Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — Technical Presentation (November 2023)
35 slides from Novo Nordisk A/s Class B's technical presentation, Nov 11, 2023
Slide 1: Novo Nordisk – a focused healthcare company
1 Investor presentation First six months of 2023 Novo Nordisk –a focused healthcare company Investor event in connection with AHA Philadelphia, 11 November 2023
Slide 2: Forward-looking statements
2 Investor event at AHA 11 November 2023 Novo Nordisk® Forward-looking statements Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the statutory Annual Report 2022 and Form 20-F, which both were filed with the SEC in February 2023 in contin
Slide 3: Agenda
3 Investor event at AHA 11 November 2023 Novo Nordisk® Agenda Introduction Daniel Bohsen SELECT Introduction to the trial Martin Holst Lange Efficacy Martin Holst Lange Safety Robin Evers Next steps Robin Evers Q&A All speakers
Slide 4: Strategic Aspirations 2025 | Highlights first nine months of 2023
4 Investor event at AHA 11 November 2023 Novo Nordisk® Strategic Aspirations 2025 | Highlights first nine months of 2023 Light blue indicates developments in Q3 2023 Progress towards zero environmental impact Further raise innovation bar for Diabetes treatment • Carbon emissions decreased by 28% vs
Slide 5: Today we focus on innovation and therapeutic focus with SELECT
5 Investor event at AHA 11 November 2023 Novo Nordisk® Today we focus on innovation and therapeutic focus with SELECT • Further raise the innovation-bar for diabetes treatment therapeutic focus • Progress towards zero environmental impact • Develop a leading portfolio of superior treatment Innovatio
Slide 6: Today’s speakers
6 Investor event at AHA 11 November 2023 Novo Nordisk® Today’s speakers Martin Holst Lange Robin Evers Executive Vice President Senior Vice President Head of Development Head of Regulatory, Safety and QA QA: Quality Assurance
Slide 7: Agenda
7 Investor event at AHA 11 November 2023 Novo Nordisk® Agenda Introduction Daniel Bohsen SELECT Introduction to the trial Martin Holst Lange Efficacy Martin Holst Lange Safety Robin Evers Next steps Robin Evers Q&A All speakers
Slide 8: SELECT assessed semaglutide 2.4 mg for cardiovascular risk in overweight and obesity
8 Investor event at AHA 11 November 2023 Novo Nordisk® SELECT assessed semaglutide 2.4 mg for cardiovascular risk in people with overweight, obesity and established CVD There is an unmet need for weight management therapies SELECT is the largest clinical trial in Novo Nordisk’s history that also red
Slide 9: The primary objective of SELECT was to demonstrate lower incidence of MACE
9 Investor event at AHA 11 November 2023 Novo Nordisk® The primary objective of SELECT was to demonstrate that semaglutide 2.4 mg lowers the incidence of MACE To demonstrate that semaglutide sc. 2.4 mg once-weekly lowers the incidence of major adverse The primary cardiovascular events (MACE) versus
Slide 10: SELECT was designed as a double-blinded, placebo-controlled, superiority trial
10 Investor event at AHA 11 November 2023 Novo Nordisk® SELECT was designed as a double-blinded, placebo-controlled, superiority trial SELECT included 17,604 people with BMI>27 and established CVD Main inclusion criteria • Patients with overweight or obesity (BMI ≥27 kg/m2) Semaglutide 2.4 mg • Esta
Slide 11: SELECT represents the general obese population with atherosclerotic cardiovascular disease
11 Investor event at AHA 11 November 2023 Novo Nordisk® SELECT represents the general obese population with atherosclerotic cardiovascular disease across risk categories Baseline characteristics CV comorbidities at baseline Mean body Mean body Myocardial Myocardial Male / Female Male/Female Mean age
Slide 12: Agenda
12 Investor event at AHA 11 November 2023 Novo Nordisk® Agenda Introduction Daniel Bohsen SELECT Introduction to the trial Martin Holst Lange Efficacy Martin Holst Lange Safety Robin Evers Next steps Robin Evers Q&A All speakers
Slide 13: Semaglutide 2.4 mg reduced cardiovascular risk by 20% vs placebo
13 Investor event at AHA 11 November 2023 Novo Nordisk® Semaglutide 2.4 mg reduced cardiovascular risk by 20% in adults with overweight or obesity and established CVD vs placebo Time-to-event analysis for primary efficacy endpoint (MACE) Trial information 10 HR: 0.80; 95% CI: (0.72; 0.90) • Trial co
Slide 14: Beneficial effects on MACE consistent across subgroups by age and BMI
14 Investor event at AHA 11 November 2023 Novo Nordisk® Beneficial effects of semaglutide 2.4 mg on MACE were directionally consistent across prespecified patient subgroups Patient subgroup analysis by age and BMI Semaglutide 2.4mg Placebo Hazard ratio 95% CI E n E n MACE events 569 8803 701 8801 0.
Slide 15: Beneficial effects on MACE consistent across subgroups by CV comorbidities
15 Investor event at AHA 11 November 2023 Novo Nordisk® Beneficial effects of semaglutide 2.4 mg on MACE were directionally consistent across prespecified patient subgroups Patient subgroup analysis by CV comorbidities Semaglutide 2.4mg Placebo Hazard ratio 95% CI E n E n Only MI 362 5962 455 5944 0
Slide 16: All three components of the primary endpoint contributed to MACE reduction
16 Investor event at AHA 11 November 2023 Novo Nordisk® All three components of the primary endpoint contributed to the superior MACE reduction demonstrated by semaglutide 2.4 mg Time-to-event for cardiovascular death Time-to-event for non-fatal MI Time-to-event for non-fatal stroke 5 HR: 0.85; 95%
Slide 17: Reduced risk of composite HF endpoint and all-cause death
17 Investor event at AHA 11 November 2023 Novo Nordisk® In SELECT, semaglutide 2.4 mg reduced risk of the composite HF endpoint with 18% and all-cause death with 19% vs placebo Time-to-event for composite heart failure Time-to-event for all-cause death Secondary Confirmatory Endpoints 8 HR: 0.82; 95
Slide 18: Beneficial effects directionally consistent across cardiovascular events
18 Investor event at AHA 11 November 2023 Novo Nordisk® Beneficial effects of semaglutide 2.4 mg were directionally consistent across cardiovascular events Primary and secondary cardiovascular time-to-event clinical endpoints Semaglutide 2.4 mg Placebo Hazard ratio 95% CI n % n % Primary MACE endpoi
Slide 19: SELECT establishes semaglutide as the only anti-obesity medication with proven CV benefits
19 Investor event at AHA 11 November 2023 Novo Nordisk® SELECT establishes semaglutide 2.4 mg as the only anti-obesity medication with proven cardiovascular benefits SELECT met the primary endpoint: 20% risk reduction in major adverse cardiovascular outcomes demonstrated with semaglutide 2.4 mg vs p
Slide 20: Sustained weight loss over the course of the trial
20 Investor event at AHA 11 November 2023 Novo Nordisk® The SELECT trial showed that patients on semaglutide 2.4 mg had sustained weight-loss over the course of the trial Observed change in weight from baseline by month SELECT underlines the durability of weight loss 0 • In the SELECT trial, patient
Slide 21: Higher proportion of pre-diabetic patients returned to normoglycemia vs placebo
21 Investor event at AHA 11 November 2023 Novo Nordisk® In SELECT, a higher proportion of pre-diabetic patients on semaglutide 2.4 mg returned to normoglycemia vs placebo More patients reached normoglycaemia with semaglutide 2.4 mg Glycaemic control with semaglutide 2.4 mg Semaglutide 2.4 mg Placebo
Slide 22: In SELECT, reduced cardiovascular risk factors
22 Investor event at AHA 11 November 2023 Novo Nordisk® In SELECT, semaglutide 2.4 mg reduced cardiovascular risk factors Change in systolic blood pressure Change in blood lipids Change in hsCRP 0 0 –2.1 –2.77 Total cholesterol Relative mean change in hsCRP (%) -0.5 (-3.37, -2.16) -1 -10 Mean change
Slide 23: 22% risk reduction of chronic kidney disease progression and renal death
23 Investor event at AHA 11 November 2023 Novo Nordisk® In SELECT, semaglutide 2.4 mg showed a 22% risk reduction of chronic kidney disease progression and renal death First nephropathy outcome Chronic kidney disease progression or renal death 3 HR: 0.78; 95% CI: (0.63; 0.96) • Further, the FLOW kid
Slide 24: Agenda
24 Investor event at AHA 11 November 2023 Novo Nordisk® Agenda Introduction Daniel Bohsen SELECT Introduction to the trial Martin Holst Lange Efficacy Martin Holst Lange Safety Robin Evers Next steps Robin Evers Q&A All speakers
Slide 25: SELECT is the largest trial completed and adds to safety data on semaglutide
25 Investor event at AHA 11 November 2023 Novo Nordisk® SELECT is the largest trial ever completed in Novo Nordisk and adds to the totality of safety data on semaglutide Magnitude of safety data collection + 14,000 SAEs +74,000 follow-up visits 6,632 adjudicated events + 6,000,000 lab values + 10,00
Slide 26: Fewer serious adverse events reported in the semaglutide arm
26 Investor event at AHA 11 November 2023 Novo Nordisk® Fewer serious adverse events were reported in the semaglutide 2.4 mg arm compared to placebo Semaglutide Placebo P value (n = 8,803) (n = 8,801) n % n % Serious adverse events1,2 2,941 33.4 3,204 36.4 <0.001 Cardiac disorders 1,008 11.5 1,184 1
Slide 27: No unexpected findings in adverse events of special interest
27 Investor event at AHA 11 November 2023 Novo Nordisk® There were no unexpected findings in pre-specified adverse events of special interest evaluated in SELECT Semaglutide Placebo P value (n = 8,803) (n = 8,801) n % n % Prespecified adverse events of special interest, irrespective of seriousness1,
Slide 28: No causal association with thyroid cancer or suicidal ideation
28 Investor event at AHA 11 November 2023 Novo Nordisk® SELECT safety data supports lack of causal association between use of semaglutide and thyroid cancer or suicidal ideation Semaglutide Placebo P value (n = 8,803) (n = 8,801) Other serious adverse events n % n % Malignant neoplasms 422 4.8 418 4
Slide 29: Higher discontinuation rate driven by gastrointestinal events
29 Investor event at AHA 11 November 2023 Novo Nordisk® Higher permanent discontinuation rate in the semaglutide 2.4 mg arm was driven by gastrointestinal events Semaglutide Placebo P value (n = 8,803) (n = 8,801) n % n % Adverse events leading to permanent 1,461 16.6 718 8.2 <0.001 discontinuation
Slide 30: Safe and well-tolerated profile in line with previous semaglutide trials
30 Investor event at AHA 11 November 2023 Novo Nordisk® In SELECT, semaglutide 2.4 mg appeared to have a safe and well- tolerated profile in line with previous semaglutide trials Serious adverse events were reported by a lower proportion of subjects in the semaglutide sc 2.4 mg group versus placebo
Slide 31: Agenda
31 Investor event at AHA 11 November 2023 Novo Nordisk® Agenda Introduction Daniel Bohsen SELECT Introduction to the trial Martin Holst Lange Efficacy Martin Holst Lange Safety Robin Evers Next steps Robin Evers Q&A All speakers
Slide 32: SELECT has been filed for regulatory review in the US and EMA
32 Investor event at AHA 11 November 2023 Novo Nordisk® SELECT has been filed for regulatory review in the US and EMA SELECT trial with 17,604 people with BMI>27 and established CVD Next steps: Semaglutide 2.4 mg • SELECT submitted to FDA (September 2023) and EMA (October 2023) for a label expansion
Slide 33: Closing remarks
33 Novo Nordisk® Investor event at American Heart Association Closing remarks SELECT met its primary objective by demonstrating that semaglutide 2.4 mg lowers the incidence of MACE by 20% compared to placebo Beneficial effects were seen consistently across measured CV endpoints with semaglutide 2.4
Slide 34: Agenda
34 Investor event at AHA 11 November 2023 Novo Nordisk® Agenda Introduction Daniel Bohsen SELECT Introduction to the trial Martin Holst Lange Efficacy Martin Holst Lange Safety Martin Holst Lange Next steps Robin Evers Q&A All speakers
Slide 35: Investor contact information
36 Investor event at AHA 11 November 2023 Novo Nordisk® Investor contact information Share information Investor Relations contacts Novo Nordisk’s B shares are listed on the stock exchange in Copenhagen Novo Nordisk A/S under the symbol ‘NOVO B’. Its ADRs are listed on the New York Stock Investor Rel
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