2014 - Exane BNP Paribas Healthcare Conference
-
Upload
sanofi -
Category
Health & Medicine
-
view
1.022 -
download
2
description
Transcript of 2014 - Exane BNP Paribas Healthcare Conference
Exane BNP Paribas Healthcare Conference Fabrice Baschiera, General Manager, Sanofi Greater China
Paris – March 25th, 2014
2
Forward Looking Statements
This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of
1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include
projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events, operations, services, product development and potential,
and statements regarding future performance. Forward-looking statements are generally identified by the words
"expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's
management believes that the expectations reflected in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which
are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to
differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
These risks and uncertainties include among other things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the
EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such
product candidates as well as their decisions regarding labeling and other matters that could affect the availability or
commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will
be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability
to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost
containment policies and subsequent changes thereto, the average number of shares outstanding as well as those
discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under
"Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form
20-F for the year ended December 31, 2013. Other than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or statements.
Agenda
3
Emerging Markets – Strong Contribution from China
A Leading Presence in the Chinese Healthcare Market
Strategic Pillars for continued Growth in China
Providing Solutions to the Diabetes Pandemic in China
Conclusion
Sanofi 2013 Review
2013 Year in Review
From Sep to Dec 2013, the underlying growth profile of the new
Sanofi emerged
Throughout 2013, we left the patent cliff further behind us and
took decisive action to resolve temporary operational challenges
Growth platforms now account for 73% of sales(1)
compared to 43% in 2008
Sanofi has currently 9 high-potential late-stage projects(2)
45% of sales(3) come from biologics and 80%
of development pipeline projects(4) are biologics
1
2
3
4
4
(1) Growth Platforms include Emerging Markets, Diabetes Solutions, Vaccines, Consumer Healthcare, Animal Health, Genzyme & Other Innovative
Products. In Q4 2013, sales from Growth Platforms accounted for 72.9% of Group sales
(2) U300, 6-in-1 vaccine PR5I (U.S.), alirocumab, Dengue vaccine, lixisenatide (U.S.), sarilumab, LixiLan, dupilumab, C. Diff vaccine
(3) Sales from biologics include insulins (Lantus®, Apidra®, Insuman®), Genzyme rare disease products, Lovenox®, vaccines from Sanofi Pasteur,
vaccines from Merial, selected oncology products (Thymoglobulin®, Mozobil®, Zaltrap®), Lemtrada™ and half of SPMSD sales (non-consolidated)
(4) 39 NMEs and vaccines out of a total of 49
5
Genzyme(3)
Vaccines
Growth Platforms Grew by +10.0% in Q4 2013
Reaching 72.9% of Sales(1)
5
(1) FY 2013 sales of Growth Platforms reached €23,905m, up +6.6% at CER and accounted for 72.5% of sales
(2) Sales in Emerging Markets excluding other Growth Platforms were €1,525m for Q4 2013 and €5,785m for FY 2013
(3) Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises
(4) Products launched since 2009 which are not included in the Growth Platforms listed above: Multaq®, Jevtana®, Auvi-Q™, Mozobil® and Zaltrap®
Other Innovative Products(4) €186m
€959m
Diabetes Solutions €1,735m
€722m
Animal Health
€595m
Emerging Markets(2) €2,917m
€705m
€3,716m
€6,568m
€3,004m
€2,142m
€10,957m
Q4 2013
Sales & Growth at CER
FY 2013
Sales & Growth at CER
€444m
Consumer Healthcare
€1,985m
+19.0%
+0.1%
+6.1%
+31.4%
-6.3%
+15.7%
+10.4%
+18.7%
-0.1%
+5.2%
+25.9%
-5.3%
+18.8%
+4.4%
+7.1% ex Brazil generics
9 Late-Stage Projects Potentially Filed over Next 4 Years
9 Potential Filings in 2014-2018
● U300 in Diabetes
● 6-in-1 vaccine PR5I (U.S.)
● Alirocumab in Hypercholesterolemia
● Dengue vaccine
● Lixisenatide in Diabetes (U.S.)
6
● Sarilumab in Rheumatoid Arthritis
● LixiLan in Diabetes
● Dupilumab in Atopic Dermatitis
and Asthma
● C. Diff vaccine
Agenda
7
Emerging Markets – Strong Contribution from China
A Leading Presence in the Chinese Healthcare Market
Strategic Pillars for continued Growth in China
Providing Solutions to the Diabetes Pandemic in China
Conclusion
Sanofi 2013 Review
Q4 2013 Geographic Sales Mix
(1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal,
Holland, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark), Japan, Australia, and New Zealand
Double Digit Sales Growth in Emerging Markets
in Q4 2013
34.5%
31.4%
23.0%
11.1%
8
(1)
+12.3% +5.2% +15.4% +10.1% Growth
at CER
+1.2%
-5.6%
+11.3%
+10.4%
Sanofi China – A Strong and Growing Contributor to Our
Leadership Position in Emerging Markets
9
(1) IMS CHPA MAT December 2013
(2) Mainland China; CAGR 2008-2013
Sanofi Sales in China(2)
€347m
2012 2011 2010 2009 2008
+33%
2013
Ranked #4 in China(1)
Sanofi China represented 13% of Emerging Markets and 4.5% of Group sales in 2013
€1,471m PFIZER
ASTRAZENECA
SHANDONG QILU FTY
BAYER
JS. YANGZIJIANG FTY
ROCHE
KE LUN
NOVARTIS
JS.L.Y.G. HENGRUI
1
2
3
4
5
6
7
8
9
10
10
Progressively Developing Our Growth Platforms in China
Breakdown of Sanofi Sales in China(1) by Business(2)
Total Sales €1,471m
72%
2007 2013
Total Sales €273m
(1) Mainland China
(2) Illustrative 10
Pharmaceuticals
Genzyme
Consumer Healthcare
Diabetes
Vaccines
Animal Health/Merial
Agenda
11
Emerging Markets – Strong Contribution from China
A Leading Presence in the Chinese Healthcare Market
Strategic Pillars for continued Growth in China
Providing Solutions to the Diabetes Pandemic in China
Conclusion
Sanofi 2013 Review
12
(1) Health care expenditure reflects the total expenditure on medical and health care services, which includes government expenditure,
social expenditure and individual out-of-pocket expenditure.
(2) China National Bureau of Statistics, Ministry of Finance; projections: BCG, McKinsey, internal analysis
(3) WHO : ‘Total expenditure on health as % of Gross National Product’ (GDP); 2011: U.S. = 17.9%; France = 11.6%; Brazil = 8.9%
(4) IMS Market Prognosis, September 2013, at ex-manufacturer price levels, not including rebates and discounts; IMS CHPA 2013 M12
Fundamental Drivers for Continued Strong Growth in
the Chinese Healthcare Market
Healthcare Expenditure(1) Expected to Grow
Strongly, but to Remain Low as % of GDP(2)
HC expenditure as % of GDP(3)
2015e
2012 2009 2005
RMB bn
4,100
2020e
8.9%
11.6%
17.9%
5.4%
● Ageing Population
● Strong patient flow growth
● Growing Middle Class
● Higher disposable income
● Rapid Urbanization
● Change in life-style
● Higher incidence of chronic diseases
● Rise in disease burden
● Favorable healthcare reform policies
● Expanded insurance coverage and
improved infrastructure
China has become the 2nd largest Pharmaceutical Market,+13.8% in 2013(4)
A Dynamic Environment with Sustained Pricing Pressure
Multiple Rounds of Price Cuts by
NDRC(3)
May 2007 260 drugs (excl. TCM(4)) 19%
162 anti-infective and cardiovascular drugs
21%
Nov 2010
Mar 2011
19% 176 drugs
128 drugs including hormone treatments, endocrine system and neurological disorder drugs
14% Sep 2011
Target
Average %
of price cut
(1) RDL – Reimbursement Drug List
(2) EDL – Essential Drug List
(3) China National Bureau of Statistics, Ministry of Finance, NDRC – National Development and Reform Commission, internal analysis
(4) TCM - Traditional Chinese Medicines
(5) ‘Good Manufacturing Practices’; Notice on Implementation the 2010 Revised GMP, CFDA, 25 February 2011
May 2012
13
Time
53 digestive system and gastrointestinal drugs
17%
Oct 2012 95 hematology, oncology and immunology drugs
17%
Jan 2013 400 respiratory, antipyretic, analgesics and other specialty drugs
15%
● Regular RDL(1) price cuts
● Erosion of price premium for non-
patented originator drugs
● Broader EDL(2) system and usage
● High EDL usage in lower tier CHC
(Consumer Healthcare Centers)
● New Provincial tender models
● Increased frequency and emphasis
on price
● Emergence of strong local players
● Enhanced quality of non-EDL
un-/differentiated generics
● All Chinese manufacturers to comply
with recent ‘GMP 2010’ guidelines(5)
11
Sanofi China - Well Poised to Seize the Opportunities in
the Chinese Healthcare Market
14
Shanghai
Tianjin
Shenyang
Wuhan Chengdu
Urumqi
Ji’nan
Beijing
Hangzhou
Guangzhou
Nanjing
Nanchang
Tangshan
Shenzhen
Regional offices Production Sites R&D center Regional R&D
● >8,500 Employees
● >5,000 Sales force
● 11 Regional Offices
● Regional R&D Platform
● 7 Manufacturing Sites
● Local Production for
Pharmaceuticals, Vaccines,
CHC and Animal Health
● Highest Standards for
Quality, Sustainability and
Supply Chain
A Fully Integrated
Presence
A Large Portfolio of Flagship Brands and Powerful
Commercial Operations
15
Oncology BU
Cardiovascular BU 1. Cancer
2. Heart disease
3. Cerebro-vascular
diseases
4. Respiratory
System
5. Injury/Poisoning
6. Metabolic/
Endocrine
diseases
7. Digestive
system
8. CNS
9. Genitourinary
system
10. Infectious
diseases
Top 10 Causes of
Death in China(1)
(1) China’s Health Statistics Yearbook 2012, Ministry of Health (Urban population)
Consumer Healthcare BU
Diabetes Solutions BU
Primary Care BU
A dedicated regional BU which covers the county market in China
Addressing the Medical Needs in China with 5 Business Units
Driving Leadership and Innovation at Sanofi China R&D
16
Four Dimensions of Innovation at Sanofi China R&D
to Address Unmet Medical Needs
● Over 30 local R&D
Collaborations and
Partnerships
● Focus on Liver
Disease, Asian
Cancers and
Diabetes
● More than 15
ongoing clinical
development
programs to bring
global innovation &
minimize drug-lag
● Eloxatin® in HCC
● Lyxumia® (1)
under
regulatory review
● China R&D
Translational
Medicine Platform
for Regional and
Global R&D
● Genotyping Study
for prevention and
treatment of
Diabetes in
Chinese patients
Research Clinical
Development
External
Innovation
Medicine
Leadership
● Enrich pipeline with
in-licensing
opportunities
(2)
● R&D investment to
leverage and
capture TCM
opportunity
(1) Lyxumia® is the proprietary name approved by the EMA for lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration
(2) Takeda and Sanofi signed a co-promotion agreement to expand reach of diabetes treatment Nesina® (alogliptin) in China
Agenda
17
Emerging Markets – Strong Contribution from China
A Leading Presence in the Chinese Healthcare Market
Strategic Pillars for continued Growth in China
Providing Solutions to the Diabetes Pandemic in China
Conclusion
Sanofi 2013 Review
Total Pharma Market by Institution(1) (in € bn)
(1) BCG, internal analysis (1 EUR = 8.6212 CNY); China’s Health Statistics Yearbook 2012; National Health and Family Planning Commission
(2) THC = Township Healthcare Center
(3) CHC = Community Healthcare Center
(4) National Health and Family Planning Commission of PRC (NHFPC), 2014
Capturing the Growth in China’s County Hospital Market
by Reaching out to the Next Billion Customers
18
2011 2015e 2020e
+13%
18%
20%
23% County
hospitals
City
hospitals
CHC(3)
THC(2)
Retail
48%
50%
50% 20%
19%
17%
80
141
237
● The County market is the focus of
public healthcare investments(4)
● ‘County hospitals’ expected to be
the fastest growing market
segment(1)
● 16% growth (2011-2020 CAGR)
● ‘City hospitals’ forecasted to
represent half of the total market
● Declining share of basic
healthcare system (CHC, THC)
and retail market projected
Chongzhou County Hospital(2)
● County – Chongzhou
● Population – ~670,000
● County hospital – Built in 2008
● Number of beds – 694
● Outpatient visits in 2013 – 581,782
Modern Healthcare Infrastructure is Driving the Growth in
China’s Huge County Market
19
(1) Defined as county-level cities or counties; 32 provinces, autonomous regions and municipalities, excluding Hong Kong, Macao, and Taiwan
(2) Sichuan Chongzhou Hospital website: http://www.cz-hospital.cn/
China’s ~2,000 Counties(1)
Population ~900 million
Opportunity
● Huge base
● Lower affordability
● Geographically broad
Coverage Very limited presence of
Multinational Companies
Example: Sichuan Province, Chongzhou County
Sichuan
Province
● Reaching out to >1,000 counties in multiple provinces
● Almost 1,000 dedicated sales representatives, covering several thousand hospitals
● Portfolio approach to secure sales force efficiency and profitability
● Strict selection criteria for targeted county hospitals
● Significant growth contribution and further expansion underway
Our Rapid Expansion into the County Hospital Market
follows a Highly Selective Approach
2013 2014
Sanofi Primary Care Business Unit
20
Top 10 OTC Markets in 2013(1)
21
● Highly attractive CHC market with
solid growth in recent years
● Sanofi is present in the 2 largest and
fastest growing CHC categories in
China(2)
● Cough&Cold and Vitamins
● Improved performance of our CHC
business in China throughout 2013
● Reorganization of our distribution
network
● Reduced inventory levels
● New management appointed
(1) Nicholas Hall & Company (2014); Growth 2013 vs 2012
(2) Nicholas Hall & Company DB6 (2013)
1. USA 28.8bn
2. 20.3bn
3. Japan 7.9bn
4. Russia 6.0bn
5. Germany 5.7bn
6. France 4.8bn
7. Brazil 3.6bn
8. Italy 3.6bn
9. UK 3.0bn
10. Canada 2.6bn
3.5%
6.8%
-0.3%
14.0%
3.7%
-3.7%
16.9%
3.8%
1.2%
2.5%
Rank by Country Sales in USD Growth
Strong Ambition to Realize Our Growth Potential in the
World’s 2nd largest Consumer Healthcare Market
Our Strategy for Sustainable Growth in the Chinese
Consumer Healthcare Market
Reinforce the Business Expand the Portfolio
Value Enhancing
External Opportunities
Two Umbrella Brands
in key CHC Categories
(Cough/Cold & Vitamins)
OTC Switch of Essentiale®
and
VMS Specialty Segments
Market screening and target
assets identification
1 2 3
22
● Targeting domestic
players
● Presence in Sanofi CHC
core categories required
● Strong brand equity
● Liver Care
Category
with
Essentiale®
● Specialty
VMS Category
with “Silver”
variant
for Seniors
Agenda
23
Emerging Markets – Strong Contribution from China
A Leading Presence in the Chinese Healthcare Market
Strategic Pillars for continued Growth in China
Providing Solutions to the Diabetes Pandemic in China
Conclusion
Sanofi 2013 Review
The Diabetes Pandemic in China Creates Significant
Challenges for the Hospital Care System
113.9(3)
China Has the World’s Largest Population Living
with Diabetes(1) (population in million)
24
(1) International Diabetes Federation (IDF) Diabetes Atlas, Sixth Edition 2013; Top 10 countries/territories of people with diabetes (20-79 years)
(2) The Lancet, Vol 378, August 6, 2011
(3) Ning Guang, JAMA September 4, 2013, Vol 310, No. 9
● Control of chronic diseases,
such as diabetes, is a major
challenge in China(2)
● Low rate of diagnosis in diabetes(3)
● Low number of patients treated
● Only 25.8% or ~29.4m treated(3)
● Hurdles to providing chronic care at
the hospital level
● Crowded out-patient environment
● Short physician consultation
● No continuous follow-up treatment
with the same physician
65.1
24.4
11.9
10.9
8.7
8.5
7.6
7.5
7.2
Insulins:
CAGR 2009-2013, +21.5%
MAT Dec 2013, +18.6%
Sales Value of Diabetes Therapy Segments (in € m)(2)
2013
49%
2012
50%
50%
2011
52%
48%
2010
54%
46%
2009
55%
45%
2008
56%
44%
2007
59%
41%
50%
Insulin has Overtaken OADs(1) to Become the Largest
Diabetes Therapeutic Segment in China
25
Oral Anti-Diabetics (OADs):
CAGR 2009-2013, +14.9%
MAT Dec 2013, +15.3%
Total Market
CAGR 2009-2013, +18.2%
MAT Dec 2013, +17.1%
(3)
China’s diabetes drug market expected to reach >€4bn in 2018(4)
(1) OAD – Oral Anti-Diabetic (2) IMS CHPA MAT 2007 – 2013; 1 EUR = 8.6212 CNY (www.ecb.europa.eu, March 19, 2014)
(3) GLP-1 market share 0.68% in 2013 (4) IMS and internal analysis
1,534
1,310
1,146
966
785
607
435
Analog:
CAGR 2009-2013, +37.4%
MAT Dec 2013, +27.8%
Human:
CAGR 2009-2013, +7.6%
MAT Dec 2013, +6.2%
Sales Value of Insulin Class (in € m)(1)
43%
57%
2011
50%
50%
2010
55%
45%
2009 2012 2013
62%
38% 62%
38%
2008
72%
28%
2007
81%
19%
Analogs Account for >60% of Total Insulin Sales in China
26 (1) IMS CHPA MAT 2007 – 2013; 1 EUR = 8.6212 CNY (www.ecb.europa.eu, March 19, 2014)
547
445
355
652
774
269
178
● Lantus® drives the paradigm shift in
the Chinese insulin market
● Shift from Premix to Basal
● Basal regimen included in Chinese
diabetes treatment guidelines
● Leading insulin in several big cities(2)
● Low average daily dosing per patient
● ‘Biosimilar’ to Lantus® competing in
the market since 2005
27
Paradigm Shift Drives Strong Sales of Lantus® in China
(1) IMS MAT 12/2009 – 12/2013; 1 EUR = 8.6212 CNY (www.ecb.europa.eu, March 19, 2014)
(2) IMS CHPA MAT 12/13; Cities where Lantus is the #1 insulin include Guangzhou, Hangzhou, Suxi, Nanjing, Chengdu, Xi’an, Shenzhen, Shijiazhuang, Changsha, Guiyang,
Wenzhou
2012
2011 2010
2009
Lantus Sales in China(1) (in € m)
29%
2013
45
64
84
106
125
Expanding our Lantus® Options in China
● SoloSTAR® disposable pen
● Convenience option
● Lantus® available in China only in
SoloStar® until 2013
● Lantus® SoloSTAR® pen assembly
at Sanofi’s facility in Beijing
● Inaugurated in May 2012
● ClikSTAR® re-usable pen for
Lantus® cartridges
● Durable solution
● Differentiated price
● Registration approval in Q4 2012
● Launched in March 2013
Easy-to-use, Accurate and Affordable
28
AllStar™, the next step to further improve access to innovative, affordable devices
Amaryl® is Driving the Growth of the entire Sulfonylurea
Class in China despite Generic Competition
Share in Glimepiride (value)(2)
Share in Glimepiride (volume)(2)
(1) OAD – Oral Anti-Diabetic; In December 2013, Amaryl® reached 7.0% of the market share of the total OAD market, growing at 23.3%
(2) IMS CHPA MAT December 2013
Generics
Amaryl®
Generics
Amaryl®
Generic
Glimepiride
Glurenorm
Diamicron
Glipizide XL
Market Share of sulfonylureas (value)(2)
29
● Patient-centric, integrated diabetes
management programs
● CIDE – ‘China Initiative for Diabetes
Excellence’
● A major public-private
partnership
● Enhancing patients’ self-management
capabilities through ‘PEP’
● Basal Insulin Patient
Education Program
● Multiple programs addressing the
educational needs of doctors, nurses
and other healthcare professionals
● Providing hospitals with technology &
tools to improve treatment success
Providing Support for the Management of Diabetes in
China at the Point of Care
Broad range of innovative
therapeutic solutions
30
Private-public partnerships for
best practice diabetes care
Agenda
31
Emerging Markets – Strong Contribution from China
A Leading Presence in the Chinese Healthcare Market
Strategic Pillars for continued Growth in China
Providing Solutions to the Diabetes Pandemic in China
Conclusion
Sanofi 2013 Review
A Compelling Strategy for Sustainable Growth in China
32
1
2
3
4
Long term commitment to China with a fully-integrated presence
Medicine leadership through a broad portfolio of products and innovation
Expansion into Counties aligned with the focus of public healthcare investments
Reinforcing our platform in the growing Chinese CHC Market
Leadership in diabetes by maximizing the value of the entire portfolio
Investment into medical education and public-private partnerships
5
6