Presentation

Deutsche Bank Healthcare Conference
Jérôme Contamine, Executive Vice President, Chief Financial Officer
Boston – May 6, 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
Q1 2015 - A Good Start to the Year
1
Delivering
top line growth
● Sales up +2.4% despite lower vaccines and U.S. Lantus®
sales(1)
● Solid performance of Genzyme and Merial
2
Posting
strong financial
results
● Higher OpEx driven by new launches
● Business EPS up +2.6% at CER(2)
3
Bringing
innovative
medicines
to market
● Important milestones achieved for late stage R&D projects
● Multiple new product launches underway or imminent
(1) On a reported basis, Q1 2015 sales were up +12.3%
(2) On a reported basis, Business EPS was up +12.8%
3
Solid Sales and Business EPS Delivered in Q1 2015
Net Sales
Business EPS
€1.32
€8,810m
+€0.12
+€782m
+€0.03
+€186m
+2.4%
at
CER(1)
+2.6%
€1.17
at CER(1)
€7,842m
Q1 2014
Incremental
Sales at CER
FX Impact
Q1 2015
Q1 2014
Incremental
EPS at CER
FX Impact
Q1 2015
(1) On a reported basis, Q1 2015 sales were up +12.3% and Business EPS was up +12.8%
4
Strong FX Tailwind on Top and Bottom Line in Q1 2015
as the U.S. Dollar Strengthened
Quarterly Currency Impact
Net Sales(1)
Business EPS
+9.9%
+10.2%
+€782m
+€0.12
+2.7%
+1.5%
+€229m
Q1 2014
Q2 2014
Q3 2014
-€81m
Q1 2014
Q4 2014
Q2 2014
Q1 2015
Q3 2014
-€0.03
-1.0%
+€0.02
Q4 2014
Q1 2015
-2.2%
-€497m
-6.2%
-€443m
-5.5%
-€0.11
-9.1%
-€0.10
-8.9%
(1) Main currency impact on sales in Q1 2015: U.S. Dollar (+€551.3m); Chinese Yuan (+€77.5m);
Russian Ruble (-€64.0m);
5
Balanced Geographical Sales Split in Q1 2015
with Solid Growth in Emerging Markets
Q1 2015 Sales by Geographies (in €m)
Emerging Markets Total Sales by Region
(2)
Western EU
€2,031m
+0.6% at CER
RoW
€944m
€846m
-3.5% at CER
€849m
10.6%
23.1%
32.5%
€530m
Emerging
Markets (1)
€2,859m
€586m
+7.3% at CER
U.S.
33.8%
€2,976m
+1.0% at CER
Africa & Middle Eastern Europe, Latin America
East
Russia & Turkey
Growth at CER
+2.7%
+8.6%
(1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta,
Belgium, Luxembourg, Portugal, the Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway,
Iceland, Denmark), Japan, South Korea, Australia, and New Zealand
(2) RoW: Japan, South Korea, Canada, Australia, and New Zealand
+7.1%
Asia
+8.6%
6
Sales Growth Driven by Genzyme and Merial
in Q1 2015(1)
% of Sales
Q1 2015 Sales by Business Areas
Growth at CER
Pharmaceuticals
€7,455m
+2.2%
20.9%
Diabetes
€1,837m
-3.2%
11.1%
Consumer Healthcare
€979m
+5.3%
9.3%
Genzyme
€821m
+30.9%
5.4%
Generics
€478m
+10.2%
4.1%
Oncology
€357m
-7.3%
33.8%
Established Rx Brands
€2,983m
-1.5%
84.6%
7.9%
Vaccines
€697m
-4.6%
7.5%
Animal Health
€658m
+13.5%
(1) Q1 2015 sales were up +12.3% on a reported basis
7
Genzyme Rare Disease Products Delivered Double-Digit
Growth in Q1 2015
● Rare Disease sales reached €613m in
Q1 2015, up 15.9%
Top 3 Rare Disease Sales (€m)
€199m
● Sustained leadership positions(1)
in Gaucher, Fabry and Pompe diseases
€141m
at CER
+19.0%
+27.6%
● Gaucher disease products grew
10.1% to €199 million, including €10m
of Cerdelga® sales
● Over 60% of Cerdelga® patients are from
sources that do not cannibalize existing
Cerezyme sales
+10.1%
€156m
at CER
at CER
Q1
2014
Q1
2015
Q1
2014
Q1
2015
Q1
2014
Q1
2015
● Cerdelga® launched in its first EU market,
Germany, in April 2015
&
&
(1) Cerezyme® value share is 72% and Fabrazyme® value share is 62% based on Q1 2015 reported sales by Sanofi and Shire
8
Genzyme’s Multiple Sclerosis Business Continued
to Accelerate in Q1 2015
Genzyme MS Franchise Sales (€m)
● MS sales up +118% at CER to €208m in
Q1 2015
€208m
● Aubagio® sales of €170m more than
doubled vs. €78m in Q1 last year
● Only oral treatment with sustained
accumulation of disability data in U.S. label
€83m
● Q1 2015 sales of Lemtrada® were €38m,
surpassing FY 2014 sales of €34m
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
2013 2013 2013 2014 2014 2014 2014 2015
Lemtrada®
Aubagio®
9
Merial Started 2015 with Strong Growth Driven
by NexGard® Launch and Frontline® Stabilization
● Q1 2015 sales of €658m up +13.5%
Merial Sales Growth at CER
+12.7%
+11.5%
● Companion animal sales up +13.1% to
€443m (67% of sales)
● Production animal sales up +14.5% to
€215m
+6.2%
● NexGard® sales more than doubled
in Q1 2015 compared to the same
period of 2014
● Frontline® family continued stable
performance with sales up +1.2%
+13.5%
-1.6%
-5.7% -6.4% -6.3%
Q2
2013
Q3
2013
Q4
2013
Q1
2014
Q2
2014
Q3
2014
Q4
2014
Q1
2015
10
Sanofi Pasteur Sales in Q1 2015 Reflect the Delay of the
Southern Hemisphere Influenza Campaign
● Q1 2015 Sanofi Pasteur sales were
€697m, down 4.6% at CER
● Excluding influenza vaccines, sales grew
17.2% in Q1
Vaccine Sales (€m)
€697m
€628m
-4.6%
at CER
● Strong PPH sales of €282m, +15.6%
were driven by the continued recovery
of Pentacel® in the U.S.
Influenza Vaccines
Polio/Pertussis/Hib
● Sanofi Pasteur continues to address
remaining supply constraints in 2015
● Menactra® sales grew 50.0% to €87m
due to favorable CDC order phasing in
the U.S.
Meningitis/Pneumo
Adult Boosters
Travel/Endemic
Other
Q1
2014
PPH: Polio, Pertussis, Hib vaccines
(1) Includes VaxServe, a U.S. healthcare supplier serving primary care physician offices, community
immunization providers, immunizing pharmacies, travel clinics and corporations
(1)
Q1
2015
11
Diabetes Sales Reflect Expected Change in U.S. Lantus®
Net Pricing
Diabetes Sales (€m)
● Global diabetes sales of €1,837m
down -3.2% at CER(1) in Q1 2015
● In Emerging Markets and Western EU,
diabetes sales were up +18.5% and
+4.7%, respectively
€1,837m
€1,662m
● U.S. Lantus® sales were down 13.1% due
to expected rebates required to maintain
favorable formulary positions
-3.2%
at CER(1)
● Toujeo® sales were €7m reflecting
pre-launch wholesaler demand
● Afrezza® was launched in the U.S. in
Feb 2015
(1) On a reported basis, Q1 2015 diabetes sales were up +10.5%
Q1Q1
2014
Q2Q2
2014
Q3Q3
2014
Q4Q4
2014
Q1Q1
2015
2014
2014
2014
2014
2015
12
Global Launch of a New Once-Daily Long-Acting Basal
Insulin Underway
● Toujeo® was launched in the U.S. at the end of March
● Secured earlier and broader market access than expected
● Toujeo® COACH patient support program available at launch
● European Commission approved Toujeo® in April 2015
● Launch in Germany and UK expected in Q2 2015
● Launches in other countries expected in H2 2015 and early
2016
13
Sanofi Expects to Launch High Potential New Medicines
and Vaccines at an Accelerated Pace
ILLUSTRATIVE
Up to 18 Launches
2014 - 2020
Shan5
®
Dengue
PR5i
Vaccine Vaccine
(U.S.)
sarilumab
(U.S.)
Praluent™ is the intended trade name for alirocumab.
insulin patisiran Anti-CD38 Rotavirus
Vaccine
mAb
lispro
Vaccine
14
Regulatory Filings for Three Major New Medicines
or Vaccines Submitted over the Last Year
Key Regulatory Filings
Hypercholesterolemia
U.S.
Pediatric hexavalent vaccine
Dengue
PR5i 6-in-1
Dengue vaccine
U.S.
E.U.
Praluent® (alirocumab) is developed in collaboration with Regeneron
(1) Rolling submission process initiated in some endemic countries in Asia and Latin America in 2015.
Endemic
markets(1)
15
Praluent® Has the Potential to Transform Management
of Hypercholesterolemic Patients with High CV Risk
● Regulatory reviews underway in the U.S. and Europe
● FDA decision expected in July 2015(1)
● EU decision expected in Q1 2016
● 18-month results of ODYSSEY LONG TERM study were
published in NEJM(2)
● Fewer major CV events observed in post hoc analysis(3)
● ODYSSEY OUTCOMES trial ongoing(4)
● Assess potential to demonstrate CV benefit
(1) FDA PDUFA target action date of July 24, 2015
(2) Robinson JG, Farnier M, Krempf M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular
events. N Engl J Med 2015;372:1489-99. DOI: 10.1056/NEJMoa1501031
(3) 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)
(4) ODYSSEY OUTCOMES (n=18,000): Rationale and design in Schwartz GG et al. Am Heart J 2014;0:1-8.e1.
16
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 endemic countries in Asia and Latin America
● First completed submission expected in H1 2015
● First commercial batches produced and
inventory build-up underway
● 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
17
Additional Clinical Milestones and Regulatory Filings
Expected in 2015
Key Milestones in 2015
(2)
Type 2 Diabetes
Type 2 Diabetes
ELIXA study results
support U.S. regulatory
submission expected in
Q3 2015(1)
Completion of two
Phase III trials
expected in Q3 2015(3)
U.S. regulatory
submission anticipated
in Q4 2015
sarilumab
Rheumatoid Arthritis
Further Phase III data
expected in 2015
Regulatory submission
expected in late 2015
in the U.S. and H2
2016 in EU
(1) ELIXA evaluated 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
and LixiLan-L focuses on patients not at goal on basal insulin
18
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. & EU)
●
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

19
Net Debt Increased by 5.6% in Q1 2015 due to Translation
Impact of our Debt Held in U.S. Dollars
Net Debt (in €m)
-€773m
€7,171m
€1,602m
-€327m
FCF
€1,247m
€7,571m
-€794m
-€355m
Net Debt (1)
Mar 31, 2014
Net Cash from
Operating Activities(2)
CapEx
€247m
Proceeds from
Share Repurchase
Issuance of Shares
Acquisitions,
Licensing, Net
of Disposals
Other (3)
FCF: Free Cash Flow
(1) Including derivatives related to the financial debt of +€302m at December 31st, 2014 and of +€360m at March 31st, 2015
(2) Excluding Restructuring costs
(3) Other including Restructuring costs of -€148m and FX impact of -€593m
Net Debt (1)
Mar 31, 2015
20
Outlook for 2015 - Investing in Future Growth Drivers
FY 2015
Business EPS Growth
FX impact on Business EPS
Stable to slightly growing at CER(1)
Approximately +12%(2)
(1) FY 2014 Business EPS of €5.20
(2) Difference between variation on a reported basis and variation at CER, when applying March 2015 average exchange rates
to the remaining three quarters of the year
21
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
22