Slide 1. Investor presentation Full year London, 4 February Shanghai part of Cities Changing Diabetes

Transcription

1 Slide 1 Investor presentation Full year 2015 London, 4 February 2016 Shanghai part of Cities Changing Diabetes

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 the company s Annual Report 2015 and Form 20-F, which are both filed with the SEC in February 2016 in continuation of the publication of the Annual Report 2015, 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 Managing risks on p of the Annual Report 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 approved in the US and EU for the treatment of obesity only

4 Slide 4 Highlights Full year 2015 Sales development Sales increased by 22% in Danish kroner and 8% in local currencies North America and International Operations grew by 32% and 19% in Danish kroner, respectively Victoza increased by 34% in Danish kroner and continues to drive the growth of the GLP-1 market Levemir increased by 29% in Danish kroner and gains market share in the US despite increased competition Tresiba launched in the US and continues to perform well in countries with similar reimbursement as insulin glargine Research and Development Tresiba shows lower rate of hypoglycaemia than insulin glargine in SWITCH 2 trial in people with type 2 diabetes SUSTAIN 2 trial, comparing semaglutide vs sitagliptin in people with type 2 diabetes, successfully completed SUSTAIN 4 trial, comparing semaglutide vs insulin glargine in people with type 2 diabetes, successfully completed Financials Operating profit growth of 43% in Danish kroner; adjusted for partial NNIT divestment, growth was 14% in local currencies Diluted earnings per share increased 34% to DKK per share 2016 financial outlook: Sales growth is expected to be 5-9% measured in local currencies Operating profit growth is also expected to be 5-9% measured in local currencies, adjusted for the partial divestment of NNIT and out-licensing income from the divestment of inflammation assets, both in 2015 Updated long-term financial targets The target for operating profit growth has been set at 10% A new operating margin target has not been established, as operating margin is expected to remain around 44% The targets for operating profit after tax to net operating assets and cash-to-earnings ratio remain unchanged

5 Slide 5 North America is the main contributor to growth Sales as reported Full year 2015 Region China +22% Japan & Korea +11% 9% 5% Growth analysis Full year 2015 Local currencies Growth Share of growth North America 11% 62% Europe 2% 4% International Operations +19% 14% 53% North America +32% International Operations 15% 26% Region China 4% 4% Europe +3% 19% Japan & Korea 5% 4% Total sales 8% 100% Sales of DKK billion (+22%)

6 Slide 6 Growth is driven by modern insulin and Victoza Sales as reported Full year 2015 Growth analysis Full year 2015 Other Norditropin +28% +20% 3% 7% 4% Haemophilia +14% 10% 11% 79% 79% Diabetes and obesity care +22% Sales of DKK billion (+22%) Local currencies Growth Share of growth New-generation insulin 1 109% 10% Modern insulin 7% 41% Human insulin (1%) (1%) Victoza 18% 32% Other diabetes and obesity care 2 5% 2% Diabetes and obesity care 9% 84% Haemophilia 3 3% 4% Norditropin 8% 7% Other biopharmaceuticals 4 13% 5% Biopharmaceuticals 6% 16% Total 8% 100% 1 Comprises Tresiba, Ryzodeg and Xultophy 2 Predominantly oral antidiabetic products, needles and Saxenda 3 Comprised NovoSeven, NovoEight and NovoThirteen 4 Predominantly hormone replacement therapy

7 Slide 7 Victoza maintains leadership in the faster growing US GLP-1 market US GLP-1 market development US GLP-1 market shares MAT GLP-1 TRx (000) 6,000 Growth rate Total TRx MAT volume growth rate 30% GLP-1 TRx market share 100% Victoza albiglutide exenatide dulaglutide 5,000 25% 80% 4,000 3,000 2,000 20% 15% 10% 60% 40% 56% 24% 1,000 5% 20% 11% 0 Dec 2012 Dec % 0% Dec % Dec 2015 Source: IMS NPA MAT, December 2015 Source: IMS NPA MAT, December 2015

8 Slide 8 North America drives strong Levemir growth despite increased competition DKK billion 19% Levemir sales growth driven by strong performance in North America North America -2% 11% 68% Growth in local currency 5% -15% Europe IO China Japan & Korea 80% 60% 40% 20% 0% Levemir has gained US market share despite introduction of glargine U300 Nov 2012 glargine U300 Levemir NPH glargine U100 65% 24% 10% 1% Nov 2015 Note: Reported sales full year 2015 Source: IMS MAT volume figures, November 2015

9 Slide 9 Roll-out of Tresiba is progressing and Tresiba is now launched in the US Key launch observations Tresiba launched in 39 countries Tresiba has shown solid penetration in markets with similar reimbursement as insulin glargine Penetration of Tresiba remains modest in markets with restricted market access compared to insulin glargine Tresiba distribution in Germany ceased in January 2016 Tresiba launched in Spain in January 2016 Tresiba launched in the US in January 2016 Dialogue with payers regarding formulary access is ongoing and coverage is increasing Tresiba value share of basal insulin segment in selected countries Switzerland Japan Mexico 35% 30% 25% Netherlands Sweden Denmark 24% 22% UK Argentina Brazil India Greece Italy 33% 27% 20% 14% 15% 15% 12% 12% 10% 7% 5% 4% 4% 0% 3% Months from launch Note: Limited IMS coverage in India Source: IMS Monthly value figures, November 2015

10 Slide 10 Steady prescription uptake for Saxenda Prescription volume uptake of anti-obesity medications (AOM) recently launched in the US TRx Contrave Belviq Volume(000) Qsymia Saxenda Months from launch Note: IMS reporting for new launches may reflect data instability due to small volume and/or supplier reporting Source: IMS NPA TRx, weekly data, 8 January Key observations Encouraging Saxenda uptake continues in Q despite market seasonality with lower anti-obesity prescription volumes in the second half compared to the first half of the year Saxenda is now the leader in value market share 1 at ~31% among branded AOM, and the only branded product significantly growing value in Q Saxenda has contracted coverage with multiple large pharmacy benefit managers, and is currently growing share in each account 2 Saxenda has been launched in the US, Canada, Denmark and Italy 1 IMS NSP, Monthly data, November IMS Xponent PlanTrak

11 Slide 11 Tresiba shows lower rate of hypoglycaemia than insulin glargine in SWITCH 2 trial SWITCH 2 Trial design Headline results 721 people with type 2 diabetes Tresiba once daily ± OAD IGlar once daily ± OAD Tresiba once daily ± OAD IGlar once daily ± OAD Event rate per 100 patient years exposed in maintenance period Severe or BG confirmed symptomatic hypoglycemia Severe or BG symptomatic nocturnal confirmed hypoglycemia Tresiba IGlar Tresiba reduction vs IGlar % % Severe hypoglycaemia % Randomised 1:1 Double-blinded 16 week titration 1 16 week HbA 1c stable 16 week titration 16 week HbA 1c stable 1 After 20% dose reduction if coming from previous twice-daily treatment Note: Daily injections of both Tresiba and insulin glargine evenly split between morning and evening IGlar: insulin glargine; OAD: oral anti-diabetic Severe hypoglycaemia (Full treatment period) % p < 0.001; BG: blood glucose; Note: The confirmatory secondary endpoint of proportions of subjects experiencing severe hypoglycaemia during the maintenance period did not reach statistical significance.

12 Change in HbA 1c (%) Investor presentation Full year 2015 Slide 12 In phase 3a trials semaglutide shows best in-class potential on HbA 1c reduction across treatment cascade Comparison of HbA 1c lowering effect in SUSTAIN 1, 2, 3 and 4 trials % patients HbA 1c 7% Sema 1 mg Sema 0.5 mg Placebo Sitagliptin 100 mg Exenatide QW Insulin glargine QD SUSTAIN 1 SUSTAIN 2 SUSTAIN 3 SUSTAIN 4 Baseline 8.1% 8.1% 8.4% 8.2% % 74% 25% 78% 69% 36% 67% 40% 73% 58% % p < 0.001; QD: once daily; QW: once weekly; sema: semaglutide Source: Novo Nordisk on file (NN , NN , NN , NN )

13 Change in weight (kg) Investor presentation Full year 2015 Slide 13 In phase 3a trials semaglutide shows best in-class weight lowering potential across treatment cascade Comparison of weight lowering effect in SUSTAIN 1, 2, 3 and 4 trials Sema 1 mg Sema 0.5 mg Placebo Sitagliptin 100 mg Exenatide QW Insulin glargine QD SUSTAIN 1 SUSTAIN 2 SUSTAIN 3 SUSTAIN 4 Baseline 92kg 89kg 96kg 93kg p < 0.001; QD: once daily; QW: once weekly; sema: semaglutide Source: Novo Nordisk on file (NN , NN , NN , NN )

14 Slide 14 Key development milestones Diabetes Obesity Haemophilia Other Phase 3b trial initiated comparing Xultophy (IDegLira) (NN9068) with insulin glargine in 104-week study Faster-acting insulin aspart (NN1218) filed for regulatory approval in the EU and the US for the treatment of type 1 and 2 diabetes Phase 1 trial initiated with a liver-preferential prandial insulin (NN1406) LATIN T1D (NN9211) discontinued in phase 3 development Phase 2 trial iniated with Anti-IL 21 and liraglutide in people with recent onset type 1 diabetes (NN9828) OG987GT (NN9926) and OG987SC (NN9927) discontinued in phase 1 development following the decision to enter phase 3a with oral semaglutide Novo Nordisk files for regulatory approval of long-acting factor IX, N9-GP (NN7999) in the EU for the treatment of haemophilia B Novo Nordisk completes 3b extension trial mentor 2 with rfxiii, NovoThirteen Novo Nordisk plans to initiate a phase 2 clinical programme in 2H 2016 to investigate semaglutide for the treatment of non-alcoholic steatohepatitis (NASH)

15 Slide 15 Strong R&D newsflow expected to continue in 2016 Results available Project Past 3 months Within 3 months Within 6 months In ~6-9 months In ~9-12 months SWITCH 2 Tresiba SWITCH 1 DEVOTE SUSTAIN 2 Once-weekly semaglutide SUSTAIN 4 SUSTAIN 5 SUSTAIN 6 Victoza LEADER OI338GT Amylin analogue N9-GP Phase 2a Phase 1 US submission Xultophy FDA regulatory decision Glucagon 530L Phase 1 Diabetes Obesity Haemophilia Note: Indicated timeline as of financial release for full year 2015 on 3 February 2016

16 Slide 16 Financial results Full year 2015 DKK million Change Sales 107,927 88,806 22% Gross profit 91,739 74,244 24% Gross margin 85.0% 83.6% Sales and distribution costs 28,312 23,223 22% Percentage of sales 26.2% 26.2% Research and development costs 13,608 13,762 (1%) Percentage of sales 12.6% 15.5% Administration costs 3,857 3,537 9% Percentage of sales 3.6% 4.0% Other operating income, net 3, N/A Non-recurring income from the IPO of NNIT 2,376 - Operating profit 49,444 34,492 43% Net financials (5,961) (396) N/A Profit before income tax 43,483 34,096 28% Tax 8,623 7,615 13% Effective tax rate 19.8% 22.3% Net profit 34,860 26,481 32% Diluted earnings per share (DKK) % Diluted earnings per share (DKK) adjusted for partial divestment of NNIT %

17 Non-hedged currencies Index (1 Jan 2014 = 100) Hedged currencies Index (1 Jan 2014 = 100) Investor presentation Full year 2015 Slide 17 Appreciation of key currencies against the Danish krone drive significant positive currency impact in USD/DKK CNY/DKK JPY/DKK GBP/DKK CAD/DKK Hedged 2014 Currencies average 2015 average 2 Spot rate 2 Impact of a 5% move 3 Hedging (months) USD , CNY JPY GBP , CAD RUB/DKK INR/DKK ARS/DKK BRL/DKK TRY/DKK Non-hedged 2014 Currencies average 2015 average 2 Spot rate 2 RUB INR ARS BRL TRY DKK per 100; 2 As of 01 February 2016; 3 Operating profit in DKK million per annum; 4 USD and Chinese Yuan traded offshore (CNH) used as proxy; 5 Operating profit impact of one of the nonhedged currencies fluctuating 5% is in the range of DKK -10 to +30 million

18 Slide 18 Financial outlook for 2016 Sales growth - local currencies Sales growth - reported Operating profit growth - local currencies Operating profit growth - reported Net financials Effective tax rate Capital expenditure Depreciation, amortisation and impairment losses Free cash flow Expectations 3 February % Around 1 percentage point lower 5-9% Around 1 percentage point lower Loss of around DKK 1.3 billion 20-22% Around DKK 7.0 billion Around DKK 3.0 billion DKK 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 01 February 2016

19 Slide 19 Long-term financial targets are based on the pursuit of double digit growth for the diabetes care franchise DKK billion Reported Novo Nordisk diabetes care sales by treatment class Insulin GLP-1 CAGR % Other diabetes care Expected future growth drivers for Novo Nordisk s diabetes care franchise Volume growth Market share gain Continued underlying growth of the global insulin market Market share gains driven by best in-class insulin portfolio 40 Value upgrade Continued upgrade from older generations of insulin GLP-1 franchise Continued expansion of the GLP-1 market and launch of once-weekly GLP-1 1 CAGR in local currencies for

20 Slide 20 Updated long-term financial targets Performance against long-term financial targets Average Result Previous Target 2 Updated Target Operating profit growth 23% Operating profit growth in local currencies 3 15% 43% 14% 15% 10% Operating margin 40% 46% 40% N/A 4 Operating profit after tax to net operating assets 111% 149% 125% 125% Cash to earnings (three year average) 97% 97% 90% 90% Note: The targets have been revised based on an assumption of a continuation of the current business environment 1 Simple average of reported figures ; 2 The long-term financial targets were last updated in connection with the 2012 annual results; 3 Adjusted for the partial divestment of NNIT in 2015; 4 A new target has not been established, as operating margin is expected to remain around 44%

21 Slide 21 Organic growth enables steady cash return to shareholders via dividends and share repurchase programmes DKK billion Annual cash return to shareholders E Note: Dividends are allocated to the year of dividend pay. For 2016 expected free cash flow is DKK billion. Share repurchase programmes run for 12 months starting February until end January of the following year Proposed dividend and introduction of interim dividend Free cash flow Share repurchase Dividend Board of Directors to propose 28.0% increase in dividend to DKK 6.40 per share of DKK 0.20 at Annual General Meeting on 18 March 2016 Proposal corresponds to a payout ratio of 46.6% Adjusted for the partial divestment of NNIT the payout ratio is 50.0% Board of Directors to propose introduction of interim biannual dividends at the Annual General Meeting on 18 March 2016 Subject to final approval, Novo Nordisk intends to introduce the first interim dividend in August 2016

22 Slide 22 Closing remarks Solid market performance Promising pipeline > 10% annual diabetes care market growth driven The only company with a full portfolio of novel by diabetes prevalence insulin products 28% 47% 45% c 67% market share in diabetes care and solid leadership position insulin volume market share with leadership position across all regions modern and new-generation insulin volume market share GLP-1 value market share with strong global leadership position Semaglutide portfolio offers expansion opportunity with both injectable and oral administration Xultophy supports promising outlook for insulin and GLP-1 combination therapy Saxenda and multiple early stage development projects hold potential within obesity Broad pipeline within haemophilia and growth hormone disorders Source: IMS MAT November 2015 volume and value (DKK) figures

23 Slide 23 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 18 Mar 2016 Annual General Meeting Apr 2016 Financial statement for the first three months of Aug 2016 Financial statement for the first six months of 2016 Investor Relations contacts Novo Nordisk A/S Investor Relations Novo Allé, DK-2880 Bagsværd Peter Hugreffe Ankersen phak@novonordisk.com Daniel Bohsen dabo@novonordisk.com Melanie Raouzeos mrz@novonordisk.com Kasper Veje kpvj@novonordisk.com 28 Oct 2016 Financial statement for the first nine months of 2016