Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — Novo Nordisk investor event in connection with ADA 2023
48 slides from Novo Nordisk A/s Class B's conference presentation, Jun 25, 2023
Slide 1: Novo Nordisk – a focused healthcare company
1 Investor presentation Novo Nordisk –a focused healthcare company Novo Nordisk investor event in connection with ADA Erik Hageman (on the right) is one of Denmark’s longest-living people with type 1 diabetes, pictured here with his son Lars, who also has type 1 diabetes, and his grandchildren (from
Slide 2: Forward-looking statements
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 continuation of the publication of this Annual Report 2022, t
Slide 3: Strategic Aspirations 2025 | Highlights first three months 2023
Strategic Aspirations 2025 | Highlights first three months 2023 Progress towards zero environmental impact Further raise innovation bar for Diabetes treatment • Regulatory submission of once-weekly insulin icodec • Carbon emissions decreased by 21% vs Q1 20191 • Completion of phase 3 trial PIONEER P
Slide 4: Strategic Aspirations 2025 | Today with emphasis on Innovation and therapeutic focus
Strategic Aspirations 2025 | Today with emphasis on Innovation and therapeutic focus • Further raise the innovation-bar for diabetes treatment therapeutic focus • Progress towards zero environmental impact • Develop a leading portfolio of superior treatment Innovation and solutions for obesity susta
Slide 5: Today's speakers
Today’s speakers Martin Holst Lange Stephen Charles Langford Gough Executive Vice President and Senior Vice President and Head of Development Global Chief Medical Officer
Slide 6: Agenda
Agenda Introduction Daniel Bohsen & Martin Holst Lange Insulin Insulin Icodec Stephen Gough GLP-1 in diabetes CagriSema in diabetes Martin Holst Lange Oral semaglutide in diabetes Stephen Gough GLP-1 in obesity Oral semaglutide in obesity Stephen Gough Semaglutide 2.4 mg: STEP HFpEF Martin Holst Lan
Slide 7: Since ADA 2022, progress has been made across the Novo Nordisk pipeline
Since ADA 2022, progress has been made across the Novo Nordisk pipeline FHD with cell therapy Higher doses in heart failure and injectable sema Parkinson’s disease ph. 2 initiation Sogroya® Concizumab ph. 3 US approval Acquisition of completion Ph. 1 trials initiated Forma in NASH utilising the Oral
Slide 8: Agenda
Agenda Introduction Daniel Bohsen & Martin Holst Lange Insulin Insulin Icodec Stephen Gough GLP-1 in diabetes CagriSema in diabetes Martin Holst Lange Oral semaglutide in diabetes Stephen Gough GLP-1 in obesity Oral semaglutide in obesity Stephen Gough Semaglutide 2.4 mg: STEP HFpEF Martin Holst Lan
Slide 9: Diabetes is a serious chronic disease requiring treatment intensification over time
Diabetes is a serious chronic disease requiring treatment intensification over time Diabetes is associated with multiple Despite many new treatment options, The burden of treatment may be a barrier comorbidities many patients eventually need insulin for good glycaemic control Macrovascular • Include
Slide 10: Once-weekly insulin icodec effective and safe in phase 3 ONWARDS programme
Once-weekly insulin icodec appeared to be effective and to have a safe profile in the phase 3 ONWARDS programme ONWARDS 1 ONWARDS 3 ONWARDS 5 ONWARDS 2 ONWARDS 4 ONWARDS 6 BASAL INITIATION BASAL INITIATION BASAL INITIATION BASAL SWITCH BASAL/BOLUS SWITCH BASAL/BOLUS SWITCH Trial duration (weeks) 522
Slide 11: ONWARDS 1 compared insulin icodec with insulin glargine U100 in T2D
ONWARDS 1 compared insulin icodec with insulin glargine U100 in people with T2D initiating basal insulin ONWARDS 1 enrolled 984 patients with Type 2 Diabetes Objective: • To confirm the efficacy and safety of once-weekly insulin icodec in insulin-naïve patients with type 2 diabetes Primary endpoint:
Slide 12: Once-weekly insulin icodec showed HbA1c reduction of -1.55% after 78 weeks
Once-weekly insulin icodec showed HbA1c reduction of -1.55% after 78 weeks of treatment in phase 3 trial ONWARDS 1 Greater reduction in HbA1c after 78 weeks with insulin icodec Overall hypoglycaemia in the trial Mean baseline HbA1c : 8.5% 0.0 Once-weekly insulin Once-daily insulin On treatment icode
Slide 13: More patients on insulin icodec reached HbA1c target without hypoglycaemia
In the trial, more patients on insulin icodec reached HbA1c target without hypoglycaemia and a longer TIR vs insulin glargine U100 Achievement of HbA1c target after 78 weeks without hypoglycaemia1 Statistically significantly longer TIR for insulin icodec vs insulin glargine U100 measured with CGM fr
Slide 14: ONWARDS 5 included real-world elements
ONWARDS 5 included real-world elements and compared once- weekly insulin icodec with once-daily basal insulins in T2D Objective: Onwards 5 enrolled 1085 patients with Type 2 Diabetes • To confirm the efficacy of HbA1c and safety of insulin icodec with a dosing guide app providing dosing recommendati
Slide 15: Insulin icodec showed superior HbA1c reduction vs daily basal insulin analogues
In the trial, insulin icodec appeared to have a safe profile and showed superior HbA1c reduction vs daily basal insulin analogues Superior reduction in HbA1c from baseline to 52 weeks Overall hypoglycaemia in the trial Mean baseline HbA1c : 8.9% 0.0 Once-weekly insulin Once-daily basal insulin On tr
Slide 16: Insulin icodec showed superiority in patient reported outcomes in ONWARDS 5
Insulin icodec showed superiority in both patient reported outcomes endpoints vs daily basal insulins in ONWARDS 5 DTSQ total treatment score: Health-related quality of life questionnaire TRIM-D compliance domain score: Compliance questionnaire Treatment satisfaction score: 1-6 Treatment satisfactio
Slide 17: Insulin icodec has the potential to reduce treatment burden
Insulin icodec has the potential to reduce treatment burden for both insulin naïve people or those switching from a daily basal Icodec has the potential to reduce treatment burden Icodec titration scheme in type 2 diabetes Once daily Once-weekly basal insulin insulin icodec Single Starting Dose Naïv
Slide 18: Insulin: Key take-aways
Insulin: Key take-aways Despite many new treatment options, many patients eventually need insulin treatment The burden of treatment and daily injections can be a barrier for good glycaemic control Insulin icodec appears to have a superior efficacy profile with added weekly convenience and a low rate
Slide 19: Agenda
Agenda Introduction Daniel Bohsen & Martin Holst Lange Insulin Insulin Icodec Stephen Gough GLP-1 in diabetes CagriSema in diabetes Martin Holst Lange Oral semaglutide in diabetes Stephen Gough GLP-1 in obesity Oral semaglutide in obesity Stephen Gough Semaglutide 2.4 mg: STEP HFpEF Martin Holst Lan
Slide 20: GLP-1 RAs have proven positive effects beyond glycaemic control in T2D
GLP-1 RAs have proven positive effects beyond glycaemic control in T2D and may hold further potential Proven GLP-1 RA effects in T2D Glycaemic control Weight loss CV risk reduction Hypothesized GLP-1 RA effects Chronic kidney disease Alzheimer’s disease Metabolic liver syndrome Peripheral artery dis
Slide 21: GLP-1 RAs recommended as first line treatment for T2D with established ASCVD
GLP-1 RAs recommended as first line treatment for people with T2D with established ASCVD or with multiple CV risk factors Updated ADA/EASD diabetes treatment guidelines Lifestyle management Goal: Cardiorenal risk reduction in high-risk T2D patients (on top of CV SoC) Goal: HbA1c and weight managemen
Slide 22: Phase 2 trial for CagriSema in type 2 diabetes completed
Phase 2 trial for CagriSema in people with type 2 diabetes was successfully completed in Q3 2022 Exploratory phase 2a trial of CagriSema in 92 patients with T2D Objective: • To compare the efficacy and safety of CagriSema vs its individual components in patients with T2D Primary endpoint: Cagrilinti
Slide 23: CagriSema mean HbA1c reduction of -2.18 %-points
Mean HbA1c reduction from baseline was -2.18 %-points and 89% reached HbA1c target when treated with CagriSema Higher HbA1c reduction with CagriSema compared to monocomponents Achievement of HbA1c target <7.0% after 32 weeks Mean baseline HbA1c: 8.4% 100 0.0 89% Change in HbA1c (%-points) 80 69% -0.
Slide 24: With CagriSema, time in range reached ~90% at week 32
With CagriSema, time in range reached ~90% at week 32 and mean glucose levels decreased by ~64 mg/dL Longer time in range for CagriSema vs semaglutide and cagrilintide Time in range CagriSema Semaglutide Cagrilintide • Time in range goes “beyond” HbA1c for detailed 1.5% 5.5% 8.8% 8.7% 10.0% insights
Slide 25: CagriSema mean weight loss of -15.6%
Mean weight loss was -15.6% and more than half of patients achieved ≥15% weight loss when treated with CagriSema Higher body weight reduction with CagriSema compared to semaglutide Categorical weight loss after 32 weeks of treatment and cagrilintide alone Mean baseline body weight: 105.7 kg 100 0 Ch
Slide 26: CagriSema appeared to have a safe and well-tolerated profile
In the phase 2 trial, CagriSema appeared to have a safe and well- tolerated profile CagriSema 2.4 mg Semaglutide 2.4 mg Cagrilintide 2.4 mg (n = 31) (n = 31) (n = 30) n % n % n % AEs 21 67.7 22 71.0 24 80.0 Severity of AEs Mild 18 58.1 13 41.9 20 66.7 Moderate 14 45.2 16 51.6 13 43.3 Severe 0 0.0 1
Slide 27: Phase 3 trial programme REIMAGINE expected to initiate in H2 2023
Phase 3 trial programme in type 2 diabetes, REIMAGINE, expected to initiate in second half of 2023 CagriSema characteristics Global phase 3 trial programme REIMAGINE 1 • 180 patients with T2D vs placebo • 40-week vs. placebo • Primary endpoint: HbA1c CagriSema is a fixed dose REIMAGINE 2 • 2700 pati
Slide 28: PIONEER PLUS with oral semaglutide in T2D completed
PIONEER PLUS with oral semaglutide in people with type 2 diabetes was successfully completed in Q2 2023 PIONEER PLUS enrolled 1606 patients with T2D Objective: • To compare the safety and efficacy of once daily oral semaglutide 25 mg and 50 mg with oral semaglutide 14 mg in people with T2D Oral sema
Slide 29: Oral semaglutide 25 and 50 mg superior HbA1c reduction vs 14 mg
Oral semaglutide 25 and 50 mg demonstrated statistically significant and superior reduction in HbA1C compared to 14 mg Superior reduction in HbA1c from baseline to 52 weeks Achievement of HbA1c target <7.0% after 52 weeks Mean baseline HbA1c: 9.0% 0.0 100 -0.4 Change in HbA1c (%-points) 80 74.2% % o
Slide 30: Oral semaglutide 25 and 50 mg higher weight loss vs 14 mg
Oral semaglutide 25 and 50 mg demonstrated statistically significant higher weight loss vs 14 mg in the PIONEER plus trial Higher body weight reduction with oral semaglutide 25 mg Categorical weight loss after 52 weeks of treatment and 50 mg compared to 14 mg Mean baseline body weight: 96.4kg 100 0.
Slide 31: Safety profile of oral semaglutide 25 and 50 mg
The safety profile of oral semaglutide 25 and 50 mg was generally consistent with the GLP-1 receptor agonist drug class Oral semaglutide Oral semaglutide Oral semaglutide 14 mg 25 mg 50 mg (n = 534) (n = 534) (n = 534) Safety: n % n % n % • Majority of gastrointestinal adverse events were mild or mo
Slide 32: GLP-1 diabetes: Key take-aways
GLP-1 diabetes: Key take-aways: GLP-1 RA’s have demonstrated several benefits and are recommended as first line treatment for some people with T2D in international treatment guidelines In the phase 2 trial, CagriSema showed improved reduction of HbA1c and of body weight as well as longer time in ran
Slide 33: Agenda
Agenda Introduction Daniel Bohsen & Martin Holst Lange Insulin Insulin Icodec Stephen Gough GLP-1 in diabetes CagriSema in diabetes Martin Holst Lange Oral semaglutide in diabetes Stephen Gough GLP-1 in obesity Oral semaglutide in obesity Stephen Gough Semaglutide 2.4 mg: STEP HFpEF Martin Holst Lan
Slide 34: OASIS 1 with oral semaglutide 50 mg in overweight or obesity completed
OASIS 1 with oral semaglutide 50 mg in people with overweight or obesity has been successfully completed OASIS 1 enrolled 667 patients with overweight or obesity Objective: • To compare the safety and efficacy of 50 mg oral semaglutide with placebo in people with overweight or obesity without T2D Co
Slide 35: Oral semaglutide 50 mg superior body weight reduction in OASIS 1
Oral semaglutide 50 mg in overweight or obesity demonstrated superior body weight reduction in the OASIS 1 trial vs placebo OASIS 1 showed significantly greater weight loss compared to placebo Categorical weight loss % at week 68 Mean baseline body weight: 105.4kg 0 100 89.2 -1.8 -3 Change in body w
Slide 36: Safety profile of oral semaglutide 50 mg
The safety profile of oral semaglutide 50 mg was generally consistent with the GLP-1 receptor agonist drug class Oral semaglutide Placebo 50 mg Safety: (n = 333) (n = 334) • Majority of gastrointestinal adverse events were mild or n % n % moderate in severity AEs • The majority occurred during dose
Slide 37: Phase 3 trial programme for oral semaglutide 50 mg, OASIS
Phase 3 trial programme for oral semaglutide 50 mg in overweight or obesity, OASIS Oral semaglutide characteristics Focused phase 3 trial programme OASIS 1 • 667 patients 50 mg dose • 68 week Oral semaglutide 50mg: • Primary endpoint: BW % • Semaglutide tablets in overweight or obesity OASIS 2 • 198
Slide 38: Obesity is associated with multiple comorbidities
Obesity is associated with multiple comorbidities, which may be improved with weight management Life expectancy decreases as BMI increases1 Obesity related comorbidities2 Normal BMI Mental Metabolic • Depression • NAFLD Almost 80% chance of reaching age 70 • Anxiety • Gallstones • Infertility • Type
Slide 39: HFpEF comprises ~50% of all HF cases, ~80% live with overweight or obesity
HFpEF compromises ~50% of all HF cases, and ~80% of HFpEF patients live with overweight or obesity Heart failure with preserved ejection fraction Patients with HFpEF are under a great burden3 Higher mortality rate • Impaired filling capacity Higher risk of hospitalisation • Stiff and thick ventricle
Slide 40: Phase 3 trial STEP HFpEF with semaglutide 2.4 mg completed
Phase 3 trial STEP HFpEF with semaglutide 2.4 mg has been successfully completed in Q2 2023 STEP HFpEF trial with 529 people with obesity and HFpEF STEP HFpEF Objective: • Evaluate the effect on HF specific symptoms, physical function and body weight compared with placebo Dual primary endpoints: Sem
Slide 41: KCCQ was primary endpoint in the STEP HFpEF trial
The Kansas City Cardiomyopathy Questionnaire, a patient reported outcome, was primary endpoint in the STEP HFpEF trial Kansas City Cardiomyopathy Questionnaire1 Function Quality of Disease Symptoms limitations life Symptom domains Functional limitation domains Quality of life domain Symptom Symptom
Slide 42: Semaglutide 2.4 mg superior improvement on KCCQ-CSS vs placebo
Semaglutide 2.4 mg demonstrated superior improvement on the primary endpoint of KCCQ-CSS vs placebo Superior improvement in KCCQ-CSS score in patients treated with semaglutide 2.4 mg Key highlights Mean baseline KCCQ-CSS score: 56.7 Primary endpoints: 20 • KCCQ-CSS estimated treatment difference bet
Slide 43: Semaglutide 2.4 mg superior body weight reduction vs placebo
Semaglutide 2.4 mg demonstrated superior reduction on the other primary endpoint of body weight vs placebo Clinically relevant and sustained weight loss in patients treated with Key highlights semaglutide 2.4 mg Mean baseline body weight: 108.4 kg 0 Primary endpoint: -2.6 • Estimated treatment diffe
Slide 44: Ongoing STEP HFpEF-DM trial to be included in regulatory submission
The ongoing STEP HFpEF-DM trial is to be included in the regulatory submission STEP HFpEF-DM trial with 610 people with obesity, HFpEF and T2D Trial design and next steps Dual primary endpoints: • Change in KCCQ from baseline to week 52 • Change in body weight from baseline to week 52 Inclusion crit
Slide 45: GLP-1 obesity: Key take-aways
GLP-1 obesity: Key take-aways: In OASIS 1, oral semaglaglutide 50 mg showed efficacy broadly on par with injectable semaglutide 2.4 mg A high unmeet need exists within obesity-related HFpEF Semaglutide 2.4 mg demonstrated superiority on the dual primary endpoint vs placebo in the STEP HFpEF trial
Slide 46: Strategic aspirations 2025
Strategic aspirations 2025 • Further raise the innovation-bar for diabetes treatment therapeutic focus • Progress towards zero environmental impact • Develop a leading portfolio of superior treatment Innovation and solutions for obesity sustainability • Being respected for adding value to society Pu
Slide 47: Agenda
Agenda Introduction Daniel Bohsen & Martin Holst Lange Insulin Insulin Icodec Stephen Gough GLP-1 in diabetes CagriSema in diabetes Martin Holst Lange Oral semaglutide in diabetes Stephen Gough GLP-1 in obesity Oral semaglutide in obesity Stephen Gough Semaglutide 2.4 mg: STEP HFpEF Martin Holst Lan
Slide 48: Investor contact information
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 Relations Exchange under the symbol ‘NVO’. Novo Alle 1 DK-2
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