Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global...

38
Novo Nordisk 1 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003

Transcript of Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global...

Page 1: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

Novo Nordisk

1

A focused healthcare companyInvestor presentation – Merrill Lynch Global Pharmaceutical ConferenceLondon, 24 September 2003

Page 2: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Forward-looking statements

This presentation contains forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of 1995.

Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk's products, introduction of competing products, Novo Nordisk's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, unexpected growth in costs and expenses.

Risks and uncertainties are further described in reports filed by Novo Nordisk with the US Securities and Exchange Commission (SEC) including the company's Form 20-F, which was filed on 27 March 2003. Novo Nordisk is under no duty to update any of the forward-looking statements after the date of this report or to conform such statements to actual results, unless required by law.

Novo Nordisk has the copyright to the information contained in this presentation. © 2003 Novo Nordisk A/S.

Page 3: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Agenda

• Novo Nordisk in brief

• Diabetes care

• The diabetes care business case

• Realising the diabetes care business case in the US

• Haemostasis management

• Research and development

• Diabetes care

• Biopharmaceuticals

• Financial update and outlook 2003

Page 4: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Novo Nordisk in brief

• Consistent, strong organic growth• Focused on few therapeutic

areas with large unmet medical needs

• Leadership in diabetes and most extensive diabetes pipeline in the industry

• Becoming an established player in general haemostasis management

• Proven biotech and drug delivery capabilities

• Low exposure to patent expirations

Long-term financial targets:

EBIT growth of 15%

EBIT margin of 25%

ROIC of 25% (post-tax)

Cash to earnings of 60%

Balancing growth and value

Page 5: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Sales in first half year 2003

North America

Japan & Oceania Europe

InternationalOperations 45%

24%

16%

15%

HRT

Haemostasis management

Diabetes careGrowth hormone therapy

14%

5%

70%

8%

By therapy By region

Total DKK 12.6 billion +5% reported and +17% in local currencies

Page 6: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Diabetes - an unfolding epidemic

Source: Mokdad et al., Diabetes Care 2000;23:1278-83; J Am Med Assoc 2001;286:10.

No Data <4% 4%-6% 6%-8% 8%-10% >10%

1990

1995

2001

Diabetes prevalence

.

Page 7: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Insulin – the ultimate treatment

-ce

ll fu

nctio

n

Diet and exercise alone

Oral therapy

Insulin therapy

Oral/insulin

Time from diagnosis

Type 2 – slope

Type 1 – immediate need for insulin

Page 8: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Insulin market overview – volume

Source: IMS/BW. Volume data for USA, Europe, Japan, Canada, New Zealand, South Africa and Australia. Wal*Mart figures not included. Market size and share as MAT Q1 2003 and growth as MAT Q1 2003 versus MAT Q1 2002. The arrows next to the market shares illustrate the direction of change compared to MAT Q1 2002.

Novo Nordiskmarket share

28% ▲

59% ▲

76% ▼

47% ▲World

Japan

Europe

USA

Market

41%

48%

5%

Market size

100% 8.7%

8.4%

7.0%

13.6%

5.7%

12.0%

6.3%

4.3%

Novo Nordisk

Growth rates

Page 9: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Hum

an in

sulin

Vials

Dur

able

Ani

mal

insu

linAdding value to volume

Pre

fille

d

Insu

lin a

nalo

gue

Impr

oved

con

trol

Improved accuracy and compliance

Page 10: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Increasing the analogue market share

Source: IMS/BW

Note: quarterly data, volume figures

Q1 2000 Q1 2003

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

Q1 2000 Q1 2003

Analogue penetration Novo Nordisk’s analogue market share

Analogues

Human insulin

26%

Page 11: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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50

55

60

65

70

75

80

No

vo

No

rdis

k m

ark

et

sh

are

Continued conversion

Pen penetration

Q1 2000 Q1 2003

32%

Source: IMS/BW

Novo Nordisk market shares

Q1 2000 Q1 2003

Note: quarterly data, volume figures

21%

Vial

Prefilled

Durable

PrefilledDurable

63%

59%

28%

13%

Meg

a un

its

Page 12: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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The insulin business case

5%

Volumedrivers

Valuedrivers

• Conversion from human insulin to insulin analogues

• Conversion from vials and syringes to devices

• Conversion from durable to prefilled devices

• Epidemic growth in number of people with diabetes

• One third are diagnosed• Trend towards earlier and

more intensive therapy

5%

+

Page 13: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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The diabetes business case - on regional basis

North America:• Analogue conversions • Volume growth• Device penetration

Europe:• Analogue conversions• Volume growth Japan & Oceania:

• Volume growth• Conversion to disposable devices

International Operations:• Volume growth • Conversion to devices • Insulin conversion5%

5%

+

Page 14: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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0

0.5

1

1.5

2

MAT Q1/97 MAT Q1/99 MAT Q1/01 MAT Q1/03

$Bn

US insulin market

Volume market Value marketCAGR: 15%CAGR: 3%

Source: IMS/BW

CAGR: 22%

CAGR: 4%

45,000

50,000

55,000

60,000

65,000

70,000

75,000

80,000

85,000

MAT Q1/97 MAT Q1/99 MAT Q1/01 MAT Q1/03

Vol (MU)

43%

24%

17%

16%

North America

Page 15: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Key strategic changes in 2000

Prior to change

Strategic decision

Current status

Distribution Partnership Alone

First detailing Prandin® Insulin

Own field people Approx 175 Increase to some 600

Approx 675

Type of products Human insulin and few devices

Focus on analogues and

new devices

All newest analogues and

devices launched

Drug development Mostly out of Europe

Increase US presence

Significantly increased

Insurance coverage Less than 30% of insured life's

Increase More than 60% of insured life’s

43%

24%

17%

16%

North America

Page 16: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Outcome of strategic initiatives – so far

Source: IMS/BWNote: US, Quarterly data, volume figures

Q1 2000 Q1 2003

Novo Nordisk market shares

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

Human insulin Analogues

Key observations:• Overall market share now

above 30% from 26%• Retail market share increased

to above 15% from about 13%• Non-retail market share

increased to above 75% from below 70%

• Selected product launches• NovoLog® - 2001• FlexPen® - 2002• NovoLog® Mix 70/30 – 2002• InnoLet® - 2002

43%

24%

17%

16%

North America

Page 17: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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NovoLog® driver of market share

Source: IMS/BW

Note: US, Quarterly data, volume figures

Short-acting segment - US

Q1 2000 Q1 2003

Key observations:

• Short-acting segment 28% of insulin sold – 56% being analogues

• NovoLog® launched in September 2001

• NovoLog® only analogue approved for pump use

• NovoLog® in FlexPen®

launched in February 20030%

10%

20%

30%

40%

50%

60%

70%

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

Analogue conversion

NovoLog® market share oftotal segment (right axis)

43%

24%

17%

16%

North America

Page 18: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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NovoLog® Mix a future contributor

Source: IMS/BW

Note: US, Quarterly data, volume figures

Premix segment - US

Q1 2000 Q1 2003

Key observations:

• Premixed segment 32% of insulin sold – 23% being analogues

• NovoLog® Mix 70/30 in FlexPen® launched in September 2002

• NovoLog® Mix in vials launched in March 2003

0%

5%

10%

15%

20%

25%

0%

1%

2%

3%

4%

5%

6%

7%

8%

9%

10%

Analogue conversion

NovoLog® Mix market shareof total segment (right axis)

43%

24%

17%

16%

North America

Page 19: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Growth set to continue

Q1 2000 index 100

Novo Nordisk insulin salesNorth America, local currencies

CAGR 22%

0

50

100

150

200

Q100

Q200

Q300

Q400

Q101

Q201

Q301

Q401

Q102

Q202

Q302

Q402

Q103

Q203

43%

24%

17%

16%

North America

Insulin market growth potential• “An epidemic”• Increased diagnosis rate• Earlier switches to insulin• >2/3 of patients are not in control

with current treatment

Product Upgrade Potential• Human insulin (65% MS)

Analogue

• Vial (89% MS) Devices

• Human vial (61% MS) Analogue Devices

Page 20: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Adding value to volume – key to delivering high growth

Hum

an in

sulin

(65%

)

Vials (89%)

Dur

able

s

(3%

)

Dis

posa

bles

(8

%)

Insu

lin a

nalo

gues

(35%

)

Source: IMS/BWNote: US, Q1 2003, volume figures

Impr

oved

con

trol

Improved accuracy and compliance

43%

24%

17%

16%

North America

Page 21: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Only Novo Nordisk offers full range of analogues

NovoLog®

NovoLog® Mix 70/30

Levemir™, launch 2004

Short-acting

Premix

Long-acting

FlexPen®

PenFill®

Vial

43%

24%

17%

16%

North America

Page 22: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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US – a huge upgrade potential

US

Source: IMS/BW

Note: Q1, 2003, volume figures

0% 20% 40% 60% 80% 100%

DENMARK

NETHERLANDSPOLAND

PORTUGAL

GERMANYNORWAY

SPAINJAPAN

FRANCESWITZERLANDNEW ZEALAND

IRELANDBELGIUM

UNITED KINGDOMAUSTRALIA

CANADAITALY

SOUTH AFRICA

Durable Disposable Vial

43%

24%

17%

16%

North America

Page 23: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Novo Nordisk offers the most advanced devices

DurableDisposable

InDuo®

NovoPen® Junior

Innovo®

FlexPen®

InnoLet®

43%

24%

17%

16%

North America

Page 24: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Trends to look out for:• Volume growth

• Demographics• Obesity• Intensified treatment

• Value growth• Analogue conversion will continue• Device conversion will continue

Novo Nordisk’s strategy:• Volume growth

• Further increase contract and partner developments

• Facilitate education and awareness

• Value growth• Continue focus on NovoLog® and

NovoLog® Mix 70/30• Continue pushing device penetration

concept via newly launched devices• Convert contract segment to

analogues and devices• Launch Levemir™ in 2004

Novo Nordisk’s US insulin strategy

43%

24%

17%

16%

North America

Page 25: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Haemostasis management -NovoSeven®

Ke

y o

bse

rva

tion

s•

In lo

cal c

urre

nci

es g

row

th w

as

24%

in th

e se

con

d q

uart

er. A

ll re

gio

ns c

ont

ribu

ted

to th

e g

row

th

•S

ale

s g

row

th w

as d

rive

n b

y in

cre

ased

use

in th

e in

hib

itor

segm

ent b

oth

with

in c

ong

eni

tal

and

acq

uire

d h

aem

oph

ilia

an

d a

pe

rce

ived

incr

eas

e in

in

vest

iga

tiona

l use

•N

orth

Am

eric

a th

e m

ain

gro

wth

dr

ive

r

Sales by quarter+8%

0

100

200

300

400

500

600

700

800

900

1,000

Q1 Q3 Q1 Q3 Q1 Q3

DK

K m

illio

n

Q1

2000 2001 2002 2003

Page 26: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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NovoSeven®

– current business

Key observations

• Penetration increases as confidence in NovoSeven® increases

• Increased treatment intensity and earlier onset of treatment

• Increased confidence in elective surgery with NovoSeven®

• Awareness creation within acquired haemophilia progressesConfidence/Awareness

Pe

netration

Elective surgery within haemophilia

Acquired haemophilia

Spontaneous bleedings in congenital haemophilia

Page 27: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Low exposure to patent expiration

Accumulated % of 2002 Novo Nordisk sales with

patents expiring

0

5

10

15

20

25

30

35

40

2003

2004

2005

2006

2007

2008

2009

2010

2011

0

5

10

15

20

25

30

35

40

Bay

er

GS

K

Tak

eda

Pfi

zer

Mer

ck

No

vart

is

BM

S

Ave

nti

s

Eli

Lil

ly

% of 2001 sales with patents expiring in 2002-2006

Source: Nordea Securities and Novo Nordisk.

No

vo N

ord

isk

Page 28: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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R&D

Diabetes expertise

Protein expertise

NovoSeven® expansion

liraglutide

balaglitazone

NN2501

AERx® iDMS

insulin analogues

NN414

hGH expansion

ASIS

Drug delivery expertise

Protein Delivery System unit

(PDS)

Page 29: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Diabetes care pipeline

Compound Type Indication Phase

Levemir™ (insulin detemir) Insulin Type 1+2 diabetes Filed EU+US

NovoMix® 50 and 70 Insulin Type 1+2 diabetes Phase 3

AERx® iDMS (NN1998) Insulin Type 1+2 diabetes Phase 3

Liraglutide (NN2211) GLP-1 analogue Type 2 diabetes Phase 2

Balaglitazone (NN2344) OAD Type 2 diabetes Phase 2

NN414 OAD Type 1+2 diabetes Phase 2

NN344 Insulin Type 1+2 diabetes Phase 1

NN2501 OAD Type 2 diabetes Phase 1

Page 30: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Levemir™ – better efficacy with fewer side effects

HbA1c reduction

Relative nocturnal

hypoglycaemia 100

0

% Index

Note: data from phase 3b study presented at International Diabetes Federation, August 2003, involving 595 type 1 diabetes patients over 18 weeks. LevemirTM and NovoRapid® versus long- and short-acting human insulin.

p<0.001

p<0.005

0

1

LevemirTM and NovoRapid®

Long- and short-acting human insulin

Key observations:• Intensive analogue therapy

superior to human insulin regime on HbA1c

• Significant weight improvement• Very high predictability

resulting in significantly improved side-effect profile:

• 24-hour hypoglycaemia, p<0.05

• Nocturnal hypoglycaemia, p<0.001

100

Page 31: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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A dual approach towards proof of concept

General haemostatic agent

Bleeding in emergenciesElective bleeding

Page 32: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Biopharmaceuticals – pipeline outside diabetes care

Compound Indication Phase

Growth hormone IUGR/SGA* Approved by EU

NovoSeven® Upper gastro-intestinal bleeding Phase 2

NovoSeven® Liver transplantation Phase 2

NovoSeven® Trauma Phase 2

NovoSeven® Stem cell transplantation Phase 2

NovoSeven® Intra-cerebral haemorrhage Phase 2

NovoSeven® Hepatectomy Phase 2

Growth hormone Complicated fractures Phase 2

ASIS** ARDS Phase 2

* Intra-uterine Growth Retardation/Small for Gestational Age** ASIS - Active Site Inhibited Seven/ARDS - Acute Respiratory Distress Syndrome

Page 33: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Towards general haemostasis management

Haemophilia treatment

Haemostasis management

Page 34: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Financials

Page 35: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Net turnover 12,630 12,034 5

Operating profit 2,939 2,856 3

Net financials 662 99 569

Profit before tax 3,601 2,955 22

Net profit 2,377 1,925 23

EPS (DKK)* 6.88 5.51 25

Financial results

* EPS on a fully-diluted basis.

DKK million First half year 2003 2002 % change

Page 36: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Currency exposure

Effect of 5% depreciation on full-

year operating profit* (DKK million)

USD -160

JPY -130

GBP -75* currency hedging income

is recorded as financial income

5.25

6.25

7.25

8.25

avg = 8.32

avg = 6.85

2001 2002 2003

avg = 6.30

avg = 7.88

USD

JPY

YTD 2003 avg = 5.65

YTD 2003 avg = 6.71

Page 37: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Outlook for 2003

Note: the above outlook is based on the assumption that exchange and interest rates remain at the current levels (4 August 2003)

• Operating profit still expected to grow by a low single-digit percentage rate

• Expectations for net financial income increased to DKK 900 million

• Tax rate of 34%

• Net profit now expected to grow by more than 10%

Key currency ratesDKK

per 1002002

average

USD 788

JPY 6.30

GBP 1182

Current rate*

657

5.45

1059

* As of 4 August 2003

2003 ytd avg

671

5.65

1082

Page 38: Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global Pharmaceutical Conference London, 24 September 2003.

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Investor information

Investor relations contactsNovo Nordisk A/S Investor Relations Novo Allé, DK 2880 BagsværdFax (+45) 4443 6633

Peter HaahrTel (direct): (+45) 4442 1207 E-mail: [email protected]

Palle Holm Olesen Tel (direct): (+45) 4442 6175 E-mail: [email protected]

Christian KanstrupTel (direct): (+45) 4443 7801 E-mail: [email protected]

Investor Relations Office USTel (direct): (+1) 609 919 7846

Share information

Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. 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

http://www.novonordisk.com