Presentation

Exane Healthcare Conference
Jérôme Contamine, Executive Vice President, Chief Financial Officer
Paris, March 18, 2015
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, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to
update or revise any forward-looking information or statements.
2
In 2014, Sanofi Focused on Delivering Growth
and Strengthening Innovation
1
Returning
to top line
growth
2
Delivering
strong financial
results
3
Bringing
innovative
medicines
to market
● Sales growth up 4.9% at CER
● Solid performance across Growth platforms(1)
● Business EPS up +7.3% at CER in line with expectations
● Free Cash Flow up +12.3%
● Nearly €5.5bn of capital returned to shareholders(2)
● Important milestones achieved for late stage R&D projects
● Multiple new product launches underway or imminent
(1) FY 2014 Growth Platforms sales were up +10.7% at CER, representing 76.4% of total sales
(2) Capital returned to shareholders reached €5,477m in 2014 (dividend on 2013 results of €3,676m paid in 2014
and share buy back of €1,801m executed in 2014)
3
Strong Performance across Growth Platforms(1)
Q4 2014
FY 2014
Sales & Growth at CER
Sales & Growth at CER
Emerging Markets(2)
€3,126m
+7.9%
€11,347m
+9.3%
Diabetes Solutions
€2,024m
+11.0%
€7,273m
+12.1%
Vaccines
€1,177m
+16.2%
€3,974m
+7.2%
Consumer Healthcare(3)
€817m
+14.0%
-4.2%
€3,337m
+16.5%
Genzyme
€746m
+22.2%
€2,604m
+24.3%
Animal Health
€507m
+11.5%
€2,076m
+6.7%
Other Innovative Products(4)
€209m
+5.9%
€815m
+14.7%
(1) FY 2014 Growth Platforms sales were €25,802m (76.4% of total sales) and up +10.7% at CER. Excluding Generics in Brazil, Growth Platforms grew
+9.4% in FY 2014 at CER
(2) Excluding Generics in Brazil, Emerging Markets grew +6.5% in FY 2014 at CER and +7.6% in Q4 2014 at CER
(3) Some products recorded in prescription pharmaceuticals in 2013 were transferred as Consumer Healthcare products and totaled €68m in Q4 2013
and €273m in FY 2013. When excluding this category change, sales of Consumer Healthcare grew +4.2% in Q4 2014 and +6.8% in FY 2014 at CER
(4) Includes products launched since 2009 which do not belong to the Growth Platforms listed above: Multaq®, Jevtana®, Auvi-Q®, Mozobil® and Zaltrap®
4
Growth Platforms Collectively Provide a Sustainable Base
Quarterly Sales Growth from Growth Platforms(1)
+11.5%
10.7%
+10.0%
+10%
at CER
(2)
10.0%
10.3%
+8.6%
+7.9%
+7.6%
+6.4%
+5.7%
+5%
+6.2%
(2)
+5.5%
at CER
Q1 2012 Q2 2012 Q3 2012 Q4 2012 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014
% of Group sales
63.2%
(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
77.2%
5
Four New Products Granted Regulatory Approvals
over the Last Year
Key Regulatory Approvals
U.S. (Feb 2015)
1
New once-daily longacting basal insulin
2
Protection against four
strains of influenza virus
U.S. (Dec 2014)
3
Relapsing forms of
multiple sclerosis
U.S. (Nov 2014)
4
Oral Therapy for
Gaucher Disease Type 1
Positive CHMP
Opinion (Feb 2015)(1)
U.S. (Aug 2014)
E.U. (Jan 2015)
(1) The European Commission (EC) is expected to make a final decision on granting marketing authorization for Toujeo® in the EU in the
coming months.
6
Regulatory Filings for Three Major New Medicines
or Vaccines Submitted over the Last Year
Key Regulatory Filings
Hypercholesterolemia
Pediatric hexavalent vaccine
Dengue
Praluent®
PR5i 6-in-1
Dengue vaccine
alirocumab
U.S.
U.S.
E.U.
Praluent® (alirocumab) is developed in collaboration with Regeneron
(1) Rolling submission process in some endemic countries in Asia initiated in January 2015
Endemic
markets(1)
7
A Successful Model for Productive R&D Collaborations
● Global strategic collaboration
● World-class RNAi technology
● Access to highly productive
therapeutic human antibody
platform
● Focus on genetically defined
diseases with a clear translational
model for RNA interference
● Market value of 22.3% ownership
of €7,724m on Dec 31, 2014(1,2)
● Market value of 11.8% ownership
of €728m on Dec 31, 2014(3)
(1) REGN closing share price on Dec 31, 2014 was $410.25
(2) “Significant influence” under IFRS rules allows Sanofi to account for its investment in Regeneron using the Equity
8
method from April 4, 2014
(3) ALNY closing share price on Dec 31, 2014 was $97.00.
8
Our Diabetes Team Is Focused on Ensuring Successful
Execution of Two Launches
New Diabetes Launches in 2015
A rapid-acting inhaled insulin
Smoother PK/PD profile than Lantus®
An innovative and patient friendly
device
Similar HbA1c lowering with lower
hypoglycemia than Lantus®
Addressing resistance to insulin
initiation and insulin intensification
Improved patient experience
Launched in the U.S.
in Feb 2015
U.S. approval (Feb 2015)
Positive CHMP opinion
(Feb 2015)
9
Additional Milestones Expected in 2015
to Further Expand our Diabetes Franchise
Key Milestones for Lixisenatide in 2015
1
2
(1)
3
(2)
®
study
Completion of
CV outcome trial
evaluating lixisenatide in
type 2 diabetic patients
after an ACS event
expected in Q2 2015
U.S. regulatory submission
expected in Q3 2015
Completion of two Phase III
trials expected in Q3 2015
LixiLan-O(3)
LixiLan-L(3)
ACS: Acute Coronary Syndrome
(1) ELIXA evaluates cardiovascular outcomes in patients with Type 2 Diabetes after Acute Coronary Syndrome during
treatment with lixisenatide
(2) LixiLan is a once-daily fixed-ratio combination of insulin glargine and lixisenatide
(3) LixiLan-O evalutates the combination of insulin glargine and lixisenatide in patients insufficiently controlled on OADs
while LixiLan-L focuses on patients not at goal on basal insulin
10
Praluent® Has the Potential to Transform Management
of Hypercholesterolemic Patients with High CV Risk
1● Regulatory applications accepted in the U.S. and EU
● 6-month FDA priority review granted(1)
Praluent
alirocumab
®
2● 18-month results of odyssey LONG TERM Trial published in
NEJM
● Fewer major CV events observed in post hoc analysis(2)
3● ODYSSEY OUTCOMES trial ongoing(3)
● Assess potential to demonstrate CV benefit
(1) FDA PDUFA date of July 24, 2015
(2) Praluent group (27 of 1550 patients, 1.7%) compared with placebo group (26 of 788 patients, 3.3%; hazard ratio 0.52; 95 % CI, 0.31 to
0.90; nominal p < 0.01).
(3) ODYSSEY OUTCOMES (n=18,000): Rationale and design in Schwartz GG et al. Am Heart J 2014;0:1-8.e1.
11
On Track to Make Dengue
the Next Vaccine-Preventable Disease
A Breakthrough Innovation to Help Reduce the Burden of Dengue(1)
● Rolling submission for Dengue vaccine
initiated in several endemic countries in Asia
● First completed submission expected in H1 2015
● First commercial batches produced and
inventory build-up underway
● 22m lyophilized doses produced by end of 2014
● Up to 80m lyophilized doses expected to be
available by end of 2015
● First license anticipated before year-end 2015
(1) WHO, 2012, Global Strategy for Dengue Prevention and Control
12
Expanding Genzyme’s Gaucher Franchise with Cerdelga®
(1)
Source of Patients
● Oral therapy eliminating infusion
challenges
Other therapies
19%
● Launched in the U.S. in Sep 2014
New treatment
starts
4%
● Reimbursement progressing well
with coverage by 88% of plans
● EU approval granted in Jan 2015
● First launches anticipated to be
in Germany and Nordic countries
Clinical trials
40%
37% Cerezyme®
(1) Proportion of patients on Cerdelga® since launch
13
Robust Growth and Steady Market Share Gains
Achieved by Genzyme’s Aubagio® in 2014
● FY 2014 sales of €433m vs. €166m
last year
Quarterly Sales (€m)
€146m
● Results from 2 Phase III studies
added to U.S. label
● Only oral treatment to significantly reduce
the risk of sustained accumulation of
disability in 2 Phase III studies
in RMS (TEMSO and TOWER)
● Positive data in early MS(1) (TOPIC)
● Majority of switches coming from
Tecfidera® in Q4 2014(2)
(1) Patients with a first clinical event consistent with MS
(2) IMS U.S.
14
Lemtrada® Acceleration Expected with FDA Approval
1● FY 2014 sales of €34 million
2● FDA approval received in Nov 2014
●
Infrastructure to support REMS program fully operational
●
First patients infused within 2 weeks of approval
3● New dedicated field teams in place in U.S.(1)
●
Ensuring appropriate education and confidence to prescribe
●
Full team in field started in February
(1) Genzyme holds the worldwide rights to alemtuzumab and has responsibility for its development and commercialízation in MS.
Bayer Healthcare receives contingent payments based on global sales revenue.
15
Returns from R&D Are Expected to Substantially Improve
2007 - 2013
 10 launches achieved
Potential cumulative
first 5 years sales
~€7.5bn(1,2)
2014 - 2020
 Up to 18 launches expected
Praluent®
alirocumab
Dengue
Vaccine
(1) At CER, 5 years for each product from and including the first full year of launch
(2) Non-risk adjusted sales projections
Potential cumulative
first 5 years sales
>€30bn(1,2)
16
Innovation Momentum Set to Continue in 2015
2015
Expected Regulatory Decisions
●
Toujeo® in Diabetes in U.S. & EU
●
Praluent® (alirocumab) in Hypercholesterolemia (U.S.)
●
PR5i 6-in-1 pediatric vaccine (U.S.)
●
Dengue vaccine in Endemic Countries
Expected Regulatory Submissions
●
Lyxumia® in Diabetes (U.S.)
●
LixiLan in Diabetes (U.S. & E.U.)
●
Sarilumab in Rheumatoid Arthritis (U.S.)
Expected Headline Phase III Data Releases
●
Lyxumia® ELIXA CV outcome study in Diabetes
●
LixiLan in Diabetes
●
Sarilumab in Rheumatoid Arthritis
Expected Phase III Starts
●
Dupilumab in Asthma and Nasal Polyposis
Q1
Q2
Q3
Q4




Q1
Q2
Q3
Q4



Q1
Q2
Q3
Q4


Q1
Q2
Q3


Q4
17
Strong Commitment to Shareholder Return
Evolution of Dividend
● Proposed dividend of €2.85 per share
for 2014 financial year(1)
● Increase of 5 cents per share
€2.40
€2.50
€2.65
€2.77 €2.80 €2.85
(1)
€2.20
● 21st consecutive year of dividend
increase
● Payout of 54.8%
2008 2009 2010 2011 2012 2013 2014
(1) To be submitted for approval by shareholders at the Annual General Meeting on May 4, 2015
18
Significant Increase in Share Buyback Program in 2014
Evolution of Share Buyback
€1,801m
€1,641m
€645m
€823m
€1,121m
€1,004m
Net SBB
€680m
€637m
€178m
Net SBB
Net SBB
Issuance
Share count (m) (1)
Buyback
Issuance
Buyback
Issuance
Buyback
2012
2013
2014
1,323.2
1,320.7
1,309.9
Net share buyback activity was up by €484m in 2014
SBB: Share Buyback
(1) Number of shares outstanding in million on Dec 31st 2012, Dec 31st 2013 and Dec 31st 2014
19
Outlook for 2015 - Investing in Future Growth Drivers
FY 2015 Guidance(1)
•
Taking into account the outlook for U.S. Diabetes as well as new
product launches and late stage pipeline development, 2015
business EPS is expected to be stable to slightly growing vs. 2014
at constant average exchange rates(2), barring major unforeseen
adverse events
•
Applying December 31, 2014 exchange rates to this FY 2015
guidance, the additional positive FX impact on 2015 business EPS
is estimated to be between 4% and 5%(3)
(1) Announced on February 5, 2015
(2) FY 2014 Business EPS of €5.20
(3) Difference between variation on reported basis and variation at constant exchange rates
20
Our Focus Continues to Be on Excellence in Execution
of Sanofi’s Strategy
Strategy
2015 Focus
1
Grow a global healthcare leader
with synergistic platforms
Sustain leadership positions
2
Bring innovative products
to market
Ensure successful launches
3
Adapt structure for future
challenges and opportunities
Focus company resources
on must-win priorities
4
Seize value-enhancing
growth opportunities
Maintain financial discipline
21