Investor presentation London 6 February 2020 - Novo Nordisk
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Investor presentation Full year 2019 Slide Slide 2 2 Agenda Highlights Sales update R&D update Financials and outlook Strategic aspirations 2025
Investor presentation Full year 2019 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 2019 and Form 20-F, which are both expected to be filed with the SEC in February 2020 in continuation of the publication of the Annual Report 2019, 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 Novo Nordisk’s results or the accuracy of forward-looking statements in this presentation, reference is made to the overview of risk factors in ‘Managing risks to protect value’ on pp 33-35 of the Annual Report 2019. 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® is approved for the management of type 2 diabetes only • Saxenda® is approved in the USA and the EU for the treatment of obesity only
Investor presentation Full year 2019 Slide 4 Strategic aspirations for 2025 - Highlights 2019 Diabetes: Patients reached with Novo Nordisk products • Rybelsus® received approval for the treatment of type increased by 3% to 30 million 2 diabetes in the US and positive EU CHMP opinion • Ozempic® approved in the US for CV risk reduction Access to Insulin Commitment expanded with 29 • Insulin icodec (LAI287) phase 2 trial successfully therapeutic focus middle-income countries, reaching 2.9 million patients completed Innovation and sustainability Obesity: Purpose and Circular for Zero environmental strategy introduced • AM833 phase 2 trial initiated Biopharm: • Esperoct® approved in the US, the EU and Japan for the treatment of haemophilia A Diabetes sales increased by 4%: Sales increased by 6% to DKK 122.0 billion • Value market share leadership expanded by 0.8%- • 11% and 1% growth in IO and NAO, respectively point to 28.6% • Sales of GLP-1 increased by 22% reflecting solid Operating profit increased by 6% to DKK 52.5 billion launch of Ozempic® Commercial Obesity sales increased by 42% to DKK 5.7 billion Free cash flow of DKK 34.5 billion Financials execution Biopharm increased by 4% driven by key products Total dividend of DKK 8.35 per share of DKK 0.20 NovoEight®, Refixia®, and Esperoct® Note: Unless otherwise specified growth rates are at constant exchange rates; CV: Cardiovascular; IO: International operations; NAO: North America operations
Investor presentation Full year 2019 Slide Slide 5 5 Sales growth of 6% at CER, driven by solid sales growth in International Operations Reported sales split for FY 2019 Growth drivers for FY 2019 Insulin GLP-1 Other diabetes International Operations sales growth of 11% at Obesity Biopharm Growth at CER DKK CER supported by all regions billion • Increasing sales across all therapy areas 70 11% 1% • Broad innovative portfolio of products and new product launches 60 • Solid commercial execution applying a Market Fit approach 50 International Operations regions • Underlying demographic trends across IO countries 40 North America Operations sales increased by 1% 30 7% at CER 20 14% • Sales growth in GLP-1 (+19%), Obesity (+28%), 12% and Biopharm (+2%), offset by declining insulin 10 5% 24% sales (-16%) 0 IO Region Region Region Region Region NAO Europe AAMEO China J&K LATAM IO: International Operations; AAMEO: Africa, Asia, Middle East & Oceania; J&K: Japan & Korea; LATAM: Latin America; NAO: North America Operations; FY: Full year
Investor presentation Full year 2019 Slide Slide 6 6 Sales growth of 6% at CER, driven by GLP-1, Obesity, and Biopharm, partly offset by declining US insulin sales Added reported sales and growth per therapy area and Growth drivers for FY 2019 operational unit at CER International Operations North America Operations • Novo Nordisk expands global diabetes value market DKK Growth at CER leadership by 0.8%-point to 28.6% billion Therapy areas 12 • Global insulin volume market share increased 0.2%- 6% -3% 22% 42% 4% point to 46.5% 10 • Novo Nordisk expands GLP-1 market leadership by 8 1.3%-points to 47.5% value market share 11% 6 32% • Saxenda® now launched in 46 countries • Biopharm sales increased 4%, at CER, driven by new 4 19% 73% products and both operating units 1% 5% 2 7% 0 -16% 28% 2% -2 Total Insulin GLP-1 Obesity Biopharm 1 1“Other diabetes“ is included in Total Source: IQVIA MAT, Nov 2019 CER: Constant exchange rates
Investor presentation Full year 2019 Slide Slide 7 7 Ozempic® and Rybelsus® US launches have increased Novo Nordisk GLP-1 NBRx market share, resulting in TRx market leadership USA GLP-1 NBRx market share USA GLP-1 TRx market growth and market share NN GLP-1 Ozempic® Rybelsus® NN GLP-1 Ozempic® dulaglutide other dulaglutide Victoza® other Weekly TRx volume TRx share NBRx share (million) 60% 56.6% 2.0 80% Market growth: 32%1 50% 1.5 60% 40% 36.8% 46.8% 30% 36.4% 1.0 40% 44.9% 20% 13.3% 20.6% 0.5 20% 10% 7.1% 8.3% 6.4% 0% 0.0 0% Jan Dec Jan Dec 2019 2019 2019 2019 Source: NBRx-IQVIA National LRx Weekly, week ending 27 Dec 2019 Source: TRx-IQVIA Xponent, Dec 2019 NBRx: New-to-brand prescriptions TRx: Total prescriptions 1 Q4 2019 vs. Q4 2018
Investor presentation Full year 2019 Slide Slide 8 8 Strong GLP-1 sales growth in IO driven by Ozempic® launch uptake in Europe and GLP-1 portfolio across regions GLP-1 value market share and share of growth in select Reported GLP-1 sales, growth, and share of European launch markets regional growth per region NN market share NN share of growth GLP-1 growth at CER GLP-1 share of growth DKK Market billion Share 32% 1st European 80% launch 9 35% International Operations regions 61.4% 31% 60% 6 60.0% 76% 40% 3 15% 70% 55% 14% 20% 7% 26% 31% 29% 0% 0 Nov Nov IO Region Region Region Region Region 2017 2019 Europe AAMEO China LATAM Japan & Korea Source: IQVIA 3 months rolling value, Nov 2019 SoG: Share of growth Countries included: Belgium, Czech Republic, Denmark, Finland, France, Hungary, Ireland, Italy, IO: International Operations Luxembourg, Netherlands, Norway, Slovakia, Spain, Sweden, Switzerland and the UK
Investor presentation Full year 2019 Slide Slide 9 9 Global rollout and promotional activities drive 42% at CER, Saxenda® sales growth for 2019 Reported sales split in operational units Novo Nordisk remains global market leader International Operations North America Operations • Novo Nordisk expands market leadership to 56% DKK Market Growth at CER Value market share value market share from 48% Global billion Share 42% • Saxenda® is now launched in 46 countries 1.6 • Continued investments in market development 51% 56% 60% activities 1.2 • Sales growth of 73% driven by all regions 64% 40% • Novo Nordisk currently has a value market share of IO 0.8 36% in the obesity market 20% 0.4 • Sales growth of 28% driven by both the USA and NAO Canada 0.0 0% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 • Novo Nordisk currently has a value market share of 70% in the obesity market 2017 2018 2019 Note: Numbers in the graph are reported quarterly sales Source: IQVIA monthly, Nov 2019 CER: Constant exchange rates Note: Growth rates are at CER IO: International Operations; NAO: North America Operations
Investor presentation Full year 2019 Slide Slide10 10 Solid commercial execution and new product launches drive 4%, at CER, Biopharm sales growth Increase in reported Biopharm sales across products Biopharm sales driven by global commercial execution DKK Growth at CER Biopharm sales growth driven by 5% in International billion Operations and by 2% in North America Operations 4% 0% 10% 81% 2% 6% 1.2 Haemophilia sales increased by 4% driven by 1.0 • Continued global rollout of NovoEight®, Refixia® ,and Esperoct® 0.8 • Stable NovoSeven® sales, reflecting the solid position in a competitive market 0.6 0.4 Haemophilia Novo Nordisk retains global market leadership in the human growth disorder market with a 33% value 0.2 market share 0.0 Total Novo- NovoEight® Other Nordi- Other Seven® haemo- tropin® Biopharm philia Note: ‘Other haemophilia’ includes Esperoct®, NovoThirteen® and Refixia®; ‘Other Biopharm’ includes Note: Sales growth reported at constant exchange rates primarily Vagifem® and Activelle®
Investor presentation Full year 2019 Slide Slide11 11 Ozempic® receives CV risk reduction indication in the US, Rybelsus® receives CV safety label update in the US and positive CHMP opinion 15 MACE Patients with an Ozempic® is indicated for1: event (%) • Adults with type 2 diabetes 10 Placebo: 8.9% • Reducing the risk of major Cardiovascular adverse cardiovascular indication in the US 5 events in adults with type 2 diabetes and established Semaglutide: 6.6% 0 cardiovascular disease 0 4 8 12 16 20 24 Months The proportion of patients who SOUL Cardiovascular Outcomes trial experienced at least one MACE was 3.8% with Rybelsus® and Oral sema 14 mg + SOC Cardiovascular 4.8% with placebo 9,642 people update in the US with type 2 diabetes Placebo + SOC Non-inferiority was established, with a hazard ratio equal to 0.79 Event-driven [95% CI: 0.57, 1.11] Rybelsus® is indicated as Positive CHMP monotherapy when metformin is opinion in the EU considered inappropriate for the treatment of type 2 diabetes1 CV: Cardiovascular; CVD: Cardiovascular disease; MACE: Major adverse cardiovascular event; 1 Abbreviated version of the approved product information
Investor presentation Full year 2019 Slide 12 Insulin icodec (LAI287) phase 2 and icosema (LAIsema) phase 1 trials successfully completed Insulin icodec (LAI287), a novel once-weekly insulin Icosema (LAIsema), a combination of once-weekly analog, versus insulin glargine icodec and once-weekly semaglutide 1 2 Icodec (weekly) + metformin ± DPP-4i 247 people 30 people (+ daily placebo) Icosema Sema Icodec with type 2 1:1 with type 2 diabetes diabetes Insulin glargine U100 (daily) + metformin ± DPP-4i (+ weekly placebo) 5 weeks 1-4 week 5 weeks 1-4 week 5 weeks PK washout PK washout PK Results Details • Change in HbA1c from baseline: insulin icodec, -1.33%-points • Investigated safety, tolerability and pharmacokinetics vs. insulin glargine U100, -1.15%-points • Following the completion of the phase 1 trial, icosema is now • Low rates of hypoglycaemic events for both arms being evaluated for further clinical trial development • No unexpected safety events • Phase 3 initiation planned for second half of 2020 1A phase 2, double-blinded and treat-to-target trial 2A phase 1 trial with only one of six possible treatment sequences shown PK: Pharmacokinetics Sema: Semaglutide; PK: Pharmacokinetics Note: Insulin icodec is the international non-proprietary name Note: Icosema is the international non-proprietary name
Investor presentation Full year 2019 Slide 13 R&D milestones in 2020 Clinical milestones1 Regulatory milestones1 Project Q1 2020 Q2 2020 Q3 2020 Q4 2020 Ozempic® CV label indication China submission ✓✓ SUSTAIN FORTE – Phase 3 results Xultophy® China submission Icodec Phase 2 results ✓ Phase 3 initiation Rybelsus® CV label update ✓ EU commission decision ✓ (Oral semaglutide) EU CHMP decision ✓ JP PMDA decision Sema+OW GIP Phase 1 initiation √ ✓ ✓ Semaglutide ✓ Phase 3 results ✓ Amylin - AM833 Phase 2 results LA-GDF 15 Phase 1 results Obesity Projects2 Phase 1 results Mim8 Phase 1/2 initiation ✓ Somapacitan (AGHD) JP submission US/EU decision Phase 2 results Semaglutide NASH Phase 2 results (PoC, Gilead) ✓ FGF-21 NASH Phase 2 initiation PCSK9i Phase 1 results Diabetes Obesity Haemophilia Growth disorders Other serious chronic diseases 1Expected to be published in the given quarter or in the subsequent quarterly company announcement; Obesity projects include GG-co-agonist and Tri-agonist 1706 2 Sema: Semaglutide; GIP: Gastric inhibitory polypeptide; EU: European Union; JP PMDA: Japanese Pharmaceutical and Medical Devices Agency; OW: Once-weekly; AGHD: Adult growth hormone deficiency; PoC: Proof of Concept
Investor presentation Full year 2019 Slide Slide14 14 Financial results – Full year 2019 Change Change In DKK million 2019 2018 (reported) (CER) Sales 122,021 111,831 9% 6% Gross profit 101,933 94,214 8% Gross margin 83.5% 84.2% Sales and distribution costs 31,823 29,397 8% 6% Percentage of sales 26.1% 26.3% Research and development costs 14,220 14,805 (4%) (6%) Percentage of sales 11.7% 13.2% Administration costs 4,007 3,916 2% 1% Percentage of sales 3.3% 3.5% Other operating income, net 600 1,152 (48%) Operating profit 52,483 47,248 11% 6% Operating margin 43.0% 42.2% Financial items (net) (3,930) 367 Profit before income tax 48,553 47,615 2% Income taxes 9,602 8,987 7% Effective tax rate 19.8% 18.9% Net profit 38,951 38,628 1% Diluted earnings per share (DKK) 16.38 15.93 3% CER: Constant exchange rates
Investor presentation Full year 2019 Slide 15 Expected cash return to shareholders in 2020 and long-term financial targets have been met Annual cash return to Cash return priorities Novo Nordisk has met its long- shareholders term financial targets Share Interim Dividend DKK repurchase dividend billion Free cash flow Free cash flow guidance • For 2019, the proposed total dividend Cash Conversion 45 increased 2.5% to DKK 8.35 per share (three-year average) including interim dividend of DKK 3.00 Target: 85% per share paid in August 2019. 2019: 86% 30 17 • For 2020, a new share repurchase 17 15 15 OPAT/NOA programme of up to DKK 17 billion is Target: 80% expected 2019: 98% 15 7 7 7 • Total programme may be reduced in 13 size if significant bolt-on acquisition Average operating profit growth 11 12 12 opportunities arise during 2020 Target: 5% 0 2016-2019: 4.9% 1 2017 2018 2019 2020E 1For 2020, expected free cash flow is DKK 36-41 billion. Note: Share repurchase programmes run for 12 months starting Feb until end-Jan of the following year.
Investor presentation Full year 2019 Slide Slide16 16 Financial outlook for 2020 Expectations 5 Feb 2020 Sales growth – at CER 3% to 6% Sales growth - reported Around 1 percentage point higher Operating profit growth – at CER 1% to 5% Operating profit growth - reported Around 1 percentage point higher Financial items (net) Loss of around DKK 1.5 billion Effective tax rate 20% to 22% Capital expenditure Around DKK 6.5 billion Depreciation, amortisation and impairment losses Around DKK 5 billion Free cash flow DKK 36 to 41 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 31 January 2020. CER: Constant exchange rates
Investor presentation Full year 2019 Slide 17 Strategic aspirations for 2025 - Milestones expected for 2020 Diabetes: • Sema FORTE phase 3 results due Q4 2020 • Insulin icodec phase 3 initiation due in the second Expansion of the US affordability offerings half of 2020 Obesity: Utilise solar energy power across all US operations • Semaglutide obesity phase 3 results due mid-2020 therapeutic focus Innovation and • Amylin phase 2 results sustainability Biopharm: Purpose and 100% renewable power in 2020 for all production sites • Mim8 phase 1/2 initiated • Somapacitan regulatory feedback from the FDA/EMA for the treatment of AGHD Other serious chronic diseases: • Phase 2 readouts from two NASH trials Expand diabetes market leadership led by launches Sales growth expected to be 3-6% and penetration of Ozempic®, Rybelsus®, and new- (reported: around 1 percentage point higher) generation insulin Operating profit growth expected to be 1-5% Strengthen Obesity leadership with continued global (reported: around 1 percentage point higher) rollout and penetration of Saxenda® Commercial Free cash flow in the range of DKK 36-41 billion Financials execution Continued launches of key Biopharm products Refixia® and Esperoct® support sustained growth outlook DKK 17 billion share repurchase programme Note: Outlook as of 5 February 2020; Unless otherwise specified growth rates are at constant exchange rates; FDA: Food and Drug Administration; EMA: European Medicines Agency; AGHD: Adult growth hormone disease; NASH: Non-alcoholic steatohepatitis; New-generation insulin: Tresiba®, Xultophy®, Ryzodeg®, Fiasp®
Investor presentation Full year 2019 Slide Slide18 18 Investor contact information Share information Investor Relations contacts Novo Nordisk’s B shares are listed on the stock exchange in Novo Nordisk A/S Copenhagen under the symbol ‘NOVO B’. Its ADRs are listed on Investor Relations the New York Stock Exchange under the symbol ‘NVO’. Novo Allé DK-2880 Bagsværd For further company information, visit Novo Nordisk on: www.novonordisk.com Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com Upcoming events Valdemar Borum Svarrer +45 3079 0301 jvls@novonordisk.com 26 Mar 2020 Annual General Meeting Ann Søndermølle Rendbæk +45 3075 2253 arnd@novonordisk.com 06 May 2020 Financial statement for the first three months of 2020 06 Aug 2020 Financial statement for the first six months of 2020 Mark Joseph Root +45 3079 4211 mjhr@novonordisk.com 30 Oct 2020 Financial statement for the first nine months of 2020 Kristoffer Due Berg (USA) +1 609 235 2989 krdb@novonordisk.com
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