Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — FY2018 Earnings Presentation
123 slides from Novo Nordisk A/s Class B's earnings presentation, Feb 1, 2019
Slide 1: Investor presentation Full year 2018
Slide 1 Investor presentation Full year 2018
Slide 2: Agenda
Investor presentation Full year 2018 Slide 2 Agenda Highlights and key events Sales update R&D update Financials and outlook
Slide 3: Forward-looking statements
Investor presentation Full year 2018 Slide 3 Forward-looking statements Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this presentation as well as the company’s statutory Annual Report 2018 and Form 20-F, which are both filed with the SE
Slide 4: Highlights – Full year 2018
Investor presentation Full year 2018 Slide 4 Highlights – Full year 2018 Sales development • Sales were broadly unchanged in Danish kroner and increased by 5% in local currencies to DKK 111.8 billion • International Operations sales increased by 2% in Danish kroner and by 7% in local currencies • No
Slide 5: Sales growth of 5% mainly driven by Victoza, Ozempic and Saxenda
Investor presentation Full year 2018 Slide 5 Sales growth of 5% mainly driven by Victoza®, Ozempic® and Saxenda® Sales as reported – full year 2018 Growth break down – full year 2018 Growth Other Local currencies Growth Share of growth disorders biopharmaceuticals Long-acting insulin1 (2%) (7%) 3% (
Slide 6: Sales growth driven by 18% growth in GLP-1 sales
Investor presentation Full year 2018 Slide 6 Sales growth is primarily driven by 18% growth in GLP-1 sales, while global insulin sales are broadly unchanged 2018 reported sales split and local currency 2018 added sales and local currency growth for growth for NAO and IO NAO and IO Insulin GLP-1 Othe
Slide 7: Ozempic gains market share and is now launched in 11 countries
Investor presentation Full year 2018 Slide 7 Ozempic® gains market share and is now launched in 11 countries USA GLP-1 NBRx Canada GLP-1 NBRx European1 GLP-1 volume market share market share market share NN GLP-1 Victoza® Ozempic® dulaglutide exenatide albiglutide Weekly Monthly Monthly NBRx share N
Slide 8: In the USA, Victoza CV indication and Ozempic launch contribute to GLP-1 market growth
Investor presentation Full year 2018 Slide 8 In the USA, Victoza® CV indication and Ozempic® launch contribute to the 27% GLP-1 market growth USA GLP-1 TRx market development USA GLP-1 volume market share Annual market growth (RHS)1 Exenatide ER NN GLP-1 dulaglutide Quarterly Monthly Other GLP-1s Oz
Slide 9: Tresiba has since launch gained around 15% market share in the USA
Investor presentation Full year 2018 Slide 9 Tresiba® has since launch gained around 15% market share in the USA Weekly TRx volume market shares1 in the USA Tresiba® in the USA glargine U100 NN total basal2 Levemir® • Novo Nordisk basal insulin volume market share is now Basal volume Tresiba® glargi
Slide 10: Saxenda sales increased by 60% in 2018
Investor presentation Full year 2018 Slide 10 Saxenda® sales increased by 60% in 2018 and continues to gain market share in the global anti-obesity market Solid Saxenda® sales growth since launch Continued global roll-out of Saxenda® DKK North America Operations International Operations • Novo Nordi
Slide 11: Biopharm strategy focus on in-market execution and innovation
Investor presentation Full year 2018 Slide 11 Biopharm strategy focus on in-market execution as well as internal and external innovation Broadly unchanged biopharm sales driven by Norditropin® and NovoEight® ‘Return to growth’ strategy on track DKK Succeeded in-market despite competition in the inhi
Slide 12: Completed PIONEER programme showed reductions in HbA1c and body weight
Investor presentation Full year 2018 Slide 12 Completed PIONEER programme showed consistent statistically significant reductions in HbA1c and body weight Oral semaglutide lowered HbA1c by 1.0–1.8%- Oral semaglutide lowered body weight by points by end of trial1 ~2–5 kg by end of trial1 Mean change i
Slide 13: Oral semaglutide ready for regulatory filing following PIONEER 6
Investor presentation Full year 2018 Slide 13 Oral semaglutide ready for regulatory filing following the successful completion of the CV safety trial, PIONEER 6 Headline results for PIONEER 6 Regulatory update for oral semaglutide • The trial met the primary endpoint1 by demonstrating non- • Oral se
Slide 14: Key development milestones
Investor presentation Full year 2018 Slide 14 Key development milestones • Completion of the phase 3a PIONEER programme for oral semaglutide, following successful completion of PIONEER 6 and 9 • Oral semaglutide ready for regulatory filing. Filing expected in the USA around end-Q1 2019 with use of D
Slide 15: R&D milestones in 2019
Investor presentation Full year 2018 Slide 15 R&D milestones in 2019 Clinical milestones1 Regulatory milestones1 Project Q1 2019 Q2 2019 Q3 2019 Q4 2019 Phase 3b results Tresiba® ✓ (vs glargine U300) US submission Ozempic® (CV label update) Anti-IL-21 Phase 2 results LAI287 Phase 2 results LAIsema P
Slide 16: Financial results – Full year 2018
Investor presentation Full year 2018 Slide 16 Financial results – Full year 2018 Change Change In DKK million 2018 2017 (reported) (local currency) Sales 111,831 111,696 0% 5% Gross profit 94,214 94,064 0% Gross margin 84.2% 84.2% Sales and distribution costs 29,397 28,340 4% 7% Percentage of sales
Slide 17: Financial outlook for 2019 including adjusted LTFTs
Investor presentation Full year 2018 Slide 17 Financial outlook for 2019 including adjusted LTFTs Expectations 1 Feb 2019 Sales growth - local currencies 2% to 5% Sales growth - reported Around 2 percentage points higher Operating profit growth - local currencies 2% to 6% Operating profit growth - r
Slide 18: Cash return to shareholders in 2019
Investor presentation Full year 2018 Slide 18 Cash return to shareholders in 2019 Annual cash return to shareholders Cash return priorities DKK Share repurchase Interim dividend Dividend • New share repurchase programme of up to DKK 15 billion billion Free cash flow Free cash flow guidance to be exe
Slide 19: Key take-aways – Full year 2018
Investor presentation Full year 2018 Slide 19 Key take-aways – Full year 2018 Diabetes franchise grew 4% and Novo Nordisk retains world leader position with a market share of 27.9% (27.4% in 2017) • Insulin sales were flat and Novo Nordisk has expanded its volume market leader position to 46.4% insu
Slide 20: Investor contact information
Investor presentation Full year 2018 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 Exc
Slide 21: Appendix
Investor presentation Full year 2018 Slide 21 Appendix 1. Novo Nordisk at a glance 22 2. Insulin 42 3. GLP-1 diabetes 67 4. Obesity 84 5. Biopharmaceuticals & Other serious chronic diseases 93 6. Financials 105 7. Sustainable business 117 NN: Novo Nordisk
Slide 22: Novo Nordisk at a glance
Investor presentation Full year 2018 Slide 22 Novo Nordisk at a glance Global leader in diabetes care and obesity Global insulin market leadership • A focused pharmaceutical company with leading positions in Global insulin market share: 46% diabetes, obesity, haemophilia and growth hormone Region Eu
Slide 23: Sales growth driven by International Operations and North America Operations
Investor presentation Full year 2018 Slide 23 Sales growth driven by 7% growth in International Operations and 3% growth in North America Operations Sales as reported – full year 2018 Growth break down – full year 2018 Region Region Latin America Local currencies Growth Share of growth Japan & Korea
Slide 24: Sales growth driven by the diabetes and obesity franchise
Investor presentation Full year 2018 Slide 24 Sales growth driven by the diabetes and obesity franchise Novo Nordisk reported quarterly sales Reported sales split by product segments for by therapy full year 2018 Diabetes and obesity Haemophilia2 Long-acting insulin Premix insulin Fast-acting insuli
Slide 25: Novo Nordisk has leading positions in diabetes, obesity and haemophilia
Investor presentation Full year 2018 Slide 25 Novo Nordisk has leading positions in diabetes, obesity and haemophilia Diabetes Obesity Haemophilia Market value Market value Market value Novo Nordisk value market share Novo Nordisk value market share Novo Nordisk value market share bDKK Global market
Slide 26: Global diabetes prevalence is increasing
Investor presentation Full year 2018 Slide 26 Global diabetes prevalence is increasing and 629 million people are expected to have diabetes by 2045 Around 10% of all adults globally The number of people with diabetes is expected have diabetes to increase by 48% by 2045 North America Region Europe Re
Slide 27: Focus on driving global insulin growth
Investor presentation Full year 2018 Slide 27 Focus on driving global insulin growth by increasing the number of people benefitting from Novo Nordisk products Around 29 million people are currently treated Only 6% of all people with diabetes are treated with Novo Nordisk insulin and GLP-1 products w
Slide 28: Opportunity is in the large unmet needs across all therapy areas
Investor presentation Full year 2018 Slide 28 Novo Nordisk’s opportunity is in the large unmet needs across all therapy areas in scope DIABETES OBESITY HAEMOPHILIA OTHER SERIOUS CHRONIC DISEASES 650 million 80% of diagnosed NASH patients are obese 425 million and 35% have T2DM 70% of diabetes ~425,0
Slide 29: Six strategic priorities
Investor presentation Full year 2018 Slide 29 Six strategic priorities EXPAND THE DRIVE BUILD THE RETURN TO DRIVE INNOVATE GLP-1 MARKET INSULIN GLOBAL GROWTH IN COMMERCIAL AND EXPAND AND WIN WITH VOLUME AND OBESITY BIOPHARM INNOVATION PATIENT BASE SEMAGLUTIDE VALUE SHARE MARKET
Slide 30: Strong leadership position within the growing diabetes care market
Investor presentation Full year 2018 Slide 30 Novo Nordisk has a strong leadership position within the growing diabetes care market Global diabetes care market Global diabetes care by treatment class value market share DKK OAD GLP-1 Insulin Novo Nordisk Sanofi Eli Lilly Merck Takeda billion J&J Nova
Slide 31: North America Operations at a glance
Investor presentation Full year 2018 Slide 31 North America Operations at a glance Diabetes market by value and Diabetes trend in population Novo Nordisk market share Novo Nordisk reported sales Population with diabetes NN Insulin MS NN GLP-1 MS Sales Diabetes growth rate NN OAD MS Full Year 2018 Gr
Slide 32: Region Europe at a glance
Investor presentation Full year 2018 Slide 32 Region Europe at a glance Diabetes market by value and Diabetes trend in population Novo Nordisk market share Novo Nordisk reported sales Population with diabetes NN Insulin MS NN GLP-1 MS Sales Diabetes growth rate NN OAD MS Full year 2018 Growth2 Milli
Slide 33: Region AAMEO at a glance
Investor presentation Full year 2018 Slide 33 Region AAMEO at a glance Diabetes market by value and Diabetes trend in population Novo Nordisk market share Novo Nordisk reported sales Population with diabetes NN Insulin MS NN GLP-1 MS NN OAD MS Sales Million Diabetes growth rate bDKK Full year 2018 G
Slide 34: Region China at a glance
Investor presentation Full year 2018 Slide 34 Region China at a glance Diabetes market by value and Diabetes trend in population Novo Nordisk market share Novo Nordisk reported sales Population with diabetes NN Insulin MS NN GLP-1 MS Sales Diabetes growth rate NN OAD MS Full year 2018 Growth2 Millio
Slide 35: Region Latin America at a glance
Investor presentation Full year 2018 Slide 35 Region Latin America at a glance Diabetes market by value and Diabetes trend in population Novo Nordisk market share Novo Nordisk reported sales Population with diabetes NN Insulin MS NN GLP-1 MS Sales Diabetes growth rate NN OAD MS Full year 2018 Growth
Slide 36: Region Japan & Korea at a glance
Investor presentation Full year 2018 Slide 36 Region Japan & Korea at a glance Diabetes market by value and Diabetes trend in population Novo Nordisk market share Novo Nordisk reported sales Population with diabetes NN Insulin MS NN GLP-1 MS Sales Diabetes growth rate bDKK NN OAD MS Full year 2018 G
Slide 37: Biopharm constitutes 16% of sales and 'return to growth' strategy on track
Investor presentation Full year 2018 Slide 37 Biopharm constitutes 16% of Novo Nordisk sales and the ‘return to growth’ strategy is well on track NovoSeven® and Norditropin® ‘Return to Growth’ strategy builds on organic, account for 82% of Biopharm sales1 non-organic and organisational initiatives O
Slide 38: Novo Nordisk Corporate Strategy and R&D strategy
Investor presentation Full year 2018 Slide 38 Novo Nordisk Corporate Strategy R&D strategy and priorities STRATEGIC PRIORITIES R&D PRIORITIES • Develop disruptive insulin and GLP-1 based products with distinct clinical and/or delivery advantages Strengthen leadership in DIABETES CARE • Develop novel
Slide 39: Pipeline supports growth opportunities across four focus areas
Investor presentation Full year 2018 Slide 39 Pipeline supports significant growth opportunities across all four strategic focus areas PHASE 1 PHASE 2 PHASE 3 SUBMITTED APPROVED NN1535 – LAIsema NN1436 – LAI287 Oral semaglutide N8-GP – Long-acting rFVIII Levemir® NN9023 – OG2023SC Anti-IL-21 and lir
Slide 40: Growth supported by global presence in sales and manufacturing
Investor presentation Full year 2018 Slide 40 Growth opportunities supported by strong global presence in both sales and manufacturing Employees in sales regions1 Global manufacturing setup Kaluga, Russia Denmark (~9,000 employees) North America Operations: ~4,100 (~266 employees) • Diabetes and bio
Slide 41: Solid patent protection of innovative drugs
Investor presentation Full year 2018 Slide 41 Solid patent protection of innovative drugs Novo Nordisk’s position is protected by patents and value chain setup Barriers to entry for biosimilar players EU patent protection1 US patent protection1 Research & Development 20312 203132 • Need to show comp
Slide 42: Insulin
Investor presentation Full year 2018 Slide 42 Insulin 1. Diabetes at a glance 43 2. Diabetes treatment classes 46 3. Branded diabetes market 47 4. Diabetes market segments 48 5. Novo Nordisk Diabetes product portfolio 50 6. Insulin market and NN market share 51 7. US Healthcare and NN 55 8. Regional
Slide 43: Diabetes – the inability to manage blood sugar levels
Investor presentation Full year 2018 Slide 43 Diabetes – the inability to manage blood sugar levels appropriately The aim of insulin therapy is to recreate normal Facts about diabetes blood insulin profile Diabetes is a chronic disease that occurs either when the pancreas does not produce enough ins
Slide 44: Diabetes pandemic is fuelled by growing rates of obesity
Investor presentation Full year 2018 Slide 44 Diabetes pandemic is fuelled by growing rates of obesity USA CDC data on obesity and diabetes prevalence among adults 1994 2000 2014 Obesity prevalence (BMI ≥30 kg/m2) <14.0% 14.0-17.9% 18.0-21.9% 22.0-25.9% 26.0-29.9% ≥30% Diabetes prevalence <4.5% 4.5-
Slide 45: Poor diagnosis rates and poor glycaemic control remain global problems
Investor presentation Full year 2018 Slide 45 Poor diagnosis rates, lack of access to optimal treatment and poor glycaemic control remain global problems Diagnosis and optimal treatment The worldwide challenge of glycaemic control: remains a challenge – the rule of halves Mean HbA1C in type 2 diabet
Slide 46: Insulin is the ultimate care for people with diabetes
Investor presentation Full year 2018 Slide 46 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 SGLT-2 DPP-IV Other OADs 100% 6% Diet and exercise 20% OAD 80% 37
Slide 47: Total branded diabetes market has a global value of DKK ~270 billion
Investor presentation Full year 2018 Slide 47 The total branded diabetes market has a global value of DKK ~270 billion annually 2016/17 2017/18 Growth Global diabetes market -7% The USA -1% bDKK bDKK 269 266 148 139 150 -16% 250 100 77 65 18% -11% 3% 50 29 34 28 25 200 14 15 -9% 0 Total Insulin GLP-
Slide 48: The insulin market is comprised of three segments
Investor presentation Full year 2018 Slide 48 The insulin market is comprised of three segments Insulin action profiles Global insulin volume market by segment tMU CAGR volume1: 4.5% 600 CAGR value1: 13.7% Fast-acting 500 35% 400 34% Fast-acting Premix 300 25% 29% Premix 200 Long-acting 100 37% 40%
Slide 49: Medications used for treatment of type 2 diabetes
Investor presentation Full year 2018 Slide 49 Medications used for treatment of type 2 diabetes Commonly prescribed product classes for the treatment of type 2 diabetes HbA1C Hypoglycae- Weight Dosing Contraindication/ Class CVD risk change mia risk change (per day) undesired effects Metformin 1.5 N
Slide 50: Product portfolio covers the type 2 diabetes treatment cascade
Investor presentation Full year 2018 Slide 50 Novo Nordisk’s current and future product portfolio covers the type 2 diabetes treatment cascade1 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 O
Slide 51: Stable global insulin volume growth
Investor presentation Full year 2018 Slide 51 Stable global insulin volume growth Regional insulin volume growth Regional insulin volume market split North America Region Europe Region AAMEO North America Region Europe Region AAMEO Region China Region J&K Region LATAM Region China Region J&K Region
Slide 52: Continued single digit volume growth within insulin segments
Investor presentation Full year 2018 Slide 52 Continued single digit volume growth within the insulin segments globally Fast-acting insulin Premix insulin Long-acting insulin Segment volume Segment volume Segment volume Levemir® share NovoRapid® market share NovoMix® market share Tresiba® share tMU
Slide 53: Increased market share in long-acting insulin
Investor presentation Full year 2018 Slide 53 Novo Nordisk increased market share in long-acting insulin and sustained leadership in fast-acting and premix insulin Long-acting insulin1 volume Fast-acting insulin2 volume Premix insulin3 volume market market share across regions market share across re
Slide 54: Novo Nordisk sustains global volume market share leadership
Investor presentation Full year 2018 Slide 54 Stable global insulin market growth and Novo Nordisk sustains global volume market share leadership Global modern and new-generation insulin Global insulin market volume market shares Device penetration Modern insulin penetration1 Novo Nordisk Sanofi Eli
Slide 55: Market leader in the USA in modern and new-generation insulin
Investor presentation Full year 2018 Slide 55 Novo Nordisk is the market leader in the USA within the modern and new-generation insulin segment Modern insulin and new-generation insulin USA insulin market by segment volume market shares in the USA Device penetration Modern insulin penetration Novo N
Slide 56: Increases market share in long-acting insulin segment
Investor presentation Full year 2018 Slide 56 Novo Nordisk increases its market share in the long-acting insulin segment USA fast-acting insulin USA premix insulin USA long-acting insulin Segment volume FIASP® share Segment volume Segment volume Levemir® share NovoLog® share Combined NN NovoLog® Mix
Slide 57: US health insurance dominated by few large commercial payers
Investor presentation Full year 2018 Slide 57 US health insurance is dominated by few large commercial payers with slow expansion of public insurance coverage The US population by health insurance status In 2018, PBMs covered 288 million lives and expected to remain stable in coming years the market
Slide 58: US healthcare system is complex and rebates have increased
Investor presentation Full year 2018 Slide 58 The US healthcare system is complex and rebates paid by Novo Nordisk have increased significantly in recent years Illustrative example of the Development of Novo Nordisk rebates US healthcare system and net sales in the US Product flow Payment flow Rebat
Slide 59: Key diabetes care products remain broadly available in the USA
Investor presentation Full year 2018 Slide 59 Novo Nordisk’s key diabetes care products remain broadly available in the USA Value market shares of Share of unrestricted market access of Novo Nordisk key products in the USA Novo Nordisk key products in the USA Value market Victoza® NovoLog® Levemir®
Slide 60: Leadership in European modern and new-generation insulin market
Investor presentation Full year 2018 Slide 60 Sustained leadership position in the European modern and new-generation insulin market European modern insulin and new-generation European insulin market by segment insulin volume market shares Device penetration MI and NGI penetration Novo Nordisk Sanof
Slide 61: Stable insulin leadership position in Region AAMEO
Investor presentation Full year 2018 Slide 61 Stable insulin leadership position in Region AAMEO Region AAMEO modern and new-generation Region AAMEO insulin market by segment insulin volume market shares Device penetration MI and NGI penetration Novo Nordisk Sanofi Eli Lilly Other tMU Penetration CA
Slide 62: Solid insulin market leadership in Region Japan & Korea
Investor presentation Full year 2018 Slide 62 Solid insulin market leadership position in Region Japan & Korea Region Japan & Korea insulin market Region Japan & Korea modern and new- by segment generation insulin volume market shares Device penetration MI and NGI penetration Novo Nordisk Sanofi Eli
Slide 63: Solid Tresiba performance strengthens basal insulin share in Japan
Investor presentation Full year 2018 Slide 63 Solid Tresiba® performance strengthens basal insulin market share in Japan Japanese basal value market shares Japanese total insulin value market shares Tresiba® Levemir® glargine U100 glargine U300 Novo Nordisk Eli Lilly Sanofi NPH biosimilar glargine U
Slide 64: Continued value and volume growth in Chinese insulin segments
Investor presentation Full year 2018 Slide 64 Continued value and volume growth in the Chinese insulin segments Chinese insulin market by segment Chinese total insulin value market shares DKK Device penetration Modern insulin penetration Novo Nordisk Eli Lilly Tonghua Dongbao billion Penetration San
Slide 65: Strengthened insulin volume market share in Latin America
Investor presentation Full year 2018 Slide 65 Novo Nordisk has strengthened its insulin volume market share in Region Latin America Region Latin America insulin market Region Latin America modern and new- by segment generation insulin volume shares Device penetration Modern insulin penetration Novo
Slide 66: Tresiba sets a new standard for basal insulin initiation
Investor presentation Full year 2018 Slide 66 Tresiba® sets a new standard for basal insulin initiation by lowering the risk of hypoglycaemia Tresiba® is a leap on the innovation ladder by Tresiba® has consistently demonstrated further reducing nocturnal hypoglycaemia relevant reductions in severe h
Slide 67: GLP-1
Investor presentation Full year 2018 Slide 67 GLP-1 1. GLP-1 treatment 68 2. GLP-1 market 69 3. Regional GLP-1 growth 70 4. GLP-1 patient profile 71 5. Victoza® 72 6. Ozempic® 73 7. GLP-1 market value in Regions 75 8. Clinical trials (SUSTAIN & PIONEER) 81
Slide 68: GLP-1 effect dependent on level of blood glucose
Investor presentation Full year 2018 Slide 68 GLP-1 effect dependent on level of blood glucose 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 Glucose Type 2 diabetes patients, no GLP
Slide 69: GLP-1 segment accounts for 14% of global diabetes care market value
Investor presentation Full year 2018 Slide 69 The GLP-1 segment accounts for 14% of the global diabetes care market value GLP-1 value and patient share of the total Global GLP-1 market diabetes care market GLP-1 value Victoza® Ozempic® Share of total Share of total GLP-1 value share of total diabete
Slide 70: Strong GLP-1 volume growth in all regions
Investor presentation Full year 2018 Slide 70 Strong GLP-1 volume growth in all regions Regional GLP-1 volume growth Regional GLP-1 volume market split North America Region Europe Region AAMEO North America Region Europe Region AAMEO Region China Region J&K Region LATAM Region China Region J&K Regio
Slide 71: Main GLP-1 source of business comes from OAD patients
Investor presentation Full year 2018 Slide 71 Main GLP-1 source of business comes from OAD patients as many OAD patients are not in good control GLP-1 source of business Share of patients on OADs achieving (new-to-brand prescription market share) HbA1c below 7% in major European countries Insulin an
Slide 72: Significant growth in GLP-1 market with leading share for Victoza
Investor presentation Full year 2018 Slide 72 Significant growth in GLP-1 market with leading market share for Victoza® Global GLP-1 market value and share of total Novo Nordisk GLP-1 value market share diabetes care market value leading in all regions except Japan & Korea Victoza® Ozempic® dulaglut
Slide 73: Ambition for Ozempic to become leading weekly GLP-1
Investor presentation Full year 2018 Slide 73 Ambition for Ozempic® to become leading weekly GLP-1, with daily GLP-1 users shifting to oral semaglutide Promotional focus shifted from Victoza® Aim for Ozempic® and oral semaglutide towards Ozempic® as market access emerges to replace Victoza® as marke
Slide 74: Ozempic approved in the USA and in the EU
Investor presentation Full year 2018 Slide 74 Ozempic® approved in the USA and in the EU CV data from SUSTAIN 6 trial Ozempic® label in the USA in Ozempic® EU label • Adjunct to diet and exercise to improve Profile glycaemic control Safety Ozempic® label Victoza® label • Two therapeutic dosages, 0.5
Slide 75: GLP-1 segment accounts for 17% of diabetes care value in North America
Investor presentation Full year 2018 Slide 75 The GLP-1 segment accounts for 17% of total diabetes care market value in North America North America GLP-1 market Key points on Victoza® and Ozempic® in the USA DKK Victoza® Ozempic® Share of total billion Dulaglutide Other diabetes care • Victoza® and
Slide 76: GLP-1 segment accounts for around 12% in Region Europe
Investor presentation Full year 2018 Slide 76 The GLP-1 segment accounts for around 12% of total diabetes care market value in Region Europe European GLP-1 market Victoza® value market share in Region Europe DKK Victoza® Dulaglutide Share of total GLP-1 value Victoza® Dulaglutide billion Exenatide O
Slide 77: GLP-1 segment accounts for 3% in Region AAMEO
Investor presentation Full year 2018 Slide 77 The GLP-1 segment accounts for 3% of total diabetes care market value in Region AAMEO Region AAMEO GLP-1 market Victoza® value market share in Region AAMEO DKK Victoza® Dulaglutide Share of total GLP-1 value Victoza® Dulaglutide billion diabetes care mar
Slide 78: GLP-1 segment accounts for around 1% in Region China
Investor presentation Full year 2018 Slide 78 The GLP-1 segment accounts for around 1% of the total diabetes care market value in Region China Chinese GLP-1 market Victoza® value market share in Region China DKK Victoza® Exenatide Share of total GLP-1 value Victoza® Exenatide billion diabetes care m
Slide 79: GLP-1 segment accounts for around 6% in Region Japan & Korea
Investor presentation Full year 2018 Slide 79 The GLP-1 segment accounts for around 6% of the total diabetes care market in Region Japan & Korea Victoza® value market share in Region Region Japan & Korea GLP-1 market Japan & Korea DKK Victoza® Dulaglutide Share of total GLP-1 value Victoza® Dulaglut
Slide 80: GLP-1 segment accounts for around 6% in Region Latin America
Investor presentation Full year 2018 Slide 80 The GLP-1 segment accounts for around 6% of the total diabetes care market in Region Latin America Victoza® value market share Region Latin America GLP-1 market in Region Latin America DKK Victoza® Dulaglutide Share of total GLP-1 value Victoza® Dulaglut
Slide 81: SUSTAIN trials with semaglutide
Investor presentation Full year 2018 Slide 81 SUSTAIN trials with semaglutide SUSTAIN 1 2 3 4 5 6 7 Baseline 8.1% 8.1% 8.3% 8.2% 8.4% 8.7% 8.2% 0.0 -0.1 -0.4 -0.5 Change in HbA1c (%) -0.9 -0.8 -1.1* -1.1 -1.3* -1.2* -1.4* -1.3 -1.5* -1.5* -1.4* -1.6* -1.6* -1.5* -1.6* -1.8* -1.8* 1.2 Baseline 92 kg
Slide 82: 52–80% of patients on oral semaglutide achieved HbA1c <7%
Investor presentation Full year 2018 Slide 82 In the completed PIONEER trials between 52–80% of patients on oral semaglutide achieved an HbA1c level <7% In completed PIONEER trials 52–80% of patients In completed PIONEER trials 28–49% of patients achieved an HbA1c level <7.0% (ADA guidance)1 achieve
Slide 83: PIONEER programme completed for oral semaglutide
Investor presentation Full year 2018 Slide 83 PIONEER programme completed for oral semaglutide and global trials showed consistent efficacy profile PIONEER 1 2 3 4 5 7 8 Baseline 8.0% 8.1% 8.3% 8.0% 8.0% 8.3% 8.2% -0.1 -0.1 -0.1 Change in -0.5 HbA1c (%) -0.6 -0.8 -0.8 -0.7 -0.9 -1.0 -1.1 -1.3 -1.1 -
Slide 84: Obesity
Investor presentation Full year 2018 Slide 84 Obesity 1. Obesity as a chronic disease 85 2. Obesity treatment 86 3. Saxenda® 88 4. Obesity pipeline 90 5. STEP and SELECT 92
Slide 85: Obesity is a chronic disease that requires treatment
Investor presentation Full year 2018 Slide 85 Obesity is a chronic disease that requires treatment The set-point theory portrays how metabolic The body fights weight loss for changes affect the ability to lose weight people with obesity • The body “remembers” its highest body weight and defends Diet
Slide 86: Treatment rate is low and requires a change of mindset
Investor presentation Full year 2018 Slide 86 Treatment rate is low and an increase requires a change of mindset and physician engagement Only 2% of the 650 million people with obesity are treated with prescription medication Key barriers to effective obesity management 650 million • Belief that obe
Slide 87: Healthcare cost associated with obesity expected to increase
Investor presentation Full year 2018 Slide 87 Healthcare cost associated with obesity expected to increase Global healthcare cost related to obesity Increase in healthcare costs primarily driven expected to increase by 50% by 2025 by obesity-related comorbidities • Today, 650 million people have obe
Slide 88: Saxenda now launched in 41 countries
Investor presentation Full year 2018 Slide 88 Saxenda® now launched in 41 countries Saxenda® value share of anti-obesity medications in selected countries Saxenda® reported sales for full year 20181 Mexico Australia USA Canada DKK Saxenda® local currency growth Germany Italy Brazil Denmark billion B
Slide 89: Saxenda has rapidly grown value market share
Investor presentation Full year 2018 Slide 89 Saxenda® has rapidly grown value market share, but market development efforts are required to expand the market Despite strong Saxenda® growth, US obesity care Novo Nordisk is investing in overcoming the market remains small at around USD 839 million bar
Slide 90: The obesity pipeline addresses appetite reduction and energy expenditure
Investor presentation Full year 2018 Slide 90 The obesity pipeline consists of projects addressing both appetite reduction and energy expenditure How to address obesity from a medical perspective Novo Nordisk obesity products and pipeline Projects: 2019 expectations Saxenda® Launched Weight Weight r
Slide 91: Semaglutide demonstrated unprecedented weight loss in phase 2 obesity trial
Investor presentation Full year 2018 Slide 91 Semaglutide demonstrated unprecedented weight loss in a phase 2 obesity trial 16.2% weight reduction with the highest semaglutide dose in phase 2 obesity trial Key results and next steps Change in sema 0.05 mg sema 0.1 mg • Participants in the highest do
Slide 92: Phase 3a programme STEP and SELECT initiated in 2018
Investor presentation Full year 2018 Slide 92 Phase 3a programme STEP and CV outcomes study SELECT were initiated in 2018 Semaglutide in obesity phase 3a programme, Cardiovascular outcomes study, SELECT, STEP, expected to include ~4,500 patients1 initiated for semaglutide in obesity 2018 2019 2020 S
Slide 93: Biopharm and other chronic areas
Investor presentation Full year 2018 Slide 93 Biopharm and other chronic areas 1. Biopharm at a glance 94 2. Haemophilia – a rare disease 95 3. Haemophilia market 96 4. NovoSeven® 97 5. NovoEight® 98 6. Refixia®/Rebinyn® 99 7. N8-GP 100 8. Growth Hormone market 101 9. Clinical trial for Somapacitan
Slide 94: Biopharm R&D efforts reflect commitment to unmet patient needs
Investor presentation Full year 2018 Slide 94 Biopharm R&D efforts reflect Novo Nordisk’s commitment to satisfy unmet patient needs Aim to develop subcutaneous haemophilia products and long-acting growth hormone Novo Nordisk Biopharm portfolio Haemophilia Growth hormone Pursue subcutaneous Research/
Slide 95: Haemophilia is a rare disease with severe unmet medical needs
Investor presentation Full year 2018 Slide 95 Haemophilia is a rare disease with severe unmet medical needs Number of people with haemophilia A and B Low diagnosis and treatment rates and haemophilia with inhibitors within haemophilia Number of Average percentage of people people (000) with haemophi
Slide 96: Global haemophilia market is growing by high-single digit
Investor presentation Full year 2018 Slide 96 Global haemophilia market is growing by high-single digit Strategic positioning of Novo Nordisk’s Sales of recombinant coagulation factors haemophilia portfolio NovoSeven® Recombinate®/Advate® Idelvion® Novo Nordisk Coagil VII® Kogenate®/Helixate® Rixubi
Slide 97: ~50% of historic NovoSeven sales exposed to competition
Investor presentation Full year 2018 Slide 97 ~50% of historic NovoSeven® sales exposed to competition, but opportunities remain in other indications Opportunities and challenges for Estimated NovoSeven® sales by indication1 NovoSeven® franchise CHwI PPx (A&B) CHwI on demand (A&B) Challenge CHwI sur
Slide 98: NovoEight volumes continue to grow
Investor presentation Full year 2018 Slide 98 NovoEight® volumes continue to grow despite increasing penetration of long-acting FVIII products NovoEight® roll-out continues and the number NovoEight® has potential to increase volume of patients has steadily increased share in selected segments and ma
Slide 99: Refixia/Rebinyn launched in twelve countries
Investor presentation Full year 2018 Slide 99 Strong growth in the long-acting haemophilia B market and Refixia®/Rebinyn® has been launched in twelve countries Reported recombinant FIX sales Refixia®/Rebinyn® launched in twelve countries Sales Benefix® Alprolix® Idelvion® • Launched in the first EU
Slide 100: N8-GP reduces median bleeding rate in phase 3 trial
Investor presentation Full year 2018 Slide 100 N8-GP administered every fourth day reduces median bleeding rate to 1.3 episode per year in phase 3 trial N8-GP phase 1 pharmacokinetics Pathfinder 2 headline results (phase 3) FVIII activity FVIII N8-GP • PK documented single dose half-life of 18.4 hou
Slide 101: Novo Nordisk maintains leadership within growth disorder
Investor presentation Full year 2018 Slide 101 Novo Nordisk maintains leadership within growth disorder Development in global growth disorder market Growth disorder volume market share DKK MAT volume kg MAT value Novo Nordisk Pfizer Sandoz billion kg Eli Lilly Merck Kgaa Other1 CAGR volume1: 17.7% 2
Slide 102: Phase 3 extension trial in adults and phase 2 trial in children for somapacitan
Investor presentation Full year 2018 Slide 102 Phase 3 extension trial in adults and phase 2 trial in children for once-weekly somapacitan Somapacitan IGF-1 levels similar to daily Phase 3a AGHD extension trial and phase 2 Norditropin® in REAL 1 phase 3 AGHD trial GHD successfully completed Cumulati
Slide 103: Other serious chronic diseases
Investor presentation Full year 2018 Slide 103 Other serious chronic diseases Serious chronic diseases are often associated New therapeutic areas represent patient with diabetes and obesity populations with high unmet medical needs • 70% of people with diabetes Estimated patients Number of related d
Slide 104: Trials in obesity and other serious chronic disease areas
Investor presentation Full year 2018 Slide 104 Trials in obesity and other serious chronic disease areas building on the semaglutide molecule Planned or ongoing trials with semaglutide Ongoing phase 2 trial with daily semaglutide vs addressing other serious chronic diseases placebo in patients with
Slide 105: Financials
Investor presentation Full year 2018 Slide 105 Financials 1. Sales growth 106 2. Operating Profit growth 108 3. Cost distribution 109 4. COGS & CAPEX as percent of sales 110 5. Long-term financial targets 111 6. Cash return to shareholders 112 7. Currency impact 113 8. Ownership structure 116
Slide 106: Solid sales growth driven by diabetes care and obesity
Investor presentation Full year 2018 Slide 106 Solid sales growth driven by diabetes care and obesity Reported annual sales 2014-2018 Reported annual sales split by region North America Region Europe Region AAMEO DKK Diabetes and obesity care Biopharmaceuticals Region China Region J&K Region LATAM b
Slide 107: Sales per key product for Q4 2018 and full year 2018
Investor presentation Full year 2018 Slide 107 Sales per key product for Q4 2018 and full year 2018 Reported currencies Sales Q4 2018 (mDKK) Sales split Sales full year 2018 (mDKK) Sales split Tresiba® 2,172 7% 8,035 7% Levemir® 2,832 10% 11,195 10% Fiasp® 206 1% 590 1% NovoRapid® 4,824 16% 18,763 1
Slide 108: Solid operating profit growth driven by diabetes
Investor presentation Full year 2018 Slide 108 Solid operating profit growth driven by diabetes Operating profit Operating profit split per franchise DKK Operating profit Operating profit as % of sales Diabetes care and obesity Biopharm billion Reported operating profit growth 60 Operating profit gr
Slide 109: Higher profitability in the biopharmaceuticals segment
Investor presentation Full year 2018 Slide 109 Higher profitability in the biopharmaceuticals segment driven by lower S&D costs Diabetes & Obesity P&L – full year 2018 Biopharmaceuticals P&L – full year 2018 DKK DKK billion Sales ratios billion Sales ratios 100 -16% 25 -28% 80 20 -16% -17% 60 -13% 1
Slide 110: Stable COGS level and increasing CAPEX level
Investor presentation Full year 2018 Slide 110 Stable COGS level as percentage of sales and increasing CAPEX level for new production facilities Cost of goods sold Capital expenditure DKK COGS DKK CAPEX Expected CAPEX billion billion COGS as % of sales (RHS) CAPEX as % of sales (RHS) 20 25% 12 10% T
Slide 111: Long-term financial targets support profitable growth and cash conversion
Investor presentation Full year 2018 Slide 111 Long-term financial targets support focus on profitable growth, capital allocation and cash conversion Operating profit growth in Operating profit after tax to Cash to earnings local currencies net operating assets (three-year average) Current long-term
Slide 112: Cash return to shareholders in 2019
Investor presentation Full year 2018 Slide 112 Cash return to shareholders in 2019 Annual cash return to shareholders Cash return priorities DKK Share repurchase Interim dividend Dividend • New share repurchase programme of up to DKK 15 billion billion Free cash flow Free cash flow guidance to be ex
Slide 113: Currency impact on Novo Nordisk's P/L
Investor presentation Full year 2018 Slide 113 EXAMPLE Currency impact on Novo Nordisk’s P/L Operational currency impact Financial currency impact • All movements in currencies will directly • All gain/losses from hedging contracts are impact the individual reported functional included in the financ
Slide 114: Currency impact on operating profit
Investor presentation Full year 2018 Slide 114 EXAMPLE Currency impact on operating profit Operational currency impact Yearly impact of Estimated impact Key Avg. FX Avg. FX %-change 5% change2 from key currencies rate 2017 rate 2018 Operational currency impact in 2018 (mDKK) currencies • The operati
Slide 115: Unfavourable currency impact primarily driven by unhedged currencies
Investor presentation Full year 2018 Slide 115 Unfavourable currency impact in 2018 primarily driven by unhedged currencies Avg. FY 2018 vs. FY 2017 Exp. avg. FY 20191 vs. FY 2018 Hedged 2017 2018 Impact of a Hedging Currencies average average Spot rate3 5% move4 (months) 5% USD2 2,000 11 Hedged cur
Slide 116: Stable ownership structure
Investor presentation Full year 2018 Slide 116 Stable ownership structure - secured through A and B-share structure Share structure The Novo Nordisk Foundation • The Novo Nordisk Foundation is a self-governing institution Novo Nordisk Foundation that Institutional and private • provides a stable bas
Slide 117: Sustainability
Investor presentation Full year 2018 Slide 117 Sustainability 1. Sustainable business 118 2. Novo Nordisk Way and Triple Bottom Line 119 3. Changing Diabetes® 120 4. Circular for Zero 122
Slide 118: Ambition to be a sustainable business
Investor presentation Full year 2018 Slide 118 Novo Nordisk’s ambition is to be a sustainable business …creating long-term value for patients, employees, partners and shareholders by developing innovative and competitive solutions to patients’ unmet needs By sustainable business, …doing business in
Slide 119: The Triple Bottom Line is the foundation for creating value
Investor presentation Full year 2018 Slide 119 The Triple Bottom Line is the foundation for how Novo Nordisk creates value and stays successful The Triple Bottom Line Business Principle The Novo Nordisk Way Financially responsible Socially Environmentally responsible responsible The Triple Bottom Li
Slide 120: Cities Changing Diabetes aims to break the 'Rule of Halves'
Investor presentation Full year 2018 Slide 120 Cities Changing DiabetesTM aims to break the ‘Rule of Halves’ by tackling urban diabetes Global partnership platform to develop At present nineteen partner cities an approach to fight urban diabetes with more than 130 million citizens • Beijing • Madrid
Slide 121: Enhancing access to affordable medicines is a key priority
Investor presentation Full year 2018 Slide 121 Enhancing access to affordable medicines is a key priority Product quality and patient safety is material Access to insulin commitment expanded 29.2 million 5 million people Novo Nordisk guarantees to make low-priced human insulin patients reached with
Slide 122: Healthy, engaging and inclusive workplace
Investor presentation Full year 2018 Slide 122 Novo Nordisk offers a healthy, engaging and inclusive workplace with development opportunities for employees Employee health, safety and engagement Novo Nordisk is committed to building are key focus areas for management a diverse and inclusive culture
Slide 123: Ambition of zero negative environmental impact
Investor presentation Full year 2018 Slide 123 Novo Nordisk has set a bold ambition to have zero negative environmental impact – based on a circular mindset Use of resources, emissions and waste On track to have all production sites with a focus on recovery and re-use run 100% on renewable power by