Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — Q1 2016 Earnings Presentation
113 slides from Novo Nordisk A/s Class B's earnings presentation, Apr 29, 2016
Slide 1: Investor presentation First quarter of 2016
Slide 1 Investor presentation First quarter of 2016 Shanghai – part of Cities Changing Diabetes
Slide 2: Agenda
Investor presentation First quarter of 2016 Slide 2 Agenda Highlights and key events Sales update R&D update Financials and outlook
Slide 3: Forward-looking statements
Investor presentation First quarter of 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 2015 and Form 20-F, which are both filed with the SEC in February 2016 in continuati
Slide 4: Highlights – First quarter of 2016
Investor presentation First quarter of 2016 Slide 4 Highlights – First quarter of 2016 Sales development • Sales increased by 9% in local currencies and 8% in Danish kroner • USA and International Operations grew by 12% and 15% in local currencies, respectively • Victoza® increased by 15% in local c
Slide 5: USA is the main contributor to sales growth
Investor presentation First quarter of 2016 Slide 5 USA is the main contributor to sales growth Sales as reported – First quarter of 2016 Growth analysis – First quarter of 2016 Pacific Local currencies Growth Share of growth +7% USA 12% 64% Region China +1% 8% Europe 1% 3% 11% International Operati
Slide 6: Sales growth is driven by Victoza® and new-generation insulin
Investor presentation First quarter of 2016 Slide 6 Sales growth is driven by Victoza® and new-generation insulin Sales as reported – First quarter of 2016 Growth analysis – First quarter of 2016 Other Local currencies Growth Share of growth Norditropin® +15% New-generation insulin1 136% 17% +32% 4%
Slide 7: Victoza® maintains leadership in the faster growing US GLP-1 market
Investor presentation First quarter of 2016 Slide 7 Victoza® maintains leadership in the faster growing US GLP-1 market US GLP-1 market development US GLP-1 market shares MAT GLP-1 Growth rate Total TRx MAT volume GLP-1 TRx Victoza® exenatide TRx (000) growth rate market share albiglutide dulaglutid
Slide 8: Roll-out of new-generation insulin portfolio is progressing
Investor presentation First quarter of 2016 Slide 8 Roll-out of new-generation insulin portfolio is progressing Tresiba® value share of basal insulin segment Key launch observations in selected countries, excl US Switzerland Netherlands UK India • Tresiba® launched in 43 countries with solid penetra
Slide 9: Encouraging uptake of Tresiba® in the US
Investor presentation First quarter of 2016 Slide 9 Encouraging uptake of Tresiba® in the US Weekly US NBRx volume market shares Tresiba® launched in the US Tresiba® Levemir® NN Total Basal • Full commercial launch in January 2016 following specialist Basal glargine U100 glargine U300 engagement in
Slide 10: Victoza® significantly reduces the risk of major adverse cardiovascular events in the LEADER trial
Investor presentation First quarter of 2016 Slide 10 Victoza® significantly reduces the risk of major adverse cardiovascular events in the LEADER trial LEADER trial design Headline results Standard of care + liraglutide • Non-inferiority as well as superiority demonstrated for (0.6-1.8 mg once daily
Slide 11: Tresiba® shows lower rate of hypoglycaemia than insulin glargine U100 in SWITCH trials
Investor presentation First quarter of 2016 Slide 11 Tresiba® shows lower rate of hypoglycaemia than insulin glargine U100 in SWITCH trials – filing expected Q3 2016 SWITCH 1 – type 1 diabetes SWITCH 2 – type 2 diabetes Hypoglycaemic Hypoglycaemic Tresiba® glargine U100 events per 100 PYE events per
Slide 12: Semaglutide significantly reduces the risk of major adverse cardiovascular events in the SUSTAIN 6 trial
Investor presentation First quarter of 2016 Slide 12 Semaglutide significantly reduces the risk of major adverse cardiovascular events in the SUSTAIN 6 trial SUSTAIN 6 trial design Headline results • Non-inferiority demonstrated for the primary endpoint of major cardiovascular events (MACE) with sem
Slide 13: Key development milestones
Investor presentation First quarter of 2016 Slide 13 Key development milestones SUSTAIN 5 comparing semaglutide with insulin glargine U100 successfully completed Phase 3a trial, PIONEER 3, initiated comparing oral semaglutide (NN9924) with sitagliptin Advisory Committee meeting scheduled on 24 May 2
Slide 14: Strong R&D newsflow expected to continue in 2016
Investor presentation First quarter of 2016 Slide 14 Strong R&D newsflow expected to continue in 2016 Results available Regulatory milestone Project Past 6 months Past 3 months Within 3 months In ~3-6 months In ~6-9 months Variation application Tresiba® SWITCH 2 √ SWITCH 1 √ in the US DEVOTE Once-we
Slide 15: Financial results – First quarter of 2016
Investor presentation First quarter of 2016 Slide 15 Financial results – First quarter of 2016 DKK million Q1 2016 Q1 2015 Change Sales 27,212 25,200 8% Gross profit 22,978 21,326 8% Gross margin 84.4% 84.6% Sales and distribution costs 6,741 6,147 10% Percentage of sales 24.8% 24.4% Research and de
Slide 16: Depreciation of key currencies against the Danish krone drives negative currency impact in 2016
Investor presentation First quarter of 2016 Slide 16 Depreciation of key currencies against the Danish krone drives negative currency impact in 2016 USD/DKK CNY/DKK JPY/DKK GBP/DKK CAD/DKK 125 Hedged 2015 2016 Spot Impact of a Hedging Index (1 Jan 2015= 100) 120 Currencies average average2 rate2 5%
Slide 17: Financial outlook for 2016
Investor presentation First quarter of 2016 Slide 17 Financial outlook for 2016 Expectations Previous expectations 29 Apr 2016 3 Feb 2016 Sales growth - local currencies 5-9% 5-9% Sales growth - reported Around 3 percentage points lower Around 1 percentage point lower Operating profit growth - local
Slide 18: Closing remarks
Investor presentation First quarter of 2016 Slide 18 Closing remarks Solid market performance Promising pipeline >≥10% annual diabetes care market growth driven •> • The only company with a full portfolio of novel by diabetes prevalence insulin products • 27% market share in diabetes care and solid
Slide 19: Investor contact information
Investor presentation First quarter of 2016 Slide 19 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 St
Slide 20: Appendix
Investor presentation First quarter of 2016 Slide 20 Appendix 1. Novo Nordisk at a glance 2. Diabetes 3. Biopharmaceuticals 4. Financials 5. Sustainability
Slide 21: Novo Nordisk at a glance
Investor presentation First quarter of 2016 Slide 21 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% Europe: in diabetes, haemophilia and growth hormone Market share 46
Slide 22: Novo Nordisk works with four strategic focus areas based on five core capabilities
Investor presentation First quarter of 2016 Slide 22 Novo Nordisk works with four strategic focus areas based on five core capabilities Strategic priorities Core capabilities Engineering, Deep Efficient Planning Building formulating, disease large-scale and and Expand leadership in developing under-
Slide 23: Novo Nordisk has leading positions in diabetes, haemophilia and growth disorders
Investor presentation First quarter of 2016 Slide 23 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 sha
Slide 24: Double digit top line growth driven by diabetes pandemic
Investor presentation First quarter of 2016 Slide 24 Double digit top line growth driven by diabetes pandemic Novo Nordisk reported quarterly sales Diabetes Atlas 7th Edition projects that by therapy 642 million people will have diabetes by 2040 Diabetes and obesity Haemophilia2 USA Europe Pacific D
Slide 25: Novo Nordisk has a strong leadership position within the growing diabetes care market
Investor presentation First quarter of 2016 Slide 25 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 GLP-1 Insulin OAD Novo Nordisk Sanofi Eli Lilly Merck billion AstraZen
Slide 26: Significant growth opportunities fuelled by strong R&D pipeline across all four strategic focus areas
Investor presentation First quarter of 2016 Slide 26 Significant growth opportunities fuelled by strong R&D pipeline across all four strategic focus areas PHASE 1 PHASE 2 PHASE 3 SUBMITTED APPROVED3 LAI287 – QW basal insulin OI338GT – Oral insulin1 Semaglutide – QW GLP-1 Xultophy® (US) Levemir® OI32
Slide 27: Growth opportunities supported by strong global presence in both sales and manufacturing
Investor presentation First quarter of 2016 Slide 27 Growth opportunities supported by strong global presence in both sales and manufacturing FTEs in sales regions1 Global manufacturing setup Denmark (~9,400 FTEs) Kaluga, Russia (~200 FTEs) USA: ~5,100 • Diabetes and biopharmaceutical • Filling West
Slide 28: High barriers to entry in biologics
Investor presentation First quarter of 2016 Slide 28 High barriers to entry in biologics Novo Nordisk’s position is protected Significant barriers to entry by patents and value chain setup for biosimilar players Patent protection1 Unique value chain position EU/US0 Research & Development Research &
Slide 29: Diabetes and obesity
Investor presentation First quarter of 2016 Slide 29 Diabetes and obesity
Slide 30: Diabetes – the inability to manage blood sugar levels appropriately
Investor presentation First quarter of 2016 Slide 30 Diabetes – the inability to manage blood sugar levels appropriately Facts about diabetes Insulin secretion profile Diabetes is a chronic disease that occurs either when the 70 pancreas does not produce enough insulin or when the body cannot effect
Slide 31: Insulin – a hormone enabling blood sugar to enter cells
Investor presentation First quarter of 2016 Slide 31 Insulin – a hormone enabling blood sugar to enter cells The aim of insulin therapy is to recreate normal Insulin enables glucose to become energy blood insulin profile 70 Short-lived, rapidly generated • Facilitates uptake of blood sugar into cell
Slide 32: Diabetes pandemic is fuelled by growing rates of obesity
Investor presentation First quarter of 2016 Slide 32 Diabetes pandemic is fuelled by growing rates of obesity US CDC data on obesity and diabetes prevalence among adults 1994 2000 2013 Obesity prevalence (BMI ≥30 kg/m2) No Data <14.0% 14.0-17.9% 18.0-21.9% 22.0-25.9% >26.0% Diabetes prevalence No Da
Slide 33: Poor diagnosis rates, lack of access to optimal treatment and poor glycaemic control remain global problems
Investor presentation First quarter of 2016 Slide 33 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
Slide 34: UKPDS: Tight glycaemic control reduces risk of micro- and macrovascular complications
Investor presentation First quarter of 2016 Slide 34 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 Microvascu
Slide 35: Insulin is the ultimate care for people with diabetes
Investor presentation First quarter of 2016 Slide 35 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 6
Slide 36: The insulin market is comprised of three segments
Investor presentation First quarter of 2016 Slide 36 The insulin market is comprised of three segments Insulin action profiles Global insulin volume market by segment tMU CAGR volume1: 5.0% Fast-acting CAGR value1: 20.4% 450 400 350 39% Fast-acting 300 37% Premix 250 27% 200 Premix 30% 150 Long-acti
Slide 37: Medications used for the treatment of type 2 diabetes
Investor presentation First quarter of 2016 Slide 37 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 Metformi
Slide 38: Sustained double-digit growth in insulin market
Investor presentation First quarter of 2016 Slide 38 Sustained double-digit growth in insulin market The fundamental growth drivers Global insulin market growth of the insulin market DKK billion CAGR: CAGR: Volume 250 15.5%1 19.6%1 • Rising prevalence of diabetes • Growing overweight and obesity pre
Slide 39: Solid insulin volume growth in key regions
Investor presentation First quarter of 2016 Slide 39 Solid insulin volume growth in key regions Novo Nordisk Market Market volume Volume market regions value1 size & growth composition shares 36% 174.4 124.9 4% 38% 51% USA 62% 38% 11% 27.2 2% 3% 28.6 40% Europe 40% 54% 46% 20% International 8.5 10%
Slide 40: Stable global insulin volume growth
Investor presentation First quarter of 2016 Slide 40 Stable global insulin volume growth Regional insulin volume growth Regional insulin volume market split USA Europe Int. Operations USA Europe Int. Operations Pacific World Region China Region China Pacific 30% 100% 8% 25% 8% 80% 20% 21% 60% 15% 34
Slide 41: Maintaining insulin leadership by sustaining modern insulin market share
Investor presentation First quarter of 2016 Slide 41 Maintaining insulin leadership by sustaining modern insulin market share Novo Nordisk volume market share across insulin classes Novo Nordisk class MS (%) class volume tMU Human insulin1 tMU Modern insulin3 tMU Total insulin 500 100% 500 100% 500
Slide 42: Strong underlying insulin market growth and steady market share development
Investor presentation First quarter of 2016 Slide 42 Strong underlying insulin market growth and steady market share development Global insulin market Global modern insulin3 volume market shares Device penetration Modern insulin penetration1 Novo Nordisk Sanofi Eli Lilly tMU Penetration 500 CAGR vol
Slide 43: Novo Nordisk's modern insulins continue strong performance within their respective segments
Investor presentation First quarter of 2016 Slide 43 Novo Nordisk’s modern insulins continue strong performance within their respective segments Fast-acting insulin Premix insulin Long-acting insulin Segment volume Segment volume Segment volume NovoRapid® market share NovoMix® market share Levemir®
Slide 44: USA drives strong Levemir® growth despite increased competition
Investor presentation First quarter of 2016 Slide 44 USA drives strong Levemir® growth despite increased competition Levemir® sales growth driven by strong Levemir® has gained US market share performance in the US despite introduction of glargine U300 DKK Growth in local currency Levemir® NPH billio
Slide 45: Still a significant potential for Novo Nordisk on the US modern insulin market
Investor presentation First quarter of 2016 Slide 45 Still a significant potential for Novo Nordisk on the US modern insulin market US insulin market by segments US modern insulin volume market shares Device penetration Modern Insulin penetration Novo Nordisk Sanofi Eli Lilly tMU CAGR volume1: 2.6%
Slide 46: Novo Nordisk's modern insulins have gained market share in expanding US insulin market
Investor presentation First quarter of 2016 Slide 46 Novo Nordisk’s modern insulins have gained market share in expanding US insulin market US fast-acting insulin US premix insulin US long-acting insulin Segment volume Segment volume Segment volume NovoLog® market share NovoMix® market share Levemir
Slide 47: US health insurance is dominated by few large commercial payers
Investor presentation First quarter of 2016 Slide 47 US health insurance is dominated by few large commercial payers with slow expansion of public insurance coverage US Population by health insurance status In 2015 PBMs covered 245 million expected to remain stable in coming years lives and the mark
Slide 48: Sustained leadership position on the European modern insulin market
Investor presentation First quarter of 2016 Slide 48 Sustained leadership position on 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.
Slide 49: Stable leadership position in International Operations
Investor presentation First quarter of 2016 Slide 49 Stable leadership position in International Operations International Operations insulin International Operations insulin market by segments volume market shares Device penetration Modern Insulin penetration2 Novo Nordisk Sanofi Eli Lilly Biocon tM
Slide 50: Sustained leadership position in the Chinese insulin market
Investor presentation First quarter of 2016 Slide 50 Sustained leadership position in the Chinese insulin market Chinese insulin market by segments Chinese insulin volume market shares Device penetration Modern Insulin penetration Novo Nordisk Sanofi Eli Lilly Shanghai Fosun Tonghua Dongbao tMU CAGR
Slide 51: Expanding market leadership position in Japan
Investor presentation First quarter of 2016 Slide 51 Expanding market leadership position in Japan Japanese insulin market by segments Japanese modern insulin volume market shares Device penetration Modern Insulin penetration2 Novo Nordisk Sanofi Eli Lilly tMU CAGR volume1: -0.6% Penetration 14 CAGR
Slide 52: Promising Tresiba® performance strengthens total insulin market share in Japan
Investor presentation First quarter of 2016 Slide 52 Promising Tresiba® performance strengthens total insulin market share in Japan Japanese basal value market shares Japanese total insulin value market shares Tresiba® Levemir® NN Total Basal NPH Novo Nordisk Sanofi Eli Lilly glargine U100 glargine
Slide 53: GLP-1 effect dependent on level of blood glucose
Investor presentation First quarter of 2016 Slide 53 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 panc
Slide 54: The 8% GLP-1 share of the global diabetes care market is increasing
Investor presentation First quarter of 2016 Slide 54 The 8% GLP-1 share of the global diabetes care market is increasing with opportunities for further penetration Victoza® sales and GLP-1 value market share Global GLP-1 market of total diabetes care market GLP-1 value Share of total DKK GLP-1 share
Slide 55: Victoza® has a strong position in the global DPP-IV, GLP-1 and SGLT-2 segment
Investor presentation First quarter of 2016 Slide 55 Victoza® has 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 160 100% 100% 14% 13% 140 80% 80% 120 CAGR1 value:
Slide 56: The US GLP-1 market reflects steady growth
Investor presentation First quarter of 2016 Slide 56 The US GLP-1 market reflects steady growth US GLP-1 market Key observations for Victoza® in the US market GLP-1 TRx GLP-1 % of diabetes care market scripts (000) • Victoza® volume market share within the GLP-1 segment is 600 10% 54%1 500 8% • Arou
Slide 57: Key Novo Nordisk diabetes care products remain broadly available in the US
Investor presentation First quarter of 2016 Slide 57 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® Unres
Slide 58: Novo Nordisk current and future product portfolio covers the type 2 diabetes treatment flow
Investor presentation First quarter of 2016 Slide 58 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
Slide 59: R&D pipeline: Diabetes and obesity
Investor presentation First quarter of 2016 Slide 59 R&D pipeline: Diabetes and obesity Product/project Type Indication Status (phase) 1 2 3 Filed Appr. Xultophy® (NN9068)1 Combination of insulin degludec and liraglutide Type 2 Faster-acting insulin aspart (NN1218) New formulation of insulin aspart
Slide 60: In phase 3a trials semaglutide shows best in-class potential on HbA1c reduction
Investor presentation First quarter of 2016 Slide 60 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 E
Slide 61: In phase 3a trials semaglutide shows best in-class weight lowering potential
Investor presentation First quarter of 2016 Slide 61 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 gla
Slide 62: Competitive Tresiba® label across all three triad markets
Investor presentation First quarter of 2016 Slide 62 Competitive Tresiba® label across all three triad markets Tresiba® label characteristics in triad markets US Europe Japan • Half-life of 25 hours and duration of • Duration of action beyond 42 hours • Duration of action up to 26 hours in action of
Slide 63: US Tresiba® label reflects the distinctly different product features compared to competitor basal insulins
Investor presentation First quarter of 2016 Slide 63 US Tresiba® label reflects the distinctly different product features compared to competitor basal insulins glargine U100 glargine U300 Duration of action1 • At least 42 hours2 • Up to 24 hours3 • Up to 36 hours4 • Once daily at any time of day5 •
Slide 64: Real-world data for Tresiba® confirms strong clinical profile and enables uptake
Investor presentation First quarter of 2016 Slide 64 Real-world data for Tresiba® confirms strong clinical profile and enables uptake Study aim and key results • Study aim: Exploring whether the higher cost of insulin An independent, prospective, degludec compared with insulin detemir or insulin gla
Slide 65: Competitive European label for Xultophy®
Investor presentation First quarter of 2016 Slide 65 Competitive European label for Xultophy® Xultophy® is indicated for the treatment of adults with type 2 diabetes in combination with oral glucose-lowering agents • Xultophy® is a fixed combination product consisting of insulin degludec and liraglu
Slide 66: Xultophy® has documented strong efficacy across the treatment cascade
Investor presentation First quarter of 2016 Slide 66 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 ± b
Slide 67: Faster-acting insulin aspart provides superior glucose control vs NovoRapid® in onset 1 trial
Investor presentation First quarter of 2016 Slide 67 Faster-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 Faster-acting insulin aspart is an innova
Slide 68: Oral peptide delivery challenges and solutions
Investor presentation First quarter of 2016 Slide 68 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.
Slide 69: Oral semaglutide dose dependently reduced HbA1c and body weight in a 26-week phase 2 trial
Investor presentation First quarter of 2016 Slide 69 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
Slide 70: PIONEER, the global phase 3a programme for oral semaglutide
Investor Investor presentation presentation First quarter Full year of 2016 2015 Slide 70 PIONEER, the global phase 3a programme for oral semaglutide to include >9,300 people with type 2 diabetes 2016 2017 2018 PIONEER 1: monotherapy 26 weeks, n=704 PIONEER 2: vs empagliflozin 52 weeks, n=816 PIONEE
Slide 71: Oral insulin OI338GT has the potential to control blood glucose similar to modern insulins
Investor presentation First quarter of 2016 Slide 71 Oral insulin OI338GT has the potential to control blood glucose similar to modern insulins Phase 1 headline results Phase 2a study design • Three clinical pharmacology trials in a total of 118 healthy volunteers and people with type 2 diabetes OI3
Slide 72: Anti-IL-21 in combination with liraglutide for the treatment of type 1 diabetes
Investor presentation First quarter of 2016 Slide 72 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
Slide 73: Insulin LAI287 offers potential for once-weekly dosing
Investor presentation First quarter of 2016 Slide 73 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
Slide 74: Liver-preferential mealtime insulin analogue has potential to reduce hypoglycaemia and weight gain
Investor presentation First quarter of 2016 Slide 74 Liver-preferential mealtime 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 pr
Slide 75: More than 20 million people in the US have a BMI above 35
Investor presentation First quarter of 2016 Slide 75 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 billio
Slide 76: Significant unmet need in obesity management
Investor presentation First quarter of 2016 Slide 76 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 di
Slide 77: Small but growing market for anti-obesity medication in the US
Investor presentation First quarter of 2016 Slide 77 Small but growing market for anti-obesity medication in the US Value of US obesity market remains Few people treated with AOM in the US, but relatively small, but it is growing recent launches have fuelled market growth USD TRx volume Generic TRx
Slide 78: Steady prescription uptake for Saxenda®
Investor presentation First quarter of 2016 Slide 78 Steady prescription uptake for Saxenda® Prescription volume uptake of anti-obesity medications (AOM) recently launched in the US Key observations TRx Contrave® Belviq® • Saxenda® has been launched in the US, Canada, Denmark, Volume(000) Qsymia® Sa
Slide 79: Saxenda® targeted at patients with BMI ≥35 and weight-related comorbidities
Investor presentation First quarter of 2016 Slide 79 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
Slide 80: Saxenda® demonstrated weight loss in all SCALE® trials
Investor presentation First quarter of 2016 Slide 80 Saxenda® demonstrated weight loss in all SCALE® trials Overview of weight loss (%) in the SCALE® programme Saxenda® Placebo % patients with ≥5% weight loss Obesity & Pre-diabetes2 Diabetes3 Sleep Apnoea4 Maintenance1,5 (56 weeks and n=3,731) (56 w
Slide 81: Competitive US label for Saxenda®
Investor presentation First quarter of 2016 Slide 81 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 a
Slide 82: Semaglutide once daily phase 2 dose-finding trial in obesity
Investor presentation First quarter of 2016 Slide 82 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 re
Slide 83: Long-acting obesity compounds in phase 1 development
Investor presentation First quarter of 2016 Slide 83 Long-acting obesity compounds in phase 1 development may have complimentary modes of action Key features of compounds in phase 1 development for obesity Compound G530L – Glucagon analogue NN9838 – Amylin analogue NN9747 – PYY analogue • Once-daily
Slide 84: Biopharmaceuticals
Investor presentation First quarter of 2016 Slide 84 Biopharmaceuticals
Slide 85: Haemophilia: Location of bleedings and the consequences
Investor presentation First quarter of 2016 Slide 85 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 delay
Slide 86: Haemophilia is a rare disease with severe unmet medical needs
Investor presentation First quarter of 2016 Slide 86 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 h
Slide 87: The global haemophilia market is growing by mid-single digits
Investor presentation First quarter of 2016 Slide 87 The global haemophilia market is growing by mid-single digits Strategic positioning of Novo Nordisk’s Sales of recombinant coagulation factors haemophilia portfolio NovoSeven® Recombinate®/Advate® Rixubis® Novo Nordisk Coagil VII® Kogenate®/Helixa
Slide 88: NovoSeven® − a unique biologic for the treatment of rare bleeding disorders
Investor presentation First quarter of 2016 Slide 88 NovoSeven® − a unique biologic for the treatment of rare bleeding disorders NovoSeven® reported sales Key NovoSeven® properties DKK • Product characteristics: powder and solvent for solution billion for intravenous injection, available in multiple
Slide 89: NovoEight® is launched in the US, Europe and Japan
Investor presentation First quarter of 2016 Slide 89 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 pa
Slide 90: NovoThirteen® provides efficacious and safe haemostatic coverage
Investor presentation First quarter of 2016 Slide 90 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 a
Slide 91: R&D pipeline: Haemophilia and growth disorders
Investor presentation First quarter of 2016 Slide 91 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
Slide 92: N9-GP administered once weekly reduces median bleeding rate in phase 3 trial
Investor presentation First quarter of 2016 Slide 92 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) •
Slide 93: N8-GP administered every fourth day reduces median bleeding rate in phase 3 trial
Investor presentation First quarter of 2016 Slide 93 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)1 FVIII activity FVIII N8-GP • PK documented single dose half-life of 1
Slide 94: Novo Nordisk continues to expand leadership within human growth hormone market
Investor presentation First quarter of 2016 Slide 94 Novo Nordisk continues to expand 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 Roc
Slide 95: Solid Norditropin® sales growth
Investor presentation First quarter of 2016 Slide 95 Solid Norditropin® sales growth Norditropin® reported sales Key Norditropin® properties DKK • Product characteristics: Premixed, prefilled multi-use billion delivery systems available in multiple strengths, and stable at room temperature 2.0 CAGR1
Slide 96: Financials
Investor presentation First quarter of 2016 Slide 96 Financials
Slide 97: Novo Nordisk has delivered sustained double digit growth throughout the last decade
Investor presentation First quarter of 2016 Slide 97 Novo Nordisk has delivered sustained double digit growth throughout the last decade Sales growth in local currencies Operating profit growth in local currencies 2006–2015 2006–2015 Sales growth Average growth Operating profit growth Average growth
Slide 98: Solid sales growth driven by the US, International Operations and Region China
Investor presentation First quarter of 2016 Slide 98 Solid sales growth driven by the US, International Operations and Region China Reported annual sales Reported annual sales split by region DKK Diabetes Biopharmaceuticals USA Europe Int. Operations billion Region China Pacific 120 CAGR1 12.9% 5% T
Slide 99: Solid operating profit growth driven by diabetes
Investor presentation First quarter of 2016 Slide 99 Solid operating profit growth driven by diabetes Operating profit Operating profit therapy split1 DKK Operating profit Operating profit as % of sales Diabetes Biopharm billion Operating profit growth vs last year 60 Operating profit growth in loca
Slide 100: Profitability per segment
Investor presentation First quarter of 2016 Slide 100 Profitability per segment Diabetes P&L – full year 2015 Biopharmaceuticals1 P&L – full year 2015 DKK DKK billion billion 100 30 -16% 80 -29% 24 -11% -15% 60 18 -14% -12% -4% +1% 57% 40 -4% +1% 40% 12 20 6 0 0 Sales COGS S&D R&D Admin OOI OP Sales
Slide 101: Decline in relative COGS level combined with stable investment level
Investor presentation First quarter of 2016 Slide 101 Decline in relative COGS level combined with stable investment level Cost of Goods Sold (COGS) Capital Expenditure (CAPEX) DKK COGS as % of sales DKK CAPEX as % of sales billion COGS billion CAPEX 15 25% 6 6% Thousands 20% 5 5% 10 4 4% 15% 3 3% 1
Slide 102: Limited future productivity gains expected in manufacturing
Investor presentation First quarter of 2016 Slide 102 Limited future productivity gains expected, reflecting an increasing level of manufacturing complexity and maturity After significant improvements, reductions in The complexity of molecules by number of unit costs of mature products are declining
Slide 103: Long term financial targets: Operating profit growth and operating margin
Investor presentation First quarter of 2016 Slide 103 Long term financial targets: Operating profit growth and operating margin Operating profit growth Operating margin New long term financial target Previous long term financial targets Previous long term financial targets 35% 45% 30% 25% 20% 30% 15
Slide 104: Long term financial targets: Operating profit after tax to net operating assets and cash to earnings
Investor presentation First quarter of 2016 Slide 104 Long term financial targets: Operating profit after tax to net operating assets and cash to earnings Cash to earnings Operating profit after tax to net operating assets (three year average) New long term financial target New long term financial t
Slide 105: Organic growth enables steady cash return to shareholders
Investor presentation First quarter of 2016 Slide 105 Organic growth enables steady cash return to shareholders via dividends and share repurchase programmes Share repurchase programmes have enabled Annual cash return to shareholders continued reduction in share capital DKK DKK Share capital Free ca
Slide 106: Stable ownership structure
Investor presentation First quarter of 2016 Slide 106 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 st
Slide 107: Sustainability
Investor presentation First quarter of 2016 Slide 107 Sustainability
Slide 108: We are guided by a strong values-based management system
Investor presentation First quarter of 2016 Slide 108 We are guided by a strong values-based management system with patients at the centre of everything we do The Novo Nordisk way The Triple Bottom Line business principle • Our ambition is to strengthen our leadership in diabetes. • We aspire to cha
Slide 109: Long term social performance targets
Investor presentation First quarter of 2016 Slide 109 Long term social performance targets Patients reached with diabetes care products Working the Novo Nordisk Way Realised Target (2020) Realised Target Number of people million1 Average score2 60 5 50 4 40 3 30 2 20 1 10 0 0 2011 2015 2011 2015 1 N
Slide 110: Treating 40 million patients with diabetes by 2020
Investor presentation First quarter of 2016 Slide 110 Treating 40 million patients with diabetes by 2020 is a long term target to be achieved by addressing needs locally Number of patients treated with To reach our target, the global strategy is Novo Nordisk’s diabetes care products translated into
Slide 111: Changing Diabetes® initiatives aim at changing the rule of halves
Investor presentation First quarter of 2016 Slide 111 Changing Diabetes® initiatives aim at changing the rule of halves Prevention Diagnosis Access to care Reach target Desired outcome Initiative examples Prevent in • Changing Diabetes® in Pregnancy future generations • Changing Future Health • Worl
Slide 112: Cities Changing Diabetes aims to break the Rule of Halves
Investor presentation First quarter of 2016 Slide 112 Cities Changing Diabetes aims to break the Rule of Halves and stop urban diabetes from ruining millions of lives • Cities Changing Diabetes is our response Urban diabetes is on the rise Public-private partnerships City partners City leaders Globa
Slide 113: Long term environmental performance targets
Investor presentation First quarter of 2016 Slide 113 Long term environmental performance targets Energy consumption Water consumption Target (not to exceed)* Target (not to exceed)* Realised Realised 1,000,000 GJ 1,000,000 m3 4 4 3 3 2 2 1 1 0 0 2011 2015 2011 2015 * From 2007 to 2011 the target wa