Region China overview and strategy Camilla Sylvest SVP ... · Slide 3Capital Markets Day 2015...
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Region China overview and strategy
Camilla Sylvest SVP Region China
TEAM NOVO NORDISK Professional cycling team
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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 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 ‘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 approved in the US and EU for the treatment of obesity only
Capital Markets Day 2015 Region China overview and strategy
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13th Five-Year Plan focusing on mature growth
-2%
0%
2%
4%
6%
8%
10%
12%
14%
GDP growth historically and estimated
China is adopting the new normal of mature growth
Source: China Five-Year Plan Source: OECD Statistics
Speed of growth Quality and sustainability
Double GDP cap by 2010 (vs 2000)
Maintain GDP growth at
7-8%
Double GDP cap by 2021 (vs 2010) G
ro
wth
ta
rg
et
Achieve rapid economic growth
Adapt to the New Normal of mature
growth Eco
no
mic
th
em
e Transform with
sustainable and balanced growth
2018 2010
US China Europe 11th Five-Year Plan (2006-2010)
12th Five-Year Plan (2011-2015)
13th Five-Year Plan (2016-2020)
6.4%
2.5%
1.8%
GDP growth (%)
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2008
Source: IMS Health Market Prognosis, November 2014. Market size ranking in constant exchange rates
The importance of China’s pharma market is still increasing
2018 2013
Rank Country Index 1 United States 100
2 Japan 27
3 China 14
4 France 13
5 Germany 13
6 Italy 8
7 Canada 7
8 United Kingdom 7
9 Spain 7
10 Brazil 5
11 Mexico 4
12 Australia 4
13 Russia 3
14 South Korea 3
15 Turkey 3
16 India 3
17 Greece 2
18 Netherlands 2
19 Poland 2
20 Belgium 2
Rank Country Index 1 United States 100
2 China 29
3 Japan 26
4 Germany 14
5 France 11
6 Brazil 9
7 Italy 8
8 United Kingdom 8
9 Spain 7
10 Canada 6
11 Russia 6
12 Mexico 5
13 India 4
14 Australia 4
15 South Korea 4
16 Argentina 4
17 Poland 2
18 Turkey 2
19 Belgium 2
20 Netherlands 2
Rank Country Index 1 United States 100
2 China 36
3 Japan 22
4 Brazil 12
5 Germany 11
6 France 8
7 United Kingdom 7
8 Italy 7
9 Canada 5
10 Russia 5
11 India 5
12 Spain 5
13 Mexico 4
14 South Korea 3
15 Australia 3
16 Turkey 2
17 Saudi Arabia 2
18 Poland 2
19 Argentina 2
20 Indonesia 2
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0
20
40
60
80
100
120
140
160
Category 1
Source: IDF Diabetes Atlas edition 1-7, year 2000-2015, respectively
Continued growth in number of people with diabetes Few Chinese patients reach treatment target
The diabetes prevalence in China is expected to continue growing and people with diabetes remain poorly controlled
Source: Prevalence and Control of Diabetes in Chinese Adults, JAMA, September 2013
151
110
People with diabetes (million)
0
20
40
60
80
100
Diabetes Diagnosed Drug treated
Adequate glycaemic
control
37%
23%
10%
2000 2003 2006 2009 2011 2013 2015 2040E
Share of people with diabetes (%)
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Increasing focus on quality enhancement and cost containment
Source: Framework adapted from BCG analysis
Phase I: Broad insurance coverage and equal access to health care
Phase II: Cost containment Phase III: Quality of healthcare, efficiency and innovation
Focus of 2009-11 Current focus Ongoing focus
Cost
Quality Access Quality Access
Cost
Access
Cost
Quality
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54% 37% 34%
29%
35% 36%
17% 27% 30%
0%
25%
50%
75%
100%
2004 2009 2013
Phase I: Focus on access to healthcare by broad coverage Estimated source of funding
Access to health care driven by increased government spending
EDL: Essential Drug List
Sources: China Health Statistics Yearbook (2014), National Health and Family Planning Commission of China
Phase I: Broad insurance coverage and equal access to health care; ~130bnUSD government investment
Focus of 2009-11
Cost
Quality Access
Government funding Public funding Out of pocket
210 372 93
Health care spend per capita (USD)
Key objectivesrowing GDP • Investment of more than USD 130 billion • Basic coverage to reach >95% • Establish basic healthcare system • Establish EDL system
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Phase II: Cost containment
Drug prices will be subject to multiple reviews but pricing remains attractive
Phase II: Cost containment
Quality Access
Cost
Drug prices reviewed on Central, Provincial, City and Hospital level
1 Policies are still being developed and not fully in place 2 Without regional policy support NRDL: National Reimbursement Drug List; PRDL: Provincial Reimbursement Drug List
Entering Hospital
Patent/ exclusive
drugs
Drugs with high sales
value
Other drugs
Central/
Provincial
price
negotiation
Provincial
bidding
Hospital
negotiation
City 2nd
bidding1
Hospital negotiation2
Reimburse-ment
pricing
NRDL/PRDL drugs
Key objectivesrowing GDP • Push for more rationalised drug supply • Reduce hospital reliance on drug sales • Stricter compliance requirements
Current focus
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Phase III: Quality of healthcare, efficiency and innovation
Historically, China has been slow in adopting new treatment options
Focus on quality of healthcare, innovative products and faster access to market
1 New Molecular Entities (NMEs) from 2008-12 availability as of 2013 Source: IMS Health
Phase III: Healthcare quality, efficiency and innovation
Access
Cost
Quality
0
20
40
60
80
100
120
140
160
180
USA Germany UK South Korea
Canada China Global India
Key objectives:ently ~5.8% of outgrowing GDP • Enhance drug quality and encourage innovation • Encourage private investments • Encourage private health insurance
Ongoing focus
NMEs available in 20131
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Macro social environment
RDPAC: R&D Based Pharmaceutical Association Committee; AIC: Administration for Industry and Commerce
• Anti-corruption campaign driven by president Xi
The regulatory environment is rapidly changing with implications for all pharma companies in China
Implication
• Corruption cases • AIC investigations • Access to hospitals • Medical promotion
Rules and enforcement
• 9-bans • Blacklist rule • RDPAC
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• Novo Nordisk China established in 1994
• Largest diabetes sales force in China
• Approximately 2,800 FTEs
• Tianjin factory established in 1997
• Manufacturing of NovoPen® and filling of devices
• Expanded in 2003 and 2008
• Approximately 1,000 FTEs
• Research centre established in 2002
• Focus on discovery technology, discovery biology, E.coli research and mini-pilot
• Expanded in 2012
• Approximately 200 FTEs
1 CAGR for 9-year period Note: Revenue in constant exchange rates
Region China historic revenue development
Region China historic development
0
2
4
6
8
10
FTE: full-time employee equivalents
DKK billion
7.9
Novo Nordisk has invested in changing diabetes in Region China for more than 20 years
2005 2014
Capital Markets Day 2015 Region China overview and strategy
CAGR1 +22.9%
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Sales organisation divided into nine regions covering 31 provinces
Largest cities cover 20% of the population, but ~50% of the diabetes market
Novo Nordisk China sales force is divided into nine regions covering all key provinces
NEC
BCH
NCH
CCH
WCH
SCH
ECH
SEC
CSC
#of cities
Share of population
Share of diabetes market
Diabetes market growth
rate
Big cities ~30 ~20% 51% 7%
Rest of China
- ~80% 49% 12%
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Initiatives leveraged to cater for different city segments
Novo Nordisk’s commercial activities are tailored to city segmentation
Segment 1
Big cities
Segment 2
Smaller cities
Segment 3
Counties
Strengthen leading position
Strengthen leading position
Educate, expand presence and stay ahead
~1,000
~300
~500
Positioning Sales Reps
• New product launches
• Product upgrade initiatives
• High level academic meetings
• New patient capture
• Training healthcare professionals
• Patient education
• Meeting-the-expert program
• improving patient treatment
• Diagnosis and treatment
• e-Education
• Mentor program
• Improving diabetes awareness
Initiatives
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Total pharma
Source: IMS CHPA Data, September 2015 Note: Data is sensitive to changes in IMS data collection and reporting methodology
The Chinese pharma market has displayed a significant slowdown in growth across all therapy areas
Total insulin Total diabetes care
5.5%
0%
10%
20%
30%
40%
50%
60%
0%
10%
20%
30%
40%
50%
60%
9.4%
0%
10%
20%
30%
40%
50%
60%
9.8%
2008 2015 YTD
2008 2015 YTD
2008 2015 YTD
Market growth
Market growth
Market growth
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40%
Value MS (%)
0%
20%
40%
60%
80%
100%
Total diabetes market share Total diabetes market value
by product categories
Source: IMS MAT monthly September 2015 value figures OAD: oral anti-diabetic Source: IMS MAT monthly September 2015 value figures
Novo Nordisk Sanofi Bayer
Tonghua Dongbao Other BJ Ganli
Eli Lilly BMS
33%
Dec 2012
Sep 2015
Dec 2012
Sep 2015
Animal insulin Human insulin Modern insulin
GLP-1 DPP-IV
46%
17%
34%
Novo Nordisk maintains overall market leadership despite changing market dynamics
Value MS (%)
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OAD
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Novo Nordisk is the clear market leader within human insulin despite intensified competition
The human insulin market is dominated by premix insulin
Source: IMS MAT monthly September 2015 volume figures Source: IMS MAT monthly September 2015 volume figures
Volume MS (%)
Premix (83%)
Long-acting (7%) Fast-acting (10%)
Human insulin market breakdown by insulin segment
Dec 2012
Sep 2015
0%
10%
20%
30%
40%
50%
60%
70%
Volume MS (%)
15%
61%
19%
Dec 2012
Sep 2015
3%
Tonghua Dongbao Novo Nordisk
HK Union
Eli Lilly
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Bayer
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100%
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10%
20%
30%
40%
50%
Long-acting insulin growth outpaces the overall modern insulin market growth
The modern insulin market is gradually shifting towards increasing long-acting insulin usage
Source: IMS MAT monthly September 2015 volume figures Source: IMS MAT monthly September 2015 volume figures
Volume growth (%) Premix
Long-acting Fast-acting
Modern insulin
11%
15% 20%
24%
Premix (58%)
Long-acting (24%)
Fast-acting (18%)
Modern insulin market breakdown by insulin segment
Sep 2013
Sep 2015
Volume MS (%)
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Sep 2015
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1 State Council Document 2015 No.44 - 18 August 2015
Policy changes expected to lead to faster access for key Novo Nordisk products Expected timelines for key products
Innovation and market access are key to future growth
2015
Reimbursement Regulatory review Phase 3
China is currently reforming the Evaluation and Approval System for Drugs and Medical Devices1
• Accelerate drug registration process
• Eliminate the drug-application backlog
• Improve drug quality
Key objectives for Novo Nordisk in the coming years:
• Improve Victoza® reimbursement status
• Obtain Tresiba® approval after filing in August 2015
• Complete phase 3 trial with Ryzodeg® and prepare file
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2016 2017 2018 2019 2020 2020+
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Key challenges Key opportunities
Concluding remarks
• Growth in GDP and growth in health care spend coming down
• Prices under pressure with possible price erosion in the coming years
• Increased competition in diabetes from both international and local competitors
• Basal modern insulin market growing faster than modern insulin premix market
• GDP growth of 6-7% attractive on a global scale
• Insulin volume growth of 5-7%, 110 million people with diabetes hereof 70 million not diagnosed
• High unexploited insulinisation potential and significant value upgrade potential
• Attractive insulin prices despite ongoing reforms
• Increase presence in basal segment with Levemir® and Tresiba® approval
Capital Markets Day 2015 Region China overview and strategy