investor presentation full year 2014 copenhagen 30 january 2015€¦ · 30-01-2015 · investor...

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Investor presentation

Full year 2014

Copenhagen 30 January 2015

Mexico City – part of Cities Changing Diabetes

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Agenda

Investor presentation Full year 2014

Highlights and key events

R&D update

Financials and outlook

Sales update

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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:

• 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, as of 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.

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 for the treatment of obesity only


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Highlights – full year 2014


Sales development • Sales increased by 8% in local currencies and 6% in Danish kroner

• North America, International Operations and Region China grew by 11%, 14% and 13% in local currencies, respectively • Modern insulin increased by 11% in local currencies driven by solid Levemir® growth

• Victoza® increased by 16% in local currencies and continues to drive the growth of the GLP-1 market • Tresiba® continues to perform well in countries with similar market access as insulin glargine

Research and Development • DEVOTE recruitment completed and the required number of MACE for the interim analysis accumulated • Saxenda® (liraglutide 3 mg) approved for the treatment of obesity in the US and received positive CHMP opinion in Europe • Phase 3b trial with Xultophy® shows benefits for people with type 2 diabetes inadequately controlled on insulin glargine

• Phase 3a trial with faster-acting insulin aspart shows effective lowering of HbA1c

Financials • Operating profit increased 13% in local currencies and diluted earnings per share increased 8% • 2015 financial outlook:

• Sales growth expected to be 6-9% in local currencies (around 12% higher as reported) • Operating profit growth around 10% in local currencies (around 19% higher as reported)

• 11% increase in dividend to DKK 5.00 per share of DKK 0.2 proposed

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Growth analysis – full year 2014

North America is the main contributor to growth


Sales as reported – full year 2014

Local currencies Growth Share of growth

North America 11% 61%

Europe 0% 1%

International Operations 14% 25%

Region China 13% 14%

Japan & Korea (1%) (1%)

Total sales 8% 100%

International Operations

+4%

Region China +13%

Japan & Korea (8%)

North America +11%

Europe 0%

49%

23%

14%

9%

5%

Sales of DKK 88.8 billion (+6%)

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Sales as reported – full year 2014

Sales of DKK 88.8 billion (+6%)

Growth is driven by modern insulin and Victoza®


Local currencies Growth Share of growth

New-generation insulin n/a 8%

Modern insulin 11% 61%

Human insulin (3%) (5%)

Protein-related products 0% 0%

Victoza® 16% 27%

OAD (22%) (7%)

Diabetes care 9% 84%

NovoSeven® 0% 0%

Norditropin® 10% 9%

Other biopharmaceuticals 17% 7%

Biopharmaceuticals 6% 16%

Total 8% 100%

Other +16%

7% NovoSeven®

(1%) 11%

Diabetes care +7%

79%

3%

79%

10%

7% 4%

Growth analysis – full year 2014

Norditropin®

+6%

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66%

33%

0%

20%

40%

60%

80%

100%

Source: IMS NPA Monthly, Nov 2014

US GLP-1 market development

Source: IMS NPA Monthly, Nov 2014

Victoza® maintains leadership in the US GLP-1 market


Nov 2014

Nov 2011

Nov 2014

Nov 2011

Total TRx Growth rate

0%

5%

10%

15%

20%

25%

0

1,000

2,000

3,000

4,000

5,000

Thousands

US GLP-1 market shares

MAT GLP-1 TRx (000)

GLP-1 TRx market share

MAT volume growth rate

exenatide Victoza®

albiglutide dulaglutide

1.3%

0.2%

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0%

5%

10%

15%

20%

25%

30%

40%

50%

60%

70%

0

2

4

6

8

10

Levemir® sales growth driven by strong performance in North America

North America drives strong Levemir® performance aided by continued market share gains in the US

68%

1%

North America

Europe IO China Japan & Korea

DKK billion

38%

Growth in local currency

1%

19%

42% -21%

Note: Reported sales full year 2014


Levemir® market share and device penetration in the US modern basal insulin segment

Nov 2014

Market share

Nov 2013

Nov 2012

Nov 2011

Device penetration

0%

Levemir® market share Levemir® device penetration

Source: IMS MAT volume figures

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25%

15%

26%

13%

6%

2%

2%

6% 6%

2% 0% 0%

5%

10%

15%

20%

25%

30%

1 3 5 7 9 11 13 15 17 19 21

Mexico

Note: Limited IMS coverage in India Source: IMS Monthly value figures, Nov 2014

Tresiba® value market share in basal insulin segment in selected markets Key launch observations

Tresiba® continues to perform well in countries with similar market access as insulin glargine


Months from launch

• Tresiba® grows share of basal insulin market steadily in countries with reimbursement similar to insulin glargine

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

• Tresiba® has been launched in 23 countries, recently in Brazil, Slovakia, Chile, Russia and Italy

• Ryzodeg® commercially launched in Mexico in September and recently in India with encouraging early feedback

• Xultophy® launched in Switzerland as first country

Switzerland

Japan India Sweden Denmark

United Kingdom Germany Argentina Brazil Netherlands

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1 Key inclusion criteria: Age ≥ 50 years at screening with established CV disease or chronic kidney disease or Age ≥ 60 years at screening with risk factors for CV disease. Treatment with one or more oral or injectable anti-diabetic drug(s). Insulin naïve with HbA1c≥7.0 and eligible for insulin treatment or insulin treated with HbA1c ≥ 7.0 or HbA1c < 7.0 and current insulin treatment corresponding to at least 20IU of basal insulin. OAD: Oral Anti-Diabetic drug; HR: Hazard Ratio; MACE: Major Adverse Cardiovascular Event.

• Recruitment completed and data for interim analysis accumulated

• Access to interim data is restricted to a small team. Novo Nordisk management does not have access to the data

• Decision during the first half of 2015 whether to submit the result of this interim analysis to the FDA or whether to await completion of the trial

• The trial is now expected to be completed in the second half of 2016 (previously between Oct 2016 and Oct 2017)

Status and next steps

Decision to submit interim analysis to the FDA still expected during the first half of 2015


DEVOTE (EX1250-4080) trial design

Insulin glargine (blinded vial) + standard of care

Tresiba® (blinded vial) + standard of care

Oct 2013 H2 2016

7,644 people with type 2 diabetes currently on OADs or insulin1

Interim analysis Final analysis

Early 2015

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Saxenda® approved in the US for chronic weight management in individuals with a BMI ≥30, or ≥27 in the presence of at least one weight-related comorbidity1

1 Examples include hypertension, type 2 diabetes and dyslipidemia. 2 Saxenda® US Package Information. 3 When used with an insulin secretagogue

Competitive US label for Saxenda®


• Improvements in cardiometabolic risk factors such as hypertension and dyslipidaemia

• Boxed warning on thyroid C-cell tumours

• Precautions on acute pancreatitis, acute gallbladder disease, serious hypoglycaemia3, heart rate increase, renal impairment, hypersensitivity and suicidal ideation

Profile

Safety

Effect on body weight

Effect on comorbidities

• GLP-1 receptor agonist – a physiological regulator of appetite and calorie intake

• Saxenda® is the first and only GLP-1 receptor agonist approved for weight management

• 9 in 10 lose weight and 1 in 3 people lose more than 10% of their body weight2

• Average weight loss of 9.2% in completers at one year2

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DUALTM V trial design Headline results

People inadequately controlled on insulin glargine benefit from switching to Xultophy® in phase 3b trial


Insulin glargine + metformin

Xultophy® + metformin

0

1:1 randomisation Primary end-point: HbA1c reduction

557 people with type 2 diabetes, currently on insulin glargine + metformin1

* Xultophy® statistically significantly better than insulin glargine 1 Inclusion criteria: Type 2 diabetes, 7.0% ≤ HbA1c ≤ 10.0%, BMI ≤ 40 kg/m2, age ≥ 18 years and

insulin glargine dose 20-50 units

Xultophy® Insulin glargine

Baseline HbA1c 8.4% 8.2%

HbA1c reduction 1.8%* 1.1%

% reaching HbA1c target of 7%

72%* 47%

Weight change -1.4 kg* +1.8 kg

Confirmed and nocturnal hypoglycaemia

Lower rate* n/a 26

weeks

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• Further improved HbA1c from 7.9 % to 6.8% in the faster- acting insulin + basal insulin arm

• Treatment difference in HbA1C of 0.9 % compared to patients continuing with basal therapy

• Overall improvement in post-meal glucose parameters

• As expected, higher rate of hypoglycaemia and more weight gain with bolus insulin therapy compared with continued basal therapy

• Previously reported safety and tolerability profile confirmed

1 Inclusion criteria: Type 2 diabetes, once daily basal insulin ≥ 3 months, HbA1c 7.5-9.5% (metformin group) or 7.5%-9.0% (metformin + other OAD group), BMI ≤ 40.0 kg/m2. 236 people randomised.. TID: Three times a day

onset® 3 trial design Results achieved by randomised patients

Phase 3a trial with faster-acting insulin aspart shows effective lowering of HbA1c


Basal insulin + metformin

Faster-acting insulin aspart (TID) + basal insulin +

metformin

323 people with type 2 diabetes, currently on basal insulin1

Basal insulin

optimisation

-8 18 weeks

1:1 randomisation of patients above target Primary end-point: HbA1c change from baseline

0

Run in

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Key development milestones


● SUSTAIN™ 5, the last trial in the global phase 3a programme for semaglutide (NN9535) initiated

● Phase 1 development initiated with long-acting amylin analogue (NN9838) for the treatment of obesity

● Oral GLP-1, OG217GT (NN9928) discontinued in phase 1

● Completion of phase 3a paediatric trial with N8-GP (NN7088) in children with haemophilia A

● Phase 3 development for AGHD1 with once-weekly growth hormone (NN8640) initiated

1 Adults with growth hormone deficiency

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Timing of upcoming key R&D milestones

Note: Indicated timeline as of full year financial release 2014

Project Within ~3 months In ~3-6 months In ~6-9 months In ~9-12 months

Oral GLP-1 Phase 2a

Tresiba® Resubmission decision on DEVOTE interim data

Faster-acting insulin aspart onset® 1

onset® 2

LATIN T1D ADJUNCT TWOTM

ADJUNCT ONETM

Results available

In ~12-15 months

Semaglutide

SUSTAIN™ 1

SUSTAIN™ 3

SUSTAIN™ 2

SUSTAIN™ 4

SUSTAIN™ 5

Victoza®

SUSTAIN™ 6

LEADER™

Saxenda® SCALE™ extension data


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DKK million 2014 2013 Change

Sales 88,806 83,572 6% Gross profit 74,244 69,432 7% Gross margin 83.6% 83.1%

Sales and distribution costs 23,223 23,380 (1%) Percentage of sales 26.2% 28.0%

Research and development costs 13,762 11,733 17% Percentage of sales 15.5% 14.0%

Administration costs 3,537 3,508 1% Percentage of sales 4.0% 4.2%

Other operating income, net 770 682 13% Operating profit 34,492 31,493 10% Net financials (396) 1,046 N/A Profit before income tax 34,096 32,539 5% Tax 7,615 7,355 Effective tax rate 22.3% 22.6%

Net profit 26,481 25,184 5% Diluted earnings per share (DKK) 10.07 9.35 8%

Financial results – full year 2014


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40

60

80

100

120

140

160

80

90

100

110

120

130

140

Recent appreciation of the US dollar against the Danish krone will provide positive currency impact for 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)

2013 2014

CAD/DKK GBP/DKK

1 DKK per 100; 2 As of 27 Jan 2015; 3 Operating profit in DKK million per annum; 4 USD used as proxy; 5 Operating profit impact of one of the non-hedged currencies fluctuating 5% is in the range of DKK 15-30 million

Hedged Currencies

2013 average

2014 average2

Spot rate2

Impact of a 5% move3

Hedging (months)

USD1 562 562 659 1,600 11

CNY1 91.3 91.2 105.6 260 114

JPY1 5.77 5.32 5.60 115 12

GBP1 878 925 997 80 11

CAD1 545 509 529 60 11

Non-hedged Currencies5

2013 average

2014 average2

Spot rate2

RUB1 17.6 14.8 9.7

INR1 9.62 9.20 10.73

ARS1 1.03 0.69 0.76

BRL1 261 239 254

TRY1 296 257 278

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

3 1 2 4


3 1 2 4

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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 Jan 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 30 Jan 2015

6-9%

Around 12% percentage points higher

Around 10%

Around 19% percentage points higher

Loss of around DKK 5 billion

Around 22%

Around DKK 5.0 billion

Around DKK 3.0 billion

DKK 29-31 billion

Depreciation, amortisation and impairment losses


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Annual cash return to shareholders Share repurchase programmes have enabled

continued reduction in share capital

6 8 10 12 13

12 12

14 15 15

0

5

10

15

20

25

30

35

2011 2012 2013 2014 2015E

Organic growth enables steady cash return to shareholders via dividends and share repurchase programmes

Note: 2015 dividend and share repurchase programme pending approval at the Annual General Meeting. Dividends are allocated to the year of dividend pay. For 2015 expected free cash flow is DKK 29-31 billion.

Note: Share repurchase programmes run for 12 months starting February until end January of the following year.


580 560 550 530 520

300

350

400

450

500

550

600

2011 2012 2013 2014 2015E

DKK billion

DKK million

0

Share repurchase Dividend Share capital Free cash flow CAGR -2.7%

-3% -2%

-4% -2%

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Solid market performance Promising pipeline

Closing remarks


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

insulin products

• GLP-1 portfolio offers expansion opportunity within type 1 and 2 diabetes

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

• Saxenda® holds potential within obesity

• Promising pipeline within haemophilia and growth hormone disorders

• 12% annual diabetes care market growth driven by diabetes prevalence

• 27% market share in diabetes care and solid leadership position

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

• 46% modern and new-generation insulin volume c market share

• 72% GLP-1 value market share with strong global leadership position

Source: IMS MAT Nov 2014 value and volume figures

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Upcoming events

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

Kasper Roseeuw Poulsen +45 3079 4303 [email protected]

Jannick Lindegaard Denholt +45 3079 8519 [email protected]

Daniel Bohsen +45 3079 6376 [email protected]

Melanie Raouzeos +45 3075 3479 [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

19 Mar 2015 Annual General Meeting and Shareholder Meeting

30 Apr 2015 Financial statement for the first three months of 2015

06 Aug 2015 Financial statement for the first six months of 2015

29 Oct 2015 Financial statement for the first nine months of 2015

03 Feb 2016 Financial statement for 2015

Share information

mailto:[email protected]





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Appendix

1. Novo Nordisk at a glance

3. Biopharmaceuticals

4. Financials

2. Diabetes


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Global leader in diabetes care

Novo Nordisk at a glance

Source: IMS MAT Nov 2014 volume figures

R&D facility Manufacturing Global/regional headquarter

North America: Market share 37%

International Operations: Market share 55%

Japan & Korea: Market share 49%

Europe: Market share 48%

China: Market share 58%

Global insulin market share: 47%


• A focused pharmaceutical company with leading positions

in diabetes, haemophilia and growth hormone

• Double digit top line growth driven by diabetes pandemic

• Significant growth opportunities fuelled by global

presence and strong R&D pipeline

• High barriers to entry in biologics

• Operating margin targeting 40%

• Operating profit growth targeting 15%

• Earnings conversion to cash targeting 90%

• Cash generated returned to shareholders

The core equity story

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Slide 24

Novo Nordisk works with four strategic focus areas based on five core capabilities

Core capabilities

Expand leadership

Expand leadership in DIABETES

Pursue leadership in HAEMOPHILIA

Establish presence in OBESITY

Expand leadership in GROWTH DISORDERS

Strategic focus areas


Novo Nordisk Way and the Triple Bottom Line business principle

Engineering, formulating, developing and delivering protein- based treatments

Deep disease under- standing

Efficient large-scale production of proteins

Building and maintaining a leading position in emerging markets

Planning and executing global launches of new products

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Slide 25

Novo Nordisk has leading positions in diabetes, haemophilia and growth disorders


DKK billion

1 CAGR for 5-year period Source: IMS MAT value figures

Growth hormone disorders Diabetes

DKK billion Novo Nordisk value market share

Global market position

Novo Nordisk value market share

Market value


1 CAGR for 5-year period Source: IMS MAT value figures

0%

5%

10%

15%

20%

25%

30%

35%

0

50

100

150

200

250

300#1

0%

5%

10%

15%

20%

25%

30%

35%

0

4

8

12

16

20#1

CAGR1 value: 13.4% CAGR1 value: 4.6%

Nov 2009

Nov 2014

Nov 2009

Nov 2014

Market value

0%

5%

10%

15%

20%

25%

30%

35%

0

10

20

30

40

50

60

70

DKK billion

Haemophilia Market value

Note: Annual sales figures for Haemophilia A,B and inhibitor segment. 1 CAGR for 5-year period Source: Company reports

#2

CAGR1 value: 8.6%

FY 2008

FY 2013

Novo Nordisk value market share


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Slide 26

0

100

200

300

400

500

600

0

5

10

15

20

25

30

Novo Nordisk reported quarterly sales by therapy

The number of people with diabetes according to IDF

Double digit top line growth driven by diabetes pandemic

Note: 20-79 age group 1 CAGR for 14-year period Source: International Diabetes Federation: Diabetes Atlas, 2000 and 2014

DKK billion

Diabetes care NovoSeven®

Norditropin® Other Million people

Reported sales CAGR1: 12.0%

10.8%

8.1%

13.0%

7.9%

Q4 2004

Q4 2014

2000 2014 2035E

151

387

215

99

34 29

CAGR1: 7.0%

592

10

355

146

45 33

13


1 CAGR for 10-year period

Europe North America Japan & Korea

International Operations China

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Slide 27

0%

10%

20%

30%

Global diabetes care value market share

Novo Nordisk has a strong leadership position within the growing diabetes care market

Source: IMS Monthly MAT value figures

Nov 2004

Nov 2014

27%


GSK

Merck Eli Lilly Sanofi

Takeda

Novo Nordisk

AstraZeneca Novartis

Global diabetes care market by treatment class

0

50

100

150

200

250

300

1CAGR for 10-year period Source: IMS Monthly MAT value figures

DKK billion

OAD Insulin GLP-1

Total market: CAGR1 12.1%

CAGR1 16.0%

Injectables: CAGR1 17.3%

CAGR1 7.1%

Nov 2004

Nov 2014

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Slide 28

NovoEight®

NovoSeven®

NovoThirteen®/TRETTEN®

Norditropin®

Significant growth opportunities fuelled by strong R&D pipeline in diabetes, obesity and biopharmaceuticals

1 First Phase 2a trial to be initiated H1 2015 2 Approved in all triad markets (US, EU and Japan), unless noted 3 Approved in Europe on 18 Sep 2014 4 Approved in the US on 23 Dec 2014, positive CHMP opinion on 22 Jan 2015


Saxenda® (US4)

Semaglutide – QW GLP-1

Faster-acting insulin aspart

OI338GT – Oral insulin1

OG987GT – Oral GLP-1 OG217SC – Oral GLP-1

LATIN – Type 1 diabetes

OG987SC – Oral GLP-1

LAI287 – QW basal insulin

PHASE 1 PHASE 2 PHASE 3 SUBMITTED APPROVED2

NovoRapid®

NovoMix®

Victoza®

Levemir®

NN8640 – Once-weekly GH

NN7415 – Concizumab

N8-GP – Long-acting rFVIII

N9-GP – Long-acting rFIX

Tresiba® (EU/Japan)

Ryzodeg® (EU/Japan)

Diabetes

Obesity

Haemophilia

Growth hormone

Xultophy® (EU3) G530L – Glucagon analogue

LAI338 – QD basal insulin

NN9838 – Amylin analogue

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FTEs in sales regions1 Global manufacturing setup

Growth opportunities supported by strong global presence in both sales and manufacturing

1 FTEs represent full-time employee equivalents in Novo Nordisk’s sales regions (excludes a.o. employees in headquarter, research sites and manufacturing sites) as of December 2014 2 Kaluga is expected to start producing during 2015

Denmark

Chartres

• Formulation & filling • Assembly • Packaging

Clayton

• Formulation & filling

• Assembly • Packaging

Montes Claros • Formulation & filling • Assembly • Packaging

• Formulation & filling

• Assembly • Packaging • Device

manufacturing

• Packaging

Koriyama

Tianjin

China: ~2,900

Japan & Korea: ~1,000

International Operations: ~4,600

North America: ~5,500

Europe: ~2,800

Total non-HQ/manufacturing FTEs: 17,0001


• Filling & formulation

• Packaging

Kaluga2

• API production • Formulation & filling • Assembly • Packaging • Device & needle manufacturing

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Novo Nordisk’s position is protected by patents and value chain setup

Significant barriers to entry for biosimilar players

High barriers to entry in biologics

1 List is not exhaustive of all marketed Novo Nordisk products. 2 Formulation patent expiration year 3 Protected by patents on the individual compounds insulin degludec and liraglutide as listed. 4 Saxenda patent identical to the Victoza® patent Source: Novo Nordisk

Research & Development

Manufacturing

Commercialisation

Unique value chain position Patent protection1

2018/192

2014-15/1722

20172/172

2023/2342

2017/172

exp/exp

EU/US0

• History of protein engineering

• Highly efficient, flexible and capital intensive manufacturing

• Global commercial footprint

• Need to show comparability in PK/PD trials

• Strict regulatory requirements in EU and US

• Requirement for both drug and device offering

Research & Development

• Significant economies of scale with incumbents

• Significant up-front CAPEX requirements with slow return on investment

Manufacturing

Commercialisation

• Large and fragmented target audience

• Cost pressure from payers

• On-going conversion to next generation drugs and slow market dynamics


PK: Pharmacokinetic, PD: Pharmacodynamics

2028/302

2028/302

202832

5,05

4,10

3,50

4,72

11,82 11,82

Average 2009-20131

Result

2014 Target2

Operating profit growth

Operating profit growth in local currencies

21%

18%

10%

13% 15%

Operating margin 34% 39% 40%

Operating profit after tax to net operating assets 77% 101% 125%

Cash to earnings (three years’ average) 108% 93% 90%

Performance against long-term financial targets

Long-term financial targets

Note: The long term financial targets are 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 stable 1 Simple average of reported figures 2009-2013; 2 The long-term financial targets were last updated in connection with the FY2012 Financial Release


5,05

4,10

3,50

4,72

11,82 11,82

Diabetes and obesity


5,05

4,10

3,50

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Facts about diabetes Insulin secretion profile

Diabetes – the inability to manage blood sugar levels appropriately

1 Diabetes fact sheet N˚312, WHO, October 2013 2 Polonsky et al. J Clin Invest 1988;81:442–48

Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces1

Primary classifications2:

Type 1 diabetes: Complete insulin deficiency due to destruction of beta-cells in pancreas

Type 2 diabetes: Characterised by some degree of insulin resistance and insulin deficiency

6:00

0

10

20

30

40

50

60

70

10:00 14:00 18:00

Insulin (

µ U

/ m

L )

22:00 2:00 6:00


Time of day

Breakfast Lunch Dinner

5,05

4,10

3,50

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11,82 11,82

Insulin enables glucose to become energy The aim of insulin therapy is to recreate normal

blood insulin profile

Insulin – a hormone enabling blood sugar to enter cells

Polonsky et al. J Clin Invest 1988;81:442–48

Liver Pancreas

Muscle

Fat cell

• Facilitates uptake of blood sugar into cells

• Inhibits glucose release from the liver

6:00

0

10

20

30

40

50

60

70

10:00 14:00 18:00

Insulin (

µ U

/ m

L )

22:00 2:00 6:00

Short-lived, rapidly generated meal-related peaks (prandial)

Sustained Insulin profile (basal)


Time of day


5,05

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11,82 11,82

US CDC data on obesity and diabetes prevalence among adults

Diabetes pandemic is fuelled by growing rates of obesity

Obesity prevalence (BMI ≥30 kg/m2)

Diabetes prevalence

No Data <14.0% 14.0-17.9% 18.0-21.9% 22.0-25.9% >26.0%

No Data <4.5% 4.5-5.9% 6.0-7.4% 7.5-8.9% >9.0%

1994 2000 2010

CDC: Centers for Disease Control and Prevention Source: CDC’s Division of Diabetes Translation. National Diabetes Surveillance System available at http://www.cdc.gov/diabetes


5,05

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Diagnosis and optimal treatment remains a challenge – the rule of halves

The worldwide challenge of glycaemic control: mean HbA1C in type 2 diabetes

Poor diagnosis rates, lack of access to optimal treatment and poor glycaemic control remain global problems

1 Lopez Stewart et al. Rev Panam Salud Publica 2007;22:12–20; 2 Oguz et al. Curr Med Res Opin 2013;29:911–20; 3 Ko et al. Diab Med 2007;24:55–62; 4 Arai et al. J Diabetes Investig. 2012 Aug 20;3(4):396-401; 5 Harris et al. Diabetes Res Clin Pract 2005;70:90–7; 6 Hoerger et.al. Diabetes Care 2008;31:81–6; 7 Liebl et al. Diab Ther 2012;3:e1–10; 8 Valensi et al. Int J Clin Pract 2009;63(3):522-31; Blak et al. Diab Med 2012;29:e13-20


50% reach target 50% reach target

All people with diabetes

50% are diagnosed

50% have access to care

50% get decent care

100%

50%

25%

12%

Canada 7.35

US 7.2%6

Latin America 7.6%1

China 7.2-9.5%8

India 7.3-9.3%8

Japan 7.3–7.7%4

Korea 7.9–8.7%3

Russia 7.2-9.5%8

Germany 6.7-9.2%2

Greece 7.1–9.7%2,7,8

Italy 7.7-8.3%8

Poland 7.3-8.9%8

Portugal 7.9-9.7%2

Romania 7.9-9.9%2

Spain 7.6-9.2%7

Sweden 7.4-8.7%2

Turkey 7.6-10.6%2

UK 7.4-8.7%9

5,05

4,10

3,50

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11,82 11,82

Risk reduction by lowering HbA1c by 1%-point UKPDS 10 year follow-up:

Legacy effect of tight glycaemic control

UKPDS: Tight glycaemic control reduces risk of micro- and macrovascular complications

Source: UKPDS, Stratton et al. BMJ 2000; vol. 321:405–12 Source: NEJM, vol. 359, Oct 2008

In

cid

en

ce r

isk (

%)

–21%*

–14%

–37%*

–43%* *p<0.0001 –50

–40

–30

–20

–10

0

Diabetes-related death

Myocardial infarction

Microvascular complications

Peripheral vascular disease

Relative risk reduction of intensive vs. conventional treatment (%)

25 24 Microvascular disease

16 15 Myocardial infarction

6 13 All-cause mortality

SU/Insulin 1997 2007

10 17 Diabetes-related death

SU/Insulin treated pts.

Statistically significant improvement


5,05

4,10

3,50

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11,82 11,82

Progression of type 2 diabetes and treatment intensification

Distribution of patients and value across treatment classes

Insulin is the ultimate care for people with diabetes

OAD: Oral Anti-diabetic Drugs

Note: Patient distribution across treatment classes is indicative and based on data for US, UK, Germany and France. Value figures based on IMS MAT Nov 2014 Source: IMS PharMetrix claims data, IMS disease analyser, IMS Midas


-c

ell f

un

cti

on

Time

Diet and exercise

OAD

GLP-1

Insulin

0%

20%

40%

60%

80%

100%

OAD GLP-1 Insulin

Patients Value

5,05

4,10

3,50

4,72

11,82 11,82

Slide 39

0

50

100

150

200

250

300

350

400

450

Nov 2014

Insulin action profiles Global insulin volume market by segment

The insulin market is comprised of three segments

Time of day

6:00 10:00 14:00 18:00 22:00 2:00 6:00


Long-acting

Premix

Fast-acting


1 CAGR for 5-year period. Value in DKK Note: US trend data reflect changes to IMS data collection coverage and methodology as of Jan 2012 Source: IMS Monthly MAT volume and value (DKK) figures

tMU CAGR volume1: 5.8% CAGR value1: 17.2%

36%

31%

33%

34%

28%

38%

Nov 2009

Fast-acting

Premix

Long-acting

5,05

4,10

3,50

4,72

11,82 11,82

Commonly prescribed products for the treatment of type 2 diabetes

Note: TG and HDL: Beneficial effect on triglycerides and HDL cholesterol; CHF: Congestive heart failure; GI: Gastro intestinal; MTC: Medullary thyroid cancer. TBD: to be defined. Sources: Adapted from: Nathan DM, et al. Diabetes Care. 2006; 29:1963-1972; Nathan DM, et al. Diabetes Care. 2007;30:753-759; Nathan DM, et al. Diabetes Care. 2008;31:173-175. ADA. Diabetes Care. 2008;31:S12-S54. WelChol PI. 1/2008.

Medications used for the treatment of type 2 diabetes

Class HbA1C

change

Hypo-

glycaemia

Weight

change

CVD risk

factors

Dosing

(pr. day)

Contraindication/ undesired effects

Metformin 1.5 No Neutral Minimal 2 OADs Kidney, liver

Sulfonylurea 1.5 Yes Gain None 1 OAD Essentially none

TZDs 0.5 - 1.4 No Gain Variable 1 OAD CHF, liver

DPP-IV inhibitors 0.6 - 0.8 No Neutral TBD 1-2 OAD None

SGLT-2 inhibitors 0.5 - 0.9 No Loss TBD 1 OAD Genital infections, urinary

tract infections

GLP-1 1.0 - 2.0 No Loss TBD Varies GI side effects, MTC

Long-acting insulin 1.5 - 2.5 Yes Gain TG and HDL 1 injection Hypoglycaemia

Fast-acting insulin 1.5 - 2.5 Yes Gain TG and HDL 1-4 injections Hypoglycaemia


5,05

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Slide 41

Key products represent more than 75% of sales within diabetes care

Novo Nordisk is the market leader in the insulin and GLP-1 segments


Brand name Type 2014 Sales1

Percent of diabetes care sales2

Patent expiration

NovoRapid® Fast-acting insulin 17.4 bDKK

(+5%) 25%

EU: 20173 US: 20173

NovoMix® Premixed insulin 9.9 bDKK

(+4%) 14%

EU: 2014-15 US: 20173

Levemir® Long-acting insulin 14.2 bDKK

(+25%) 20%

EU: 2018 US: 2019

Victoza® Long-acting GLP-1 agonist 13.4 bDKK

(+16%) 19%

EU: 2023 US: 2023

1 Reported sales full year 2014 and growth in local currencies compared to full year 2013 2 Based on full year 2014 sales 3 Formulation patent. The molecule patent for NovoRapid® expired in EU and the US. The NovoMix® molecule patent expired in the US

5,05

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The fundamental growth drivers of the insulin market

Sustained double-digit growth in insulin market

Volume

• Rising prevalence of diabetes

• Growing overweight and obesity prevalence

• Ageing of populations

• Rising diagnosis rates and treatment rates

• Intensification of insulin regimens

Value

• Conversion to modern insulin and new-generation insulin

• Continued device penetration

• Favourable net pricing


Global insulin market growth Nov 2009 – Nov 2014

1 CAGR for 5-year period Note: US trend data reflect changes to IMS data collection coverage and methodology as of Jan 2012 Source: IMS Monthly MAT value figures

DKK billion

66

139

0

20

40

60

80

100

120

140

160

71 bDKK

156 bDKK

30 bDKK

55 bDKK

Nov 2009

Nov 2014

Volume contribution

Mix/price contribution

CAGR: 5.8%1

CAGR: 11.4%1

CAGR: 17.2%1

5,05

4,10

3,50

4,72

11,82 11,82

1 IMS only covers part of the channels in China and International Operations. 2 Measured in DKK Note: US trend data reflect changes to IMS data collection coverage and methodology as of Jan 2012 Source: IMS Nov 2013 & 2014 Monthly MAT volume and value (DKK) figures

Solid insulin volume growth in key regions

Novo Nordisk regions

Market value size & growth

Market volume composition

Volume market shares

North America

Europe

International Operations1

Region China1

Japan & Korea

2013 bDKK

Volume growth

Mix/price growth2

2014 bDKK


83.1 2% 30% 109.7

25.9 2% 1% 26.8

9.2 9% -6% 9.5

4.6 0% -7% 4.3

4.7 10% 3% 5.4

Novo Nordisk

Others Premix

Fast-acting

Long-acting

42% 58%

51% 49%

45% 55%

52% 48%

63% 37%

66%

13% 21%

34%

28%

38%

31%

46%

23%

38%

22%

40%

50%

12%

38%

5,05

4,10

3,50

4,72

11,82 11,82

Regional insulin volume growth Regional insulin volume market split

Stable global insulin volume growth

Note: US trend data reflect changes to IMS data collection coverage and methodology as of Jan 2012 Source: IMS Monthly MAT volume figures

0%

20%

40%

60%

80%

100%

World

0%

5%

10%

15%

20%

25%

30%

35%

40%

4.00 54.00 104.00Nov 2004

Nov 2014

Nov 2004

Nov 2014

8%

21%

4%

36%

31%


4.0%

North America Int. Operations

China Japan & Korea

Europe North America Int. Operations

China Japan & Korea

Europe

Note: China growth rate in 2008-2009 impacted by change in reporting methodology Int. Operations growth rate in 2010 impacted by inclusion of Russia not previously reported US trend data reflect changes to IMS data collection coverage and methodology as of Jan 2012 Source: IMS Monthly MAT volume figures

5,05

4,10

3,50

4,72

11,82 11,82

0%

20%

40%

60%

80%

100%

0

50

100

150

200

250

300

350

400

450

Th

ou

san

ds

0%

20%

40%

60%

80%

100%

0

50

100

150

200

250

300

350

400

450

Thousands

0%

20%

40%

60%

80%

100%

0

50

100

150

200

250

300

350

400

450

Thousands

Novo Nordisk volume market share across insulin classes

1 Includes animal insulin. 2 Annual value of total insulin class. 3 Includes new generation insulin Note: US trend data reflect changes to IMS data collection coverage and methodology as of Jan 2012 Source: IMS, Monthly MAT value and volume figures

Maintaining insulin leadership by sustaining modern insulin market share

Nov 2009

Nov 2014

Nov 2009

Nov 2014

Nov 2009

Nov 2014

Novo Nordisk class MS (%) class volume

Human insulin1

Market value2: DKK 18 billion

Modern insulin3


Total insulin



tMU tMU tMU

5,05

4,10

3,50

4,72

11,82 11,82

0%

10%

20%

30%

40%

50%

60%

Global insulin market Global modern insulin1 volume market shares

Strong underlying insulin market growth and steady market share development

1 Includes new generation insulin 2 CAGR for 5-year period. Value in DKK Note: US trend data reflect changes to IMS data collection coverage and methodology as of Jan 2012 Source: IMS Monthly MAT volume figures

1 Includes new generation insulin Note: US trend data reflect changes to IMS data collection coverage and methodology as of Jan 2012 Source: IMS Monthly MAT volume figures

Nov 2014

Nov 2009

Nov 2014

Eli Lilly Novo Nordisk Sanofi

0%

20%

40%

60%

80%

100%

0

100

200

300

400

500

Modern insulin1

Human insulin

tMU Penetration

Device penetration Modern insulin penetration1

CAGR volume2: 5.8% CAGR value2: 17.2% 46%

35%

18%


Nov 2009

5,05

4,10

3,50

4,72

11,82 11,82

0%

20%

40%

60%

80%

100%

0

20

40

60

80

100

120

140

160

180

Novo Nordisk’s modern insulins continue strong performance within their respective segments

1 CAGR for 5-year period Note: Modern insulin (MI) penetration is of total segment, i.e. including animal and human insulin; NG: new generation; US trend data reflect changes to IMS data collection coverage and methodology as of Jan 2012 Source: IMS Monthly MAT volume figures


Fast-acting insulin Long-acting insulin

tMU Levemir® market share Segment volume

NovoRapid® market share Segment volume

NovoMix® market share Segment volume

tMU tMU

0%

20%

40%

60%

80%

100%

0

20

40

60

80

100

120

140

160

180

0%

20%

40%

60%

80%

100%

0

20

40

60

80

100

120

140

160

180

Nov 2009

Nov 2014

Nov 2009

Nov 2014

Nov 2009

Nov 2014

Premixed insulin

CAGR1 volume: 7.1% MI/NG penetration:

79%

CAGR1 volume: 6.0% MI penetration: 76%

CAGR1 volume: 3.5% MI penetration: 48%

5,05

4,10

3,50

4,72

11,82 11,82

Fast-acting insulin market by volume Example of NovoRapid® promotional sales aid1

NovoRapid® remains the preferred modern fast-acting insulin in all key markets


0%

20%

40%

60%

NovoRapid Other modern insulin

Human insulin

2% 1% 3%

13% 10%

4%

North America

Europe IO Japan & Korea

Region China

Global

®

1 Picture of sales aid is not intended for promotional purposes Source: NovoRapid® Summary of Product Characteristics

Share of total insulin market Segment volume growth

Note: Segment volume growth Nov 2014 vs Nov 2013. US trend data reflect changes to IMS data collection coverage and methodology as of Jan 2012. IO: International Operations. Human insulin includes animal insulin Source: IMS MAT Nov 2014 volume figures

5,05

4,10

3,50

4,72

11,82 11,82

Premix insulin market by volume Example of NovoMix® promotional sales aid1

Continued growth potential for NovoMix® in the premix insulin segment in key markets


0%

20%

40%

60%

80%

NovoMix Other modern insulinHuman insulin

North America


Region China

-8%

-9% -3%

6%

10%

1%

Global

®

1 Picture of sales aid is not intended for promotional purposes Source: NovoMix® Summary of Product Characteristics

Share of total insulin market


Segment volume growth

5,05

4,10

3,50

4,72

11,82 11,82

0%

20%

40%

60%

Tresiba LevemirOther modern insulin Human insulin

Basal insulin market by volume Example of Levemir® promotional sales aid1

Solid growth potential for Levemir® in the long-acting insulin segment


4%

7% 5%

10%

15%

Segment volume growth

5%

North America


Region China

Global

Share of total insulin market

®

1 Picture of sales aid is not intended for promotional purposes Sources: Blonde L. et al. Diabetes, Obesity and Metabolism 2009; Hermansen K. et al. Diabetes Care 2006; Levemir® EU Summary of Product Characteristics, April 2012; Philis-Tsimikas A. et al. Clinical Therapeutics 2006; Rosenstock J et al. Diabetologia 2008; IMS Worldwide Data Q3 2012; Reimer T. et al. Clinical Therapeutics 2008


®

5,05

4,10

3,50

4,72

11,82 11,82

0%

10%

20%

30%

40%

50%

60%

US modern insulin volume market shares

Still a significant potential for Novo Nordisk on the US modern insulin market

1 CAGR for 5-year period. Value in DKK 2 US trend data reflect changes to IMS data collection coverage and methodology as of Jan 2012 Source: IMS Monthly MAT volume and value (DKK) figures Source: IMS Monthly MAT volume figures

Modern Insulin penetration Device penetration

Nov 2009

Nov 2014

Nov 2009

Nov 2014


0%

20%

40%

60%

80%

100%

0

20

40

60

80

100

120

140

tMU Penetration CAGR volume1: 2.6% CAGR value1: 23.9%

38%

42%

20%


US insulin market segments

2

Fast-acting

Long-acting

Premix

5,05

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11,82 11,82

Novo Nordisk’s modern insulins have gained market share in expanding US insulin market

1 CAGR for 5-year period Note: US trend data reflect changes to IMS data collection coverage and methodology as of Jan 2012 . Modern insulin (MI) penetration is of total segment, i.e. including animal and human insulin Source: IMS Monthly MAT volume figures


US long-acting insulin

tMU Levemir® market share Segment volume

0%

20%

40%

60%

80%

100%

0

10

20

30

40

50

60

70 CAGR volume1: 5.1% MI penetration: 89%

Nov 2009

Nov 2014

0%

20%

40%

60%

80%

100%

-

10

20

30

40

50

60

70

0 0%

20%

40%

60%

80%

100%

0

10

20

30

40

50

60

70

US fast-acting insulin

NovoLog® market share Segment volume

NovoMix® market share Segment volume

tMU tMU

US premixed insulin

CAGR volume1: 4.5% MI penetration: 83%

CAGR volume1: (6.8%) MI penetration: 57%

Nov 2009

Nov 2014

Nov 2014

Nov 2009

5,05

4,10

3,50

4,72

11,82 11,82

0%

10%

20%

30%

40%

50%

60%

0%

20%

40%

60%

80%

100%

0

20

40

60

80

100

120

140

160

180

European insulin market by segments European modern insulin1

volume market shares

Sustained leadership position on the European modern insulin market

1 CAGR for 5-year period 2 Includes new generation insulin Source: IMS Monthly MAT volume and value (DKK) figures

Modern Insulin penetration2 Device penetration

Nov 2009

Nov 2014

Nov 2009

Nov 2014


Fast-acting

Long-acting

tMU Penetration

Premix

48%

33%

17%

1 Includes new generation insulin Source: IMS Monthly MAT volume figures, numbers do not add up to 100% due to smaller insulin manufacturers

CAGR volume1: 2.5% CAGR value1: 3.8%


5,05

4,10

3,50

4,72

11,82 11,82

0%

10%

20%

30%

40%

50%

60%

70%

0%

20%

40%

60%

80%

100%

0

10

20

30

40

50

60

70

80

90

International Operations insulin market by segments

International Operations insulin volume market shares

Stable leadership position in International Operations

Note: Only top-4 shown Source: IMS Monthly MAT volume figures, numbers do not add up to 100% due to smaller insulin manufacturers

Device penetration


Nov 2009

Nov 2014

Biocon

1 CAGR for 5-year period. Value in DKK 2 Includes new generation insulin Note: IMS only covers the following 13 markets in IO (retail data): Algeria, Argentina, Australia, Brazil, Colombia, Egypt, India, Mexico, NZ, Russia, Saudi Arabia, South Africa & Turkey. Source: IMS Monthly MAT volume and value (DKK) figures.


55%

17%

19%

Nov 2009

3%

Sanofi Novo Nordisk

Fast-acting

Long-acting

Premix

Nov 2014

Eli Lilly Modern Insulin penetration2

5,05

4,10

3,50

4,72

11,82 11,82

0%

20%

40%

60%

80%

100%

0

5

10

15

20

25

30

35

Chinese insulin market by segments Chinese insulin volume market shares

Sustained leadership position on the rapidly growing Chinese insulin market

1 CAGR for 5-year period. Value in DKK Note: IMS covers around 50% of the total Chinese market (hospital data) Source: IMS Monthly MAT volume and value (DKK) figures

Modern Insulin penetration Device penetration


Fast-acting

Long-acting

Premix

Nov 2014

0%

10%

20%

30%

40%

50%

60%

70%


Shanghai Fosun Tonghua Dongbao

58%

5%

15%

9%

8%

Nov 2009


Note: Only top-5 shown Source: IMS Monthly MAT volume figures, numbers do not add up to 100% due to smaller insulin manufacturers

Nov 2014

Nov 2009

5,05

4,10

3,50

4,72

11,82 11,82

0%

10%

20%

30%

40%

50%

60%

70%

0%

20%

40%

60%

80%

100%

0

2

4

6

8

10

12

14

Japanese insulin market by segments Japanese modern insulin volume market shares

Stabilising market leadership position in Japan

1 CAGR for 5-year period. Value in DKK 2 Includes next generation insulin Source: IMS Monthly MAT volume and value (DKK) figures Source: IMS Monthly MAT volume figures

Device penetration Eli Lilly Novo Nordisk Sanofi

tMU Penetration CAGR volume1: 0.2% CAGR value1: (0.3)%

Fast-acting

Long-acting

Premix

Nov 2009

Nov 2014

49%

28%

23%

Nov 2009


Nov 2014

Modern Insulin penetration2

5,05

4,10

3,50

4,72

11,82 11,82

0%

20%

40%

60%

80%

Japanese basal value market shares Japanese total insulin value market shares

Promising Tresiba® performance strengthens total insulin market share in Japan

Source: IMS Monthly Nov 2014 value figures Source: IMS Monthly Nov 2014 value figures


Nov 2011

Nov 2014

Tresiba®

NN Total Basal

glargine Levemir® NPH

39%

59%

26%

10%

5% 0%

20%

40%

60%

80%


Nov 2011

Nov 2014

55%

19%

26%

5,05

4,10

3,50

4,72

11,82 11,82

GLP-1 mechanism of action when blood sugar levels increase

GLP-1 lowers blood glucose in patients with type 2 diabetes

GLP-1 effect dependent on level of blood glucose − which reduces risk of hypoglycaemia

Source: Rachman et al. Diabetologia 1997;40:205–11

• Increases insulin secretion in the pancreas

• Reduces glucagon secretion in the liver

• Slows gastric emptying in the gut

• Creates sense of satiety in the brain

Pancreas

Liver

Brain

Gut

Glucose (mmol/L)

12

8

6

0

22.00 02.00 06.00 10.00 14.00

10

4

14

16

Time

2 Breakfast Lunch Snack

18.00

18

Type 2 diabetes patients, no GLP-1

Healthy controls receiving saline

Type 2 diabetes patients, with GLP-1


5,05

4,10

3,50

4,72

11,82 11,82

DPP-IV SGLT-2 Victoza® Other GLP-1

Share of segment value growth Segment value market shares

0

10

20

30

40

50

60

70

80

90

1CAGR for 5-year period, Note: Segment only includes DPP-IV, GLP-1 & SGLT-2. Other oral anti-diabetic agents and insulin excluded Source: IMS MAT Nov 2014 value figures

Victoza® has a strong position in the global DPP-IV, GLP-1 and SGLT-2 segment


22% 15%

0%

20%

40%

60%

80%

100%

Segment value

DKK billion

0%

20%

40%

60%

80%

Nov 2009

Nov 2014

Nov 2009

Nov 2014

CAGR1 value: 38.1%

15%

2014 vs. 2013

2013 vs. 2012

5,05

4,10

3,50

4,72

11,82 11,82

North America constitutes the majority of the GLP-1 value market1

Victoza® has a strong leadership in the global GLP-1 market


1 Annual value of diabetes market Nov 2014 Source: IMS Monthly value figures (DKK)

Europe North America

Japan & Korea

International Operations

China (0.4%)

4% 4%

Nov 2014

22%

73%

2% 3%

Global GLP-1 market

1 CAGR for 5-year period Source: IMS Monthly MAT, value figures (DKK)

GLP-1 sales in bDKK (right axis)

Exenatide

Victoza®

Nov 2009

Nov 2014

CAGR value1: 37.0%

0

4

8

12

16

20

0%

1%

2%

3%

4%

5%

6%

7%

8%

Share of total diabetes care market

Other GLP-1

Victoza®

5,05

4,10

3,50

4,72

11,82 11,82

• Victoza® market share within the GLP-1 segment is 66%1

• Roughly 66% of Commercial and 80% of Medicare Part D lives are covered without restrictions2

• Around 63% of new patients are new to treatment or from OAD-only regimens3

• More than two-thirds of prescriptions are for the 3-pen pack1

• Victoza® represents 1.5% of total prescriptions in the US diabetes care market1

Source: IMS TRx retail value, monthly NPA data, Nov 2014

US GLP-1 market Key observations for Victoza® in the US market

The US GLP-1 market continues to expand

GLP-1 % of diabetes care market GLP-1 TRx scripts (thousands)

Investor presentation First six months of 2014

0%

2%

4%

6%

8%

0

50

100

150

200

250

300

350

400

Feb 2010

Nov 2014

1 IMS monthly NPA data, Nov 2014 2 Fingertip Formulary, Dec 2014 3 IMS Monthly LRx Weekly, Dec 26, 2014

Other GLP-1

Victoza®

5,05

4,10

3,50

4,72

11,82 11,82

Slide 62

0%

20%

40%

60%

80%

100%

Victoza NovoLog Levemir

0%

20%

40%

60%

80%

Victoza NovoLog Levemir

Value market shares of key Novo Nordisk products in the US

% unrestricted market access of key Novo Nordisk products in the US

Key Novo Nordisk diabetes care products remain broadly accesible in the US

Note: Market shares: NovoLog®=share of rapid acting insulin segment, Levemir®=share of basal insulin segment, Victoza®=share of GLP-1 segment Source: IMS NSP Monthly, Nov 2014; data displayed as MAT value share

Source: Access FingerTip Formulary, Dec 2014 Note: Unrestricted access excludes prior authorisation, step edits and other restrictions


Nov 2009

Nov 2014

Nov 2009

Nov 2014

Value market share

Unrestricted Market access

® ® ® ® ® ®

5,05

4,10

3,50

4,72

11,82 11,82

Slide 63

0%

2%

4%

6%

8%

10%

12%

14%

0%

2%

4%

6%

8%

10%

12%

14%

0%

2%

4%

6%

8%

10%

12%

14%

Development in key European markets following Victoza® launch

1 MAT value of diabetes market, Nov 2014 Source: IMS Monthly value figures

Victoza® maintains GLP-1 class leadership position in key European markets


Germany Market value1: DKK 13 billion

UK Market value1: DKK 6 billion

France Market value1: DKK 8 billion

Jul 2009

Nov 2014

Jul 2009

Nov 2014

Jul 2009

Nov 2014

Dia

bete

s m

arket

sh

are (

valu

e)

lixisenatide Victoza® exenatide

5,05

4,10

3,50

4,72

11,82 11,82

Slide 64

Example of Victoza® promotional sales aid1

Strong Victoza® position in the GLP-1 segment across all markets


1 Picture of sales aid is not intended for promotional purposes Source: Victoza® Summary of Product Characteristics

GLP-1 market by value

Note: Segment volume growth Nov 2014 vs Nov 2013 Source: IMS MAT Nov 2014 volume figures in DKK

0%

2%

4%

6%

8%

10%

Victoza exenatidealbiglutide lixisenatide

North America


Region China

27%

-2%

13%

-6%

52%

GLP-1 value growth

8%

Global

® Share of total diabetes care market

5,05

4,10

3,50

4,72

11,82 11,82

R&D pipeline: Diabetes and obesity


Product/project Type Indication Status (phase)

1 2 3 Filed Appr.

Tresiba® (NN1250)1 New-generation once-daily basal insulin analogue Type 1+2

Ryzodeg® (NN5401)1 Co-formulation of insulin degludec and insulin aspart Type 1+2

Xultophy® (NN9068)2 Combination of insulin degludec and liraglutide Type 2

Faster-acting insulin aspart (NN1218) New formulation of insulin aspart Type 1+2

Semaglutide (NN9535) Once-weekly GLP-1 analogue Type 2

LATIN T1D (NN9211) Once-daily GLP-1 analogue Type 1

OG217SC (NN9924) Long-acting once-daily oral GLP-1 analogue Type 2

OG987GT (NN9926) Long-acting once-daily oral GLP-1 analogue Type 2

OG987SC (NN9927) Long-acting once-daily oral GLP-1 analogue Type 2

LAI287 (NN1436) Long-acting once-weekly basal insulin analogue Type 1+2

LAI338 (NN1438) Long-acting once-daily basal insulin anlagoue Type 1+2

OI338GT (NN1953)3 Long-acting oral basal insulin analogue Type 1+2

Saxenda® (NN8022)4 Once-daily GLP-1 analogue Obesity

G530L (NN9030) Novel glucagon analogue Obesity

NN9838 Novel long-acting amylin analogue Obesity

1 Approved in EU, Japan and a number of other markets. 2 Approved in EU on 18 Sep 2014. 3 First Phase 2a trial to be initiated H1 2015. 4 Approved in US on 23 Dec 2014 and positive CHMP opinion in EU on 22 Jan 2015

5,05

4,10

3,50

4,72

11,82 11,82

OR

Optimisation

Type 2 diabetes progression and Novo Nordisk ideal treatment flow

1 Pending clinical development programmes and regulatory processes for Xultophy®, semaglutide and faster-acting insulin aspart

Novo Nordisk current and future product portfolio covers the type 2 diabetes treatment flow1


Metformin

OAD’s GLP-1 Insulin initiation Intensification

OR

Diet & exercise

5,05

4,10

3,50

4,72

11,82 11,82

Tresiba® OD vs insulin glargine OD1 results from BEGIN phase 3a trial

OD: once-daily

1 Based on trial NN1250-3579, NN1250-3586, NN1250-3668, NN1250-3672, NN1250-3770, NN1250-3582 and NN1250-3583

BEGIN phase 3a programme confirms stable and efficacious profile of insulin degludec


• Improved fasting glucose control

• Less impact of missed dose

• Lower rate of overall hypoglycaemia

• Lower rate of nocturnal hypoglycaemia

• Dosing flexibility, enabling administration at any time on any day

• Reduced injection volume (U200) – one injection for all

• Superior pen with easy-touch dosing mechanism

• Basal insulin with flatter, less variable profile and a doubling in half-life

Convenience

Safety

Efficacy

Profile

5,05

4,10

3,50

4,72

11,82 11,82

Xultophy® is indicated for the treatment of adults with type 2 diabetes in combination with oral glucose-lowering agents

1 Source: DUALTM I (NN9068-3697), DUALTM II (NN9068-3912)

2 Insulin degludec, liraglutide and placebo

Competitive European label for Xultophy®


• Lower rates of confirmed hypoglycaemia than with insulin degludec in patients on metformin +/- pioglitazone

• Fewer experienced gastrointestinal side effects than patients treated with liraglutide

• On average HbA1c reduction of 1.9%1 from baseline to end of trial confirmed to be superior against all comparators2

• On average 2.7 kg weight loss from baseline in patients inadequately controlled on basal insulin

• Once-daily administration at any time of the day, preferably at the same time of the day

• The pre-filled pen can provide from 1 up to 50 dose steps in one injection

• Xultophy® is a fixed combination product consisting of insulin degludec and liraglutide having complementary mechanisms of action to improve glycaemic control

• Administered as dose steps: One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide

Convenience

Efficacy

Profile

Safety

5,05

4,10

3,50

4,72

11,82 11,82

Xultophy® key clinical results document strong efficacy across the treatment cascade

Xultophy® key clinical results1

Note: Typical confirmed hypoglycaemia event rates for treatment with basal insulin are 142-369 episodes per 100 PYE (based on insulin glargine event rates from trials NN1250-3586, 3579 and 3672 where the FPG target and hypoglycaemia definition is similar to the DUAL trials. 1 For DUAL V data, see slide 12 Source: Novo Nordisk Trial IDs: DUALTM I (NN9068-3697), DUALTM II (NN9068-3912), DUALTM III (NN9068-3851), DUALTM IV (NN9068-3951)

DUAL™ I Add-on to metformin

± Pio n = 833

DUAL™ IV Add-on to SU ±

metformin n = 289

DUAL™ III Switch from GLP-1

n = 292

DUAL™ II Add-on to metformin

± basal insulin n = 199

Mean trial start HbA1c (%) 8.3 7.9 7.8 8.7

Mean trial end HbA1c (%) 6.4 6.4 6.4 6.9

HbA1c change (%) -1.9 -1.45 -1.3 -1.9

% to target < 7% (%) 80.6 79.2 75.3 60.3

% to target < 6.5% (%) 69.7 64.0 63.0 45.2

Confirmed hypoglycaemia (Episodes per 100 PYE)

180.2 351.7 282 153.4

Weight change (kg) -0.5 +0.5 +2.0 -2.7


5,05

4,10

3,50

4,72

11,82 11,82

Weight loss in 12 week phase 2 trial

In a phase 2 trial, semaglutide dose dependently reduced HbA1c and body weight from baseline

HbA1c reduction in 12 week phase 2 trial


-0.5 -0.58

-0.9*

-1.1**

-1.46** -1.44**

-1.69**#

-1.18

-1.34

0.0

0.3

0.5

0.8

1.0

1.3

1.5

1.8

2.0

Placebo 0.1 mg 0.2 mg 0.4 mg 0.8 mg 0.8 mg T 1.6 mg T 1.2 mg 1.8 mg

-

-

-

-

-

-

-

-

-

Semaglutide

*p<0.05 vs. placebo; **p<0.001 vs. placebo; #Semaglutide 1.6 mg T superior to Victoza® 1.2 mg and 1.8 mg; data are LS means Source: Nauck et al. EASD 2012: Oral presentation 2 (trial 9535-1821)

Baseline

Hb

A1

c r

ed

ucti

on

(%

)

8.1 8.2 8.2 8.1 8.2 8.1 8.1

Victoza®

8.0 8.1

-1.2

-0.8 -1.0

-2.0

-3.4* -3.6**

-4.8**

-1.9

-2.6

0.0

1.0

2.0

3.0

4.0

5.0

Placebo 0.1 mg 0.2 mg 0.4 mg 0.8 mg 0.8 mg T 1.6 mg T 1.2 mg 1.8 mg

-

-

Semaglutide

Baseline1

Weig

ht

loss (

kg

)

90.5 89.5 86.3 87.0 86.2 85.0 84.9

Victoza®

90.5 84.9

*p<0.001; **p<0.0001. 0.8 mg T/1.6 mg T superior to Victoza® 1.8 mg and 0.8 mg/0.8 mg T/1.6 mg T superior to Victoza® 1.2 mg (based on unadjusted means); 1Baseline values for information only: data are model-adjusted for baseline weight. Data are LS means, FAS LOCF (ANOVA)

-

-

-

-

5,05

4,10

3,50

4,72

11,82 11,82

SUSTAIN™ phase 3a programme to support a broad competitive label for semaglutide1

2013 2014 2015 2016

SUSTAIN™ 1: Monotherapy 30 weeks, n= 400

SUSTAIN™ 2: Semaglutide vs. sitagliptin 56 weeks, n= 1,200

SUSTAIN™ 3: Semaglutide vs. exenatide once-weekly 56 weeks, n= 800

SUSTAIN™ 4: Semaglutide vs. insulin glargine 30 weeks, n=1,000

SUSTAIN™ 5: Add-on to basal insulin 30 weeks, n=400

SUSTAIN™ 6: Long-term outcomes trial Min. 104 weeks, n=3,200


1 In the SUSTAIN™ phase 3a programme, 0.5 mg and 1.0 mg doses of semaglutide are being tested in people with type 2 diabetes. Note: Estimated timing of trials as listed on www.clinicaltrials.gov excl. data analysis; n= approximate no of randomised patients

5,05

4,10

3,50

4,72

11,82 11,82

PD: Mean GIR profiles (0–30 minutes) for faster-acting insulin aspart vs insulin aspart

PD: Mean GIR profiles (0–30 minutes) for insulin aspart vs human insulin

Improvement in early glucose lowering with faster-acting insulin aspart vs insulin aspart in phase 1 trial

Source: Haahr et al. ADA 2014, Abstract number 910-P Source: Novo Nordisk data on file


Faster-acting insulin aspart

Insulin aspart

AUCGIR,0–30 min ratio [95% CI] faster aspart / insulin aspart

1.48 [1.13; 2.02]

Glu

co

se i

nfu

sio

n r

ate

(m

g/

kg

*m

in)

0

2

4

6

8

10

0

Nominal time (min)

5 10 15 20 25 30

AUCGIR,0–30 min ratio [95% CI] IAsp / human insulin

1.38 [0.78; 2.89]

Glu

co

se i

nfu

sio

n r

ate

(m

g/

kg

*m

in)

0

2

4

6

8

10

0 Nominal time (min)

5 10 15 20 25 30

Insulin aspart

Human insulin

5,05

4,10

3,50

4,72

11,82 11,82

Faster-acting insulin aspart phase 3a programme for onset®

2013 2014 2015

onset® 4: insulin pump compatibility 6 weeks, n=30


Note: Estimated timing of trials as listed on www.clinicaltrials.gov excl. data analysis; n= approximate number of randomised patients

Type 1 diabetes Type 2 diabetes

onset® 1: basal-bolus insulin therapy 26+26 weeks, n=1,095

onset® 2: basal-bolus insulin therapy 26 weeks, n=676

onset® 3: bolus intensification 18 weeks, n=236

5,05

4,10

3,50

4,72

11,82 11,82

1.0 1.1 0.8

1.4 1.7

1.3

0.0

0.5

1.0

1.5

2.0

0.6 mg 1.2 mg 1.8 mg

Key results from phase 1 trial

Hypoglycaemic episodes during CGM2


2 Interstitial glucose ≤3.9 mmol/L PDE: Person Days of Exposure Source: EASD 2013 oral presentation #3, Simon Heller et al

• Reduction in insulin dose at same HbA1c

• Significant body weight loss

• No significant change in overall hypoglycaemia

• Reduction in hypoglycaemic episodes during CGM1

• No unexpected safety or tolerability issues

Even

ts p

er P

DE

p=0.091 p=0.044 p=0.052

Liraglutide 0.6 mg (n=11) Liraglutide 1.8 mg (n=9)

Liraglutide 1.2 mg (n=12) Placebo (n=35)

1 Compared to the relevant placebo group CGM: Continuous Glucose Monitoring

-31% -35% -39%

Positive effects of liraglutide as adjunct therapy to insulin in type 1 diabetes were observed in a phase 1 trial

5,05

4,10

3,50

4,72

11,82 11,82

ADJUNCT™ phase 3a trials and design

ADJUNCT™ phase 3a programme for LATIN T1D − liraglutide as adjunct therapy to insulin in type 1 diabetes

ADJUNCT™ phase 3a programme


• Global clinical phase 3 program in type 1 diabetes with more than 2,000 patients

• Designed to demonstrate efficacy and safety of liraglutide as adjunct therapy to insulin in type 1 diabetes

• Trials will seek to demonstrate:

o Lower HbA1c or decrease in insulin dose

o Lower body weight and/or lower number of hypoglycaemic episodes

2013 2014 2015

ADJUNCT ONE™: Liraglutide versus placebo as adjunct to insulin1, 52 weeks, n=1,400

ADJUNCT TWOTM: Liraglutide versus placebo as adjunct to insulin2, 26 weeks, n=800

1 ADJUNCT ONETM: Treat-to-target trial with no upper limit on total daily insulin dose 2 ADJUNCT TWOTM: Upper limit on total daily insulin dose corresponding to pre-trial average total daily insulin dose

5,05

4,10

3,50

4,72

11,82 11,82

Oral peptide delivery − the gastro-intestinal route poses many challenges to absorption of intact macromolecules


Challenges

1. Breakdown of drug in the stomach/gastrointestinal tract

2. Passage across the gut barrier into the circulation

3. Ensuring a long circulation half-life

Solutions

1. Stabilisation of peptide backbone and side chain

2. Tablet formulation including carrier and/or coating

3. Engineered systemic protraction mechanism

5,05

4,10

3,50

4,72

11,82 11,82

0

HbA1c reduction is comparable with sc semaglutide at similar exposure

Body weight reduction is comparable with sc semaglutide at similar exposure

Proof of principle achieved in phase 1 trial with oral semaglutide (OG217SC)

Sc: Subcutaneous. Note: High dose = 40 mg, which was the only dose tested in people with type 2 diabetes Source: Novo Nordisk, data on file.


Time (weeks)

Placebo, type 2 diabetes (n=6)

Oral semaglutide (OG217SC), high dose, type 2 diabetes (n=11)

Placebo, type 2 diabetes (n=6)

Oral semaglutide (OG217SC), high dose, type 2 diabetes (n=11)

Oral semaglutide (OG217SC), high dose, healthy (n=32)

0 2 4 6 8 10 2 4 6 8 10

Time (weeks)

-2.0

-1.5

-0.5

0

-1.0

0.5

-8

-6

-4

-2

0

Ch

an

ge i

n b

od

y w

eig

ht

(K

g)

Ch

an

ge i

n H

bA

1c (

%)

5,05

4,10

3,50

4,72

11,82 11,82

Phase 2 trial objective and endpoints

Oral semaglutide (OG217SC) phase 2 trial

Phase 2 trial design


Trial objective

• To examine the dose range, escalation and efficacy of semaglutide tablets in subjects with type 2 diabetes

Primary endpoint

• Change in HbA1c from baseline to end of treatment

Secondary endpoints

• Body weight

• Safety and tolerability

Semaglutide tablet 2.5 mg (QD)

Semaglutide tablet 5 mg (QD)


Slow dose escalation

Placebo



Fast dose escalation

Sc semaglutide 1.0 mg (QW)

0 26 weeks

Clinical pharmacology trials

• Additional clinical pharmacology trials will be conducted in parallel to support a global phase 3 start

• To investigate exposure in special populations and to investigate drug/drug interactions

1 Key inclusion criteria: People with type 2 diabetes treated with diet and exercise and/or on a stable dose of metformin; HbA1c 7.0-9.5% (both inclusive); BMI 25-40 (both inclusive); T2DM: Type 2 diabetes; Sc: Subcutaneous QD: once daily; QW: once weekly

600 T2DM patients diabetes drug naïve or on metformin1

5,05

4,10

3,50

4,72

11,82 11,82

Glucose Infusion Rate vs. Time (Predicted Mean)

Time (days)

Glu

cose

Infu

sio

n R

ate

(m

g/k

g/m

in)

0 2 4 6

01

23

45

6 18 nmol/kgIGlar 0.4 U/kg

2013-Oct-25T11:20:20 E:/Project/NN1436/NN1436-3955/current/Splus/Final/09_MultipleDoseComparison.ssc

Key observations

Long-acting insulin LAI287 intended for once-weekly dosing

Note: Pharmacokinetic simulation


• The peak-to-trough ratios for Glucose Infusion Rate are comparable for ultra-long-acting insulin LAI287 and once-daily insulin glargine (approx. 65% for both)

• Half-life deemed adequate for once-weekly dosing

Glucose Infusion Rate vs. time (predicted mean at steady state)

LAI287, 18 nmol/kg

Insulin glargine, 0.4 U/kg

Glu

co

se I

nfu

sio

n R

ate

(m

g/k

g/m

in)

1

0

3

2

5

4

0 2 4 6

Time (days)

5 1 3

Time (days)

7

5,05

4,10

3,50

4,72

11,82 11,82

1 Impaired Fasting Glucose Source: NHANES and revised 2011 CDC estimates

Incidence of obesity in the US Comments to the US obesity burden

Obesity burden in the US

2 Finkelstein et al. Health Affairs 28, no. 5 (2009): w822-831 3 Flegal, KM. JAMA. 2012;307(5): Doi:10.1001/jama.2012.39 4 Obesity. Decision resources, Inc. December 2010:38

• Cost of obesity to health care systems of USD 147 billion annually2 with continued growth

• Around 35% of the US adult population (over 20 years) are clinically obese (BMI>27)3

• Only around 23% of all obesity cases in the US were diagnosed in 20103

• In 2010, only 3 million people in the US or around 3% of the adult obese population were treated with weight loss medication4

Million people

Over-weight BMI 25-29.9

Obese

TOTAL Class I BMI 30-34.9

Class II BMI 35-39.9

Class III BMI 40+

Normal Glucose

39 17 x7 - 62

Pre-Diabetes1

34 21 10 x9 74

T2DM x7 x6 x4 x4 22

TOTAL 80 44 21 13 158


5,05

4,10

3,50

4,72

11,82 11,82

0

200

400

600

800

1,000

AOM TRx Volume

Phentermine TRx volume

Value of the US obesity market remains small compared to the US diabetes market

Few people treated with AOM in US, but recent launches have contributed to market growth

Small but growing market for anti-obesity medication in the US

Note: Phentermine and topiramate is the fixed combination; naltrexone HCI and bupropion HCI is the second fixed dosed combination to market. AOM: anti-obesity medication Source: IMS NPA Monthly, Nov 2014

TRx volume (thousands)

Phentermine and topiramate

launch

Lorcaserin

launch


Note: 2014 is MAT Nov 2014 Source: IMS NSP data

0

500

1,000

1,500

2,000

2009 2010 2011 2012 2013 2014

DKK million

Naltrexone HCI and

bupropion HCI

launch

Nov 2010

Nov 2014

5,05

4,10

3,50

4,72

11,82 11,82

Overview of weight loss (%) in the SCALE™ programme

Note: Observed means, last observation carried forward (LOCF) at end of trial. N=number of randomised participants

1Trial includes 12 week run-in period before randomization Source: 2Fujioka K et al, Diabetologia 2014; 57 (Suppl 1): Abstract 904-OR at EASD 2014; 3Davies M, Diabetologia 2014; 57 (Suppl 1): Abstract 39-OR at EASD 2014; 4Wadden et al. Int J Obes (Lond). 2013;37:1443-51; 5Blackman A, Diabetologia 2014; 57 (Suppl 1): Abstract 184-OR at EASD 2014

Saxenda® demonstrated weight loss in all SCALE™ trials


Saxenda® Placebo % patients with ≥5% weight loss

2.0%

5.9%

0.2%

6.2%

1.6%

5.7%

Maintenance1,5

(56 weeks and n= 422) Diabetes3

(56 weeks and n=846) Obesity & Pre-diabetes2 (56 weeks and n=3,731)

Sleep Apnoea4

(32 weeks and n=359)

2.6%

8.0%

63.2% 27.1% 49.9% 13.8% 50.5% 21.8% 46.3% 18.5%

5,05

4,10

3,50

4,72

11,82 11,82

-5.9

-4.6

-2.0

-8

-6

-4

-2

0

0 8 16 24 32 40 48 56

Placebo Victoza Saxenda

Statistically significant largest reduction in weight with Saxenda®

50% and 23% of Saxenda® patients loose ≥5% or >10% of body weight respectively

Saxenda® is associated with statistically significant weight loss in people with type 2 diabetes in phase 3 trial

Note: Baseline weight 106 kg. FAS, fasting visit data only. Lines are observed means (±SE). Diamonds are means last observation carried forward (LOCF). Statistical analysis is ANCOVA. *p<0.05, **p<0.0001. Source: Davies et al. ADA 2014. Abstract number: 97-OR

Note: Proportions are observed means, FAS-LOCF. Estimates are from a logistic regression model using FAS-LOCF. *p<0.05, **p<0.001, ***p<0.0001. Source: Davies et al. ADA 2014. Abstract number: 97-OR

**

**

*

Weeks

0%

10%

20%

30%

40%

50%

60%

≥ 5% weight loss > 10% weight loss

Saxenda Victoza Placebo

% subjects OR: 6.81***

OR: 3.69*** OR: 1.84** OR: 7.10***

OR: 3.84** OR: 1.85*


® ® ® ® Change in body weight (%)

5,05

4,10

3,50

4,72

11,82 11,82

Patient funnel

Saxenda® sales will come from a small segment of people with obesity


Saxenda® aspiration Market approach

~107 million people with obesity1

~0.7 million people on anti-obesity medication2

1 Estimated number of people with BMI>27 with comorbidities and class I,II and III in key markets 2 Patient year equivalents Sep 2012-Sep 2013

Clear patient segmentation

Focused prescriber targeting

Clear product value proposition

Capture share of people currently treated

Contribute to market expansion

US example

http://www.koolavatar.com/preview.php?id=232&cat=13&s=224&e=247

5,05

4,10

3,50

4,72

11,82 11,82

Biopharmaceuticals


5,05

4,10

3,50

4,72

11,82 11,82

Slide 86

Locations Consequences of bleedings

Haemophilia: Location of bleedings and the consequences


• Bleeding in the joint space causes a strong inflammatory reaction which predisposes to further bleeding

• Inadequate or delayed treatment of repeated joint bleeds results in a “target joint”

• The joint is tense, swollen and extremely painful and the mobility is restricted

• Eventually the cartilage erodes completely and permanent joint damage (arthropathy) occurs

• Treatment of arthropathy is orthopaedic surgery

Nose and gums

Joints

Gut

Kidneys

Head and neck

Joints

Joints

Muscles

Joints

5,05

4,10

3,50

4,72

11,82 11,82

Slide 87

Number of people with haemophilia A and B and haemophilia with inhibitors

Low diagnosis and treatment rates within haemophilia

Haemophilia is a rare disease with severe unmet medical needs

Note: The inhibitor segment represents people with haemophilia and high titre inhibitors to their normal replacement treatment Source: Estimates based on prevalence data in literature (Stonebraker JS et al. Haemophilia. 2010; 16: 20-32), World Federation of Haemophilia – Annual Global Survey 2012, UDC database in the US Source: World Federation of Haemophilia – Annual Global Survey 2012

Haemophilia A

App. 350,000 patients

Haemophilia B

App. 70,000 patients

Inhibitor segment app. 3,500-4,000

patients

Average percentage of people with haemophilia

0

50

100

150

200

250

300

350

400

450

People with

haemophilia

Diagnosed Treated Prophylactic Pristine joints

45%

15%

3% 6%

Thousand people


5,05

4,10

3,50

4,72

11,82 11,82

Slide 88

Novo Nordisk compound

Status Strategic position

NovoSeven® Launched Maintain market leadership

NovoEight® Launched Establish presence in a competitive market place

N8-GP Phase 31 Contribute to market conversion

N9-GP Phase 32 Establish new treatment paradigm

NovoThirteen® Launched Launch first recombinant choice

Strategic positioning of Novo Nordisk’s haemophilia portfolio

The global haemophilia market is growing by mid-single digits

1 Submission of N8-GP expected 2017/2018 pending expansion of production capacity 2 Submission expected in 2015


Sales of recombinant coagulation factors

0

5

10

15

20

25

30

2008 2013 2008 2013 2008 2013

1 CAGR for 5-year period Source: Company reported sales for 2013

DKK billion

rFVIIa rFVIII rFIX

CAGR1: 7%

CAGR1: 5%

CAGR1: 7%

NovoSeven® Xyntha®/Refacto®

Kogenate®/Helixate® Recombinate®/Advate®

Coagil VII® Benefix®

5,05

4,10

3,50

4,72

11,82 11,82

Slide 89

0.0

0.5

1.0

1.5

2.0

2.5

3.0

NovoSeven® reported sales Key NovoSeven® properties

NovoSeven® − a unique biologic for the treatment of rare bleeding disorders

1 Only indicated in Europe and the US

• Product characteristics: powder and solvent for solution

for intravenous injection, available in multiple doses, stable

at room temperature

• MixPro® administration system launched in 2013

• Indications: treatment of spontaneous and surgical

bleedings in:

• Haemophilia A or B patients with inhibitors

• Acquired haemophilia

• Congenital FVII deficiency

• Glanzmann’s thrombasthenia1

Q4 2009

Q4 2014

DKK billion

CAGR1 7.9%



5,05

4,10

3,50

4,72

11,82 11,82

Slide 90

Indications:

• Treatment and prophylaxis of bleeding in patients with congenital factor VIII deficiency for all age groups

Key product characteristics:

• Reliability: No inhibitor development in largest pivotal trial programme of any approved rFVIII (n=213)1,2

• Purity and safety: First rFVIII to use a 20nm filter in its purification process3

• Portability: Room temperature stability with storage at 30 degrees celsius1

Launch status:

• NovoEight® has been launched in 8 countries: Japan, Germany, Denmark, Switzerland, Austria, Netherlands, Sweden and France

1Picture is not intended for promotional purposes

Example from NovoEight® promotional campaign1 NovoEight® properties and launch performance

NovoEight® is launched in Europe and Japan for the treatment of people with haemophilia A

Sources:1 NovoEight® Summary of Product Characteristics. 2 Iorio A et al., Blood 2012; 120(4): 720 – 727. 3 NovoEight® Prescribing Information.


5,05

4,10

3,50

4,72

11,82 11,82

Slide 91

1Picture is not intended for promotional purposes

Example from NovoThirteen® promotional campaign1

NovoThirteen® properties and launch performance

NovoThirteen®, a recombinant FXIII, provides efficacious and safe haemostatic coverage


Indication:

• Long term prophylactic treatment of bleeding in adult and paediatric patients with congenital factor XIII A-subunit deficiency

Key product characteristics:

• NovoThirteen® is the only effective recombinant product for prophylaxis

• NovoThirteen® is well tolerated and has low volume dosing

• NovoThirteen® effectively prevents bleeds and provides a convenient once-monthly regimen

Launch status: • NovoThirteen® has been launched in nine countries

Source: European Medicines Agency, summary of opinion (post-authorisation) 23 January 2014. NovoThirteen® Summary of product characteristics.

5,05

4,10

3,50

4,72

11,82 11,82

R&D pipeline: Haemophilia and growth disorders


Product/project Type Indication Status (phase)

1 2 3 Filed Appr.

N9-GP (NN7999) GlycoPEGylated long-acting rFIX Haemophilia B

N8-GP (NN7088) GlycoPEGylated long-acting rFVIII Haemophilia A

Concizumab (NN7415) Monoclonal anti-TFPI Haemophilia A, B and with inhibitors

NN8640 Once-weekly human growth hormone Growth disorder

5,05

4,10

3,50

4,72

11,82 11,82

Source: Negrier et al. Blood. 2011;115:2693-2701

Paradigm™ 2 headline results (phase 3)

Positive results from phase 3 trial with long-acting factor IX for treatment of haemophilia B

Source: Novo Nordisk data on file

N9-GP phase 1 pharmacokinetics


• Median bleeding rate for patients treated on demand was 15.6 episodes per year

• Patients on prophylactic treatment had a median bleeding rate of 2.9 and 1.0 episodes per year when treated with doses of 10 U/kg and 40 U/kg, respectively

• Among patients receiving 40 U/kg:

• 99% of bleeding episodes were treated with only one infusion

• Two thirds of patients experienced complete resolution of bleeding in their target joints

• Steady-state half-life of 110 hours

• N9-GP appeared to have a safe and well tolerated profile with no patients developing inhibitors

Dose normalised 50 IU/kg (N=15) One stage clot assay

1.2

1.0

0.8

0.6

0.4

0.2

0.0

FIX activity (IU/mL)

N9-GP pdFIX rFIX

168 0 24 48 72 96 120 144

Time (h)

5,05

4,10

3,50

4,72

11,82 11,82

N8-GP

Pathfinder™ 2 headline results (phase 3)

Positive results from phase 3 trial with long-acting factor VIII for treatment of haemophilia A

• Median bleeding rate for patients treated on demand was 30.9 episodes per year

• Patients on prophylactic treatment had a median bleeding rate of 1.3 per year

• Pharmacokinetic documented single dose half-life of 18.4 hours

• Mean trough level of 8%

• N8-GP appeared to have a safe and well tolerated profile

• One patient developed an FVIII inhibitor, which is in-line with expectations for a population of previously treated haemophilia A patients

Source: Novo Nordisk data on file

N8-GP phase 1 pharmacokinetics

FVIII activity (IU/mL)

168

1.2

1.0

0.8

0.6

0.4

0.2

0.0

0 24 48 72 96 120 144

Source: Tiede et al. J Thromb Haemot. 2013;11:670-675


FVIII

Dose 50 IU/kg (N=8) One stage clot assay

Time (h)

5,05

4,10

3,50

4,72

11,82 11,82

Development in global hGH market Growth hormone volume market share

Novo Nordisk continues to expand leadership within growth hormone market

1 CAGR for 5-year period. Value in DKK Source: IMS Monthly MAT value and volume figures Source: IMS Monthly MAT volume figures

Nov 2009

Nov 2014

0%

5%

10%

15%

20%

25%

30%

35%

Sandoz

Roche Eli Lilly

33%

Novo Nordisk Pfizer

Merck Kgaa


0

20

40

60

80

0

5

10

15

20

Thousands

Nov 2009

Nov 2014

CAGR volume1: 5.8% CAGR value DKK1: 2.2%

MAT value DKK MAT volume kg kg

DKK billion

5,05

4,10

3,50

4,72

11,82 11,82

Slide 96

0.0

0.5

1.0

1.5

2.0

Norditropin® reported sales Key Norditropin® properties

Solid Norditropin® sales growth

CAGR 9.1%

• Product characteristics: Premixed, prefilled multi-use

delivery systems available in multiple strengths, and stable

at room temperature

• Expanded indications: GHD, GHDA, Noonan Syndrome,

Turner Syndrome, SGA indication, Idiopathic short stature

• Easy to use FlexPro® device

• Medical and Clinical support programmes

• Patient support programmes

Q4 2009

Q4 2014



DKK billion

5,05

4,10

3,50

4,72

11,82 11,82

Financials


5,05

4,10

3,50

4,72

11,82 11,82

0%

10%

20%

30%

2005 2014

0%

10%

20%

30%

2005 2014

12%

Sales growth in local currencies 2005–2014

Operating profit growth in local currencies 2005–2014

Novo Nordisk has delivered sustained double digit growth throughout the last decade

Note: Numbers for 2007 and 2008 are adjusted for the impact of the discontinuation of pulmonary insulin projects


Sales growth Average growth Operating profit growth Average growth

19%

5,05

4,10

3,50

4,72

11,82 11,82

Reported annual sales Reported annual sales split by region

Solid sales growth with especially North America, International Operations and China expanding

Note: China was separated as an independent sales region in connection with the release of 2010 full year results

Europe North America Int. Operations

Japan & Korea China

Biopharmaceuticals Diabetes

0

10

20

30

40

50

60

70

80

90

100

1 2 3 4 5

Th

ou

san

ds

2010 2011 2012 2013 2014

CAGR1 9.9%

75% 76%

78%

78% 79%

2010 2014

39%

31%

49%

23%

14%

6%

21%

9%



9%

DKK billion

5,05

4,10

3,50

4,72

11,82 11,82

0%

10%

20%

30%

40%

0

5

10

15

20

25

30

35

40

45

1 2 3 4 5

Operating profit Operating profit therapy split

Solid operating profit growth driven by diabetes

Diabetes Biopharm

2010 2014

26%

74% 64%

36%


27% 18%

32%

10% 7%

Operating profit growth vs last year

Operating profit as % of sales Operating profit

2010 2011 2012 2013 2014

Operating profit growth in local currencies

16% 22% 20% 15% 13%

DKK billion

5,05

4,10

3,50

4,72

11,82 11,82

Diabetes P&L – full year 2014 Biopharmaceuticals1 P&L – full year 2014

Profitability per segment

0

10

20

30

40

50

60

70

80

Sales COGS S&D R&D Admin OOI OP

-18%

-29%

-13%

-4% 36% +1%

0

10

20

30

40

50

60

70

80

Sales COGS S&D R&D Admin OOI OP

-11% -15% -15% -4% 56% +1%


DKK billion

1 Excluding inflammation

DKK billion

5,05

4,10

3,50

4,72

11,82 11,82

0%

5%

10%

15%

20%

25%

0

5

10

15

Th

ou

san

ds

Cost of Goods Sold (COGS) Capital expenditures (CAPEX)

Continued decline in relative COGS level combined with stable investment level

2010 2011 2012 2013 2014 0%

2%

4%

6%

0

1

2

3

4

1 2 3 4 52010 2011 2012 2013 2014

COGS as % of sales CAPEX as % of sales

COGS CAPEX

Investor presentation First nine months of 2014

DKK billion

DKK million

5,05

4,10

3,50

4,72

11,82 11,82

0

2

4

6

8

10

12

14

16

2011 2012 2013 2014 2015E

Dividend and pay-out ratio (year of dividend pay)

Share repurchase programmes (year of repurchase)

Cash generated is returned to shareholders in the form of dividends and share buybacks

Note: 12 month share repurchase programme of up to 15 billion DKK initiated in Feb 2015

20%

25%

30%

35%

40%

45%

50%

55%

0

2

4

6

8

10

12

14

2011 2012 2013 2014 2015E

Pay-out ratio Dividend paid

5.7 7.7

9.7

11.9

13.0

Share repurchase programmes 2011–2015

12.0 12.0

14.0

15.0 15.0


DKK billion

DKK million

5,05

4,10

3,50

4,72

11,82 11,82

Operating profit growth Operating margin

Long term financial targets: Operating profit growth and operating margin

Note: The long term financial targets are 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 stable

Current long term financial target

Previous long term financial targets



0%

5%

10%

15%

20%

25%

30%

35%

2010 2011 2012 2013 2014 0%

15%

30%

45%

2010 2011 2012 2013 2014


5,05

4,10

3,50

4,72

11,82 11,82

Operating profit after tax to net operating assets

Cash to earnings (three years’ average)

Long term financial targets: Operating profit after tax to net operating assets and cash to earnings

Note: The long term financial targets are 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 stable

0%

20%

40%

60%

80%

100%

120%

140%

0%

20%

40%

60%

80%

100%

120%

140%





2010 2011 2012 2013 2014 2010 2011 2012 2013 2014


5,05

4,10

3,50

4,72

11,82 11,82

Slide 106

The Novo Nordisk Foundation

Stable ownership structure - secured through A and B-share structure

• The Novo Nordisk Foundation is a self-governing institution that: • provides a stable basis for Novo Nordisk • supports scientific, humanitarian and social purposes

• All strategic and operational matters are governed by the board and management of Novo Nordisk

• Overlapping board memberships ensure that the Novo Nordisk Foundation and Novo Nordisk share vision and strategy


Share structure

Note: Treasury shares are included in the capital but have no voting rights

Novo Nordisk A/S

Novo Nordisk Foundation Institutional and private

investors Novo A/S

A shares

537m shares

B shares

2,113m shares

74.5% of votes

26.5% of capital

25.5% of votes

73.5% of capital

investor presentation full year 2014 copenhagen 30 january 2015€¦ · 30-01-2015 · investor...

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