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RESULTS FOR THE YEAR
12 Months Ended
Dec. 31, 2017
Analysis of income and expense [abstract]  
RESULTS FOR THE YEAR
RESULTS FOR THE YEAR

Basis of preparation
Results for the year
Operating assets
and liabilities
Capital structure and
financing items
Other disclosures


This section comprises notes related to the results for the year and hence provides information related to Novo Nordisk’s long-term financial target for growth in operating profit in local currencies. Operating profit increased by 1.1% in 2017 (decrease of 2.0% in 2016).
The article ‘2017 performance and 2018 outlook’ on p 6 includes Management’s review of the results for the year and the articles 'Performing while transforming: building a bolder and more competitive US business' and 'Opportunities and challenges: Novo Nordisk's international Operations' on pp 32-39 includes Management's perspective on the various markets, which is not part of the audited financial statements (unaudited).

 

Pricing mechanisms in the US market
In the US, sales rebates are paid in connection with public healthcare insurance programmes, namely Medicare and Medicaid, as well as rebates to pharmacy benefit managers (PBMs) and managed healthcare plans.
Key customers in the US include private payers, PBMs and government payers. PBMs and managed healthcare plans play a role in negotiating price concessions with drug manufacturers on behalf of private payers for both the commercial and government channels, and determine which drugs are covered on their formularies (or 'preferred drug lists').  Specifically, Management views the rising healthcare cost trend and highly competitive environment as the primary drivers of payer pressure to reduce overall drug costs.
This has resulted in greater focus on negotiating higher rebates from drug manufacturers. As new products enter the market, private payers are increasingly likely to adopt narrow formularies that exclude certain drugs, while securing higher rebates from the preferred brand(s).

From Management's perspective, in 2017 payers have continued to leverage their size and influence to negotiate higher rebates.  Moreover, intense competition in the diabetes space limits the impact of price increases, as much of it is given back to payers in the form of higher rebates and price protection, leading to continued downward pressure on prices.


 
NET SALES AND REBATES

Accounting policies
Revenue is recognised when Novo Nordisk has transferred the significant risks and rewards from products sold to the buyer, the Group no longer has managerial involvement, and the amount of revenue can be measured reliably.

Sales are measured at the fair value of the consideration received or receivable. When sales are recognised, Novo Nordisk also records estimates for a variety of sales deductions, including product returns as well as rebates and discounts to government agencies, wholesalers, health insurance companies, managed healthcare organisations and retail customers. Sales deductions are recognised as a reduction of gross sales to arrive at net sales. Where contracts contain customer acceptance provisions, Novo Nordisk recognises sales when the acceptance criteria are satisfied.

Revenue recognition for new product launches is based on specific facts and circumstances relating to those products, including estimated demand and acceptance rates for well-established products with similar market characteristics. Where shipments of new products are made on a sale-or-return basis, without sufficient historical experience for estimating sales returns, revenue is only recorded when there is evidence of consumption or when the right of return has expired.

Key accounting estimate of sales deductions and provisions for sales rebates
Sales deductions are estimated and provided for at the time the related sales are recorded. These estimates of unsettled obligations require use of judgement, as not all conditions are known at the time of sale, for example total sales volume to a given customer.

The estimates are based on analyses of existing contractual obligations and historical experience. Provisions are calculated on the basis of a percentage of sales for each product as defined by the contracts with the various customer groups. Provisions for sales rebates are adjusted to actual amounts as rebates, discounts and returns are processed.

Novo Nordisk considers the provisions established for sales rebates to be reasonable and appropriate based on currently available information. However, the actual amount of rebates and discounts may differ from the amounts estimated by Management as more detailed information becomes available.


2.1 NET SALES AND REBATES (CONTINUED)

GROSS-TO-NET SALES RECONCILIATION
 
 
 
 
DKK million
2017

2016

2015

Gross sales
216,174

198,924

182,779

 
 
 
 
US Managed Care and Medicare
(53,077
)
(40,874
)
(33,235
)
US wholesaler charge-backs
(28,324
)
(25,416
)
(22,030
)
US Medicaid rebates
(12,491
)
(10,862
)
(9,838
)
Other US discounts and sales returns
(5,771
)
(5,147
)
(4,685
)
Non-US rebates, discounts and sales returns
(4,815
)
(4,845
)
(5,064
)
 
 
 
 
Total gross-to-net sales adjustments
(104,478
)
(87,144
)
(74,852
)
Net sales
111,696

111,780

107,927



Sales discounts and sales rebates are predominantly issued in the US. As such, rebates amount to 64% of gross sales in the US (59% in 2016 and 56% in 2015). Novo Nordisk sales are impacted by exchange rate changes. For development in key currencies refer to note 4.2 on p 83.

US Managed Care and Medicare
For Managed Care and Medicare, rebates are offered to a number of PBMs and managed healthcare plans. These rebate programmes allow the customer to receive a rebate after attaining certain performance parameters relating to formulary status or pre-established market shares relative to competitors. Rebates are estimated according to the specific terms in each agreement, historical experience, anticipated channel mix, growth rates and market share information. Novo Nordisk adjusts the provision periodically to reflect actual sales performance.

US wholesaler charge-backs
Wholesaler charge-backs relate to contractual arrangements between Novo Nordisk and indirect customers in the US whereby products are sold at contract prices lower than the list price originally charged to wholesalers. A wholesaler charge-back represents the difference between the invoice price to the wholesaler and the indirect customer’s contract price. Accruals are calculated for estimated charge-backs using a combination of factors such as historical experience, current wholesaler inventory levels, contract terms and the value of claims received but not yet processed. Wholesaler charge-backs are generally settled within 30 days of the liability being incurred.

US Medicaid rebates
Medicaid is a government insurance programme. Medicaid rebates have been calculated using a combination of historical experience, product and population growth, price increases, and the impact of contracting strategies. Further, the calculation involves interpretation of relevant regulations that are subject to changes in interpretative guidance from government authorities. Although provisions are made for Medicaid rebates at the time sales are recorded, the actual rebates related to the specific sale will typically be invoiced to Novo Nordisk 6-9 months later. Due to the time lag, the rebate adjustments to sales in any particular period may incorporate adjustments of provisions from prior periods.

Other US discounts and sales returns
Other discounts are provided to wholesalers, hospitals, pharmacies etc. They are usually linked to sales volume or provided as cash discounts. Accruals are calculated based on historical data and recorded as a reduction in gross sales at the time the related sales are recorded. Sales returns are related to damaged or expired products.

Arrangements with certain healthcare providers may require Novo Nordisk to make refunds to the healthcare providers if anticipated treatment outcomes do not meet predefined targets.

PROVISIONS FOR SALES REBATES
 
 
 
 
DKK million
2017

2016

2015

 
 
 
 
At the beginning of the year
19,971

16,508

11,002

Additional provisions, including increases to existing provisions
63,772

56,954

45,190

Amount used during the year
(61,017
)
(53,217
)
(40,958
)
Adjustments, including unused amounts reversed during the year
(117
)
(822
)

Effect of exchange rate adjustment
(2,393
)
548

1,274

 
 
 
 
At the end of the year
20,216

19,971

16,508



Unsettled rebates are recognised as Provisions when the timing or amount is uncertain (note 3.6). Where absolute amounts are known, the rebates are recognised as Other liabilities. Wholesaler charge-backs are netted against trade receivable balances. Hence, provisions for sales rebates include US Managed Care, Medicare, Medicaid and other minor US rebate types, as well as rebates in Canada.
SEGMENT INFORMATION

Accounting policies
Operating segments are reported in a manner consistent with the internal reporting provided to Executive Management and the Board of Directors.

We consider Executive Management to be the operating decision-making body, as all significant decisions regarding business development and direction are taken in that forum.

Business segments
Novo Nordisk operates in two business segments based on therapies: Diabetes care and obesity and Biopharmaceuticals.

The Diabetes care and obesity business segment includes research, development, manufacturing and marketing of products within the areas of insulin, GLP-1 and related delivery systems, oral antidiabetic products (OAD), obesity and other chronic diseases.

The Biopharmaceuticals business segment includes research, development, manufacturing and marketing of products within the areas of haemophilia, growth disorders and hormone replacement therapy.
Segment performance is evaluated on the basis of operating profit consistent with the Consolidated financial statements. Financial income and expenses and income taxes are managed at Group level and are not allocated to business segments. Further, non-recurring income from the partial divestment of NNIT A/S in 2015 was not allocated to segments.

There are no sales or other transactions between the business segments. Costs have been split between business segments according to a specific allocation. In addition, a minor number of corporate overhead costs are allocated systematically between the segments. Other operating income has been allocated to the two segments based on the same principle. Segment assets comprise the assets that are applied directly to the activities of the segment, including intangible assets, property, plant and equipment, inventories, trade receivables, and other receivables and prepayments.

No operating segments have been aggregated to form the reported business segments.


BUSINESS SEGMENTS
DKK million
2017
2016
2015
 
2017
2016
2015
 
2017
2016
2015
Segment sales
Diabetes care and obesity
 
Biopharmaceuticals
 
Total
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
New-generation insulin
 
8,647

4,459

1,438

 
 
 
 
 
 
 
 
 
 
- of which Tresiba®
 
7,327

4,056

1,278

 
 
 
 
 
 
 
 
 
 
Total modern insulin
 
44,400

47,510

50,164

 
 
 
 
 
 
 
 
 
 
NovoRapid® / NovoLog®
 
20,025

19,945

20,720

 
 
 
 
 
 
 
 
 
 
NovoMix® / NovoLog® Mix
 
10,257

10,482

11,144

 
 
 
 
 
 
 
 
 
 
Levemir®
 
14,118

17,083

18,300

 
 
 
 
 
 
 
 
 
 
Human insulin
 
10,072

11,090

11,231

 
 
 
 
 
 
 
 
 
 
Total insulin
 
63,119

63,059

62,833

 
 
 
 
 
 
 
 
 
 
Victoza®
 
23,173

20,046

18,027

 
 
 
 
 
 
 
 
 
 
Other diabetes care
 
4,023

4,267

4,270

 
 
 
 
 
 
 
 
 
 
Total diabetes care
 
90,315

87,372

85,130

 
 
 
 
 
 
 
 
 
 
Obesity (Saxenda®)
 
2,562

1,577

460

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Diabetes care and obesity total sales
 
92,877

88,949

85,590

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Haemophilia
 
 
 
 
 
 
10,469

10,472

10,647

 
 
 
 
 
- of which NovoSeven®  
 
 
 
 
 
 
9,206

9,492

10,064

 
 
 
 
 
- of which NovoEight®
 
 
 
 
 
 
1,103

851

477

 
 
 
 
 
Growth disorders
 
 
 
 
 
 
6,655

8,770

7,820

 
 
 
 
 
Other biopharmaceuticals
 
 
 
 
 
 
1,695

3,589

3,870

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Biopharmaceuticals total sales
 
 
 
 
 
 
18,819

22,831

22,337

 
 
 
 
 
Segment key figures
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total net sales
 
92,877

88,949

85,590

 
 
18,819

22,831

22,337

 
 
111,696

111,780

107,927

Cost of goods sold
 
15,014

14,337

13,725

 
 
2,618

2,846

2,463

 
 
17,632

17,183

16,188

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sales and distribution costs
 
25,475

24,387

24,926

 
 
2,865

3,990

3,386

 
 
28,340

28,377

28,312

Research and development costs
 
11,358

11,481

10,475

 
 
2,656

3,082

3,133

 
 
14,014

14,563

13,608

Administrative costs
 
3,143

3,128

3,051

 
 
641

834

806

 
 
3,784

3,962

3,857

Other operating income, net
 
466

486

488

 
 
575

251

618

 
 
1,041

737

1,106

Income from partial divestment of NNIT A/S (not allocated to segments)
 



 
 



 
 


2,376

Operating profit
 
38,353

36,102

33,901

 
 
10,614

12,330

13,167

 
 
48,967

48,432

49,444

Operating margin
 
41.3
%
40.6
%
39.6
%
 
 
56.4
%
54.0
%
58.9
%
 
 
43.8
%
43.3
%
45.8
%
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Depreciation, amortisation and impairment losses expensed
 
2,536

2,674

2,514

 
 
646

519

445

 
 
3,182

3,193

2,959

Additions to Intangible assets and Property, plant and equipment
 
7,565

6,144

4,991

 
 
2,226

2,123

1,415

 
 
9,791

8,267

6,406

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assets allocated to business segments
 
61,542

55,081

46,444

 
 
14,994

14,798

11,759

 
 
76,536

69,879

58,203

Non-allocated assets1
 
 
 
 
 
 
 
 
 
 
 
25,819

27,660

33,596

Total assets
 
 
 
 
 
 
 
 
 
 
 
102,355

97,539

91,799

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1.
The part of total assets that remains unallocated to either of the two business segments includes Investment in associated company, Deferred income tax assets, Other financial assets, Tax receivables, Marketable securities, Derivative financial instruments and Cash at bank.
2.2 SEGMENT INFORMATION (CONTINUED)

GEOGRAPHICAL AREAS
Novo Nordisk operates in two main commercial units:
    
North America Operations (US and Canada)
International Operations
Region Europe: the EU, EFTA, Albania, Bosnia-Hercegovina, Macedonia, Serbia, Montenegro and Kosovo
Region AAMEO (Africa, Asia, Middle East & Oceania)
Region China: China, Hong Kong and Taiwan
Region Japan & Korea: Japan and South Korea
Region Latin America: countries in South America, Central America and Mexico


As of 1 January 2017, the geographical regions were changed to align with management structure as listed above. Comparative figures have been updated to reflect the new regional structure. Please refer to note 5.5 for an overview of subsidiaries.

Sales are attributed to geographical regions according to the location of the customer. Allocation of property, plant and equipment, trade receivables, allowance for trade receivables and total assets is based on the location of the assets.

The country of domicile is Denmark, which is part of Region Europe. Denmark is immaterial to Novo Nordisk’s activities in terms of geographical size and the operational business segments. 99.6% of total sales are realised outside Denmark.

Sales to external customers attributed to the US are collectively the most material to the Group. The US is the only country where sales contribute more than 10% of total sales.

In 2017, Novo Nordisk had three major wholesalers distributing products, representing 21%, 13% and 12% respectively of total net sales (21%, 13% and 12% in 2016 and 21%, 12% and 11% in 2015). Sales to these three wholesalers are within both Diabetes care and obesity and Biopharmaceuticals.

Net sales will be impacted by exchange rate fluctuations. Conversely, Financial income and Financial expenses will be impacted by the corresponding results of hedging activities. Please refer to notes 4.2, 4.3 and 4.8 for more details on hedging.

For patent expiry in key markets by product, please refer to note 2.4 of the Consolidated social statement.



GEOGRAPHICAL AREAS
 
2017
 
2016

2015

 
2017
 
2016

2015

 
2017
 
2016

2015

 
2017
 
2016

2015

 
 
 
 
 
 
 
 
DKK million
North America Operations
 
International Operations
 
Total
 
Of which US
 
Total
 
Region Europe
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sales by business segment:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
New-generation insulin
 
5,152

2,246

33

 
 
5,132

2,246

33

 
 
3,495

2,213

1,405

 
 
1,643

886

545

- of which Tresiba®
 
4,982

2,246

33

 
 
4,970

2,246

33

 
 
2,345

1,810

1,237

 
 
966

665

441

Total modern insulin
 
22,364

26,043

28,708

 
 
21,651

25,337

27,945

 
 
22,036

21,467

21,456

 
 
8,496

8,728

9,349

NovoRapid® / NovoLog®
 
10,960

11,427

12,576

 
 
10,574

11,058

12,184

 
 
9,065

8,518

8,144

 
 
4,275

4,200

4,239

NovoMix® / NovoLog® Mix
 
1,790

2,080

2,837

 
 
1,743

2,032

2,779

 
 
8,467

8,402

8,307

 
 
1,852

2,025

2,181

Levemir®
 
9,614

12,536

13,295

 
 
9,334

12,247

12,982

 
 
4,504

4,547

5,005

 
 
2,369

2,503

2,929

Human insulin
 
1,937

2,011

2,094

 
 
1,766

1,827

1,884

 
 
8,135

9,079

9,137

 
 
1,770

2,103

2,014

Total insulin
 
29,453

30,300

30,835

 
 
28,549

29,410

29,862

 
 
33,666

32,759

31,998

 
 
11,909

11,717

11,908

Victoza®
 
17,465

14,624

13,014

 
 
16,929

14,146

12,570

 
 
5,708

5,422

5,013

 
 
3,451

3,391

3,394

Other diabetes care
 
943

930

950

 
 
782

776

785

 
 
3,080

3,337

3,320

 
 
605

649

679

Total diabetes care
 
47,861

45,854

44,799

 
 
46,260

44,332

43,217

 
 
42,454

41,518

40,331

 
 
15,965

15,757

15,981

Obesity (Saxenda®)
 
1,993

1,446

459

 
 
1,828

1,366

452

 
 
569

131

1

 
 
102

28

1

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Diabetes care and obesity total
 
49,854

47,300

45,258

 
 
48,088

45,698

43,669

 
 
43,023

41,649

40,332

 
 
16,067

15,785

15,982

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Haemophilia
 
5,023

4,934

5,208

 
 
4,852

4,710

5,086

 
 
5,446

5,538

5,439

 
 
2,828

2,520

2,405

- of which NovoSeven®  
 
4,609

4,589

5,021

 
 
4,451

4,378

4,914

 
 
4,597

4,903

5,043

 
 
2,245

2,082

2,137

- of which NovoEight®
 
315

254

110

 
 
315

254

110

 
 
788

597

367

 
 
551

416

249

Growth disorders
 
2,550

4,498

3,625

 
 
2,543

4,495

3,625

 
 
4,105

4,272

4,195

 
 
1,572

1,661

1,675

Other biopharmaceuticals
 
582

2,510

2,765

 
 
348

2,291

2,559

 
 
1,113

1,079

1,105

 
 
722

716

736

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Biopharmaceuticals total
 
8,155

11,942

11,598

 
 
7,743

11,496

11,270

 
 
10,664

10,889

10,739

 
 
5,122

4,897

4,816

Total sales by business and geographical segment
 
58,009

59,242

56,856

 
 
55,831

57,194

54,939

 
 
53,687

52,538

51,071

 
 
21,189

20,682

20,798

Total sales growth as reported
 
(2.1
%)
4.2
%
31.8
%
 
 
(2.4
%)
4.1
%
32.9
%
 
 
2.2
%
2.9
%
11.8
%
 
 
2.5
%
(0.6
%)
3.2
%
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Property, plant and equipment
 
7,318

4,599

3,049

 
 
7,298

4,599

3,047

 
 
27,929

25,580

22,496

 
 
24,665

22,040

19,097

Trade receivables, net
 
10,742

10,604

6,619

 
 
10,517

10,426

6,456

 
 
9,423

9,630

8,866

 
 
3,273

3,304

3,203

Allowance for doubtful trade receivables
 
(32
)
(41
)
(25
)
 
 
(32
)
(41
)
(25
)
 
 
(1,262
)
(1,182
)
(1,166
)
 
 
(223
)
(166
)
(139
)
Total assets
 
20,612

18,684

12,830

 
 
20,180

18,349

12,594

 
 
81,743

78,855

78,969

 
 
65,600

63,407

64,590

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GEOGRAPHICAL AREAS (CONTINUED)
2017

2016

2015

 
2017
 
2016

2015

 
2017
 
2016

2015

 
2017
 
2016

2015

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
International Operations (continued)
Region AAMEO
 
Region China
 
Region Japan & Korea
 
Region Latin America
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
451

279

162

 
 
2



 
 
992

769

495

 
 
407

279

203

261

181

122

 
 
2



 
 
739

711

491

 
 
377

253

183

5,725

5,284

5,099

 
 
5,500

4,969

4,312

 
 
1,518

1,787

1,713

 
 
797

699

983

2,261

1,995

1,825

 
 
1,253

1,059

866

 
 
941

998

888

 
 
335

266

326

2,503

2,291

2,297

 
 
3,555

3,363

3,036

 
 
444

619

632

 
 
113

104

161

961

998

977

 
 
692

547

410

 
 
133

170

193

 
 
349

329

496

2,201

2,494

2,431

 
 
3,096

3,361

3,537

 
 
232

302

324

 
 
836

819

831

8,377

8,057

7,692

 
 
8,598

8,330

7,849

 
 
2,742

2,858

2,532

 
 
2,040

1,797

2,017

858

715

584

 
 
309

255

213

 
 
590

623

470

 
 
500

438

352

475

505

613

 
 
1,566

1,697

1,594

 
 
376

434

354

 
 
58

52

80

9,710

9,277

8,889

 
 
10,473

10,282

9,656

 
 
3,708

3,915

3,356

 
 
2,598

2,287

2,449

190

46


 
 



 
 



 
 
277

57


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9,900

9,323

8,889

 
 
10,473

10,282

9,656

 
 
3,708

3,915

3,356

 
 
2,875

2,344

2,449

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1,163

1,101

1,319

 
 
216

158

195

 
 
681

737

643

 
 
558

1,022

877

1,097

1,082

1,310

 
 
215

158

195

 
 
497

559

524

 
 
543

1,022

877

52

11


 
 
1



 
 
169

170

118

 
 
15



676

906

818

 
 
15

15

15

 
 
1,579

1,469

1,339

 
 
263

221

348

279

250

246

 
 
5

3

5

 
 
104

104

97

 
 
3

6

21

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2,118

2,257

2,383

 
 
236

176

215

 
 
2,364

2,310

2,079

 
 
824

1,249

1,246

12,018

11,580

11,272

 
 
10,709

10,458

9,871

 
 
6,072

6,225

5,435

 
 
3,699

3,593

3,695

3.8
%
2.7
%
15.1
%
 
 
2.4
%
5.9
%
22.0
%
 
 
(2.5
%)
14.5
%
10.8
%
 
 
3.0
%
(2.8
%)
33.7
%
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
566

525

353

 
 
1,884

2,095

2,291

 
 
146

161

153

 
 
668

759

602

3,468

3,164

2,620

 
 
1,541

1,773

1,541

 
 
279

305

466

 
 
862

1,084

1,036

(823
)
(817
)
(786
)
 
 



 
 
(5
)
(5
)
(5
)
 
 
(211
)
(194
)
(211
)
5,876

4,937

4,160

 
 
5,927

5,697

5,603

 
 
1,304

1,248

1,338

 
 
3,036

3,566

3,278

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RESEARCH AND DEVELOPMENT COSTS

Accounting policies
Novo Nordisk’s research and development is mainly focused on:

Insulins, GLP-1s and other therapeutic new anti-diabetic drugs for diabetes treatment
GLP-1s, combinations and new modes of action for weight management
Blood-clotting factors and new modes of action for haemophilia treatment
Human growth hormone for treatment of growth disorders
New modes of action including GLP-1 for treatment of NASH, cardiovascular- and chronic kidney disease

The research activities utilise biotechnological methods based on advanced protein chemistry and protein engineering. These methods have played a key role in the development of the production technology used to manufacture insulin, GLP-1, recombinant blood-clotting factors and human growth hormone.

In line with industry practice, Novo Nordisk expenses all internal research costs. Internal development costs are also expensed as incurred, due to regulatory and other uncertainties inherent in the development of new products. Hence, these do not qualify for capitalisation as intangible assets until marketing approval by a regulatory authority is obtained or highly probable.

Research and development activities are carried out by Novo Nordisk’s research and development centres, mainly in Denmark, the US and China. Research and development trials are carried out all over the world. Novo Nordisk also enters into partnerships and licence agreements.

Research and development costs primarily comprise employee costs, and internal and external costs related to execution of studies, including manufacturing costs and facility costs of the research centres. Further, the costs comprise amortisation, depreciation and impairment losses related to intangible assets and property, plant and equipment used in the research and development activities.

A very limited part of the research and development activities is recognised outside Research and development costs:

Up-front payments and milestone payments paid to partnerships prior to or upon regulatory approval are capitalised as intangible assets and amortised as Cost of goods sold over the useful life.
Royalty expenses paid to partnerships after regulatory approval are expensed as Cost of goods sold.
Royalty income received from partnerships is recognised as part of Other operating income, net.
Contractual research and development obligations to be paid in the future are disclosed separately as Commitments in note 5.2.

RESEARCH AND DEVELOPMENT COSTS BY BUSINESS SEGMENT (NOTE 2.2)
DKK million
2017

2016

2015

 
 
 
 
Diabetes care and obesity
11,358

11,481

10,475

Biopharmaceuticals
2,656

3,082

3,133

 
 
 
 
Total
14,014

14,563

13,608

 
 
 
 


RESEARCH AND DEVELOPMENT COSTS
DKK million
2017

2016

2015

 
 
 
 
Internal and external Research and development costs
7,430

7,494

7,352

Employee costs (note 2.4)
5,848

6,149

5,584

Amortisation and impairment losses, intangible assets (note 3.1)
211

427

247

Depreciation and impairment losses, property, plant and equipment
(note 3.2)
525

493

425

 
 
 
 
Total Research and development costs
14,014

14,563

13,608

As percentage of sales
12.5
%
13.0
%
12.6
%
 
 
 
 

For a review of the development in Research and development costs, refer to p 7 and p 10, ‘2017 performance and 2018 outlook’, which is not part of the audited financial statements.

Research costs comprise the very early stages of the drug development cycle from the initial drug discovery until the drug is ready for administration to humans. The activities initially focus on identifying a single drug candidate with a profile that will support a decision to initiate development activities. Before selection of the final drug candidate, it is tested in animals to gather efficacy, toxicity and pharmacokinetic information.

Development costs are incurred from the start of phase 1, when the drug is administered to humans for the first time; these are the projects captured in the pipeline overview on pp 22-23 (unaudited). The final product is developed, and subsequent clinical trials (phase 2 and 3) are conducted to further test the drug in humans, using the results from these trials to attempt to obtain marketing authorisation, permitting Novo Nordisk to market and sell the developed products.
EMPLOYEE COSTS

Accounting policies
Wages, salaries, social security contributions, annual leave and sick leave, bonuses and non-monetary benefits are recognised in the year in which the associated services are rendered by employees of Novo Nordisk. Where Novo Nordisk provides long-term employee benefits, the costs are accrued to match the rendering of the services by the employees concerned.

EMPLOYEE COSTS
DKK million
2017

2016

2015

 
 
 
 
Wages and salaries
23,869

24,651

23,289

Share-based payment costs (note 5.1)
292

368

442

Pensions – defined contribution plans
1,800

1,829

1,715

Pensions – defined benefit plans
165

145

154

Other social security contributions
1,910

1,853

1,783

Other employee costs
2,102

2,110

2,117

 
 
 
 
Total employee costs for the year
30,138

30,956

29,500

Employee costs capitalised as intangible assets and property, plant and equipment
(1,435
)
(1,258
)
(957
)
Change in employee costs capitalised as inventories
(91
)
(127
)
(191
)
 
 
 
 
Total employee costs
in the Income statement
28,612

29,571

28,352

 
 
 
 
Included in the Income statement:
 
 
Cost of goods sold
7,854

7,841

7,239

Sales and distribution costs
11,994

12,447

12,231

Research and development costs
5,848

6,149

5,584

Administrative costs
2,505

2,721

2,658

Other operating income, net
411

413

640

 
 
 
 
Total employee costs
in the Income statement
28,612

29,571

28,352

 
 
 
 

 
 
 
 
Average number of full-time employees
41,665

41,993

40,342

Year-end number of full-time employees
42,076

41,971

40,638

 
 
 
 

REMUNERATION TO EXECUTIVE MANAGEMENT AND BOARD OF DIRECTORS
DKK million
2017

2016

2015

 
 
 
 
Salary and cash bonus
74

77

89

Pension
18

20

22

Benefits4
6

10

7

Share-based incentive5
7

11

44

Severance payments1,4
0

66

73

 
 
 
 
Executive Management in total1,2,3
105

184

235

Fee to Board of Directors
16

14

12

Total
121

198

247

 
 
 
 
1.
Please refer to note 5.1 and ’Remuneration’, pp 50-53 (unaudited), for further information.
2.
President and CEO Lars Rebien Sørensen retired from Novo Nordisk on 31 December 2016. The 2016 remuneration for Lars Rebien Sørensen is included in the above table together with a severance payment of DKK 65.7 million. EVPs Jerzy Gruhn and Jesper Højland stepped down from Novo Nordisk´s Executive Management in 2016. The 2016 remuneration for Jerzy Gruhn and Jesper Høiland is included in the above table. EVP Kåre Schultz left Novo Nordisk on 30 April 2015. The 2015 remuneration for Kåre Schultz is included in the above table together with a severance payment of DKK 72.7 million.
3.
Total remuneration for registered members of Executive Management and the Board of Directors amounts to DKK 90 million (DKK 152 million in 2016 and DKK 120 million in 2015).
4.
Benefits are included in Other employee costs, and severance payments are included in Wages and salaries in the table above.
5.
Until 2017 the cost of the programme was expensed when shares was granted as the pool was fixed. From 2017 onwards, the programme will be expensed equally over the grant year and the subsequent 3 years of vesting as the number of shares will be reduced if a participant terminates employment with Novo Nordisk.
OTHER OPERATING INCOME, NET

Accounting policies
Other operating income, net, comprises licence income and income of a secondary nature in relation to the main activities of Novo Nordisk. Licence income is recognised on an accrual basis in accordance with the terms and substance of the relevant agreement. Operating profit from the wholly owned subsidiary NNE A/S, not related to Novo Nordisk’s main activities, is recognised as Other operating income. Other operating income also includes income from sale of intellectual property rights.

Divested subsidiaries are recognised in the Consolidated income statement until control is lost. Net gain or loss on divestments is determined as the difference between the sales proceeds and the carrying amount of net assets.

In March 2015, Novo Nordisk A/S disposed of 74.5% of its 100% interest in NNIT A/S. In total, DKK 2,376 million of non-recurring income from the partial divestment after costs of DKK 150 million was recorded as Other operating income in 2015. A total consideration of DKK 2,303 million was received and recorded in the cash flow statement.
INCOME TAXES AND DEFERRED INCOME TAXES

INCOME TAXES

Accounting policies
The tax expense for the period comprises current and deferred tax as well as interest on tax cases ongoing or settled during the year. Further, it includes adjustments to previous years and changes in provision for uncertain tax positions. Tax is recognised in the Income statement, except to the extent that it relates to items recognised in Equity or Other comprehensive income.

Ongoing tax disputes, primarily related to transfer pricing cases, are included as part of Deferred tax assets, Tax receivables and Tax payables.

Management judgement regarding recognition of deferred income tax assets and provision for uncertain tax positions
Novo Nordisk is subject to income taxes around the world. Significant judgement and estimates are required in determining the worldwide accrual for income taxes, deferred income tax assets and liabilities, and provision for uncertain tax positions.

Novo Nordisk recognises deferred income tax assets if it is probable that sufficient taxable income will be available in the future against which the temporary differences and unused tax losses can be utilised.

Management has considered future taxable income and used judgement in assessing whether deferred income tax assets should be recognised.

In the course of conducting business globally, tax and transfer pricing disputes with tax authorities may occur. Management judgement is applied to assess the possible outcome of such disputes. The 'most probable outcome' method is applied when making provisions for uncertain tax positions, and Novo Nordisk considers the provisions made to be adequate. However, the actual obligation may deviate and depends on the result of litigations and settlements with the relevant tax authorities.

US tax reform
The net deferred US tax asset has been reevaluated as a consequence of new US tax legislation, increasing the tax expense for 2017 by DKK 171 million.


INCOME TAXES EXPENSED
DKK million
2017

2016

2015

 
 
 
 
Current tax on profit for the year
10,562

8,981

9,648

Deferred tax on profit for the year
182

3,014

(1,130
)
 
 
 
 
 
 
 
 
Tax on profit for the year
10,744

11,995

8,518

Adjustments recognised for
current tax of prior years
(425
)
(3,191
)
3

Adjustments recognised for
deferred tax of prior years
231

1,069

102

 
 
 
 
Income taxes in the
Income statement
10,550

9,873

8,623

 
 
 
 
Current tax on Other comprehensive income for the year
(2
)
(28
)

Deferred tax on Other comprehensive income for the year
1,043

(296
)
87

 
 
 
 
Tax on other comprehensive income for the year, (income)/expense
1,041

(324
)
87

 
 
 
 

Adjustments recognised for prior years include adjustments caused by events that occurred in the current year related to current and deferred tax of prior years. Such adjustments predominantly arise from tax payments regarding tax disputes and reversal of the associated tax liability recognised in prior years.

DKK million
2017

2016

2015

 
 
 
 
Computation of effective tax rate:
 
 
 
Statutory corporate income tax rate
in Denmark
22.0
%
22.0
%
23.5
%
Deviation in foreign subsidiaries’
tax rates compared with the Danish
tax rate (net)
0.0
%
0.2
%
(2.9
%)
Non-taxable income from the partial divestment of NNIT A/S


(1.3
%)
Non-taxable income less non-tax-deductible expenses (net)
0.1
%
0.1
%
0.1
%
Others, including adjustment of
prior years
(0.4
%)
(1.6
%)
0.4
%
 
 
 
 
Effective tax rate
21.7
%
20.7
%
19.8
%
 
 
 
 

The impact of the deviation in foreign subsidiaries’ tax rates compared with the Danish tax rate is mainly driven by Swiss and US business activities.

2.6 INCOME TAXES AND DEFERRED INCOME TAXES (CONTINUED)

INCOME TAXES PAID
DKK million
2017

2016

2015

 
 
 
 
Income taxes paid in Denmark for
current year
6,798

5,506

5,926

Income taxes paid outside Denmark
for current year
2,639

2,645

3,040

Income taxes paid/
repayments relating to prior years
(336
)
(5,252
)
408

 
 
 
 
Total income taxes paid
9,101

2,899

9,374

 
 
 
 

The income taxes paid relating to prior years include repayments and adjustments arising from tax disputes primarily regarding transfer pricing.


DEFERRED INCOME TAXES

Accounting policies
Deferred income taxes arise from temporary differences between the accounting and taxable values of the individual consolidated companies and from realisable tax loss carry-forwards. The tax value of tax loss carry-forwards is included in deferred tax assets to the extent that these are expected to be utilised in future taxable income. The deferred income taxes are measured according to current tax rules and at the tax rates assumed in the year the assets are expected to be utilised. In general, the Danish tax rules related to company dividends provide exemption from tax for most repatriated profits. A provision for withholding tax is only recognised if a concrete distribution of earnings is planned.

The potential withholding tax amounts to DKK 343 million for 2017 (DKK 330 million in 2016).

The value of future tax deductions in relation to share programmes is recognised as deferred tax until the shares are paid out to the employees. Any estimated excess tax deduction compared to the costs realised in the Income statement is charged to Equity.

DEVELOPMENT IN DEFERRED INCOME TAX ASSETS AND LIABILITIES
DKK million
Property,
plant and
equipment

 Intangible
assets

Inventories

Provisions
and other
liabilities

Other2

Offset
within
countries

Total

 
 
 
 
 
 
 
 
2017
 
 
 
 
 
 
 
Net deferred tax asset/(liability) at 1 January
(966
)
(359
)
1,176

2,005

814


2,670

Income/(charge) to the Income statement
61

(132
)
(192
)
(182
)
32


(413
)
Income/(charge) to Other comprehensive income


(151
)
(26
)
(866
)

(1,043
)
Income/(charge) to Equity1




17


17

Effect of exchange rate adjustment
37

(9
)

(139
)
(25
)

(136
)
 
 
 
 
 
 
 
 
Net deferred tax asset/(liability) at
31 December
(868
)
(500
)
833

1,658

(28
)

1,095

 
 
 
 
 
 
 
 
Classified as follows:
 
 
 
 
 
 
 
Deferred tax asset at 31 December
237

57

2,194

1,748

318

(2,613
)
1,941

Deferred tax liability at 31 December
(1,105
)
(557
)
(1,361
)
(90
)
(346
)
2,613

(846
)
 
 
 
 
 
 
 
 
1.
Deferred tax related to value adjustment of restricted stock units. In addition, DKK 1 million related to current tax has also been charged to Equity. The net charge to Equity is DKK 18 million.
2.
Other includes hedging and tax loss carry forwards, etc.
2016
 
 
 
 
 
 
 
Net deferred tax asset/(liability) at 1 January
(765
)
(337
)
3,593

2,559

1,750


6,800

Income/(charge) to the Income statement
(188
)
(23
)
(2,390
)
(632
)
(850
)
 
(4,083
)
Income/(charge) to Other comprehensive income


(27
)
54

269

 
296

Income/(charge) to Equity3




(355
)
 
(355
)
Effect of exchange rate adjustment
(13
)
1


24


 
12

 
 
 
 
 
 
 
 
Net deferred tax asset/(liability) at 31 December
(966
)
(359
)
1,176

2,005

814


2,670

 
 
 
 
 
 
 
 
Classified as follows:
 
 
 
 
 
 
 
Deferred tax asset at 31 December
183

96

2,400

2,081

930

(3,007
)
2,683

Deferred tax liability at 31 December
(1,149
)
(455
)
(1,224
)
(76
)
(116
)
3,007

(13
)
 
 
 
 
 
 
 
 
3. Deferred tax related to value adjustment of restricted stock units. In addition, DKK 440 million related to current tax has also been charged to Equity. The net charge to Equity is DKK 85 million.

SPECIFICATION OF TAX LOSS CARRY-FORWARDS AT 31 DECEMBER
DKK million
2017

2016

Recognised deferred tax on tax loss carry forwards
24

39

Unrecognised tax base of tax loss carry-forwards
364

235

Classified as follows:
 
 
Expiry within one year

19

Expiry within two to five years
16


Expiry after more than five years
348

216

 
 
 


The total tax value of unrecognised tax loss carry forward amounts to DKK 93 million in 2017 (DKK 73 million in 2016).