Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — Investor Presentation (June 2013)
37 slides from Novo Nordisk A/s Class B's investor presentation, Jun 22, 2013
Slide 1: ADA 2013 Novo Nordisk investor and analyst event
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 1 ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Chicago
Slide 2: Forward-looking statements
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 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 2012 and Form 20-F, both filed with the S
Slide 3: Agenda
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 3 Agenda Time Topic Welcome 6.05pm Jesper Brandgaard, EVP & CFO Update on Tresiba® launch performance 6.10pm Jakob Riis, EVP Marketing & Medical Affairs New meta-analyses and clinical data on insulin degludec 6.20pm Mads Krogsgaard
Slide 4: Broad Novo Nordisk presence - abstracts accepted at ADA 2013
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 4 Broad Novo Nordisk presence - 50 Novo Nordisk abstracts accepted at ADA 2013 ® ® ® Note: Tresiba® is the brand name for insulin degludec; Ryzodeg® is the brand name for insulin degludec/insulin aspart; IDegLira is the internal des
Slide 5: Update on launch performance
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 5 Update on launch performance Jakob Riis EVP Marketing & Medical Affairs
Slide 6: Regulatory update for Tresiba and Ryzodeg
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 6 Regulatory update for Tresiba® and Ryzodeg® Submitted1 Approved1 Launched5 US2 Colombia Canada Malaysia South Africa Philippines3 Japan EU India Bangladesh UK Australia Lebanon3 Norway Denmark Brazil Indonesia Iceland Mexico Russi
Slide 7: Early feedback from launch markets shows strong execution of Tresiba strategy
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 7 Early feedback from launch markets shows strong execution of Tresiba® strategy Summary of customer feedback* Example of a Tresiba® promotional detail aid in the UK Most recalled messages (Top 3) • Long duration of action • Less hy
Slide 8: Update on Tresiba launch in Japan after 15 weeks in the market
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 8 Update on Tresiba® launch in Japan after 15 weeks in the market Tresiba® launch in Japan, Basal insulin value market share in Japan1 key observations after 15 weeks2 ® Tresiba insulin glargine • 67% of target accounts opened ® Lev
Slide 9: New meta-analyses on insulin degludec
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 9 New meta-analyses on insulin degludec Mads Krogsgaard Thomsen EVP & CSO
Slide 10: 82% higher chance of reaching FPG target without nocturnal hypoglycaemia
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 10 82% higher chance of reaching FPG target without nocturnal hypoglycaemia with insulin degludec vs. insulin glargine Conclusion from pooled meta-analysis comparing percentage of people with type 2 diabetes using basal insulin and
Slide 11: Meta-analysis shows lower risk of hypoglycaemia with insulin degludec
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 11 Meta-analysis shows lower risk of hypoglycaemia with insulin degludec vs. insulin glargine in people with type 2 diabetes of >10 years Conclusion from meta-analysis of five randomised trials in 1,651 people with type 2 diabetes I
Slide 12: Adding liraglutide or rapid-acting insulin to insulin degludec in type 2 diabetes
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 12 Adding liraglutide or rapid-acting insulin to insulin degludec in type 2 diabetes Mads Krogsgaard Thomsen EVP & CSO
Slide 13: Extension trial comparing addition of liraglutide or rapid-acting insulin
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 13 Extension trial comparing addition of liraglutide or rapid-acting insulin to insulin degludec in type 2 diabetes Trial design Baseline characteristics IDeg + IDeg + IDeg IDeg + liraglutide + met Lira IAsp (n=88) HbA1c Mean age, y
Slide 14: Extension trial shows significantly less confirmed hypoglycaemia with degludec + liraglutide
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 14 Extension trial shows significantly less confirmed hypoglycaemia with insulin degludec + liraglutide vs. insulin degludec + insulin aspart Comparison of overall Comparison of HbA1c confirmed hypoglycaemia HbA1c (%) Cumulative eve
Slide 15: Extension trial: adding liraglutide improves HbA1c with weight loss
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 15 Extension trial shows that adding liraglutide to insulin degludec improves HbA1c with weight loss and low risk of hypoglycaemia Conclusion • Adding liraglutide to insulin degludec statistically significantly lowered Hba 1c by -0.
Slide 16: IDegLira, DUAL I phase 3a trial
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 16 IDegLira, DUAL™ I phase 3a trial Mads Krogsgaard Thomsen EVP & CSO
Slide 17: DUAL I, the first phase 3 trial for IDegLira
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 17 DUAL™ I, the first phase 3 trial for IDegLira, a fixed-dose combination product of insulin degludec and liraglutide Trial design Baseline characteristics IDegLira once daily IDegLira Tresiba® Victoza® + met ± TZD (n=834) Mean age
Slide 18: DUAL I shows substantial improvement in HbA1c with low hypoglycaemia risk
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 18 DUAL™ I shows substantial improvement in HbA1c with a low risk of hypoglycaemia with IDegLira compared to insulin degludec Comparison of HbA1c with IDegLira Comparison of overall confirmed vs. comparators hypoglycaemia with IDegL
Slide 19: DUAL I phase 3 trial confirms IDegLira efficacy and safety
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 19 DUAL™ I phase 3 trial confirms IDegLira efficacy and safety in people with type 2 diabetes Conclusion • Once daily IDegLira achieved a statistically significantly greater reduction in HbA1c (-1.9%) than insulin degludec (-1.4%) o
Slide 20: Liraglutide in clinical practice
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 20 Liraglutide in clinical practice Alan Moses SVP & Global CMO
Slide 21: Clinical practice data confirm superior HbA1c reduction with liraglutide
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 21 Clinical practice (real-world) data confirm superior HbA1c reduction with liraglutide vs. other incretin-based therapies Results from retrospective comparison of HbA1c outcomes in clinical practice among patients ≥18 years with t
Slide 22: Liraglutide in type 1 diabetes
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 22 Liraglutide in type 1 diabetes Alan Moses SVP & Global CMO
Slide 23: Phase 1 trial investigating safety of liraglutide as adjunct to insulin in type 1 diabetes
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 23 Phase 1 trial investigating safety of liraglutide as adjunct to insulin in type 1 diabetes Trial design Treatment period 1 Treatment period 2 2–3 weeks 4 weeks washout 4 weeks Liraglutide 0.6 mg Liraglutide 0.6 mg 0.6 mg Placebo
Slide 24: Phase 1 trial did not result in unexpected safety or tolerability issues
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 24 Phase 1 trial with liraglutide as adjunct to insulin in type 1 diabetes did not result in unexpected safety or tolerability issues Key findings in trial Insulin dose reduction with liraglutide IU Liraglutide 0.6 mg Placebo 0.1 mL
Slide 25: Liraglutide safety profile
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 25 Liraglutide safety profile Alan Moses SVP & Global CMO
Slide 26: Incretin safety debates over time
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 26 Incretin safety debates over time Oct 2007 Jan 2010 Mar 2011 Apr 2012 Feb 2013 •FDA alert •Diabetologia •Gastroenterology •Diabetes •JAMA •New pancreatitis •Butler, editorial •Elashoff, Butler, •Gier, Kras mouse •Singh, Claims pr
Slide 27: Liraglutide pancreas safety supported by non-clinical toxicology studies
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 27 Liraglutide pancreas safety supported by non-clinical toxicology studies Results from liraglutide studies in rodents and non-human primates • Animal safety studies are useful to identify target organs and potential signals of pot
Slide 28: No clear association to acute pancreatitis and pancreatic cancer with liraglutide
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 28 No clear association to acute pancreatitis and pancreatic cancer with liraglutide administration in diabetes clinical development program Pancreatitis incidence in all completed Pancreatic cancer incidence in all completed liragl
Slide 29: Preclinical data shows no detectable effect of liraglutide on pancreas weight
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 29 Preclinical data shows no detectable effect of liraglutide on overall pancreas weight Pancreas weight in ZDF rats with hyperglycaemia after 13 weeks exposure to liraglutide Male ZDF rats Female ZDF rats 1.5 1.5 Pancreas weight (g
Slide 30: Preclinical data shows no detectable effect on acinar or duct cell mass
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 30 Preclinical data shows no detectable effect on acinar or duct cell mass Male ZDF rats with hyperglycaemia after 13 Female ZDF rats with hyperglycaemia after 13 weeks exposure to liraglutide weeks exposure to liraglutide 100 100 *
Slide 31: Post-marketing surveillance confirms low incidences of pancreatic cancer and pancreatitis
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 31 Liraglutide post-marketing surveillance confirms low incidences of pancreatic cancer and pancreatitis cases Pancreatic cancer Pancreatitis Events Number of events RR/1000PYE RR Events Number of events RR/1000PYE RR 40 0.08 450 0,
Slide 32: Reassuring pancreas safety data from OptumInsight Claims Database Study
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 32 Reassuring liraglutide pancreas safety data from OptumInsight Claims Database Study: Interim analysis, June 2013 Initiators from 1 Feb 2010 to 30 Sep 2012 with follow-up through 31 Dec 2012; 24,822 liraglutide initiators: propens
Slide 33: Totality of information supports a favorable benefit-risk balance for liraglutide
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 33 The totality of efficacy and safety information supports a favorable benefit-risk balance for liraglutide Overall conclusion • Nonclinical studies do not demonstrate histopathological changes in the exocrine or endocrine pancreas
Slide 34: Concluding remarks
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 34 Concluding remarks Jesper Brandgaard EVP & CFO
Slide 35: Concluding remarks
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 35 Concluding remarks Tresiba® roll out continues with encouraging early feedback from patients and physicians New meta-analyses document competitive profile of insulin degludec Benefits of combined use of liraglutide and insulin de
Slide 36: Q&A session
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 36 Q&A session Jesper Brandgaard, EVP & CFO Jakob Riis, EVP Marketing & Medical Affairs Mads Krogsgaard Thomsen, EVP & CSO Alan Moses, SVP & Global CMO
Slide 37: Investor contact information
ADA 2013 Novo Nordisk investor and analyst event 22 June 2013 Slide 37 Investor contact information Share information Investor Relations contacts Novo Nordisk’s B shares are listed on the stock exchange in Novo Nordisk A/S Copenhagen under the symbol ‘NOVO B’. Its ADRs are listed on the Investor Rel