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Novo Nordisk A/S 1 A focused healthcare company Sal. Oppenheim - Investor presentation – March 2003.

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Presentation on theme: "Novo Nordisk A/S 1 A focused healthcare company Sal. Oppenheim - Investor presentation – March 2003."— Presentation transcript:

1 Novo Nordisk A/S 1 A focused healthcare company Sal. Oppenheim - Investor presentation – March 2003

2 2 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 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. Novo Nordisk has the copyright to the information contained in this presentation. © 2003 Novo Nordisk A/S.

3 3 Agenda Introduction Diabetes care Insulin therapy Novo Nordisk’s diabetes commitment outside insulin Biopharmaceuticals

4 4 Diabetes – an unfolding epidemic 370 million people with diabetes expected by 2030 Source: WHO, January 2003 # of people with diabetes (million)

5 5 Diabetes care - Treatment matters Only a small number of patients are in control Intensive treatment matters Distribution of patients HbA1c * Measured according to Guidelines for Diabetes Care, IDF Europe ** According to epidemiological analysis of the UKPDS data, 1998 HbA1c lowering by one percentage point reduces micro vascular risk by 35%** Close to 80% are exposed to arterial or microvascular risk*

6 6 6.0% to <7.0% 7.0% to <8.0% 8.0% to <9.0% 9.0% to <10.0% >10% 1.4x 1.8x 2.1x 2.9x3.5x Risk of any complication relative to HbA1c below 6.0% Poor control leads to higher risk Source: Adapted from UKPDS 35

7 7 Late stage complications represent a huge burden Relative cost of diabetes complications* Macro vascular Micro vascular No compli- cation Both 1.7x 2.0x 3.5x * Cost for sociaty relative to no complication. Source: Adapted from Rhys Williams, IDF ** ADA, Diabetes Care, March 2003 Diabetes cost the US an estimated $132 billion in 2002 in medical expen- diture and lost produc- tivity** Health care expendi- tures incurred by people with diabetes comprises 19% of total health care expenditure in the US**

8 8 Pharmaceutical needs in diabetes Type 1 diabetes Intervention in  -cell destruction Blood glucose regulation* Type 2 diabetes Blood glucose regulation* Regulation of energy balance (diabetes-associated obesity) Reduction of triglycerides, FFA and LDL/HDL ratio (diabetic dyslipidaemia) * Including, but not restricted to, new pharmaceuticals

9 9 Novo Nordisk to leverage on growth Building on 80 years of experience within diabetes Dominant position in the European and Japanese insulin markets – solid growth in the US. Moreover, market leader in International Operations Around 2,500 R&D employees dedicated to diabetes, representing approximately ¾ of R&D resources Most complete portfolio of new insulins Leadership in insulin delivery systems – one new device per year Most comprehensive diabetes pipeline in the industry

10 10 The three core competences Diabetes expertiseProtein expertiseDrug delivery expertise Protein formulation Device technology Protein discovery Genetic engineering Protein engineering, production and characterisation Protein technology IPR Biochemistry Pharmacology Clinical development External networks Understanding of patient needs

11 11 R&D strategy - based on core competences Diabetes expertise Protein expertise NovoSeven ® expansion NN2211 balaglitazone NN2501 AERx ® iDMS insulin analogues NN414 hGH expansion ASIS Drug delivery expertise Protein Delivery System unit (PDS)

12 12 Diabetes R&D at Novo Nordisk - sources of innovation Clinical research Steno Diabetes Centre Oxford Diabetes Centre Clinical research centres worldwide Evidence-based medicine NN disease mgt programmes Outcomes data from > 100.000 individuals with diabetes Molecular diversity & design Protein chemistry since ’23 Medicinal chemistry since ’68 Computational chemistry since ’75 Rational drug design since ’83 Combinatorial chemistry since ’93 Trinomics Genomics: Incyte since ’95 Proteomics: CPA since ’97 Metabonomics since ’99 Drug target & screening Molecular biology since ’80 HT screening: Amersham since ’92 Chemoinformatics since ’95 Dundee MRC consortium since ’98 Ultra HT Screening since ’00 Basic research Hagedorn Research Institute Oxford and Steno Diabetes Centre Academic collaborations Consortia R&D projects

13 13 The miracle of insulin Patient J.L., December 15, 1922February 15, 1923

14 14 Insulin - the ultimate treatment  -Cell function Diet and exercise alone Oral therapy (66%) Insulin therapy (27%) Oral/insulin (7%) Time from diagnosis Type 2 - slope Type 1 - Immediate need for insulin

15 15 Novo Nordisk leadership in insulin therapy Innovation within insulin therapy will continue to drive the insulin market by providing more efficacious, reproducible and convenient treatment modalities Novo Nordisk will expand its leadership by maintaining the world’s richest insulin portfolio including new insulin analogues, new insulin formulations and new insulin delivery systems

16 16 Novo Nordisk Eli LillyAventis Short- acting Marketed Phase 3 Long- acting Filed?Marketed PremixMarketed Novo Nordisk to be the first company with a full range of insulin analogues Novo Nordisk leadership in insulin therapy

17 17 p < 0.05 -10% p < 0.001 -17% NovoMix ® 30 - the premix analogue of choice Hermansen K et al. Diabetes Care 2002;25:883-888. 12 13 14 15 16 17 18 19 20 21 Humalog ® Mix 25NovoMix ® 30BHI 30 Serum glucose excursion 0-5h (mmol/l h)

18 18 Profile of the ideal basal insulin Desirable properties: Solubility Soluble at neutral pH Mixable with other insulins Absorption Predictable Glucose lowering effect Peakless with low variability Safety profile Low risk of hypoglycaemia at all times Injection site No local reactions Limitations of current insulins: Solubility Most current basal insulins require re-suspension Absorption Highly variable Glucose lowering effect Not predictable Safety profile Risk of hypoglycaemia Injection site Injection pain with acidic insulin

19 19 Devices important to Novo Nordisk facilitate intensification & initiation total insulin market market share profitability differentiation clear competitive advantage leverage price premiums more profitable than vials Part of NN Vision Leadership, commitment, care, control

20 20 Modern insulin pens and dosers ControlCompliance Simple & Convenient

21 21 AERx ® iDMS - Pulmonary insulin administration Pulmonary insulin opportunity Non-invasive insulin delivery Mainly poorly controlled Type 2 diabetes patients Expanded insulin sales Product requirements Accuracy, precision, dose adjustment Patient friendly device interface Scaleable manufacturing Aradigm is the ideal partner Liquid insulin formulation Breath control Increment of single insulin units Performance monitoring

22 22 Novo Nordisk’s diabetes commitment outside insulin Time horizon Value + Insulin detemir and future devices Intensified - NovoRapid ® + AERx ® iDMS (NN1998) + NN2211 + Balaglitazone (NN2344) + New superior OADs (eg NN414; NN2501) + New proteins and concepts + FlexPen ® Convenience - NovoMix ® Development of balaglitazone (NN2344) continues Benefit/risk assessment supports further development NN414 has concluded phase 1 NN2501 (glucagon antagonist) has entered phase 1 Phase 2 data on NN2211 in H1 2003

23 23 Type 2 diabetes – the metabolic syndrome NovoNorm TM / Prandin ® NovoNorm TM /Prandin ® NN304 NN1998 NN2344 Glucose-induced insulin secretion Tissue response to insulin Hepaticglucoseproduction Glucoseuptake Impaired beta cell function Basal hyper- insulinemia Postreceptordefect Glucosetransport Insulinbinding NN414 Genetic Acquired Obesity Age Genetic Acquired Obesity Age Insulindeficiency NovoRapid Insulinresistance Hyperglycemia NN2211 NN2211 Genetic Acquired Glucotoxicity Lipotoxicity Genetic Acquired Glucotoxicity Lipotoxicity NN344 NovoMix NN2501

24 24 NN2211 - t o report phase 2 data in H1 2003 The first once-daily human GLP-1 analogue Glucose dependent insulin secretion Glucose dependent glucagon inhibition Appetite suppression Possible beta cell rescue 0 2 4 6 8 10 12144681012 Glucose (mmol/L) Insulin Secretion Rate Placebo NN2211 Healthy Controls Healthy Controls NN2211 normalises beta cell sensitivity to glucose in type 2 diabetes

25 25 Diabetes care pipeline CompoundTypeIndicationPhase Insulin detemir (NN304)InsulinType 1+2 diabetesFiled EU+US NovoMix ® 50 and 70InsulinType 1+2 diabetesPhase 3 AERx ® iDMS (NN1998)InsulinType 1+2 diabetesPhase 3 Balaglitazone (NN2344)OADType 2 diabetesPhase 2 NN2211GLP-1 analogueType 2 diabetesPhase 2 NN414OADType 1+2 diabetesPhase 1 NN344InsulinType 1+2 diabetesPhase 1 NN2501OADType 2 diabetesPhase 1

26 26 Biopharmaceuticals - outside diabetes care Phase 2 with ASIS* in acute respiratory distress syndrome (ARDS) initiated Growth hormone expansion programme EU approval is expected in first half of 2003 for SGA/IUGR ** Phase 2 in complicated fractures initiated Life-cycle management Time horizon Value Norditropin® SimpleXx® - growth disorders NovoSeven® - haemophilia + hGH - SGA/IUGR + New indications + New formulations + New devices + New areas + NovoSeven® expansion + ASIS + hGH - complicated fractures * Active Site Inhibited Seven ** Small for Gestational Age / Intra Uterine Growth Retardation

27 27 Biopharmaceuticals - pipeline outside diabetes care CompoundIndicationPhase Growth hormoneIUGR/SGAFiled in EU Growth hormoneComplicated fracturesPhase 2 NovoSeven ® HepatectomyPhase 2 NovoSeven ® Liver transplantationPhase 2 NovoSeven ® TraumaPhase 2 NovoSeven ® Stem cell transplantationPhase 2 NovoSeven ® ICH*Phase 2 ASISARDSPhase 2 * Intra-cerebral haemorrhage

28 28 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 progresses Confidence/Awareness Penetration Elective surgery within haemophilia Acquired haemophilia Spontaneous bleedings in congenital haemophilia

29 29 Beyond haemophilia treatment Haemostasis Management Haemophilia Treatment

30 30 NovoSeven ® - the expansion programme General haemostatic agent Elective surgeryBleeding in emergencies Hepatectomy Liver transplantation Intra-cerebral haemorrhage Stem cell transplantation Upper gastrointestinal bleedings Trauma

31 31 Increasing awareness - NovoSeven ® Articles and abstracts * Patients enrolled in clinical programmes * Source: Literature search in Medline, Embase and Biosis for articles and abstracts mentioning NovoSeven®, Niastase; Factor VIIa; fVIIa; recombinant Factor VIIa and rfVIIa

32 32 Pipeline reporting - development H1 2003 H2 2003 H1 2004 CompoundIndicationEvent Growth hormoneIUGR/SGAApproval* NN2211 (GLP-1 analogue)Type 2 diabetesPhase 2 data NovoSeven ® Hepatectomy in cirrhoticsPhase 2 data NovoSeven ® Liver transplantationPhase 2 data NovoMix ® 50 and 70Type 1+2 diabetesFiling NovoSeven ® TraumaPhase 2 data NovoSeven ® Stem cell transplantationPhase 2 data NovoSeven ® ICHPhase 2 data Insulin detemirType 1+2 diabetesApproval** Growth hormoneComplicated fracturesPhase 2 data ASISARDSPhase 2 data * In Europe ** In Europe and US

33 33 Low exposure to patent expiration Accumulated % of 2002 Novo Nordisk sales with patents expiring % of 2001 sales with patents expiring in 2002-2006 Source: Nordea Securities and Novo Nordisk A/S. Novo Nordisk

34 34 Key growth drivers Novo Nordisk sales* Leadership in diabetes care NovoSeven ® expanding into general haemostasis Strong IP portfolio with low exposure to patent expirations Billion DKK 13Y CAGR 13+% * Since the merger between Novo and Nordisk in 1989

35 35 Appendix slides

36 36 Highlights Sales 2002 +6% as reported and +11% in local currencies for the full year +4% as reported and +11% in local currencies for the fourth quarter Operating profit 2002 +7%; revised target for the year met +8% for the fourth quarter Outlook 2003 Sales up more than 5% reported or 13% in local currencies Operating profit will grow towards 5% reported or close to 20% in local currencies Net profit to grow towards 10%

37 37 Sales in 2002 - by therapy and region By therapy By region Total DKK 25.2 billion +6% reported and +11% in local currencies

38 38 Sales by therapy DKK million20022001% of total % change (2002) Insulin etc16,03415,22364 5 OAD*1,6311,4016 16 Diabetes care, total17,66516,624 70 6 Haemostasis management3,6213,09614 17 Growth hormone therapy2,131 2,1649 (2) HRT1,3421,4355 (6) Other4284572 (6) Total25,18723,776100 6 * Oral antidiabetic products (OAD) include NovoNorm®/Prandin® as well as Glucoformin ® (metformin) sales by Biobrás in full year 2002.

39 39 Sales by region DKK million20022001 % of total % change (2002) Europe 10,88010,55343 3 North America5,9135,2772412 Japan & Oceania4,2394,49817 (6) International Operations4,1553,4481621 Total 25,18723,776100 6

40 40 Full year Fourth quarter 11 6 22 17 4 -2 -5 -6 11 6 12 5 25 17 -8 -14 -15 11 4 Sales by therapy - currency impact

41 41 Sales by region - currency impact Full year Fourth quarter 4 3 18 12 2 -6 34 21 11 6 -2 25 13 0 -9 44 29 11 4

42 42 5% 10% 5% 9% Q1 2002 Growth compared to previous years 7% 9% 6% 9% Q3 2002 4% 8% 9% 12% 8% 9% 12% Novo Nordisk growth: Volume Value Q2 2002 Q4 2001 Q3 2001 Q2 2001 4% 7% 9% 13% 9% 11% 9% 14% Total market growth: Volume Value ’In-market’ sales Insulin sales in Europe - ‘in-market’ sales Note: Data based on IMS. ‘In-market data’ reflects sale of insulin products from the wholesalers to the pharmacists.

43 43 European analogue conversion - NovoRapid® Short-acting segment in Europe Q4 1996 Q3 2002 Short-acting human insulin Short-acting insulin analogues Dec 2000 NovoRapid® market share 14.6%* Humalog market share 26.7%* Share of short-acting segment Nov 2002 41% Note: Data based on IMS

44 44 US analogue conversion - NovoLog® Short-acting segment in the US Q4 1996Q3 2002 Short-acting human insulin Short-acting insulin analogues 54% Dec 2001 NovoRapid® market share 7.4%* Share of short-acting segment Nov 2002 Humalog market share 49.3%* Note: Data based on IMS

45 45 Launch of NovoMix ® 30 - still in progress Share of segment in Europe (volume) Sales development in Europe (MU) Quarters from launch Note: Data based on IMS

46 46 Novo Nordisk market share since Lantus launch Total insulin (MU) Month of Lantus launch November 2002 USA26%28% Europe57% Germany44% UK67% Germany * Oct-02 MS in the basal impacted by hoarding of Lantus in anticipation of the Nov-02 price increase. * Note: Data based on IMS

47 47 Novo Nordisk regaining strength in Germany * Oct-02 MS impacted by hoarding of Lantus in anticipation of the Nov-02 price increase. * * Germany, volumeGermany, value Sep 2001 Nov 2002 Sep 2001 Nov 2002 * * Note: Data based on IMS

48 48 Insulin segmentation - Europe and the US Europe US Note: Data based on IMS

49 49 0600 Normal Type 2 diabetes 100014001800 220002000600 800 700 600 500 400 300 200 100 Insulin Secretion (pmol/min) Source: O'MEARA et al. Am. J. Medicine, 1990; 89. Insulin secretion in normal people and people with type 2 diabetes

50 50 -0.5 0 0.5 1 1.5 Insulin detemir (NN304) NPH Change in weight (Kg) over 12 months -1.7 Kg Source: E. Standl et al. Abstract number 467 ADA 2002 No weight gain with insulin detemir Body weight control with insulin detemir p = 0.002 Type 1 diabetes

51 NovoMix ® 30 provides improved postprandial control -10%-17% p < 0.05p < 0.0001 S-glucose excursion 0-5h (mmol/l h) Source: Hermansen K et al. Diabetes Care 2002;25:883-888.

52 52 Advantages of NovoSeven ® A bleeding episode ® FVIIa/NovoSeven ® Tissue factor Faster haemostasis leads to Fewer transfusions / transfusion- free surgery Reduced rebleeding Faster recovery Reduced morbidity and mortality Improved quality of life

53 53 Growth hormone therapy Key observations Sales decreased by 1% in local currencies in the fourth quarter as a result of lower sales in Japan In Europe, North America and International Operations growth is driven by Norditropin® SimpleXx®. 199819992000200120021997 DKK billion

54 54 HRT Key observations Sales in local currencies decreased by 14% in the fourth quarter Sales in Europe decreased by 24%, reflecting increased parallel trading and lower overall demand for treatment with hormone replacement products The overall market demand was negatively influenced by a recently published US study of another company’s product 199819992000200120021997 DKK billion


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