Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — EASD 2016 Investor and Analyst Event
27 slides from Novo Nordisk A/s Class B's conference presentation, Sep 16, 2016
Slide 1: European Association for the Study of Diabetes Investor and analyst event
Slide 1 European Association for the Study of Diabetes Investor and analyst event Munich, 16 September 2016 Shanghai – part of Cities Changing Diabetes
Slide 2: Forward-looking statements
EASD 2016 investor and analyst event Slide 2 Forward-looking statements Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the company’s Annual Report 2015 and Form 20-F, which are both filed with the SEC in February 2016 in continuation of t
Slide 3: Agenda
EASD 2016 investor and analyst event Slide 3 Agenda Time Topic Welcome and introduction 11.00 Mads Krogsgaard Thomsen, EVP and Chief Science Officer Tresiba® and glargine U300 PK/PD trial 11.05 Mads Krogsgaard Thomsen, EVP and Chief Science Officer Victoza® significantly reduced the risk of diabetic
Slide 4: Tresiba and glargine U300 PK/PD trial
EASD 2016 investor and analyst event Slide 4 Tresiba® and glargine U300 PK/PD trial Mads Krogsgaard Thomsen EVP and Chief Science Officer
Slide 5: Tresiba showed lower variability in glucose-lowering effect compared to insulin glargine U300
EASD 2016 investor and analyst event Slide 5 Tresiba® showed lower variability in the glucose-lowering effect compared to insulin glargine U300 in PK/PD trial Within-subject variability in steady state Key results and next step Day-to-day Tresiba® insulin glargine U300 variability1 • The day-to-day
Slide 6: Victoza reduced risk of diabetic kidney disease progression in the LEADER trial
EASD 2016 investor and analyst event Slide 6 Victoza® significantly reduced the risk of diabetic kidney disease progression in the LEADER trial Mads Krogsgaard Thomsen EVP and Chief Science Officer
Slide 7: Victoza significantly reduced the risk of diabetic kidney disease progression in LEADER
EASD 2016 investor and analyst event Slide 7 Victoza® significantly reduced the risk of diabetic kidney disease progression in the LEADER trial The risk of nephropathy was significantly The reduction in nephropathy is driven by 26% reduced by 22% in the LEADER trial less occurrence of macroalbuminur
Slide 8: Lower urinary albumin-creatinine ratio across subgroups with Victoza vs placebo
EASD 2016 investor and analyst event Slide 8 Lower levels of urinary albumin-creatinine ratio observed across subgroups with Victoza® vs placebo in LEADER trial Observations consistent across subgroups with different levels of renal impairment Key results Estimated treatment ratio [95% CI] • Statist
Slide 9: SUSTAIN 5 results
EASD 2016 investor and analyst event Slide 9 SUSTAIN 5 results Mads Krogsgaard Thomsen EVP and Chief Science Officer
Slide 10: SUSTAIN 5 trial design and baseline characteristics
EASD 2016 investor and analyst event Slide 10 The SUSTAIN 5 trial evaluated the efficacy and safety of once-weekly semaglutide versus placebo SUSTAIN 5 trial design Baseline characteristics Sema Sema Placebo 0.5 mg 1.0 mg Basal insulin + sema 0.5 mg QW Mean age (years) 59.1 58.5 58.8 397 people Basa
Slide 11: Semaglutide showed superior HbA1c and weight reduction vs placebo in SUSTAIN 5
EASD 2016 investor and analyst event Slide 11 Semaglutide showed superior HbA1c and weight reduction compared to placebo in the SUSTAIN 5 trial Statistically significantly greater reduction Statistically significantly greater weight loss in HbA1c with semaglutide with semaglutide Sema 1.0 mg Sema 0.
Slide 12: SUSTAIN 6 results
EASD 2016 investor and analyst event Slide 12 SUSTAIN 6 results Mads Krogsgaard Thomsen EVP and Chief Science Officer
Slide 13: SUSTAIN 6 trial designed to demonstrate no increased CV risk
EASD 2016 investor and analyst event Slide 13 SUSTAIN 6 trial designed to demonstrate no increased risk of major CV events of semaglutide compared to placebo SUSTAIN 6 trial design Baseline characteristics Sema Placebo Semaglutide 0.5 mg Mean age (years) 64.7 64.6 3,297 people Mean diabetes duration
Slide 14: Semaglutide significantly reduced risk of major cardiovascular events in SUSTAIN 6
EASD 2016 investor and analyst event Slide 14 Semaglutide significantly reduced the risk of major cardiovascular events in the SUSTAIN 6 trial Semaglutide demonstrated 26% reduction in composite CV outcome compared with placebo Key results semaglutide placebo • Non-inferiority of semaglutide compare
Slide 15: MACE risk reduction driven by non-fatal MI and non-fatal stroke
EASD 2016 investor and analyst event Slide 15 The MACE risk reduction was driven by non-fatal MI and non-fatal stroke in the SUSTAIN 6 trial Non-fatal Cardiovascular death myocardial infarction Non-fatal stroke semaglutide placebo Patients with an event (%)1 5 5 5 HR = 0.98 HR = 0.74 HR = 0.61 95% C
Slide 16: No significant differences in all-cause death and heart failure hospitalisation
EASD 2016 investor and analyst event Slide 16 No significant differences in risk of all-cause-death and hospitalisation for heart failure with sema in SUSTAIN 6 No significant difference in the risk of No significant difference in the risk of patients all-cause-death being hospitalised for heart fai
Slide 17: Greater weight loss and lower HbA1c sustained with semaglutide in SUSTAIN 6
EASD 2016 investor and analyst event Slide 17 Greater weight loss and lower HbA1c levels sustained with semaglutide compared to placebo in the SUSTAIN 6 trial Lower HbA1c levels maintained for Statistically significantly greater weight loss semaglutide throughout the trial period was sustained with
Slide 18: Semaglutide reduced nephropathy risk but increased retinopathy complications
EASD 2016 investor and analyst event Slide 18 Semaglutide reduced the risk of nephropathy but increased risk of retinopathy complications vs placebo in SUSTAIN 6 Semaglutide-treated subjects had significantly Risk of retinopathy complications significantly lower risk of new or worsening nephropathy
Slide 19: Retinopathy exclusion in SUSTAIN 1-5 and Japan trials versus SUSTAIN 6
EASD 2016 investor and analyst event Slide 19 SUSTAIN 1-5 and trials in Japan excluded advanced retinopathy at baseline while no exclusion in SUSTAIN 6 Fewer people with retinopathy at baseline in Reported retinopathy events driven by people SUSTAIN 1-5 and JP trials vs SUSTAIN 6 with pre-existing r
Slide 20: Semaglutide appeared to have a safe and well tolerated profile in SUSTAIN 6
EASD 2016 investor and analyst event Slide 20 Semaglutide appeared to have a safe and well tolerated profile in the SUSTAIN 6 trial Proportion of people with adverse events reported during the trial Safety results Sema Placebo Sema Placebo • With the exception of complications of retinopathy, Advers
Slide 21: Results from DUAL V and key regulatory milestones
EASD 2016 investor and analyst event Slide 21 Results from DUAL V and key regulatory milestones Robin Evers SVP of Global Safety, Regulatory & Medical Affairs
Slide 22: Xultophy demonstrated lower hypoglycaemia and weight gain vs insulin glargine U100 in DUAL V
EASD 2016 investor and analyst event Slide 22 Xultophy® demonstrated lower risk of hypoglycaemia and weight gain compared to insulin glargine U100 in DUAL V Significant reduction in Significant reduction in weight Lower rates of hypoglycaemia HbA1c with Xultophy® with Xultophy® with Xultophy® Change
Slide 23: Xultophy patients reached glycaemic targets with less hypos and weight gain
EASD 2016 investor and analyst event Slide 23 Xultophy® patients showed less hypos and weight gain while reaching glycaemic targets vs IGlar U100 in DUAL V Significantly more likely to achieve HbA1c<7% Around 4.5 times more likely to reach FPG<130 without hypos or weight gain with Xultophy® without
Slide 24: Several regulatory decisions expected in the next six months
EASD 2016 investor and analyst event Slide 24 Several regulatory decisions expected in the next six months Regulatory milestone Project Past 3 months Before year-end SWITCH: Variation application Tresiba® in the USA Once-weekly semaglutide USA and EU submission LEADER: Variation application Victoza®
Slide 25: Q&A session
EASD 2016 investor and analyst event Slide 25 Q&A session Mads Krogsgaard Thomsen, EVP and CSO Robin Evers, SVP of Global Safety, Regulatory & Medical Affairs
Slide 26: Investor contact information
EASD 2016 investor and analyst event Slide 26 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 Investor Relations the New York Stock Exc
Slide 27: Appendix – Glossary
EASD 2016 investor and analyst event Slide 27 Appendix – Glossary Abbreviation Meaning Abbreviation Meaning Abbreviation Meaning Area under glucose infusion AUCGIR GIR Glucose infusion rate OAD Oral anti-diabetic curve BMI Body mass index (kg/m2) GLP-1 Glucagon-like peptide-1 QD Once-daily BP Blood