Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — 9M 2016 Earnings Presentation
113 slides from Novo Nordisk A/s Class B's earnings presentation, Oct 28, 2016
Slide 1: Investor presentation First nine months of 2016
Slide 1 Investor presentation First nine months of 2016 Shanghai – part of Cities Changing Diabetes
Slide 2: Agenda
Investor presentation First nine months 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 nine months 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 contin
Slide 4: Highlights – First nine months of 2016
Investor presentation First nine months of 2016 Slide 4 Highlights – First nine months of 2016 Sales development • Sales increased by 6% in local currencies and 4% in Danish kroner • USA grew by 6% in local currencies and accounted for 44% share of growth in local currencies • International Operatio
Slide 5: All regions contribute to sales growth in local currencies
Investor presentation First nine months of 2016 Slide 5 All regions contribute to sales growth measured in local currencies for the first nine months of 2016 Sales as reported – first nine months of 2016 Growth analysis – first nine months of 2016 Pacific Local currencies Growth Share of growth +11%
Slide 6: Continued modest US sales growth in the third quarter of 2016
Investor presentation First nine months of 2016 Slide 6 Continued modest US sales growth in the third quarter of 2016 Quarterly sales in the US Key factors impacting sales growth Sales as reported MAT quarterly local currency growth % • Sales growth primarily driven by Tresiba®, Victoza® and bDKK Av
Slide 7: Sales growth rebounds in China in the first nine months of 2016
Investor presentation First nine months of 2016 Slide 7 Sales growth rebounds in China in the first nine months of 2016 Quarterly sales in China Key factors impacting sales growth Sales as reported MAT quarterly local currency growth % • Increasing modern insulin sales growth driven by: Average loca
Slide 8: Sales growth is driven by new-generation insulin and Victoza
Investor presentation First nine months of 2016 Slide 8 Sales growth is driven by new-generation insulin and Victoza® Sales as reported – first nine months of 2016 Growth analysis – first nine months of 2016 Local currencies Growth Share of growth Other biopharmaceuticals Norditropin® +3% New-genera
Slide 9: Victoza maintains leadership in the faster growing US GLP-1 market
Investor presentation First nine months of 2016 Slide 9 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 Growt
Slide 10: Roll-out of new-generation insulin portfolio is progressing
Investor presentation First nine months of 2016 Slide 10 Roll-out of new-generation insulin portfolio is progressing Tresiba® value share of basal insulin segment Key launch observations in selected countries, excluding the USA Switzerland Netherlands UK India • Tresiba® launched in 47 countries wit
Slide 11: Steady uptake of Tresiba in the USA
Investor presentation First nine months of 2016 Slide 11 Steady uptake of Tresiba® in the USA Weekly US NBRx volume market shares Tresiba® launched in the USA Tresiba® Levemir® NN Total Basal • Full commercial launch in January 2016 following specialist Basal glargine U100 glargine U300 engagement i
Slide 12: Semaglutide significantly reduced risk of major cardiovascular events in SUSTAIN 6
Investor presentation First nine months of 2016 Slide 12 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 semaglut
Slide 13: Updated R&D strategy including raised innovation threshold in diabetes
Investor presentation First nine months of 2016 Slide 13 Updated R&D strategy including a raised innovation threshold for R&D projects specifically within diabetes Utilisation of core protein capabilities to enter adjacent areas Updated R&D strategy • R&D strategy and priorities have been updated to
Slide 14: Key development milestones
Investor presentation First nine months of 2016 Slide 14 Key development milestones Supplemental application for the SWITCH hypoglycaemia trials submitted for Tresiba® (NN1250) in the US Supplemental applications for the LEADER CV trial submitted for Victoza® (NN2211) in the US and EU FDA extended r
Slide 15: R&D news flow with several regulatory decisions in the past six months
Investor presentation First nine months of 2016 Slide 15 R&D news flow with several regulatory decisions in the past six months Results available Regulatory milestone Project Past 6-9 months Past 3-6 months Within 3 months In ~3-6 months Variation application DEVOTE Tresiba® SWITCH 1 √ in the USA √
Slide 16: Financial results – first nine months of 2016
Investor presentation First nine months of 2016 Slide 16 Financial results – first nine months of 2016 DKK million 9M 2016 9M 2015 Change Sales 82,208 79,051 4% Gross profit 69,943 67,471 4% Gross margin 85.1% 85.4% Sales and distribution costs (20,468) (20,273) 1% Percentage of sales 24.9% 25.6% Re
Slide 17: Negative currency impact in 2016
Investor presentation First nine months of 2016 Slide 17 Negative 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 average
Slide 18: Financial outlook for 2016
Investor presentation First nine months of 2016 Slide 18 Financial outlook for 2016 Expectations Previous expectations 28 Oct 2016 5 Aug 2016 Sales growth - local currencies 5-6% 5-7% Sales growth - reported Around 2 percentage points lower Around 2 percentage point lower Operating profit growth - l
Slide 19: Updated long-term financial targets
Investor presentation First nine months of 2016 Slide 19 Updated long-term financial targets Challenging environment in the US leads to the Updated operating profit growth target of 5% update of operating profit target Previous Updated • Updated operating profit growth target of 5% on average primar
Slide 20: Closing remarks
Investor presentation First nine months of 2016 Slide 20 Closing remarks Solid market performance Promising pipeline > > • The only company with a full portfolio of novel • 27% value market share in diabetes care insulin and GLP-1 products and solid leadership position • Semaglutide portfolio offers
Slide 21: Investor contact information
Investor presentation First nine months of 2016 Slide 21 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 Yor
Slide 22: Appendix
Investor presentation First nine months of 2016 Slide 22 Appendix 1. Novo Nordisk at a glance 2. Diabetes 3. Biopharmaceuticals 4. Financials 5. Sustainability
Slide 23: Novo Nordisk at a glance
Investor presentation First nine months of 2016 Slide 23 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 shar
Slide 24: Four strategic focus areas based on five core capabilities
Investor presentation First nine months of 2016 Slide 24 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 maintainin
Slide 25: Leading positions in diabetes, haemophilia and growth disorders
Investor presentation First nine months of 2016 Slide 25 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
Slide 26: Top line growth driven by the diabetes pandemic
Investor presentation First nine months of 2016 Slide 26 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 USA Europe Pacific
Slide 27: Strong leadership position within growing diabetes care market
Investor presentation First nine months of 2016 Slide 27 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 Astr
Slide 28: Growth opportunities fuelled by strong R&D pipeline
Investor presentation First nine months of 2016 Slide 28 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 Semaglutide – QW GLP-1 Xultophy® (US) Levemir® N
Slide 29: Strong global presence in sales and manufacturing
Investor presentation First nine months of 2016 Slide 29 Growth opportunities supported by strong global presence in both sales and manufacturing FTEs in sales regions1 Global manufacturing setup Denmark (~9,700 FTEs) Kaluga, Russia (~230 FTEs) USA: ~5,100 • Diabetes and biopharmaceutical • Filling
Slide 30: High barriers to entry in biologics
Investor presentation First nine months of 2016 Slide 30 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 Researc
Slide 31: Diabetes and obesity
Investor presentation First nine months of 2016 Slide 31 Diabetes and obesity
Slide 32: Diabetes – the inability to manage blood sugar levels
Investor presentation First nine months of 2016 Slide 32 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 g
Slide 33: Diabetes pandemic is fuelled by growing rates of obesity
Investor presentation First nine months of 2016 Slide 33 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 N
Slide 34: Poor diagnosis rates and glycaemic control remain global problems
Investor presentation First nine months of 2016 Slide 34 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 ty
Slide 35: UKPDS: Tight glycaemic control reduces complication risk
Investor presentation First nine months of 2016 Slide 35 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 Microv
Slide 36: Insulin is the ultimate care for people with diabetes
Investor presentation First nine months of 2016 Slide 36 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
Slide 37: The insulin market is comprised of three segments
Investor presentation First nine months of 2016 Slide 37 The insulin market is comprised of three segments Insulin action profiles Global insulin volume market by segment CAGR volume1: 4.6% tMU CAGR value1: 20.4% Fast-acting 450 400 350 40% Long-acting 300 37% Premix 250 26% 200 Premix 29% 150 100 3
Slide 38: Medications used for the treatment of type 2 diabetes
Investor presentation First nine months of 2016 Slide 38 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 Metf
Slide 39: Solid position in diabetes care market across all regions
Investor presentation First nine months of 2016 Slide 39 Solid position in the diabetes care market across all regions with leading insulin market share Diabetes care value Diabetes care value Insulin market Insulin volume Regions market composition market share volume composition market share 29% 3
Slide 40: Stable global insulin volume growth
Investor presentation First nine months 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% 9% 80% 20% 21% 60% 15
Slide 41: Maintaining global insulin leadership
Investor presentation First nine months of 2016 Slide 41 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
Slide 42: Strong underlying insulin market growth and sustained market share
Investor presentation First nine months of 2016 Slide 42 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
Slide 43: Modern insulins continue solid performance within segments
Investor presentation First nine months of 2016 Slide 43 Novo Nordisk’s modern insulins continue solid 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 Levemi
Slide 44: Solid US modern insulin market share
Investor presentation First nine months of 2016 Slide 44 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 140 CAGR value1: 28.6% 100
Slide 45: Modern insulins maintain market share in expanding US market
Investor presentation First nine months of 2016 Slide 45 Novo Nordisk’s modern insulins maintain 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 NovoLog® Mix 70/30 market sh
Slide 46: US health insurance dominated by few large commercial payers
Investor presentation First nine months of 2016 Slide 46 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 and health plans covered 245 expected to remain stable in coming years milli
Slide 47: Leadership position in European modern insulin market
Investor presentation First nine months of 2016 Slide 47 Sustained 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
Slide 48: Stable leadership position in International Operations
Investor presentation First nine months of 2016 Slide 48 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 Bioco
Slide 49: Continued solid growth in Chinese insulin market
Investor presentation First nine months of 2016 Slide 49 Continued 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 Shanghai Fosun tMU Penetration Tonghua Dongbao Sa
Slide 50: Solid market leadership position in Japan
Investor presentation First nine months of 2016 Slide 50 Solid 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: -0.8% Penetration 14 CAGR
Slide 51: Solid Tresiba performance strengthens insulin share in Japan
Investor presentation First nine months of 2016 Slide 51 Solid 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 Eli Lilly Sanofi glargine U100 glargine
Slide 52: GLP-1 effect dependent on level of blood glucose
Investor presentation First nine months of 2016 Slide 52 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
Slide 53: GLP-1 share of global diabetes care market is increasing
Investor presentation First nine months of 2016 Slide 53 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 DKK GLP-
Slide 54: Increasing global GLP-1 volume growth across all regions
Investor presentation First nine months of 2016 Slide 54 Increasing global GLP-1 volume growth across all regions Regional GLP-1 volume growth Regional GLP-1 volume market split USA Europe Int. Operations USA Europe Pacific Pacific World Region China Int. Operations Region China 60% 100% 1% 5% 10% 5
Slide 55: GLP-1 segment accounts for 11% of US diabetes care market
Investor presentation First nine months of 2016 Slide 55 The GLP-1 segment accounts for 11% of the total diabetes care market in the US US GLP-1 market Key observations for Victoza® in the US market GLP-1 value Victoza® albiglutide Share of total • Victoza® volume market share within the GLP-1 segme
Slide 56: GLP-1 segment accounts for 9% of European diabetes care market
Investor presentation First nine months of 2016 Slide 56 The GLP-1 segment accounts for 9% 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 exena
Slide 57: GLP-1 segment in International Operations
Investor presentation First nine months of 2016 Slide 57 The GLP-1 segment accounts for around 3% of the total diabetes care market in International Operations Victoza® value market share in International Operations GLP-1 market International Operations GLP-1 value Victoza® exenatide Share of total
Slide 58: GLP-1 segment in Pacific
Investor presentation First nine months of 2016 Slide 58 The GLP-1 segment accounts for around 4% of the total diabetes care market in Pacific Pacific GLP-1 market Victoza® value market share in Pacific GLP-1 value Victoza® exenatide Share of total GLP-1 value Victoza® exenatide in bDKK lixisenatide
Slide 59: Victoza maintains strong position in DPP-IV, GLP-1 and SGLT-2 segment
Investor presentation First nine months of 2016 Slide 59 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 180 100% 100% 14% 12% 160 140 80% 80% CA
Slide 60: Current and future product portfolio covers type 2 diabetes treatment flow
Investor presentation First nine months of 2016 Slide 60 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 ins
Slide 61: R&D pipeline: Diabetes and obesity
Investor presentation First nine months of 2016 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 asp
Slide 62: Victoza reduced major adverse cardiovascular events in LEADER
Investor presentation First nine months of 2016 Slide 62 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
Slide 63: All components of 3-point MACE contributed to risk reduction
Investor presentation First nine months of 2016 Slide 63 All components of 3-point MACE contributed to the reduction in cardiovascular risk in the LEADER trial Non-fatal Cardiovascular death myocardial infarction Non-fatal stroke Victoza® Placebo Patients with an event (%) 10 10 10 HR = 0.78 HR = 0.
Slide 64: Tresiba shows lower hypoglycaemia rate in SWITCH trials
Investor presentation First nine months of 2016 Slide 64 Tresiba® shows lower rate of hypoglycaemia than insulin glargine U100 in SWITCH trials – filed in Q3 2016 SWITCH 1 – type 1 diabetes SWITCH 2 – type 2 diabetes Hypoglycaemic Hypoglycaemic Tresiba® glargine U100 events per 100 PYE events per 10
Slide 65: Tresiba lower day-to-day variability than glargine U300
Investor presentation First nine months of 2016 Slide 65 Tresiba® showed lower day-to-day variability in the glucose-lowering effect compared to insulin glargine U300 Within-subject variability in steady state Key results and next step Day-to-day Tresiba® insulin glargine U300 variability1 • The day
Slide 66: Semaglutide best in-class potential on HbA1c reduction
Investor presentation First nine months of 2016 Slide 66 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
Slide 67: Semaglutide best in-class weight lowering potential
Investor presentation First nine months of 2016 Slide 67 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
Slide 68: Competitive Tresiba label across all three triad markets
Investor presentation First nine months of 2016 Slide 68 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 Japan
Slide 69: US Tresiba label reflects distinct product features
Investor presentation First nine months of 2016 Slide 69 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 day
Slide 70: Competitive European label for Xultophy
Investor presentation First nine months of 2016 Slide 70 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 lir
Slide 71: Xultophy documented strong efficacy across treatment cascade
Investor presentation First nine months of 2016 Slide 71 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 ± ba
Slide 72: Faster-acting insulin aspart superior glucose control in onset 1
Investor presentation First nine months of 2016 Slide 72 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 in
Slide 73: Oral peptide delivery challenges and solutions
Investor presentation First nine months of 2016 Slide 73 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 chai
Slide 74: Oral semaglutide reduced HbA1c and body weight in phase 2
Investor presentation First nine months of 2016 Slide 74 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
Slide 75: Initiation of PIONEER trials for oral semaglutide
Investor presentation First nine months of 2016 Slide 75 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
Slide 76: Anti-IL-21 with liraglutide for type 1 diabetes
Investor presentation First nine months of 2016 Slide 76 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 autoimmu
Slide 77: Insulin LAI287 offers potential for once-weekly dosing
Investor presentation First nine months of 2016 Slide 77 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 glar
Slide 78: Liver-preferential mealtime insulin analogue
Investor presentation First nine months of 2016 Slide 78 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-preferenti
Slide 79: More than 20 million people in US have BMI above 35
Investor presentation First nine months of 2016 Slide 79 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 bi
Slide 80: Significant unmet need in obesity management
Investor presentation First nine months of 2016 Slide 80 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 Peopl
Slide 81: Small but growing market for anti-obesity medication in the US
Investor presentation First nine months of 2016 Slide 81 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 val
Slide 82: Steady prescription uptake for Saxenda in the US
Investor presentation First nine months of 2016 Slide 82 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
Slide 83: Saxenda targeted at patients with BMI ≥35 and comorbidities
Investor presentation First nine months of 2016 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 curr
Slide 84: Competitive US label for Saxenda
Investor presentation First nine months of 2016 Slide 84 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
Slide 85: Semaglutide once daily phase 2 dose-finding trial in obesity
Investor presentation First nine months of 2016 Slide 85 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 dos
Slide 86: Long-acting obesity compounds in phase 1 development
Investor presentation First nine months of 2016 Slide 86 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 G530S – Glucagon analogue NN9838 – Amylin analogue NN9747 – PYY analogue • Once-d
Slide 87: Biopharmaceuticals
Investor presentation First nine months of 2016 Slide 87 Biopharmaceuticals
Slide 88: Haemophilia: Location of bleedings and consequences
Investor presentation First nine months of 2016 Slide 88 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 d
Slide 89: Haemophilia is a rare disease with severe unmet medical needs
Investor presentation First nine months of 2016 Slide 89 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) wi
Slide 90: Global haemophilia market is growing by mid-single digit
Investor presentation First nine months of 2016 Slide 90 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®/Helixat
Slide 91: NovoSeven – a unique biologic for rare bleeding disorders
Investor presentation First nine months of 2016 Slide 91 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 mult
Slide 92: NovoEight launched in US, Europe and Japan
Investor presentation First nine months of 2016 Slide 92 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 i
Slide 93: NovoThirteen provides efficacious and safe haemostatic coverage
Investor presentation First nine months of 2016 Slide 93 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
Slide 94: R&D pipeline: Haemophilia and growth disorders
Investor presentation First nine months of 2016 Slide 94 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 Conciz
Slide 95: N9-GP once weekly reduces median bleeding rate in phase 3
Investor presentation First nine months of 2016 Slide 95 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/m
Slide 96: N8-GP every fourth day reduces median bleeding rate in phase 3
Investor presentation First nine months of 2016 Slide 96 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 o
Slide 97: Novo Nordisk maintains leadership in hGH market
Investor presentation First nine months of 2016 Slide 97 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
Slide 98: Solid Norditropin sales growth
Investor presentation First nine months of 2016 Slide 98 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 2.5 C
Slide 99: Financials
Investor presentation First nine months of 2016 Slide 99 Financials
Slide 100: Sustained double digit growth throughout the last decade
Investor presentation First nine months of 2016 Slide 100 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 g
Slide 101: Solid sales growth driven by US, International Operations and China
Investor presentation First nine months of 2016 Slide 101 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%
Slide 102: Modern insulin and Victoza comprise around 60% of total sales
Investor presentation First nine months of 2016 Slide 102 Modern insulin and Victoza® comprise around 60% of total sales in the first nine months of 2016 Reported sales split by product segments the Reported sales split by selected key products first nine months of 2016 the first nine months of 2016
Slide 103: Solid operating profit growth driven by diabetes
Investor presentation First nine months of 2016 Slide 103 Solid operating profit growth driven by diabetes Operating profit Operating profit therapy split1 DKK Operating profit Operating profit as % of sales Diabetes Biopharm billion Reported operating profit growth 60 Operating profit growth in loc
Slide 104: Profitability per segment
Investor presentation First nine months of 2016 Slide 104 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 S
Slide 105: Decline in relative COGS level combined with stable investment
Investor presentation First nine months of 2016 Slide 105 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
Slide 106: Long term financial targets: operating profit growth and margin
Investor presentation First nine months of 2016 Slide 106 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
Slide 107: Long term financial targets: returns and cash to earnings
Investor presentation First nine months of 2016 Slide 107 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 financi
Slide 108: Steady cash return via dividends and share repurchases
Investor presentation First nine months of 2016 Slide 108 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 Share repurchase Inte
Slide 109: Stable ownership structure
Investor presentation First nine months of 2016 Slide 109 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
Slide 110: Sustainability
Investor presentation First nine months of 2016 Slide 110 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 Princi
Slide 111: Good progress towards long-term sustainability goals
Investor presentation First nine months of 2016 Slide 111 In 2015, good progress was made towards achieving the long-term sustainability goals Patients reached with Working the Novo diabetes care products Nordisk Way2 Energy consumption3 Operating profit growth Realised Realised Realised Realised Mi
Slide 112: Cities Changing Diabetes aims to break the Rule of Halves
Investor presentation First nine months of 2016 Slide 112 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 Seven partner cities are addressing to fight urban diabetes the threat of urban diab
Slide 113: Committed to continued development of its employees
Investor presentation First nine months of 2016 Slide 113 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 Total S