Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — Investor Presentation (June 2008)
41 slides from Novo Nordisk A/s Class B's investor presentation, Jun 8, 2008
Slide 1: ADA 2008 investor and analyst event
ADA investor and analyst event ADA 2008 investor and analyst event San Francisco, 8 June 2008
Slide 2: Forward-looking statements
ADA investor and analyst event 8 June 2008 Slide no 2 Forward-looking statements Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document as well as the company’s Annual Report 2007 and Form 20-F both expected to be filed with the SEC
Slide 3: Today's agenda
ADA investor and analyst event 8 June 2008 Slide no 3 Today’s agenda 17.00: Welcome and introduction 17.05: Review of modern insulin data 17.15: Review of liraglutide data 17.50: Q&A 18.20: Buffet and drinks 19.00: End of meeting
Slide 4: What we will present today
ADA investor and analyst event 8 June 2008 Slide no 4 What we will present today • Due to ADA embargo policy there will be no presentation of the clinical data in OR-13 (LEAD 1) • The oral presentation will take place tomorrow, Monday 9 June 3:45-4:00pm • The data presented today is based on posters
Slide 5: Increasing Novo Nordisk presence at the ADA
ADA investor and analyst event 8 June 2008 Slide no 5 Increasing Novo Nordisk presence at the ADA Number of Novo Nordisk abstracts presented at ADA 2004-2008* 70 60 50 40 30 20 10 0 2004 2005 2006 2007 2008 *Abstracts on liraglutide, modern insulins, NovoNorm® and devices
Slide 6: Abstracts are focused on liraglutide and modern insulins in 2008
ADA investor and analyst event 8 June 2008 Slide no 6 Abstracts are focused on liraglutide and modern insulins in 2008 30 25 34 abstracts on 20 modern insulins 15 10 5 0 liraglutide Levemir® NovoRapid® NovoMix® NovoNorm® Devices
Slide 7: Insulin world market leader with 52% market share
ADA investor and analyst event 8 June 2008 Slide no 7 Insulin world market leader with 52% market share Europe North America Novo Nordisk #1 Novo Nordisk #1 Market share 56% Market share: 43% International Operations Japan & Oceania Novo Nordisk #1 Novo Nordisk #1 Market share: 59% Market share: 73%
Slide 8: The GLP-1 opportunity
ADA investor and analyst event 8 June 2008 Slide no 8 The GLP-1 opportunity World DKK MAT market billion growth OAD 64 -3% OAD Insulin Insulin 54 9% GLP-1 4 24% GLP-1 Note: Absolute data represent MAT March 2008 and growth data represent MAT March 2008 over MAT March 2007. Source: IMS
Slide 9: Expanding the clinical profile of Novo Nordisk's modern insulins
ADA investor and analyst event 8 June 2008 Slide no 9 Expanding the clinical profile of Novo Nordisk's modern insulins
Slide 10: Levemir results in less weight gain than glargine when used once daily
ADA investor and analyst event 8 June 2008 Slide no 10 Levemir® results in less weight gain than glargine when used once daily *p<0.001 4.5 *p<0.001 4.0 Weight change (kg)† 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 IDet OD IDet BD IGla † After 52 weeks of treatment Note: The study included 582 patients with t
Slide 11: Similar overall glycemic control of once and twice daily Levemir
ADA investor and analyst event 8 June 2008 Slide no 11 Similar overall glycemic control of once and twice daily Levemir® Insulin detemir OD Insulin detemir BD Insulin glargine NS HbA1c(%) 9.0 End trial: 7.12% End trial: 7.12% –1.57%, p<0.01 8.0 –1.61%, p<0.01 End trial: 7.06% 7.0 –1.71%, p<0.01 –2 0
Slide 12: Similar time-action profile of Levemir and glargine
ADA investor and analyst event 8 June 2008 Slide no 12 Similar time-action profile of Levemir® and glargine Note: Each point represents the mean hourly glucose value and standard deviation of 29 type 2 patients treated with once-daily Levemir® or glargine starting at 2000 hr. Source: Abstract 436-P,
Slide 13: IMPROVE: HbA1c reduction on NovoLog Mix 70/30
ADA investor and analyst event 8 June 2008 Slide no 13 IMPROVE™: HbA1c reduction on NovoLog® Mix 70/30 Baseline ***p<0.001 Final visit –2.6*** –3.3*** –2.4*** –3.0*** –2.2*** –2.4*** 12 11 9.9 9.6 9.4 9.2 9.1 10 8.9 9 A1C (%) 8 6.9 7 6.6 6.8 6.6 6.6 6.7 6 5 4 3 2 1 0 Global No therapy 1 OAD only Ins
Slide 14: Liraglutide phase 3 programme overview
ADA investor and analyst event 8 June 2008 Slide no 14 Liraglutide phase 3 programme overview
Slide 15: Liraglutide phase 3 programme — LEAD
ADA investor and analyst event 8 June 2008 Slide no 15 Liraglutide phase 3 programme — LEAD: Liraglutide Effect and Action in Diabetes diet & OADs 1 OAD 2 OAD exercise and/or insulin LEAD 3 LEAD 2 LEAD 4 Mono- Metformin Met + TZD therapy combination combination LEAD 1 LEAD 5 SU SU SU Met + SU combin
Slide 16: LEAD demographics and baseline characteristics
ADA investor and analyst event 8 June 2008 Slide no 16 LEAD demographics and baseline characteristics LEAD 2 LEAD 3 LEAD 5 Metformin Mono- Metformin+ therapy SU Patients 1091 746 581 randomized Age (years) 56.8 53.0 57.5 Duration of 7.4 5.4 9.4 diabetes (years) 36:64 Previously on 36:64 (diet/exerci
Slide 17: LEAD 2 design
ADA investor and analyst event 8 June 2008 Slide no 17 LEAD 2 design Liraglutide 1.8 mg (n=242) Adults 18-80 years with type 2 diabetes Liraglutide 1.2 mg (n=241) HbA1c 7.0-10.0% (combination therapy) Liraglutide 0.6 mg (n=242) 7.0-11.0% (monotherapy) Placebo (n=122) FPG 7.0 -12.8 mmol/L (both incl.
Slide 18: LEAD 3 design
ADA investor and analyst event 8 June 2008 Slide no 18 LEAD 3 design Adults 18-80 years with type 2 diabetes Liraglutide 1.8 mg once daily (n = 247) Diet/exercise or OAD monotherapy Liraglutide 1.2 mg once daily (n = 251) HbA1c ≥7.0% ≤10.0% (OAD) Glimepiride 8 mg once daily (n = 248) ≤11.0% (diet) F
Slide 19: LEAD 5 design
ADA investor and analyst event 8 June 2008 Slide no 19 LEAD 5 design Adults 18-80 years with type 2 diabetes Liraglutide 1.8 mg once daily (n = 232) ≥3 months OAD therapy Placebo(n = 115) HbA1c ≥7.0% (OAD combination) ≥7.5% (OAD monotherapy) Insulin glargine once daily (n = 234) ≤10.0% -6 -4 -2 0 2
Slide 20: Blood sugar control and hypoglycaemia
ADA investor and analyst event 8 June 2008 Slide no 20 Blood sugar control and hypoglycaemia
Slide 21: Absolute HbA1c reduction
ADA investor and analyst event 8 June 2008 Slide no 21 Absolute HbA1c reduction Liraglutide 1.8 mg once daily Start HbA1c: 8.4 8.2 8.2 8.6 8.3 LEAD 2 (mono*) LEAD 2 (all) LEAD 5 (all) LEAD 3 (diet**) LEAD 3 (all) -0.2 -0.4 Change in HbA1c (%) -0.6 -0.8 -1.0 -1.2 -1.4 -1.6 -1.8 Metformin Mono Metform
Slide 22: Percent of patients reaching ADA target of HbA1c < 7%
ADA investor and analyst event 8 June 2008 Slide no 22 Percent of patients reaching ADA target of HbA1c < 7% Liraglutide 1.8 mg once daily Start Hba1c: 8.4 8.2 8.2 8.6 8.3 70 60 Patients achieving target (%) 50 40 LEAD 2 (mono*) 30 LEAD 3 (diet**) LEAD 5 (all) LEAD 3 (all) LEAD 2 (all) 20 10 0 Metfo
Slide 23: Glycemic control of liraglutide versus insulin glargine
ADA investor and analyst event 8 June 2008 Slide no 23 Glycemic control of liraglutide versus insulin glargine Baseline: 8.3 8.1 8.3 -0.2 Change in HbA1c (%) -0.4 -0.6 -0.8 -1.0 -1.2 -1.4 p=0.0015 p=0.0001 Liraglutide 1.8 mg Insulin glargine Placebo Source: Abstract 536-P (LEAD 5), ADA 2008
Slide 24: Effect of liraglutide monotherapy on glycaemic durability
ADA investor and analyst event 8 June 2008 Slide no 24 Effect of liraglutide monotherapy on glycaemic durability Patients previously on diet and exercise 9.0 Glimepiride 8 mg Liraglutide 1.2 mg monotherapy Liraglutide 1.8 mg monotherapy 8.5 HbA1c (%) 8.0 7.5 7.0 6.5 0 4 8 12 16 20 24 28 32 36 40 44
Slide 25: Effect of liraglutide at different baseline HbA1c levels
ADA investor and analyst event 8 June 2008 Slide no 25 Effect of liraglutide at different baseline HbA1c levels Baseline Baseline Baseline Baseline HbA1c HbA1c HbA1c HbA1c quartile 1 quartile 2 quartile 3 quartile 4 <7.4 7.4-8.0 8.0-8.9 ≥8.9 0 -0.5 Change in HbA1c (%) -1.0 -1.5 -2.0 1.8 mg liragluti
Slide 26: Low levels of hypoglycaemia
ADA investor and analyst event 8 June 2008 Slide no 26 Low levels of hypoglycaemia 1.4 Minor hypos/patient/year 1.2 mg 1.2 1 1.8 mg 0.8 Placebo 0.6 Glimepiride 0.4 0.2 0 Source: LEAD 2 data
Slide 27: Weight and blood pressure
ADA investor and analyst event 8 June 2008 Slide no 27 Weight and blood pressure
Slide 28: Relative and absolute weight loss
ADA investor and analyst event 8 June 2008 Slide no 28 Relative and absolute weight loss Baseline 88 93 86 weight (kg) Weight change (kg) -1 -2 -3 -4 LEAD 2 LEAD 3 LEAD 5 1.8 mg liraglutide versus comparator 1.8 mg liraglutide versus baseline Source: Abstracts 504-P (LEAD 2), 7-LB (LEAD 3) and 536-P
Slide 29: Liraglutide weight profile versus insulin glargine
ADA investor and analyst event 8 June 2008 Slide no 29 Liraglutide weight profile versus insulin glargine 89 88 Body weight (kg) 87 86 85 84 83 82 81 0 4 8 12 16 20 24 Time (weeks) Liraglutide 1.8 mg/day Placebo Insulin glargine Source: Abstract 536-P (LEAD 5), ADA 2008
Slide 30: Relation between weight loss and baseline BMI
ADA investor and analyst event 8 June 2008 Slide no 30 Relation between weight loss and baseline BMI BMI<25 25≤BMI<30 30≤BMI<35 BMI≥35 4 3 Change in bodyweight (kg) 2 1 0 -1 -2 -3 -4 Liraglutide 1.8 mg + met + SU Glargine + met + SU Note: Mean ± 1.96 x SE Source: LEAD 5 data
Slide 31: Effect of liraglutide on systolic blood pressure
ADA investor and analyst event 8 June 2008 Slide no 31 Effect of liraglutide on systolic blood pressure Change in systolic blood pressure 4 3 2 1 0 (mmHg) -1 -2 -3 -4 -5 -6 -7 p=0.0001 Liraglutide 1.8 mg/day Placebo Insulin glargine Note: Mean ± 2 SE Source: Abstract 554-P (LEAD 5), ADA 2008
Slide 32: Tolerability
ADA investor and analyst event 8 June 2008 Slide no 32 Tolerability
Slide 33: Nausea with liraglutide is transient
ADA investor and analyst event 8 June 2008 Slide no 33 Nausea with liraglutide is transient % of subjects 0 10 20 30 40 50 Week since randomisation Liraglutide 1.2 mg Liraglutide 1.8 mg Glimepiride Source: LEAD 3 data
Slide 34: Few patients withdrew due to gastrointestinal side effects
ADA investor and analyst event 8 June 2008 Slide no 34 Few patients withdrew due to gastrointestinal side effects Nausea Withdrawals due to nausea, (%) n (%) LEAD 2 Metformin Liraglutide 1.8 mg 18.6 15/242 on liraglutide (6.2) combination LEAD 3 Liraglutide 1.8 mg 29 5/247 on liraglutide (2.0) mono
Slide 35: Low antibody levels
ADA investor and analyst event 8 June 2008 Slide no 35 Low antibody levels • Across the LEAD trials the number of patients developing antibodies was less than 10% • No effect on blood glucose control Source: Data across the LEAD trials
Slide 36: Headline LEAD 6 data and comparison to other incretin-based therapies
ADA investor and analyst event 8 June 2008 Slide no 36 Headline LEAD 6 data and comparison to other incretin-based therapies
Slide 37: Steady state levels of GLP-1 after treatment with liraglutide and exenatide
ADA investor and analyst event 8 June 2008 Slide no 37 Steady state levels of GLP-1 after treatment with liraglutide and exenatide exenatide BD liraglutide OD pM nM T½ 2.4 h T½ 13 h 28 Normalised concentration (%) 50 100 24 Absolute concentration 80 40 20 60 30 16 40 20 12 8 20 10 0 0 0 4.0 4.5 5.0
Slide 38: LEAD 6 design
ADA investor and analyst event 8 June 2008 Slide no 38 LEAD 6 design screening 26 weeks liraglutide – 233 subjects 0.6mg qd 1 week type 2 diabetes 1.2mg qd 1 week 1.8mg qd 24 weeks metformin and/or metformin and/or SU sulfonylurea cont’d at pre-study dose HbA1c: 7.0-11.0% exenatide – 231 subjects 5µ
Slide 39: LEAD 6 - headline efficacy data
ADA investor and analyst event 8 June 2008 Slide no 39 LEAD 6 - headline efficacy data • Average baseline HbA1c level was slightly above 8% • Patients treated with liraglutide achieved a reduction in HbA1c of more than 1.1%, compared to a reduction in HbA1c of less than 0.8% in the exenatide arm, a
Slide 40: LEAD 6 - headline tolerability data
ADA investor and analyst event 8 June 2008 Slide no 40 LEAD 6 - headline tolerability data • The most frequently reported adverse event for both liraglutide and exenatide was nausea at a level of around 25% (percent of all study participants reporting nausea at least once) • Liraglutide: the percent
Slide 41: Concluding remarks
ADA investor and analyst event 8 June 2008 Slide no 41 Concluding remarks Modern insulins: Supporting already broad labels and expanding clinical body of evidence for Levemir®, NovoLog® and NovoLog® Mix 70/30 Liraglutide has shown statistically significantly better HbA1c reductions compared to the f