Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — Non-Deal Roadshow (October 2003)
50 slides from Novo Nordisk A/s Class B's roadshow presentation, October 2003
Slide 1: Novo Nordisk: A focused healthcare company
Novo Nordisk A focused healthcare company Investor presentation – Autumn 2003 1
Slide 2: Agenda
Agenda • Highlights • Diabetes care • Haemostasis management (NovoSeven®) • Research and development • Financials and outlook for 2003 2
Slide 3: Forward-looking statements
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
Slide 4: Highlights
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 fro
Slide 5: Sales in the first nine months - by therapy and region
Sales in the first nine months - by therapy and region By therapy By region HRT International Growth hormone -7% Operations Europe therapy Diabetes care 0% +7% +4% 5% +4% 15% 8% Haemostasis management Japan & Oceania (NovoSeven®) 15% -1% 16% 44% +11% 70% 25% North America +8% Total DKK 19.3 billion
Slide 6: Diabetes care: Key observations
DKK million 500 0 1,000 1,500 2,000 2,500 3,000 3,500 4,000 4,500 5,000 Q1 2000 Q3 Q1 2001 Q3 Q1 Diabetes care 2002 Q3 Sales by quarter Q1 2003 Q3 +3% Key observations • Growth in local currencies was 10% in the third quarter. All regions contributed to growth • In local currencies insulin and deliv
Slide 7: Diabetes - a growth market
Diabetes -a growth market Diabetes Market characteristics A high-growth market 25 • Epidemic growth in number of people with diabetes • Worldwide diabetes prevalence 5.1%, % CAGR 1998-2002 20 Diabetes care worldwide IGT prevalence (a pre-state 15 Cancer to diabetes) 8.2%1 CNS Arthritis • The number
Slide 8: Out of 'guideline' control
Out of ‘guideline’ control HbA1c 50% Real-life 10% insulin initiation It is estimated 9% that Tmore yp e 2- than 8% 2/3 ofslothe pe 7% Target US Target Europe -cell function patients are 6% not in control Time from diagnosis Source: Novo Nordisk type 2 diabetes market research, Roper Starch, ADA, E
Slide 9: Novo Nordisk's main focus within diabetes care is insulin
Novo Nordisk’s main focus within diabetes care is insulin Diet and exercise Novo Nordisk’s primary market alone continues to be insulin Oral therapy • More than 50% of Novo Nordisk’s insulin is sold to type 2 patients • Focus on devices results in -Cell function Typ Oral/insulin e 2-s lope competit
Slide 10: Delivering the insulin – the portfolio approach continues
Delivering the insulin – the portfolio approach continues Disposable Durable Inhaled Pumps Int.BGM/Doser Existing products FlexPen® NovoPen® 3 InDuo Inventor and Inventor and Novo Nordisk Inventor and No product on market leader market leader markets only only Comments market yet in segment in segme
Slide 11: Insulin market overview
Insulin market overview - volume Market size Growth rates Novo Nordisk Market Novo Nordisk market share USA 5.8% 30% ▲ 42% 17.8% Europe 6.7% 47% 7.6% 59% ▲ Japan 10.6% 8.1% 75% ▼ 5% 6.4% World 10.2% 48% ▲ 100% Source: IMS/BW. Volume data for USA, Europe, Japan, Canada, New Zealand, South Africa and
Slide 12: Market dynamics
Market dynamics Market segmentation Novo Nordisk market shares 50 % 60 % 40 % 50 % Volume share Volume share 30 % 40 % 20 % Long-acting Long-acting 30 % 10 % Premix Premix Short-acting Short-acting 0% 20 % Q1 2000 Q2 2003 Q1 2000 Q2 2003 Note: Quarterly data, volume figures Source: IMS/BW 12
Slide 13: Strong development in analogues
Strong development in analogues Analogue conversion Novo Nordisk market shares 60% 27% 59% 50% Analogues Novo Nordisk market share 7% 40% Mega unit Analogues 30% Human insulin Human insulin 20% 20% 10% 0% Q1 2000 Q2 2003 Q1 2000 Q2 2003 Note: Quarterly data, volume figures Source: IMS/BW 13
Slide 14: Market dynamics - the US
Market dynamics - the US Market segmentation Novo Nordisk market shares 50 % 50 % 40 % 40 % Volume share Volume share 30 % 30 % 20 % 20 % Long-acting Long-acting 10 % Premix 10 % Premix Short-acting Short-acting 0% 0% Q1 2000 Q2 2003 Q1 2000 Q2 2003 Note: Quarterly data, volume figures Source: IMS/B
Slide 15: Analogues - a key growth driver
Analogues - a key growth driver Short-acting segment Premix segment US US 70% 20% 30% 20% Analogue penetration Analogue penetration 60% Novo Nordisk analogue Novo Nordisk analogue 15% 15% 50% market share market share 20% 40% 10% 10% 30% 10% 20% 5% 5% 10% 0% 0% 0% 0% Q1 2000 Q2 2003 Q1 2000 Q2 2003
Slide 16: Novo Nordisk - a clear competitive edge
Novo Nordisk - a clear competitive edge Profitable manufacturing Analogue conversion Delivery systems, a key Being profitable in the of insulin requires resulting in insulin differentiating factor and insulin market requires economies of scale and market going back on a key competitive the right inf
Slide 17: The insulin business case
The insulin business case • Epidemic growth in number Volume of people with diabetes • One third are diagnosed drivers • Trend towards earlier and more intensive therapy • Conversion from human 10%+ insulin to insulin analogues Value • Conversion from vials and drivers syringes to devices • Conversi
Slide 18: Haemostasis management - NovoSeven: Key observations
DKK million 0 100 200 300 400 500 600 700 800 900 1,000 Q1 Q3 2000 Q1 2001 Q3 Q1 Sales by quarter 2002 Q3 Q1 2003 Q3 +11% 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 s
Slide 19: Existing indication - still some growth potential
Existing indication - still some growth potential Distribution of inhibitor patients Inhibitor patients require first-line Japan & treatment with NovoSeven® Oceania • 2 bleeds per month 6% • 2-3 doses/bleed • 90 micrograms/kg Europe As well as additional treatment 31% + Surgical intervention North E
Slide 20: Towards a general haemostatic agent
Towards a general haemostatic agent Congenital bleeding disorders Trauma Stem cell transplantation Identify and NovoSeven® capture value- Liver transplantation creating Intracerebral haemorrhage opportunities Upper gastro-intestinal bleeding early Liver resection Other indications Marketed indicatio
Slide 21: Pipeline update - diabetes care
Pipeline update - diabetes care Compound Phase Status Next update NovoRapid® 30 Mix Approved To be launched in Q1 Q1 2004 (in Japan) 2004 Insulin detemir Filed • Approvable Letter Q1 2004 received from the FDA • In the EU, CPMP opinion Q1 2004 is targeted around year- end NN414 Phase 2 Discontinued
Slide 22: Pipeline update - biopharmaceuticals
Pipeline update - biopharmaceuticals Compound/Indication Phase Status Next update NovoSeven® Factor VII deficiency Filed in EU Positive CPMP opinion Q1 2004 Glanzmann’s thrombasthenia Filed in EU Positive CPMP opinion Q1 2004 Liver transplantation Phase 2 Enrolment completed Q1 2004 Trauma Phase 2 E
Slide 23: Insulin detemir - an update
Insulin detemir - an update Current status in Europe Current status in US • Filed November 2002 • Approvable Letter received • Median EMEA CP approval time for • Average FDA approval time for industry: industry: 16-17 months* 19-23 months** Outlook for Europe • FDA has performed pre-approval inspect
Slide 24: Financials
Financials Diabotes isa silent killer. Itsignificantly increases the risk of cardiovascular disease, stioke and serious long-term complications. The need for answersis urgent, and Novo Nordisk is determined tofind ther. NovoNordisk is committed to creating long-term value for its shareholders. Inves
Slide 25: Financial results
Financial results DKK million First nine months Third quarter 2003 2002 % change 2003 2002 % change Net turnover 19,333 18,479 5 6,703 6,445 4 Operating profit 4,575 4,374 5 1,636 1,518 8 Net financials 739 123 501 77 24 221 Profit before tax 5,314 4,497 18 1,713 1,542 11 Net profit 3,507 2,928 20 1
Slide 26: Currency impact - first nine months of 2003
Currency impact - first nine months of 2003 Therapy area Region Diabetes care 15 9 Europe 4 7 Haemostasis 25 28 North America management 11 8 Growth hormone 14 16 International therapy 4 0 Operations Hormone replace- -3 10 ment therapy -7 -1 Japan & Oceania Total 15 15 5 Total 5 -10 -5 0 5 10 15 20
Slide 27: Currency exposure
Currency exposure avg = 8.32 8,75 avg = 7.88 8,25 Effect of 5% depreciation on full- 7,75 USD year operating profit* (DKK million) 7,25 USD -160 6,75 JPY YTD 2003 JPY -130 avg = 6.85 avg = 6.65 GBP -75 6,25 * currency hedging income is recorded as financial 5,75 avg = 6.30 YTD 2003 income avg = 5.67
Slide 28: Outlook for 2003
Outlook for 2003 • Operating profit now expected to grow by around Key currency rates 5% DKK 2002 2003 Current per 100 average ytd avg rate* • Net financial income still USD 788 666 633 JPY 6.30 5.83 expected at DKK 900 million GBP 1182 5.67 1076 1072 • Tax rate of 34% * As of 27 October 2003 • Net
Slide 29: Key growth drivers
Key growth drivers Novo Nordisk sales* • Leadership in diabetes care with full portfolio of insulin 25 analogues +% 20 13 G R CA • NovoSeven® expanding into Billion DKK 15 Y 13 general haemostasis 10 • Strong IP portfolio with low 5 exposure to patent 0 expirations 1989 1991 1997 1999 2001 1993 1995
Slide 30: Investor Information
Investor Information Share information Investor Relations contacts Novo Nordisk A/S Novo Nordisk’s B shares are Investor Relations listed on the stock exchanges in Novo Allé, DK2880 Bagsværd Fax (+45) 4443 6633 Copenhagen and London. Its Peter Haahr ADRs are listed on the New York Tel (direct): (+4
Slide 31: Sales by therapy
Sales by therapy - first nine months of 2003 DKK million 2003 2002 % of total % change (2003) Insulin and delivery systems 12,495 11,725 65 7 Oral antidiabetic drugs 1,050 1,242 5 (15) Diabetes care, total 13,545 12,967 70 4 Haemostasis management 2,934 2,635 15 11 Growth hormone therapy 1,613 1,553
Slide 32: Sales by region
Sales by region - first nine months of 2003 DKK million 2003 2002 % of total % change (2003) Europe 8,578 8,030 44 7 North America 4,741 4,409 25 8 International Operations 2,995 2,991 15 0 Japan & Oceania 3,019 3,049 16 (1) Total 19,333 18,479 100 5 32
Slide 33: Diabetes - an unfolding epidemic
Diabetes – an unfolding epidemic 370 million people with diabetes expected by 2030 # of people with diabetes (million) 300 2000 250 2030 200 150 100 50 0 US Japan Europe Rest of World Source: WHO, January 2003 33
Slide 34: Insulin - the ultimate treatment
Insulin - the ultimate treatment Diet and exercise alone -Cell function Oral therapy (66%) Typ e2 Oral/insulin - slo pe (7%) Insulin therapy (27%) Type 1 - Immediate need for Insulin Time from diagnosis 34
Slide 35: Adding value to volume – key to delivering high growth
Adding value to volume – key to delivering high growth Disposables (21%) Vials (27%) Insulin analogues Durables (47%) (32%) Improved control Human insulin (73%) Improved accuracy and compliance Note: IMS World, Q2 2003, volume figures Source: IMS/BW 35
Slide 36: Insulin segmentation - Europe and the US
Insulin segmentation - Europe and the US Europe US 50% 50% 40% 40% Volume share Volume share 30% 30% 20% 20% Long-acting Long-acting Premix 10% 10% Premix Short-acting Short-acting 0% 0% Q3 1997 Q2 2003 Q3 1997 Q2 2003 Source: IMS/BW 36
Slide 37: Launch of NovoMix 30 - still in progress
Launch of NovoMix® 30 - still in progress Sales development in Share of segment in Europe (MU) Europe (volume) 20% 18% NovoMix® 30 1,400 16% NovoRapid® 1,200 LisproMix 25 14% 1,000 12% 800 10% 600 8% NovoMix® 30 6% 400 NovoRapid® 4% 200 2% LisproMix 25 0 0% 1 3 5 7 9 11 13 15 1 3 5 7 9 13 15 11 Quar
Slide 38: Novo Nordisk market share since Lantus launch
Novo Nordisk market share since Lantus launch Total Month of Europe insulin Lantus August (MU) launch 2003 70% 65% US 26% 33% Volume share 60% Europe 57% 58% 55% 50% Germany 44% 45% Long-acting 45% Premix Short-acting UK 67% 65% 40% Jan 2002 August 2003 Source: IMS/BW 38
Slide 39: Lantus impact? - volume
Lantus impact? Index - Month of launch equals 100 - volume Novo Nordisk Indexed 130 market share Germany 125 Novo Nordisk Indexed market share UK 120 Novo Nordisk Indexed 115 market share US 110 105 100 95 90 1 6 11 16 21 26 31 36 Months since Lantus launch Source: IMS/BW 39
Slide 40: Lantus impact? - value
Lantus impact? Index - Month of launch equals 100 - value Novo Nordisk Indexed 130 market share Germany 125 Novo Nordisk Indexed 120 market share UK 115 Novo Nordisk Indexed 110 market share US 105 100 95 90 1 6 11 16 21 26 31 36 Months since Lantus launch Source: IMS/BW 40
Slide 41: Growth hormone therapy: Key observations
DKK million 100 200 300 400 500 600 0 700 Q1 2001 Q3 Q1 2002 Q3 Q1 Sales by quarter 2003 Q3 -3% Key observations • Growth in local currencies of 5% Growth hormone therapy for the third quarter. North America the main growth driver • Growth for the first nine months 4% reported or 14% in local curren
Slide 42: HRT: Key observations
DKK million 100 200 300 400 0 HRT Q1 2001 Q3 Q1 2002 Q3 Q1 Sales by quarter 2003 Q3 12% 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-
Slide 43: NovoSeven - a life-saving product
NovoSeven® - a life-saving product… • 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 m
Slide 44: NovoSeven - a unique mechanism of action
NovoSeven® - a unique mechanism of action NovoSeven® directly activates factor X on the surface of the locally activated platelets 44
Slide 45: NovoSeven - current business
NovoSeven® - current business Spontaneous bleedings in congenital haemophilia Key observations • Penetration increases as confidence in NovoSeven® Penetration increases • Increased treatment intensity Elective surgery and earlier onset of treatment within haemophilia • Increased confidence in electi
Slide 46: Segmentation and targeting
Segmentation and targeting Surgery Acquired First-line haemophilia position in Intensive care Introduce haemophilia & build confidence Haemophilia Treatment Centres Haematologists New Internists physician Intensive care groups Anaesthesiologists 46
Slide 47: Low exposure to patent expiration
Low exposure to patent expiration Accumulated % of 2002 % of 2001 sales with patents 40 Novo Nordisk sales with 40 expiring in 2002-2006 35 patents expiring 35 30 30 25 25 20 20 15 15 10 10 5 5 0 0 Novo Nordisk Novartis Bayer Takeda 2008 2009 2010 2011 2003 2004 2005 2006 2007 Aventis Pfizer Merck G
Slide 48: Insulin secretion in people without diabetes and with type 2 diabetes
Insulin secretion in people without diabetes and people with type 2 diabetes 800 Insulin Secretion (pmol/min) 700 People without diabetes Type 2 diabetes 600 500 400 300 200 100 0600 1000 1400 1800 2200 0200 0600 Source: O'MEARA et al. Am. J. Medicine, 1990; 89. 48
Slide 49: Diabetes care pipeline
Diabetes care pipeline Compound Type Indication Phase Insulin detemir Insulin Type 1+2 diabetes Filed EU+US NovoMix® 50 and 70 Insulin Type 1+2 diabetes Phase 3 AERx® iDMS (NN1998) Insulin Type 1+2 diabetes Phase 3 Liraglutide (NN2211) GLP-1 analogue Type 2 diabetes Phase 2 Balaglitazone (NN2344) OA
Slide 50: Biopharmaceuticals - pipeline outside diabetes care
Biopharmaceuticals - pipeline outside diabetes care Compound Indication Phase NovoSeven® Liver transplantation Phase 2 NovoSeven® Trauma Phase 2 NovoSeven® Stem cell transplantation Phase 2 NovoSeven® Intracerebral haemorrhage Phase 2 NovoSeven® Upper gastro-intestinal bleeding Phase 2 Growth hormon