Novo Nordisk A focused healthcare company

28
1 Novo Nordisk Novo Nordisk A focused healthcare company A focused healthcare company Investor Presentation Investor Presentation August 2002 August 2002

Transcript of Novo Nordisk A focused healthcare company

Page 1: Novo Nordisk A focused healthcare company

1

Novo NordiskNovo Nordisk

A focused healthcare company A focused healthcare company

Investor PresentationInvestor Presentation

August 2002August 2002

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Forward-looking statementsForward-looking statements

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

Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. 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 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 results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk's products, introduction 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 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 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. 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 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 Securities and Exchange Commission (SEC) including the company's Form 20-F, which was filed on 26 April 2002. Novo Nordisk is under no duty to update any of the forward-looking statements on 26 April 2002. 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. 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. Novo Nordisk has the copyright to the information contained in this presentation. © 2002 Novo Nordisk A/S.© 2002 Novo Nordisk A/S.

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Agenda Agenda

Update on the first half year of 2002Update on the first half year of 2002

Diabetes careDiabetes care

Haemostasis managementHaemostasis management

Financial resultsFinancial results

Outlook 2002Outlook 2002

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First half year 2002 in briefFirst half year 2002 in brief

Sales up 6% from first half 2001Sales up 6% from first half 2001

Operating profit up 4% from first half 2001Operating profit up 4% from first half 2001

Second quarter sales up 9% and operating profit up 16% Second quarter sales up 9% and operating profit up 16%

compared to Q2 2001compared to Q2 2001

Continued depreciation of USD, JPY and GBP versus Continued depreciation of USD, JPY and GBP versus

DKKDKK

Full-year outlook maintained at 5-10% operating profit Full-year outlook maintained at 5-10% operating profit

growth growth

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Sales by therapy first half year 2002Sales by therapy first half year 2002

Insulin sales growth in Insulin sales growth in International Operations (IO), International Operations (IO), Europe and North America. Europe and North America. NovoNormNovoNorm®® growth in Europe growth in Europe and IOand IO

North America and Europe both North America and Europe both drive growthdrive growth

Growth in Europe and the US, but Growth in Europe and the US, but Japan hit by depreciation of JPY, Japan hit by depreciation of JPY, increased competition and low increased competition and low market growthmarket growth

Negatively affected by parallel Negatively affected by parallel trade within Europe and by trade within Europe and by lower market growthlower market growth

Insulin sales growth in Insulin sales growth in International Operations (IO), International Operations (IO), Europe and North America. Europe and North America. NovoNormNovoNorm®® growth in Europe growth in Europe and IOand IO

North America and Europe both North America and Europe both drive growthdrive growth

Growth in Europe and the US, but Growth in Europe and the US, but Japan hit by depreciation of JPY, Japan hit by depreciation of JPY, increased competition and low increased competition and low market growthmarket growth

Negatively affected by parallel Negatively affected by parallel trade within Europe and by trade within Europe and by lower market growthlower market growth

Diabetes careDiabetes care

+6%+6%

Haemostasis Haemostasis managementmanagement

+15%+15%

(1%)(1%)

hGHhGH

HRTHRT(1%)

Key observations:Key observations:

Total turnover of DKK 12,035 mn: +6%Total turnover of DKK 12,035 mn: +6%

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Key observations:Key observations:

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EuropeEurope

+4%+4%

InternationalInternationalOperationsOperations

+20%+20%

North North AmericaAmerica

+10%+10%

Japan Japan & Oceania& Oceania

(4%)(4%)

Sales by region first half year 2002Sales by region first half year 2002

Total turnover of DKK 12,035 mn: +6%Total turnover of DKK 12,035 mn: +6%

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HRTHRTGrowth hormone Growth hormone therapytherapy

Intellectual Intellectual propertyproperty

Diabetes careDiabetes care Haemostasis Haemostasis managementmanagement

PrimaryPrimarygrowth growth driversdrivers

Novo Nordisk – future key driversNovo Nordisk – future key drivers

Diabetes careDiabetes care

Secondary Secondary value value

driversdrivers

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Diabetes care Diabetes care

SSales by quarterales by quarter

Key

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Key

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DKK millionDKK million

1999 2000 2001 20021999 2000 2001 2002

00

500500

1,0001,000

1,5001,500

2,0002,000

2,5002,500

3,0003,000

3,5003,500

4,0004,000

4,5004,500

5,0005,000

Q2Q2 Q3Q3 Q4Q4 Q1Q1 Q2Q2 Q3Q3 Q4Q4 Q1Q1 Q2Q2 Q3Q3 Q4Q4 Q1Q1 Q2Q2

+ 9%+ 9%

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Insulin – the ultimate diabetes therapyInsulin – the ultimate diabetes therapy -

Ce

ll fu

nc

tio

n-C

ell

fun

cti

on

Diet and Diet and exercise aloneexercise alone

Oral therapyOral therapy(66%)(66%)

Insulin Insulin therapytherapy(27%)(27%)

Oral/insulinOral/insulin(approx 7%)(approx 7%)

Time from diagnosisTime from diagnosis

Type 2 - slope

Type 1 - Immediate need for Insulin

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The insulin business caseThe insulin business case

VolumeVolume

Number of people with diabetes Number of people with diabetes expected to double by 2025expected to double by 2025

Less than half of those affected Less than half of those affected are diagnosed are diagnosed

Ageing population and a move Ageing population and a move towards affluent lifestyle leading towards affluent lifestyle leading to increased prevalenceto increased prevalence

A drive towards intensified A drive towards intensified therapytherapy

5% annual growth5% annual growth 5% annual growth5% annual growth++

Product upgradesProduct upgrades

Conversion from human insulin Conversion from human insulin to insulin analoguesto insulin analogues

Conversion from vials and Conversion from vials and syringes to delivery systems syringes to delivery systems

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Insulin market overview Insulin market overview (MATQ1 2002 Volumes)(MATQ1 2002 Volumes)

Notes: Notes: Industrialised world only. Based on IMS data. Monthly data used for Canada. Industrialised world only. Based on IMS data. Monthly data used for Canada. Wal*Mart figures not included. Growth in Europe effected by conversion of Wal*Mart figures not included. Growth in Europe effected by conversion of formulation. formulation.

Novo NordiskNovo Nordiskmarket sharemarket share

2266%%

5588%%

7878%%

60%60%

4466%%World World

Rest of IMS world Rest of IMS world

Japan Japan

Europe Europe

USA USA

Market growth Market growth

4343%%

4848%%

4%4%

66%%

% market size % market size

100%100%

3.6%3.6%

7.9%7.9%

7.0%7.0%

7.8%7.8%

6.1%6.1%

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Upgrading the insulin market Upgrading the insulin market

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an in

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SD

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Estimated averageEstimated averagetreatment cost per daytreatment cost per day

VialsVials

Pen

sP

ens

US

D 1

.5U

SD

1.5

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Analogue case still intactAnalogue case still intact

Strong analogue penetration Strong analogue penetration continuescontinues

NovoRapid®/NovoLogNovoRapid®/NovoLog®® continues to increase share in the continues to increase share in the short-acting segmentshort-acting segment

NovoMixNovoMix®® 30 being rolled out in 30 being rolled out in EuropeEurope

NovoMixNovoMix® ® 30 to be launched in 30 to be launched in the US later this yearthe US later this year

Analogues backed by new Analogues backed by new devices: InDuodevices: InDuo®®, FlexPen, FlexPen®, ®, InnoLet®InnoLet® and NovoPen and NovoPen®® Jr Jr

Analogues Analogues share of insulin share of insulin sales worldwidesales worldwide

Novo Nordisk's Novo Nordisk's share of short-share of short-

acting analogue acting analogue market worldwidemarket worldwide

Notes:Notes: Volumes in industrialised world IMSVolumes in industrialised world IMS

1996 1997 1998 1999 2000 2001 2002 1996 1997 1998 1999 2000 2001 2002

17%17%

20%20%

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European analogue conversion - NovoRapidEuropean analogue conversion - NovoRapid®®

Short-acting segment in EuropeShort-acting segment in Europe

Q2 1996Q2 1996 Q1 2002Q1 2002

Short-acting human insulinShort-acting human insulin

37%37%Short-actingShort-acting

insulin analoguesinsulin analogues

Short-acting human insulinShort-acting human insulin

June 2000June 2000

NovoRapidNovoRapid®® market market share 12.3%*share 12.3%*

Humalog market Humalog market share 26.5%*share 26.5%*

* IMS ‘brand’ volume market share of short-acting insulin. * IMS ‘brand’ volume market share of short-acting insulin. Preliminary information for Apr/May 2002Preliminary information for Apr/May 2002

Share of short-acting segmentShare of short-acting segment

May 2002May 2002

37%37%

* IMS ‘brand’ volume market share of short-acting insulin. * IMS ‘brand’ volume market share of short-acting insulin.

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US analogue conversion - NovoLogUS analogue conversion - NovoLog®®

Key observations:Key observations:

Market share increase Market share increase backed by continued backed by continued penetration of NovoLog®penetration of NovoLog®

NovoLog® launched NovoLog® launched September 2001 - pump September 2001 - pump indication added in indication added in December 2001December 2001

Launch of NovoLogLaunch of NovoLog®®Mix to Mix to follow this yearfollow this year0%0%

5%5%

10%10%

15%15%

20%20%

25%25%

30%30%

Q1

199

9Q

1 19

99

Q2

199

9Q

2 19

99

Q3

199

9Q

3 19

99

Q4

199

9Q

4 19

99

Q1

200

0Q

1 20

00

Q2

200

0Q

2 20

00

Q3

200

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3 20

00

Q4

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4 20

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1 20

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2 20

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Q3

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3 20

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02

Novo Nordisk total market share (vol) in the USNovo Nordisk total market share (vol) in the US

NovoLogNovoLog® share® share

Novo Nordisk share of the Novo Nordisk share of the US short-acting marketUS short-acting market

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NovoMixNovoMix® ® 30 – simple control30 – simple control

Blood glucose controlBlood glucose control

Co

nve

nie

nce

Co

nve

nie

nce

Basal-Basal-BolusBolus

OADsOADs

Human MixHuman MixNPHNPH

NovoMix® 30NovoMix® 30

Key observations:Key observations:

NovoMixNovoMix®®30 covers the 30 covers the basal insulin need while basal insulin need while adding the benefit of adding the benefit of targeting post-prandial targeting post-prandial glucose controlglucose control

NovoMixNovoMix®®30 comes in 30 comes in FlexPenFlexPen®® - the preferred - the preferred disposable device disposable device

Full premix analogue Full premix analogue programme scheduledprogramme scheduled

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Diabetes pipelineDiabetes pipeline

NN2211NN2211 (GLP-1 analogue)(GLP-1 analogue)

NN344NN344 (Basal analogue)(Basal analogue)

NN1998NN1998(AERx(AERx®iDMS®iDMS))

NN304NN304 (Insulin detemir) (Insulin detemir)

NN414NN414 (Beta cell rest)(Beta cell rest)

Phase 1Phase 1 Phase 2Phase 2 Phase 3Phase 3

NN2344NN2344 (Insulin sensitiser)(Insulin sensitiser)

Note: Clinical development of ragaglitazar (NN622) was suspended in July 2002. Note: Clinical development of ragaglitazar (NN622) was suspended in July 2002.

NovoMixNovoMix®® 50 50(Premixed analogue)(Premixed analogue)

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Insulin detemir to be filed at the turn of the yearInsulin detemir to be filed at the turn of the year

Detemir compared with NPH :Detemir compared with NPH :

Has significantly less within-Has significantly less within-subject variabilitysubject variability

Results in a slight decrease in Results in a slight decrease in body weight body weight

Has significantly less nocturnal Has significantly less nocturnal hypoglycaemic eventshypoglycaemic events

Produces a smoother nocturnal Produces a smoother nocturnal glucose profileglucose profile

The duration of action of detemir The duration of action of detemir is 20 hours at a therapeutically is 20 hours at a therapeutically relevant dose of 0.4 U/kg. relevant dose of 0.4 U/kg.

CCmaxmax

CV (%)CV (%)

AUCAUC0-24h,0-24h,

CV insulin CV insulin concconc.. (%)(%)

Insulin detemirInsulin detemir 1313 2020

NPH insulinNPH insulin 2626 3737

ReductionReduction 51%51% 45%45%

p-p-valuevalue <0.001<0.001 0.0010.001

Significantly lower within-subject variabilitySignificantly lower within-subject variability

Within-subject variability of Within-subject variability of pharmacokineticspharmacokinetics

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AERxAERx®® s.c.s.c.

Hb

AH

bA

1c1c

(%)

(%

)

HbAHbA1c1c mean profiles, ITT population, mean profiles, ITT population, mean mean ±± 2 SEM2 SEM

Our inhaled insulin – ready to enter Phase 3Our inhaled insulin – ready to enter Phase 3

77

7.57.5

88

8.58.5

99

ADA2002ADA2002

-0.74%-0.74% -0.74%-0.74%

HbAHbA1c1c(%) reduction(%) reductionKey observations:Key observations:

Deep lung deposition of aerosolsDeep lung deposition of aerosols

““Breath Check”, one unit Breath Check”, one unit increments, highly reproducible increments, highly reproducible deliverydelivery

Rapid-acting profile, one unit Rapid-acting profile, one unit increments and patient-friendly increments and patient-friendly featuresfeatures

1 oral presentation and 4 posters 1 oral presentation and 4 posters at ADAat ADA

3 posters accepted for EASD3 posters accepted for EASD

Phase 3 to start later this yearPhase 3 to start later this year

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Novo Nordisk – future key driversNovo Nordisk – future key drivers

Diabetes careDiabetes careHaemostasisHaemostasismanagementmanagement

PrimaryPrimarygrowth growth driversdrivers

Secondary Secondary valuevalue

driversdrivers HRTHRT Intellectual Intellectual

propertypropertyGrowth hormone Growth hormone

therapytherapy

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Haemostasis management (NovoSevenHaemostasis management (NovoSeven®®) )

Ke

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s:K

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obs

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ns:

Gro

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in N

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me

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ingl

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abl

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abl

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1999 2000 2001 20021999 2000 2001 2002

00

100100

200200

300300

400400

500500

600600

700700

800800

900900

Q2Q2 Q3Q3 Q4Q4 Q1Q1 Q2Q2 Q3Q3 Q4Q4 Q1Q1 Q2Q2 Q3Q3 Q4Q4 Q1Q1 Q2Q2

DKK millionDKK million

SSales by quarterales by quarter

+ 20%+ 20%

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NovoSeven® – current indicationNovoSeven® – current indication

CreateCreateconfidenceconfidence

First-lineFirst-lineposition inposition in

haemophiliahaemophilia

AcquiredAcquiredhaemophiliahaemophilia

Estimated close to Estimated close to 1,000 patients in 1,000 patients in industrialised worldindustrialised world

75-100% efficacy in 75-100% efficacy in acquired haemophiliaacquired haemophilia

Awareness creation Awareness creation and outcome dataand outcome data

~~300,000 doses with 300,000 doses with excellent safety dataexcellent safety data

Effective haemostasis Effective haemostasis established in established in orthopaedic surgeryorthopaedic surgery

Early treatment Early treatment provides faster provides faster recoveryrecovery

3,500 pts in 3,500 pts in industrialised worldindustrialised world

93% efficacy in bleeding 93% efficacy in bleeding episodes treated at homeepisodes treated at home

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Unmet needs in haemostasis managementUnmet needs in haemostasis management

Bleeding a is serious Bleeding a is serious clinical challengeclinical challenge

Common cause of deathCommon cause of death

Morbidity associated with Morbidity associated with blood transfusions is of great blood transfusions is of great concernconcern

Alternatives are scarceAlternatives are scarce

Blood products are Blood products are becoming more scarce becoming more scarce and expensiveand expensive

Surveys indicate large Surveys indicate large unmet clinical needunmet clinical need

10 million severe bleeding 10 million severe bleeding conditions annuallyconditions annually

Severe bleeding conditions Severe bleeding conditions growing in relation to growing in relation to medical proceduresmedical procedures

Growing industry attentionGrowing industry attention

EPO manufacturersEPO manufacturers

Oxygen carriersOxygen carriers

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Haemophilia Haemophilia & congenital & congenital

bleeding disordersbleeding disorders

NovoSeven® expansion projectNovoSeven® expansion project

Haemophilia with Haemophilia with inhibitorsinhibitors

Acquired haemophiliaAcquired haemophilia

FVII and FXI deficiencyFVII and FXI deficiency

GlanzmannGlanzmann

Bernard-SoulierBernard-Soulier

Other coagulation Other coagulation factor defectsfactor defects

Surgery & Intensive careSurgery & Intensive care

*) = Patients with chronic liver disease*) = Patients with chronic liver disease

Upper gastro-Upper gastro-intestinal bleeding *)intestinal bleeding *)

Orthotopic liver Orthotopic liver transplantation *)transplantation *)

Liver resection *)Liver resection *)

Reversal of anti-Reversal of anti-coagulation therapycoagulation therapy

Stem cell Stem cell transplantationtransplantation

Intra-cerebral Intra-cerebral bleedingsbleedings

Liver resectionLiver resection

TraumaTrauma

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FFinancial resultsinancial results

Net turnoverNet turnover 12,03412,034 11,351 11,351 6 6 6,5536,553 6,0016,001 99

Operating profit Operating profit 2,8562,856 2,740 2,740 4 4 1,6061,606 1,3821,382 1616

Net financialsNet financials 99 99 241241 (59) (59) 8282 44 --

Profit before taxProfit before tax 2,9552,955 2,9812,981 (1) (1) 1,6881,688 1,3861,386 2222

Net profitNet profit 1,925 1,925 1,908 1,908 1 1 1,1011,101 887887 2424

EPS (DKK)* EPS (DKK)* 5.51 5.51 5.48 5.48 1 1 3.153.15 2.552.55 2424

* * Earnings per share on a diluted basis, ie 349.6 million shares in H1 2002 and 349.4 Earnings per share on a diluted basis, ie 349.6 million shares in H1 2002 and 349.4 million Q2 2002.million Q2 2002.

DKK millionDKK million First half year First half year Second quarter Second quarter

20022002 20012001 % change % change 20022002 20012001 % change% change

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Currency exposureCurrency exposure

6

7

8

9

2001 avg = 8.32

2001 avg = 6.85

2000 2001 2002

Effect of 5% Effect of 5% appreciation on appreciation on

operating profit* operating profit* (DKK million)(DKK million)

JPYJPY +140+140

USDUSD +110+110

GBPGBP +50+50

* * ie before hedging activities.ie before hedging activities.

1H 2002 avg = 6.39

1H 2002 avg = 8.29

Aug 5 Apr 30DKK per USD 7.55 8.25 (8.5%)DKK per 100 JPY 6.34 6.43 (1.4%)

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Outlook for 2002Outlook for 2002

Expected sales growth between 6-8%Expected sales growth between 6-8%

Growth in operating profit of 5-10% is reaffirmed Growth in operating profit of 5-10% is reaffirmed

Net financial income now expected to be approximately DKK Net financial income now expected to be approximately DKK 250 million250 million

Tax rate still expected at the level of 35%Tax rate still expected at the level of 35%

Investments still expected at DKK 4.5Investments still expected at DKK 4.5 billionbillion

Share repurchasing programme of DKK 2 billion initiatedShare repurchasing programme of DKK 2 billion initiated

Above outlook is based on the assumption that Above outlook is based on the assumption that exchange and interest rates remain at the current level exchange and interest rates remain at the current level (6 August 2002).(6 August 2002).

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Investor InformationInvestor Information

Investor Relations contacts:Investor Relations contacts:

Novo Nordisk A/S Novo Nordisk A/S Investor Relations Investor Relations Novo Allé Novo Allé DK 2880 BagsværdDK 2880 BagsværdDenmark Denmark Fax (+45) 4444 2314 Fax (+45) 4444 2314

Peter HaahrPeter HaahrPhone (+45) 4442 1207Phone (+45) 4442 1207 E-mail: [email protected]: [email protected]

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

Rasmus JorgensenRasmus JorgensenPhonePhone (+1) 212 878 9607 (+1) 212 878 9607 E-mail: [email protected]: [email protected]

Share informationShare information

Novo Nordisk’sNovo Nordisk’s B shares are listed B shares are listed on the stock exchanges in on the stock exchanges in Copenhagen and London. Its Copenhagen and London. Its ADRs are listed on the New York ADRs are listed on the New York Stock Exchange under the symbol Stock Exchange under the symbol "NVO". For further company "NVO". For further company information, visit Novo Nordisk on information, visit Novo Nordisk on the Internet at the Internet at

http://www.novonordisk.comhttp://www.novonordisk.com