Slide 1. First three months of 2018 Conference call

Transcription

1 Slide First three months of 208 Conference call Manato Shirley Ohara, Adelia Stewart diagnosed has type with 2 diabetes type diabetes Kanagawa, New Orleans, Japan Louisiana, US

2 Slide 2 Agenda Highlights and key events Sales update R&D update Financials and outlook

3 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 207 and Form 20-F, which are both filed with the SEC in ruary 208 in continuation of the publication of the Annual Report 207, and 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 recalls, 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. For an overview of some, but not all, of the risks that could adversely affect our results or the accuracy of forward-looking statements in this presentation, reference is made to the overview of risk factors in The Risks of Doing Business on pp of the Annual Report 207. 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.2 mg &.8 mg) is approved for the management of type 2 diabetes only Saxenda (liraglutide 3 mg) is approved in the US and EU for the treatment of obesity only

4 Slide 4 Highlights First three months of 208 Sales development Sales decreased by 5% in Danish kroner and increased by 5% in local currencies to DKK 26.9 billion International Operations sales were flat in Danish kroner and grew by 8% in local currencies Region Latin America sales increased by 44% in Danish kroner and increased by 73% in local currencies Region AAMEO sales declined by 2% in Danish kroner and grew by 2% in local currencies Region China declined by % in Danish kroner and grew by 6% in local currencies North America Operations sales decreased by % in Danish kroner and increased by 3% local currencies Victoza and Tresiba accounted for the largest share of growth and grew by 8% and 33% in local currencies, respectively Research and Development Ozempic granted marketing authorisation by the European Commission and approved in Japan Successful completion of the first phase 3a trial, PIONEER, with oral semaglutide Tresiba label in the USA updated to include cardiovascular safety data and 40% reduction of severe hypoglycaemic events compared to insulin glargine U00 Financials Operating profit decreased by 8% in Danish kroner and increased by 6% in local currencies to DKK 2.4 billion Net profit increased by 6% to DKK 0.8 billion Diluted earnings per share increased by 8% to 4.40 DKK per share 208 financial outlook: Sales growth is now expected to be 3-5% measured in local currencies (now around 6% lower reported) Operating profit growth is now expected to be 2-5% measured in local currencies (now around 9% lower reported)

5 Slide 5 Sales growth driven by both International Operations and North America Operations Sales as reported first quarter of 208 Region AAMEO (2%) Region Japan & Korea (4%) Region China (%) Region Europe 0% % % Region Latin America +44% 4% 5% 9% 50% Sales of DKK 26.9 billion (5%) North America Operations (%) Growth break down first quarter of 208 Local currencies Growth Share of growth North America Operations 3% 30% Hereof USA 3% 30% International Operations 8% 70% Region Europe % 2% Region AAMEO 2% 23% Region China 6% 2% Region Japan & Korea (6%) (6%) Region Latin America 73% 39% Total sales 5% 00% AAMEO: Africa, Asia, Middle East & Oceania

6 Slide 6 Sales growth in local currencies of 5% mainly driven by Victoza and Saxenda Sales as reported first quarter of 208 Growth break down first quarter of 208 Haemophilia (3%) Obesity +43% Growth hormone (0%) 7% 6% 9% 2% % Other biopharmaceuticals (28%) 3% 2% 79% 8% Sales of DKK 26.9 billion (5%) Diabetes care (6%) Local currencies Growth Share of growth Long-acting insulin (3%) (0%) Premix insulin 2 % 2% Fast-acting insulin 3 0% 0% Human insulin 3% 4% GLP- 4 9% 73% Other diabetes care 5 5% 4% Total diabetes care 5% 73% Obesity (Saxenda ) 64% 23% Diabetes care and obesity total 6% 96% Haemophilia 6 7% 2% Growth disorders 0% 0% Other biopharmaceuticals 7 (23%) (8%) Biopharmaceuticals % 4% Total 5% 00% Comprises Tresiba, Xultophy and Levemir ; 2 Comprises Ryzodeg and NovoMix 3 Comprises Fiasp and NovoRapid ; 4 Comprises Ozempic and Victoza 5 Primarily NovoNorm and needles; 6 Comprises NovoSeven, NovoEight, NovoThirteen and Refixia ; 7 Primarily Vagifem and Activelle

7 Slide 7 Novo Nordisk aims for leadership in long-acting insulin and sustained leadership for fast-acting and premix insulin Long-acting insulin volume market share across regions 80% 70% 60% 50% 40% 30% 20% 0% 0% 203 Novo Nordisk Region China 208 Fast-acting insulin 2 volume market share across regions North America Operations Region Japan & Korea 80% 70% 60% 50% 40% 30% 20% 0% 0% Long-acting insulin comprises: Tresiba, Levemir, Xultophy and Insulatard (basal human insulin). Please note that not all products are launched in all markets 2 Short-acting insulin includes: Fiasp, NovoLog and Mixtard 30 (premix human insulin). Please note that not all products are launched in all markets 3 Premix insulin includes: Ryzodeg, NovoMix and Actrapid (bolus human insulin). Please note that not all products are launched in all markets Premix insulin 3 volume market share across regions Region Europe Region Latin America 80% 70% 60% 50% 40% 30% 20% 0% 0% 203 Region AAMEO 208

8 Slide 8 Novo Nordisk holds ~35% volume market share of the basal market in the USA Weekly TRx volume market shares in the USA glargine U00 Basal volume TRx MS 70% 60% 50% 40% 30% 20% 0% 0% Mar 206 NN Total Basal Levemir Tresiba glargine U300 biosimilar glargine U00 Mar 208 Note: The graph does not show NPH, which accounts for the residual market share Source: IQVIA weekly Xponent Plantrak, 23 March 208 Excludes Medicaid that represents ~2% of retail basal market volume and basal insulin and GLP- combination products such as Xultophy TRx volume: Insulin volume in mega units (MU) associated with total number of prescriptions; MS: Market share 42.2% 34.8% 22.8%.8% 8.5% 8.4% Tresiba launch in the USA Tresiba TRx volume market share is now.8% Main market share driver in Q 208 has been the formulary change at CVS part D Tresiba formulary access is now estimated to be around 80% 2 for Commercial and Medicare Part D combined, following formulary access on United Health Care Part D Tresiba label in the USA updated to include cardiovascular safety data and 40% reduction of severe hypoglycaemic events compared to insulin glargine U00. The updated Tresiba label was launched mid-april 208 in the USA Source: IQVIA weekly Xponent Plantrak, 23 March, 208 CVS formulary Silverscript 2 Projected access calculated from VANTAGE FingerTip Formulary bridge ruary 208, week ending 2 March 208.

9 Slide 9 Victoza sales growth of 20% in the USA driven by GLP- market volume growth of ~23% USA GLP- market development MAT GLP- TRx volume (million) Total TRx Growth rate MAT volume growth rate % 30% 25% 20% 5% 0% 5% 0% USA GLP- market monthly TRx GLP- TRx volume (thousand) NN GLP- Victoza Ozempic dulaglutide exenatide albiglutide 208 USA GLP- volume market share GLP- TRx market share 00% 80% 60% 40% 20% 0% 205 NN GLP- Victoza Ozempic dulaglutide exenatide albiglutide 44% 37% 5% 4% 208 Source: IQVIA NPA monthly, 208

10 Slide 0 First phase 3a trial with oral semaglutide, PIONEER, in adults with type 2 diabetes completed Reduction in HbA c with oral semaglutide, administered once daily as a tablet vs placebo Reduction in body weight with oral semaglutide, administered once daily as a tablet vs placebo HbA c reduction (%) Oral sema 3 mg 0.0 Oral sema 7 mg Oral sema 4 mg Placebo Weight loss (kg) 0.0 Oral sema 3 mg Oral sema 7 mg Oral sema 4 mg Placebo % % kg -2.5 kg -.5 kg % -.5% kg Results illustrated by using the secondary statistical method called hypothetical estimand: Treatment effect, if all participants followed the treatment without rescue medication (analysed by using Mixed Models for Repeated Measurements (MMRM)). The statistical method is consistent with e.g. the statistical method used for the SUSTAIN programme for subcutaneous semaglutide. Sema: Semaglutide

11 Slide All 0 PIONEER trials for oral semaglutide expected to read-out during PIONEER : monotherapy 2 26 weeks, n=704 PIONEER 2: vs empagliflozin 2 52 weeks, n=86 PIONEER 3: vs sitagliptin 2 78 weeks, n=,860 PIONEER 4: vs liraglutide 2 52 weeks, n=690 PIONEER 5: moderate renal impairment 2 26 weeks, n=324 PIONEER 6: cardiovascular outcomes 3 Event driven (>22 MACE), n=3,76 PIONEER 7: flexible dose escalation 4 52 weeks, n=500 PIONEER 8: insulin add-on weeks, n=720 PIONEER 9: JAPAN monotherapy 2 52 weeks, n=230 PIONEER 0: JAPAN OAD combination 4 52 weeks, n=336 Q 208 Q2 208 Q3 208 Q weeks extension trial Expected to be published in the given quarter or in the subsequent quarterly company announcement. Estimated timing from first patient first visit to completion of trial 2 Primary endpoint after 26 weeks of treatment by using the statistical method: Treatment policy estimand approach 3 Primary endpoint after >22 major adverse cardiovascular events (MACE), defined by non-fatal stroke, non-fatal myocardial infarction or CV death 4 Primary endpoint after 52 weeks of treatment by using the statistical method: Treatment policy estimand approach Note: n = approximate number of randomised people; OAD: oral anti-diabetic

12 Slide 2 Tresiba label in the USA updated based on DEVOTE trial data Lower rates of severe hypoglycaemia demonstrated in DEVOTE trial FDA approved a label update for Tresiba for people with type 2 diabetes glargine U00 Tresiba Food and Drug Administration (FDA) approved updates to the US prescribing information for Tresiba to include data -40% * from the DEVOTE trial including: % * Cardiovascular safety based on Tresiba demonstrated non-inferiority compared to insulin glargine U00 with regards to major adverse cardiovascular events (MACE) with a hazard ratio of Statistically significant 40% reduction of severe hypoglycaemic events compared to insulin glargine U00 Subjects with one or more severe events Number of overall severe events The supplemental applications to include the two SWITCH trials have been withdrawn following interactions with FDA * Statistically significant Source: Marso et al. New England Journal of Medicine 207;377: MACE defined as first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke

13 Slide 3 Key development milestones Ozempic granted marketing authorisation by European Commission and approved in Japan Variation applications for Ozempic submitted to the EMA for the devices and inclusion of SUSTAIN 7 data New drug application for Ryzodeg submitted to the China FDA Diabetes Xultophy label to include LEADER and DEVOTE data submitted to the FDA and positive opinion adopted by CHMP in the EU DUAL I Japan phase 3a trial with Xultophy completed LAI287 phase trials completed and phase 2 initiation expected before end of 208 Development of PI406 to be discontinued following phase results HypoPen 53 initiated in phase Obesity Biopharm AM833 phase results completed and phase 2 initiation expected early 209 N8-GP submitted for regulatory approval in the USA and the EU for treatment of haemophilia A Phase /2 multiple dose trial with subcutaneous N8-GP initiated following completion of single dose trial Worldwide license to EpiDestiny s sickle cell disease programme (EPI0) obtained Norditropin label in the USA updated with two additional indications

14 Slide 4 R&D milestones in 208 Results available Regulatory milestone Project Q 208 Q2 208 Q3 208 Q4 208 Tresiba Xultophy DEVOTE and SWITCH 2 US regulatory decision DUAL I Japan Phase 3a DUAL II Japan Phase 3a Japan submission Fiasp Japan submission Ozempic Oral semaglutide LAI287 AM833 N9-GP EU and Japan regulatory decision PIONEER data Phase data PIONEER 2, 3, 4 and 7 data Phase data PIONEER 5 and 0 data Japan regulatory decision PIONEER 6, 8 and 9 data N8-GP US/EU submission Japan submission Concizumab explorer 5 data explorer 4 data EU variation applications Somapacitan REAL 3 Phase 2, GHD data REAL (extension) Phase 3, AGHD data Diabetes Obesity Haemophilia Growth disorders Expected to be published in the given quarter or in the subsequent quarterly company announcement 2 Supplemental applications to include the two SWITCH trials have been withdrawn based on interactions with FDA GHD: Growth hormone deficiency; AGHD: Adult growth hormone deficiency Note: G530L has been removed from the overview as the project is still being evaluated in phase Note: Tresiba vs insulin glargine U300 trial has been postponed and is no longer expected to read-out in Q4 208

15 Slide 5 Financial results First three months of 208 DKK million Q 208 Q 207 Change (reported DKK) Change (local currency) Sales 26,930 28,452 (5%) 5% Gross profit 22,733 24,20 (6%) Gross margin 84.4% 85.% Sales and distribution costs (6,45) (6,787) (5%) 5% Percentage of sales 24.0% 23.9% Research and development costs (3,32) (3,289) % 5% Percentage of sales 2.3%.6% Administration costs (864) (93) (5%) 0% Percentage of sales 3.2% 3.2% Other operating income, net % Operating profit 2,448 3,490 (8%) 6% Operating margin 46.2% 47.4% Financial items (net),6 (486) Profit before income tax 3,609 3,004 5% Income taxes (2,858) (2,848) 0% Effective tax rate 2.0% 2.9% Net profit 0,75 0,56 6% Diluted earnings per share (DKK) %

16 Non-hedged currencies Index ( Jan 207 = 00) Hedged currencies Index ( Jan 207= 00) Conference call First three months of 208 Slide 6 Unfavourable currency impact in Q 208 driven by development in both hedged and unhedged currencies USD/DKK RUB/DKK CNY/DKK INR/DKK JPY/DKK ARS/DKK GBP/DKK BRL/DKK CAD/DKK TRY/DKK Hedged 207 Currencies average Non-hedged 207 Currencies average 208 average average 2 Spot rate 2 Spot rate 2 ARS TRY INR RUB BRL Impact of a 5% move 3 DKK per 00; 2 As of 25 April 208; 3 Impact on operating profit in the next 2 months of a 5% immediate currency move. DKK million per annum; 4 Chinese Yuan traded offshore (CNH) Note: Operating profit impact of one of the non-hedged currencies appreciating 5% is in the range of DKK -5 to +50 million Hedging (months) USD ,900 2 CNY JPY GBP CAD

17 Slide 7 Financial outlook for 208 Sales growth - local currencies Expectations 2 May 208 3% to 5% Previous expectations 208 2% to 5% Sales growth - reported Operating profit growth - local currencies Operating profit growth - reported Financial items (net) Effective tax rate Capital expenditure Depreciation, amortisation and impairment losses Free cash flow Around 6 percentage point lower 2% to 5% Around 9 percentage point lower Gain of around DKK.9 billion 20% to 22% Around DKK 9.5 billion Around DKK 3 billion Around DKK 27 to 32 billion Around 7 percentage points lower % to 5% Around 0 percentage points lower Gain of around DKK 2.5 billion 20% to 22% Around DKK 9.5 billion Around DKK 3 billion Around DKK 27 to 32 billion The financial outlook is based on an assumption of a continuation of the current business environment and given the current scope of business activities and has been prepared assuming that currency exchange rates remain at the level as of 25 April 208

18 Slide 8 Closing remarks Solid leadership positions and continued market opportunities Promising pipeline and product launches 27% Novo Nordisk value market share in diabetes > The only company with a full portfolio of novel care and solid leadership position insulin and GLP- products ~5% insulin market volume growth 45% Novo Nordisk insulin volume market share with leadership position across all regions >2% GLP- volume market growth 54% Novo Nordisk GLP- volume market share with global leadership position 38% Saxenda value market share with a global leadership in the anti obesity market Semaglutide portfolio offers expansion opportunity with both once-weekly Ozempic and oral administration Xultophy supports promising outlook for insulin and GLP- combination therapy Saxenda and multiple clinical stage development projects hold potential within obesity Broad pipeline within haemophilia Source: IQVIA MAT 208 volume and value (DKK) figures

19 Slide 9 Investor contact information Share information Novo Nordisk s B shares are listed on the stock exchange in Copenhagen under the symbol NOVO B. Its ADRs are listed on the New York Stock Exchange under the symbol NVO. For further company information, visit Novo Nordisk on the internet at: novonordisk.com Upcoming events 24 Jun 208 American Diabetes Association investor presentation 08 Aug 208 Financial statement for the first six months of 208 Investor Relations contacts Novo Nordisk A/S Investor Relations Novo Allé, DK-2880 Bagsværd Peter Hugreffe Ankersen phak@novonordisk.com Anders Mikkelsen armk@novonordisk.com Christina Kjær cnje@novonordisk.com 0 Nov 208 Financial statement for the first nine months of Financial statement for 208