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Investor presentation First nine months of 2015 London, 30 October 2015 Mexico City – part of Cities Changing Diabetes

Investor presentation First nine months of 2015 London, 30 ...Oct 30, 2015  · Slide 3 5,05 4,10 3,50 4,72 11,82 11,82 Investor presentation First nine months of 2015 Forward-looking

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Page 1: Investor presentation First nine months of 2015 London, 30 ...Oct 30, 2015  · Slide 3 5,05 4,10 3,50 4,72 11,82 11,82 Investor presentation First nine months of 2015 Forward-looking

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Investor presentation

First nine months of 2015

London, 30 October 2015

Mexico City – part of Cities Changing Diabetes

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Agenda

Investor presentation First nine months of 2015

Highlights and key events

R&D update

Financials and outlook

Sales update

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Investor presentation First nine months of 2015

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:

• Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk’s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto

• Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures

• Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and

• Statements regarding the assumptions underlying or relating to such statements.

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 recall, 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 p 42-43 of the Annual Report 2014 on the company’s website novonordisk.com.

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.

Important drug information

• Victoza® (liraglutide 1.2 mg & 1.8 mg) is approved for the management of type 2 diabetes only

• Saxenda® (liraglutide 3 mg) is approved in the US and EU for the treatment of obesity only

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Highlights – first nine months of 2015

Investor presentation First nine months of 2015

Research and Development • US FDA approves Tresiba® and Ryzodeg® 70/30 for the treatment of diabetes in adults • SUSTAIN® 3, comparing semaglutide with once-weekly exenatide in people with type 2 diabetes, successfully completed • Based on evaluation of ADJUNCT trials, liraglutide label expansion in type 1 diabetes will currently not be pursued

Sales development • Sales increased by 23% in Danish kroner and 9% in local currencies

• North America and International Operations grew by 33% and 23% in Danish kroner, respectively • Victoza® increased by 39% in Danish kroner and continues to drive the growth of the GLP-1 market • Levemir® increased by 27% in Danish kroner and gains market share in the US despite increased competition

• Tresiba® continues to perform well in countries with similar reimbursement as insulin glargine

Financials • Operating profit growth of 51% in Danish kroner; adjusted for partial NNIT divestment, growth was 16% in local currencies • Diluted earnings per share increased 36% to 10.28 DKK per share • 2015 financial outlook:

• Sales growth is still expected to be 7-9% in local currencies (now around 13% higher in Danish kroner) • Operating profit growth is now expected around 20% in local currencies compared to 19% previously (now around 22% higher in Danish kroner)

• 2016 preliminary financial outlook in local currencies: • Sales growth is expected to be mid to high single-digit • Operating profit growth is expected to be mid to high single-digit, adjusted for the partial divestment of NNIT and

out-licensing income from the divestment of inflammation assets, both in 2015

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Growth analysis – First nine months of 2015

North America is the main contributor to growth

Sales as reported – First nine months of 2015

Local currencies Growth Share of growth

North America 10% 56%

Europe 3% 8%

International Operations 17% 27%

Region China 5% 6%

Japan & Korea 5% 3%

Total sales 9% 100%

International Operations

+23%

Region China +26%

Japan & Korea +10%

North America +33%

Europe +4%

52%

19%

14%

10%

5%

Sales of DKK 79.1 billion (+23%)

Investor presentation First nine months of 2015

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Local currencies Growth Share of growth

New-generation insulin 137% 10%

Modern insulin 6% 32%

Human insulin 1% 1%

Victoza® 21% 36%

Other diabetes and obesity care1 4% 2%

Diabetes and obesity care 9% 81%

Haemophilia 4% 5%

Norditropin® 10% 8%

Other biopharmaceuticals2 14% 6%

Biopharmaceuticals 8% 19%

Total 9% 100%

Growth is driven by Victoza® and modern insulin

Sales as reported – First nine months of 2015 Growth analysis – First nine months of 2015

1 Predominantly oral antidiabetic products, needles and Saxenda®

2 Predominantly hormone replacement therapy

Other biopharmaceuticals +31%

7% Haemophilia

+17% 11%

Diabetes and obesity care

+24%

79%

3%

79%

10%

7% 4%

Norditropin®

+23%

Sales of DKK 79.1 billion (+23%)

Investor presentation First nine months of 2015

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59%

7% 7%

27%

0%

20%

40%

60%

80%

100%

Source: IMS NPA MAT, August 2015

US GLP-1 market development

Source: IMS NPA MAT, August 2015

Total TRx Growth rate

0%

5%

10%

15%

20%

25%

0

1.000

2.000

3.000

4.000

5.000

6.000

Thousands

US GLP-1 market shares

exenatide Victoza®

albiglutide dulaglutide MAT GLP-1 TRx (000)

GLP-1 TRx market share

MAT volume growth rate

Victoza® maintains leadership in the faster growing US GLP-1 market

Aug 2015

Aug 2012

Aug 2012

Aug 2015

Investor presentation First nine months of 2015

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0%

20%

40%

60%

80%

Levemir® gains US market share despite introduction of glargine U300

0,0

2,0

4,0

6,0

8,0

10,0

12,0

Note: Reported sales first nine months of 2015

Levemir® sales growth driven by strong performance in North America

North America drives strong Levemir® growth despite increased competition

68%

North America

Europe IO China Japan & Korea

DKK billion

14%

Growth in local currency

-1% 9%

6% -17%

Source: IMS MAT volume figures, August 2015

glargine U100

Levemir® NPH

Aug 2012

Aug 2015

glargine U300

0.5%

66%

24%

10%

Investor presentation First nine months of 2015

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Key launch observations Tresiba® value share of basal insulin segment

in selected countries

Roll-out of degludec portfolio is progressing

Note: Limited IMS coverage in India Source: IMS Monthly value figures, August 2015 *Tresiba® distribution in Germany to be ceased following the negative price negotiation outcome with the German national association of statutory health insurance funds

Months from launch

• Tresiba® launched in 36 countries

• Tresiba® has shown solid penetration in markets with similar reimbursement as insulin glargine

• Penetration of Tresiba® remains modest in markets with restricted market access compared to insulin glargine

• Tresiba® to be launched in the US early 2016

• Ryzodeg® commercially launched in Mexico, India and Bangladesh

• Xultophy® launched in Switzerland, Germany, the United Kingdom and now Sweden

31%

6%

15%

8%*

3%

3%

10%

14% 16%

26%

0%

5%

10%

15%

20%

25%

30%

35%

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30

Mexico

Switzerland

Japan India Sweden Denmark

Germany Argentina Brazil

United Kingdom

Investor presentation First nine months of 2015

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10,206

5,021

2,122

1,600 0

2.000

4.000

6.000

8.000

10.000

12.000

• Encouraging Saxenda® uptake continues

• Temporary and contracted coverage emerging earlier than expected with gradual improvements in formulary access with more than 50 million lives now covered

• The SCALE Diabetes Trial manuscript was published in the Journal of the American Medical Association (JAMA) on 18 August, 2015, highlighting key efficacy and safety data points

Note: IMS reporting for new launches may reflect data instability due to small volume and/or supplier reporting Source: IMS NPA TRx, Weekly data, 25 September 2015

Prescription volume uptake of anti-obesity medications recently launched in the US Key launch observations

Encouraging early prescription development for Saxenda®

Investor presentation First nine months of 2015

TRx volume

Weeks from launch

Saxenda®

lorcaserin

phentermine & topiramate

naltrexone HCI & bupropion HCI

0 2 4 6 8 10 12 14 16 18 20 22 24

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Tresiba® approved in the US for glycaemic control in adults with diabetes mellitus

Competitive US label for Tresiba®

Investor presentation First nine months of 2015

• Reduction in HbA1c confirmed to be non-inferior in all trials against all comparators

• Numerically greater FPG reduction

• Numerically lower insulin dose observed in majority of comparator trials

• Injection at any time of day

• Two concentrations enabling dosing of up to 80 and 160 units per injection, respectively

• Half-life of 25 hours and duration of action of at least 42 hours

• Day to day variability of 20%

Convenience

Safety

Efficacy

Profile

• Overall safety consistent with other insulins

• Hypoglycaemia rates for Tresiba®, but not comparators

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SUSTAIN® 3 trial design Headline results

Semaglutide 1.0 mg QW

Exenatide 2.0 mg QW

Change in HbA1c (8.4% baseline)

-1.5%* -0.9%

Proportion of patients reaching HbA1c target of <7%

67%*2 40%

Change in body weight (96 kg baseline)

-5.6 kg* -1.9 kg2

Discontinuation rate due to adverse events

9.4% 7.2%

Semaglutide shows superior HbA1c reduction and weight loss compared with exenatide once-weekly in SUSTAIN® 3

1 Inclusion criteria: Type 2 diabetes, treated with 1-2 oral antidiabetic drugs, HbA1c 7.0-10.5% (53 - 91 mmol/mol) (both inclusive) QW = Once weekly

* Statistically significantly greater compared to placebo 2 Adjusted from 66% and -1.8 kg respectively after post-trial validation

Investor presentation First nine months of 2015

Exenatide 2.0 mg QW

0 56 weeks

813 people with type 2 diabetes1

Semaglutide 1.0 mg QW

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• Greater improvement in HbA1c and statistically significantly greater weight reduction with 1.2 mg and 1.8 mg doses of liraglutide compared with placebo

• Numerically, but not statistically significantly lower rates of severe hypoglycaemia for all doses of liraglutide compared with placebo

• A statistically significantly higher rate of confirmed symptomatic hypoglycaemia was observed among people treated with liraglutide 1.2 mg and 1.8 mg compared with placebo

• Based on a benefit/risk assessment of the two ADJUNCT trials, Novo Nordisk does currently not intend to submit an application to expand the label of liraglutide for use in type 1 diabetes

ADJUNCT ONE trial design Headline results

Based on assessment of ADJUNCT results, liraglutide label expansion in type 1 diabetes will not be pursued at present

Investor presentation First nine months of 2015

52 weeks

1,398 people with type 1 diabetes1

1 Inclusion criteria: Type 1 diabetes as diagnosed clinically 12 months or prior to visit 1, 18 years or older, treatment with basal bolus or continuous subcutaneous insulin infusion 6 months or longer prior to visit 1, stable insulin treatment 3 months or longer prior visit 1, HbA1c 7.0-10.0% (53 - 86 mmol/mol) (both incl.)

0

Placebo + insulin

Liraglutide 1.8 mg + insulin

Liraglutide 1.2 mg + insulin

Liraglutide 0.6 mg + insulin

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Key development milestones

Investor presentation First nine months of 2015

• Xultophy® (IDegLira) filed with the US FDA for regulatory review

• Faster-acting insulin aspart (NN1218) completed the planned additional 26-week treatment period of the onset® 1 trial

• Phase 3a development of oral semaglutide (NN9924), a once-daily oral GLP-1 treatment, to be initiated

• Phase 2 trial initiated with semaglutide (NN9535) administered once daily for people with type 2 diabetes

• Phase 1 development successfully completed with once-weekly insulin LAI287 (NN1436)

• Phase 2 trial initiated with semaglutide (NN9536) administered once daily for treatment of obesity

• Phase 1 trial initiated with PYY (NN9747) for treatment of obesity

• Novo Nordisk acquired US research companies Calibrium LLC and MB2 LLC

Diabetes

Obesity

Other

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DKK million 9M 2015 9M 2014 Change Sales 79,051 64,221 23% Gross profit 67,471 53,658 26% Gross margin 85.4% 83.6%

Sales and distribution costs 20,273 16,544 23% Percentage of sales 25.6% 25.8%

Research and development costs 9,574 9,897 (3%) Percentage of sales 12.1% 15.4%

Administration costs 2,693 2,470 9% Percentage of sales 3.4% 3.8%

Other operating income, net 3,388 588 N/A Non-recurring income from the IPO of NNIT 2,376

Operating profit 38,319 25,335 51% Net financials (5,150) 409 N/A Profit before income tax 33,169 25,744 29% Tax 6,567 5,792 13% Effective tax rate 19.8% 22.5%

Net profit 26,602 19,952 33% Diluted earnings per share (DKK) 10.28 7.56 36% Diluted earnings per share (DKK) adjusted for NNIT IPO 9.40 7.56 24%

Financial results – first nine months of 2015

Investor presentation First nine months of 2015

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40

60

80

100

120

140

3 1 2 4 1 3

90

95

100

105

110

115

120

125

130

135

Appreciation of key currencies against the Danish krone drive significant positive currency impact in 2015

Investor presentation First nine months of 2015

Hedged c

urr

encie

s

Index (

1 J

an 2

014 =

100)

CNY/DKK JPY/DKK USD/DKK

Non-h

edged c

urr

encie

s

Index (

1 J

an 2

014 =

100)

2014

CAD/DKK GBP/DKK

1 DKK per 100; 2 As of 27 October 2015; 3 Operating profit in DKK million per annum; 4 USD and Chinese Yuan traded offshore (CNH) used as proxy; 5 Operating profit impact of one of the non-hedged currencies fluctuating 5% is in the range of DKK -15 to +25 million

Hedged Currencies

2014 average

2015 average2

Spot rate2

Impact of a 5% move3

Hedging (months)

USD1 562 669 678 1,800 11

CNY1 91.2 106.9 106.7 300 114

JPY1 5.32 5.54 5.60 130 12

GBP1 925 1,025 1,038 85 11

CAD1 509 529 515 70 11

Non-hedged Currencies5

2014 average

2015 average2

Spot rate2

RUB1 14.8 11.2 10.8

INR1 9.20 10.50 10.4

ARS1 0.69 0.74 0.71

BRL1 239 210 176

TRY1 257 250 235

INR/DKK ARS/DKK RUB/DKK TRY/DKK BRL/DKK

2015

2

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Financial outlook for 2015

The financial outlook is based on an assumption of a continuation of the current business environment and given the current scope of business activities and has been prepared assuming that currency exchange rates remain at the level as of 27 October 2015

Investor presentation First nine months of 2015

Sales growth - local currencies

Sales growth - reported

Operating profit growth - local currencies

Operating profit growth - reported

Net financials

Effective tax rate

Capital expenditure

Free cash flow

Expectations 29 October 2015

7-9%

Around 13 percentage points higher

Around 20%

Around 22 percentage points higher

Loss of around DKK 5.6 billion

Around 20%

Around DKK 5.0 billion

Around DKK 2.9 billion

Around DKK 33-35 billion

Previous expectations 6 August 2015

Depreciation, amortisation and impairment losses

7-9%

Around 14 percentage points higher

Around 19%

Around 23 percentage points higher

Loss of around DKK 5.7 billion

Around 21%

Around DKK 5.0 billion

Around DKK 3.0 billion

Around DKK 33-35 billion

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Source: IMS MAT August 2015 volume and value (DKK) figures

Solid market performance Promising pipeline

Closing remarks

> > • The only company with a full portfolio of novel insulin products

• GLP-1 portfolio offers expansion opportunity with both injectable and oral administration

• Xultophy® supports promising outlook for insulin and GLP-1 combination therapy

• Saxenda® and multiple early stage development projects hold potential within obesity

• Broad pipeline within haemophilia and growth hormone disorders

• ≥10% annual diabetes care market growth driven by diabetes prevalence

• 28% market share in diabetes care and solid leadership position

• 47% insulin volume market share with leadership position across all regions

• 45% modern and new-generation insulin volume c market share

• 69% GLP-1 value market share with strong global leadership position

Investor presentation First nine months of 2015

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Share information Investor Relations contacts

Investor contact information

Novo Nordisk’s B shares are listed on the stock exchange in Copenhagen under the symbol ‘NOVO B’. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For further company information, visit Novo Nordisk on the internet at: novonordisk.com

Peter Hugreffe Ankersen +45 3075 9085 [email protected]

Daniel Bohsen +45 3079 6376 [email protected]

Melanie Raouzeos +45 3075 3479 [email protected]

Kasper Veje +45 3079 8519 [email protected]

In North America:

Frank Daniel Mersebach

+1 609 235 8567

[email protected]

Novo Nordisk A/S Investor Relations Novo Allé, DK-2880 Bagsværd

Upcoming events

Investor presentation First nine months of 2015

19 Nov 2015 Capital Markets Day 2015

03 Feb 2016 Financial statement for 2015

18 Mar 2016 Annual General Meeting 2016

29 Apr 2016 Financial statement for the first three months of 2016

05 Aug 2016 Financial statement for the first six months of 2016

28 Oct 2016 Financial statement for the first nine months of 2016