Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — FY2016 Earnings Presentation
117 slides from Novo Nordisk A/s Class B's earnings presentation, Feb 2, 2017
Slide 1: Investor presentation Full year 2016
Slide 1 Investor presentation Full year 2016 Manato Ohara, diagnosed with type 1 diabetes Kanagawa, Japan
Slide 2: Agenda
Investor presentation Full year 2016 Slide 2 Agenda Highlights and key events Sales update R&D update Financials and outlook
Slide 3: Forward-looking statements
Investor presentation Full year 2016 Slide 3 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 2016 and Form 20-F, which are both filed with the SEC in February 2017 in continuation of t
Slide 4: Highlights – Full year 2016
Investor presentation Full year 2016 Slide 4 Highlights – Full year 2016 Sales development • Sales increased by 6% in local currencies and 4% in Danish kroner • North America grew by 4% in local currencies and accounted for 41% share of growth in local currencies • Latin America and Region China gre
Slide 5: Novo Nordisk’s strategic priorities build on the Novo Nordisk Way
Investor presentation Full year 2016 Slide 5 5 Novo Nordisk’s strategic priorities build on the Novo Nordisk Way Novo Nordisk strategic priorities The Novo Nordisk Way and 10 Essentials 1. We create value by having a patient centred business Expand leadership in DIABETES approach Expand leadership i
Slide 6: Driving future growth opportunities in International Operations
Investor presentation Full year 2016 Slide 6 6 Driving future growth opportunities in International Operations Key priorities for regions ensuring future ‘New’ IO sales growth – full year of 2016 growth in International Operations • Continued market share gains with Tresiba® and Region Xultophy® Sha
Slide 7: Key focus areas to ensure sustainable growth in the US
Investor presentation Full year 2016 Slide 7 7 Key focus areas to ensure sustainable growth in the US US sales by product – full year of 2016 US reorganisation and key priorities Growth Growth Organisation Local currencies (%) (mDKK) • Reorganisation in the US completed New-generation insulin n/a 2,
Slide 8: Key assumptions supporting the long-term financial target of 5% operating profit growth
Investor presentation Full year 2016 Slide 8 8 Key assumptions supporting the long-term financial target of an average of 5% operating profit growth1 Expected future sales drivers, partly offset by 2-3% negative impact on global pricing Expected future cost drivers • Continued underlying 3-4% volume
Slide 9: Organic growth enables steady cash return to shareholders
Investor presentation Full year 2016 Slide 9 Organic growth enables steady cash return to shareholders via dividends and share repurchase programmes Cash return priorities and business Annual cash return to shareholders development activities DKK Share repurchase Interim dividend Dividend Cash retur
Slide 10: New regional structure introduced 1 January 2017
Investor presentation Full year 2016 Slide 10 New regional structure introduced 1 January 2017. All regions contributed to local currency sales growth in 2016 Sales as reported – full year 2016 Growth analysis – full year 2016 Region Latin America Local currencies Growth Share of growth Region Japan
Slide 11: Sales growth is driven by new-generation insulin and Victoza
Investor presentation Full year 2016 Slide 11 Sales growth is driven by new-generation insulin and Victoza® Sales as reported – full year 2016 Growth analysis – full year 2016 Local currencies Growth Share of growth Other biopharmaceuticals Norditropin® (7%) New-generation insulin1 212% 51% +12% Mod
Slide 12: Roll-out of new-generation insulin portfolio continuing
Investor presentation Full year 2016 Slide 12 Roll-out of new-generation insulin portfolio continuing Tresiba® value share of basal insulin segment Key launch observations in selected countries, excluding the USA Switzerland Netherlands UK India • Tresiba® launched in 52 countries with solid penetra
Slide 13: Increasing total market share of the basal insulin franchise in the US
Investor presentation Full year 2016 Slide 13 Increasing total market share of the basal insulin franchise in the US Weekly US NBRx volume market shares Tresiba® launch in the US Tresiba® Levemir® NN Total Basal • Full commercial launch in January 2016 following specialist Basal glargine U100 glargi
Slide 14: Victoza maintains leadership in the faster growing US GLP-1 market
Investor presentation Full year 2016 Slide 14 Victoza® maintains leadership in the faster growing US GLP-1 market US GLP-1 market development US GLP-1 market TRx volume US GLP-1 market shares MAT Total TRx MAT volume GLP-1 TRx Victoza® exenatide GLP-1 TRx Victoza® exenatide GLP-1 TRx Growth rate gro
Slide 15: Tresiba demonstrated CV safety in DEVOTE trial
Investor presentation Full year 2016 Slide 15 Tresiba® demonstrated CV safety and reduced severe hypoglycaemia risk vs insulin glargine U100 in DEVOTE trial DEVOTE trial design Key results and next step • Non-inferiority on CV safety demonstrated with a hazard Tresiba® once daily (blinded vial) + ra
Slide 16: Xultophy showed significant reduction of hypoglycaemic events vs basal-bolus
Investor presentation Full year 2016 Slide 16 Xultophy® showed significant reduction of hypoglycaemic events and weight loss vs basal-bolus in phase 3b study DUAL VII phase 3b trial design Key results and next steps • Xultophy® successfully demonstrated similar glucose control compared to insulin gl
Slide 17: Fast-acting insulin aspart approved in the EU and Canada
Investor presentation Full year 2016 Slide 17 Fast-acting insulin aspart approved in the EU and Canada, resubmission of the NDA in the US within three months Regulatory decisions and next steps Fiasp® vs NovoRapid® EU label characteristics • Fiasp® HbA1c reduction of -0.32% compared Efficacy NovoRap
Slide 18: Key development milestones reached
Investor presentation Full year 2016 Slide 18 Key development milestones reached • FDA approval for Xultophy® 100/3.6 (NN9068) in the US • Supplemental application for the SWITCH trials submitted for Tresiba® (NN1250) in the EU • Real-world evidence study EU-TREAT with Tresiba® completed • Submissio
Slide 19: Significant regulatory news flow in 2017
Investor presentation Full year 2016 Slide 19 Significant regulatory news flow in 2017 Results available Regulatory milestone Project Past 3 months Within 3 months In ~3-6 months In ~6-9 months In ~9-12 months DEVOTE data √ US & EU submission of DEVOTE data Tresiba® Variation US label update EU labe
Slide 20: Financial results – full year 2016
Investor presentation Full year 2016 Slide 20 Financial results – full year 2016 DKK million FY 2016 FY 2015 Change Sales 111,780 107,927 4% Gross profit 94,597 91,739 3% Gross margin 84.6% 85.0% Sales and distribution costs (28,377) (28,312) 0% Percentage of sales 25.4% 26.2% Research and developme
Slide 21: Currency impact in 2016
Investor presentation Full year 2016 Slide 21 Currency impact in 2016 driven by unfavourable development in both hedged and unhedged currencies USD/DKK CNY/DKK JPY/DKK GBP/DKK CAD/DKK 140 Hedged 2015 2016 Spot Impact of a Hedging Index (1 Jan 2015= 100) Currencies average average2 rate2 5% move3 (mo
Slide 22: Financial outlook for 2017
Investor presentation Full year 2016 Slide 22 Financial outlook for 2017 Expectations 2 Feb 2017 Sales growth - local currencies -1 to 4% Sales growth - reported Around 2 percentage points higher Operating profit growth - local currencies -2% to 3% Operating profit growth - reported Around 2 percent
Slide 23: Closing remarks
Investor presentation Full year 2016 Slide 23 Closing remarks Solid leadership positions and continued market opportunities Promising pipeline and product launches > 27% > Novo Nordisk value market share in diabetes • The only company with a full portfolio of novel care and solid leadership position
Slide 24: Investor contact information
Investor presentation Full year 2016 Slide 24 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 25: Appendix
Investor presentation Full year 2016 Slide 25 Appendix 1. Novo Nordisk at a glance 2. Diabetes and obesity 3. Biopharmaceuticals 4. Financials 5. Sustainability
Slide 26: Novo Nordisk at a glance
Investor presentation Full year 2016 Slide 26 Novo Nordisk at a glance Global leader in diabetes care Global insulin market leadership • A focused pharmaceutical company with leading positions Global insulin market share: 46% in diabetes, haemophilia and growth hormone Region Europe: Market share 45
Slide 27: Four strategic focus areas based on five core capabilities
Investor presentation Full year 2016 Slide 27 Novo Nordisk works with four strategic focus areas based on five core capabilities STRATEGIC PRIORITIES CORE CAPABILITIES Engineering, Deep disease Efficient Planning and Building and formulating, understanding large-scale executing maintaining a Expand
Slide 28: Leading positions in diabetes, haemophilia and growth disorders
Investor presentation Full year 2016 Slide 28 Novo Nordisk has leading positions in diabetes, haemophilia and growth disorders Diabetes Haemophilia Growth disorders DKK Market value DKK Market value DKK Market value billion Novo Nordisk value market share billion Novo Nordisk value market share bill
Slide 29: Top line growth driven by the diabetes pandemic
Investor presentation Full year 2016 Slide 29 Top line growth driven by the diabetes pandemic Novo Nordisk reported quarterly sales International Diabetes Federation projects that by therapy 642 million people will have diabetes by 2040 Diabetes and obesity Haemophilia2 North America Reg Europe Reg
Slide 30: Strong leadership position within the growing diabetes care market
Investor presentation Full year 2016 Slide 30 Novo Nordisk has a strong leadership position within the growing diabetes care market Global diabetes care market Global diabetes care by treatment class value market share DKK OAD GLP-1 Insulin Novo Nordisk Sanofi Eli Lilly Merck billion AstraZeneca Nov
Slide 31: Growth opportunities fuelled by strong R&D pipeline
Investor presentation Full year 2016 Slide 31 Significant growth opportunities fuelled by strong R&D pipeline across all four strategic focus areas PHASE 1 PHASE 2 PHASE 3 SUBMITTED APPROVED1 LAI287 – QW basal insulin Semaglutide – QD GLP-1 OG217SC – Oral GLP-1 Fast-acting insulin aspart (US) Levemi
Slide 32: Strong global presence in sales and manufacturing
Investor presentation Full year 2016 Slide 32 Growth opportunities supported by strong global presence in both sales and manufacturing FTEs in sales regions1 Global manufacturing setup Kaluga, Russia (~240 FTEs) North America Operations: ~5,000 Denmark (~9,700 FTEs) • Diabetes and biopharmaceutical
Slide 33: Solid patent protection of innovative drugs
Investor presentation Full year 2016 Slide 33 Solid patent protection of innovative drugs Novo Nordisk’s position is protected Barriers to entry by patents and value chain setup for biosimilar players Patent protection1 Unique value chain position EU/US0 Research & Development Research & 203022 Deve
Slide 34: Diabetes and obesity
Investor presentation Full year 2016 Slide 34 Diabetes and obesity
Slide 35: Diabetes – the inability to manage blood sugar levels
Investor presentation Full year 2016 Slide 35 Diabetes – the inability to manage blood sugar levels appropriately The aim of insulin therapy is to recreate normal Facts about diabetes blood insulin profile Diabetes is a chronic disease that occurs either when the 70 Short-lived, rapidly generated pa
Slide 36: Diabetes pandemic is fuelled by growing rates of obesity
Investor presentation Full year 2016 Slide 36 Diabetes pandemic is fuelled by growing rates of obesity US CDC data on obesity and diabetes prevalence among adults 1994 2000 2014 Obesity prevalence (BMI ≥30 kg/m2) <14.0% 14.0-17.9% 18.0-21.9% 22.0-25.9% 26.0-29.9% ≥30% Diabetes prevalence <4.5% 4.5-5
Slide 37: Poor diagnosis rates and lack of access to treatment remain global problems
Investor presentation Full year 2016 Slide 37 Poor diagnosis rates, lack of access to optimal treatment and poor glycaemic control remain global problems Diagnosis and optimal treatment The worldwide challenge of glycaemic control: remains a challenge – the rule of halves Mean HbA1C in type 2 diabet
Slide 38: UKPDS: Tight glycaemic control reduces risk of complications
Investor presentation Full year 2016 Slide 38 UKPDS: Tight glycaemic control reduces risk of micro- and macrovascular complications UKPDS 10 year follow-up: Risk reduction by lowering HbA1c by 1%-point Legacy effect of tight glycaemic control Diabetes- Peripheral related Myocardial Microvascular vas
Slide 39: Insulin is the ultimate care for people with diabetes
Investor presentation Full year 2016 Slide 39 Insulin is the ultimate care for people with diabetes Progression of type 2 diabetes and treatment Distribution of patients and value across intensification treatment classes Insulin GLP-1 OAD 100% Diet and exercise 80% -cell function OAD GLP-1 60% 40%
Slide 40: The insulin market is comprised of three segments
Investor presentation Full year 2016 Slide 40 The insulin market is comprised of three segments Insulin action profiles Global insulin volume market by segment CAGR volume1: 4.6% tMU CAGR value1: 20.3% Fast-acting 500 450 400 40% 350 Long-acting 37% 300 Premix 250 26% 29% Premix 200 150 Long-acting
Slide 41: Medications used for the treatment of type 2 diabetes
Investor presentation Full year 2016 Slide 41 Medications used for the treatment of type 2 diabetes Commonly prescribed products for the treatment of type 2 diabetes HbA1C Hypo- Weight CVD risk Dosing Contraindication/ Class change glycaemia change factors (pr. day) undesired effects Metformin 1.5 N
Slide 42: Solid position in the diabetes care market across all regions
Investor presentation Full year 2016 Slide 42 Solid position in the diabetes care market across all regions with leading insulin market share Diabetes care value Diabetes care value Insulin volume Insulin volume Regions market composition market share market composition market share 30% 38% North Am
Slide 43: Stable global insulin volume growth
Investor presentation Full year 2016 Slide 43 Stable global insulin volume growth Regional insulin volume growth Regional insulin volume market split North America Reg Europe Reg AAMEO Reg China North America Reg Europe Reg AAMEO Reg J&K Reg LATAM World Reg China Reg J&K Reg LATAM 30% 100% 3% 3% 25%
Slide 44: Maintaining global insulin leadership
Investor presentation Full year 2016 Slide 44 Maintaining global insulin leadership by sustaining modern insulin market share Novo Nordisk global volume market share across insulin classes class volume Novo Nordisk class MS (%) tMU Human insulin1 tMU Modern insulin3 tMU Total insulin 500 100% 500 10
Slide 45: Strong underlying insulin market growth
Investor presentation Full year 2016 Slide 45 Strong underlying insulin market growth and sustained global volume market share Global insulin market Global modern insulin3 volume market shares Device penetration Modern insulin penetration1 Novo Nordisk Sanofi Eli Lilly tMU Penetration 500 CAGR volum
Slide 46: Continued single digit volume growth within modern insulin segments
Investor presentation Full year 2016 Slide 46 Continued single digit volume growth within the modern insulin segments Fast-acting insulin Premix insulin Long-acting insulin Segment volume Segment volume Segment volume NovoRapid® market share NovoMix® market share Levemir® market share tMU tMU tMU 20
Slide 47: Solid US modern insulin market share
Investor presentation Full year 2016 Slide 47 Solid US modern insulin market share US insulin market by segments US modern insulin volume market shares Device penetration Modern Insulin penetration Novo Nordisk Sanofi Eli Lilly tMU CAGR volume1: 2.1% Penetration 60% 160 CAGR value1: 28.4% 100% 50% 1
Slide 48: Modern insulins maintain market share in the US
Investor presentation Full year 2016 Slide 48 Novo Nordisk’s modern insulins maintain market share in the US insulin market US fast-acting insulin US premix insulin US long-acting insulin Segment volume Segment volume Segment volume NovoLog® market share NovoLog® Mix 70/30 market share Levemir® mark
Slide 49: US health insurance dominated by few large commercial payers
Investor presentation Full year 2016 Slide 49 US health insurance is dominated by few large commercial payers with slow expansion of public insurance coverage US Population by health insurance status In 2016 PBMs covered 266 million lives and the expected to remain stable in coming years market has
Slide 50: Leadership in the European modern insulin market
Investor presentation Full year 2016 Slide 50 Maintained leadership position in the European modern insulin market European modern insulin3 European insulin market by segments volume market shares Device penetration Modern Insulin penetration2 Novo Nordisk Sanofi Eli Lilly tMU CAGR volume1: 2.4% Pen
Slide 51: Stable leadership position in AAMEO
Investor presentation Full year 2016 Slide 51 Stable leadership position in Africa, Asia, Middle-East and Oceania (AAMEO) AAMEO insulin market by segments AAMEO insulin volume market shares Device penetration Modern Insulin penetration2 Novo Nordisk Sanofi Eli Lilly Biocon tMU CAGR volume1: 9.3% Pen
Slide 52: Solid market leadership in Japan & Korea
Investor presentation Full year 2016 Slide 52 Solid market leadership position in Japan & Korea Japan & Korea modern insulin Japan & Korea insulin market by segments volume market shares Device penetration Modern Insulin penetration2 Novo Nordisk Eli Lilly Sanofi tMU CAGR volume1: 0.3% Penetration 1
Slide 53: Tresiba strengthens basal insulin share in Japan
Investor presentation Full year 2016 Slide 53 Solid Tresiba® performance strengthens basal insulin market share in Japan Japanese basal value market shares Japanese total insulin value market shares Tresiba® Levemir® NN Total Basal NPH Novo Nordisk Eli Lilly Sanofi glargine U100 glargine U300 biosim
Slide 54: Solid growth in the Chinese insulin market
Investor presentation Full year 2016 Slide 54 Solid growth in the Chinese insulin market Chinese insulin market by segments Chinese insulin volume market shares Device penetration Modern Insulin penetration Novo Nordisk Eli Lilly Tonghua Dongbao tMU Penetration Sanofi Gan & Lee United Lab CAGR volum
Slide 55: Continued expansion of the modern insulin market in China
Investor presentation Full year 2016 Slide 55 Continued expansion of the modern insulin market in China Chinese insulin market by segments Chinese total insulin value market shares Device penetration Modern Insulin penetration Novo Nordisk Sanofi Eli Lilly bDKK Penetration Gan & Lee Tonghua Dongbao
Slide 56: Strengthened insulin volume market share in Latin America
Investor presentation Full year 2016 Slide 56 Strengthened insulin volume market share in Latin America Latin America insulin market by segments Latin America insulin volume market shares Device penetration Modern Insulin penetration Novo Nordisk Eli Lilly Sanofi tMU CAGR volume1: 14.8% Penetration
Slide 57: GLP-1 effect dependent on level of blood glucose
Investor presentation Full year 2016 Slide 57 GLP-1 effect dependent on level of blood glucose − which reduces risk of hypoglycaemia GLP-1 mechanism of action when blood GLP-1 lowers blood glucose in patients sugar levels increase with type 2 diabetes • Increases insulin secretion in the pancreas Gl
Slide 58: GLP-1 share of the global diabetes care market is increasing
Investor presentation Full year 2016 Slide 58 The 9% GLP-1 share of the global diabetes care market is increasing, opportunities for further penetration remain Victoza® sales and GLP-1 value market share Global GLP-1 market of total diabetes care market GLP-1 value Share of total GLP-1 share of diab
Slide 59: Strong GLP-1 volume growth across the regions
Investor presentation Full year 2016 Slide 59 Strong GLP-1 volume growth across the regions Regional GLP-1 volume growth Regional GLP-1 volume market split North America Region Europe Region China North America Region Europe Region AAMEO Region J&K Region AAMEO Region LATAM World Region China Region
Slide 60: GLP-1 segment in North America
Investor presentation Full year 2016 Slide 60 The GLP-1 segment accounts for 11% of the total diabetes care market in North America North America GLP-1 market Key observations for Victoza® in the US market GLP-1 value Victoza® albiglutide Share of total • Victoza® value market share within the GLP-1
Slide 61: GLP-1 segment in Europe
Investor presentation Full year 2016 Slide 61 The GLP-1 segment accounts for 10% of the total diabetes care market in Europe European GLP-1 market Victoza® value market share in Europe GLP-1 value Victoza® lixisenatide Share of total GLP-1 value Victoza® exenatide in bDKK dulaglutide exenatide diabe
Slide 62: GLP-1 segment in AAMEO
Investor presentation Full year 2016 Slide 62 The GLP-1 segment accounts for around 2% of the total diabetes care market in AAMEO AAMEO GLP-1 market Victoza® value market share in AAMEO GLP-1 value Victoza® exenatide Share of total GLP-1 value Victoza® exenatide in bDKK lixisenatide dulaglutide diab
Slide 63: GLP-1 segment in Japan & Korea
Investor presentation Full year 2016 Slide 63 The GLP-1 segment accounts for around 4% of the total diabetes care market in Japan & Korea Japan & Korea GLP-1 market Victoza® value market share in Japan & Korea GLP-1 value Victoza® exenatide Share of total GLP-1 value Victoza® exenatide in bDKK lixis
Slide 64: GLP-1 segment in Latin America
Investor presentation Full year 2016 Slide 64 The GLP-1 segment accounts for around 4% of the total diabetes care market in Latin America Latin America GLP-1 market Victoza® value market share in Latin America GLP-1 value Victoza® exenatide Share of total GLP-1 value Victoza® exenatide in bDKK lixis
Slide 65: Victoza maintains strong position in DPP-IV, GLP-1 and SGLT-2 segment
Investor presentation Full year 2016 Slide 65 Victoza® maintains a strong position in the global DPP-IV, GLP-1 and SGLT-2 segment Segment value Share of segment value growth Segment value market shares DKK Victoza® Other GLP-1 SGLT-2 DPP-IV billion 200 100% 100% 180 13% 13% 160 80% 80% CAGR1 value:
Slide 66: Key diabetes care products remain broadly available in the US
Investor presentation Full year 2016 Slide 66 Key Novo Nordisk diabetes care products remain broadly available in the US Value market shares of key % unrestricted market access of key Novo Nordisk products in the US Novo Nordisk products in the US Value market Victoza® NovoLog® Levemir® Unrestricted
Slide 67: Current and future product portfolio covers type 2 diabetes treatment flow
Investor presentation Full year 2016 Slide 67 Novo Nordisk current and future product portfolio covers the type 2 diabetes treatment flow1 Overview of current and future products in Novo Nordisk’s diabetes portfolio When basal insulin is not enough When When it's time metformin is for insulin Once-d
Slide 68: R&D pipeline: Diabetes, obesity and other areas
Investor presentation Full year 2016 Slide 68 R&D pipeline: Diabetes, obesity and other areas Product/project Type Indication Status (phase) 1 2 3 Filed Appr. Xultophy®/Xultophy® 100/3.6 (NN9068) Combination of insulin degludec and liraglutide Type 2 Fast-acting insulin aspart (NN1218)1 New formulat
Slide 69: Victoza reduced risk of major adverse cardiovascular events in LEADER
Investor presentation Full year 2016 Slide 69 Victoza® statistically significantly reduced the risk of major adverse cardiovascular events in the LEADER trial 13% reduction in 3-point MACE with Victoza® compared with placebo Key results Patients1 with an Victoza® Placebo • Superiority of Victoza® vs
Slide 70: Tresiba shows lower hypoglycaemia rate in SWITCH trials
Investor presentation Full year 2016 Slide 70 Tresiba® shows lower rate of hypoglycaemia than insulin glargine U100 in SWITCH trials – filed in H2 2016 SWITCH 1 – type 1 diabetes SWITCH 2 – type 2 diabetes Hypoglycaemic Hypoglycaemic Tresiba® glargine U100 events per 100 PYE events per 100 PYE -30%*
Slide 71: Semaglutide reduced risk of major cardiovascular events in SUSTAIN 6
Investor presentation Full year 2016 Slide 71 Semaglutide significantly reduced the risk of major cardiovascular events with 26% vs placebo in SUSTAIN 6 Semaglutide demonstrated 26% reduction in composite CV outcome compared with placebo Key results and next step Patients with an semaglutide placebo
Slide 72: Semaglutide HbA1c reduction across treatment cascade
Investor presentation Full year 2016 Slide 72 In phase 3a trials semaglutide shows best in-class potential on HbA1c reduction across treatment cascade Comparison of HbA1c lowering effect in SUSTAIN 1, 2, 3, 4 and 5 trials % patients HbA1c ≤7% Sema 1 mg Sema 0.5 mg Placebo Sitagliptin 100 mg Exenatid
Slide 73: Semaglutide weight lowering across treatment cascade
Investor presentation Full year 2016 Slide 73 In phase 3a trials semaglutide shows best in-class weight lowering potential across treatment cascade Comparison of weight lowering effect in SUSTAIN 1, 2, 3, 4 and 5 trials Sema 1 mg Sema 0.5 mg Placebo Sitagliptin 100 mg Exenatide QW Insulin glargine Q
Slide 74: Competitive Tresiba label across all three triad markets
Investor presentation Full year 2016 Slide 74 Competitive Tresiba® label across all three triad markets Tresiba® label characteristics in triad markets US Europe Japan • Duration of action up to 26 hours in • Half-life of 25 hours and duration of • Duration of action beyond 42 hours Japanese patient
Slide 75: Competitive labels for Xultophy in the US and EU
Investor presentation Full year 2016 Slide 75 Competitive labels for Xultophy® in both the US and EU US – Xultophy® 100/3.6 Europe - Xultophy® • Adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus inadequately controlled on basal • Xultophy® is indicated
Slide 76: Xultophy has documented strong efficacy across the treatment cascade
Investor presentation Full year 2016 Slide 76 Xultophy® has documented strong efficacy across the treatment cascade Xultophy® key clinical results DUAL I DUAL II DUAL III DUAL IV DUAL V Add-on to Add-on to Switch from GLP-1 Add-on to SU ± Switch from insulin metformin ± Pio metformin ± basal n = 292
Slide 77: Fast-acting insulin aspart superior glucose control in onset 1 trial
Investor presentation Full year 2016 Slide 77 Fast-acting insulin aspart provides superior glucose control vs NovoRapid® in onset 1 trial Creating a new formulation that satisfies an unmet medical need HbA1c reduction in onset 1 trial after 26 weeks Fast-acting insulin aspart is an innovative formul
Slide 78: Oral peptide delivery challenges and solutions
Investor presentation Full year 2016 Slide 78 Oral peptide delivery − the gastro-intestinal route poses many challenges to absorption of intact macromolecules Challenges Solutions 1. Breakdown of drug in the 1. Stabilisation of peptide backbone stomach/gastrointestinal tract and side chain 2. Passag
Slide 79: Oral semaglutide reduced HbA1c and body weight in phase 2
Investor presentation Full year 2016 Slide 79 Oral semaglutide dose dependently reduced HbA1c and body weight in a 26-week phase 2 trial in type 2 diabetes HbA1c reduction from a mean baseline of 7.9% Weight loss from a mean base line of 92 kg Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema
Slide 80: Initiation of PIONEER trials for oral semaglutide
Investor presentation Full year 2016 Slide 80 Initiation of PIONEER trials for oral semaglutide 2016 2017 2018 PIONEER 1: monotherapy 26 weeks, n=704 PIONEER 2: vs empagliflozin 52 weeks, n=816 PIONEER 3: vs sitagliptin 78 weeks, n=1,860 PIONEER 4: vs liraglutide 52 weeks, n=690 PIONEER 5: moderate
Slide 81: Anti-IL-21 with liraglutide for type 1 diabetes
Investor presentation Full year 2016 Slide 81 Anti-IL 21 in combination with liraglutide is an alternative approach for the treatment of type 1 diabetes Rationale for Anti-IL 21 and liraglutide Phase 2 trial design combination product for T1D Anti-IL 21 plays an important role in autoimmunity with A
Slide 82: Insulin LAI287 offers potential for once-weekly dosing
Investor presentation Full year 2016 Slide 82 Insulin LAI287 offers potential for once-weekly dosing LAI287 pharmacodynamic profile is compatible Glucose Infusion Rate vs. Time with once-weekly (Predicted Mean)dosing Key results of phase 1 trial Glucose18Infusion nmol/kg Rate Insulin glargine LAI287
Slide 83: Liver-preferential mealtime insulin analogue
Investor presentation Full year 2016 Slide 83 Liver-preferential meal time insulin analogue has potential to reduce hypoglycaemia and weight gain Rationale and expected benefits of The liver is important for insulin action physiologically distributed insulin sc insulin sc liver-preferential prandial
Slide 84: More than 20 million people in the US have a BMI above 35
Investor presentation Full year 2016 Slide 84 More than 20 million people in the US have a BMI above 35 with either pre-diabetes or CV related comorbidities Incidence of obesity in the US (million people) The US obesity burden Obesity • Cost of obesity to health care systems of USD 147 billion Comor
Slide 85: Significant unmet need in obesity management
Investor presentation Full year 2016 Slide 85 Significant unmet need in obesity management Insufficient treatment options Significant gaps in obesity treatment Mean weight loss 100% All people with obesity Bariatric surgery High Medium Anti-obesity medication 30% with weight loss of People diagnosed
Slide 86: Small but growing market for anti-obesity medication in the US
Investor presentation Full year 2016 Slide 86 Small but growing market for anti-obesity medication in the US AOM Market Value has grown quickly in recent Few people treated with AOM, but in recent years, fuelled by branded treatment uptake years launches have fuelled market growth AOM value Generic
Slide 87: Steady prescription uptake for Saxenda in the US
Investor presentation Full year 2016 Slide 87 Steady prescription uptake for Saxenda® in the US Prescription volume uptake of anti-obesity medications (AOM) recently launched in the US Key observations TRx Contrave® Belviq® • Saxenda® has been launched in 15 markets, including the Volume (000) Qsymi
Slide 88: Saxenda targeted at patients with BMI ≥35
Investor presentation Full year 2016 Slide 88 Saxenda® targeted at patients with BMI ≥35 and weight-related comorbidities Saxenda® market approach Saxenda® launch execution Aspiration Focus on patients with BMI Clear patient ≥35 with weight-related segmentation comorbidities Focus on current prescri
Slide 89: Competitive US label for Saxenda
Investor presentation Full year 2016 Slide 89 Competitive US label for Saxenda® Saxenda® approved in the US for chronic weight management in individuals with a BMI ≥30, or ≥27 in the presence of at least one weight-related comorbidity1 • GLP-1 receptor agonist – a physiological regulator of appetite
Slide 90: Semaglutide once daily phase 2 dose-finding trial in obesity
Investor presentation Full year 2016 Slide 90 Semaglutide once daily phase 2 dose-finding trial in obesity is designed to optimise treatment outcomes Once-daily semaglutide phase 2 trial design Phase 2 trial purpose and endpoints Purpose semaglutide 0.05 mg • To assess and compare the dose response
Slide 91: Long-acting obesity compounds in phase 1 development
Investor presentation Full year 2016 Slide 91 Long-acting obesity compounds in phase 1 development may have complimentary modes of action Key features of compounds in phase 1 development for obesity G530S – NN9838 – Amylin NN9747 – PYY NN9499 – FGF21 NN9277 – GG-co- Compound Glucagon analogue analog
Slide 92: Biopharmaceuticals
Investor presentation Full year 2016 Slide 92 Biopharmaceuticals
Slide 93: Haemophilia: Location of bleedings and the consequences
Investor presentation Full year 2016 Slide 93 Haemophilia: Location of bleedings and the consequences Locations Consequences of bleedings • Bleeding in the joint space causes a strong inflammatory reaction which predisposes to further bleeding Head and neck Nose and gums • Inadequate or delayed trea
Slide 94: Haemophilia is a rare disease with severe unmet medical needs
Investor presentation Full year 2016 Slide 94 Haemophilia is a rare disease with severe unmet medical needs Number of people with haemophilia A and B Low diagnosis and treatment rates and haemophilia with inhibitors within haemophilia Number of Average percentage of people people (000) with haemophi
Slide 95: Global haemophilia market is growing by mid-single digit
Investor presentation Full year 2016 Slide 95 Global haemophilia market is growing by mid-single digit Strategic positioning of Novo Nordisk’s Sales of recombinant coagulation factors haemophilia portfolio NovoSeven® Recombinate®/Advate® Rixubis® Novo Nordisk Coagil VII® Kogenate®/Helixate® Alprolix
Slide 96: NovoSeven – a unique biologic for rare bleeding disorders
Investor presentation Full year 2016 Slide 96 NovoSeven® − a unique biologic for the treatment of rare bleeding disorders NovoSeven® reported quarterly sales Key NovoSeven® properties DKK • Product characteristics: powder and solvent for solution billion for intravenous injection, available in multi
Slide 97: NovoEight launched in the US, Europe and Japan
Investor presentation Full year 2016 Slide 97 NovoEight® is launched in the US, Europe and Japan for the treatment of people with haemophilia A Example from NovoEight® promotional campaign1 NovoEight® properties and launch performance Indications: • Treatment and prophylaxis of bleeding in patients
Slide 98: NovoThirteen provides efficacious and safe haemostatic coverage
Investor presentation Full year 2016 Slide 98 NovoThirteen®, a recombinant FXIII, provides efficacious and safe haemostatic coverage Example from NovoThirteen® NovoThirteen® properties and launch promotional campaign1 performance Indication: • Long term prophylactic treatment of bleeding in adult an
Slide 99: R&D pipeline: Haemophilia and growth disorders
Investor presentation Full year 2016 Slide 99 R&D pipeline: Haemophilia and growth disorders Product/project Type Indication Status (phase) 1 2 3 Filed Appr. N9-GP (NN7999)1 GlycoPEGylated long-acting rFIX Haemophilia B N8-GP (NN7088) GlycoPEGylated long-acting rFVIII Haemophilia A Concizumab (NN741
Slide 100: N9-GP once weekly reduces median bleeding rate
Investor presentation Full year 2016 Slide 100 N9-GP administered once weekly reduces median bleeding rate to 1.0 episode per year in phase 3 trial N9-GP phase 1 pharmacokinetics Paradigm 2 headline results (phase 3) FIX activity rFIX pdFIX N9-GP • Steady-state half-life of 110 hours (IU/mL) • Media
Slide 101: N8-GP every fourth day reduces median bleeding rate
Investor presentation Full year 2016 Slide 101 N8-GP administered every fourth day reduces median bleeding rate to 1.3 episode per year in phase 3 trial N8-GP phase 1 pharmacokinetics Pathfinder 2 headline results (phase 3) FVIII activity FVIII N8-GP • PK documented single dose half-life of 18.4 hou
Slide 102: Leadership within human growth hormone market
Investor presentation Full year 2016 Slide 102 Novo Nordisk maintains leadership within human growth hormone (hGH) market Development in global hGH market Growth hormone volume market share DKK MAT volume kg MAT value DKK Novo Nordisk Pfizer Sandoz billion kg Eli Lilly Merck Kgaa Roche 20 100 35% 30
Slide 103: Solid Norditropin sales growth
Investor presentation Full year 2016 Slide 103 Solid Norditropin® sales growth Norditropin® reported quarterly sales Key Norditropin® properties DKK • Product characteristics: Premixed, prefilled multi-use billion delivery systems available in multiple strengths, and stable CAGR1 10.4% at room tempe
Slide 104: Financials
Investor presentation Full year 2016 Slide 104 Financials
Slide 105: Sustained growth throughout the last decade
Investor presentation Full year 2016 Slide 105 Novo Nordisk has delivered sustained growth throughout the last decade Sales growth in local currencies Operating profit growth in local currencies 2006–2016 2006–2016 Sales growth Average growth Operating profit growth Average growth 30% 30% 18% 20% 20
Slide 106: Solid sales growth and expanding share of sales from the US
Investor presentation Full year 2016 Slide 106 Solid sales growth and expanding share of sales from the US Reported annual sales Reported annual sales split by region DKK Diabetes Biopharmaceuticals North America Region Europe Region AAMEO billion Region China Region J&K Region LATAM 120 CAGR1 9.4%
Slide 107: Modern insulin and Victoza comprise around 60% of total sales
Investor presentation Full year 2016 Slide 107 Modern insulin and Victoza® comprise around 60% of total sales in the full year 2016 Reported sales split by product segments the Reported sales split by selected key products full year 2016 the full year 2016 New Generation Insulin Modern Insulin Human
Slide 108: Solid operating profit growth driven by diabetes
Investor presentation Full year 2016 Slide 108 Solid operating profit growth driven by diabetes Operating profit Operating profit therapy split DKK Operating profit Operating profit as % of sales Diabetes Biopharm billion Reported operating profit growth 60 Operating profit growth in local currencie
Slide 109: Profitability per segment
Investor presentation Full year 2016 Slide 109 Profitability per segment Diabetes & Obesity P&L – full year 2016 Biopharmaceuticals P&L – full year 2016 DKK DKK billion billion 100 30 -15% 80 -28% 24 -12% -17% 60 18 -13% -12% -4% +1% 54% -3% +1% 42% 40 12 20 6 0 0 Sales COGS S&D R&D Admin OOI OP Sal
Slide 110: Stable COGS level as % of sales and increasing CAPEX level
Investor presentation Full year 2016 Slide 110 Stable COGS level as % of sales and increasing CAPEX level Cost of Goods Sold (COGS) Capital Expenditure (CAPEX) DKK COGS as % of sales DKK CAPEX as % of sales billion COGS billion CAPEX 20 25% 8 8% Thousands 7 7% 20% 15 6 6% 15% 5 5% 10 4 4% 10% 3 3% 5
Slide 111: Long term financial targets: operating profit growth and margin
Investor presentation Full year 2016 Slide 111 Long term financial targets: Operating profit growth and operating margin Operating profit growth Operating margin New long term financial target1 Previous long term financial targets Previous long term financial targets 40% 45% 30% 30% 20% 15% 10% 0% 0
Slide 112: Long term financial targets: returns and cash to earnings
Investor presentation Full year 2016 Slide 112 Long term financial targets: Operating profit after tax to net operating assets and cash to earnings Operating profit after tax to Cash to earnings net operating assets (three year average) New long term financial target1 New long term financial target1
Slide 113: Stable ownership structure
Investor presentation Full year 2016 Slide 113 Stable ownership structure - secured through A and B-share structure Share structure The Novo Nordisk Foundation • The Novo Nordisk Foundation is a self-governing institution Novo Nordisk Foundation that: Institutional and private • provides a stable ba
Slide 114: Sustainability
Investor presentation Full year 2016 Slide 114 Sustainability The Novo Nordisk Way The Triple Bottom Line Business Principle Financially responsible Socially Environmentally responsible responsible We build on the purpose set by our founders and live by their The Triple Bottom Line Principle guides
Slide 115: 2016 performance towards long-term sustainability goals
Investor presentation Full year 2016 Slide 115 2016 performance towards achieving long-term sustainability goals Patients reached with Working the Novo Share of renewable diabetes care products Nordisk Way2 power for production Operating profit growth Realised Realised Realised Realised Million1 Tar
Slide 116: Cities Changing Diabetes aims to break the Rule of Halves
Investor presentation Full year 2016 Slide 116 Cities Changing Diabetes aims to break the ‘Rule of Halves’ and stop urban diabetes from ruining millions of lives Global partnerships to develop an approach Eight partner cities are addressing to fight urban diabetes the threat of urban diabetes Copenh
Slide 117: Commitment to the continued development of employees
Investor presentation Full year 2016 Slide 117 Novo Nordisk is committed to the continued development of its employees Employee health and safety and engagement Novo Nordisk is committed to building a are key focus areas for management diverse and inclusive organisation Management All managers Sr. M