2014/09 - CLSA Investors Forum

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CSLA Investors Forum 2014 Jean-Marie Arnaud, Vice President, South East Asia & IndoChina, Global Operations Hong Kong, September 17, 2014

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September 17, 2014 - CLSA Investors Forum, Hong Kong, China

Transcript of 2014/09 - CLSA Investors Forum

Page 1: 2014/09 - CLSA Investors Forum

CSLA Investors Forum 2014 Jean-Marie Arnaud, Vice President, South East Asia & IndoChina,

Global Operations

Hong Kong, September 17, 2014

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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.

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Sanofi Highlights to Date

Emerging Markets - Strong Contribution from Asia Region

Agenda

The Opportunity with Sanofi

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Sanofi is a Global Integrated Healthcare Company

(1) As of December 31, 2013

more than

110,000 Employees(1)

present in

100 countries

€33bn in sales in 2013

A diversified offer of medicines, vaccines and innovative therapeutic solutions

112 industrial Sites in 41 countries

• We are a global integrated healthcare company engaged in

research, development, manufacturing and marketing of

healthcare products.

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Executing a Successful Strategy

Deliver sustainable

long-term growth

and maximize

shareholder returns Seize value-enhancing growth

opportunities 3

Bring innovative products to market 2

Grow a global healthcare leader

with synergistic platforms 1

5

Adapt structure for future

challenges and opportunities 4

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● Net sales up +6.4% at CER and Business EPS up +13.4% at CER

● Free Cash Flow up +33% in H1 2014

● €3.7bn dividend payment and €1.1bn share buyback

● 76.3% of Group sales

● Solid execution in Emerging Markets

● Merial back to growth

● 3 significant regulatory reviews ongoing

● 4 major projects with Phase IIb/III readouts

● 2 new important collaborations

Sanofi Delivered Solid Results in Q2 2014

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3

2

1 Solid financial performance

Strong performance

of Growth Platforms

Significant progress

in late stage pipeline

FCF: Free Cash Flow

(1) Excluding Generics in Brazil, Q2 2014 sales were up +3.9% at CER

(2) Dividend payment of €3,676m on full-year 2013 results made in Q2 2014

(3) As of July 15th 2014, Sanofi bought back shares for €1,100m in YTD 2014

(1)

(3) (2)

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Q2 2014

-€0.10

FX Impact Incremental

EPS at CER Q2 2013

+€0.15

Net Sales(1) Business EPS(1)

Solid Q2 2014 Financial Performance Reflects

Consistent Execution of our Growth Strategy

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(1) On a reported basis, Q2 2014 sales were up +0.9% and Business EPS was up +4.5%

(2) With retroactive application of IFRIC21

+13.4% at CER(1)

Incremental

Sales at CER Q2 2014 Q2 2013 FX Impact

+€515m -€443m

+6.4% at CER(1)

€8,003m €8,075m

€1.12

€1.17

(2)

(2)

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+9.2% Consumer Healthcare(3)

€816m

Vaccines -4.2% €718m

Genzyme(4)

Growth Platforms Grew +14.5%(1) in Q2 2014

Reaching 76.3% of Sales

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(1) Excluding Generics in Brazil, Growth Platforms grew +10.7% in Q2 2014 and +9.0% in H1 2014 at CER

(2) Excluding Generics in Brazil, Emerging Markets grew +8.6% in Q2 2014 and +6.5% in H1 2014 at CER

(3) Some products recorded in prescription pharmaceuticals in 2013 were transferred as Consumer Healthcare products and totaled €73m in Q2 2013

Including this category change, sales of Consumer Healthcare grew +20.2% in Q2 2014 and +19.4% in H1 2014 at CER

(4) Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises

(5) Includes products launched since 2009 which do not belong to the Growth Platforms listed above: Multaq®, Jevtana®, Auvi-Q™, Mozobil® and Zaltrap®

+16.2%

-0.4%

+29.1%

+6.2%

Other Innovative Products(5) €189m +13.3%

+16.5%

Diabetes Solutions €1,788m

Animal Health

€643m

Emerging Markets(2) €2,855m

€537m

Q2 2014 Growth at CER

-4.2%

H1 2014 Growth at CER

+9.3%

+14.7%

-2.2%

+25.4%

+2.2%

+17.8%

+11.0%

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Quarterly Sales Growth from Growth Platforms(1)

+6.2%

Q1 2013

+8.6%

Q4 2012

+11.5%

Q3 2012

+6.4%

Q2 2012

+7.6%

Q1 2012

+5.7%

Q4 2013

+10.0%

Q3 2013 Q2 2013

+5.5%

+7.9%

Q1 2014 Q2 2014

+10.7%

(1) Growth at CER. Q1 2012 growth restated for Genzyme Q1 2011 (€396m)

(2) Growth at CER including Generics in Brazil was +2.5% in Q2 2013 and +14.5% in Q2 2014 9

Growth Platforms Show Consistent Strong Performance

Demonstrating the Value of our Business Model

(2)

(2)

+5% at CER

+10% at CER

% of Group sales 63.2% 76.3%

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Sanofi Highlights to Date

Emerging Markets - Strong Contribution from Asia Region

Agenda

The Opportunity with Sanofi

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H1 2014 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

(2) Pharmaceuticals sales growth at CER was +2.2% in Africa & Middle East, +4.3% in Eastern Europe, Russia & Turkey, +10.6% in Asia and

+18.2% in Latin America excluding Generics in Brazil in H1 2014

Solid Sales Performance in Emerging Markets in H1 2014

as Operational Issues from 2013 Have Been Addressed

34.2%

31.3%

24.5%

10.0%

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(1)

+8.5%

+4.7% +5.4% +14.6% Growth at CER

-1.5%

-7.4%

-0.7%

+11.0%

Emerging Markets Total Sales by Region

excluding Brazil Generics

(2)

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Poised for Continued Strong Growth in the ‘Asia Region’

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Taiwan

Malaysia

Philippines

Affiliates/HQ

Manufacturing site

Hong

Kong

Thailand

Vietnam

Indonesia

China

Perimeter of ‘Asia Region’ at Sanofi ● Regional headquarters in Shanghai

● Strategic hub in Singapore

● 10 country affiliates

● >12,000 employees in the ‘Asia

region’

● Growing presence in Consumer

Healthcare, Vaccines, Genzyme and

Animal Health

● Strong local industrial footprint

● Addressing a market of ~2bn people(1)

(1) CIA – The World Fact Book 2013 ’

Singapore

Cambodia

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Sanofi in China - Well Poised to Seize the Opportunities

in the Chinese Healthcare Market

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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

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Sanofi in China – A Strong and Growing Contributor to

Our Leadership Position in Emerging Markets

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(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

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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 15

Pharmaceuticals

Genzyme

Consumer Healthcare

Diabetes

Vaccines

Animal Health/Merial

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10%

8%

5%

(1) Wordlbank, IMF; GDP Growth (2012),

(2) Worldbank, IMF; ‘Total expenditure on health as % of Gross National Product’ (GDP); 2012

South East Asia Represents a Major Growth Opportunity

● GDP growth in most SEA countries

higher than in developed markets

● Diverse political systems and

economic trends

● Unequal pace of development offers

opportunities for a diversified

healthcare leader

● Increase in healthcare expenditure

driven by an emerging middle class

● Largely out-of-pocket markets

● Improved affordability and coverage

through public healthcare reforms

4% 3%

5% 4%

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Heathcare Expenditure as a % of GDP

still low in most fast growing SEA economies

7%

6%

-0.4

Healthcare expenditure

as % of GDP(2) GDP growth in %(1)

Global

OECD

PHL THA IDN MYS VNM SGP

E.U.

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2.5

1.9

12.1

1.3

2013

3.3

Cambodia

1.7

5.4

Thailand

Vietnam

Indonesia

2017

17.2

2.4

3.2

3.0

Malaysia

Singapore

Philippines

Myanmar

2.1

In € billion(2)

(1) IMS Prognosis 2014-2018

(2) At constant exchange rates (2014)

CAGR

‘13-’17

+14%

+13%

Positive Outlook for the Pharmaceutical Market in

South East Asia

South East Asia Pharmaceutical Market(1)

● Population of >500m people

● South East Asia Pharmaceutical

market estimated to be ~€12bn(1)

● Growth of +9%, 2013 – 2017 CAGR

● Fastest growing markets

Indonesia and Vietnam

● Expected to represent 68% of

incremental growth in the region

(2014-2018)

+9%

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Sanofi is an Established Leader in South East Asia

Top 10 Pharmaceutical Companies in South East Asia(1)

Sales in € million (2013)

(1) IMS 2013, South East Asia countries = Indonesia, Thailand, Philippines, Singapore, Malaysia, Vietnam

Pfizer

Unilab

GSK

Novartis

Merck

Kalbe

Roche

AstraZeneca

Bayer

● A broad portfolio to address local

market needs and to capture growth

opportunities

● Investment focus on priority markets

● Improved access through

geographical expansion

● E.g., Cambodia and Myanmar

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Sanofi Highlights to Date

Emerging Markets - Strong Contribution from Asia Region

Agenda

The Opportunity with Sanofi

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● Filed in the U.S. and EU

in Q2 2014 and recently

in Japan

● Regulatory decisions for

marketing authorization

in the U.S. and EU

anticipated in H1 2015

Three New Medicines Under Regulatory Review

with the Potential to Meaningfully Improve Patient Lives

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● FDA approval granted in

August 2014

● EU regulatory decision

expected in Q4 2014

● NDA submitted in Japan

in June 2014

● sBLA resubmission

accepted for review

by FDA in May 2014

● FDA action expected

in Q4 2014

● New dedicated salesforce

being recruited

Three major new drug approvals expected over the next 12 months

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Alirocumab Illustrates Sanofi’s Focus on Gearing Up

to Successful Launches of Biologics

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PCSK9 Inhibitors Have the Potential to Improve LDL-C

Management of High Cardiovascular (CV) Risk Patients

● High LDL-C and CV diseases remain an area of high unmet

medical need

● Large and comprehensive Phase 3 ODYSSEY clinical program

designed to assess the safety and efficacy of alirocumab in patients

with hypercholesterolemia at high CV risk

● Detailed positive efficacy and safety results of four pivotal alirocumab

studies(1) recently highlighted at a hotline session at ESC

● Submission planned in the U.S. and EU by end of 2014

(1) ODYSSEY LONG TERM, FH I & II, and COMBO II studies.

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First-in-Class Dengue Vaccine Met Primary Endpoint in

2 Phase III Trials in Asia and Latin America

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Sanofi’s Dengue vaccine candidate

Two successfully

completed

Phase III studies(2)

Study in

Asia

Study in

LatAm

Number of

participants in study 10,275 20,875

Reduction in

symptomatic dengue 56.5% 60.8%

Reduction in

hospitalization 67.2% 80.3%

(1) Dengue and severe dengue; WHO Fact Sheet No. 117 updated March 2014 http://www.who.int/mediacentre/factsheets/fs117/en/index.html; WHO 2009,

Dengue Guidelines for Diagnosis, Treatment, Prevention and Control; WHO 2012, Global Strategy for Dengue Prevention and Control, Guzman, 2010,

Nat Rev Micro.

(2) The Lancet, July 2014; Sanofi press release, September 3, 2014

Aedes aegypti

The Global Disease Burden of Dengue(1)

2.5 billion

people live in

dengue-endemic

countries

50-100 million

dengue infections

occur worldwide

every year

500,000 people

with severe dengue

requiring

hospitalization

every year

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Sarilumab and dupilumab are developed in collaboration with Regeneron

NEJM: New England Journal of Medicine

(1) Mean % change in EASI score from baseline to Week 16 / Clearing or near-clearing of skin lesions, measured by an investigator's global assessment

(IGA) score of 0 or 1 / Mean reduction in itching measured by the pruritus numerical-rating scale (NRS) score

(2) Improvement in signs and symptoms of RA / Improvement in physical function / Inhibition of progression of structural damage

Strong Late Stage Pipeline of Biologics Demonstrates

the Shift of our Portfolio towards Innovative Products

● First Phase III study in Asia

published in The Lancet

● Final Dengue Landmark

Phase III study successfully

completed in Latin America

● Regulatory submission in

priority countries expected

in Q1 2015

Dengue Vaccine

● Detailed data from positive

Phase III MOBILITY trial

presented at EULAR

● Statistically significant

improvements

in all three co-primary

endpoints(2)

Sarilumab Rheumatoid Arthritis

● Strong Phase IIa data

published in the NEJM

● Positive Phase IIb top-line

results

● Statistically significant and

dose-dependent

improvements in all key

efficacy measures(1)

Atopic Dermatitis

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Two New Collaborations Signed in Q2 2014

Strengthening our CHC and Diabetes Growth Platforms

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● Licensing agreement with Lilly

● Opportunity to switch Cialis® from Rx to OTC in the U.S., Europe,

Canada and Australia(1)

● Ambition to transform how this important medicine for erectile

dysfunction (ED) is offered to millions of men in the world

● Global strategic alliance(2) in diabetes structured as open-innovation model

● Initial focus on novel drug-device combinations and care management

● Objective to improve adherence, simplify insulin treatment and help patients

better manage their condition

(1) Subject to Sanofi's receipt of all necessary regulatory approvals

(2) Implementation of the alliance is subject to the negotiation and execution of a definitive agreement between the companies

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Solid H1 Performance Reflects Consistent Execution

of our Growth Strategy

Over 75% of sales now being generated by Growth Platforms

Business EPS guidance for 2014 adjusted slightly upwards

Late stage pipeline moving to launch execution

Expected new medicine launches to further redefine Sanofi

as a biopharmaceutical leader

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The Opportunity with Sanofi

Sanofi has transformed into a company

positioned for sustainable growth

through its Growth Platforms(1) and

has a robust late-stage pipeline

of new biologics

27 (1) Growth Platforms include Emerging Markets, Diabetes Solutions, Vaccines, Consumer Healthcare, Animal Health, Genzyme

& Other Innovative Products. In Q2 2014, sales from Growth Platforms accounted for 76.3% of Group sales