Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — FY2013 Earnings Presentation
114 slides from Novo Nordisk A/s Class B's earnings presentation, Feb 3, 2014
Slide 1: Investor conference call Full year 2013
Slide 1 Investor conference call Full year 2013 3 Feb 2014
Slide 2: Agenda
Investor presentation Full year 2013 Slide 2 Agenda Highlights and key events by Lars Rebien Sørensen, CEO Sales update by Kåre Schultz, President and COO R&D update by Mads Krogsgaard Thomsen, CSO Financials and outlook by Jesper Brandgaard, CFO Questions & answers session
Slide 3: Forward-looking statements
Investor presentation Full year 2013 Slide 3 Forward-looking statements Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document as well as the company’s Annual Report 2013 and Form 20-F, both expected to be filed with the SEC in Febr
Slide 4: Highlights – full year 2013
Investor presentation Full year 2013 Slide 4 Highlights – full year 2013 Sales development • Sales increased by 12% in local currencies and 7% in Danish kroner • North America, International Operations and Region China grew by 18%, 17% and 13% in local currencies, respectively • Modern insulin and V
Slide 5: North America remains the main contributor to growth
Investor presentation Full year 2013 Slide 5 North America remains the main contributor to growth Sales as reported – full year 2013 Growth analysis – full year 2013 Japan & Korea Local currencies Growth Share of growth Region China (20%) +12% 6% North America 18% 66% 9% International Europe 3% 5% O
Slide 6: Growth is driven by modern insulin and Victoza
Investor presentation Full year 2013 Slide 6 Growth is driven by modern insulin and Victoza® Sales as reported – full year 2013 Growth analysis – full year 2013 Other Local currencies Growth Share of growth Norditropin® +9% Modern insulin 14% 54% +7% 3% 3% 7% 7% Human insulin 0% 0% NovoSeven® +4% Vi
Slide 7: Robust modern insulin performance driven by North America, International Operations and Region China
Investor presentation Full year 2013 Slide 7 Robust modern insulin performance driven by North America, International Operations and Region China Modern insulin regional share of Modern insulin reported sales growth – full year 2013 DKK NovoMix® NovoRapid® Levemir® North America Europe Japan & Korea
Slide 8: North America and Europe drive Victoza sales
Investor presentation Full year 2013 Slide 8 North America and Europe drive Victoza® sales Victoza® reported sales (MAT) Victoza® regional sales – full year 2013 DKK billion Japan & Region China 12 11.6 Korea 10.8 11.1 International 1% 10.2 9.5 Operations 3% 3% 10 8.9 6% 7%7% 7.9 8 6.9 6.0 6 4.8 Eur
Slide 9: In the US, Victoza has a strong and expanding position in the DPP-IV, GLP-1 and SGLT-2 segment
Investor presentation Full year 2013 Slide 9 In the US, Victoza® has a strong and expanding position in the DPP-IV, GLP-1 and SGLT-2 segment Segment value growth Share of segment value growth Segment value market shares DKK Victoza® Other GLP-1 SGLT-2 DPP-IV billion 40 CAGR1 value: 32% 100% 80% 80%
Slide 10: Tresiba roll-out continues with encouraging performance in countries with competitive reimbursement
Investor presentation Full year 2013 Slide 10 Tresiba® roll-out continues with encouraging performance in countries with competitive reimbursement Tresiba® value market share in basal insulin segment in selected markets Key launch observations Switzerland Mexico Japan • Tresiba® grows share of basal
Slide 11: Two new double-blinded trials initiated with Tresiba vs. insulin glargine
Investor presentation Full year 2013 Slide 11 Two new double-blinded trials initiated with Tresiba® vs. insulin glargine to further assess hypoglycaemia profile Trial designs Purpose and endpoints Purpose NN1250-3995: IDeg once daily IDeg once daily • NN1250-3995: To document hypoglycaemia benefit i
Slide 12: Key events within Diabetes & Obesity Research and Development
Investor presentation Full year 2013 Slide 12 Key events within Diabetes & Obesity Research and Development Liraglutide 3 mg filed for regulatory approval as a treatment for obesity in the US and EU DUAL™ IV phase 3b trial shows benefits of adding IDegLira to SU and metformin treatment in type 2 dia
Slide 13: Key events within Biopharmaceuticals Research and Development
Investor presentation Full year 2013 Slide 13 Key events within Biopharmaceuticals Research and Development NovoEight® launched in EU and approved in Japan for the treatment of congenital factor VIII deficiency TRETTEN® approved in the US for the treatment of congenital factor XIII A-subunit deficie
Slide 14: Financial results – full year 2013
Investor presentation Full year 2013 Slide 14 Financial results – full year 2013 DKK million FY 2013 FY 2012 Change Sales 83,572 78,026 7% Gross profit 69,432 64,561 8% Gross margin 83.1% 82.7% Sales and distribution costs 23,380 21,544 9% Percentage of sales 28.0% 27.6% Research and development cos
Slide 15: Current rates for US dollar and Japanese yen are below 2013 average
Investor presentation Full year 2013 Slide 15 Current rates for US dollar and Japanese yen are below 2013 average 650 Spot rates Quarterly average Annual average Currency 2012 2013 Current assumptions1 average average2 rate2 600 USD/DKK USD 579 562 546 550 CNY 91.8 91.3 90.4 500 JPY 7.27 5.77 5.32 G
Slide 16: Financial outlook for 2014
Investor presentation Full year 2013 Slide 16 Financial outlook for 2014 Expectations 30 January 2014 Sales growth - local currencies 8-11% Sales growth - reported Around 3.5 percentage points lower Operating profit growth – local currencies Around 10% Operating profit growth - reported Around 5.5 p
Slide 17: Cash generated is returned to shareholders in the form of dividends and share buybacks
Investor presentation Full year 2013 Slide 17 Cash generated is returned to shareholders in the form of dividends and share buybacks Dividend and pay-out ratio Share repurchases programmes (year of dividend pay) (year of repurchase) DKK Dividend paid Payout ratio DKK Share repurchase programmes 2009
Slide 18: Closing remarks
Investor presentation Full year 2013 Slide 18 Closing remarks Solid market performance Promising pipeline • >10% annual diabetes care market growth driven • The only company with a full portfolio of novel by diabetes prevalence insulin products • 27% market share in diabetes care and solid • GLP-1 p
Slide 19: Investor contact information
Investor presentation Full year 2013 Slide 19 Investor contact information Share information Investor Relations contacts Novo Nordisk’s B shares are listed on the stock exchange in Novo Nordisk A/S Copenhagen under the symbol ‘NOVO B’. Its ADRs are listed on Investor Relations the New York Stock Exc
Slide 20: Appendix
Investor presentation Full year 2013 Slide 20 Appendix 1. Novo Nordisk at a glance 2. Diabetes 3. Biopharmaceuticals 4. Financials
Slide 21: Novo Nordisk at a glance
Investor presentation Full year 2013 Slide 21 Novo Nordisk at a glance The core equity story Global leader in diabetes care • A focused pharmaceutical company with leading positions Global insulin market share: 48% in diabetes, haemophilia and hGH Europe: • Double digit top line growth driven by dia
Slide 22: Novo Nordisk works with five strategic focus areas based on five core capabilities
Investor presentation Full year 2013 Slide 22 Novo Nordisk works with five strategic focus areas based on five core capabilities Strategic focus areas Core capabilities Engineering, Deep Efficient Planning Building formulating, disease large-scale and Expand leadership and developing under- producti
Slide 23: Novo Nordisk has leading positions in diabetes, haemophilia and growth disorders
Investor presentation Full year 2013 Slide 23 Novo Nordisk has leading positions in diabetes, haemophilia and growth disorders Growth hormone Diabetes Haemophilia deficiency DKK Market value DKK Market value DKK Market value billion Novo Nordisk value market share billion Novo Nordisk value market s
Slide 24: Double digit top line growth driven by diabetes pandemic
Investor presentation Full year 2013 Slide 24 Double digit top line growth driven by diabetes pandemic Novo Nordisk reported quarterly sales The number of people with diabetes by therapy according to IDF Diabetes care Haemophilia North America Europe Japan & Korea DKK Million Growth Disorders Other
Slide 25: Significant growth opportunities fuelled by strong R&D pipeline
Investor presentation Full year 2013 Slide 25 Significant growth opportunities fuelled by strong R&D pipeline in diabetes, obesity, haemophilia and inflammation PHASE 1 PHASE 2 PHASE 3 SUBMITTED APPROVED2 OG217GT – Oral GLP-1 OG217SC - Oral GLP-1 Faster-acting insulin aspart IDegLira (EU) Levemir® O
Slide 26: Diabetes pandemic is fuelled by growing rates of obesity
Investor presentation Full year 2013 Slide 26 Diabetes pandemic is fuelled by growing rates of obesity US CDC data on obesity and diabetes prevalence among adults 1994 2000 2010 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 27: Insulin is the ultimate care for people with diabetes
Investor presentation Full year 2013 Slide 27 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 90% 80% -cell function OAD 70% GLP-1
Slide 28: Novo Nordisk current and future product portfolio covers the type 2 diabetes treatment flow
Investor presentation Full year 2013 Slide 28 Novo Nordisk current and future product portfolio covers the type 2 diabetes treatment flow1 Type 2 diabetes progression and Novo Nordisk ideal treatment flow Diet & OAD’s GLP-1 Insulin initiation Optimisation Intensification Exercise Metformin OR OR 1 P
Slide 29: Novo Nordisk continues to expand leadership position within diabetes care
Investor presentation Full year 2013 Slide 29 Novo Nordisk continues to expand leadership position within diabetes care Global diabetes care market Global diabetes care by treatment class value market share DKK GLP-1 Insulin OAD Novo Nordisk Sanofi Merck Lilly billion Takeda Novartis AstraZeneca GSK
Slide 30: Modern insulin and Victoza constitute 76% of diabetes care sales
Investor presentation Full year 2013 Slide 30 Modern insulin and Victoza® constitute 76% of diabetes care sales Diabetes care sales as reported – full year 2013 MAT diabetes care sales development OAD DKK Modern insulin Human insulin Victoza® Protein related billion (19%) OAD Protein related 2% 4% 3
Slide 31: Strong underlying insulin market growth and steady market share development
Investor presentation Full year 2013 Slide 31 Strong underlying insulin market growth and steady market share development Global insulin market Global modern insulin volume market shares Device penetration Modern Insulin penetration1 Novo Nordisk Sanofi Eli Lilly tMU Penetration 500 100% 60% CAGR vo
Slide 32: The global GLP-1 market continues to expand
Investor presentation Full year 2013 Slide 32 The global GLP-1 market continues to expand Victoza® is driving the expansion of North America constitutes the majority the global GLP-1 market of the GLP-1 value market1 GLP-1 sales in bDKK (right axis) North America Europe International Operations DKK
Slide 33: Growth opportunities supported by strong global presence in both sales and manufacturing
Investor presentation Full year 2013 Slide 33 Growth opportunities supported by strong global presence in both sales and manufacturing FTEs in sales regions1 Global manufacturing setup • API production North America: ~5,300 • Formulation & filling Kaluga2 • Assembly • Packaging • Filling & • Device
Slide 34: High barriers to entry in biologics
Investor presentation Full year 2013 Slide 34 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 & Develop
Slide 35: Operating profit continues to grow, driven by gross margin improvements and operational leverage
Investor presentation Full year 2013 Slide 35 Operating profit continues to grow, driven by gross margin improvements and operational leverage The fundamental drivers of Operating profit operating profit growth Operating profit Operating profit as % of sales Gross margin improvement DKK Operating pr
Slide 36: Stable net operating assets drive growth in operating profit after tax to net operating assets
Investor presentation Full year 2013 Slide 36 Stable net operating assets drive growth in operating profit after tax to net operating assets Operating profit after tax to net operating assets Free cash flow DKK Net operating assets Free cash flow as % of net profit billion Operating profit after tax
Slide 37: Increasing net profit converted into free cash flow
Investor presentation Full year 2013 Slide 37 Increasing net profit converted into free cash flow Net profit Free cash flow (absolute) Net profit EPS diluted Free cash flow as % of net profit DKK DKK Free cash flow billion DKK billion 30 10 25 120% Thousands 25 8 20 100% 20 80% 6 15 15 60% 4 10 10 4
Slide 38: Diabetes
Investor presentation Full year 2013 Slide 38 Diabetes
Slide 39: Diabetes – the inability to manage blood sugar levels appropriately
Investor presentation Full year 2013 Slide 39 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
Slide 40: Insulin – a hormone enabling blood sugar to enter cells
Investor presentation Full year 2013 Slide 40 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 41: Poor diagnosis rates, lack of access to optimal treatment and poor glycaemic control remain global problems
Investor presentation Full year 2013 Slide 41 Poor diagnosis rates, lack of access to optimal treatment and poor glycaemic control remain global problems Diagnosis and optimal treatment Glycaemic control in selected countries well remains a challenge – the rule of halves above recommended levels 100
Slide 42: Poor diabetes diagnosis rates are leading to death and significant costs to world society
Investor presentation Full year 2013 Slide 42 Poor diabetes diagnosis rates are leading to death and significant costs to world society Diabetes prevalence and diagnosis rates Comments to the diabetes pandemic and by IDF reported regions impact on society made by IDF Diabetes Prevalence Diagnosed •
Slide 43: UKPDS: Tight glycaemic control reduces risk of micro- and macrovascular complications
Investor presentation Full year 2013 Slide 43 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 44: Medications used for the treatment of type 2 diabetes
Investor presentation Full year 2013 Slide 44 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 45: Sustained double-digit growth in insulin market
Investor presentation Full year 2013 Slide 45 Sustained double-digit growth in insulin market Global insulin market growth The fundamental growth drivers 2008-2013 of the insulin market DKK Volume billion CAGR: CAGR: • Rising prevalence of diabetes 140 9.8%1 15.7%1 - Growing overweight and obesity p
Slide 46: Solid insulin growth across diverse regions
Investor presentation Full year 2013 Slide 46 Solid insulin growth across diverse regions Novo Nordisk Market Market volume Volume market regions value size & growth composition shares 69.3 -3% 20% 81.1 13% Basal Novo Nordisk North America 49% 60% 40% 38% Fast acting Rest 25.4 3% 0% 26.0 23% Pre-mix
Slide 47: Stable global insulin volume growth
Investor presentation Full year 2013 Slide 47 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 40% 100% 7% 35% 19% 80% 30% 4%
Slide 48: The insulin market is comprised of three segments
Investor presentation Full year 2013 Slide 48 The insulin market is comprised of three segments Action profiles of insulins Global insulin volume market by segments tMU CAGR volume1: 6.4% Fast acting CAGR value1: 16.2% 400 350 34% 300 Fast acting Premix 250 33% 200 28% 150 32% Premix Long acting 100
Slide 49: Maintaining insulin leadership by sustaining modern insulin market share
Investor presentation Full year 2013 Slide 49 Maintaining insulin leadership by sustaining modern insulin market share Novo Nordisk volume market share across insulin classes Novo Nordisk segment MS (%) Segment volume tMU Human insulin tMU Modern insulin tMU Total insulin 450 100% 450 100% 450 100%
Slide 50: Novo Nordisk is the market leader in the insulin and GLP-1 segments
Investor presentation Full year 2013 Slide 50 Novo Nordisk is the market leader in the insulin and GLP-1 segments Key products represent more than 75% of sales within diabetes care Percent of Patent Brand name Type YTD Sales1 diabetes care sales expiration EU: 20172 NovoRapid® Fast-acting insulin 16
Slide 51: Performance of Novo Nordisk's modern insulins within their respective segments
Investor presentation Full year 2013 Slide 51 Performance of Novo Nordisk’s modern insulins within their respective segments Long acting insulin Rapid-acting insulin Premixed insulin Segment volume Segment volume Segment volume Levemir® market share NovoRapid® market share Novomix® market share tMU
Slide 52: Solid growth potential for Levemir in the long acting insulin segment
Investor presentation Full year 2013 Slide 52 Solid growth potential for Levemir® in the long acting insulin segment Basal insulin market by volume Example of Levemir® promotional sales aid1 Share of total Levemir ® Basal segment volume growth insulin market Other modern basal insulins Other 60% -2%
Slide 53: NovoRapid remains the preferred modern short acting insulin in all key markets
Investor presentation Full year 2013 Slide 53 NovoRapid® remains the preferred modern short acting insulin in all key markets Rapid-acting insulin market by volume Example of NovoRapid® promotional sales aid1 Share of total NovoRapid® Bolus segment volume growth insulin market Other modern bolus ins
Slide 54: Continued growth potential for NovoMix in the premix insulin segment
Investor presentation Full year 2013 Slide 54 Continued growth potential for NovoMix® in the premix insulin segment in key markets Premix insulin market by volume Example of NovoMix® promotional sales aid1 Share of total NovoMix® Premix segment volume growth insulin market Other modern premix insuli
Slide 55: Still a significant potential for Novo Nordisk on the US modern insulin market
Investor presentation Full year 2013 Slide 55 Still a significant potential for Novo Nordisk on the US modern insulin market US insulin market segments changes to IMS data collection reflected US modern insulin volume market shares Device penetration Modern Insulin penetration Novo Nordisk Sanofi El
Slide 56: IMS not fully representative of underlying performance due to data collection methodology
Investor presentation Full year 2013 Slide 56 IMS not fully representative of underlying performance due to data collection methodology and coverage Novo Nordisk ex-factory and IMS Key factors driving discrepancy between insulin volume in the US ex-factory and IMS Index Ex-factory IMS • Differences
Slide 57: Novo Nordisk's modern insulins continue strong performance in all insulin segments in the US
Investor presentation Full year 2013 Slide 57 Novo Nordisk’s modern insulins continue strong performance in all insulin segments in the US US long-acting insulin US rapid-acting insulin US premixed insulin Segment volume Segment volume Segment volume Levemir® market share NovoLog® market share NovoL
Slide 58: Stable leadership position on the European modern insulin market
Investor presentation Full year 2013 Slide 58 Stable leadership position on the European modern insulin market European modern insulin European insulin market by segments volume market shares Device penetration Modern Insulin penetration Novo Nordisk Sanofi Eli Lilly tMU CAGR volume1: 2.9% Penetrati
Slide 59: Stable leadership position on the rapidly growing Chinese insulin market
Investor presentation Full year 2013 Slide 59 Stable leadership position on the rapidly growing 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 tM
Slide 60: Stable leadership position in International Operations
Investor presentation Full year 2013 Slide 60 Stable leadership position in International Operations International Operations insulin International Operations insulin market by segments volume market shares Device penetration Modern Insulin penetration Novo Nordisk Sanofi Lilly tMU CAGR volume1: 13.
Slide 61: Sustained leadership position in Japan
Investor presentation Full year 2013 Slide 61 Sustained leadership position in Japan Japanese insulin market by segments Japanese modern insulin volume market shares Device penetration Modern Insulin penetration Novo Nordisk Sanofi Eli Lilly tMU CAGR volume1: 1.3% Penetration 14 CAGR value1: 6.0% 10
Slide 62: GLP-1 effect dependent on level of blood glucose - which reduces risk of hypoglycaemia
Investor presentation Full year 2013 Slide 62 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 63: Victoza, the only once-daily human GLP-1 analogue for type 2 diabetes
Investor presentation Full year 2013 Slide 63 Victoza®, the only once-daily human GLP-1 analogue for type 2 diabetes Characteristics of Victoza® • Reduces blood glucose levels with a very low risk of hypoglycaemia • 13 hours half-life allows for once-daily dosing • Reduces weight • Reduces systolic
Slide 64: The US GLP-1 market continues to grow
Investor presentation Full year 2013 Slide 64 The US GLP-1 market continues to grow US GLP-1 market Key observations for Victoza® in the US market GLP-1 TRx scripts GLP-1 % of diabetes care market • Victoza® market share within the GLP-1 segment is more (thousands) than 65%1 US diabetes care market
Slide 65: Victoza maintains GLP-1 class leadership position in key European markets
Investor presentation Full year 2013 Slide 65 Victoza® maintains GLP-1 class leadership position in key European markets Development in key European markets following Victoza® launch Victoza® Exenatide Lixisenatide Germany UK France Market value1: DKK 12 billion Market value1: DKK 6 billion Market v
Slide 66: R&D pipeline: Diabetes and obesity
Investor presentation Full year 2013 Slide 66 R&D pipeline: Diabetes and obesity Product/project Type Indication Status (phase) 1 2 3 Filed Appr. Tresiba® (NN1250)1 Ultra long-acting basal insulin Type 1+2 Ryzodeg® (NN5401)1 Ultra long-acting basal insulin with a bolus boost Type 1+2 IDegLira (NN906
Slide 67: Meta-analysis confirms hypoglycaemic profile of insulin degludec
Investor presentation Full year 2013 Slide 67 Meta-analysis across type 1 and type 2 diabetes trials confirms hypoglycaemic profile of insulin degludec = statistical significance Confirmed hypoglycaemia Nocturnal hypoglycaemia Total period Maintenance period2 Total period Maintenance period2 Subject
Slide 68: Competitive label for Tresiba in Europe and Japan
Investor presentation Full year 2013 Slide 68 Competitive label for Tresiba® in Europe and Japan European label Japanese label • Duration of action beyond 42 hours • Duration of action tested up to 26 hours in Japanese patients • Four times lower day-to-day variability compared to (Duration of actio
Slide 69: Competitive label for Ryzodeg in Europe and Japan
Investor presentation Full year 2013 Slide 69 Competitive label for Ryzodeg® in Europe and Japan European label Japanese label • Duration of action beyond 24 hours with a single injection • Duration of action beyond 24 hours in Japanese patients with a • An action profile reflecting, the rapid-actin
Slide 70: Early feedback from launch markets shows strong execution of Tresiba strategy
Investor presentation Full year 2013 Slide 70 Early feedback from launch markets shows strong execution of Tresiba® strategy Most recalled messages1 Example of Tresiba® promotional detail aid in the UK • Less hypoglycaemia • Long duration of action • Flexible in dosing time (UK)2 • Mode of protracti
Slide 71: DEVOTE cardiovascular outcomes trial for Tresiba
Investor presentation Full year 2013 Slide 71 DEVOTE cardiovascular outcomes trial for Tresiba® DEVOTE (NN1250-4080) trial design Trial execution and governance 7,500 Trial execution people with Insulin degludec (blinded vial) • Trial initiated in October 2013 type 2 + standard of care • Double blin
Slide 72: Faster-acting insulin aspart improved glucose control after a standard meal
Investor presentation Full year 2013 Slide 72 In a phase 1 study, people on faster-acting insulin aspart experienced improved glucose control after a standard meal Key results of phase 1 trial1 Incremental meal-test glucose profiles • Trial evaluated short term efficacy, safety and pump Faster-actin
Slide 73: Faster-acting insulin aspart phase 3a clinical development programme, onset
Investor presentation Full year 2013 Slide 73 Faster-acting insulin aspart phase 3a clinical development programme, onset™ 2013 2014 2015 onset® 1: basal-bolus insulin therapy 26+26 weeks, n=1,095 onset® 2: basal-bolus insulin therapy 26 weeks, n=676 onset® 3: bolus intensification 18 weeks, n=218 o
Slide 74: Ultra-long-acting insulin LAI287 intended for once-weekly dosing
Investor presentation Full year 2013 Slide 74 Ultra-long-acting insulin LAI287 intended for once-weekly dosing Glucose Infusion Rate vs. time (predicted mean Glucose at steady Infusion state) Rate vs. Time Key observations (Predicted Mean) 18 nmol/kg LAI287, 18 nmol/kg • The peak-to-trough ratios fo
Slide 75: In DUAL I and II, IDegLira demonstrated improved glycaemic control
Investor presentation Full year 2013 Slide 75 In DUALTM I and II, IDegLira demonstrated improved glycaemic control and additional benefits vs. comparator DUAL™ I: Lower HbA1c with reduced DUALTM II: Lower HbA1c with no increase in hypoglycaemia vs individual components hypoglycaemia and substantial
Slide 76: DUAL IV phase 3b trial shows benefits of adding IDegLira to SU and metformin
Investor presentation Full year 2013 Slide 76 DUALTM IV phase 3b trial shows benefits of adding IDegLira to SU and metformin treatment DUALTM IV (NN9068-3951) trial design Headline results Placebo IDegLira 435 IDegLira once-daily (n=289) Baseline HbA1c 7.9% 7.9% people with type 2 End of trial HbA1c
Slide 77: IDegLira phase 3 clinical development programme
Investor presentation Full year 2013 Slide 77 IDegLira phase 3 clinical development programme 2011 2012 2013 2014 DUAL™ I: IDegLira vs. individual extension components, 26+26 weeks, n=1,660 EU DUAL™ II: IDegLira vs. submission insulin degludec, n=400 DUAL™ III: Switch from GLP-1 therapy, 26 weeks, n
Slide 78: Semaglutide dose dependently reduced HbA1c and body weight in phase 2
Investor presentation Full year 2013 Slide 78 In a phase 2 trial, semaglutide dose dependently reduced HbA1c and body weight from baseline HbA1c reduction in 12 week phase 2 trial Weight loss in 12 week phase 2 trial Semaglutide Liraglutide Semaglutide Liraglutide Baseline 8.1 8.2 8.2 8.1 8.2 8.1 8.
Slide 79: SUSTAIN phase 3a programme to support a broad competitive label
Investor presentation Full year 2013 Slide 79 SUSTAIN™ phase 3a programme to support a broad competitive label1 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 weeks, n= 800 S
Slide 80: Liraglutide 3 mg demonstrated weight loss in all SCALE trials
Investor presentation Full year 2013 Slide 80 Liraglutide 3 mg demonstrated weight loss in all SCALE™ trials Overview of weight loss (%) in the SCALE™ programme Liraglutide 3 mg Placebo % patients with ≥5% weight loss Obesity & Pre-diabetes Diabetes Maintenance Sleep Apnoea (56 weeks and n=3,731) (5
Slide 81: 56-week trial: liraglutide 3 mg promoted weight maintenance and additional weight loss
Investor presentation Full year 2013 Slide 81 In a 56-week trial, liraglutide 3 mg promoted weight maintenance and additional weight loss in obese adults Conclusions on the Change in body weight by week SCALETM-Maintenance trial • Subjects lost >5% (6 kg) during 12 week hypo-caloric diet Run-in Trea
Slide 82: Obesity burden in the US
Investor presentation Full year 2013 Slide 82 Obesity burden in the US Incidence of obesity in the US Comments to the US obesity burden • Cost of obesity to health care systems of US $147 billion Obese Over- annually2 with continued growth Million weight Class I Class II Class III TOTAL people BMI 2
Slide 83: Small market for anti-obesity medication in US
Investor presentation Full year 2013 Slide 83 Small market for anti-obesity medication in US Value of US obesity market People on anti-obesity medication in US DKK Patient year equivalents phentermine orlistat million (thousands) lorcaserin phendimetrazine 2.000 800 phentermine and topiramate1 700 1
Slide 84: Liraglutide 3 mg sales will come from a small segment of people with obesity
Investor presentation Full year 2013 Slide 84 Liraglutide 3 mg sales will come from a small segment of people with obesity Patient funnel Market approach Liraglutide 3 mg aspiration US example Clear patient segmentation ~107 million people with obesity1 Capture share of people currently treated Focu
Slide 85: Positive effects of liraglutide as adjunct therapy to insulin in type 1 diabetes
Investor presentation Full year 2013 Slide 85 Positive effects of liraglutide as adjunct therapy to insulin in type 1 diabetes were observed in a phase 1 trial Key results from phase 1 trial Hypoglycaemic episodes during CGM2 • Reduction in insulin dose at same HbA1c Liraglutide 0.6 mg (n=11) Liragl
Slide 86: ADJUNCT phase 3a programme - liraglutide as adjunct therapy to insulin in type 1
Investor presentation Full year 2013 Slide 86 ADJUNCT™ phase 3a programme - liraglutide as adjunct therapy to insulin in type 1 diabetes ADJUNCT™ phase 3a programme ADJUNCT™ phase 3a trials and design • Global clinical phase 3 program in type 1 diabetes with more 2013 2014 2015 than 2,000 patients A
Slide 87: Oral peptide delivery - challenges and solutions
Investor presentation Full year 2013 Slide 87 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 88: Proof of principle achieved in phase 1 trial with oral semaglutide
Investor presentation Full year 2013 Slide 88 Proof of principle achieved in phase 1 trial with oral semaglutide HbA1c reduction is comparable with Body weight reduction is comparable with sc semaglutide at similar exposure sc semaglutide at similar exposure Placebo, type 2 diabetes (n=6) Placebo, t
Slide 89: Ongoing oral semaglutide (OG217SC) phase 2 trial
Investor presentation Full year 2013 Slide 89 Ongoing oral semaglutide (OG217SC) phase 2 trial Phase 2 trial design Phase 2 trial objective and endpoints Semaglutide tablet 2.5 mg Trial objective Semaglutide tablet 5 mg • To examine the dose range, escalation and efficacy of semaglutide tablet in su
Slide 90: Biopharmaceuticals
Investor presentation Full year 2013 Slide 90 Biopharmaceuticals
Slide 91: Biopharmaceuticals – global leadership in selected high-value disease areas
Investor presentation Full year 2013 Slide 91 Biopharmaceuticals – global leadership in selected high- value disease areas Haemophilia Growth Hormone Inflammation with inhibitors Therapy 2013 sales: DKK 9.3 billion 2013 sales: DKK 6.1 billion 2013 sales: DKK 0 Global market position: #1 Global marke
Slide 92: Haemophilia: Location of bleedings and the consequences
Investor presentation Full year 2013 Slide 92 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 93: Haemophilia - a significant market suited for Novo Nordisk's core strengths
Investor presentation Full year 2013 Slide 93 Haemophilia - a significant market suited for Novo Nordisk’s core strengths within human proteins Number of people with haemophilia A and B and haemophilia with inhibitors Sales of recombinant coagulation factors Novoseven® Xyntha®/Refacto® Benefix® USD
Slide 94: NovoSeven - a unique biologic for the treatment of rare bleeding disorders
Investor presentation Full year 2013 Slide 94 NovoSeven® - a unique biologic for the treatment of rare bleeding disorders Reported sales Key NovoSeven® properties DKK • Product characteristics: powder and solvent for solution billion for i.v. injection, available in multiple doses, stable at room- C
Slide 95: NovoEight now launched in Europe for the treatment of people with haemophilia A
Investor presentation Full year 2013 Slide 95 NovoEight® now launched in Europe for the treatment of people with haemophilia A Example from NovoEight® Key NovoEight® properties promotional campaign Indications: • Treatment and prophylaxis of bleeding in patients with congenital factor VIII deficienc
Slide 96: NovoThirteen provides efficacious and safe haemostatic coverage
Investor presentation Full year 2013 Slide 96 NovoThirteen®, a recombinant FXIII, provides efficacious and safe haemostatic coverage FXIII activity levels in mentor™ 1 phase 3 trial Key results from pivotal phase 3 trial Berichrom FXIII • NovoThirteen® was effective in preventing bleeding after 10%
Slide 97: Core capabilities are applied within haemophilia to expand the product portfolio
Investor presentation Full year 2013 Slide 97 Core capabilities are applied within haemophilia to expand the product portfolio development development development development Plasma- Recombinant FVIIa Recombinant FVIIa Market Factor VIIa derived analogues FVIIa1 Plasma-derived Recombinant Longer-act
Slide 98: R&D pipeline: Haemophilia and hGH
Investor presentation Full year 2013 Slide 98 R&D pipeline: Haemophilia and hGH Product/project Type Indication Status (phase) 1 2 3 Filed Appr. N9-GP (NN7999) Long-acting rFIX derivative Haemophilia B N8-GP (NN7088) Long-acting rFVIII derivative Haemophilia A Concizumab (NN7415) Monoclonal anti-TFP
Slide 99: Pharmacokinetic profile of N8-GP supported less frequent dosing
Investor presentation Full year 2013 Slide 99 In a phase 1 trial, the pharmacokinetic profile of N8-GP supported less frequent dosing PK profile of N8-GP1 compared with other rFVIII product Key results from phase 1 trial FVIII 25 IU/kg previous FVIII product • N8-GP was well tolerated at single iv d
Slide 100: Positive results from phase 3 trial with long-acting factor IX
Investor presentation Full year 2013 Slide 100 Positive results from phase 3 trial with long-acting factor IX for treatment of haemophilia B ParadigmTM 2 (NN7999 - 3747) trial design Headline results 74 patients with haemophilia B: • Median bleeding rate for patients treated on demand was 15.6 episo
Slide 101: Novo Nordisk continues to expand market leadership within human growth hormone
Investor presentation Full year 2013 Slide 101 Novo Nordisk continues to expand market leadership within human growth hormone Development in global hGH market Growth hormone volume market share MAT value DKK (left axis) Novo Nordisk Pfizer Sandoz MAT Volume kg (right axis) Eli Lilly Merck Kgaa Roche
Slide 102: Solid Norditropin sales growth
Investor presentation Full year 2013 Slide 102 Solid Norditropin® sales growth Reported Norditropin® sales Key Norditropin® properties • Product characteristics: Premixed, prefilled multi-use DKK delivery systems available in multiple strengths, some stable billion CAGR 9.4% at room-temperature 1,5
Slide 103: R&D pipeline: Inflammation
Investor presentation Full year 2013 Slide 103 R&D pipeline: Inflammation Compound Type Indication Status (phase) 1 2a 2b 3 Filed Appr. Anti-IL-20 (NN8226) Monoclonal antibody Rheumatoid arthritis Anti-IL-21 (NN8828) Monoclonal antibody Crohn’s Disease Anti-NKG2D (NN8555) Monoclonal antibody Crohn’s
Slide 104: Inflammation well suited to leverage Novo Nordisk's core capabilities
Investor presentation Full year 2013 Slide 104 Inflammation well suited to leverage Novo Nordisk’s core capabilities Protein focus • Mainstay of modern anti-inflammatory therapies • Novo Nordisk core competence Immunology focus • Direct pathogenic mechanism for all autoimmune diseases Protein • Well
Slide 105: Financials
Investor presentation Full year 2013 Slide 105 Financials
Slide 106: Sustained double digit growth throughout the last decade
Investor presentation Full year 2013 Slide 106 Novo Nordisk has delivered sustained double digit growth throughout the last decade Sales growth in local currencies Operating profit growth in local currencies from 2004 to 2013 from 2004 to 2013 Sales growth Average growth Operating profit growth Aver
Slide 107: Solid sales growth with North America, International Operations and China expanding
Investor presentation Full year 2013 Slide 107 Solid sales growth with especially North America, International Operations and China expanding Reported annual sales Reported annual sales split by region Diabetes Biopharmaceuticals North America Europe Japan & Korea DKK China Int. Operations billion 9
Slide 108: Solid operating profit growth driven by diabetes
Investor presentation Full year 2013 Slide 108 Solid operating profit growth driven by diabetes Operating profit Operating profit therapy split Operating profit Operating profit as % of sales Diabetes Biopharm DKK Operating profit growth vs. last year billion Operating profit growth in local currenc
Slide 109: Profitability per segment
Investor presentation Full year 2013 Slide 109 Profitability per segment Diabetes P&L, FY2013 Biopharmaceuticals P&L, FY2013 DKK DKK billion billion 70 -18% 70 60 60 -31% 50 50 40 40 -12% 30 -4% 30 +1% 35% 20 20 -12% -15% -22% -4% +1% 47% 10 10 0 0 Sales COGS S&D R&D Admin OOI OP Sales COGS S&D R&D
Slide 110: Continued decline in relative COGS level combined with stable investment level
Investor presentation Full year 2013 Slide 110 Continued decline in relative COGS level combined with stable investment level Cost of Goods Sold (COGS) Capital expenditures (CAPEX) COGS as % of sales CAPEX as % of sales DKK COGS DKK CAPEX billion billion 15 25% 4 6% Thousands 20% 3 10 4% 15% 2 10% 5
Slide 111: Long-term financial targets
Investor presentation Full year 2013 Slide 111 Long-term financial targets Performance against long-term financial targets Average Result Targets2 2009-20131 2013 Operating profit growth 21% 7% 15% Operating margin 34% 38% 40% Operating profit after tax to net operating assets 77% 97% 125% Cash to e
Slide 112: Long term financial targets: Operating profit growth and operating margin
Investor presentation Full year 2013 Slide 112 Long term financial targets: Operating profit growth and operating margin Operating profit growth Operating margin Current long term financial target Current long term financial target Previous long term financial targets Previous long term financial ta
Slide 113: Long term financial targets: Operating profit after tax to net operating assets, cash to earnings
Investor presentation Full year 2013 Slide 113 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 years’ average) Current long term financial target Current long term financi
Slide 114: Stable ownership structure
Investor presentation Full year 2013 Slide 114 Stable ownership structure - secured through A and B-share structure Share structure The Novo Nordisk Foundation Novo Nordisk • The Novo Nordisk Foundation is a self-governing institution Foundation that: Institutional and • provides a stable basis for