Slide 1 Diabetes care strategy Lars Fruergaard Jørgensen EVP Corporate Development
Diabetes care strategy Slide 2 Forward-looking statements Novo Nordisk s reports filed with or furnished to the US Securities and Exchange Commission (SEC), as well as the company s Annual Report 2014 and Form 20-F, both filed with the SEC in February, and presentations made, written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as believe, expect, may, will, plan, strategy, prospect, foresee, estimate, project, anticipate, can, intend, target and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to: Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and Statements regarding the assumptions underlying or relating to such statements. These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this presentation, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recall, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk s products, introduction of competing products, reliance on information technology, Novo Nordisk s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees, and failure to maintain a culture of compliance. Please also refer to the overview of risk factors in Be aware of the risk on p 42-43 of the Annual Report 2014 on the company s website novonordisk.com. Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this presentation, whether as a result of new information, future events or otherwise. Important drug information Victoza (liraglutide 1.2 mg & 1.8 mg) is approved for the management of type 2 diabetes only Saxenda (liraglutide 3 mg) is approve in the US and EU for the treatment of obesity only
Diabetes care strategy Slide 3 Diabetes care market has historically been growing double digit partly driven by underlying insulin volume growth DKK billion 350 300 250 200 150 100 50 0 2005 Global diabetes care market by treatment class 1 CAGR for 10-year period; OAD: oral anti-diabetic Source: IMS MIDAS Monthly MAT value figures GLP-1 Total market: CAGR 1 14.5% Injectables: CAGR 1 19.6% CAGR 1 18.1% CAGR 1 9.4% Insulin OAD 35% 3 25% 2 15% 1 5% Regional insulin volume growth North America China Europe Int. Operations Japan & Korea World 4.4% 2010 0.00 0.00 0.00 Millions Note: Data is sensitive to changes in IMS data collection and reporting methodology Source: IMS MIDAS Monthly MAT volume figures
Thousands Capital Markets Day Diabetes care strategy Slide 4 Novo Nordisk has generated double-digit diabetes sales growth and holds a strong diabetes market leadership DKK billion 80 Reported annual diabetes care sales Insulin GLP-1 CAGR 1 11.2% Other diabetes care Global diabetes care value market share Novo Nordisk Sanofi Merck Eli Lilly AstraZeneca Novartis Takeda GSK 3 28% 60 2 40 20 1 0 2,010 2010 2,011 2011 2,012 2012 2,013 2013 2,014 2014 2005 1 CAGR for 2010-2014 Source: IMS MIDAS Monthly MAT value figures
Diabetes care strategy Slide 5 Volume growth and value upgrade have been the main insulin sales growth drivers for Novo Nordisk 2 15% 1 5% -5% -1 Estimated composition of Novo Nordisk insulin sales growth 2010-15% 3% 9% 4% Market growth 8% 3% 1-4% North America Europe International Operations Market share Price Mix -7% -5% -3% 17% 2% 2% 15% -2% Total insulin sales CAGR 8% 2% 1% 6% Japan & Korea Region China Global Note: Mix = conversion from vial/syringe to devices and conversion from human insulin to modern insulin and from modern insulin to new-generation insulin Source: Realised sales in local currencies, IMS market share estimates for the period Q3 2010 to Q3
Diabetes care strategy Slide 6 Significant growth opportunities but the complexity of the injectable diabetes care market is increasing Continued growth opportunities... but commercial landscape is complex... and competitive pressure continues... although entry barriers are high Notable unmet need for new and better treatments Less than half of people are diagnosed Continued willingness to pay for innovation in private markets Price pressure is expected to increase including considerable rebating Large number of prescribers and complex distribution channels All incumbent players pursue portfolio strategies Biosimilar competition expected to increase High volume production with significant capital investment required A pen device providing simple product delivery is crucial
Diabetes care strategy Slide 7 The diabetes care market is expected to grow faster than the average of the pharmaceutical market 15% Sales by main categories of the pharmaceutical market expected CAGR for 2014-2020 Average 1 5% 4% -5% Oncology Diabetes care Vaccines Respiratory Anticoagulant Musculoskeletal Central nerve system Cardiovascular Source: EvaluatePharma, 11 November
Diabetes care strategy Slide 8 Portfolio strategy provides opportunity to treat patients throughout the treatment cascade and across segments Overview of current and future products in Novo Nordisk s diabetes portfolio When metformin is not enough When it's time for insulin Once-daily optimisation When basal insulin is not enough Mealtime insulin control Second generation analogues First generation analogues semaglutide or or Faster acting insulin aspart Human insulin Insulatard Mixtard 30 Actrapid
Diabetes care strategy Slide 9 Upgrade to higher value products is expected to continue contributing to growth Components of insulin sales growth Market growth Market share Price Mix Sales growth 1 8% 2% Composition of product mix growth Continued conversion from vial/syringe to devices 6% 4% 2% -2% 1% 6% -1% 2010- Future Continued upgrade from human insulin to modern insulin Upgrade from modern insulin to newgeneration insulin Roll-out of insulin/glp-1 combination Mix: conversion from vial/syringe to devices and conversion from human insulin to modern insulin and from modern insulin to new-generation insulin Source: IMS market share estimates for the period Q3 2010 to Q3
Diabetes care strategy Slide 10 The diabetes care market will continue to be driven by both value and volume Value of diabetes market will be driven by North America Volume of diabetes market will be driven by International Operations and China North America Europe International Operations China Japan & Korea Note: Illustration of expected future value and volume drivers of insulin market by region. Size of circles refers to size of market
Slide 11 GLP-1 market dynamics Jakob Riis EVP China, Pacific and Marketing TEAM NOVO NORDISK professional cycling team
GLP-1 market dynamics Slide 12 Forward-looking statements Novo Nordisk s reports filed with or furnished to the US Securities and Exchange Commission (SEC), as well as the company s Annual Report 2014 and Form 20-F, both filed with the SEC in February, and presentations made, written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as believe, expect, may, will, plan, strategy, prospect, foresee, estimate, project, anticipate, can, intend, target and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to: Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and Statements regarding the assumptions underlying or relating to such statements. These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this presentation, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recall, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk s products, introduction of competing products, reliance on information technology, Novo Nordisk s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees, and failure to maintain a culture of compliance. Please also refer to the overview of risk factors in Be aware of the risk on p 42-43 of the Annual Report 2014 on the company s website novonordisk.com. Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this presentation, whether as a result of new information, future events or otherwise. Important drug information Victoza (liraglutide 1.2 mg & 1.8 mg) is approved for the management of type 2 diabetes only Saxenda (liraglutide 3 mg) is approve in the US and EU for the treatment of obesity only
-cell function Capital Markets Day GLP-1 market dynamics Slide 13 The majority of people with diabetes are on oral anti-diabetic drugs Distribution of patients and value across treatment classes OAD GLP-1 Insulin Progression of type 2 diabetes and treatment intensification 10 8 6 Diet and exercise OAD 4 2 GLP-1 Insulin Patients Value Time Note: Patient distribution across treatment classes is indicative and based on data for US, UK, Germany and France. Value figures based on IMS MAT tember Source: IMS Pharmetrics claims data, IMS disease analyser, IMS Midas OAD: oral anti-diabetic
GLP-1 market dynamics Slide 14 GLP-1 patients are primarily coming from OAD and have comparable patient retention rates to DPP-IV and SGLT-2 Source of patients for GLP-1s Insulin SGLT-2 DPP-IV OAD other Naïve Patient retention on GLP-1s and OADs SGLT-2 Victoza DPP-IV exenatide 10 10 8 8 6 6 4 4 2 2 2012 2013 2014 1 2 3 4 5 6 7 8 9 10 11 12 13 Months on product Note: OAD other refers to all other oral anti-diabetics than DPP-IV and SGLT-2 Source: Patient Data Warehouse (PADAWA), IMS disease analyser, IMS LRx & Pharmetrics (US) Source: Patient Data Warehouse (PADAWA), IMS disease analyser, IMS LRx & Pharmametrics (US). Patients started on the brand of interest during Jun 2012 Jun 2013
GLP-1 market dynamics Slide 15 Continued growth of the GLP-1 class in the US despite the rapidly growing SGLT-2 class DKK billion 90 80 70 60 50 40 30 20 10 0 Market value of the DPP-IV, SGLT-2 and GLP-1 segment 2010 Victoza Other GLP-1 SGLT-2 DPP-IV NBRx DPP-IV SGLT-2 GLP-1 market share DPP-IV/SGLT-2 combo CAGR value 1 : 37.0 % 10 8 6 4 2 Market shares in the DPP-IV, SGLT-2 and GLP-1 segment 2012 46% 28% 24% 2% 1 CAGR for 5-year period Source: IMS MAT tember value figures Source: IMS LRx Weekly, tember rolling 4-week averages
GLP-1 market dynamics Slide 16 Victoza prescriptions continue to increase as new GLP-1 products contribute to further market expansion DKK billion 30 Value of GLP-1 segment NBRx shares for GLP-1s NBRx GLP-1 class share 10 10 Source of business for new GLP-1s Victoza exenatide Insulin Insulin + GLP-1 GLP-1 dulaglutide albiglutide SGLT-2 DPP-IV OAD other 20 10 Victoza 8 6 4 2 46% 25% 17% 8 6 4 2 0 2010 Other GLP-1 2012 12% albiglutide dulaglutide Source: IMS MAT tember value figures Source: IMS LRx Weekly, 10 tember ; data shown in rolling 4- week averages Note: OAD other refers to all other oral anti-diabetics than DPP-IV and SGLT-2 Source: Patient Data Warehouse (PADAWA), IMS disease analyser, IMS LRx & Pharmametrics (US)
GLP-1 market dynamics Slide 17 The 8% GLP-1 share of the global diabetes care market is increasing with opportunities for further penetration GLP-1 value in bdkk 30 25 20 15 10 5 0 2010 Global GLP-1 market CAGR value 1 : 39.5% Share of total diabetes care market Victoza Other GLP-1 1 9% 8% 7% 6% 5% 4% 3% 2% 1% 10 Victoza sales and GLP-1 value market share of total diabetes care market DKK billion 8 6 4 2 0 9% North America 9% GLP-1 share of diabetes care market 2% 1% 2% Europe IO China Japan & Korea 1 CAGR for 5-year period Source: IMS Monthly MAT, value figures (DKK) Source: Novo Nordisk reported sales first nine months of and IMS data, tember
GLP-1 market dynamics Slide 18 The key focus with Victoza is to continue leading the growth of the GLP-1 class Example of current Victoza promotional sales aid 1 Promotional focus Key messages for Victoza Quick and lasting HbA 1c reductions The additional benefit of quick and lasting weight loss Opportunity for utilising new data and indications Well-known and prescribed by both endocrinologist and primary care physicians 1 Picture of sales aid is not intended for promotional purposes
GLP-1 market dynamics Slide 19 Three key opportunities to expand the GLP-1 market and grow Novo Nordisk s GLP-1 franchise Drive further GLP-1 market expansion with Victoza Leverage LEADER data for further LCM activities Ensure long term leadership with semaglutide Expand usage Oral semaglutide Expand label eg renal impairment Semaglutide once-weekly Expand access LCM: life cycle management
Slide 20 Insulin market dynamics Jakob Riis EVP China, Pacific and Marketing
Insulin market dynamics Slide 21 Forward-looking statements Novo Nordisk s reports filed with or furnished to the US Securities and Exchange Commission (SEC), as well as the company s Annual Report 2014 and Form 20-F, both filed with the SEC in February, and presentations made, written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as believe, expect, may, will, plan, strategy, prospect, foresee, estimate, project, anticipate, can, intend, target and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to: Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and Statements regarding the assumptions underlying or relating to such statements. These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this presentation, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recall, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk s products, introduction of competing products, reliance on information technology, Novo Nordisk s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees, and failure to maintain a culture of compliance. Please also refer to the overview of risk factors in Be aware of the risk on p 42-43 of the Annual Report 2014 on the company s website novonordisk.com. Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this presentation, whether as a result of new information, future events or otherwise. Important drug information Victoza (liraglutide 1.2 mg & 1.8 mg) is approved for the management of type 2 diabetes only Saxenda (liraglutide 3 mg) is approve in the US and EU for the treatment of obesity only
Insulin market dynamics Slide 22 The global insulin market is comprised of three different segments and three generations of insulin tmu 500 400 Global insulin volume market by segment CAGR volume 1 : 4.9% CAGR value 1 : 19.6% Global insulin market volume by generations Device penetration Modern insulin penetration 2 tmu Penetration 500 10 New-generation insulin 400 8 300 Fast-acting CAGR volume 1 : 5% 300 6 200 Premix CAGR volume 1 : 3% 200 Modern insulin 4 100 Long-acting CAGR volume 1 : 6% 100 Human insulin 2 0 2010 0 2010 1 CAGR for 5-year period. Value in DKK Note: US trend data reflect changes to IMS data collection coverage and methodology as of January 2012 Source: IMS Monthly MAT volume and value (DKK) figures 2 Includes new-generation insulin Note: Data is sensitive to changes in IMS data collection and reporting methodology Source: IMS Monthly MAT volume
Insulin market dynamics Slide 23 Diabetes treatment varies between countries despite common treatment guidelines Share of patients by type of first line treatment Share of patients by type of first injection Insulin GLP-1 DPP-VI Other OAD GLP-1 Premix Basal bolus Bolus 10 SU Metformin 10 Basal 8 8 6 6 4 4 2 2 Germany United States Germany United States Note: OAD other refers to all other oral anti-diabetics than DPP-IV and SGLT-2 Source: Patient Data Warehouse (PADAWA), IMS disease analyser, IMS LRx & Pharmametrics (Germany and the US). Period of analysis 2010-2011. Combo treatment not taken into account and hierarchy structure of treatment groups applied eg a patient on insulin and a OAD counts as an insulin patient. Source: Patient Data Warehouse (PADAWA), IMS disease analyser, IMS LRx & Pharmametrics (Germany and the US)
Insulin market dynamics Slide 24 Earlier diagnosis and extended use of OADs result in patients starting insulin at the same age as ten years ago Age 64 Age when diagnosed with type 2 diabetes Average number of days from first OAD to insulin United Kingdom France Germany Number of days Age 1,800 70 Age when starting insulin treatment 63 68 62 61 60 1,200 600 66 64 59 62 58 2005 2014 0 2005 2014 60 2005 2014 OAD: oral anti-diabetic Source: Patient Data Warehouse (PADAWA), IMS disease analyser, IMS LRx & Pharmetrics (UK, France and Germany)
Insulin market dynamics Slide 25 Dynamics of the insulin market are sticky with new generations of insulin slowly replacing the older The global insulin market (value) Animal insulin Human insulin Modern insulin New-generation insulin 10 8 6 4 2 1993 Source: IMS value figures (DKK) from May 1993 to tember
Insulin market dynamics Slide 26 In Japan, the launch of Tresiba has changed the market dynamics % of starts # of starts (x1,000) 10 16 8 6 4 2 Long-acting insulin starts 14 12 10 8 6 4 2 0 Long-acting insulin switches glargine Tresiba Levemir Human insulin glargine Tresiba Levemir Human insulin May 2012 Jan % of switches # of switches (x1,000) 10 35 8 6 4 2 May 2012 Jan 30 25 20 15 10 5 0 Note: Basal insulin starts defined as patients who are starting insulin treatment with a basal insulin Source: IMS LRx (Japan) Note: Basal insulin switches defined as patients who are switching from basal or another insulin Source: IMS LRx (Japan)
Insulin market dynamics Slide 27 The strong Tresiba performance is increasing Novo Nordisk s total insulin market share in Japan 8 Japanese basal value market shares glargine Tresiba Levemir NPH biosimilar glargine NN Total Basal Japanese total insulin value market shares Novo Nordisk Sanofi Eli Lilly 8 6 53% 6 55% 4 2 2012 43% 31% 8% 4% 4% 4 2 2012 25% 2 Source: IMS Monthly tember value figures Source: IMS Monthly MAT tember value figures
Insulin market dynamics Slide 28 Xultophy is an efficacious alternative to insulin intensification Example of Xultophy promotional sales aid 1 Objective to maximise strong clinical profile First-ever basal insulin and GLP-1 analogue combination in one pen Positioned as once-daily optimisation when basal insulin is not enough Most people with type 2 diabetes are not in good control and at increased risk of developing diabetes complications 2 To be launched in around 20 countries in /2016 US FDA regulatory decision expected Q3 2016 1 Picture of sales aid is not intended for promotional purposes 2 Dale J et al. Insulin initiation in primary care for patients with type 2 diabetes: 3-year follow-up study. Prim Care Diabetes. 2010;4:85 9. Giugliano D et al. Efficacy of insulin analogs in achieving the hemoglobin A1c target of <7% in type 2 diabetes. Diabetes Care. 2011;34:510 17
Insulin market dynamics Slide 29 Novo Nordisk s new generation insulins provide best-in-class treatment options in all insulin segments Insulin segments and Novo Nordisk new-generation insulin products Illustrative insulin segments Fast-acting Premix Long-acting Time Basal insulin + GLP-1 Greater earlier glucose lowering effect Faster-acting Opportunity to dose after the meal while maintaining insulin aspart glucose control Ryzodeg duration of action and a mealtime insulin in one pen Simple regimen with fewer injections than basal and First combination of a basal insulin with an ultra-long bolus Xultophy Positioned as once-daily optimisation when basal First-ever basal insulin and GLP-1 analogue in one pen insulin is not enough Tresiba Lower risk of nocturnal hypoglycaemia versus glargine U100 1 Successful reductions in HbA 1 1c Flexibility in day-to-day dosing time and one daily dose 1 Note: Illustration of future insulin market segments 1 Based on EU label for Tresiba
Insulin market dynamics Slide 30 Novo Nordisk s growth opportunities are supported by numerous planned launches within the coming years Tresiba Launch country segment volume as share of global segment volume 2013 & 2014 2016E 2017E 2018E Ryzodeg Xultophy Faster-acting insulin aspart 1 2 3 4 5 6 7 8 9 Source: IMS volume figures tember and Novo Nordisk launch plans % of global segment volume
Slide 31 Experiences from Tresiba launch in Europe Jerzy Gruhn EVP Region Europe CHERYL ANN BORNE USA
Experiences from Tresiba launch in Europe Slide 32 Forward-looking statements Novo Nordisk s reports filed with or furnished to the US Securities and Exchange Commission (SEC), as well as the company s Annual Report 2014 and Form 20-F, both filed with the SEC in February, and presentations made, written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as believe, expect, may, will, plan, strategy, prospect, foresee, estimate, project, anticipate, can, intend, target and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to: Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and Statements regarding the assumptions underlying or relating to such statements. These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this presentation, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recall, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk s products, introduction of competing products, reliance on information technology, Novo Nordisk s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees, and failure to maintain a culture of compliance. Please also refer to the overview of risk factors in Be aware of the risk on p 42-43 of the Annual Report 2014 on the company s website novonordisk.com. Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this presentation, whether as a result of new information, future events or otherwise. Important drug information Victoza (liraglutide 1.2 mg & 1.8 mg) is approved for the management of type 2 diabetes only Saxenda (liraglutide 3 mg) is approve in the US and EU for the treatment of obesity only
Experiences from Tresiba launch in Europe Slide 33 Novo Nordisk Europe is a diverse region spanning 36 countries Key facts about Novo Nordisk Europe Seven business areas spanning 36 countries Sales of 15 bdkk first nine months of 3% local currency growth first nine months of ~ 2,850 FTEs Seven business areas and 36 countries 34 languages spoken across the region 20 different currencies FTE: full-time employee equivalents
Experiences from Tresiba launch in Europe Slide 34 Strong uptake of Tresiba in countries with competitive reimbursement drives basal insulin market share gains 3 2 1 Tresiba value market share in the basal insulin segment Luxembourg Greece Switzerland 4 Germany United Kingdom Italy Sweden Denmark 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 Months from launch Source: IMS Monthly value figures, tember Note: Tresiba distribution in Germany to be ceased following the negative price negotiation outcome with the German national association of statutory health insurance funds 7 6 5 4 3 2 1 Basal insulin value market share in countries where Tresiba is launched 1 Novo Nordisk Sanofi Eli Lilly Other 58% 36% 4% 2% Jan 2013 Source: IMS Monthly value figures, tember 1 In addition to the countries depicted in the graph to the left, Tresiba is launched in Austria, Czech Republic, Finland, Lithuania, Netherland, Norway, Poland and Slovakia 56% 39% 4% 1%
Experiences from Tresiba launch in Europe Slide 35 Penetration of Tresiba in the UK remains low, but positive opinion from Scotland and Wales on Xultophy 7 6 UK basal insulin value market shares Xultophy glargine Tresiba Levemir glargine U300 Human Insulin NN Total Basal 56% Key launch observations Market access challenges remain for both Tresiba and Xultophy For both products, access is in most cases limited to particular patient groups or to a finite number of patients 5 4 3 2 1 2012 37% 29% 11% 4% Tresiba now has a 51% value share of growth in the basal insulin segment and continuous steady, albeit slow, uptake Positive opinion on Xultophy granted from the All Wales Medicines Strategy Group and the Scottish Medicines Consortium Continuous effort to increase market access for both brands based on key lessons learnt and using spill-over effect from positive opinions Source: IMS Monthly tember value figures
Experiences from Tresiba launch in Europe Slide 36 Steady penetration of Tresiba in Sweden 7 6 5 4 3 2 1 Sweden basal insulin value market shares glargine Tresiba Levemir Xultophy Human Insulin NN Total Basal 2012 5 41% 24% 14% 12% Key launch observations Continued steady uptake of Tresiba Xultophy launched in August with strong sales force execution Reimbursement on national level. Market access gradually improves due to Swedish regional payer set-up Real-world data for Tresiba confirms strong clinical profile and is enabling further uptake Source: IMS Monthly tember value figures
Experiences from Tresiba launch in Europe Slide 37 Real-world data for Tresiba confirms strong clinical profile and enables uptake Study design Danderyd Diabetes Clinic Levemir N=131 357 people with type 1 diabetes 1 Insulin glargine N=216 An independent, prospective, open-label, single-armed, observational study 0 Tresiba 20 weeks 2 1 The study followed 347 consecutive type 1 diabetes patients who switched to Tresiba from existing insulins according to predefined switching criteria such as twice daily injection, HbA 1c outside acceptable levels or unstable glucose and/or repeated hypoglycaemic events. A total of 10 patients were on human insulin and continuous subcutaneous insulin infusion 2 Median follow-up time Study aim and key results Study aim: exploring whether the higher cost of insulin degludec compared with insulin detemir or insulin glargine is justified by improved clinical outcomes Key results (all statistically significant) mean reduction in HbA 1c from 8.5% to 8.2% median reduction of 12% of total insulin dose reduction of hypoglycaemic events of 22% and reduction of nocturnal hypoglycaemic events of 56% Conclusion: Insulin degludec was clinically useful and economically justifiable for the patients with type 1 diabetes Controlled studies are needed to confirm these benefits in a larger sample of real-world patients Source: Changes in HbA 1c, insulin dose and incidence of hypoglycaemia in patients with type 1 diabetes after switching to insulin degludec in an outpatient setting: an observational study, Lena Landstedt-Hallin, CMRO, 8 June
Experiences from Tresiba launch in Europe Slide 38 Driven by Tresiba and Xultophy, Novo Nordisk is now the clear market leader in the Swiss basal insulin segment Switzerland basal insulin value market shares 7 6 5 4 3 2 1 glargine Tresiba Levemir Xultophy Human Insulin NN Total Basal 2012 69% 3 28% 24% 14% 4% Key launch observations Strong Tresiba and Xultophy launch execution Positive patient and physician feedback on both Tresiba and Xultophy Tresiba and Xultophy are the only brands with positive share of growth, indicating that they take the whole growth of the basal market Reimbursement on par with insulin glargine Best practices of launch execution identified and used for future launch excellence Source: IMS Monthly tember value figures
Experiences from Tresiba launch in Europe Slide 39 Concluding remarks Positive physician and patient feedback Penetration is strong in countries with market access comparable to that of competitors Market access remains a challenge in a number of countries, but persistency and close communication with payers, patients and health care professionals is paying off Real-world data studies to support continuous penetration