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 2025Investor 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 onlyInvestor 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 operationsInvestor 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 yearInvestor 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 ratesInvestor 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 2018Investor 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 UKInvestor 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 OperationsInvestor 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 informationInvestor 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 nameInvestor 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 ConceptInvestor presentation Full year 2019 Slide
Slide14
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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 ratesInvestor 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 ratesInvestor 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
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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.comYou can also read