Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — FY2015 Earnings Presentation
114 slides from Novo Nordisk A/s Class B's earnings presentation, Feb 3, 2016
Slide 1: Investor presentation Full year 2015
Slide 1 Investor presentation Full year 2015 Copenhagen, 3 February 2016 Shanghai – part of Cities Changing Diabetes
Slide 2: Agenda
Investor presentation Full year 2015 Slide 2 Agenda Highlights and key events Sales update R&D update Financials and outlook
Slide 3: Forward-looking statements
Investor presentation Full year 2015 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 continuation of t
Slide 4: Highlights – Full year 2015
Investor presentation Full year 2015 Slide 4 Highlights – Full year 2015 Sales development • Sales increased by 22% in Danish kroner and 8% in local currencies • North America and International Operations grew by 32% and 19% in Danish kroner, respectively • Victoza® increased by 34% in Danish kroner
Slide 5: North America is the main contributor to growth
Investor presentation Full year 2015 Slide 5 North America is the main contributor to growth Sales as reported – Full year 2015 Growth analysis – Full year 2015 Japan & Korea Local currencies Growth Share of growth Region China +11% North America 11% 62% +22% 5% 9% Europe 2% 4% International Interna
Slide 6: Growth is driven by modern insulin and Victoza
Investor presentation Full year 2015 Slide 6 Growth is driven by modern insulin and Victoza® Sales as reported – Full year 2015 Growth analysis – Full year 2015 Other Local currencies Growth Share of growth Norditropin® +28% New-generation insulin1 109% 10% +20% 3% 4% Modern insulin 7% 41% 7% 7% Hae
Slide 7: Victoza maintains leadership in the faster growing US GLP-1 market
Investor presentation Full year 2015 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 dulaglutide 6,000
Slide 8: North America drives strong Levemir growth despite increased competition
Investor presentation Full year 2015 Slide 8 North America drives strong Levemir® growth despite increased competition Levemir® sales growth driven by strong Levemir® has gained US market share performance in North America despite introduction of glargine U300 DKK Growth in local currency Levemir® N
Slide 9: Roll-out of Tresiba is progressing and Tresiba is now launched in the US
Investor presentation Full year 2015 Slide 9 Roll-out of Tresiba® is progressing and Tresiba® is now launched in the US Tresiba® value share of basal insulin segment Key launch observations in selected countries Switzerland Netherlands UK India • Tresiba® launched in 39 countries Japan Sweden Argent
Slide 10: Steady prescription uptake for Saxenda
Investor presentation Full year 2015 Slide 10 Steady prescription uptake for Saxenda® Prescription volume uptake of anti-obesity medications (AOM) recently launched in the US Key observations TRx Contrave® Belviq® • Encouraging Saxenda® uptake continues in Q4 2015 despite Volume(000) Qsymia® Saxenda
Slide 11: Tresiba shows lower rate of hypoglycaemia than insulin glargine in SWITCH 2 trial
Investor presentation Full year 2015 Slide 11 Tresiba® shows lower rate of hypoglycaemia than insulin glargine in SWITCH 2 trial SWITCH 2 Trial design Headline results Event rate per 100 Tresiba® Tresiba® Tresiba® patient years exposed in Tresiba® IGlar reduction once daily once daily maintenance pe
Slide 12: Semaglutide shows best in-class potential on HbA1c reduction
Investor presentation Full year 2015 Slide 12 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 and 4 trials % patients HbA1c ≤7% Sema 1 mg Sema 0.5 mg Placebo Sitagliptin 100 mg Exenatide Q
Slide 13: Semaglutide shows best in-class weight lowering potential
Investor presentation Full year 2015 Slide 13 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 and 4 trials Sema 1 mg Sema 0.5 mg Placebo Sitagliptin 100 mg Exenatide QW Insulin glargine QD S
Slide 14: Key development milestones
Investor presentation Full year 2015 Slide 14 Key development milestones • Phase 3b trial initiated comparing Xultophy® (IDegLira) (NN9068) with insulin glargine in 104-week study • Faster-acting insulin aspart (NN1218) filed for regulatory approval in the EU and the US for the treatment of type 1 a
Slide 15: Strong R&D newsflow expected to continue in 2016
Investor presentation Full year 2015 Slide 15 Strong R&D newsflow expected to continue in 2016 Results available Project Past 3 months Within 3 months Within 6 months In ~6-9 months In ~9-12 months SWITCH 2 √ Tresiba® SWITCH 1 DEVOTE SUSTAIN 2 √ Once-weekly SUSTAIN 4 √ semaglutide SUSTAIN 5 SUSTAIN
Slide 16: Financial results – Full year 2015
Investor presentation Full year 2015 Slide 16 Financial results – Full year 2015 DKK million 2015 2014 Change Sales 107,927 88,806 22% Gross profit 91,739 74,244 24% Gross margin 85.0% 83.6% Sales and distribution costs 28,312 23,223 22% Percentage of sales 26.2% 26.2% Research and development costs
Slide 17: Appreciation of key currencies drives positive currency impact in 2015
Investor presentation Full year 2015 Slide 17 Appreciation of key currencies against the Danish krone drive significant positive currency impact in 2015 USD/DKK CNY/DKK JPY/DKK GBP/DKK CAD/DKK 135 Index (1 Jan 2014 = 100) Hedged 2014 2015 Spot Impact of a Hedging 130 Currencies average average2 rate
Slide 18: Financial outlook for 2016
Investor presentation Full year 2015 Slide 18 Financial outlook for 2016 Expectations 3 February 2016 Sales growth - local currencies 5-9% Sales growth - reported Around 1 percentage point lower Operating profit growth - local currencies 5-9% Operating profit growth - reported Around 1 percentage po
Slide 19: Long-term financial targets based on double digit growth for diabetes care
Investor presentation Full year 2015 Slide 19 Long-term financial targets are based on the pursuit of double digit growth for the diabetes care franchise Reported Novo Nordisk Expected future growth drivers for diabetes care sales by treatment class Novo Nordisk’s diabetes care franchise DKK Insulin
Slide 20: Updated long-term financial targets
Investor presentation Full year 2015 Slide 20 Updated long-term financial targets Performance against long-term financial targets Average Result Previous Updated 2012-20151 2015 Target2 Target Operating profit growth 23% 43% 15% 10% Operating profit growth in local currencies3 15% 14% Operating marg
Slide 21: Organic growth enables steady cash return to shareholders
Investor presentation Full year 2015 Slide 21 Organic growth enables steady cash return to shareholders via dividends and share repurchase programmes Proposed dividend and Annual cash return to shareholders introduction of interim dividend DKK Free cash flow Share repurchase Dividend • Board of Dire
Slide 22: Closing remarks
Investor presentation Full year 2015 Slide 22 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 • 28% market share in diabetes care and solid • Semag
Slide 23: Investor contact information
Investor presentation Full year 2015 Slide 23 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 24: Appendix
Investor presentation Full year 2015 Slide 24 Appendix 1. Novo Nordisk at a glance 2. Diabetes 3. Biopharmaceuticals 4. Financials 5. Sustainability
Slide 25: Novo Nordisk at a glance
Investor presentation Full year 2015 Slide 25 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: 47% Europe: in diabetes, haemophilia and growth hormone Market share 47% • Pur
Slide 26: Four strategic focus areas based on five core capabilities
Investor presentation Full year 2015 Slide 26 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- produc
Slide 27: Leading positions in diabetes, haemophilia and growth disorders
Investor presentation Full year 2015 Slide 27 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 28: Double digit top line growth driven by diabetes pandemic
Investor presentation Full year 2015 Slide 28 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 North America Europe Japan
Slide 29: Strong leadership position within the growing diabetes care market
Investor presentation Full year 2015 Slide 29 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 Merck Eli Lilly billion AstraZeneca Nov
Slide 30: Growth opportunities fuelled by strong R&D pipeline
Investor presentation Full year 2015 Slide 30 Significant growth opportunities fuelled by strong R&D pipeline across all four strategic focus areas PHASE 1 PHASE 2 PHASE 3 SUBMITTED APPROVED5 LAI287 – QW basal insulin OG217SC – Oral GLP-11 Semaglutide – QW GLP-1 Xultophy® (US) Levemir® OI320GT – Ora
Slide 31: Strong global presence in sales and manufacturing
Investor presentation Full year 2015 Slide 31 Growth opportunities supported by strong global presence in both sales and manufacturing FTEs in sales regions1 Global manufacturing setup Denmark (~9,100 FTEs) Kaluga, Russia (~200 FTEs) North America: ~5,300 • Diabetes and biopharmaceutical • Filling W
Slide 32: High barriers to entry in biologics
Investor presentation Full year 2015 Slide 32 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 & 202922
Slide 33: Diabetes and obesity
Investor presentation Full year 2015 Slide 33 Diabetes and obesity
Slide 34: Diabetes – the inability to manage blood sugar levels
Investor presentation Full year 2015 Slide 34 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 effectively u
Slide 35: Insulin – a hormone enabling blood sugar to enter cells
Investor presentation Full year 2015 Slide 35 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 cells meal-
Slide 36: Diabetes pandemic is fuelled by growing rates of obesity
Investor presentation Full year 2015 Slide 36 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 Data <4.5
Slide 37: Poor diagnosis rates and poor glycaemic control remain global problems
Investor presentation Full year 2015 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 2015 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 2015 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 2015 Slide 40 The insulin market is comprised of three segments Insulin action profiles Global insulin volume market by segment tMU CAGR volume1: 4.8% Fast-acting CAGR value1: 19.6% 450 400 350 39% 300 Fast-acting 36% Premix 250 200 27% Premix 30% 150 Long-acting 100
Slide 41: Medications used for the treatment of type 2 diabetes
Investor presentation Full year 2015 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: Sustained double-digit growth in insulin market
Investor presentation Full year 2015 Slide 42 Sustained double-digit growth in insulin market The fundamental growth drivers Global insulin market growth of the insulin market DKK billion Volume 250 CAGR: CAGR: • Rising prevalence of diabetes 14.9%1 19.6%1 • Growing overweight and obesity prevalence
Slide 43: Solid insulin volume growth in key regions
Investor presentation Full year 2015 Slide 43 Solid insulin volume growth in key regions Novo Nordisk Market Market volume Volume market regions value1 size & growth composition shares 43% 160.6 39% 110.4 3% 51% North America 62% 38% 11% 26.6 2% 3% 28.1 39% Europe 40% 53% 47% 21% International 9.5 1
Slide 44: Stable global insulin volume growth
Investor presentation Full year 2015 Slide 44 Stable global insulin volume growth Regional insulin volume growth Regional insulin volume market split North America Europe Int. Operations North America Europe Int. Operations China Japan & Korea World China Japan & Korea 35% 100% 9% 30% 80% 22% 25% 3%
Slide 45: Maintaining insulin leadership by sustaining modern insulin market share
Investor presentation Full year 2015 Slide 45 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 250 100% 500 100% 500 100% Ma
Slide 46: Strong underlying insulin market growth and steady market share
Investor presentation Full year 2015 Slide 46 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 500 100% 60% CAGR v
Slide 47: Modern insulins continue strong performance within their segments
Investor presentation Full year 2015 Slide 47 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® market
Slide 48: Significant potential on the US modern insulin market
Investor presentation Full year 2015 Slide 48 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: 1.7% Penetra
Slide 49: Modern insulins have gained market share in expanding US market
Investor presentation Full year 2015 Slide 49 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® marke
Slide 50: US health insurance dominated by few large commercial payers
Investor presentation Full year 2015 Slide 50 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 market has
Slide 51: Sustained leadership on the European modern insulin market
Investor presentation Full year 2015 Slide 51 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: 2.3% Pene
Slide 52: Stable leadership position in International Operations
Investor presentation Full year 2015 Slide 52 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 tMU CAGR
Slide 53: Sustained leadership position in the Chinese insulin market
Investor presentation Full year 2015 Slide 53 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 volume
Slide 54: Expanding market leadership position in Japan
Investor presentation Full year 2015 Slide 54 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: -0.4% Penetration 14 CAGR value1
Slide 55: Promising Tresiba performance strengthens insulin market share in Japan
Investor presentation Full year 2015 Slide 55 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 glargine U300 biosimi
Slide 56: GLP-1 effect dependent on level of blood glucose
Investor presentation Full year 2015 Slide 56 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 57: GLP-1 share of the global diabetes care market is increasing
Investor presentation Full year 2015 Slide 57 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 of dia
Slide 58: Victoza has a strong position in DPP-IV, GLP-1 and SGLT-2 segment
Investor presentation Full year 2015 Slide 58 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 140 100% 80% 16% 13% 120 80% CAGR1 value: 60% 100 36.6% 8
Slide 59: The US GLP-1 market continues to expand
Investor presentation Full year 2015 Slide 59 The US GLP-1 market continues to expand 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 500 10% 56%1 400 8% • Roughly 67% of
Slide 60: Key diabetes care products remain broadly available in the US
Investor presentation Full year 2015 Slide 60 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 61: R&D pipeline: Diabetes and obesity
Investor presentation Full year 2015 Slide 61 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 Type 1+
Slide 62: Current and future product portfolio covers type 2 diabetes treatment flow
Investor presentation Full year 2015 Slide 62 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 63: Growth supported by numerous planned launches
Investor presentation Full year 2015 Slide 63 Novo Nordisk’s growth opportunities are supported by numerous planned launches within the coming years Launch country segment volume as share of global segment volume 2013 & 2014 2015 2016E 2017E 2018E ® Tresiba® ® Ryzodeg® ® Xultophy® Faster-acting insu
Slide 64: Competitive Tresiba label across all three triad markets
Investor presentation Full year 2015 Slide 64 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 at lea
Slide 65: US Tresiba label reflects distinct product features
Investor presentation Full year 2015 Slide 65 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 • Once da
Slide 66: SWITCH 1 trial ongoing with Tresiba vs insulin glargine
Investor presentation Full year 2015 Slide 66 SWITCH 1 trial ongoing with Tresiba® vs insulin glargine to further assess hypoglycaemia profile in type 1 diabetes Trial designs Purpose and endpoints Purpose • To document hypoglycaemia benefit in type 1 diabetes Tresiba® Tresiba® once daily once daily
Slide 67: Real-world data for Tresiba confirms strong clinical profile
Investor presentation Full year 2015 Slide 67 Real-world data for Tresiba® confirms strong clinical profile and enables uptake Study design – Danderyd Diabetes Clinic Study aim and key results • Study aim: Exploring whether the higher cost of insulin An independent, prospective, degludec compared wi
Slide 68: Faster-acting insulin aspart superior to NovoRapid in onset 1 trial
Investor presentation Full year 2015 Slide 68 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 innovative fo
Slide 69: Insulin LAI287 offers potential for once-weekly dosing
Investor presentation Full year 2015 Slide 69 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 70: Oral insulin OI338GT potential to control blood glucose
Investor presentation Full year 2015 Slide 70 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 OI338GT +
Slide 71: Liver-preferential prandial insulin analogue
Investor presentation Full year 2015 Slide 71 Liver-preferential prandial 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 72: Competitive European label for Xultophy
Investor presentation Full year 2015 Slide 72 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 liraglutide ha
Slide 73: Xultophy has documented strong efficacy across the treatment cascade
Investor presentation Full year 2015 Slide 73 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
Slide 74: SUSTAIN phase 3a programme for semaglutide
Investor presentation Full year 2015 Slide 74 SUSTAIN® phase 3a programme to support a broad competitive label for semaglutide1 2013 2014 2015 2016 SUSTAIN® 1: Monotherapy 30 weeks, n= 400 SUSTAIN® 2: Semaglutide vs sitagliptin 56 weeks, n= 1,200 SUSTAIN® 3: Semaglutide vs exenatide once-weekly 56 w
Slide 75: Oral peptide delivery challenges and solutions
Investor presentation Full year 2015 Slide 75 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 76: Oral semaglutide reduced HbA1c and body weight in phase 2 trial
Investor presentation Full year 2015 Slide 76 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 77: Anti-IL 21 with liraglutide for type 1 diabetes
Investor presentation Full year 2015 Slide 77 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 78: More than 20 million people in the US have a BMI above 35
Investor presentation Full year 2015 Slide 78 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 79: Significant unmet need in obesity management
Investor presentation Full year 2015 Slide 79 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 80: Small but growing market for anti-obesity medication in the US
Investor presentation Full year 2015 Slide 80 Small but growing market for anti-obesity medication in the US Value of US obesity market Few people treated with AOM in US, but recent remains small, but it is growing launches have contributed to market growth USD TRx volume Generic TRx volume Branded
Slide 81: Saxenda demonstrated weight loss in all SCALE trials
Investor presentation Full year 2015 Slide 81 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 weeks an
Slide 82: Competitive US label for Saxenda
Investor presentation Full year 2015 Slide 82 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 83: Saxenda targeted at patients with BMI ≥35 and comorbidities
Investor presentation Full year 2015 Slide 83 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 84: Semaglutide once daily phase 2 dose-finding trial in obesity
Investor presentation Full year 2015 Slide 84 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 85: Long-acting obesity compounds in phase 1 development
Investor presentation Full year 2015 Slide 85 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 subcut
Slide 86: Biopharmaceuticals
Investor presentation Full year 2015 Slide 86 Biopharmaceuticals
Slide 87: Haemophilia: Location of bleedings and the consequences
Investor presentation Full year 2015 Slide 87 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 88: Haemophilia is a rare disease with severe unmet medical needs
Investor presentation Full year 2015 Slide 88 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 89: The global haemophilia market is growing by mid-single digits
Investor presentation Full year 2015 Slide 89 The global haemophilia market is growing by mid-single digits Strategic positioning of Novo Nordisk’s Sales of recombinant coagulation factors haemophilia portfolio DKK NovoSeven® Coagil VII ® Xyntha®/Refacto® Benefix® Novo Nordisk billion Kogenate®/Heli
Slide 90: NovoSeven – a unique biologic for rare bleeding disorders
Investor presentation Full year 2015 Slide 90 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 doses,
Slide 91: NovoEight launched in the US, Europe and Japan
Investor presentation Full year 2015 Slide 91 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 92: NovoThirteen provides efficacious and safe haemostatic coverage
Investor presentation Full year 2015 Slide 92 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 93: R&D pipeline: Haemophilia and growth disorders
Investor presentation Full year 2015 Slide 93 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 94: N9-GP once weekly reduces median bleeding rate in phase 3 trial
Investor presentation Full year 2015 Slide 94 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) • Median
Slide 95: N8-GP every fourth day reduces median bleeding rate in phase 3
Investor presentation Full year 2015 Slide 95 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 18.4 hou
Slide 96: Novo Nordisk continues to expand leadership in growth hormone market
Investor presentation Full year 2015 Slide 96 Novo Nordisk continues to expand leadership within growth hormone 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% 32% T
Slide 97: Solid Norditropin sales growth
Investor presentation Full year 2015 Slide 97 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 10.7%
Slide 98: Financials
Investor presentation Full year 2015 Slide 98 Financials
Slide 99: Sustained double digit growth throughout the last decade
Investor presentation Full year 2015 Slide 99 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 30% 30
Slide 100: Solid sales growth with North America, IO and China expanding
Investor presentation Full year 2015 Slide 100 Solid sales growth with especially North America, International Operations and Region China expanding Reported annual sales Reported annual sales split by region DKK Diabetes Biopharmaceuticals North America Europe Int. Operations billion China Japan &
Slide 101: Solid operating profit growth driven by diabetes
Investor presentation Full year 2015 Slide 101 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 local curr
Slide 102: Profitability per segment
Investor presentation Full year 2015 Slide 102 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 COGS S
Slide 103: Continued decline in relative COGS with stable investment level
Investor presentation Full year 2015 Slide 103 Continued 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
Slide 104: Limited future productivity gains expected
Investor presentation Full year 2015 Slide 104 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 API si
Slide 105: Long term financial targets: operating profit growth and margin
Investor presentation Full year 2015 Slide 105 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% 10% 1
Slide 106: Long term financial targets: returns and cash to earnings
Investor presentation Full year 2015 Slide 106 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 target New long term financial target P
Slide 107: Stable ownership structure
Investor presentation Full year 2015 Slide 107 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 108: Sustainability
Investor presentation Full year 2015 Slide 108 Sustainability
Slide 109: Guided by a strong values-based management system
Investor presentation Full year 2015 Slide 109 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 change pos
Slide 110: Long term social performance targets
Investor presentation Full year 2015 Slide 110 Long term social performance targets Patients reached with Working the diabetes care products 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 Novo Nor
Slide 111: Treating 40 million patients with diabetes by 2020
Investor presentation Full year 2015 Slide 111 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 local a
Slide 112: Changing Diabetes initiatives aim at changing the rule of halves
Investor presentation Full year 2015 Slide 112 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 • World Diabe
Slide 113: Cities Changing Diabetes aims to stop urban diabetes
Investor presentation Full year 2015 Slide 113 Cities Changing Diabetes aims to break the Rule of Halves and stop urban diabetes from ruining millions of lives Urban diabetes is on the rise Cities Changing Diabetes is our response Public-private partnerships City partners City leaders Global fight a
Slide 114: Long term environmental performance targets
Investor presentation Full year 2015 Slide 114 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 was set a