Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — Investor Day (June 2020)
43 slides from Novo Nordisk A/s Class B's investor day presentation, Jun 19, 2020
Slide 1: R&D investor presentation 19 June 2020
R&D investor presentation 19 June 2020
Slide 2: Agenda
R&D investor presentation 2 Agenda Introduction Karsten Munk Knudsen, CFO Once-weekly insulin Martin Lange, SVP, Global Development Non-alcoholic steatohepatitis Martin Lange, SVP, Global Development Cardiovascular disease Marcus Schindler, SVP, Global Drug Discovery Obesity Mads Krogsgaard Thomsen,
Slide 3: Forward-looking statements
R&D investor presentation 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 2019 and Form 20-F, which are both expected to be filed with the SEC
Slide 4: Strategic aspirations 2025
R&D investor presentation 4 Strategic aspirations 2025 • Further raise the innovation-bar for diabetes treatment • Being respected for adding value to society • Develop a leading portfolio of superior treatment therapeutic focus solutions for obesity Innovation and • Progress towards zero environmen
Slide 5: Current COVID-19 status
R&D investor presentation 5 Current COVID-19 status Novo Nordisk status across the value chain Gradual ‘return to normal’ across regions • All manufacturing sites operating • China approaching pre COVID-19 Production • Medicines available to patients worldwide • EMEA and RoW cautiously opening up •
Slide 6: US NBRx data show early signs of recovery
R&D investor presentation Slide 6 6 US NBRx data show early signs of recovery US basal insulin NBRx count US injectable GLP-1 NBRx count US obesity NBRx count in recent 6 months in recent 6 months in recent 6 months ‘000 ‘000 ‘000 20 18 16 2.0 15.4 14 12.7 15 1.6 1.6 12 10 9.1 1.2 1.1 10 7.8 8 0.8 5
Slide 7: Early Rybelsus uptake further supports GLP-1 NBRx and TRx market leadership in the US
R&D investor presentation Slide 7 7 Early Rybelsus® uptake further supports GLP-1 NBRx and TRx market leadership in the US USA GLP-1 NBRx market share USA GLP-1 TRx market size and market share NN GLP-1 Ozempic® Rybelsus® NN GLP-1 Ozempic® Rybelsus® dulaglutide Victoza® dulaglutide Victoza® Weekly T
Slide 8: Innovation and therapeutic focus
R&D investor presentation • Further raise the innovation-bar for diabetes treatment • Develop a leading portfolio of superior treatment solutions for obesity therapeutic focus Innovation and • Strengthen and progress the Biopharm pipeline • Establish presence in other serious chronic diseases focusi
Slide 9: Icodec, a once-weekly insulin, is designed to raise the innovation-bar
R&D investor presentation 9 Icodec, a once-weekly insulin, is designed to raise the innovation-bar through better control and convenience Steady state pharmacodynamic profile of insulin The phase 2 trial compared once-weekly icodec to icodec suitable for once-weekly dosing once-daily insulin glargin
Slide 10: Icodec showed improved PPG control, HbA1c, and more patients reaching target
R&D investor presentation 10 Icodec showed improved PPG control, HbA1c, and an increased number of patients reaching target in the phase 2 trial Icodec showed statistically Numerical improvement in HbA1c The proportion of patients on icodec significant post prandial control over 26 weeks reaching Hb
Slide 11: Once-weekly insulin icodec appeared to have a similar safety profile to glargine
R&D investor presentation 11 Once-weekly insulin icodec appeared to have a similar safety profile to once-daily insulin glargine U100 in the phase 2 trial No statistically significant difference in the number of Insulin icodec appeared to have a safe profile hypoglycaemic events between icodec and g
Slide 12: Icodec displayed a similar safety profile to glargine U100 in phase 2
R&D investor presentation 12 Once-weekly insulin icodec displayed a similar safety profile to once-daily insulin glargine U100 in the phase 2 trial No statistically significant difference in the number of Insulin icodec appeared to have a safe profile hypoglycaemic events between icodec and glargine
Slide 13: The icodec phase 3 programme will aim to demonstrate superiority
R&D investor presentation 13 The icodec phase 3 programme will aim to demonstrate superiority on HbA1c and time in range Insulin icodec phase 3 Insulin icodec versus insulin Insulin icodec versus basal programme glargine analogues 970 people Icodec (open label) 1,096 people Icodec (open label) with
Slide 14: Icodec - key take aways
R&D investor presentation 14 • Once-weekly insulin icodec showed in the phase 2 trial • numerically lower HbA1c reduction compared to glargine Icodec - key take aways U100 • significantly better post-prandial glucose control • half of patients reached the HbA1c target of ≤6.5% • Icodec appeared to h
Slide 15: Innovation and therapeutic focus
R&D investor presentation • Further raise the innovation-bar for diabetes treatment • Develop a leading portfolio of superior treatment solutions for obesity therapeutic focus Innovation and • Strengthen and progress the Biopharm pipeline • Establish presence in other serious chronic diseases focusi
Slide 16: NASH is a progressive disease with no existing treatment and low diagnosis rates
R&D investor presentation 16 NASH is a progressive disease with no existing treatment and low diagnosis rates The prevalence of NASH is high, yet the number of Milestones for NASH in 2020 and 2021 treated patients is low 2018 2019 2020 2021 Phase 2b Semaglutide NASH Phase 2b F4-Sema 10% 53% 4 millio
Slide 17: The phase 2 trial investigated semaglutide in the treatment of NASH
R&D investor presentation 17 The phase 2 trial investigated semaglutide in the treatment of NASH Semaglutide NASH phase 2 trial design Baseline characteristics Semaglutide 0.1 mg s.c. OD Sema Sema Sema Placebo 0.1 mg OD 0.2mg OD 0.4mg OD 320 patients Semaglutide 0.2 mg s.c. OD Number of patients 80
Slide 18: Semaglutide showed significant improvements in NASH resolution in phase 2
R&D investor presentation 18 Semaglutide showed significant improvements in NASH resolution in phase 2 and could play a key role in preventing disease progression Semaglutide showed resolution of NASH with no Key take-aways worsening of fibrosis versus placebo in the phase 2 trial1 Proportion of pat
Slide 19: Semaglutide showed numerical improvements in fibrosis and fewer patients had progression
R&D investor presentation 19 Semaglutide showed numerical improvements in fibrosis and fewer patients had progression of fibrosis vs placebo in phase 2 Semaglutide showed numerical benefits in Fewer patients on semaglutide had progression improvement of fibrosis without worsening of NASH1 of fibrosi
Slide 20: Semaglutide showed encouraging phase 2 data across additional important endpoints
R&D investor presentation 20 Semaglutide showed encouraging phase 2 data across additional important endpoints which are considered relevant by regulators Regulatory guidelines on Mean change in ELF Relative mean change in liver non-invasive endpoints from baseline at 72 weeks stiffness3 at 72 weeks
Slide 21: NASH - key take aways
R&D investor presentation 21 • Semaglutide showed superior NASH resolution and fewer patients showed progression of fibrosis in the phase 2 trial NASH - key take aways • Semaglutide showed improvements in several biomarkers for fibrosis such as ELF and liver stiffness in the phase 2 trial • Future d
Slide 22: Innovation and therapeutic focus
R&D investor presentation • Further raise the innovation bar for diabetes treatment • Develop a leading portfolio of superior treatment solutions for obesity therapeutic focus Innovation and • Strengthen and progress the Biopharm pipeline • Establish presence in other serious chronic diseases focusi
Slide 23: Cardiovascular disease is an area with a large unmet need and strong strategic fit
R&D investor presentation 23 Cardiovascular disease is an area with a large unmet need and strong strategic fit with our core therapy areas OVERLAPPING PATIENT SEGMENTS IN T2D, ~510 million people live with cardiovascular disease1, which is OBESITY AND CVD1 estimated to increase to 530 million in 20
Slide 24: Novo Nordisk's ambition within cardiovascular disease
R&D investor presentation 24 Novo Nordisk’s ambition within cardiovascular disease In-licensing/acquisition of mid-stage assets At least one product launched between 2024-2028 targeting atherosclerotic cardiovascular disease or heart failure with a highly innovative, first to market product serving
Slide 25: CANTOS post-hoc analysis: MACE reduction only in patients whose IL-6 was lowered
R&D investor presentation 25 CANTOS post-hoc analysis: MACE reduction only in patients whose IL-6 was lowered below median IL1B lowering Limited IL6 Significant IL6 effect effect No CVD effect CVD risk lowering Source: Eur Heart J, Volume 39, Issue 38, 07 October 2018, Pages 3499–3507. MACE: Major a
Slide 26: IL-6 antibody is targeting inflammation-driven CVD in patients with CKD
R&D investor presentation 26 IL-6 antibody is targeting inflammation-driven CVD in patients with CKD IL-6: Interleukin 6; CVD: Cardiovascular disease; CRP:C-reactive protein
Slide 27: Acquisition of Corvidia Therapeutics supports Novo Nordisk's ambition within cardiovascular disease
R&D investor presentation 27 Acquisition of Corvidia Therapeutics supports Novo Nordisk’s ambition within cardiovascular disease Population: Estimated 5 million patients with ASCVD have CKD and inflammation with no approved therapies Target: IL-6 axis is shown to be a • Boston, USA, based company ce
Slide 28: Data from a phase 2a trial with Ziltivekimab indicate lowering of hsCRP
R&D investor presentation 28 Data from a phase 2a trial with Ziltivekimab indicate lowering of hsCRP, which is a marker for inflammation Data from a phase 2a trial in CKD stage 5 patients Trial design of ongoing phase 2b (RESCUE) with inflammation 7.5 mg Q4W (66 patients) Placebo Ziltivekimab 2 mg 6
Slide 29: CVD - key take aways
R&D investor presentation • Large unmet need in CVD with 510 million patients and 18 million annual deaths • Aspiration to have at least one product launched between 2024- 2028 targeting ASCVD or HF CVD - key take aways • Completed acquisition of mid-stage compound, Ziltivekimab, targeting ASCVD wit
Slide 30: Innovation and therapeutic focus
R&D investor presentation • Further raise the innovation-bar for diabetes treatment • Develop a leading portfolio of superior treatment solutions for obesity therapeutic focus Innovation and • Strengthen and progress the Biopharm pipeline • Establish presence in other serious chronic diseases focusi
Slide 31: The semaglutide obesity phase 3a STEP programme has completed
R&D investor presentation 31 The semaglutide obesity phase 3a STEP programme has completed Phase 3 STEP programme 2019 2020 2021 Semaglutide 2.4 mg Weight management STEP 1 Placebo n=1,961 Duration: 68 weeks ✓ Semaglutide 1 mg Weight management with T2D STEP 2 Semaglutide 2.4 mg n=1,210 Duration: 68
Slide 32: Semaglutide 2.4mg showed strong weight loss across the STEP programme
R&D investor presentation 32 Semaglutide 2.4mg showed strong weight loss across the STEP programme STEP 1 STEP 3 STEP 4 STEP 2 Weight mgmt Weight mgmt Sustained weight mgmt Weight mgmt with IBT After 68 weeks After 20 weeks with T2D Baseline 105.3 105.8 107.2 96.1 99.8 body weight Sema Placebo Sema
Slide 33: In the STEP 1 trial, people treated with semaglutide had a superior weight loss
R&D investor presentation 33 In the STEP 1 trial, people treated with semaglutide had a superior weight loss of up to 16.9% The pivotal STEP 1 trial showed greater than Data from STEP 1 16% weight loss % change in body weight 0 • Average age 46 -2 Placebo: -2.4% • 74.1% women -4 • Average BMI - 37.9
Slide 34: In STEP 1, 34.8% of patients reached ≥20% weight loss
R&D investor presentation 34 In STEP 1, 34.8% of patients treated with semaglutide reached ≥20% weight loss and reported improved quality of life versus placebo Categorical weight loss Sema 2.4 mg showed a statistically significant treatment difference versus placebo in the IWQoL-Lite-CT PRO Proport
Slide 35: In the STEP 4 trial, people on semaglutide sustained weight loss versus placebo
R&D investor presentation 35 In the STEP 4 trial, people on semaglutide sustained weight loss versus placebo and experienced a 18.2% weight loss after 68 weeks STEP 4 showed significantly greater weight loss Data from STEP 4 post run-in than placebo % change in body weight Randomisation 0 • Average
Slide 36: In STEP 4, 41.2% of patients reached ≥20% weight loss
R&D investor presentation 36 In STEP 4, 41.2% of patients treated with semaglutide reached ≥20% weight loss and reported improved quality of life versus placebo Categorical weight loss Sema 2.4 mg showed a statistically significant treatment difference versus placebo in the SF-36 patient reported ou
Slide 37: The safety profile for semaglutide in obesity was similar to other GLP-1s
R&D investor presentation 37 The safety profile for semaglutide in obesity was similar to other GLP-1s and in STEP 1, showed a similar time to 1st discontinuation Safety profile for semaglutide 2.4 mg in The time to first discontinuation1 was similar for STEP 1 – 4 appeared safe and well tolerated s
Slide 38: In the phase 2 trial, AM833 plus lifestyle intervention decreased weight by up to 10.8%
R&D investor presentation 38 In the phase 2 trial, AM833 plus lifestyle intervention decreased weight by up to 10.8% as monotherapy after 26 weeks Dose-finding phase 2 trial for AM833 Weight loss for AM833 plus lifestyle intervention2 at different doses with increased weight loss for higher doses3 P
Slide 39: AM833 and semaglutide decreases appetite via two complementary mechanisms
R&D investor presentation 39 AM833 and semaglutide decreases appetite via two complementary mechanisms Semaglutide and AM833 are distributed to specific Phase 1 trial design regions in the hypothalamus and hindbrain C6: amylin 4.5 mg OW + sema 2.4 mg OW C5: amylin 2.4 mg OW + sema 2.4 mg OW Semaglut
Slide 40: Phase 1 results for AM833 and semaglutide showed a 17% weight reduction
R&D investor presentation 40 Phase 1 results for AM833 and semaglutide showed a 17% weight reduction after only 20 weeks Weight loss for different doses of AM833 and Highlights from phase 1 semaglutide in phase 1 1 % change in body weight Mean baseline: 95.1 kg • 66% of people on AM833 + semaglutide
Slide 41: Progression of obesity pipeline supports the Obesity strategy
R&D investor presentation 41 Progression of obesity pipeline supports the Obesity strategy and our efforts in closing the treatment gap Novo Nordisk’s current pipeline Obesity – key take aways is closing the treatment gap % ILLUSTRATIVE • Finalisation of STEP programme with: 0 • Up to 17% weight los
Slide 42: We continue progressing on the strategic aspirations
R&D investor presentation 42 We continue progressing on the strategic aspirations • Once-weekly insulin progressing to phase 3 • Semaglutide showed encouraging profile in NASH • Being respected for adding value to society • Strategic expansion into CVD with acquisition of therapeutic focus Corvidia
Slide 43: Thank you for watching our R&D investor presentation
R&D investor presentation 43 Thank you for watching our R&D investor presentation • There will now be a short intermission before the Q&A session starts at 16.00 CET • Please dial in to the Q&A session now for which you have received separate dial-in details upon request • We ask you to keep the cam