Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — Non-Deal Roadshow (November 2001)
58 slides from Novo Nordisk A/s Class B's roadshow presentation, November 2001
Slide 1: Novo Nordisk: A focused global healthcare company with biotech expertise
Novo Nordisk A focused global healthcare company with biotech expertise Investor Presentation November 2001 1
Slide 2: Novo Nordisk today
Novo Nordisk today Consistent, strong organic growth Focused on few therapeutic areas with large unmet medical needs Leadership in diabetes and most extensive diabetes pipeline in the industry Becoming an established player in general haemostasis management Proven biotech and drug delivery capabilit
Slide 3: Novo Nordisk – Future Key Drivers
Novo Nordisk – Future Key Drivers Primary Coagulation growth Diabetes care drivers disorders Secondary Human growth Intellectual value HRT drivers hormone property 3
Slide 4: Turnover by Therapy first nine months 2001
Turnover by Therapy first nine months 2001 Key observations: HRT Growth driven by sales of hGH +12% insulin and continued growth in +3% sales of NovoNorm® /Prandin® Coagulation High growth in the US supported by increasing sales disorders in Europe and Rest of World +42% Diabetes care Solid growth i
Slide 5: Turnover by Region first nine months 2001
-5% Japan +36% USA +15% RoW +18% Europe Total turnover of DKK 17,316 mn (+16%) imarily driven by Strong insulin market growth Growth abetes affected Strong insulin care and by and market growth continued penetration of depreciation voSeven® and of sales continued andpenetration JPY NovoSeven ® andof
Slide 6: Novo Nordisk – Future Key Drivers
Novo Nordisk – Future Key Drivers Primary Coagulation growth Diabetes care drivers disorders Secondary Human growth Intellectual value HRT drivers hormone property 6
Slide 7: A high growth therapeutic area
A high growth therapeutic area Continued high growth Key Novo Nordisk features: More than 75 years of 25 Diabetes care experience within diabetes Dominant position in CNS 20 Cancer insulin markets of Europe % CAGR 1995-1999 Respiratory and Japan 15 Cardiovascular Gastrointestinal Arthritis Strong gr
Slide 8: Towards more intensive/flexible treatment
Towards more intensive/flexible treatment Novo Nordisk market share 2001 Insulin market volume 180 +5% 160 +9% 39% +8% 25% 140 +3% Mega Units in 1,000 +6% 120 20% 34% Short-acting 100 39% 80 60 52% 40 47% 36% 20 0 Premixed 1996 1997 1998 1999 2000 2001 Short-acting market growth: 11.8% CAGR since 19
Slide 9: Insulin market overview
Insulin market overview (’01/ ’00 MAT Q2 Volumes) % market size Market growth Novo Nordisk (‘01/’00) market share USA - 0.3% 26% 43% Europe 9.5% 58% 47% Japan 4% 7.8% 80% RoW 10.5% 60% 6% World 4.8% 46% 100% Notes: Industrialised world only. Wal*Mart figures not included. Growth in Europe effected b
Slide 10: Worldwide analogue and pen penetration
Worldwide analogue penetration Worldwide pen penetration Adding Value to Volume 1997 1997 1998 1998 1999 1999 2000 2000 2001 2001 0% 50% 50% 0% +50% +50% value value Unit Notes: All numbers are MAT Q2 Unit 10
Slide 11: Key insulin market observations
Key insulin market observations Volume Product upgrades No. of people with diabetes Insulin analogues expected to double by 2025 Insulin delivery systems Increased diagnosis rate Intensified therapy 5% to annual growth + 5% to annual growth 11
Slide 12: Insulin etc
Insulin etc Sales by quarter Key observations: 4,500 DKK million Growth of 13% in 9M 2001 vs 9M 2000 and growth of 4,000 12% in Q3 2001 vs Q3 2000 3,500 In the US sales growth is driven by market share 3,000 gain, primarily via major 2,500 contracts NovoLog® launched in the 2,000 US in September 1,5
Slide 13: Diabetes pipeline - insulins
Diabetes pipeline - insulins Phase 1 Phase 2 Phase 3 NN414 NN1998 NN304 (Insulin secretion) (AERx iDMS) (Basal analogue) NN4201 NN2344 NN622 (Hepatic glucose regulator) (Insulin sensitiser) (Dual-acting sensitiser) NN2211 NN1215 (GLP-1 analogue) (LABI) 13
Slide 14: NN304 versus NPH insulin
NN304 versus NPH insulin Hypoglycaemic events Key observations: Soluble at neutral pH 26% No re-suspension required 50 Mixable with other insulin Number of episodes 36% products 40 Novel mechanism of protraction 30 Predictable action profile 39% Low intra-patient variability 20 62% Contributes to lo
Slide 15: From diet and exercise to insulin
From diet and exercise to insulin Insulin OAD and 14% insulin 3% Diet and exercise 50% OAD 33% 2 patients iagnosed 15
Slide 16: NovoNorm/Prandin
NovoNorm®/Prandin® Sales by quarter DKK million Key observations: 450 Growth of 44% in 9M 2001 400 vs 9M 2000 350 Growth of 34% in Q3 2001 vs Q3 2000 300 Continued market 250 penetration in Europe 200 contributed to growth Growth in the US via 150 strong underlying market 100 growth 50 Sales in Q3 a
Slide 17: Growth opportunities in OAD
Growth opportunities in OAD Growth in USD 6.2 bn OAD market 350 Key observations Novo Nordisk 300 Sales development in USD Experience in the OAD CAGR: 27% market from NovoNorm® MATQ2.1996=100 250 /Prandin® 200 Broad pipeline of innovative approaches for 150 Type 2 diabetes No. of treated patients 10
Slide 18: Diabetes pipeline – non-insulins
Diabetes pipeline – non-insulins Phase 1 Phase 2 Phase 3 NN414 NN1998 NN304 (Insulin secretion) (AERx) (Basal analogue) NN4201 NN2344 NN622 (Hepatic glucose regulator) (Insulin sensitiser) (Dual-acting sensitiser) NN2211 NN1215 (GLP-1 analogue) (LABI) 18
Slide 19: Attractive late stage diabetes pipeline
Attractive late stage diabetes pipeline OAD drugs and Insulin Insulin Hepatic Delay of Reduc. of glucose glucose Body Beta cell diabetic Novo Nordisk defi- sensi- regula- absorp- weight rescue dyslipi- MS ciency tivity Phase 2 projects tion tion daemia Metformin (eg Glucophage, Glucovance) + 36% Sen
Slide 20: NN622 – adding lipid control to glucose regulation
NN622 – adding lipid control to glucose regulation Key observations: Lipid abnormalities much more common in Estimated 50-70% of people with Type 2 diabetes than in people people with Type 2 without diabetes deabetes have abnormal lipid values Cardiovascular disease is accountable for 75% of all dea
Slide 21: NN622 – a competitive profile
NN622 – a competitive profile HbA1C -2% Fasting plasma glucose Plasma insulin (FPG) -60% -60% Sensitisers Definitions: Fibrates NN622 Statins 0% Note: The slide is constructed for illustrative purpose including findings from the NN622 12 -60% -60% weeks phase 2 studies. The relative comparison to se
Slide 22: Protein Delivery Systems
Endocrinology Devices Proteins Protein Delivery Systems Key observations: A new research and development unit Leveraging on key core competences Innovative and superior drug delivery Focus on next generation of insulin 22 delivery
Slide 23: Novo Nordisk – Future Key Drivers
Novo Nordisk – Future Key Drivers Primary Coagulation growth Diabetes care drivers disorders Secondary Human growth Intellectual value HRT drivers hormone property 23
Slide 24: Coagulation disorders (NovoSeven) sales by quarter
0 100 200 300 400 500 600 700 800 900 1998 DKK million 1999 2000 Sales by quarter 2001 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Key observations: Growth of 42% 9M 2001 YoY and 36% Q3 2001 YoY Increased use in surgical procedures for inhibitor patients Increased use for patients with Coagulation
Slide 25: Advantages of NovoSeven
Advantages of NovoSeven® The key advantages of NovoSeven® are: FVIIa/NovoSeven® Injury site selective activation of platelets Tissue factor creates high local thrombin generation which secures a tight fibrin clot Efficacy independent of inhibitor titer Effective during & after surgery Low thrombogen
Slide 26: Beyond haemophilia treatment
Beyond haemophilia treatment NovoSeven® in bleeding conditions Coagulation factor deficiencies Platelet defects General haemostasis Haemostasis Reduction of blood and plasma transfusions No product offers this safety and efficacy profile Management Increasing supportive data from investigational use
Slide 27: NovoSeven indication expansions
NovoSeven® indication expansions Coagulation Factor Platelet General Deficiency Disorder Haemostasis Single Multiple Lack of Defective Surgical Spontaneous Factor Factors platelets platelets bleeding bleeding Haemophilia Upper Stem cell Liver resection Intra-cerebral with inhibitors gastrointestinal
Slide 28: Building Strong Scientific Evidence
Building Strong Scientific Evidence Clinical area Status on project Orthotopic liver transplantation* Ongoing Ph 2/3 project Upper GI bleeds* Ph 2 study has been initiated Liver resection* Ph 2 study has been initiated Liver resection Exploratory Ph 2 study has been initiated Bone marrow transplanta
Slide 29: Novo Nordisk – Future Key Drivers
Novo Nordisk – Future Key Drivers Primary Coagulation growth Diabetes care drivers disorder Secondar Secondary y Human growth Intellectual value HRT drivers hormone property 29
Slide 30: Norditropin SimpleXx sales by quarter
0 100 200 300 400 500 600 700 1998 DKK million 1999 2000 Sales by quarter 2001 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Key observations: Growth of 3% in 9M 2001 YoY and decrease of 3% in Q3 2001 Human growth hormone sales YoY Reported sales in Japan impacted by negative currency and wholesalers
Slide 31: Novo Nordisk – Future Key Drivers
Novo Nordisk – Future Key Drivers Primary Coagulation growth Diabetes care drivers disorder Secondar Secondary y Human growth HRT Intellectual value drivers hormone property 31
Slide 32: Hormone Replacement Therapy sales by quarter
0 50 100 150 200 250 300 350 400 1998 DKK million 1999 2000 Sales by quarter Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2001 Key observations: Growth of 12% 9M 2001 YoY and Hormone Replacement Therapy growth of 6% Q3 2001 YoY Activelle® and Vagifem® main contributors to growth in Europe Growth sup
Slide 33: Novo Nordisk – Future Key Drivers
Novo Nordisk – Future Key Drivers Primary Coagulation growth Diabetes care drivers disorders Secondary Human growth HRT Intellectual value drivers hormone property 33
Slide 34: No significant patent expirations
0% 10% 20% 30% 40% 50% 60% AstraZ. S-Plough Merck Eli Lilly Pfizer Aventis Source: Nordea Securities BMS GSK Roche Novartis Pharmacia No major patent expirations J&J AHP Abbott No significant patent expirations on this side of 2010 *) Amgen % of 2000 sales with patents expiring in 2001-2005 Products
Slide 35: Financials
Financials beeing theve . io} novo nordisk 35
Slide 36: Financial results first nine months
Financial results first nine months DKK million 2001 2000 % change Net turnover 17,316 14,936 16 Operating profit as reported 4,130 3,457 19 Financial items 334 (27) N/A Profit before tax 4,464 3,430 30 Net profit 2,857 2,136 34 Earnings per share (DKK) - diluted 8.21 6.09 35 Earnings per ADR (USD)*
Slide 37: Updated outlook for 2001
Updated outlook for 2001 Growth in operating profit of 15% is expected Net financial income is expected to be approx DKK 375 million Tax rate expected at the level of 36% Investments expected around DKK 3.5 billion Above outlook is based on the assumption that exchange and interest rates remain at t
Slide 38: Adding shareholder value at Novo Nordisk
Adding shareholder value at Novo Nordisk A holistic view on value creation Economically Four long-term financial targets viable EBIT growth of 15% per annum EBIT margin of 25% ROIC of 25% per annum Socially Environmentally responsible sound Cash to earnings of 60% Supported by shareholder value crea
Slide 39: Novo Nordisk – Key Drivers
Novo Nordisk – Key Drivers Diabetes care Coagulation disorders World leader with steady growth Estimated market potential for more than 75 years for current NovoSeven® indication of USD 350 million 2/3 of business (insulin) growing >10% pa Entering 6 new clinical areas Primary with 8 new studies Gro
Slide 40: 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 risk and uncertainties that may cause actual results to differ materially from expectatio
Slide 41: Investor Information
Investor Information Investor Relations contacts: Share information Novo Nordisk A/S Novo Nordisk’s B shares are listed Investor Relations Novo Allé on the stock exchanges in DK2880 Bagsværd Copenhagen and London. Its Denmark ADRs are listed on the New York Fax (+45) 4444 2314 Stock Exchange under
Slide 42: Appendix
Appendix O novo nordisk’ 42
Slide 43: Margin Development
Margin Development 6000 5000 Production costs Development in gross- and DKK million EBIT-margin 1997-2000 4000 3000 79% 24% 2000 77% 22% 1000 75% 20% 0 73% 18% 1997 1998 1999 2000 71% 16% 7000 Gross margin (left- R&D costs 69% hand scale) 14% 6000 S&D costs EBIT-margin (right- 67% hand scale) 12% DK
Slide 44: Profit & Loss 1998-2000
Profit & Loss 1998-2000 DKK million 1998 1999 2000 Net turnover 13,647 16,423 20,811 Y/Y growth +8.4% +20.3% +26.7% Gross profit 9,896 12,196 15,767 EBIT 2,933 3,527 4,816 EBIT-margin 21.5% 21.5% 23.1% Net finance 243 -178 24 Pre-tax profit 3,176 3,349 4,840 Tax rate 36.5% 40.3% 36.2% Net profit 2,0
Slide 45: Diabetes R&D at Novo Nordisk: Sources of innovation
Diabetes R&D at Novo Nordisk: Sources of innovation Clinical research Steno Diabetes Centre Oxford Diabetes Centre Basic research Clinical research centres worldwide Hagedorn Research Institute Evidence-based medicine Oxford and Steno Diabetes Centre NN disease mgt programmes Academic collaborations
Slide 46: Diabetes drug candidates in development at Novo Nordisk
Diabetes drug candidates in development at Novo Nordisk Genotype Insulin Resistance Obesity Type 2 Failure of Dyslipidaemia diabetes* oral drugs Phenotype Diet and Appetite Sensitizers and β-cell agents: Insulins: exercise: regulation: lipid-lowering NovoNorm® NovoRapid®, NN education agents: NN2211
Slide 47: Pharmaceutical needs in diabetes
Pharmaceutical needs in diabetes Type 1 Type 2 Intervention in -cell Blood glucose regulation* destruction Regulation of energy balance Blood glucose regulation* (diabetes-associated obesity) Reduction of triglycerides, FFA and LDL/HDL ratio (diabetic dyslipidaemia) * Including, but not restricted
Slide 48: Insulin detemir versus NPH insulin
Insulin detemir versus NPH insulin Night-time glucose profile BG (mM) 12 Insulin detemir showed reduced 11 variability compared to NPH 10 9 N = 21 8 N = 52 7 6 5 11pm 3am 7am Treatment: Insulin detemir NPH insulin Findings: Predictable glucose profiles over night with detemir J. L. Selam et al. :Ora
Slide 49: Profile of the ideal basal insulin
Profile of the ideal basal insulin Desirable properties: Limitations of current insulins: Solubility Solubility Soluble at neutral pH Most current basal insulins Mixable with other insulins require re-suspension Absorption Absorption Predictable Highly variable Glucose lowering effect Glucose loweri
Slide 50: Insulin profiles in type 1 diabetic patients treated with NovoRapid
Insulin profiles in type 1 diabetic patients treated with NovoRapid® or human insulin (pmol/l) (mU/l) NovoRapid® 600 100 Soluble human insulin 500 (0.15 U/kg) 80 Serum insulin 400 60 300 40 200 20 100 0 0 0600 1200 1800 2400 0600 Time of day Breakfast Lunch Dinner NPH Adapted from Home et al. 1998 5
Slide 51: AERx iDMS: Pulmonary insulin administration
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
Slide 52: Pulmonary insulin delivery: Competition
Pulmonary insulin delivery: Competition Aradigm Inhale Alkermes Speciality Systemic + Systemic Systemic local delivery delivery Device Single dose, Single dose - liquid aerosol Size Portable, not Portable, not Portable, pocket pocket-sized pocket-sized sized Formulation Liquid, Dry powders, Dry powd
Slide 53: The AERx iDMS: Findings on EASD
The AERx®iDMS: Findings on EASD Rapid onset of action Similar duration of action as SC Linear dose response (one AERx®Unit increments) Smoking alters PK profile No provocation of bronchospasm in asthmatic patients Low intra-subject variability Proven safety in all pre-clinical studies 55
Slide 54: The insulin market: Overall findings
The insulin market: Overall findings Both Type 1 and 2 diabetes Insulin products Mainly specialist driven, Actrapid®, Insulatard®, Monotard®, but GPs very important in US Mixtard®, Ultratard®, Velosulin®, Novolin®, NovoRapid®, NovoMix™ Few players, large volumes (registration), Insulin detemir (Phas
Slide 55: NN2211: Effect on fasting and post-prandial blood glucose
NN2211: Effect on fasting and post-prandial blood glucose in type 2 patients GLP-1 effects: 12 Mean glucose profiles Placebo Insulin 11 NN2211 -cell survival 10 (mmol/l) Glucagon 9 Appetite 8 GI-emptying 7 6 5 Insulin Standard pulse Dosing meal 4 analysis -2 0 2 4 6 8 10 12 14 16 18 From
Slide 56: Metabolic abnormalities associated with diabetes
Metabolic abnormalities associated with diabetes Type 1 Type 2 Elevated blood glucose xxx xxx Ketosis xx 0 Insulin resistance x xxx Hypertension x xx Obesity x xxx Increased LDL x/0 x/0 Increased triglycerides/FFA 0 xxx Decreased HDL 0 xxx 58
Slide 57: Findings from the Phase 2 studies (efficacy)
Findings from the Phase 2 studies (efficacy) Blood glucose control* HbA1c decrease within the range of 1-1.5%-points Fasting plasma glucose (FPG) decrease in the area of 23-35% Plasma insulin decrease of approx 50% Control of diabetic dyslipidaemia* HDL-cholesterol increase of 18-30% Trigl
Slide 58: Findings from the Phase 2 studies (safety)
Findings from the Phase 2 studies (safety) Weight Dose-dependent increase as reported with other PPAR agonists Oedema Dose-dependent occurrence as reported with other PPAR agonists Liver No effect on any parameter Haemotology Dose-dependent effects as reported with other PPAR agonists 60