novo nordisk a focused healthcare company investor presentation – august 2004

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Novo Nordisk A focused healthcare company Investor presentation – August 2004

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Page 1: Novo Nordisk A focused healthcare company Investor presentation – August 2004

Novo Nordisk

A focused healthcare companyInvestor presentation – August 2004

Page 2: Novo Nordisk A focused healthcare company Investor presentation – August 2004

2

Agenda

• Introduction

• Sales update• Diabetes care

• NovoSeven®

• North America update

• Research & development update

• Financial results

• Outlook for 2004

Page 3: Novo Nordisk A focused healthcare company Investor presentation – August 2004

3

Forward-looking statements

This presentation contains forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of 1995. Forward-looking statements provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’, ‘estimate’, ‘expect’, ‘project’, ‘intend’, ‘plan’, ’believe’ and other words and terms of similar meaning in connection with a discussion of future operating or financial performance.

Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. 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, and 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 February 2004. Please also refer to the section ‘Financial risk factors and financial risk management' in the Annual Financial Report 2003. Novo Nordisk is under no duty to update any of the forward-looking statements or to conform such statements to actual results, unless required by law.

Novo Nordisk has the copyright to the information contained in this presentation. © 2004 Novo Nordisk A/S.

Page 4: Novo Nordisk A focused healthcare company Investor presentation – August 2004

4

Highlights

Market development:• Continued solid performance of Novo Nordisk’s analogues

• Market share gains for both NovoRapid® and NovoMix® 30• Levemir® launched in UK and Finland

• NovoSeven® growth continues

Research and development:• NovoMix®50 and NovoMix®70 filed for approval in Europe Novo Nordisk expects to file for European approval of NovoSeven® in

connection with blunt trauma

Financials:• Sales: +10% as reported and +14% in local currencies• Operating profit: +12% as reported Operating profit is now expected to grow by slightly more than 5%

Page 5: Novo Nordisk A focused healthcare company Investor presentation – August 2004

5

Key products continues to drive growth

Total sales DKK 13,789 billion +14% Y/Y in local currencies

NovoSeven®

Note: Share of growth is in local currency

Share of sales

Other biopharmaceuticals

Insulin analogues

Other diabetes care

Share of growth

Other diabetes care

Other biopharmaceuticals

Insulin analogues

NovoSeven®

11%

16%

18%

55%

0% 20% 40% 60%

Page 6: Novo Nordisk A focused healthcare company Investor presentation – August 2004

6

Solid volume growth in the insulin market

Note: Wal*Mart figures not included. Market size and share as MAT Q1 2004 and growth as MAT Q1 2004 versus MAT Q1 2003. The arrows next to the market shares illustrate the direction of change compared to MAT Q1 2003. Source: IMS/BW

Novo Nordiskmarket share

32% ▲

58% -

76% -

49% ▲World

Japan

Europe

USA

Market

41%

49%

5%

Market size

100% 10.1%

10.9%

7.7%

15.6%

6.1%

10.7%

7.6%

4.1%

Novo Nordisk

Growth rates

Page 7: Novo Nordisk A focused healthcare company Investor presentation – August 2004

7

Analogues - local currency growth of 90%

Key o

bserv

ati

on

s

•G

row

th in s

eco

nd q

uart

er

of

86

% in loca

l cu

rrenci

es

•G

row

th o

f 9

0%

in loca

l cu

rrenci

es

for

the fi

rst

half o

f 2

00

4

•Str

ong N

ovoR

apid

® a

nd

NovoM

ix®

30

mark

et

share

gain

s in

all

regio

ns

•A

nalo

gue g

row

th d

riven b

y

Nort

h A

meri

ca a

nd E

uro

pe

•C

onti

nuin

g L

evem

ir®

launch

es

to u

nderp

in f

urt

her

gro

wth

Q12002

Q22004

Analogues sales development

Mill.DKK

+81%

0

200

400

600

800

1,000

1,200

Page 8: Novo Nordisk A focused healthcare company Investor presentation – August 2004

8

A continued increase in analogue market share

Source: IMS/BW

Note: Quarterly data, volume figures

Q12000

Q12004

Q12000

Q12004

Analogue penetrationNovo Nordisk’s analogue

market share

Analogues

Human insulin

33%

7%0%

5%

10%

15%

20%

25%

30%

Page 9: Novo Nordisk A focused healthcare company Investor presentation – August 2004

9

NovoRapid® - driver in short-acting segment

Source: IMS/BW

Note: Quarterly data, volume figures

Q12000

Q12004

NovoRapid®’s share of short-acting analogues

Key o

bserv

ati

on

s

•Pro

vid

ing fl

exib

le a

nd m

eal-

tim

e

rela

ted d

osi

ng

•Pro

ven e

ffica

cy a

nd s

afe

ty

•2

/3 o

f N

ovoR

apid

are

sold

in d

evic

es

•A

vaila

ble

in F

lexPen®

, N

ovoPen®

and v

ials

•Fl

exPen®

is

the p

refe

rred d

evic

e

am

ong p

ati

ents

and h

ealt

hca

re

pro

fess

ionals

0%

10%

20%

30%

40%

Page 10: Novo Nordisk A focused healthcare company Investor presentation – August 2004

10

NovoMix® - the starter insulin

Note: Quarterly data, volume figures

Q12000

Q12004

NovoMix®’s share of premixed analogues

Sources: IMS/BW and data presented at ADA 2004 involving 233 insulin naive patients in an open-label 28-week study.

Percentage of patients with HbA1c <

7%

0%

10%

20%

30%

40%

71%

45%

0%

20%

40%

60%

80%

NovoLog® Mix70/30

Insulin glargine(Lantus)

Page 11: Novo Nordisk A focused healthcare company Investor presentation – August 2004

11

Levemir®- completing the portfolio

Less hypo- and hyperglycemic events with Levemir®

Source: Diabetes, Vol 53, June 2004

Key o

bserv

ati

on

s

•Pro

vid

ing p

redic

tabili

ty w

ithout

weig

ht

gain

s

•Le

vem

ir®

launch

ed in S

wit

zerl

and in

Marc

h.

Mark

ets

hare

of

about

10

% o

f th

e long-a

ctin

g s

egm

ent

•La

unch

ed in U

K late

June a

nd

rece

ntl

y in F

inla

nd

•Le

vem

ir t

o b

e launch

ed in o

ther

key

Euro

pean m

ark

ets

late

r th

is y

ear

•U

S a

ppro

val st

ill e

xpect

ed m

id 2

00

5

Hypoglycemia (too low blood sugar)

Hyperglycemia (too high blood sugar)

0,5

10

2

27

Insulin detemir(Levemir®)

Insulin glargine(Lantus)

# o

f even

ts p

er

year

Page 12: Novo Nordisk A focused healthcare company Investor presentation – August 2004

12

Device penetration continues- driven by FlexPen™

Q12000

Pen market shares

Q12004

Disposable share of overall market

FlexPen™ share of disposable market

% of patients feeling device will result in better

compliance

Note: Quarterly data, volume figures, 15 % of patients feeling device will result in better compliance could not decide.Sources: IMS/BW and Lawton S, Berg B. Comparative evaluation of FlexPen®, a new prefilled insulin delivery system, among patients and healthcare professionals. Diabetes 2001; 50 (Suppl 2): A440

0%

5%

10%

15%

20%

25%

30%74

11

0

FlexPen™ Lilly NPH pen Aventis'prefilled pen

# in

%

Page 13: Novo Nordisk A focused healthcare company Investor presentation – August 2004

13

The insulin business case

Volume growth drivers:

• Epidemic growth

• Increased life expectancy

• Increasing awareness leading to increasing diagnosis rate

• Earlier switches from tablets to insulin

• Insulin is the ultimate treatment

Vials

Du

rab

les

Dis

posa

ble

s

Improving convenience, compliance and control

Animal insulin

Human insulin

Insulin analogues

Page 14: Novo Nordisk A focused healthcare company Investor presentation – August 2004

14

NovoSeven - growth continues

NovoSeven sales development

Q12002

Q22004

Mill.DKK

+10%

Key o

bserv

ati

on

s

•G

row

th in s

eco

nd q

uart

er

of

13

% in loca

l cu

rrenci

es

•G

row

th o

f 1

7%

in loca

l cu

rrenci

es

for

the fi

rst

half

•G

row

th d

riven b

y E

uro

pe a

nd

Nort

h A

meri

ca

•G

row

th in N

ort

h A

meri

ca d

riven

by a

cquir

ed h

aem

ophili

a a

nd

invest

igati

onal use

•G

row

th in E

uro

pe d

riven b

y

ele

ctiv

e s

urg

ery

and

invest

igati

onal use

0

200

400

600

800

1,000

1,200

Page 15: Novo Nordisk A focused healthcare company Investor presentation – August 2004

15

North America is the key growth driver

Total sales DKK 13,789 billion +14% Y/Y in local currencies

Europe

Note: Share of growth is in local currency

Share of sales

International Operation

North AmericaJapan &Oceania

Share of growth

Japan & Oceania

International operations

North America

Europe

10%

14%

21%

55%

0% 20% 40% 60%

Page 16: Novo Nordisk A focused healthcare company Investor presentation – August 2004

16

US headquarters

Formulation, filling,and packaging

Clayton

Novo Nordisk in North America - an expanding organisation

Development, sales,and marketing

Princeton

Number of employees 365 employees comparedto 198 in Q1 2000

North America

457

993 1,0141,143

1,381

Q12000

2001 2002 2003 June2004

Page 17: Novo Nordisk A focused healthcare company Investor presentation – August 2004

17

North America- a significant contributor to growth

Q12000

Q22004CAGR 24%

Sales index(local currency)

Share of Novo Nordisk growth (local currency)

North America

0

50

100

150

200

250

300

0%

10%

20%

30%

40%

50%

60%

70%Sales index

Share of Novo Nordiskgrowth (right axis)

Page 18: Novo Nordisk A focused healthcare company Investor presentation – August 2004

18

North America in early 2000- a strategic change needed

North AmericaSales composition Q2 2000

Other biopharmaceuticals

NovoSeven®Diabetes care

Key strategic issues

• Several unsuccessful partnerships

• Prandin focused strategy, though less than of 2% volume market share of overall OAD market

• Lack of penetration in the insulin market:

• 24% volume market share

• Retail market share 17%

• Analogue market share 0%

• 9% of Novo Nordisk insulin sold in devices

• Around 20% formulary coverage

• No corporate brand recognition

North America

Page 19: Novo Nordisk A focused healthcare company Investor presentation – August 2004

19

Key strategic changes

Refocus in 2000

• Change of focus. Insulin first detailing

• Establishing own diabetes care sales force

• New management team in place

• Prioritised and increased managed care group

• New HR strategy in place

Product launches

• NovoLog®

• NovoLog® Mix 70/30 FlexPen

• NovoLog® FlexPen

• NovoLog® Mix 70/30 in vials

• Norditropin®

Other changes

• Corporate branding

• Diabetes field force expansion

• Managed care and trade team expanded

• NovoSeven® sales effectiveness and medical liaisons expanded

• Dedicated hGH sales reps

• Major partnerships

North America

Page 20: Novo Nordisk A focused healthcare company Investor presentation – August 2004

20

Insulin analogues

NovoSeven®

Other diabetes care

Other biopharmaceuticals

Strategic new products driving growth

Q12000

Q22004

Sales in local currencies

Sales North America

North America

Page 21: Novo Nordisk A focused healthcare company Investor presentation – August 2004

21

Diabetes care - expansion strategy paying off

Q12000

Q12004Overall market share

Analogue market sharePremix market shareShort-acting market share

Long-acting market share

Source: IMS/BW, volume, quarterly data

Novo Nordisk’s US insulin market shares

Q12000

Q12004

North America

0%

5%

10%

15%

20%

25%

30%

35%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

Page 22: Novo Nordisk A focused healthcare company Investor presentation – August 2004

22

US pen penetration growing

Diabetes care - expansion strategy paying off

Source: IMS/BW, quarterly data, volume

Novo Nordisk now US device leaderNovo Nordisk’s pen market shares

Q1 2000 Q1 2002 Q1 2004

North America

0% 5% 10% 15% 20%

Insulinanalogues

Total insulinmarket

0% 20% 40% 60%

Insulinanalogues

Total insulinmarket

Page 23: Novo Nordisk A focused healthcare company Investor presentation – August 2004

23

Status 2004

•Competitive diabetes sales force

• Insulin analogue focused strategy, significant player in the insulin market

•Significant growing presence in the insulin market

• 33% volume market share

• Retail market share 24%

• Analogue market share 17%

• 12% of Novo Nordisk insulin sold in devices

•More than 70% formulary coverage

•Extensive corporate branding program, several partnerships

North America

Page 24: Novo Nordisk A focused healthcare company Investor presentation – August 2004

24

Further upside ahead- diabetes care

0%

10%

20%

30%

40%

50%

60%

70%

Q12000

Q12004

The US insulin market

Retail

Nonretail

Novo Nordisk’s market shares

Retail market share

Non retail market share

Source: IMS/BW, volume, quarterly data

Volume

North America

• Analogue insulin focused strategy is targeting the retail segment

• Significant value upgrade opportunities via conversion to analogues and devices

• Novo Nordisk has a highly competitive portfolio of analogues and devices

Page 25: Novo Nordisk A focused healthcare company Investor presentation – August 2004

25

Further upside ahead- biopharmacuticals

Q12000

Q12004

NovoSeven®Expanding the use

• Field force effectiveness

• Increasing the number of medical liaisons

• New indications pursued• Trauma study to be initiated within the

next 6 months

• Explorative phase 2 study in spinal surgery

• ICH study completed

• Ongoing clinical trials within the inhibitor population

• NovoSeven® patient assistance programme: SevenSecure

Novo Nordisk’s growth hormone market share

Source: IMS/BW, volume, quarterly data

North America

• Dedicated hGH reps

• Expanding the label for Norditropin®

Simplexx

0%

2%

4%

6%

Page 26: Novo Nordisk A focused healthcare company Investor presentation – August 2004

26

R&D pipeline update

• “High mix” NovoMix® filed for marketing approval in Europe (NovoMix® 50&70) and Japan (NovoMix® 50)

• AERx iDMS pharmacokinetic study, added to the ongoing phase 3 safety trial, to report in the first half of 2005.

Diabetes care

NovoSeven ®

• Filing for EU approval within blunt trauma expected first quarter 2005.

Trauma study in the US to be initiated within the next six months

ICH regulatory meetings scheduled with EU/US agencies later this year

Exploratory phase 2a study within spinal surgery initiated

Page 27: Novo Nordisk A focused healthcare company Investor presentation – August 2004

27

NovoSeven® in trauma - less transfusions and fewer complications

Complications

Note: Data on blunt trauma victims. MOF is multiple organ failure, ARDS is acute respiratory distress syndromeSource: Data presented at World Congress on Trauma, Shock, Inflammation and Sepsis, March 2004.

• 1.5 million trauma victims in the Western world

• 100,000 trauma victims receive more than two bags of red blood cells (RBC)

NovoSeven showed• Statistically significant effect on

RBC transfusion• Reduction in complications and

mortality (strong trend)• Less days in ICU (strong trend)• No increase in adverse events

Key o

bserv

ati

on

s

Perc

en

t of

pati

en

ts -

blu

nt

0

5

10

15

20

25

30

MOF ARDS 30-daymortality

PlaceborFVIIa

Page 28: Novo Nordisk A focused healthcare company Investor presentation – August 2004

28

NovoSeven® in ICH- significant effect on disability

Source: Data presented at World Stroke Conference, Vancouver, Canada, July 1 2004

• No existing treatment for ICH• 100,000 patients eligible for

treatment with NovoSeven®

NovoSeven showed• Significant reduction in ICH

volume expansion• Significant improvement in

rating on stroke scales• No significant difference in

safety end-points

Modified Rankin Scale at Day 90

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

160 μg/kg

80 μg/kg

40 μg/kg

Placebo

Key o

bserv

ati

on

s

mRS 0-1 (none)

mRS 6 (dead)

mRS 4-5 (severe)

mRS 2-3 (moderate)

Page 29: Novo Nordisk A focused healthcare company Investor presentation – August 2004

29

Financial results

* EPS on a fully diluted basis.

Sales 13,789 12,533 10 7,222 6,477 12

Operating profit 3,427 3,062 12 1,911 1,665 15

Net financials 107 521 (79) 20 287 (93)

Profit before tax 3,534 3,583 (1) 1,931 1,952 (1)

Net profit 2,367 2,361 - 1,293 1,288 -

EPS (DKK)* 6.97 6.87 1 3.81 3.76 1

DKK million First half year Second quarter

2004 2003 % change 2004 2003 % change

Page 30: Novo Nordisk A focused healthcare company Investor presentation – August 2004

30

5.0

6.0

7.0

8.0

9.0

Currency exposureEffect of 5%

depreciation on full-year operating profit*

(DKK million)USD -210JPY -130GBP -75USD rel -50

* currency hedging income is recorded as financial income

avg = 6.59

avg = 6.30

2002 2003 2004

avg = 5.68

avg = 7.88

USD

JPY

YTD 2004 avg = 5.59

YTD 2004 avg = 6.07

Page 31: Novo Nordisk A focused healthcare company Investor presentation – August 2004

31

Outlook for 2004

Note: Above outlook is based on the assumption that exchange and interest rates remain at the current level (9 August 2004)

• Sales growth expectations:

• 11–14% growth in local currencies

• Close to 10% as reported

• Operating profit growth expectations:

• Underlying growth now expected to grow by 17-20%

• By slightly more than 5% as reported

• Net financial income expected at DKK 100 million

• Tax rate expected to be 33%

• Investments around DKK 3 billion

• Free cash flow around DKK 3 billion

Key currency ratesDKK

per 1002003

average

USD 659

JPY 5.68

GBP 1075

Current rate*

607

5.48

1116

* As of 9 August 2004

2004

ytd avg

607

5.59

1108

Note: Transition to IFRS financial reporting from 2004

Page 32: Novo Nordisk A focused healthcare company Investor presentation – August 2004

32

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]

In North America

Christian KanstrupTel (direct): (+1) 609 919 7937 E-mail: [email protected]

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

Page 33: Novo Nordisk A focused healthcare company Investor presentation – August 2004

33

Appendix

Page 34: Novo Nordisk A focused healthcare company Investor presentation – August 2004

34

0600

People without diabetes

Type 2 diabetes

1000 1400 1800 2200 0200 0600

800

700

600

500

400

300

200

100

Insu

lin

Sec

reti

on

(p

mo

l/m

in)

Source: O'MEARA et al. Am. J. Medicine, 1990; 89.

Insulin secretion in people without diabetes and people with type 2 diabetes

Page 35: Novo Nordisk A focused healthcare company Investor presentation – August 2004

35

Type 2 - slope

Diagnosed - but not adequately treated

Note: Study on type 2 patients. Number of patients according to HbA1c level

% o

f su

bje

cts

0

20

40

60

80

100

OAD treated

Insulin treated

>9% 8%–9% 7%–8% <7%

38 27

20

15

27

22

19

32

HbA1c

Only 1/3 are at goalInsulin is the ultimate treatment

Source: HDS Omnibus Study, fall 2003

-C

ell

funct

ion

Diet and exercise alone

Oral therapy

Oral/insulin

Time from diagnosis

Type 1 - Immediate need for insulin

Insulin

Page 36: Novo Nordisk A focused healthcare company Investor presentation – August 2004

36

European analogue conversion - NovoRapid®

Short-acting segment in Europe

Q1 2000

Q1 2004

Short-acting human insulin

Short-actinginsulin analogues

Q12000

NovoRapid® market share 21%

Share of short-acting segment

Q1 2004

47%

Humalog market share 25%

Source: IMS/BW

Note: Quarterly data, volume figures

22%

0%

5%

10%

15%

20%

25%

30%

Page 37: Novo Nordisk A focused healthcare company Investor presentation – August 2004

37

US analogue conversion - NovoLog®

Short-acting segment in the US

Q1 2000

Q1 2004

Short-acting human insulin

Short-actinginsulin analogues

62%

Q12000

NovoLog® market share 17%

Share of short-acting segment

Q12004

Humalog market share 45%

33%

Source: IMS/BW

Note: Quarterly data, volume figures

0%

10%

20%

30%

40%

50%

60%

Page 38: Novo Nordisk A focused healthcare company Investor presentation – August 2004

38

Insulin segmentation - Europe and the US

Europe US

Q12000

Q12004

Q12000

Q12004

Source: IMS/BW

Note: Quarterly data, volume figures

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Long-acting

Premix

Short-acting

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Long-actingPremixShort-acting

Page 39: Novo Nordisk A focused healthcare company Investor presentation – August 2004

39

Superior treatment with Levemir® and NovoRapid® versus human insulin regimen

-0.8 ±2.4 kg

0.1 ±2.0 kg

-1

1 0

Better effect with fewer side

effects

0.9

2.1

1

3

28.6

11.1

5

15 10

Change in Hb1Ac

-0.5

-0.28 -0.5

0.5

0

p < 0.001p < 0.001 p < 0.001

p < 0.001

Hypoglycaemia allNocturnal hypoglycaemiaChange in body weight

Levemir®/NovoRapid®

Human insulin

Source: Diabetologia (2004) 47:622-629. Study design: 18-week study, 1:1 randomised, open-labelled, parallel trial, 595 patients with type 1 diabetes mellitus received insulin detemir or NPH insulin in the morning and at bedtime in combination with mealtime insulin aspart or regular human insulin respectively.

Page 40: Novo Nordisk A focused healthcare company Investor presentation – August 2004

40

Liraglutide - the first once-daily human GLP-1 analogue

Fasting serum glucose

Weight change

1

0

-1

-2

-3

0

-1

-2

-3

-4

mM

%

Note: Data from the double-blind, double-dummy, randomised, parallel group dose titration phase 2 study including a total of 144 patients with an average HbA1c of 9.4-9.5%. All changes are from baseline; that is, FSG of 13.0-13.2 mM and an average weight of 91-94 kg.

p<0.0001

p<0.015

• Rapid and sustained glycaemic control, weight control, increased beta-cell mass and improved beta-cell function, safe

• Phase 3 expected to start by end of 2004

• Following optimization of the liraglutide process, including up-scaling and work on the final formulation

• Number of patients in phase 3a – total 3,500 patients where over 2,300 are on liraglutide

Liraglutide and metforminGlimepiride and metformin

Page 41: Novo Nordisk A focused healthcare company Investor presentation – August 2004

41

NovoSeven® - a unique mechanism of action

NovoSeven® directly

activates factor X on the surface

of the locally activated platelets

Page 42: Novo Nordisk A focused healthcare company Investor presentation – August 2004

42

NovoSeven® - expanding into general haemostasis

Critical bleedings in elective surgery

Congenital clotting disorders Bleedings in

emergencies

Intracerebral haemorrhage

Trauma

UGI

Prophylaxis

High single-dose

Liver transplantation

Spinal surgery

Hepatectomy

Glanzmann’s

FVII deficiency

Orthopedic surgery

Acquired haemophilia

Variceal bleedings

Page 43: Novo Nordisk A focused healthcare company Investor presentation – August 2004

43

Many trauma patients require blood transfusion

• ~ 10-20% of all trauma patients receive one or more transfusions1

• ~ 50% of trauma patients admitted to an ICU will receive transfusions2

• 1-2% of trauma patients require “massive transfusion” (>20 units of red blood cells)3

1. Annual Report German Trauma Register 2002 2. MOF is multiple organ failure: Shapiro, J. Trauma 2003; 55:269-2743. Wudel, J. Trauma 1991; 31: 1-7

0 0-5 6-10 11-15 16-200

0.1

0.3

0.2

0.4

0.6

0.5

11-15

Units transfused

Incid

en

ce o

f M

OF

Relationship between no of units of blood transfused in the first 12h and the incidence of MOF2

Page 44: Novo Nordisk A focused healthcare company Investor presentation – August 2004

44

rFVIIa (n=52)

rFVIIa reduces the need for transfusion in blunt trauma

Perc

en

t of

pati

en

ts

0

10

20

30

40

50

60

70

80

90

100

RBC units within 48 hours in patients alive

0 5 10 15 20 25 30 35 40 45 50

Placebo (n=59)

P= 0.019

Source: Data presented at World Congress on Trauma, Shock, Inflammation and Sepsis, March 2004.

Page 45: Novo Nordisk A focused healthcare company Investor presentation – August 2004

45

Adverse events

Placebo (n=64) rFVIIa (n=70)n % n %

All adverse events (patients)

40 62.5 43 61.4

All adverse events (events)

113 85

Placebo (n=74) rFVIIa (n=69)n % n %

All adverse events (patients)

54 73.0 49 71.0

All adverse events (events)

135 112

Penetrating

Blunt

Source: Data presented at World Congress on Trauma, Shock, Inflammation and Sepsis, March 2004.

Page 46: Novo Nordisk A focused healthcare company Investor presentation – August 2004

46

Incidence of thrombo-embolic events similar to placebo

Placebo (n=64) rFVIIa (n=70)n % Events n % Events

Thrombo-embolic events

3 4.7 3 3 4.3 3

All adverse events

40 62.5 113 43 61.4 85

Placebo (n=74) rFVIIa (n=69)n % Events n % Events

Thrombo-embolic events

3 4.1 3 3 4.1 3

All adverse events

54 73.0 135 49 71.0 112

Penetrating

Blunt

Source: Data presented at World Congress on Trauma, Shock, Inflammation and Sepsis, March 2004.

Page 47: Novo Nordisk A focused healthcare company Investor presentation – August 2004

47

Intracerebral haemorrhage – key observations

Intracerebral haemorrhage

• In the Western world, stroke is the 3rd most common cause of death and the 2nd of neurologic disability after Alzheimer

• The number one leading cause of institutional placement for loss of independence among adults

15% of all cases of stroke are caused by intracerebral haemorrhage (ICH)

No current treatment option for ICH

Around 250,000

Around 100,000

Number of patients in triad markets

Note: * Late CT scan of a patient occurs more than three hours after onsetSources: Japanese Stroke Association 2002 (Japan); Hospital discharge statistics HCUP 2000 (US); Krankenhausstatistik, Stat. Bundesamt, 2001 (Germany); Les Pathologies Traitees en 1993 dans les services de soins de courte duree (France); Hospital discharges: Ministero della Salute, SDO, 1999, 2000 (Italy); Hospital Episode Statistics, 2001 (UK); EU15: extrapolated Europe 5 rates; NEJM, Qurshe, A., May 2001

Total ICHpopulation

Less patientsdead at ICU

arrival

Less late CTscans*

Patients eligiblefor NovoSeven®

Page 48: Novo Nordisk A focused healthcare company Investor presentation – August 2004

48

Intracerebral haemorrhage- the deadliest form of stroke

Correlation between haematoma volume and mortality*

Source: Stroke 1993, Vol 24, 987-993 & International Task Force for Prevention Of Coronary Heart Disease. Note: * 30 day mortality as a function of haematoma volume

19%

46%

75%

Less than 30mL Between 30mL and 60mL More than 60mL

Page 49: Novo Nordisk A focused healthcare company Investor presentation – August 2004

49

Significantreduction

ICH volumeexpansion

Data on primary end point

Significantimprovement

Data on secondary end points

No significantdifference

Data on overall safety

Being analysed

Data on pharmaco-economics

Score on stroke scales:day 15 and 90

Safety end points (AEs and SAEs)

• Days in hospital

• Quality of life at day 90

Results of the study

Page 50: Novo Nordisk A focused healthcare company Investor presentation – August 2004

50

Symptomatic treatment:

• Anticonvulsants • Antihypertensives• Intubation and mechanical

ventilation• Intraventricular catheter and

ICP monitoring• Intravenous mannitol• Hyperventilation

Diagnosis through CT scan:

• Ischaemic or • haemorrhagic stroke

Surgery*:

•Open craniotomy•Stereotactically guided endoscopic evacuation

Return to ICU or death

*Surgery can take place earlier on. Poor results obtained historically

Today’s treatment of intracerebral haemorrhage

Page 51: Novo Nordisk A focused healthcare company Investor presentation – August 2004

51

New share repurchase programme initiated

In % 1999 2000 2001 2002 2003 Targets

Operating profit growth 20.3 36.5 16.6 6.5 6.8 15

Operating margin 21.5 23.1 23.6 23.7 24.1 25

Cash to earnings* 76.6 87.9 4.8 12.1 79.2 60

ROIC 15.3 22.0 23.1 20.1 19.1 25

Long-term financial targets

Returning cash to shareholders

*Long-term target defined as three-year average

Note! All numbers according to Danish GAAP

Average

17%

23%

52%

20%

0.0

1.0

2.0

3.0

4.0

1999 2000 2001 2002 2003

DK

K b

illion

Dividends Share repurchase

Page 52: Novo Nordisk A focused healthcare company Investor presentation – August 2004

52

Medicare Reform

Positives Negatives

Key o

bse

rvati

on

s•

Cre

ate

s p

art

ial pre

scri

pti

on d

rug c

overa

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to 6

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tion, fr

om

200

6•

6.1

mill

ion insu

lin p

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ons

for

am

ong

65+

pop

ula

tion

•Pro

vid

es

volu

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ry d

rug d

isco

unt

card

s un

til 2

006 (

curr

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mill

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•Sh

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m A

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to A

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care

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and

dia

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s sc

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crease

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pro

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f dis

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ag

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•Pri

ce p

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/ re

bate

s, w

ith F

ed

govern

ment

to

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rchase

50%

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U.S

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in 2

00

6

•R

eim

port

ati

on?

•A

ddit

ional

legis

lati

on

?