Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — H1 2016 Earnings Presentation
119 slides from Novo Nordisk A/s Class B's earnings presentation, Aug 5, 2016
Slide 1: Investor presentation First half of 2016
Slide 1 Investor presentation First half of 2016 Shanghai – part of Cities Changing Diabetes
Slide 2: Agenda
Investor presentation First half 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 half of 2016 Slide 3 Forward-looking statements N ovo N ordisk’s reports filed with or furnis hed to the U S Sec urities and E xchange Commission (SEC), inc luding the c ompany’s A nnual Report 2 015 and Form 2 0 -F, whic h are both filed with the SE C in February 2 016 i
Slide 4: Highlights – First half of 2016
Investor presentation First half of 2016 Slide 4 Highlights – First half of 2016 Sales development • Sales increased by 7% in local currencies and 5% in Danish kroner • USA grew by 7% in local currencies and accounted for 50% share of growth in local currencies • International Operations and Region
Slide 5: All regions contribute to local sales currencies growth in the first half of 2016
Investor presentation First half of 2016 Slide 5 All regions contribute to local sales currencies growth in the first half of 2016 Sales as reported – first half of 2016 Growth analysis – first half of 2016 Pacific Local currencies Growth Share of growth +9% USA 7% 50% Region China +5% 8% Europe 2%
Slide 6: Modest US sales growth in the second quarter reflects more challenging competitive environment
Investor presentation First half of 2016 Slide 6 Modest US sales growth in the second quarter reflects more challenging competitive environment Modest sales growth in Q2 2016 Key factors impacting growth Sales as reported MAT quarterly local currency growth • Sales growth primarily driven by Tresiba
Slide 7: Sales growth is driven by Victoza and new-generation insulin
Investor presentation First half of 2016 Slide 7 Sales growth is driven by Victoza® and new-generation insulin Sales as reported – first half of 2016 Growth analysis – first half of 2016 Other biopharmaceuticals Local currencies Growth Share of growth Norditropin® +9% New -generation insulin 1 174%
Slide 8: Victoza maintains leadership in the faster growing US GLP-1 market
Investor presentation First half of 2016 Slide 8 Victoza® maintains leadership in the faster growing US GLP-1 market US GLP-1 market development US GLP-1 market TRx volume US GLP-1 market shares MAT Total TRx MAT volume GLP-1 TRx Victoza® exenatide GLP-1 TRx Victoza® exenatide GLP-1 TRx Growth rate
Slide 9: Roll-out of new-generation insulin portfolio is progressing
Investor presentation First half of 2016 Slide 9 Roll-out of new-generation insulin portfolio is progressing Tresiba® value share of basal insulin segment Key launch observations in selected countries, excl USA Switzerland Netherlands UK India • Tresiba® launched in 45 countries with solid penetrati
Slide 10: Steady uptake of Tresiba in the USA
Investor presentation First half of 2016 Slide 10 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 in Q4 20
Slide 11: Broad market access across the diabetes portfolio is expected to be maintained in the USA for 2017
Investor presentation First half of 2016 Slide 11 Broad market access across the diabetes portfolio is expected to be maintained in the USA for 2017 Current level of unrestricted market access for key Novo Nordisk products in the USA US formulary negotiations and 2017 pricing Unrestricted Commercial
Slide 12: Victoza statistically significantly reduced the risk of major adverse cardiovascular events in the LEADER trial
Investor presentation First half of 2016 Slide 12 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 and next step Patients1 with an Victoza® Placebo • Superior
Slide 13: Tresiba showed lower variability in the glucose-lowering effect compared to insulin glargine U300
Investor presentation First half of 2016 Slide 13 Tresiba® showed lower variability in the glucose-lowering effect compared to insulin glargine U300 in PK/PD trial Within-subject variability in steady state Key results and next step Day-to-day Tresiba® insulin glargine U300 variability 1 • The day-t
Slide 14: Key development milestones
Investor presentation First half of 2016 Slide 14 Key development milestones IDegLira (NN9068) received a positive 16-0 vote in favour of approval from the FDA Advisory Committee Phase 2a trial with oral insulin OI338GT (NN1953) completed with generally encouraging results, while OI320GT (NN1957) wa
Slide 15: R&D news flow with several regulatory decisions expected in the next six months
Investor presentation First half of 2016 Slide 15 R&D news flow with several regulatory decisions expected in the next six months Results available Regulatory milestone Project Past 3-6 months Past 3 months Within 3 months In ~3-6 months Variation application Tresiba® SWITCH 1 √ in the USA DEVOTE On
Slide 16: Financial results – first half of 2016
Investor presentation First half of 2016 Slide 16 Financial results – first half of 2016 DKK million H1 2016 H1 2015 Change Sales 54,671 52,259 5% Gross profit 46,392 44,526 4% Gros s margin 84.9% 85.2% Sales and distribution costs (13,608) (13,322) 2% Percentage of s ales 24.9% 25.5% Research and d
Slide 17: Negative currency impact in 2016 driven by unfavourable development in both hedged and unhedged currencies
Investor presentation First half of 2016 Slide 17 Negative currency impact in 2016 driven by unfavourable development in both hedged and unhedged currencies USD/DKK C NY/DKK JPY/DKK GBP/DKK C AD/DKK 140 Hedged 2015 2016 Spot Impact of a Hedging Index (1 Jan 2015= 100) Currencies average average2 rat
Slide 18: Financial outlook for 2016
Investor presentation First half of 2016 Slide 18 Financial outlook for 2016 Expectations Previous expectations 5 Aug 2016 29 Apr 2016 Sales growth - local currencies 5-7% 5-9% Sales growth - reported Around 2 percentage points lower Around 3 percentage point lower Operating profit growth - local cu
Slide 19: Closing remarks
Investor presentation First half of 2016 Slide 19 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% value market share in diabetes care and sol
Slide 20: Investor contact information
Investor presentation First half of 2016 Slide 20 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
Slide 21: Appendix
Investor presentation First half of 2016 Slide 21 Appendix 1. Novo Nordisk at a glance 2. Diabetes 3. Biopharmaceuticals 4. Financials 5. Sustainability
Slide 22: Novo Nordisk at a glance
Investor presentation First half of 2016 Slide 22 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 23: Novo Nordisk works with four strategic focus areas based on five core capabilities
Investor presentation First half of 2016 Slide 23 Novo Nordisk works with four strategic focus areas based on five core capabilities STRATEGIC PRIORITIES CORE CAPABILITIES Engineering, Deep disease Efficient Planning and Building and formulating, understanding large-scale executing maintaining a Exp
Slide 24: Long-term financial targets are based on the pursuit of double digit growth for the diabetes care franchise
Investor presentation First half of 2016 Slide 24 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 Ins
Slide 25: Novo Nordisk has leading positions in diabetes, haemophilia and growth disorders
Investor presentation First half 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 share
Slide 26: Top line growth driven by diabetes pandemic
Investor presentation First half of 2016 Slide 26 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 DKK Million Nordi
Slide 27: Novo Nordisk has a strong leadership position within the growing diabetes care market
Investor presentation First half 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 GLP-1 Insulin OAD Novo Nordisk Sanofi Eli Lilly Merck billion AstraZeneca
Slide 28: Significant growth opportunities fuelled by strong R&D pipeline across all four strategic focus areas
Investor presentation First half 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 OI338GT – Oral insulin Semaglutide – QW GLP-1 Xultophy ® (US) Levemir® NN1406
Slide 29: Growth opportunities supported by strong global presence in both sales and manufacturing
Investor presentation First half of 2016 Slide 29 Growth opportunities supported by strong global presence in both sales and manufacturing FTEs in sales regions1 Global manufacturing setup Denmark (~9,600 FTEs) Kaluga, Russia (~220 FTEs) USA: ~5,100 • Diabetes and biopharmaceutical • Filling West Le
Slide 30: High barriers to entry in biologics
Investor presentation First half 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 Research & 202
Slide 31: Diabetes and obesity
Investor presentation First half of 2016 Slide 31 Diabetes and obesity
Slide 32: Diabetes – the inability to manage blood sugar levels appropriately
Investor presentation First half of 2016 Slide 32 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 effective
Slide 33: Insulin – a hormone enabling blood sugar to enter cells
Investor presentation First half of 2016 Slide 33 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 m
Slide 34: Diabetes pandemic is fuelled by growing rates of obesity
Investor presentation First half of 2016 Slide 34 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
Slide 35: Poor diagnosis rates, lack of access to optimal treatment and poor glycaemic control remain global problems
Investor presentation First half of 2016 Slide 35 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 di
Slide 36: UKPDS: Tight glycaemic control reduces risk of micro- and macrovascular complications
Investor presentation First half of 2016 Slide 36 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
Slide 37: Insulin is the ultimate care for people with diabetes
Investor presentation First half of 2016 Slide 37 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%
Slide 38: The insulin market is comprised of three segments
Investor presentation First half of 2016 Slide 38 The insulin market is comprised of three segments Insulin action profiles Global insulin volume market by segment tMU CAGR volume 1: 5.0% Fast-acting CAGR value 1: 20.3% 450 400 350 39% Fast-acting 300 37% Premix 250 27% 200 Premix 29% 150 Long-actin
Slide 39: Medications used for the treatment of type 2 diabetes
Investor presentation First half of 2016 Slide 39 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
Slide 40: Sustained double-digit growth in insulin market
Investor presentation First half of 2016 Slide 40 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 20.3% 1 • Rising prevalence of diabetes • Growing overweight and obesity prev
Slide 41: Solid insulin volume growth across regions
Investor presentation First half of 2016 Slide 41 Solid insulin volume growth across regions Novo Nordisk Market Market volume Volume market regions value1 size & growth composition shares 24% 178.2 140.4 3% 38% 51% USA 63% 37% 11% 27.6 3% 2% 28.8 40% Europe 40% 54% 46% 20% International 9.1 7% -4%
Slide 42: Stable global insulin volume growth
Investor presentation First half of 2016 Slide 42 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% 34% 4
Slide 43: Maintaining global insulin leadership by sustaining modern insulin market share
Investor presentation First half of 2016 Slide 43 Maintaining global insulin leadership by sustaining modern insulin market share Novo Nordisk global volume market share across insulin classes Novo Nordisk class MS (%) class volume tMU Human insulin1 tMU Modern insulin3 tMU Total insulin 500 100% 50
Slide 44: Strong underlying insulin market growth and sustained global volume market share
Investor presentation First half of 2016 Slide 44 Strong underlying insulin market growth and sustained global volume market share Global insulin market Global modern insulin3 volume market shares Device penetration Modern insulin penetration1 Novo Nordisk Sanofi Eli Lilly tMU Penetration 500 CAGR v
Slide 45: Novo Nordisk's modern insulin continue strong performance within their respective segments
Investor presentation First half of 2016 Slide 45 Novo Nordisk’s modern insulin 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® mark
Slide 46: Improved US modern insulin market share
Investor presentation First half of 2016 Slide 46 Improved 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: 2.3% Penetration 140 CAGR value1: 28.5% 100% 60
Slide 47: Novo Nordisk's modern insulins maintain market share in expanding US insulin market
Investor presentation First half of 2016 Slide 47 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 NovoMix® market share Levemir® mark
Slide 48: US health insurance is dominated by few large commercial payers
Investor presentation First half of 2016 Slide 48 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
Slide 49: Sustained leadership position on the European modern insulin market
Investor presentation First half of 2016 Slide 49 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 volume 1: 2.5%
Slide 50: Stable leadership position in International Operations
Investor presentation First half of 2016 Slide 50 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 C
Slide 51: Sustained leadership position in the Chinese insulin market
Investor presentation First half of 2016 Slide 51 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 vo
Slide 52: Expanding market leadership position in Japan
Investor presentation First half of 2016 Slide 52 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 volume 1: -0.7% Penetration 14 CAGR v
Slide 53: Promising Tresiba performance strengthens total insulin market share in Japan
Investor presentation First half of 2016 Slide 53 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 U30
Slide 54: GLP-1 effect dependent on level of blood glucose − which reduces risk of hypoglycaemia
Investor presentation First half of 2016 Slide 54 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 pancrea
Slide 55: The 9% GLP-1 share of the global diabetes care market is increasing
Investor presentation First half of 2016 Slide 55 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-1 share
Slide 56: Increasing global GLP-1 volume growth across all regions
Investor presentation First half of 2016 Slide 56 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 Int. Operations Pacific World Region China Region China Pacific 60% 100% 1% 5% 10% 50% 80%
Slide 57: The GLP-1 segment accounts for 10% of the total diabetes care market in the US
Investor presentation First half of 2016 Slide 57 The GLP-1 segment accounts for 10% of the total diabetes care market in the US US GLP-1 market Key observations for Victoza® in the US market GLP-1 value Share of total in bDKK diabetes care market • Victoza® volume market share within the GLP-1 segm
Slide 58: The GLP-1 segment accounts for 9% of the total diabetes care market in Europe
Investor presentation First half of 2016 Slide 58 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 Share of total GLP-1 value Victoza® exenatide in bDKK diabetes care market market share lixisenatide
Slide 59: The GLP-1 segment accounts for around 3% of the total diabetes care market in International Operations
Investor presentation First half of 2016 Slide 59 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 Share of total GLP-1 value Victoza® exena
Slide 60: The GLP-1 segment accounts for around 4% of the total diabetes care market in Pacific
Investor presentation First half of 2016 Slide 60 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 Share of total GLP-1 value Victoza® exenatide in bDKK diabetes care market market share lixi
Slide 61: Victoza maintain a strong position in the global DPP-IV, GLP-1 and SGLT-2 segment
Investor presentation First half of 2016 Slide 61 Victoza® maintain 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% CAGR1 valu
Slide 62: Key Novo Nordisk diabetes care products remain broadly available in the US
Investor presentation First half of 2016 Slide 62 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® Unrestri
Slide 63: Novo Nordisk current and future product portfolio covers the type 2 diabetes treatment flow
Investor presentation First half of 2016 Slide 63 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 On
Slide 64: R&D pipeline: Diabetes and obesity
Investor presentation First half of 2016 Slide 64 R&D pipeline: Diabetes and obesity Product/project Type Indication Status (phase) 1 2 3 Filed Appr. Xultophy ® (NN9068)1 C ombination of insulin degludec and liraglutide Type 2 Faster-acting insulin aspart (NN1218) New formulation of insulin aspart T
Slide 65: Limited HbA1c difference, but lower severe hypoglycaemia rate and greater weight loss with Victoza in LEADER trial
Investor presentation First half of 2016 Slide 65 Limited HbA1c difference, but lower severe hypoglycaemia rate and greater weight loss with Victoza® in LEADER trial Limited difference in HbA1c Reduction in severe Statistically significantly greater maintained throughout trial hypoglycaemia weight l
Slide 66: All components of 3-point MACE contributed to the reduction in cardiovascular risk in the LEADER trial
Investor presentation First half of 2016 Slide 66 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 = 0.88 HR =
Slide 67: Tresiba shows lower rate of hypoglycaemia than insulin glargine U100 in SWITCH trials
Investor presentation First half of 2016 Slide 67 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 10
Slide 68: Semaglutide significantly reduces the risk of major adverse cardiovascular events in the SUSTAIN 6 trial
Investor presentation First half of 2016 Slide 68 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 semagl
Slide 69: In phase 3a trials semaglutide shows best in-class potential on HbA1c reduction
Investor presentation First half of 2016 Slide 69 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 HbA1 c ≤7% Sema 1 mg Sema 0.5 mg Placebo Sitagliptin 100 mg Exe
Slide 70: In phase 3a trials semaglutide shows best in-class weight lowering potential
Investor presentation First half of 2016 Slide 70 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 glargi
Slide 71: Competitive Tresiba label across all three triad markets
Investor presentation First half of 2016 Slide 71 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 up to 26 hours in • Duration of action beyond 42 hours action of at
Slide 72: US Tresiba label reflects the distinctly different product features compared to competitor basal insulins
Investor presentation First half of 2016 Slide 72 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 • Onc
Slide 73: Real-world data for Tresiba confirms strong clinical profile and enables uptake
Investor presentation First half of 2016 Slide 73 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 glargi
Slide 74: Competitive European label for Xultophy
Investor presentation First half of 2016 Slide 74 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 liraglutid
Slide 75: Xultophy has documented strong efficacy across the treatment cascade
Investor presentation First half of 2016 Slide 75 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 76: Faster-acting insulin aspart provides superior glucose control vs NovoRapid in onset 1 trial
Investor presentation First half of 2016 Slide 76 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 innovativ
Slide 77: Oral peptide delivery − the gastro-intestinal route poses many challenges
Investor presentation First half of 2016 Slide 77 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. Pa
Slide 78: Oral semaglutide dose dependently reduced HbA1c and body weight in a 26-week phase 2 trial
Investor presentation First half of 2016 Slide 78 Oral semaglutide dose dependently reduced HbA 1c 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
Slide 79: PIONEER, the global phase 3a programme for oral semaglutide
Investor presentation First half of 2016 Slide 79 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 PIONEER 3: vs sitagliptin 78 weeks, n=1,860 PI
Slide 80: Phase 2a trial with oral insulin OI338GT completed with generally encouraging results
Investor presentation First half of 2016 Slide 80 Phase 2a trial with oral insulin OI338GT completed with generally encouraging results Phase 2a study design Headline results and next step • The results were generally encouraging with a decrease in fasting plasma glucose of approximately 2.5mmol/L f
Slide 81: Anti-IL-21 in combination with liraglutide for the treatment of type 1 diabetes
Investor presentation First half of 2016 Slide 81 Anti-IL 21 in combination with liraglutide is an alternative approach for the treatment of type 1 diabetes Rationale for Anti-IL 21 and liraglutide Phase 2 trial design combination product for T1D Anti-IL 21 plays an important role in autoimmunity wi
Slide 82: Insulin LAI287 offers potential for once-weekly dosing
Investor presentation First half of 2016 Slide 82 Insulin LAI287 offers potential for once-weekly dosing LAI287 pharmacodynamic profile is compatible Glucose Infusion Rate vs. Time with once-weekly (Predicted Mean)dosing Key results of phase 1 trial Glucose18Infusion nmol/kg Rate Insulin glargine LA
Slide 83: Liver-preferential mealtime insulin analogue has potential to reduce hypoglycaemia and weight gain
Investor presentation First half of 2016 Slide 83 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 prand
Slide 84: More than 20 million people in the US have a BMI above 35
Investor presentation First half of 2016 Slide 84 More than 20 million people in the US have a BMI above 35 with either pre-diabetes or CV related comorbidities Incidence of obesity in the US (million people) The US obesity burden Obesity • Cost of obesity to health care systems of USD 147 billion C
Slide 85: Significant unmet need in obesity management
Investor presentation First half of 2016 Slide 85 Significant unmet need in obesity management Insufficient treatment options Significant gaps in obesity treatment Mean weight loss 100% All people with obesity Bariatric surgery High Medium Anti-obesity medication 30% with weight loss of People diagn
Slide 86: Small but growing market for anti-obesity medication in the US
Investor presentation First half of 2016 Slide 86 Small but growing market for anti-obesity medication in the US Value of US obesity market remains Few people treated with AOM, but in recent relatively small, but it is growing years launches have fuelled market growth USD Generic TRx volume Branded
Slide 87: Steady prescription uptake for Saxenda in the US
Investor presentation First half of 2016 Slide 87 Steady prescription uptake for Saxenda® in the US Prescription volume uptake of anti-obesity medications (AOM) recently launched in the US Key observations TRx Contrave® Belviq® • Saxenda® has been launched in the US, Canada, Denmark, Volume (000) Qs
Slide 88: Saxenda targeted at patients with BMI ≥35 and weight-related comorbidities
Investor presentation First half of 2016 Slide 88 Saxenda® targeted at patients with BMI ≥35 and weight-related comorbidities Saxenda® market approach Saxenda® launch execution Aspiration Focus on patients with BMI Clear patient ≥35 with weight-related segmentation comorbidities Focus on current pre
Slide 89: Competitive US label for Saxenda
Investor presentation First half of 2016 Slide 89 Competitive US label for Saxenda® Saxenda® approved in the US for chronic weight management in individuals with a BMI ≥30, or ≥27 in the presence of at least one weight-related comorbidity1 • GLP-1 receptor agonist – a physiological regulator of appe
Slide 90: Semaglutide once daily phase 2 dose-finding trial in obesity
Investor presentation First half of 2016 Slide 90 Semaglutide once daily phase 2 dose-finding trial in obesity is designed to optimise treatment outcomes Once-daily semaglutide phase 2 trial design Phase 2 trial purpose and endpoints Purpose semaglutide 0.05 mg • To assess and compare the dose respo
Slide 91: Long-acting obesity compounds in phase 1 development
Investor presentation First half of 2016 Slide 91 Long-acting obesity compounds in phase 1 development may have complimentary modes of action Key features of compounds in phase 1 development for obesity Compound G530L – Glucagon analogue NN9838 – Amylin analogue NN9747 – PYY analogue • Once-daily su
Slide 92: Biopharmaceuticals
Investor presentation First half of 2016 Slide 92 Biopharmaceuticals
Slide 93: Haemophilia: Location of bleedings and the consequences
Investor presentation First half of 2016 Slide 93 Haemophilia: Location of bleedings and the consequences Locations Consequences of bleedings • Bleeding in the joint space causes a strong inflammatory reaction which predisposes to further bleeding Head and neck Nose and gums • Inadequate or delayed
Slide 94: Haemophilia is a rare disease with severe unmet medical needs
Investor presentation First half of 2016 Slide 94 Haemophilia is a rare disease with severe unmet medical needs Number of people with haemophilia A and B Low diagnosis and treatment rates and haemophilia with inhibitors within haemophilia Number of Average percentage of people people (000) with haem
Slide 95: Global haemophilia market is growing by mid-single digit
Investor presentation First half of 2016 Slide 95 Global haemophilia market is growing by mid-single digit Strategic positioning of Novo Nordisk’s Sales of recombinant coagulation factors haemophilia portfolio NovoSeven® Recombinate®/Advate ® Rixubis® Novo Nordisk C oagil VII® Kogenate®/Helixate ® A
Slide 96: NovoSeven − a unique biologic for the treatment of rare bleeding disorders
Investor presentation First half of 2016 Slide 96 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 do
Slide 97: NovoEight is launched in the US, Europe and Japan
Investor presentation First half of 2016 Slide 97 NovoEight® is launched in the US, Europe and Japan for the treatment of people with haemophilia A Example from NovoEight® promotional campaign1 NovoEight® properties and launch performance Indications: • Treatment and prophylaxis of bleeding in patie
Slide 98: NovoThirteen, a recombinant FXIII, provides efficacious and safe haemostatic coverage
Investor presentation First half of 2016 Slide 98 NovoThirteen®, a recombinant FXIII, provides efficacious and safe haemostatic coverage Example from NovoThirteen® NovoThirteen® properties and launch promotional campaign1 performance Indication: • Long term prophylactic treatment of bleeding in adul
Slide 99: R&D pipeline: Haemophilia and growth disorders
Investor presentation First half of 2016 Slide 99 R&D pipeline: Haemophilia and growth disorders Product/project Type Indication Status (phase) 1 2 3 Filed Appr. N9-GP (NN7999)1 GlycoPEGylated long-acting rFIX Haemophilia B N8-GP (NN7088) GlycoPEGylated long-acting rFVIII Haemophilia A Concizumab (N
Slide 100: N9-GP administered once weekly reduces median bleeding rate in phase 3 trial
Investor presentation First half of 2016 Slide 100 N9-GP administered once weekly reduces median bleeding rate to 1.0 episode per year in phase 3 trial N9-GP phase 1 pharmacokinetics Paradigm 2 headline results (phase 3) FIX activity rFIX pdFIX N9-GP • Steady-state half-life of 110 hours (IU/mL) • M
Slide 101: N8-GP administered every fourth day reduces median bleeding rate in phase 3 trial
Investor presentation First half of 2016 Slide 101 N8-GP administered every fourth day reduces median bleeding rate to 1.3 episode per year in phase 3 trial N8-GP phase 1 pharmacokinetics Pathfinder 2 headline results (phase 3)1 FVIII activity FVIII N8-GP • PK documented single dose half-life of 18.
Slide 102: Novo Nordisk continues to expand leadership within human growth hormone market
Investor presentation First half of 2016 Slide 102 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 Roche
Slide 103: Solid Norditropin sales growth
Investor presentation First half of 2016 Slide 103 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 CAGR1 1
Slide 104: Financials
Investor presentation First half of 2016 Slide 104 Financials
Slide 105: Novo Nordisk has delivered sustained double digit growth throughout the last decade
Investor presentation First half of 2016 Slide 105 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 3
Slide 106: Solid sales growth driven by the US, International Operations and Region China
Investor presentation First half of 2016 Slide 106 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% 13% 5%
Slide 107: Solid operating profit growth driven by diabetes
Investor presentation First half of 2016 Slide 107 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
Slide 108: Profitability per segment
Investor presentation First half of 2016 Slide 108 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 CO
Slide 109: Decline in relative COGS level combined with stable investment level
Investor presentation First half of 2016 Slide 109 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% 10%
Slide 110: Limited future productivity gains expected, reflecting increasing manufacturing complexity
Investor presentation First half of 2016 Slide 110 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 AP
Slide 111: Long term financial targets: Operating profit growth and operating margin
Investor presentation First half of 2016 Slide 111 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% 1
Slide 112: Long term financial targets: Operating profit after tax to net operating assets and cash to earnings
Investor presentation First half of 2016 Slide 112 Long term financial targets: Operating profit after tax to net operating assets and cash to earnings Operating profit after tax to Cash to earnings net operating assets (three year average) New long term financial target New long term financial targ
Slide 113: Organic growth enables steady cash return to shareholders via dividends and share repurchase programmes
Investor presentation First half of 2016 Slide 113 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 Interim div
Slide 114: Stable ownership structure
Investor presentation First half of 2016 Slide 114 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 stabl
Slide 115: Sustainability
Investor presentation First half of 2016 Slide 115 Sustainability The Novo Nordisk Way The Triple Bottom Line Business Principle Financially responsible Socially Environmentally responsible responsible We build on the purpose set by our founders and live by their The Triple Bottom Line Principle gui
Slide 116: In 2015, good progress was made towards achieving the long-term sustainability goals
Investor presentation First half of 2016 Slide 116 In 2015, good progress was made towards achieving the long-term sustainability goals Patients reached with Working the Novo diabetes care products Nordisk Way 2 Energy consumption3 Operating profit growth Realised Realised Realised Realised Million1
Slide 117: Changing Diabetes encompasses multilevel projects that tackle the global diabetes pandemic
Investor presentation First half of 2016 Slide 117 Changing Diabetes® encompasses multilevel projects that tackle the global diabetes pandemic ‘Rule of Halves’: only ~6% of people with Changing Diabetes® addresses the largest diabetes achieve desirable outcomes potentials to overcome the ‘Rule of Ha
Slide 118: Cities Changing Diabetes aims to break the 'Rule of Halves' and stop urban diabetes
Investor presentation First half of 2016 Slide 118 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 diabetes Co
Slide 119: Novo Nordisk is committed to the continued development of its employees
Investor presentation First half of 2016 Slide 119 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 Total Appointments* Sr. M