Novo Nordisk 0 A focused healthcare company Investor presentation – Autumn 2003.

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Presentation transcript:

Novo Nordisk 0 A focused healthcare company Investor presentation – Autumn 2003

1 Agenda Highlights Diabetes care Haemostasis management (NovoSeven ® ) Research and development Financials and outlook for 2003

2 Forward-looking statements This presentation contains forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of 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 March Please also refer to the section 'Financial Risk Factors' in the Annual Financial Report 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. © 2003 Novo Nordisk A/S.

3 Highlights First nine months 2003: Sales: +5% as reported and +15% in local currencies Operating profit: +5% Net profit: +20% Outlook for 2003: Operating profit now expected to grow by around 5% Net profit now expected to grow by around 15% Insulin detemir: Approvable Letter received from the FDA in the US Targeting a CPMP opinion around year-end in Europe NovoSeven ® : Three studies on the use of NovoSeven ® to report in Q Positive CPMP opinion received for use of NovoSeven ® for Factor VII deficiency and Glanzmann’s thrombasthenia

4 Sales in the first nine months - by therapy and region By therapy By region Total DKK 19.3 billion +5% reported and +15% in local currencies HRT -7% Haemostasis management (NovoSeven®) +11% Diabetes care +4% Growth hormone therapy +4% 15% 5% 70% 8% North America +8% International Operations 0% Europe +7% Japan & Oceania -1% 44% 25% 16% 15%

5 Diabetes care Sales by quarter Key observations Growth in local currencies was 10% in the third quarter. All regions contributed to growth In local currencies insulin and delivery systems grew by 12% in the third quarter and 17% in the first nine months Analogues the main growth driver. Penetration of both NovoRapid ® and NovoMix ® continues DKK million ,000 1,500 2,000 2,500 3,000 3,500 4,000 4,500 5,000 Q1Q3Q1Q3Q1Q3 Q1 Q3 +3%

6 Market characteristics Epidemic growth in number of people with diabetes Worldwide diabetes prevalence 5.1%, worldwide IGT prevalence (a pre-state to diabetes) 8.2% 1 The number of people with diabetes is expected to more than double by 2030 In Europe and the US, 10-15% of total healthcare expenditure goes to type 2 diabetes % CAGR expected % CAGR Diabetes care CNS Infectious disease Cancer Respiratory Cardiovascular Arthritis Diabetes A high-growth market Source: IMS data & SG Cowen estimates In the age group of years, Diabetes Atlas, IDF, Second edition 2 Diabetes News, WHO Diabetes - a growth market

7 Type 2 - slope Out of ‘guideline’ control HbA 1c 10% 9% 8% 7% 6% Target US Target Europe Source: Novo Nordisk type 2 diabetes market research, Roper Starch, ADA, EASD, IDF, AACE, Wright A., Burden et al, Diabetes Care 2002; 25:330–336, Turner RC, Cull et al, JAMA 1999; 281:2005–2012 It is estimated that more than 2/3 of the patients are not in control Real-life insulin initiation  -cell function Time from diagnosis 50%

8 Insulin therapy  -Cell function Diet and exercise alone Oral therapy Oral/insulin Time from diagnosis Type 2 - slope Type 1 - Immediate need for insulin Novo Nordisk’s primary market continues to be insulin More than 50% of Novo Nordisk’s insulin is sold to type 2 patients Focus on devices results in competitive edge Insulin market trends are favourable Earlier switch from OADs to insulin Intensified insulin treatment Novo Nordisk has a secondary focus on the OAD market Novo Nordisk’s main focus within diabetes care is insulin Novo Nordisk provides a complete portfolio of diabetes products

9 DisposableDurableInt.BGM/DoserPumpsInhaled Existing products Delivering the insulin – the portfolio approach continues FlexPen ® NovoPen ® 3 InDuo Projects in development AERx ® iDMS Yes Yes* No product on market yet Comments Inventor and market leader in segment Inventor and market leader in segment Novo Nordisk markets only pump approved analogue Note: * Focused on ‘next generation pumps’ Inventor and only company present

10 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 Q and growth as MAT Q versus MAT Q The arrows next to the market shares illustrate the direction of change compared to MAT Q Novo Nordisk market share 59% ▲ 75% ▼ 48% ▲ World Japan Europe USA Market 42% 47% 5% Market size 100% 10.2% 8.1% 7.6% 6.4% 10.6% 6.7% 30% ▲ 17.8% 5.8% Novo Nordisk Growth rates

11 Market dynamics Source: IMS/BW Q Q2 2003Q1 2000Q Market segmentationNovo Nordisk market shares Note: Quarterly data, volume figures 0 % 10 % 20 % 30 % 40 % 50 % Volume share Long-acting Premix Short-acting 20 % 30 % 40 % 50 % 60 % Volume share Long-acting Premix Short-acting

12 Strong development in analogues Analogue conversion Q Q % Source: IMS/BW Note: Quarterly data, volume figures Novo Nordisk market shares Q Q Human insulin Analogues Human insulin Analogues 59% 20% 7% Mega unit

13 Market dynamics - the US Source: IMS/BW Q1 2000Q2 2003Q Q Market segmentationNovo Nordisk market shares Note: Quarterly data, volume figures

14 Analogues - a key growth driver Source: IMS/BW Note: Quarterly data, volume figures Short-acting segment US Q Q Q Q Premix segment US 0% 10% 20% 30% 40% 50% 60% 70% 0% 5% 10% 15% 20% Analogue penetration Novo Nordisk analogue market share 0% 10% 20% 30% 0% 5% 10% 15% 20% Analogue penetration Novo Nordisk analogue market share

15. Novo Nordisk - a clear competitive edge Positioned to capture the growth Profitable manufacturing of insulin requires economies of scale and know-how Analogue conversion resulting in insulin market going back on patent Delivery systems, a key differentiating factor and a key competitive advantage Being profitable in the insulin market requires the right infrastructure Novo Nordisk has 80 years of experience with insulin production Novo Nordisk is the only company with a full range of analogue products Novo Nordisk is the market leader and innovator within devices Novo Nordisk has extensive collaborations with key opinion leaders, healthcare authorities etc

16 The insulin business case Volume drivers Value drivers Conversion from human insulin to insulin analogues Conversion from vials and syringes to devices Conversion from durable to disposable devices Epidemic growth in number of people with diabetes One third are diagnosed Trend towards earlier and more intensive therapy 10%+

17 Haemostasis management - NovoSeven ® Key observations Growth in local currencies of 20% in the third quarter. All regions contributed to the growth For the first nine months sales grew by 25% in local currencies Europe and North America the main growth drivers Sales growth continues to benefit from increased investigational use Sales by quarter +11% ,000 Q1Q3Q1Q3Q1Q3 DKK million Q Q3

18 Existing indication - still some growth potential In total approximately 3,500 congenital inhibitor patients in the developed world. In addition there are close to 1,000 patients with acquired haemophilia Inhibitor patients require first-line treatment with NovoSeven ® 2 bleeds per month 2-3 doses/bleed 90 micrograms/kg As well as additional treatment + Surgical intervention Estimated cost per inhibitor patient per year: = DKK 1-2 million* Total market size x 3,500 patients at DKK 1-2 million ~ DKK 5-6 billion * A non-inhibitor haemophilia A patient: Yearly cost of treatment around DKK 800,000. Journal of Medical Economics 2002; 5 Distribution of inhibitor patients North America 63% Europe 31% Japan & Oceania 6%

19 Towards a general haemostatic agent Marketed indication NovoSeven ® Identify and capture value- creating opportunities early Congenital bleeding disorders Intracerebral haemorrhage Upper gastro-intestinal bleeding Stem cell transplantation Liver transplantation Trauma Other indications Liver resection

20 CompoundPhaseStatusNext update NovoRapid ® 30 Mix (in Japan) Approved To be launched in Q Q Insulin detemirFiled Approvable Letter received from the FDA In the EU, CPMP opinion is targeted around year- end Q NN414Phase 2DiscontinuedNA Pipeline update - diabetes care

21 Pipeline update - biopharmaceuticals Compound/IndicationPhaseStatusNext update NovoSeven ® Factor VII deficiencyFiled in EUPositive CPMP opinionQ Glanzmann’s thrombastheniaFiled in EUPositive CPMP opinionQ Liver transplantationPhase 2Enrolment completedQ TraumaPhase 2Enrolment completedQ Stem cell transplantationPhase 2Enrolment completedQ Intracerebral haemorrhagePhase 2Enrolment ongoingH Growth hormone Small for Gestational AgeApproved*Launch ongoingNA NordiFlex ® & NordiLet ® ApprovedLaunch ongoingNA * In EU

22 Insulin detemir - an update Current status in US Approvable Letter received Average FDA approval time for industry: months** FDA has performed pre-approval inspection of the insulin detemir manufacturing facilities, with few minor observations Outlook for US Discussions with the FDA are scheduled to clarify whether available clinical data may be adequate for approval, or additional clinical data will be required Current status in Europe Filed November 2002 Median EMEA CP approval time for industry: months* Outlook for Europe Novo Nordisk is now finalising answers to remaining questions on preclinical data and process documentation A CPMP opinion is targeted around year-end NovoLog ® and NovoRapid ® experience NovoLog ® : FDA approval time: 21 months NovoRapid ® : EU approval time: 13 months * Source: CMR international, ** Source: FDA Pink Sheets,

23 Financials

24 Financial results * EPS on a fully-diluted basis. Net turnover19,333 18,479 56,7036,4454 Operating profit 4,575 4,374 51,6361,5188 Net financials Profit before tax5,3144, ,7131,54211 Net profit3,507 2, ,1301,00313 EPS (DKK)* DKK million First nine monthsThird quarter % change % change

25 Currency impact - first nine months of 2003 Growth in local currencies Growth in Danish kroner International Operations Europe North America Japan & Oceania Total Therapy areaRegion Diabetes care Haemostasis management Growth hormone therapy Hormone replace- ment therapy Total

26 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 avg = 8.32 avg = avg = 6.30 avg = 7.88 USD JPY YTD 2003 avg = 5.67 YTD 2003 avg = 6.65

27 Outlook for 2003 Note: Above outlook is based on the assumption that exchange and interest rates remain at the current level (27 October 2003) Operating profit now expected to grow by around 5% Net financial income still expected at DKK 900 million Tax rate of 34% Net profit now expected to grow by around 15% Key currency rates DKK per average USD788 JPY6.30 GBP1182 Current rate* * As of 27 October ytd avg

28 Key growth drivers Novo Nordisk sales* Leadership in diabetes care with full portfolio of insulin analogues 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

29 Investor Information Investor Relations contacts Novo Nordisk A/S Investor Relations Novo Allé, DK­2880 Bagsværd Fax (+45) Peter Haahr Tel (direct): (+45) Palle Holm Olesen Tel (direct): (+45) Christian Kanstrup Tel (direct): (+45) Investor Relations Office US Tel (direct): (+1) 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

30 Sales by therapy - first nine months of 2003 DKK million % of total % change (2003) Insulin and delivery systems12,49511, Oral antidiabetic drugs1,0501,2425 (15) Diabetes care, total13,54512, Haemostasis management2,9342, Growth hormone therapy1,6131, HRT9321,0075 (7) Other (3) Total19,33318,

31 DKK million % of total % change (2003) Europe 8,5788, North America4,7414, International Operations2,9952, Japan & Oceania3,0193,04916 (1) Total 19,33318, Sales by region - first nine months of 2003

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

33 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

34 Adding value to volume – key to delivering high growth Human insulin (73%) Vials (47%) Durables (32%) Disposables (21%) Insulin analogues (27%) Source: IMS/BW Note: IMS World, Q2 2003, volume figures Improved control Improved accuracy and compliance

35 Insulin segmentation - Europe and the US Europe US Source: IMS/BW Q Q Q Q % 10% 20% 30% 40% 50% Volume share Long-acting Premix Short-acting 0% 10% 20% 30% 40% 50% Volume share Long-acting Premix Short-acting

36 Launch of NovoMix ® 30 - still in progress Share of segment in Europe (volume) Sales development in Europe (MU) Quarters from launch Source: IMS/BW

37 Novo Nordisk market share since Lantus launch Total insulin (MU) Month of Lantus launch August 2003 US26%33% Europe57%58% Germany44%45% UK67%65% Europe Source: IMS/BW Jan 2002 August % 45% 50% 55% 60% 65% 70% Volume share Long-acting Premix Short-acting

38 Lantus impact? - volume Source: IMS/BW Months since Lantus launch Index - Month of launch equals 100 Novo Nordisk Indexed market share Germany Novo Nordisk Indexed market share UK Novo Nordisk Indexed market share US

39 Source: IMS/BW Months since Lantus launch Lantus impact? - value Index - Month of launch equals 100 Novo Nordisk Indexed market share Germany Novo Nordisk Indexed market share UK Novo Nordisk Indexed market share US

40 Growth hormone therapy Sales by quarter DKK million % Key observations Growth in local currencies of 5% for the third quarter. North America the main growth driver Growth for the first nine months 4% reported or 14% in local currencies More than 90% of sales is Norditropin ® SimpleXx ®. Continuing strong penetration in all markets Increasing market share in both the US and Europe Q1Q3Q1Q3 Q1 Q3

41 HRT Sales by quarter DKK million % Key observations HRT sales increased by 20% in local currencies in the third quarter Adjusted for the change in set-up in the US, sales declined by 11% in the quarter in local currencies Novo Nordisk’s low-dose portfolio has benefited from the changes in the market Uncertainty about the market development remains high Q1Q3Q1Q3 Q1 Q3

42 The most effective product for treatment of haemophilia with inhibitors The only recombinant product, that is, no substitutable recombinant products Fewer transfusions/transfusion-free surgery Reduced re-bleeding Faster recovery Reduced morbidity and mortality Improved quality of life NovoSeven ® - a life-saving product…

43 NovoSeven ® - a unique mechanism of action NovoSeven ® directly activates factor X on the surface of the locally activated platelets

44 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

45 Segmentation and targeting Introduce & build confidence First-line position in haemophilia Intensive care Surgery Acquired haemophilia Haemophilia Treatment Centres Haematologists Internists Intensive care Anaesthesiologists New physician groups

46 Low exposure to patent expiration Accumulated % of 2002 Novo Nordisk sales with patents expiring % of 2001 sales with patents expiring in Source: Nordea Securities and Novo Nordisk. Novo Nordisk Bayer GSK Takeda Pfizer Merck Novartis BMS Aventis Eli Lilly

People without diabetes Type 2 diabetes Insulin Secretion (pmol/min) Source: O'MEARA et al. Am. J. Medicine, 1990; 89. Insulin secretion in people without diabetes and people with type 2 diabetes

48 Diabetes care pipeline CompoundTypeIndicationPhase Insulin detemirInsulinType 1+2 diabetesFiled EU+US NovoMix ® 50 and 70InsulinType 1+2 diabetesPhase 3 AERx ® iDMS (NN1998)InsulinType 1+2 diabetesPhase 3 Liraglutide (NN2211)GLP-1 analogueType 2 diabetesPhase 2 Balaglitazone (NN2344)OADType 2 diabetesPhase 2 NN344InsulinType 1+2 diabetesPhase 1 NN2501OADType 2 diabetesPhase 1

49 Biopharmaceuticals - pipeline outside diabetes care CompoundIndicationPhase NovoSeven ® Liver transplantationPhase 2 NovoSeven ® TraumaPhase 2 NovoSeven ® Stem cell transplantationPhase 2 NovoSeven ® Intracerebral haemorrhagePhase 2 NovoSeven ® Upper gastro-intestinal bleedingPhase 2 Growth hormoneComplicated fracturesPhase 2 ASIS*ARDSPhase 2 * ASIS - Active Site Inhibited Seven/ARDS - Acute Respiratory Distress Syndrome