JP Morgan Healthcare Conference Christopher A. Viehbacher, Chief Executive Officer San Francisco, January 14, 2014
JP Morgan Healthcare ConferenceChristopher A. Viehbacher, Chief Executive Officer
San Francisco, January 14, 2014
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Forward Looking Statements
This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of1995, as amended. Forward-looking statements are statements that are not historical facts. These statements includeprojections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions andexpectations 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'smanagement believes that the expectations reflected in such forward-looking statements are reasonable, investors arecautioned that forward-looking information and statements are subject to various risks and uncertainties, many of whichare difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments todiffer 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 theEMA, regarding whether and when to approve any drug, device or biological application that may be filed for any suchproduct candidates as well as their decisions regarding labeling and other matters that could affect the availability orcommercial potential of such product candidates, the absence of guarantee that the product candidates if approved willbe commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's abilityto benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of costcontainment policies and subsequent changes thereto, the average number of shares outstanding, as well as thosediscussed 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 Form20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake anyobligation to update or revise any forward-looking information or statements.
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 pipelineof new biologics
3(1) Growth Platforms include Emerging Markets, Diabetes Solutions, Vaccines, Consumer Healthcare, Animal Health, Genzyme & Other Innovative
Products. In Q3 2013, sales from Growth Platforms accounted for 74.7% of Group sales
44
Focusing on Growth Platforms and New Products
Emerging Markets1
Diabetes Solutions2
Consumer Healthcare4
Animal Health6
Vaccines3
Genzyme5
Other Innovative Products7
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A commercial presence in a large number of Emerging
Markets
Sanofi’s Scorecard in Emerging Markets
Number onecompany in Emerging
Markets by market share
A top position in most of the fast growing economies
One of the biggest sales
forces in Emerging Markets
An historical presence
and diversified product portfolio
A widenetwork of
industrial sites across
Emerging Markets
#1with
5.7% marketshare(1)
#1in BRIC
and non-BRIC
47/53sales split
between Growth platforms
and Other products
~23,000sales
representatives
37industrial
sites
~100countries with
commercialpresence
(1) IMS MIDAS MAT Q3 20135
Sanofi Is Poised to Capture Growthin Fast Growing Markets
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Quarterly Sales (€m)
€968m
€1,279m
Lantus® Is The Basal Insulin of Reference Worldwide
€1,456m
● Diabetes worldwide prevalence: 382m(1)
● 46% undiagnosed● Almost half live in just three countries
(China, India, U.S.)
● Lantus®: prescribers’ first choice for insulin therapy● >10 years of broad clinical experience● >8m Lantus® patients worldwide
● ORIGIN results on Lantus® CV safety recently integrated into product label
● State-of-the-art, easy-to-use and affordable insulin pens
(1) IDF Diabetes Atlas 2013 - 6th Edition
0 6 12 18 24 30 36
0
5
10
15
20
25
30
LLOQ 5.02 µU.mL-1
SC INJECTION
INSU
LIN
- µU
.mL-1
TIME - hour
U100 0.4 U.kg-1
U300 0.4 U.kg-1
LOESS 0.15
0 6 12 18 24 30 36
0
1
2
3
4
5DOSE 0.4 U.kg-1
U300 U100
GIR
- m
g.kg
-1.m
in-1
TIME - hour
U300: Striving to Further Enhance the Value of Current Basal Insulin
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Expected regulatory submission in H1 2014 in U.S. and EU
Dahmen R et al, ADA 2013, abstract no. 113-OR. Euglycemic clamp study in T1D in steady state
U300
Lantus®
U300
Lantus®
Flatter PK Profile More Prolonged PD ProfileSerum Insulin Glargine Concentration Glucose Infusion Rate
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● Key benefits of Lyxumia® complementing basal insulin
● Pronounced post-prandial glucose (PPG) lowering effect
● Beneficial effect on body weight
● Limited risk of hypoglycemia
● Indicated in EU for combination use with OADs and basal insulin
● Commercially available in Germany, UK, Spain, Japan and Mexico
● FDA submission expected in 2015 after completion of ELIXA CV outcome trial
Lyxumia® Is an Add-On Therapy for Patientson Basal Insulin
Lyxumia® is the proprietary name approved by the EMA for lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration. In the U.S.; lixisenatide is currently under review by the FDA. Lixisenatide was in-licensed from Zealand Pharma A/S.
Lyxumia®
Easy-to-Use Once-Daily Prandial GLP-1
First 2 weeks of therapy
Remainder of therapy
Lyxumia®
10 µg OD SC
Lyxumia®
20 µg OD SC
OD: Once-daily SC: Subcutaneous
Combining Insulin Glargine with Lixisenatide in One Single Daily Injection (LixiLan)
+®
● Opportunities in patients not at target on OADs and basal insulin
● Phase II Proof-of-concept study completed(1)
● Phase III expected to start in Q1 2014
● Potential to be the first combinationof Basal Insulin + GLP-1 in one daily injection in the U.S
(1) Full data to be submitted for publication in a medical journal 9
(1) Pentacel®, Adacel® and Daptacel®
Vaccines Have Dealt Effectively with Production Shortfalls to Allow a Return to Growth in 2014
1010
● Differentiated flu vaccines have invigorated sales
● Hexyon® rolling out in Europe and strong Pentaxim® uptake in Emerging Markets
● Shan 5® WHO prequalification expected in H1 2014
● Toronto production issues under control and volumes of Pertussis-containing vaccines(1) recovering
Differentiated Vaccines Allow for the “Right Dose, Right Patient” Approach
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Dengue Vaccine: Addressing a Growing Global Threat
Significant Disease Burden(1)
● 2.5bn people at risk
● Estimated 100m dengue infections worldwide per year ● 500,000 people with severe dengue requiring
hospitalization● 2.5% of people with severe dengue die
● Dengue is a public health priority in Asia and Latin America
● Dengue is under-reported and thus the burden is likely underestimated(2)
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Ambitious Development Program
● Phase IIb results in ~4,000 children recently published in the Lancet(3)
● Efficacy confirmed against DENV 1, 3 and 4 (in the range of 60% to 90%), and inconclusive against DENV 2
● Safe and well-tolerated
● Global Phase III program ongoing ● Large scale studies in Asia and Latin
America ● 31,000 children and adolescents
● Results expected in H2 2014
(1) Dengue and severe dengue; WHO Fact Sheet No. 117 updated Sep. 2013 http://www.who.int/mediacentre/factsheets/fs117/en/index.html
(2) Bhatt S et al. Nature. 2013 Apr 25;496(7446):504-7.(3) Sabchareon A et al. Lancet. 2012 Nov 3;380(9853):1559-67.
CDI – A Growing Healthcare Problem
● Most common cause of healthcare associated infections in developed countries(2)
● In the U.S. alone, a significant burden(3)
● ~28,000 deaths and up to 450,000 hospital admissions
● Associated cost of care: up to $3.4bn
● Targeted patients at high risk of CDI:● Elderly with antibiotic use, planned
at-risk admissions to hospital and long-term care facilities residents
C. Diff Toxoid Vaccine: Preventing Primary Symptomatic Clostridium Difficile Infections (CDI)
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● Candidate vaccine shown to be safe and immunogenic in Phase I(1)
and Phase II trials● Broad functional antibody responses
to both toxins (A and B)
● Cdiffense multinational Phase III trial started in Q3 2013● Case driven study
● Up to 15,000 adults to be included
● Fast Track Development Program designation granted by CBER
CBER – Center for Biologics Evaluation and Research within FDA (1) Greenberg R, Vaccine, March 2012(2) He M, Nature Genetics, December 2012, and Miller BA, Control Hosp Epidemiol, April 2011(3) CDC Morbidity and Mortality Weekly Report, March 2012
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Sanofi Is the World’s Third Largest CHC Player
● Double digit growth of Top 4 brands● Allegra®, Doliprane®, Enterogermina®
and Essentiale®
● Re-introduction of Rolaids® in the U.S. in Sep 2013
● Nasacort® Allergy 24HR approved by FDA in Oct 2013 for OTC use● First and only nasal spray in its class
to be available without a prescription
● Creation of a Global Consumer Healthcare Division
(1) In 9M 2013. Nicholas Hall & Company
1. J&J 2. BAYER3.4. PFIZER 5. NOVARTIS6. GSK7. RECKITT BENCKISER8. BOEHRINGER INGELHEIM9. TAKEDA 10. TAISHO
4.2%3.4%3.1%3.0%2.9%2.6%2.5%1.5%1.3%1.3%
Top 10 OTC in Market Share(1)
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Genzyme Rare Disease Products Are a Major Growth Driver for Sanofi
● Rebuilding our leadership position in Rare Diseases ● Cerezyme®: #1 therapy for Gaucher
disease● Fabrazyme®: #1 position reached in
just four quarters once supply restored● Myozyme®: the only approved therapy
for Pompe disease
● Start of clinical development on the next generation ERT for Pompe disease and a small molecule for Fabry disease
52%value share in 9M 2013(1)
for Fabry disease
73%value share in 9M 2013(1)
for Gaucher disease
(1) Based on 9M 2013 reported sales by Sanofi and Shire
Cerdelga™ (eliglustat) - A Novel Investigational Oral Therapy to Expand our Gaucher Franchise
● Oral therapy eliminating infusion challenges
● Largest ever clinical program in Gaucher: ~400 adults in 29 countries● Phase III studies included patients just
starting treatment (ENGAGE) and patients switching from ERT (ENCORE)
● All primary/secondary endpoints met in Phase III studies
● Non-inferiority criteria to Cerezyme® met (ENCORE)
● Regulatory review ongoing by EMA and FDA● Priority review granted in the U.S.
ERT : Enzyme Replacement Therapy
+2%
-28%
Placebo
Eliglustat
30%Absolute Difference
ENGAGE - Change in Spleen Volume(% change at 9 months)
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Potential to grow market and build Genzyme share further
p<0.0001
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Genzyme’s Commitment and Leadership in Rare Diseases Increases through Expansion of Alnylam Collaboration
This transaction has been approved by the boards of both companies, and is subject to customary closing conditions and clearances under the Hart-Scott Rodino Antitrust Improvements Act
● Alnylam’s world-class RNAi technology to provide a platform for sustained drug development for rare genetic diseases for Genzyme
● Focus is on genetically defined diseases with a clear translational model for RNA interference
● Genzyme becomes major Alnylam shareholder through $700 million equity investment
Program Rights(subject to opt-in)
PC P1 P2 P3
Patisiran (TTR‐FAP) in expanded territory
AS1 (Hepatic Porphyria)
TTRsc (FAC)
Unnamed
AT3 (Hemophilia)
TTR-FAP: Transthyretin-Familial Amyloïd PolyneuropathyFAC: Familial Amyloïd Cardiomyopathy
(1) Evaluate Pharma July 2013(2) Oral category includes Aubagio®, Gilenya®, Tecfidera®, laquinimod, 2nd Gen S1Ps(3) Intravenous category includes Tysabri®, Lemtrada®, ocrelizumab, daclizumab(4) Injectable category includes Avonex®, Betaseron/Betaferon®, Copaxone®, Rebif®, Extavia®, Plegridy™
Global MS Market - Significant and Growing Market Oral and IV Therapies Expected to Grow
59%
0%
15%
30%
45%
60%
75%
90%
2012 2017e
MS Market Evolution(1,2,3,4)
(% market share)
Injectables
Intravenous
Orals
~€11bn >€14bn
● Oral therapy(2) share projected to increase four-fold to nearly 40% of the MS market by 2017 driven by new entrants
● Intravenous therapies(3) expected to approach 20% of the market
● Injectable therapies(4) (ABCRE’s) projected to decline by roughly half of current usage by 2017
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1818(1) New Active Substance (NAS) status granted in Europe in Jun 2013Lemtrada™ is developed in collaboration with Bayer HealthCare
Genzyme Is Well Positioned to Enter the €11bnGlobal MS Market with a Franchise Approach
● U.S. sales of €97m in 9M 2013 ● EMA approval granted in Aug 2013(1)
● EU launch rollout started in Q4 2013● Strong launch in Germany and other
EU launch countries
● Regulatory approvals granted in EU, Canada and Australia ● EU launch rollout started in Q4 2013 ● Complete response letter received from FDA in late Dec 2013
● Genzyme plans to appeal the agency’s decision● CVR milestone of U.S. approval by March 31, 2014 will not be met
Aubagio®: Quarterly Sales
Q4 2012 Q2 2013Q1 2013
€7m
€20m
€33m
€44m
Q3 2013
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Merial Gearing Up to Launch the Next Generation of Flea and Tick Control for Pets
9M Sales (€m)● Companion Animals performance
impacted by relatively weak flea and tick season and more competition to Frontline®
● Regulatory approvals recently granted for NexGard® for dogs in the U.S. and Broadline® for cats in EU
● 10 significant new products potentially launched over next 3 years evenly split between companion and production animals
€1,560m
2011 2012 2013
€1,673m €1,541m
Alirocumab: Fully-Human PCSK9 mAbTargeting Unmet Needs in Hypercholesterolemia
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Alirocumab is developed in collaboration with RegeneronPCSK9: proprotein convertase subtilisin/kexin type 9, an enzyme that can contribute to elevated LDL-C levels through degradation of LDL-C receptorsLDL-C : Low Density Lipoprotein-Cholesterol(1) From all Phase III studies except OUTCOMES, CHOICE 1, and CHOICE 2(2) ODYSSEY MONO is the first study to report data from the Phase III ODYSSEY program
● Global Phase III ODYSSEY program ongoing with 14 clinical studies underway
● Data from Phase III program expected in mid 2014 through Q3 2014(1)
● Initial regulatory submission based on LDL-C planned for early 2015 outside the U.S.● U.S. regulatory submission
in 2015
- 15.6%
- 47.2%
ezetimibe
alirocumab
p<0.0001
ODYSSEY MONO(2) - Mean LDL-C change(at week 24)
Sarilumab: Significant Opportunity for IL-6R Inhibition in Rheumatoid Arthritis (RA)
● Fully human, high affinity, IL-6R mAb administered subcutaneously
● Positive results from SARIL-RA-MOBILITY, first Phase III trial in moderate-to-severe RA(1)
● Additional Phase III data expected in 2015
● Ongoing Phase III studies are: COMPARE, TARGET, ASCERTAIN, EXTEND
● Regulatory submission roll-out expected to start in 2015
SARIL-RA-MOBILITY (Phase III Results)
ACR – American College Of Rheumatology (ACR) Scoring SystemIL-6R – Interleukin-6 receptorSarilumab is developed in collaboration with Regeneron(1) Clinically relevant and statistically significant improvements in both sarilumab groups compared to placebo in all three co-primary endpoints:
ACR 20, Improvement of physical function and Inhibition of progression of structural damage
Sarilumab200 mg + MTX
25.0*
46.0*
66.0*
Sarilumab150 mg + MTX
20.0*
37.0*
58.0*
Placebo + MTX
7.0
17.0
33.0
ACR70ACR50ACR20**
* p<0.0001 versus placebo** Primary endpoint
Improvement in Signs & Symptoms at Week 24ACR Response (% of Patients)
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● Fully human monoclonal antibody binding to IL-4Rα● Targeting the common IL-4Rα subunit ● Dual IL-4/IL-13 cytokine antagonism
with a single agent
● Atopic Dermatitis● Phase IIa data to be presented at
AAAAI in Q1 2014● Phase IIb data expected in Q2 2014● Plan to initiate Phase III trial in 2014
● Asthma● Phase IIa data published in NEJM● Phase IIb ongoing
● Phase IIa ongoing in Nasal polyposis
22Dupilumab is developed in collaboration with RegeneronAAAAI:American Academy of Allergy, Asthma & Immunology
IL-4
IL-4R c
Type IReceptor
Type IIReceptor
IL-13
IL-4R IL-13R1
or
Dupilumab: Targeting Atopic Dermatitis (AD), Asthmaand Nasal Polyposis
Atopic Dermatitis
Sanofi’s Growth Profile Expected to Emerge in Q4 2013
● In 2014, Sanofi will continue to demonstrate strong performance of Growth Platforms, launch new products and reinforce pre-launch efforts for late-stage projects
● Growth Platforms now account for 72% of sales(1) and Sanofi has returned to sales growth since September 2013(2)
● New product launches are underway or imminent in all of Sanofi's businesses and several high potential R&D projects progressed in 2013
● The creation of Growth Platforms and the evolution of our R&D pipelinehave effectively transformed Sanofi into a major biopharmaceutical player
(1) 72.4% in 9M 2013 (2) Sales growth of +6.1% in September 2013 at constant exchange rates and constant structure basis 23