|
|
GLP-1 share of total
diabetes care market
|
|
|
Victoza® share
of GLP-1 market
|
|
|
|
February
2015
|
|
|
February
2014
|
|
|
February
2015
|
|
|
February
2014
|
|
Global
|
|
|
7.0 |
% |
|
|
6.8 |
% |
|
|
71 |
% |
|
|
72 |
% |
USA
|
|
|
8.3 |
% |
|
|
8.4 |
% |
|
|
69 |
% |
|
|
69 |
% |
Europe
|
|
|
8.2 |
% |
|
|
7.7 |
% |
|
|
78 |
% |
|
|
78 |
% |
International Operations*
|
|
|
2.3 |
% |
|
|
2.5 |
% |
|
|
75 |
% |
|
|
75 |
% |
China**
|
|
|
0.7 |
% |
|
|
0.6 |
% |
|
|
56 |
% |
|
|
67 |
% |
Japan
|
|
|
2.2 |
% |
|
|
2.0 |
% |
|
|
61 |
% |
|
|
68 |
% |
Source: IMS, February 2015 data. *: Data for 13 selected markets representing approximately 70% of Novo Nordisk’s diabetes sales in the region. **: Data for mainland China, excluding Hong Kong and Taiwan.
North America
Sales of Victoza® in North America increased by 45% in Danish kroner and by 20% in local currencies. Sales growth is driven by the underlying volume growth of the GLP-1 class. The GLP-1 class’ value share of the total diabetes care market is 8.3% and its growth continues to be driven by Victoza®. Victoza® is the market leader with a 69% value market share.
Europe
Sales in Europe increased by 15% in Danish kroner and by 13% in local currencies. Sales growth is primarily driven by Germany and France. In Europe, the GLP-1 class’ share of the total diabetes care market in value has increased to 8.2% from 7.7% in 2014. Victoza® is the GLP-1 market leader with a value market share of 78%.
International Operations
Sales in International Operations increased by 16% in Danish kroner and by 9% in local currencies. Sales growth is primarily driven by a number of countries in the Middle East. The GLP-1 class’ value share of the total diabetes care market is 2.3% and its growth continues to be driven by Victoza®. Victoza® is the GLP-1 market leader across International Operations with a value market share of 75%.
Region China
Sales in Region China increased by 35% in Danish kroner and by 14% in local currencies. In China, the GLP-1 class, which represents 0.7% of the total diabetes care market in value, is generally not reimbursed and relatively modest in size. Victoza® holds a GLP-1 value market share of 56%.
Japan & Korea
Sales in Japan & Korea increased by 47% in Danish kroner and by 39% in local currencies. The sales growth reflects a positive impact of an improved product label in Japan in September 2014. In Japan, the GLP-1 class now represents 2.2% of the total diabetes care market value compared with 2.0% in 2014. Victoza® remains the leader in the class with a value market share of 61%.
Other diabetes care
Sales of other diabetes care, which predominantly consists of oral antidiabetic products and needles, increased by 18% in Danish kroner and by 6% in local currencies to DKK
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1,195 million. Sales growth of NovoNorm® is positively impacted by increased wholesaler stocking in China.
Sales of biopharmaceutical products increased by 23% measured in Danish kroner and by 8% in local currencies to DKK 5,382 million. Sales growth was primarily driven by North America and Europe.
Haemophilia
Sales of haemophilia products increased by 21% in Danish kroner and by 6% in local currencies to DKK 2,734 million. The growth in local currencies was primarily driven by NovoSeven® in North America and International Operations as well as the continued rollout of NovoEight® in Japan and Europe.
Norditropin® (growth hormone therapy)
Sales of Norditropin® increased by 22% in Danish kroner and by 9% in local currencies to DKK 1,830 million. The sales growth is primarily derived from North America and primarily reflects increased demand driven by the prefilled FlexPro® device as well as the support programmes that Novo Nordisk offers healthcare professionals and patients. Novo Nordisk is the leading company in the global growth hormone market with a 32% market share measured in volume.
Other biopharmaceuticals
Sales of other products within biopharmaceuticals, which predominantly consist of hormone replacement therapy-related (HRT) products, increased by 30% in Danish kroner and by 14% in local currencies to DKK 818 million. Sales growth is primarily driven by a positive impact from pricing of Vagifem® in the US.
The cost of goods sold increased by 12% to DKK 3,874 million, resulting in a gross margin of 84.6% compared with 83.0% in 2014. This reflects a positive currency impact of 1.6 percentage points whereas the underlying gross margin was unchanged.
Sales and distribution costs increased by 21% in Danish kroner and by 7% in local currencies to DKK 6,147 million. The increase in costs is driven by costs to prepare the launches of Saxenda® and NovoEight® in the US as well as sales force investments in selected countries in International Operations but also impacted by a reduction in a legal provision in 2014.
Research and development costs increased by 3% in Danish kroner and decreased by 2% in local currencies to DKK 3,250 million. The decline in costs reflects the discontinuation of activities within inflammatory disorders in September 2014 whereas the underlying costs, excluding costs related to inflammatory disorders in the first quarter of 2014, increased by 8%. The increase in underlying costs reflects the progression of the late-stage diabetes care portfolio and is primarily driven by the cardiovascular outcomes trial DEVOTE and the phase 3a programme SUSTAIN® for the once-weekly GLP-1 analogue semaglutide.
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Page 10 of 29
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Administration costs increased by 6% in Danish kroner and were unchanged in local currencies to DKK 854 million.
Other operating income (net) was DKK 2,782 million compared with DKK 215 million in 2014. The increase is driven by the non-recurring income from the initial public offering of NNIT and non-recurring income related to the out-licensing of an asset for inflammatory disorders.
Operating profit increased by 73% in Danish kroner and by 47% in local currencies to DKK 13,857 million. Adjusted for the income related to the partial divestment of NNIT, the growth in operating profit was 17% in local currencies.
Net financials showed a net loss of DKK 1,372 million compared with a net income of DKK 268 million in 2014.
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 1,385 million compared with an income of DKK 237 million in 2014. This development reflects losses on foreign exchange hedging involving especially the US dollar due to its appreciation versus the Danish krone compared with the prevailing exchange rates in 2014. This negative effect is partly offset by gains on commercial balances, primarily related to non-hedged currencies.
Net capital expenditure for property, plant and equipment was DKK 0.8 billion compared with DKK 0.7 billion in 2014. Net capital expenditure was primarily related to investments in additional insulin filling capacity, construction of new research facilities and an expansion of the manufacturing capacity for biopharmaceutical products.
Free cash flow was DKK 5.6 billion compared with DKK 3.3 billion in 2014. The increase of 72% compared with 2014 primarily reflects the non-recurring proceeds from the initial public offering of NNIT.
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Company announcement No 31 / 2015
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Financial report for the period 1 January 2015 to 31 March 2015
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Page 11 of 29
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OUTLOOK 2015
The current expectations for 2015 are summarised in the table below:
Expectations are as reported,
if not otherwise stated
|
|
Current expectations
30 April 2015
|
|
Previous expectations
30 January 2015
|
|
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Sales growth
|
|
|
|
|
in local currencies
|
|
7-9%
|
|
6-9%
|
as reported
|
|
Around 16 percentage points higher
|
|
Around 12 percentage points higher
|
|
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|
|
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|
|
Operating profit growth
|
|
|
|
|
in local currencies
|
|
Around 17%
|
|
Around 10%
|
as reported
|
|
Around 25 percentage points higher
|
|
Around 19 percentage points higher
|
|
|
|
|
|
|
|
|
|
|
Net financials
|
|
Loss of around DKK 6 billion
|
|
Loss of around DKK 5 billion
|
Effective tax rate
|
|
Around 21%
|
|
Around 22%
|
Capital expenditure
|
|
Around DKK 5.0 billion
|
|
Around DKK 5.0 billion
|
Depreciation, amortisation and impairment losses
|
|
Around DKK 3.0 billion
|
|
Around DKK 3.0 billion
|
Free cash flow
|
|
DKK 32-34 billion
|
|
DKK 29-31 billion
|
Sales growth for 2015 is now expected to be 7–9% measured in local currencies. This reflects expectations for continued robust performance for the portfolio of modern insulin, Victoza® and Tresiba® as well as a modest sales contribution from the launches of Saxenda®, Xultophy® and NovoEight®. These sales drivers are expected to be partly countered by an impact from increased rebate levels in the US, intensifying competition within diabetes and biopharmaceuticals as well as macroeconomic conditions in a number of markets in International Operations. Given the current level of exchange rates versus the Danish krone, the reported sales growth is now expected to be around 16 percentage points higher than growth measured in local currencies equivalent to a reported sales growth of 23–25%.
For 2015, operating profit growth is now expected to be around 17% measured in local currencies. The expectations for operating profit growth above the level of sales growth reflect expectations for modest growth in selling, distribution and administration costs as well as declining research and development costs reflecting the 2014 cost impact of the decision to discontinue all activities within inflammatory disorders. The expectation for a higher level of operating profit growth primarily reflects the non- recurring income from the partial divestment of NNIT as well as increased expectations for non-recurring license income. Given the current level of exchange rates versus the Danish krone, the reported operating profit growth is now expected to be around 25 percentage points higher than growth measured in local currencies equivalent to a reported operating profit growth of around 42%.
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Company announcement No 31 / 2015
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Financial report for the period 1 January 2015 to 31 March 2015
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Page 12 of 29
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For 2015, Novo Nordisk expects a net financial loss of around DKK 6 billion. The current expectation primarily reflects losses associated with foreign exchange hedging contracts, particularly following the appreciation of the US dollar versus the Danish krone compared with the average prevailing exchange rates in 2014. As a consequence of these significant hedging losses, the reported pre-tax profit is expected to grow approximately 26%.
The effective tax rate for 2015 is now expected to be around 21% reflecting the non- recurring tax exempt income from the partial divestment of NNIT.
Capital expenditure is expected to be around DKK 5.0 billion in 2015, primarily related to investments in an expansion of the manufacturing capacity for biopharmaceutical products, additional capacity for insulin active pharmaceutical ingredient production, construction of new research facilities and an expansion of the insulin filling capacity. Depreciation, amortisation and impairment losses are expected to be around DKK 3.0 billion. Free cash flow is now expected to be DKK 32– 34 billion which primarily reflects the non-recurring net proceeds from the partial divestment of NNIT.
All of the above expectations are based on the assumption that the global economic environment will not significantly change business conditions for Novo Nordisk during 2015, and that currency exchange rates, especially the US dollar, will remain at the current level versus the Danish krone. Please refer to appendix 7 for key currency assumptions.
Novo Nordisk has hedged expected net cash flows in a number of invoicing currencies and, all other things being equal, movements in key invoicing currencies will impact Novo Nordisk’s operating profit as outlined in the table below.
Key invoicing
Currencies
|
|
Annual impact on Novo Nordisk’s
operating profit of a 5%
movement in currency
|
|
Hedging period
(months)
|
USD
|
|
DKK 1,675 million
|
|
10
|
CNY
|
|
DKK 270 million
|
|
10*
|
JPY
|
|
DKK 115 million
|
|
12
|
GBP
|
|
DKK 80 million
|
|
11
|
CAD
|
|
DKK 60 million
|
|
11
|
* USD used as proxy when hedging Novo Nordisk’s CNY currency exposure
The financial impact from foreign exchange hedging is included in ‘Net financials’.
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Page 13 of 29
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Tresiba® and Ryzodeg® resubmitted to the US FDA and accepted for review
In March 2015, Novo Nordisk announced that the company had decided to submit the prespecified interim analysis of DEVOTE as part of a Class II Resubmission of the New Drug Applications (NDAs) of Tresiba® and Ryzodeg® to the US Food and Drug Administration (FDA). In April 2015, the FDA accepted the resubmission for review.
The cardiovascular outcomes trial for Tresiba® (insulin degludec), DEVOTE, was initiated in October 2013, and the required number of major adverse cardiovascular events (MACE) for the prespecified interim analysis were accumulated by the end of January 2015. To preserve the integrity of the ongoing trial, only a small team within Novo Nordisk has access to the data. This team has prepared the interim analysis for the Class II resubmission and will interact with the FDA during the review on matters related to the interim analysis.
The results of an interim analysis carry a higher level of uncertainty than the final study results as this preliminary estimate is built on a substantially lower number of observations. Accordingly, the relative risk estimate derived from the interim analysis is thus only an indication of the final trial results.
Novo Nordisk management does not have access to the results of the interim analysis. The trial is expected to be completed in the second half of 2016.
Two phase 3a trials comparing faster-acting insulin aspart with NovoRapid® in people with type 1 and type 2 diabetes completed
In March, Novo Nordisk announced headline results from the final phase 3a trials for faster-acting insulin aspart, onset® 1 and onset® 2. The trials investigated the efficacy and safety of faster-acting insulin aspart compared with NovoRapid® (insulin aspart) in a basal-bolus regimen in people with type 1 and type 2 diabetes, respectively.
Both trials achieved their primary objectives by demonstrating that treatment with faster-acting insulin aspart is non-inferior to NovoRapid® with regard to lowering of HbA1c. For people with type 1 diabetes, the HbA1c lowering achieved with faster-acting insulin aspart was statistically significantly larger than that achieved with NovoRapid® when the insulins were given at mealtime. In addition, treatment with faster-acting insulin aspart was associated with less increase of postprandial glucose than NovoRapid® during meal tests in both trials.
In both trials, the previously reported safety and tolerability profiles of faster-acting insulin aspart and NovoRapid® were confirmed, and there were no apparent differences between the two treatment groups with respect to adverse events and other safety parameters.
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Company announcement No 31 / 2015
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Financial report for the period 1 January 2015 to 31 March 2015
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Page 14 of 29
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Novo Nordisk expects to file faster-acting insulin aspart for regulatory review in the US and EU around the turn of the year.
Phase 3b trial shows superior HbA1c improvement with Victoza® compared with lixisenatide in people with type 2 diabetes
In February 2015, Novo Nordisk completed a randomised, open-label phase 3b study investigating the efficacy and safety of once-daily treatment with 1.8 mg of Victoza® or 20 µg lixisenatide as add-on to metformin in 404 people with type 2 diabetes for 26 weeks.
From a mean baseline HbA1c of 8.4%, people treated with Victoza® achieved a statistically significantly larger improvement in HbA1c of 1.8% compared with 1.2% for people treated with lixisenatide. 74% of the people treated with Victoza® achieved the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) HbA1c treatment target of 7% compared with 46% of the people treated with lixisenatide. Furthermore, people treated with Victoza® experienced a statistically significantly greater improvement in fasting plasma glucose compared with people treated with lixisenatide.
From a mean baseline weight around 100 kg, people treated with Victoza® experienced a weight loss of 4.3 kg compared with a weight loss of 3.7 kg for people treated with lixisenatide.
In the trial, the previously reported safety and tolerability profile of Victoza® was confirmed.
Positive results for phase 2 trial with oral semaglutide in people with type 2 diabetes
In February 2015, Novo Nordisk announced that it had successfully completed the phase 2 trial for OG217SC; an oral formulation of the long-acting GLP-1 analogue semaglutide, investigating dose range, escalation, efficacy and safety of once-daily oral semaglutide compared with oral placebo or once-weekly subcutaneously administered semaglutide in around 600 people with type 2 diabetes treated for 26 weeks.
From a mean baseline HbA1c of 7.9%, people treated with oral semaglutide in five different doses ranging from 2.5 mg to 40 mg achieved dose-dependent improvements in HbA1c of 0.7% to 1.9% after 26 weeks. By comparison, people treated with a dose of 1 mg subcutaneous semaglutide or placebo achieved improvements of 1.9% and 0.3% respectively. Confirming the primary end-point of the trial, all doses of oral semaglutide were statistically significantly superior to placebo.
Furthermore, from a mean baseline weight of 92 kg, people treated with subcutaneous semaglutide experienced a weight loss of around 6.5 kg, which was comparable to the weight loss experienced by the people treated with the highest doses of oral semaglutide. People treated with placebo experienced a weight loss of just over 1 kg.
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Company announcement No 31 / 2015
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Financial report for the period 1 January 2015 to 31 March 2015
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Page 15 of 29
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In the trial, semaglutide appeared to have a safe and well-tolerated profile. The most common adverse events were related to the gastrointestinal system, primarily nausea and vomiting, and diminished over time. The gastrointestinal adverse events appeared to be dose-dependent and were more prevalent for the highest doses of oral semaglutide compared with subcutaneous semaglutide. No other apparent differences between the treatment groups were observed with respect to overall adverse events and standard safety parameters.
Based on these results, Novo Nordisk will initiate consultations with regulatory authorities subsequent to which a decision of whether to progress OG217SC into phase 3 development will be made.
Saxenda® approved in Europe for the treatment of obesity
In March 2015, Novo Nordisk announced that the European Commission has granted marketing authorisation for Saxenda® (liraglutide 3 mg) for the treatment of obesity. The authorisation covers all 28 European Union (EU) member states. Saxenda® is the brand name of liraglutide 3 mg, the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity approved in Europe. Saxenda® is indicated in the EU as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of ≥30 kg/m2 (obese), or ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.
Novo Nordisk expects to launch Saxenda® in several European markets starting in 2015.
NovoThirteen® approved in Japan in congenital FXIII A subunit deficiency
26 March 2015, the Japanese Ministry of Health, Labour and Welfare approved NovoThirteen®, a recombinant factor XIII compound. NovoThirteen® is approved for the suppression of bleeding tendency in patients with congenital FXIII A-subunit deficiency. It is the only recombinant treatment for this rare bleeding disorder with which approximately 1,000 people are diagnosed globally.
Number of employees in Novo Nordisk increased 4.5% adjusted for the NNIT divestment The number of full-time equivalent employees at the end of the first quarter of 2015 had decreased by 1.3% to 39,062 compared with 12 months ago reflecting the divestment of NNIT. Adjusted for the impact of the NNIT divestment, the number of employees in Novo Nordisk grew by 4.5% compared with the first quarter of 2014. The growth is driven by expansions in Denmark, primarily in Product Supply, and in India.
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Company announcement No 31 / 2015
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Financial report for the period 1 January 2015 to 31 March 2015
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Page 16 of 29
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Novo Nordisk extends programme for children with diabetes in developing countries
In April 2015, Novo Nordisk announced that the Changing Diabetes® in Children programme has been extended for another three years. The programme was initiated in 2009 to improve delivery of care to children with type 1 diabetes in resource-poor settings.
More than 13,000 children in nine countries in Africa and South-East Asia receive free insulin and access to diabetes care through this programme. 108 diabetes clinics have been established and around 5,500 healthcare professionals have received diabetes care training.
The programme is run as a public-private partnership between Novo Nordisk, Roche, the International Society for Pediatric and Adolescent Diabetes and the World Diabetes Foundation. In each country, local partners work with the national Ministry of Health which helps ensure that the programme is anchored within the existing healthcare system.
Total equity was DKK 32,108 million at the end of the first quarter of 2015, equivalent to 41.5% of total assets, compared with 53.1% at the end of the first quarter of 2014. Please refer to appendix 5 for further elaboration of changes in equity.
Reduction in share capital
At the Annual General Meeting of Novo Nordisk A/S, which was held on 19 March 2015, a 1.89% reduction in the total share capital by cancellation of 50,000,000 treasury B shares of DKK 0.20 at a nominal value of DKK 10,000,000 was approved. After the legal implementation of the share capital reduction on 22 April 2015, Novo Nordisk’s share capital now amounts to DKK 520,000,000 divided into an A share capital of DKK 107,487,200 and a B share capital of DKK 412,512,800.
Initial Public Offering of NNIT A/S completed in March 2015
In March, Novo Nordisk A/S announced that it had completed the Initial Public Offering of NNIT on Nasdaq Copenhagen under the symbol ‘NNIT’ (ISIN DK0060580512). As a consequence, Novo Nordisk A/S has divested 74.5% of NNIT and recorded a non- recurring income of DKK 2.4 billion as 'Other operating income, net' in the income statement for the first quarter of 2015. Please refer to appendix 9 for further elaboration.
2015 share repurchase programme
On 30 January 2015, Novo Nordisk announced a share repurchase programme of up to DKK 3.7 billion to be executed from 30 January to 28 April 2015, as part of an overall 2015 programme of up to DKK 15 billion to be executed during a 12-month period. The purpose of the programme is to reduce the company’s share capital. Under the programme, announced 30 January 2015, Novo Nordisk has repurchased 11,177,904 B
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Company announcement No 31 / 2015
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Financial report for the period 1 January 2015 to 31 March 2015
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Page 17 of 29
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shares for an amount of DKK 3.7 billion in the period from 30 January to 28 April 2015. The programme was concluded on 28 April 2015.
As of 29 April 2015, Novo Nordisk A/S and its wholly-owned affiliates owned 19,816,756 of its own B shares, corresponding to 0.8% of the total share capital.
The 2015 share repurchase programme of up to DKK 15 billion has been expanded by DKK 2.5 billion to DKK 17.5 billion based on the improved outlook for free cash flow generation in 2015 primarily related to the partial divestment of NNIT A/S.
The execution of Novo Nordisk’s 2015 share repurchase programme of up to DKK 17.5 billion to be executed during a 12-month period beginning 30 January 2015 continues, and a new share repurchase programme has been initiated in accordance with the provisions of the European Commission’s regulation No 2273/2003 of 22 December 2003, also referred to as the Safe Harbour rules. For that purpose, Novo Nordisk has appointed Nordea Bank Danmark A/S as lead manager to execute the programme independently and without influence from Novo Nordisk. Under the agreement, Nordea Bank Danmark A/S will repurchase B shares on behalf of Novo Nordisk for an amount of up to DKK 9.3 billion during the trading period starting 30 April 2015 and ending on 27 October 2015. A maximum of 641,815 shares of DKK 0.20 can be bought during one single trading day, equal to 20% of the average daily trading volume of Novo Nordisk B shares on Nasdaq Copenhagen during the month of March 2015. A maximum of 79,585,060 shares of DKK 0.20 in total can be bought in the period from 30 April 2015 to 27 October 2015. At least once every seven trading days, Novo Nordisk will issue an announcement in respect of the transactions made under the repurchase programme.
Novo Nordisk’s majority shareholder Novo A/S, a holding company fully owned by the Novo Nordisk Foundation, has informed Novo Nordisk that it will not participate in the 2015 share repurchase programme.
Changes in Novo Nordisk’s management
As the company is preparing for global launches of several key products, the Board of Directors has decided to elevate the leaders of the commercial activities in the US, Europe and International Operations and of Product Supply to Executive Management. This change will enhance the board’s visibility of Novo Nordisk’s international business operations and support the further development of key leadership talents. The Board of Directors has furthermore decided that CEO Lars Rebien Sørensen should remain in his role until he approaches the end of his contract, which expires in 2019. As a result of the changes, Kåre Schultz, president and COO, has decided to leave Novo Nordisk with immediate effect.
A new Operations Committee will be established with the purpose of aligning and coordinating commercial and production priorities across the company. Lars Rebien Sørensen, CEO, will become chairman of the committee with Lars Fruergaard Jørgensen,
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Company announcement No 31 / 2015
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Financial report for the period 1 January 2015 to 31 March 2015
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Page 18 of 29
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executive vice president (EVP), Corporate Development as vice chair. In addition, the committee will comprise the EVPs responsible for Novo Nordisk’s commercial activities and product supply including Jakob Riis, until now EVP, responsible for Marketing, Medical Affairs and Stakeholder Engagement. Jakob Riis will as part of the changes assume additional management responsibility for the commercial activities in China, Japan & Korea, Australasia and Canada.
Consequently, and effective today, Novo Nordisk’s Executive Management consists of:
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Lars Rebien Sørensen, president, chief executive officer
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·
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Jesper Brandgaard, EVP, chief financial officer
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·
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Maziar Mike Doustdar, EVP, International Operations
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·
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Jerzy Gruhn, EVP, Europe
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·
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Jesper Høiland, EVP, US
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·
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Lars Fruergaard Jørgensen, EVP, Corporate Development
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·
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Jakob Riis, EVP, China, Pacific & Marketing
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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
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Product liability lawsuits related to Victoza®
As of 27 April 2015, Novo Nordisk, along with the majority of incretin-based product manufacturers in the US, is a defendant in product liability lawsuits related to use of incretin-based medications. To date, 154 plaintiffs have named Novo Nordisk in product liability lawsuits, predominantly claiming damages for pancreatic cancer that allegedly developed as a result of using Victoza® and other GLP-1/DPP-IV products. 103 of the Novo Nordisk plaintiffs have also named other defendants in their lawsuits. Most Novo Nordisk plaintiffs have filed suit in California federal court. Currently, Novo Nordisk does not have any trials scheduled in 2015. Novo Nordisk does not expect the pending claims to have a material impact on its financial position, operating profit and cash flow.
Novo Nordisk settles lawsuit related to alleged sale and distribution contract in Italy
In November 2006, Novo Nordisk A/S and the Italian affiliate Novo Nordisk Farmaceutici S.p.A were sued by two Italian companies in the pharmaceutical sector (the ‘Italian Companies’) before the Civil Court in Rome. The Italian Companies claimed that Novo Nordisk breached an alleged contract for the sale and distribution of insulin and insulin analogues in the Italian market or, alternatively, had incurred a pre-contractual or extra-contractual liability arising from negotiations between the parties. Novo Nordisk disputed the claims made by the Italian Companies. The parties have now entered into and performed a mutually acceptable settlement. As a consequence, the Court of Appeal of Rome dismissed the case on 27 February. The settlement does not have a material impact on Novo Nordisk’s financial position, operating profit or cash flow.
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Company announcement No 31 / 2015
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Financial report for the period 1 January 2015 to 31 March 2015
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Page 19 of 29
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FORWARD-LOOKING STATEMENTS
Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document as well as the company’s Annual Report 2014 and Form 20-F, both filed with the SEC in February 2015, 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:
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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
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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
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statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings
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statements regarding the assumptions underlying or relating to such statements.
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In this document, examples of forward-looking statements can be found under the headings ‘Outlook’, ‘Research and Development update’, Equity’ and ‘Legal update’.
These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this document, could cause actual results to differ materially from those contemplated in any forward-looking statements.
Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recalls, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk’s products, introduction of competing products, reliance on information technology, Novo Nordisk’s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees, and failure to maintain a culture of compliance.
Please also refer to the overview of risk factors in ‘Be aware of the risk’ on pp 42-43 of the Annual Report 2014 available on novonordisk.com on 3 February 2015.
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.
Financial report for the period 1 January 2015 to 31 March 2015
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Page 20 of 29
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The Board of Directors and Executive Management have reviewed and approved the financial report of Novo Nordisk A/S for the first three months of 2015. The financial report has not been audited or reviewed by the company’s independent auditors.
The financial report for the first three months of 2015 has been prepared in accordance with IAS 34 ‘Interim Financial Reporting’ and accounting policies set out in the Annual Report 2014 of Novo Nordisk, amended with accounting policy regarding associated companies as presented in appendix 9. Furthermore, the financial report for the first three months of 2015 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 three months of 2015 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 2014.
Bagsværd, 30 April 2015
Executive Management:
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Lars Rebien Sørensen
CEO
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Kåre Schultz
President and COO
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Jesper Brandgaard
CFO
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Lars Fruergaard Jørgensen
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Jakob Riis
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Mads Krogsgaard Thomsen
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Board of Directors:
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Göran Ando
Chairman
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Jeppe Christiansen
Vice chairman
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Bruno Angelici
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Sylvie Grégoire
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Liz Hewitt
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Liselotte Hyveled
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Thomas Paul Koestler
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Eivind Kolding
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Anne Marie Kverneland
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Søren Thuesen Pedersen
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Stig Strøbæk
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Mary Szela
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Company announcement No 31 / 2015
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Financial report for the period 1 January 2015 to 31 March 2015
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Page 21 of 29
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FINANCIAL INFORMATION
(Amounts in DKK million, except number of full-time equivalent employees, earnings per share and number of shares outstanding).
|
|
2015 |
|
|
2014 |
|
|
% change
Q1 2015 vs
|
|
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
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|
Q1 2014
|
|
Net sales
|
|
|
25,200 |
|
|
|
24,585 |
|
|
|
22,249 |
|
|
|
21,629 |
|
|
|
20,343 |
|
|
|
24 |
% |
Gross profit
|
|
|
21,326 |
|
|
|
20,586 |
|
|
|
18,823 |
|
|
|
17,958 |
|
|
|
16,877 |
|
|
|
26 |
% |
Gross margin
|
|
|
84.6 |
% |
|
|
83.7 |
% |
|
|
84.6 |
% |
|
|
83.0 |
% |
|
|
83.0 |
% |
|
|
|
|
Sales and distribution costs
|
|
|
6,147 |
|
|
|
6,679 |
|
|
|
5,899 |
|
|
|
5,559 |
|
|
|
5,086 |
|
|
|
21 |
% |
Percentage of sales
|
|
|
24.4 |
% |
|
|
27.2 |
% |
|
|
26.5 |
% |
|
|
25.7 |
% |
|
|
25.0 |
% |
|
|
|
|
Research and development costs
|
|
|
3,250 |
|
|
|
3,865 |
|
|
|
3,654 |
|
|
|
3,075 |
|
|
|
3,168 |
|
|
|
3 |
% |
Hereof costs related to discontinuation of activities within inflammatory disorders
|
|
|
- |
|
|
|
- |
|
|
|
600 |
|
|
|
- |
|
|
|
- |
|
|
|
N/A |
|
Percentage of sales
|
|
|
12.9 |
% |
|
|
15.7 |
% |
|
|
16.4 |
% |
|
|
14.2 |
% |
|
|
15.6 |
% |
|
|
|
|
Administrative costs
|
|
|
854 |
|
|
|
1,067 |
|
|
|
870 |
|
|
|
795 |
|
|
|
805 |
|
|
|
6 |
% |
Percentage of sales
|
|
|
3.4 |
% |
|
|
4.3 |
% |
|
|
3.9 |
% |
|
|
3.7 |
% |
|
|
4.0 |
% |
|
|
|
|
Other operating income, net
|
|
|
2,782 |
|
|
|
182 |
|
|
|
169 |
|
|
|
204 |
|
|
|
215 |
|
|
|
N/A |
|
Hereof non-recurring income from the initial public offering of NNIT A/S
|
|
|
2,376 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
N/A |
|
Operating profit
|
|
|
13,857 |
|
|
|
9,157 |
|
|
|
8,569 |
|
|
|
8,733 |
|
|
|
8,033 |
|
|
|
73 |
% |
Operating margin
|
|
|
55.0 |
% |
|
|
37.2 |
% |
|
|
38.5 |
% |
|
|
40.4 |
% |
|
|
39.5 |
% |
|
|
|
|
Financial income
|
|
|
285 |
|
|
|
(1,141 |
) |
|
|
326 |
|
|
|
396 |
|
|
|
586 |
|
|
|
(51 |
%) |
Financial expenses
|
|
|
1,657 |
|
|
|
(336 |
) |
|
|
441 |
|
|
|
140 |
|
|
|
318 |
|
|
|
N/A |
|
Net financials
|
|
|
(1,372 |
) |
|
|
(805 |
) |
|
|
(115 |
) |
|
|
256 |
|
|
|
268 |
|
|
|
N/A |
|
Profit before income taxes
|
|
|
12,485 |
|
|
|
8,352 |
|
|
|
8,454 |
|
|
|
8,989 |
|
|
|
8,301 |
|
|
|
50 |
% |
Income taxes
|
|
|
2,609 |
|
|
|
1,823 |
|
|
|
1,954 |
|
|
|
1,995 |
|
|
|
1,843 |
|
|
|
42 |
% |
Net profit
|
|
|
9,876 |
|
|
|
6,529 |
|
|
|
6,500 |
|
|
|
6,994 |
|
|
|
6,458 |
|
|
|
53 |
% |
Depreciation, amortisation and impairment losses 1)
|
|
|
663 |
|
|
|
928 |
|
|
|
1,183 |
|
|
|
667 |
|
|
|
657 |
|
|
|
1 |
% |
Capital expenditure
|
|
|
764 |
|
|
|
1,505 |
|
|
|
986 |
|
|
|
802 |
|
|
|
693 |
|
|
|
10 |
% |
Net cash generated from operating activities
|
|
|
4,106 |
|
|
|
7,301 |
|
|
|
12,197 |
|
|
|
8,125 |
|
|
|
4,069 |
|
|
|
1 |
% |
Free cash flow
|
|
|
5,643 |
|
|
|
5,717 |
|
|
|
11,157 |
|
|
|
7,250 |
|
|
|
3,272 |
|
|
|
72 |
% |
Total assets
|
|
|
77,457 |
|
|
|
77,062 |
|
|
|
71,283 |
|
|
|
63,681 |
|
|
|
63,241 |
|
|
|
22 |
% |
Total equity
|
|
|
32,108 |
|
|
|
40,294 |
|
|
|
37,967 |
|
|
|
36,661 |
|
|
|
33,583 |
|
|
|
(4 |
%) |
Equity ratio
|
|
|
41.5 |
% |
|
|
52.3 |
% |
|
|
53.3 |
% |
|
|
57.6 |
% |
|
|
53.1 |
% |
|
|
|
|
Full-time equivalent employees end of period
|
|
|
39,062 |
|
|
|
40,957 |
|
|
|
40,700 |
|
|
|
40,226 |
|
|
|
39,579 |
|
|
|
(1 |
%) |
Basic earnings per share/ADR (in DKK)
|
|
|
3.80 |
|
|
|
2.51 |
|
|
|
2.49 |
|
|
|
2.66 |
|
|
|
2.44 |
|
|
|
56 |
% |
Diluted earnings per share/ADR (in DKK)
|
|
|
3.79 |
|
|
|
2.51 |
|
|
|
2.47 |
|
|
|
2.66 |
|
|
|
2.43 |
|
|
|
56 |
% |
Average number of shares outstanding (million)
|
|
|
2,596.7 |
|
|
|
2,599.7 |
|
|
|
2,613.9 |
|
|
|
2,628.9 |
|
|
|
2,642.4 |
|
|
|
(2 |
%) |
Average number of diluted shares outstanding (million)
|
|
|
2,604.2 |
|
|
|
2,608.2 |
|
|
|
2,622.2 |
|
|
|
2,637.3 |
|
|
|
2,653.1 |
|
|
|
(2 |
%) |
Sales by business segment: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
New-generation insulin
|
|
|
271 |
|
|
|
262 |
|
|
|
175 |
|
|
|
141 |
|
|
|
80 |
|
|
|
N/A |
|
Modern insulin (insulin analogues)
|
|
|
11,498 |
|
|
|
11,168 |
|
|
|
10,641 |
|
|
|
10,351 |
|
|
|
9,377 |
|
|
|
23 |
% |
Human insulin
|
|
|
2,897 |
|
|
|
2,772 |
|
|
|
2,478 |
|
|
|
2,475 |
|
|
|
2,573 |
|
|
|
13 |
% |
Victoza®
|
|
|
3,957 |
|
|
|
4,010 |
|
|
|
3,441 |
|
|
|
3,059 |
|
|
|
2,916 |
|
|
|
36 |
% |
Other diabetes care
|
|
|
1,195 |
|
|
|
1,064 |
|
|
|
953 |
|
|
|
1,031 |
|
|
|
1,013 |
|
|
|
18 |
% |
Diabetes care total
|
|
|
19,818 |
|
|
|
19,276 |
|
|
|
17,688 |
|
|
|
17,057 |
|
|
|
15,959 |
|
|
|
24 |
% |
Haemophilia
|
|
|
2,734 |
|
|
|
2,610 |
|
|
|
2,112 |
|
|
|
2,327 |
|
|
|
2,255 |
|
|
|
21 |
% |
Norditropin®
|
|
|
1,830 |
|
|
|
1,811 |
|
|
|
1,686 |
|
|
|
1,509 |
|
|
|
1,500 |
|
|
|
22 |
% |
Other biopharmaceuticals 2)
|
|
|
818 |
|
|
|
888 |
|
|
|
763 |
|
|
|
736 |
|
|
|
629 |
|
|
|
30 |
% |
Biopharmaceuticals total
|
|
|
5,382 |
|
|
|
5,309 |
|
|
|
4,561 |
|
|
|
4,572 |
|
|
|
4,384 |
|
|
|
23 |
% |
Sales by geographic segment: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
|
12,455 |
|
|
|
12,164 |
|
|
|
11,133 |
|
|
|
10,561 |
|
|
|
9,265 |
|
|
|
34 |
% |
Europe
|
|
|
4,977 |
|
|
|
5,413 |
|
|
|
5,045 |
|
|
|
4,989 |
|
|
|
4,703 |
|
|
|
6 |
% |
International Operations
|
|
|
3,684 |
|
|
|
3,602 |
|
|
|
2,938 |
|
|
|
2,968 |
|
|
|
3,032 |
|
|
|
22 |
% |
Region China
|
|
|
2,847 |
|
|
|
2,089 |
|
|
|
1,881 |
|
|
|
1,947 |
|
|
|
2,171 |
|
|
|
31 |
% |
Japan & Korea
|
|
|
1,237 |
|
|
|
1,317 |
|
|
|
1,252 |
|
|
|
1,164 |
|
|
|
1,172 |
|
|
|
6 |
% |
Segment operating profit:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes care
|
|
|
7,950 |
|
|
|
6,383 |
|
|
|
6,989 |
|
|
|
6,376 |
|
|
|
5,785 |
|
|
|
37 |
% |
Biopharmaceuticals
|
|
|
3,531 |
|
|
|
2,774 |
|
|
|
1,580 |
|
|
|
2,357 |
|
|
|
2,248 |
|
|
|
57 |
% |
Income from the initial public offering of NNIT A/S (unallocated to segments)
|
|
|
2,376 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
N/A |
|
1) Hereof impairments of around DKK 480 million in Q3 and Q4 2014 related to discontinuation of activities within inflammatory disorders.
2) Comparative figures have been restated as NovoEight® and NovoThirteen® are now reported as Haemophilia together with NovoSeven®.
|
Outlook
|
R&D
|
Sustainability
|
Equity
|
Corporate
Governance
|
Legal
|
|
|
|
|
|
|
Company announcement No 31 / 2015
|
Financial report for the period 1 January 2015 to 31 March 2015
|
Page 22 of 29
|
|
|
|
|
APPENDIX 2: |
STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME
|
|
|
|
Q1 |
|
|
|
Q1 |
|
DKK million
|
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
|
|
|
|
|
Income statement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales
|
|
|
25,200 |
|
|
|
20,343 |
|
Cost of goods sold
|
|
|
3,874 |
|
|
|
3,466 |
|
Gross profit
|
|
|
21,326 |
|
|
|
16,877 |
|
Sales and distribution costs
|
|
|
6,147 |
|
|
|
5,086 |
|
Research and development costs
|
|
|
3,250 |
|
|
|
3,168 |
|
Administrative costs
|
|
|
854 |
|
|
|
805 |
|
Other operating income, net
|
|
|
2,782 |
|
|
|
215 |
|
Hereof non-recurring income from the initial public offering of NNIT A/S
|
|
|
2,376 |
|
|
|
- |
|
Operating profit
|
|
|
13,857 |
|
|
|
8,033 |
|
Financial income
|
|
|
285 |
|
|
|
586 |
|
Financial expenses
|
|
|
1,657 |
|
|
|
318 |
|
Profit before income taxes
|
|
|
12,485 |
|
|
|
8,301 |
|
Income taxes
|
|
|
2,609 |
|
|
|
1,843 |
|
NET PROFIT
|
|
|
9,876 |
|
|
|
6,458 |
|
|
|
|
|
|
|
|
|
|
Basic earnings per share (DKK)
|
|
|
3.8 |
|
|
|
2.44 |
|
Diluted earnings per share (DKK)
|
|
|
3.79 |
|
|
|
2.43 |
|
|
|
|
|
|
|
|
|
|
Segment Information
|
|
|
|
|
|
|
|
|
Segment sales:
|
|
|
|
|
|
|
|
|
Diabetes care
|
|
|
19,818 |
|
|
|
15,959 |
|
Biopharmaceuticals |
|
|
5,382 |
|
|
|
4,384 |
|
Segment operating profit:
|
|
|
|
|
|
|
|
|
Diabetes care
|
|
|
7,950 |
|
|
|
5,785 |
|
Operating margin
|
|
|
40.10 |
% |
|
|
36.20 |
% |
Biopharmaceuticals
|
|
|
3,531 |
|
|
|
2,248 |
|
Operating margin
|
|
|
65.60 |
% |
|
|
51.30 |
% |
Income from the initial public offering of NNIT A/S (unallocated to segments)
|
|
|
2,376 |
|
|
|
- |
|
Total segment operating profit
|
|
|
13,857 |
|
|
|
8,033 |
|
|
|
|
|
|
|
|
|
|
Statement of comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net profit for the period
|
|
|
9,876 |
|
|
|
6,458 |
|
|
|
|
|
|
|
|
|
|
Other comprehensive income
|
|
|
|
|
|
|
|
|
Remeasurements on defined benefit plans
|
|
|
(162 |
) |
|
|
(42 |
) |
Items that will not subsequently be reclassified to the Income statement
|
|
|
(162 |
) |
|
|
(42 |
) |
Exchange rate adjustments of investments in subsidiaries
|
|
|
(338 |
) |
|
|
56 |
|
Cash flow hedges, realisation of previously deferred (gains)/losses
|
|
|
980 |
|
|
|
(526 |
) |
Cash flow hedges, deferred gains/(losses) incurred during the period
|
|
|
(3,377 |
) |
|
|
(25 |
) |
Other items
|
|
|
118 |
|
|
|
158 |
|
Items that will be reclassified subsequently to the Income statement, when specific conditions are met
|
|
|
(2,617 |
) |
|
|
(337 |
) |
Other comprehensive income before tax
|
|
|
(2,779 |
) |
|
|
(379 |
) |
Tax on other comprehensive income, income/(expense)
|
|
|
920 |
|
|
|
125 |
|
Other comprehensive income for the period, net of tax
|
|
|
(1,859 |
) |
|
|
(254 |
) |
TOTAL COMPREHENSIVE INCOME FOR THE PERIOD
|
|
|
8,017 |
|
|
|
6,204 |
|
|
Outlook
|
R&D
|
Sustainability
|
Equity
|
Corporate
Governance
|
Legal
|
|
|
|
|
|
|
Company announcement No 31 / 2015
|
Financial report for the period 1 January 2015 to 31 March 2015
|
Page 23 of 29
|
|
|
|
|
DKK million
|
|
31 Mar 2015
|
|
|
31 Dec 2014
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets
|
|
|
1,372 |
|
|
|
1,378 |
|
Property, plant and equipment
|
|
|
23,464 |
|
|
|
23,136 |
|
Investment in associated company
|
|
|
798 |
|
|
|
- |
|
Deferred income tax assets
|
|
|
7,317 |
|
|
|
5,399 |
|
Other financial assets
|
|
|
1,045 |
|
|
|
856 |
|
TOTAL NON-CURRENT ASSETS
|
|
|
33,996 |
|
|
|
30,769 |
|
Inventories
|
|
|
12,288 |
|
|
|
11,357 |
|
Trade receivables
|
|
|
14,648 |
|
|
|
13,041 |
|
Tax receivables
|
|
|
6,623 |
|
|
|
3,210 |
|
Other receivables and prepayments
|
|
|
2,460 |
|
|
|
2,750 |
|
Marketable securities
|
|
|
1,204 |
|
|
|
1,509 |
|
Derivative financial instruments
|
|
|
254 |
|
|
|
30 |
|
Cash at bank and on hand
|
|
|
5,984 |
|
|
|
14,396 |
|
TOTAL CURRENT ASSETS
|
|
|
43,461 |
|
|
|
46,293 |
|