Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — ADA 2019
36 slides from Novo Nordisk A/s Class B's conference presentation, June 2019
Slide 1: Investor presentation ADA 2019
Slide 1 Investor presentation ADA 2019
Slide 2: Agenda
Investor presentation ADA 2019 Slide 2 Agenda CV aspects of GLP-1s and clinical developments with Ozempic® PIONEER highlights Driving innovation in insulin Obesity and NASH pipeline The increasing focus on Real-World Evidence Regulatory update
Slide 3: Forward-looking statements
Investor presentation ADA 2019 Slide 3 Forward-looking statements Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this presentation as well as the company’s statutory Annual Report 2018 and Form 20-F, which were both filed with the SEC in
Slide 4: Ozempic now launched in 21 countries and continues to gain market share in the USA
Investor presentation ADA 2019 Slide 4 Ozempic® now launched in 21 countries and continues to gain market shares in the USA USA GLP-1 NBRx market share USA GLP-1 volume market share NN GLP-1 Victoza® Ozempic® dulaglutide NN GLP-1 dulaglutide Weekly Monthly NBRx share exenatide albiglutide Victoza® e
Slide 5: Progress on several projects since ADA last year
Investor presentation ADA 2019 Slide 5 Progress on several projects since ADA last year June 2018 June 2019 Bridging PIONEER 5, Ziylo acquisition PIONEER 9 DUAL VIII US filing of oral AM833 strategy for 8 and 10 for accelerating and 6 completed for semaglutide and phase 2 semaglutide results glucose
Slide 6: GLP-1s have positive effects beyond glycaemic control and guidelines updated
Investor presentation ADA 2019 Slide 6 GLP-1s have positive effects beyond glycaemic control and treatment guidelines have been updated to particularly reflect the CV risk benefits ADA/EASD diabetes treatment guidelines for second- The multifactorial effects of GLP-1s line treatment with established
Slide 7: Key inclusion criteria defining established CVD differ between GLP-1 CVOTs
Investor presentation ADA 2019 Slide 7 Key inclusion criteria defining established CVD differ between GLP-1 CVOTs but trial populations are more comparable with aligned definitions Key inclusion criteria defining established Trial population based on cardiovascular disease across selected CVOTs prev
Slide 8: Comparison of post-hoc analyses of SUSTAIN 6, LEADER and REWIND
Investor presentation ADA 2019 Slide 8 Comparison of post-hoc analyses of SUSTAIN 6, LEADER and REWIND for prior and no prior MI/stroke subgroups Prior No. events* Hazard ratio Outcome Interaction MI/stroke Sema Pbo (95% CI) p-value SUSTAIN 6 With 66 88 0.76 (0.55 ; 1.05) 3-point MACE 0.75 Without 4
Slide 9: The FLOW trial is the first dedicated GLP-1 renal outcomes trial
Investor presentation ADA 2019 Slide 9 The FLOW trial is the first dedicated GLP-1 renal outcomes trial to demonstrate that semaglutide delays renal impairment End-stage renal disease (ESRD) often results in chronic dialysis treatment or kidney transplantation1 FLOW trial design Semaglutide 1.0 mg R
Slide 10: The FOCUS trial will evaluate semaglutide vs placebo in diabetic retinopathy
Investor presentation ADA 2019 Slide 10 The FOCUS trial will evaluate long-term effects of semaglutide vs placebo regarding diabetic retinopathy Poor glucose control causes damage to blood vessels which can lead to diabetic retinopathy FOCUS trial design Healthy eye Diabetic eye Antidiabetic SOC + s
Slide 11: SUSTAIN FORTE will evaluate high-dose semaglutide in type 2 diabetes
Investor presentation ADA 2019 Slide 11 SUSTAIN FORTE will evaluate high-dose semaglutide in type 2 diabetes and is expected to conclude by end of 2020 SUSTAIN FORTE trial design Key SUSTAIN FORTE trial inclusion criteria Semaglutide 2.0 mg Randomised: 964 patients with type 2 diabetes Semaglutide 1
Slide 12: Progress on several projects since ADA last year
Investor presentation ADA 2019 Slide 12 Progress on several projects since ADA last year June 2018 June 2019 Bridging PIONEER Ziylo acquisition PIONEER 9 DUAL VIII US filing of oral AM833 strategy for 5, 8 and 10 for accelerating and 6 completed for semaglutide and phase 2 semaglutide results glucos
Slide 13: An overview of the PIONEER programme
Investor presentation ADA 2019 Slide 13 An overview of the PIONEER programme Diet and OAD Insulin users Special exercise populations PIONEER 1 PIONEER 2 PIONEER 8 PIONEER 5 vs SGLT-2 Renal impairment (Met) (± Met, ± SU, or ± insulin) vs placebo Add-on to insulin (Diet and exercise) PIONEER 3 (Insuli
Slide 14: PIONEER programme showed consistent reductions in HbA1c and body weight
Investor presentation ADA 2019 Slide 14 The PIONEER programme showed consistent statistically significant reductions in HbA1c and body weight Oral semaglutide lowered HbA1c by 1.0–1.8%- Oral semaglutide lowered body weight by points by end of trial1 ~2–5 kg by end of trial1 Mean change in HbA1c (%-p
Slide 15: The PIONEER 6 trial investigated cardiovascular safety of oral semaglutide
Investor presentation ADA 2019 Slide 15 The PIONEER 6 trial investigated cardiovascular safety of oral semaglutide vs placebo PIONEER 6 trial design PIONEER 6 headline results Oral semaglutide 14 mg + standard • 21% non-significant reduction of Randomised: of care primary endpoint1 for oral semaglut
Slide 16: The SOUL trial will provide evidence on CV benefits of oral semaglutide
Investor presentation ADA 2019 Slide 16 The SOUL trial will provide robust evidence on the cardiovascular benefits of oral semaglutide in people with type 2 diabetes SOUL trial design SOUL trial key inclusion criteria Oral semaglutide 14 mg + standard Randomised: of care 9,642 patients with type 2 d
Slide 17: Progress on several projects since ADA last year
Investor presentation ADA 2019 Slide 17 Progress on several projects since ADA last year June 2018 June 2019 Bridging PIONEER 5, Ziylo acquisition PIONEER 9 DUAL VIII US filing of oral AM833 strategy for 8 and 10 for accelerating and 6 completed for semaglutide and phase 2 semaglutide results glucos
Slide 18: In Dual VIII, 66% on glargine U100 required treatment intensification vs 37% on Xultophy
Investor presentation ADA 2019 Slide 18 In Dual VIII, 66% of people on glargine U100 required treatment intensification compared to 37% on Xultophy® Trial design Dual VIII - durability Time to need for treatment intensification* Probability of need for IDegLira glargine U100 “need for treatment inte
Slide 19: In Dual VIII, mean HbA1c comparable with lower insulin dose
Investor presentation ADA 2019 Slide 19 In Dual VIII, mean HbA1C was comparable for Xultophy® compared with glargine U100 but with a lower actual insulin dose Mean change in HbA1c (%-point) Actual daily insulin dose (U) IDegLira glargine U100 Actual daily IDegLira glargine U100 Mean change in total
Slide 20: In Dual VIII, lower weight gain and hypoglycaemia risk for Xultophy
Investor presentation ADA 2019 Slide 20 In Dual VIII, mean body weight gain was 1.7 kg lower for Xultophy® and with lower risk of hypoglycaemia compared with glargine U100 Severe or blood glucose confirmed symptomatic Body weight – change from baseline hypoglycaemic episodes over 104 weeks Mean chan
Slide 21: Once-weekly insulin LAI287 for patients on basal insulin
Investor presentation ADA 2019 Slide 21 Innovation and convenience for patients on basal insulin with once-weekly insulin LAI287 Rationale for a once-weekly insulin LAI287 phase 2 programme Provide an efficacious, safe and convenient once-weekly 2019 H1 2019 H2 2020 H1 alternative to once-daily basa
Slide 22: Connected insulin pen improved adherence and time in range in Swedish study
Investor presentation ADA 2019 Slide 22 Connected insulin pen resulting in improved adherence and ‘time in range’ in Swedish study More accurate data leading to better doctor- NovoPen® 6 with Glooko/Diasend® system patient conversations and treatment results 1. NovoPen® 6 2. Data 3. Data 4. HCP capt
Slide 23: Progress on several projects since ADA last year
Investor presentation ADA 2019 Slide 23 Progress on several projects since ADA last year June 2018 June 2019 Bridging PIONEER 5, Ziylo acquisition PIONEER 9 DUAL VIII US filing of oral AM833 strategy for 8 and 10 for accelerating and 6 completed for semaglutide and phase 2 semaglutide results glucos
Slide 24: Clinical projects in obesity and NASH
Investor presentation ADA 2019 Slide 24 Clinical projects in obesity and NASH Phase 1 Phase 2 Phase 3 Marketed PYY 1562 analogue Develop new GG-co-agonist biologics combined with Tri-agonist 1706 GLP-1 to achieve Obesity >20% weight PYY 1875 analogue Amylin AM833 Semaglutide obesity loss Semaglutide
Slide 25: STEP programme and SELECT CV outcomes study initiated for semaglutide in obesity
Investor presentation ADA 2019 Slide 25 The phase 3a programme STEP and the CV outcomes study SELECT were initiated in 2018 for semaglutide in obesity Semaglutide in obesity phase 3a programme, Cardiovascular outcomes study, SELECT, STEP, expected to include ~4,500 patients1 initiated for semaglutid
Slide 26: Amylin AM833 could become the next step toward >20% weight loss
Investor presentation ADA 2019 Slide 26 Amylin AM833 could become the next step in getting closer to the ambition of >20% weight loss Phase 1b amylin and semaglutide combination multiple dose trial Phase 2 dose finding trial Randomised: Cohort 5 – QW sema + QW AM833 Dose E Randomised: AM833, 4.5 mg
Slide 27: Novo Nordisk is investigating opportunities within NASH
Investor presentation ADA 2019 Slide 27 Novo Nordisk is investigating opportunities within NASH Semaglutide NASH phase 2 programme Proof of concept phase 2 combination trial design 2016 2017 2018 2019 2020 Sema 2.4 mg once weekly sc 100 NAFLD/NASH Sema 2.4 mg + FIR 20 mg once daily oral MRI-PDFF wit
Slide 28: Progress on several projects since ADA last year
Investor presentation ADA 2019 Slide 28 Progress on several projects since ADA last year June 2018 June 2019 Bridging PIONEER 5, Ziylo acquisition PIONEER 9 DUAL VIII US filing of oral AM833 strategy for 8 and 10 for accelerating and 6 completed for semaglutide and phase 2 semaglutide results glucos
Slide 29: Continued investment in post-approval trials to support real-world findings
Investor presentation ADA 2019 Slide 29 Novo Nordisk continues to invest in post-approval trials across the portfolio to support clinical findings in real-world settings • Semaglutide in patients with type 2 diabetes: real-world analysis in the Canadian LMC Diabetes Registry: the SPARE study (poster
Slide 30: ReFLeCT is a RWE trial of Tresiba for degludec naïve patients
Investor presentation ADA 2019 Slide 30 ReFLeCT is a RWE trial investigating the safety and efficacy profile of Tresiba® for degludec naïve patients with T1D/T2D ReFLeCT trial design Key ReFLeCT trial inclusion criteria N=1,267 T1D and T2D Degludec QD + standard of care patients planned to Hypo Hypo
Slide 31: ReFLeCT demonstrated lower hypoglycaemia risk and improved quality of life with Tresiba
Investor presentation ADA 2019 Slide 31 ReFLeCT demonstrated lower hypoglycaemia risk-profile of Tresiba® as well as increased quality of life vs other basal insulins Significant reduction of all types of hypoglycaemic events Patients’ treatment satisfaction and quality of life Observed treatment di
Slide 32: Progress on several projects since ADA last year
Investor presentation ADA 2019 Slide 32 Progress on several projects since ADA last year June 2018 June 2019 Bridging PIONEER 5, Ziylo acquisition PIONEER 9 DUAL VIII US filing of oral AM833 strategy for 8 and 10 for accelerating and 6 completed for semaglutide phase 2 semaglutide results glucose re
Slide 33: Oral semaglutide filed in the USA, EU and Canada; Ozempic CV indication filed
Investor presentation ADA 2019 Slide 33 Oral semaglutide filed in the USA, the EU and Canada, and Ozempic® CV risk reduction indication filed in the USA Expected timelines for the FDA review Oral semaglutide filed in key markets Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Three FDA filings: • NDA for or
Slide 34: R&D milestones in 2019
Investor presentation ADA 2019 Slide 34 R&D milestones in 2019 Clinical milestones1 Regulatory milestones1 Project Q1 2019 Q2 2019 Q3 2019 Q4 2019 Phase 3b results Tresiba® ✓ (vs glargine U300) ✓ Ryzodeg® CN regulatory decision ✓ US submission FOCUS trial initiation (OT ) ✓ 2 FLOW trial initiation O
Slide 35: Investor contact information
Investor presentation ADA 2019 Slide 35 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 Exchange
Slide 36: References and notes for slide 6
Investor presentation ADA 2019 Slide 36 References and notes for slide 6 1 Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus *Proven CVD benefit means it has label indication of reducing CVD Report by the American Diabetes Association (ADA) and the European events. For GLP-1 stronges