Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — 9M 2014 Earnings Presentation
104 slides from Novo Nordisk A/s Class B's earnings presentation, Oct 30, 2014
Slide 1: Investor presentation First nine months of 2014
Slide 1 Investor presentation First nine months of 2014 Copenhagen 30 October
Slide 2: Agenda
Investor presentation First nine months of 2014 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 2014 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 filed with the SEC in February
Slide 4: Highlights – first nine months of 2014
Investor presentation First nine months of 2014 Slide 4 Highlights – first nine months of 2014 Sales development • Sales increased by 8% in local currencies and 4% in Danish kroner • North America, International Operations and Region China grew by 11%, 13% and 14% in local currencies, respectively •
Slide 5: North America remains the main contributor to growth
Investor presentation First nine months of 2014 Slide 5 North America remains the main contributor to growth Sales as reported – first nine months of 2014 Growth analysis – first nine months of 2014 Japan & Korea Local currencies Growth Share of growth Region China (8%) North America 11% 65% +11% 6%
Slide 6: Growth is driven by modern insulin and Victoza
Investor presentation First nine months of 2014 Slide 6 Growth is driven by modern insulin and Victoza® Sales as reported – first nine months of 2014 Growth analysis – first nine months of 2014 Other Local currencies Growth Share of growth Norditropin® +9% New-generation insulin n/a 7% +5% 3% 4% Mod
Slide 7: Victoza maintains leadership in the decelerated US GLP-1 market
Investor presentation First nine months of 2014 Slide 7 Victoza® maintains leadership in the decelerated US GLP-1 market US GLP-1 market development US GLP-1 market shares MAT GLP-1 Growth rate Total TRx MAT volume GLP-1 TRx Other GLP-1 Victoza® Trx (000) growth rate market share 5,000 25% 100% Thou
Slide 8: North America drives strong Levemir performance
Investor presentation First nine months of 2014 Slide 8 North America drives strong Levemir® performance aided by continued market share gains in the US Levemir® sales growth driven by strong Levemir® market share and device penetration performance in North America in the US modern basal insulin seg
Slide 9: Tresiba roll-out continues with encouraging performance
Investor presentation First nine months of 2014 Slide 9 Tresiba® roll-out continues with encouraging performance in countries with similar access Tresiba® value market share in basal insulin segment in selected markets Key launch observations Switzerland Mexico Japan • Tresiba® grows share of basal
Slide 10: Promising Tresiba performance strengthens insulin share in Japan
Investor presentation First nine months of 2014 Slide 10 Promising Tresiba® performance strengthens total insulin market share in Japan Japanese basal value market shares Japanese total insulin value market shares glargine Tresiba® Levemir® NPH Novo Nordisk Sanofi Eli Lilly NN Total Basal 80% 80% 60
Slide 11: Decision to submit interim analysis to the FDA expected in H1 2015
Investor presentation First nine months of 2014 Slide 11 Decision to submit interim analysis to the FDA expected during the first half of 2015 DEVOTE interim analysis: communication DEVOTE (EX1250-4080) trial design and filing approach • Decision to submit or await completion of DEVOTE will take 7,5
Slide 12: Competitive European label for Xultophy
Investor presentation First nine months of 2014 Slide 12 Competitive European label for Xultophy® Xultophy® is indicated for the treatment of adults with type 2 diabetes in combination with oral glucose-lowering products alone or combined with basal insulin • Xultophy® is a fixed combination product
Slide 13: Key development milestones
Investor presentation First nine months of 2014 Slide 13 Key development milestones ● Phase 3a trial comparing semaglutide (NN9535) with sitagliptin in Japanese people with type 2 diabetes initiated ● Phase 1 development successfully completed with two oral GLP-1 tablets, OG987GT (NN9926) and OG987S
Slide 14: Financial results – first nine months of 2014
Investor presentation First nine months of 2014 Slide 14 Financial results – first nine months of 2014 DKK million 9M 2014 9M 2013 Change Sales 64,221 61,874 4% Gross profit 53,658 51,134 5% Gross margin 83.6% 82.6% Sales and distribution costs 16,544 16,893 (2%) Percentage of sales 25.8% 27.3% Rese
Slide 15: Recent appreciation of the US dollar indicates positive currency impact for 2015
Investor presentation First nine months of 2014 Slide 15 Recent appreciation of the US dollar against the Danish krone indicates a positive currency impact for 2015 USD/DKK CNY/DKK JPY/DKK GBP/DKK CAD/DKK 130 Index (1 Jan 2013 = 100) Hedged 2013 2014 Spot Impact of a Hedging 120 Currencies average a
Slide 16: Financial outlook for 2014
Investor presentation First nine months of 2014 Slide 16 Financial outlook for 2014 Expectations Previous expectations 30 Oct 2014 7 Aug 2014 Sales growth - local currencies 7-9% 7-10% Sales growth - reported Around 2 percentage points lower Around 3 percentage points lower Operating profit growth -
Slide 17: Closing remarks
Investor presentation First nine months of 2014 Slide 17 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 sol
Slide 18: Investor contact information
Investor presentation First nine months of 2014 Slide 18 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 19: Appendix
Investor presentation First nine months of 2014 Slide 19 Appendix 1. Novo Nordisk at a glance 2. Diabetes 3. Biopharmaceuticals 4. Financials
Slide 20: Novo Nordisk at a glance
Investor presentation First nine months of 2014 Slide 20 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: 47% Europe: in diabetes, haemophilia and growth hormone Market share 48% • Dou
Slide 21: Four strategic focus areas based on five core capabilities
Investor presentation First nine months of 2014 Slide 21 Novo Nordisk works with four 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 unde
Slide 22: Leading positions in diabetes, haemophilia and growth disorders
Investor presentation First nine months of 2014 Slide 22 Novo Nordisk has leading positions in diabetes, haemophilia and growth disorders Diabetes Haemophilia Growth hormone deficiency DKK Market value DKK Market value DKK Market value billion Novo Nordisk value market share billion Novo Nordisk val
Slide 23: Double digit top line growth driven by diabetes pandemic
Investor presentation First nine months of 2014 Slide 23 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 NovoSeven® North America Europe Japan & Korea DKK Million Norditropin ®
Slide 24: Strong leadership position within the growing diabetes care market
Investor presentation First nine months of 2014 Slide 24 Novo Nordisk has a strong leadership position within the growing diabetes care market Global diabetes care market Global diabetes care by treatment class value market share DKK GLP-1 Insulin OAD Novo Nordisk Sanofi Merck Eli Lilly billion Take
Slide 25: Strong R&D pipeline in diabetes, obesity and biopharmaceuticals
Investor presentation First nine months of 2014 Slide 25 Significant growth opportunities fuelled by strong R&D pipeline in diabetes, obesity and biopharmaceuticals PHASE 1 PHASE 2 PHASE 3 SUBMITTED APPROVED2 OG217GT – Oral GLP-1 OG217SC – Oral GLP-1 Faster-acting insulin aspart Saxenda® (US/EU) Lev
Slide 26: Upcoming key milestones within diabetes and obesity
Investor presentation First nine months of 2014 Slide 26 Upcoming key milestones within diabetes and obesity Clinical Commercial Regulatory Project 2014 2015 2016 Saxenda® US & EU approval decisions Xultophy® First commercial launch Tresiba® DEVOTE interim results Faster-acting insulin aspart Remain
Slide 27: Strong global presence in both sales and manufacturing
Investor presentation First nine months of 2014 Slide 27 Growth opportunities supported by strong global presence in both sales and manufacturing FTEs in sales regions1 Global manufacturing setup • API production North America: ~5,600 • Formulation & filling Kaluga2 • Assembly • Packaging • Filling
Slide 28: High barriers to entry in biologics
Investor presentation First nine months of 2014 Slide 28 High barriers to entry in biologics Novo Nordisk’s position is protected Significant barriers to entry by patents and value chain setup for biosimilar players Patent protection1 Unique value chain position EU/US0 Research & Development Researc
Slide 29: Long-term financial targets
Investor presentation First nine months of 2014 Slide 29 Long-term financial targets Performance against long-term financial targets Average Result Target2 2009-20131 2013 Operating profit growth 21% 7% 15% Operating profit growth in local currencies 18% 15% Operating margin 34% 38% 40% Operating pr
Slide 30: Robust cash return via dividends and share repurchases
Investor presentation First nine months of 2014 Slide 30 Robust cash return generated via dividends and share repurchase programmes Share repurchase programmes has enabled Annual cash return to shareholders continued reduction in share capital DKK Share repurchase Dividend DKK Share capital billion
Slide 31: Diabetes
Investor presentation First nine months of 2014 Slide 31 Diabetes
Slide 32: Diabetes – the inability to manage blood sugar levels
Investor presentation First nine months of 2014 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 ef
Slide 33: Insulin – a hormone enabling blood sugar to enter cells
Investor presentation First nine months of 2014 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
Slide 34: Diabetes pandemic is fuelled by growing rates of obesity
Investor presentation First nine months of 2014 Slide 34 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 N
Slide 35: Poor diagnosis rates and glycaemic control remain global problems
Investor presentation First nine months of 2014 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 ty
Slide 36: UKPDS: Tight glycaemic control reduces complication risk
Investor presentation First nine months of 2014 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 Microv
Slide 37: Insulin is the ultimate care for people with diabetes
Investor presentation First nine months of 2014 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
Slide 38: The insulin market is comprised of three segments
Investor presentation First nine months of 2014 Slide 38 The insulin market is comprised of three segments Insulin action profiles Global insulin volume market by segment tMU CAGR volume1: 5.9% Fast-acting CAGR value1: 16.1% 450 400 350 34% 300 Fast-acting Premix 250 33% 200 28% Premix 150 32% Long-
Slide 39: Medications used for the treatment of type 2 diabetes
Investor presentation First nine months of 2014 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 Metf
Slide 40: Novo Nordisk is the market leader in insulin and GLP-1
Investor presentation First nine months of 2014 Slide 40 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 diabetes Patent Brand name Type 2013 Sales1 care sales2 expiration 16.9 bDKK EU: 20173 NovoRapid®
Slide 41: Sustained double-digit growth in insulin market
Investor presentation First nine months of 2014 Slide 41 Sustained double-digit growth in insulin market Global insulin market growth The fundamental growth drivers August 2009 – August 2014 of the insulin market DKK Volume billion CAGR: CAGR: 10.3%1 16.1%1 • Rising prevalence of diabetes 140 • Grow
Slide 42: Solid insulin volume growth in key regions
Investor presentation First nine months of 2014 Slide 42 Solid insulin volume growth in key regions Novo Nordisk Market Market volume Volume market regions value size & growth composition shares 78.8 2% 27% 101.4 38% Fast-acting Novo Nordisk 50% North America 63% 37% Premix Others 12% Long-acting 25
Slide 43: Stable global insulin volume growth
Investor presentation First nine months of 2014 Slide 43 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% 8% 35% 80%
Slide 44: Maintaining insulin leadership by sustaining modern insulin share
Investor presentation First nine months of 2014 Slide 44 Maintaining insulin leadership by sustaining modern insulin market share Novo Nordisk volume market share across insulin classes Novo Nordisk class MS (%) class volume tMU Human insulin1 tMU Modern insulin3 tMU Total insulin 450 100% 450 100%
Slide 45: Strong underlying insulin market growth and steady market share
Investor presentation First nine months of 2014 Slide 45 Strong underlying insulin market growth and steady market share development Global insulin market Global modern insulin1 volume market shares Device penetration Modern insulin penetration1 Novo Nordisk Sanofi Eli Lilly tMU Penetration 500 100%
Slide 46: Modern insulins continue strong performance within segments
Investor presentation First nine months of 2014 Slide 46 Novo Nordisk’s modern insulins continue strong performance within their respective segments Fast-acting insulin Premixed insulin Long-acting insulin Segment volume Segment volume Segment volume NovoRapid® market share NovoMix® market share Lev
Slide 47: NovoRapid remains the preferred modern fast-acting insulin
Investor presentation First nine months of 2014 Slide 47 NovoRapid® remains the preferred modern fast-acting insulin in all key markets Fast-acting insulin market by volume Example of NovoRapid® promotional sales aid1 ® Share of total NovoRapid Other modern insulin insulin market Human insulin* Segm
Slide 48: Continued growth potential for NovoMix in premix segment
Investor presentation First nine months of 2014 Slide 48 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 ® Other modern insulin insulin market Human insulin * Segmen
Slide 49: Solid growth potential for Levemir in long-acting segment
Investor presentation First nine months of 2014 Slide 49 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 Next Generation Levemir insulin market Other modern insulin Human insulin* 60% Se
Slide 50: Significant potential on the US modern insulin market
Investor presentation First nine months of 2014 Slide 50 Still a significant potential for Novo Nordisk on the US modern insulin market US insulin market segments US modern insulin volume market shares Device penetration Modern Insulin penetration Novo Nordisk Sanofi Eli Lilly tMU CAGR volume1: 2.9%
Slide 51: Modern insulins have gained share in expanding US market
Investor presentation First nine months of 2014 Slide 51 Novo Nordisk’s modern insulins have gained market share in expanding US insulin market US fast-acting insulin US premixed insulin US long-acting insulin Segment volume Segment volume Segment volume NovoLog® market share NovoLog Mix® market sha
Slide 52: Sustained leadership on the European modern insulin market
Investor presentation First nine months of 2014 Slide 52 Sustained leadership position on the European modern insulin market European modern insulin1 European insulin market by segments volume market shares Device penetration Modern Insulin penetration2 Novo Nordisk Sanofi Eli Lilly tMU CAGR volume1
Slide 53: Stable leadership position in International Operations
Investor presentation First nine months of 2014 Slide 53 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 tMU C
Slide 54: Leadership on the rapidly growing Chinese insulin market
Investor presentation First nine months of 2014 Slide 54 Sustained 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 Tong
Slide 55: Stabilising market leadership position in Japan
Investor presentation First nine months of 2014 Slide 55 Stabilising 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: 0.5% Penetration 14
Slide 56: GLP-1 effect dependent on level of blood glucose
Investor presentation First nine months of 2014 Slide 56 GLP-1 effect dependent on level of blood glucose − which reduces risk of hypoglycaemia GLP-1 mechanism of action when blood GLP-1 lowers blood glucose in patients sugar levels increase with type 2 diabetes • Increases insulin secretion in the
Slide 57: Victoza has a strong position in DPP-IV, GLP-1 and SGLT-2 segment
Investor presentation First nine months of 2014 Slide 57 Victoza® has a strong position in the global DPP-IV, GLP-1 and SGLT-2 segment Segment value Share of segment value growth Segment value market shares DKK Victoza® Other GLP-1 SGLT-2 DPP-IV billion 90 CAGR1 value: 38.0% 100% 80% 80 21% 16% 70 8
Slide 58: Victoza has strong leadership in the global GLP-1 market
Investor presentation First nine months of 2014 Slide 58 Victoza® has a strong leadership in the global GLP-1 market North America constitutes the majority Global GLP-1 market of the GLP-1 value market1 GLP-1 sales in bDKK (right axis) North America Europe International Operations DKK billion Japan
Slide 59: The US GLP-1 market continues to expand
Investor presentation First nine months of 2014 Slide 59 The US GLP-1 market continues to expand US GLP-1 market Key observations for Victoza® in the US market GLP-1 TRx scripts GLP-1 % of diabetes care market • Victoza® market share within the GLP-1 segment is 67%1 (thousands) • Roughly 66% of Comm
Slide 60: Key diabetes care products remain broadly available in the US
Investor presentation First nine months of 2014 Slide 60 Key Novo Nordisk diabetes care products remain broadly available in the US Value market shares of key Unrestricted market access of key Novo Nordisk products in the US Novo Nordisk products in the US Value market Victoza® NovoLog ® Levemir ® U
Slide 61: Victoza maintains GLP-1 leadership in key European markets
Investor presentation First nine months of 2014 Slide 61 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 13 billion Market value1: DKK 6 billi
Slide 62: Strong Victoza position in GLP-1 segment across all markets
Investor presentation First nine months of 2014 Slide 62 Strong Victoza® position in the GLP-1 segment across all markets GLP-1 market by value Example of Victoza® promotional sales aid1 ® Share of total Victoza Other GLP-1 diabetes care market GLP-1 value growth 10% 21% 13% 8% 17% 6% 4% -8% -12% 2%
Slide 63: R&D pipeline: Diabetes and obesity
Investor presentation First nine months of 2014 Slide 63 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 Xult
Slide 64: Product portfolio covers the type 2 diabetes treatment flow
Investor presentation First nine months of 2014 Slide 64 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 Metformi
Slide 65: BEGIN phase 3a trial confirms profile of insulin degludec
Investor presentation First nine months of 2014 Slide 65 BEGIN phase 3a trial confirms stable and efficacious profile of insulin degludec Tresiba® OD vs insulin glargine OD1 results from BEGIN phase 3a trial Profile • Basal insulin with flatter, less variable profile and a doubling in half-life • Im
Slide 66: Xultophy key clinical results document strong efficacy
Investor presentation First nine months of 2014 Slide 66 Xultophy® key clinical results document strong efficacy across the treatment cascade Xultophy® key clinical results to date DUAL™ I DUAL™ IV DUAL™ III DUAL™ II Add-on to metformin Add-on to SU ± Switch from GLP-1 Add-on to metformin ± Pio metf
Slide 67: Xultophy phase 3 clinical development programme
Investor presentation First nine months of 2014 Slide 67 Xultophy® phase 3 clinical development programme 2011 2012 2013 2014 DUAL™ I: Xultophy® vs. individual extension components, 26+26 weeks, n=1,660 EU DUAL™ II: Xultophy® vs. submission Tresiba®, n=400 DUAL™ III: Switch from GLP-1 therapy, 26 we
Slide 68: Semaglutide reduced HbA1c and body weight in phase 2 trial
Investor presentation First nine months of 2014 Slide 68 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 Victoza® Semaglutide Victoza® Baseline 8.1 8.2 8.2 8.1 8.2 8
Slide 69: SUSTAIN phase 3a programme for semaglutide
Investor presentation First nine months of 2014 Slide 69 SUSTAIN™ phase 3a programme to support a broad competitive label for semaglutide1 2013 2014 2015 2016 SUSTAIN™ 1: Monotherapy 30 weeks, n= 400 SUSTAIN™ 2: Semaglutide vs. sitagliptin 56 weeks, n= 1,200 SUSTAIN™ 3: Semaglutide vs. exenatide onc
Slide 70: Faster-acting insulin aspart early glucose lowering in phase 1
Investor presentation First nine months of 2014 Slide 70 Improvement in early glucose lowering with faster-acting insulin aspart vs insulin aspart in phase 1 trial PD: Mean GIR profiles (0–30 minutes) for PD: Mean GIR profiles (0–30 minutes) for faster-acting insulin aspart vs insulin aspart insulin
Slide 71: Faster-acting insulin aspart Phase 3a programme for onset
Investor presentation First nine months of 2014 Slide 71 Faster-acting insulin aspart Phase 3a programme for 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=216 onset® 4
Slide 72: Liraglutide as adjunct therapy to insulin in type 1 diabetes phase 1
Investor presentation First nine months of 2014 Slide 72 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
Slide 73: ADJUNCT phase 3a programme for LATIN T1D
Investor presentation First nine months of 2014 Slide 73 ADJUNCT™ phase 3a programme for LATIN T1D − 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 2
Slide 74: Oral peptide delivery challenges and solutions
Investor presentation First nine months of 2014 Slide 74 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 75: Proof of principle achieved with oral semaglutide
Investor presentation First nine months of 2014 Slide 75 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)
Slide 76: Ongoing oral semaglutide phase 2 trial
Investor presentation First nine months of 2014 Slide 76 Ongoing oral semaglutide (OG217SC) phase 2 trial Phase 2 trial design Phase 2 trial objective and endpoints Semaglutide tablet 2.5 mg (QD) Trial objective Semaglutide tablet 5 mg (QD) • To examine the dose range, escalation and efficacy of sem
Slide 77: Ultra-long-acting insulin LAI287 intended for once-weekly dosing
Investor presentation First nine months of 2014 Slide 77 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-troug
Slide 78: Obesity burden in the US
Investor presentation First nine months of 2014 Slide 78 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 p
Slide 79: Small but growing market for anti-obesity medication in the US
Investor presentation First nine months of 2014 Slide 79 Small but growing market for anti-obesity medication in the US Value of the US obesity market remains small Few people treated with AOM in US, but recent compared to the US diabetes market launches have contributed to market growth DKK Monthly
Slide 80: Saxenda demonstrated weight loss in all SCALE trials
Investor presentation First nine months of 2014 Slide 80 Saxenda® demonstrated weight loss in all SCALE™ trials Overview of weight loss (%) in the SCALE™ programme Saxenda® Placebo % patients with ≥5% weight loss Obesity & Pre-diabetes Diabetes Sleep Apnoea Maintenance1 (56 weeks and n=3,731) (56 we
Slide 81: Saxenda weight loss in people with type 2 diabetes
Investor presentation First nine months of 2014 Slide 81 Saxenda® is associated with statistically significant weight loss in people with type 2 diabetes in phase 3 trial Statistically significant largest reduction in 50% and 23% of Saxenda® patients loose ≥5% weight with Saxenda® or >10% of body we
Slide 82: Saxenda sales will come from a small segment of people with obesity
Investor presentation First nine months of 2014 Slide 82 Saxenda® sales will come from a small segment of people with obesity Patient funnel Market approach Saxenda® aspiration US example Clear patient segmentation ~107 million people with obesity1 Capture share of people currently treated Focused p
Slide 83: Biopharmaceuticals
Investor presentation First nine months of 2014 Slide 83 Biopharmaceuticals
Slide 84: Haemophilia: Location of bleedings and the consequences
Investor presentation First nine months of 2014 Slide 84 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 85: Haemophilia is a rare disease with severe unmet medical needs
Investor presentation First nine months of 2014 Slide 85 Haemophilia is an 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 Thousand Average percentage of people people with hae
Slide 86: The global haemophilia market is growing by mid-single digits
Investor presentation First nine months of 2014 Slide 86 The global haemophilia market is growing by mid-single digits Strategic positioning of Novo Nordisk’s Sales of recombinant coagulation factors haemophilia portfolio NovoSeven® Coagil Xyntha®/Refacto® Benefix® VII® Novo Nordisk Status Strategic
Slide 87: NovoSeven – a unique biologic for rare bleeding disorders
Investor presentation First nine months of 2014 Slide 87 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 intravenous injection, available in multiple doses,
Slide 88: NovoEight launched in Europe and Japan for haemophilia A
Investor presentation First nine months of 2014 Slide 88 NovoEight® is launched in 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 patien
Slide 89: NovoThirteen, a recombinant FXIII
Investor presentation First nine months of 2014 Slide 89 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 90: R&D pipeline: Haemophilia and GH
Investor presentation First nine months of 2014 Slide 90 R&D pipeline: Haemophilia and GH 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) Monoclona
Slide 91: Positive phase 3 results with long-acting factor IX
Investor presentation First nine months of 2014 Slide 91 Positive results from phase 3 trial with long-acting factor IX for treatment of haemophilia B N9-GP phase 1 pharmacokinetics Paradigm™ 2 headline results (phase 3) N9-GP • Median bleeding rate for patients treated on demand was 1.2 Dose normal
Slide 92: Positive phase 3 results with long-acting factor VIII
Investor presentation First nine months of 2014 Slide 92 Positive results from phase 3 trial with long-acting factor VIII for treatment of haemophilia A N8-GP phase 1 pharmacokinetics Pathfinder™ 2 headline results (phase 3) N8-GP • Median bleeding rate for patients treated on demand was 1.2 Dose 50
Slide 93: Continuing to expand leadership within growth hormone market
Investor presentation First nine months of 2014 Slide 93 Novo Nordisk continues to expand leadership within growth hormone market Development in global hGH market Growth hormone volume market share MAT value DKK Novo Nordisk Pfizer Sandoz DKK MAT Volume kg kg Eli Lilly Merck Kgaa Roche billion 20 80
Slide 94: Solid Norditropin sales growth
Investor presentation First nine months of 2014 Slide 94 Solid Norditropin® sales growth Reported Norditropin® sales Key Norditropin® properties DKK • Product characteristics: Premixed, prefilled multi-use billion delivery systems available in multiple strengths, some stable at room-temperature 2 CA
Slide 95: Financials
Investor presentation First nine months of 2014 Slide 95 Financials
Slide 96: Sustained double digit growth throughout the last decade
Investor presentation First nine months of 2014 Slide 96 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 g
Slide 97: Solid sales growth across North America, International Operations and China
Investor presentation First nine months of 2014 Slide 97 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
Slide 98: Solid operating profit growth driven by diabetes
Investor presentation First nine months of 2014 Slide 98 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 loc
Slide 99: Profitability per segment
Investor presentation First nine months of 2014 Slide 99 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 COG
Slide 100: Continued decline in relative COGS with stable investment level
Investor presentation First nine months of 2014 Slide 100 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%
Slide 101: Cash returned to shareholders via dividends and share buybacks
Investor presentation First nine months of 2014 Slide 101 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) Dividend paid Pay-out ratio Share repurchase programmes
Slide 102: Long term financial targets: Operating profit growth and margin
Investor presentation First nine months of 2014 Slide 102 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 f
Slide 103: Long term financial targets: Returns and cash to earnings
Investor presentation First nine months of 2014 Slide 103 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 t
Slide 104: Stable ownership structure
Investor presentation First nine months of 2014 Slide 104 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