Upload
sanofi
View
436
Download
2
Tags:
Embed Size (px)
Citation preview
Exane Healthcare Conference Jérôme Contamine, Executive Vice President, Chief Financial Officer
Paris, March 18, 2015
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, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to
update or revise any forward-looking information or statements.
3
2
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)
● Sales growth up 4.9% at CER
● Solid performance across Growth platforms(1)
● Important milestones achieved for late stage R&D projects
● Multiple new product launches underway or imminent
In 2014, Sanofi Focused on Delivering Growth
and Strengthening Innovation
3
Returning to top line
growth
Delivering strong financial
results
Bringing innovative medicines to market
(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)
Strong Performance across Growth Platforms(1)
4
(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®
Q4 2014 Sales & Growth at CER
FY 2014 Sales & Growth at CER
Vaccines €1,177m €3,974m
Diabetes Solutions €2,024m €7,273m
Consumer Healthcare(3)
-4.2% €817m €3,337m
Genzyme €746m €2,604m
Emerging Markets(2) €3,126m €11,347m
Animal Health €507m €2,076m
Other Innovative Products(4) €209m €815m
+7.2%
+12.1%
+16.5%
+24.3%
+9.3%
+6.7%
+14.7%
+16.2%
+11.0%
+14.0%
+22.2%
+7.9%
+11.5%
+5.9%
Q3 2014 Q4 2014
10.3% 10.0%
Q2 2014
10.7%
Q1 2014
+7.9%
Q4 2013
+10.0%
Q3 2013
+5.5%
Q2 2013
+6.2%
Q1 2013
+8.6%
Q4 2012
+11.5%
Q3 2012
+6.4%
Q2 2012
+7.6%
Q1 2012
+5.7%
(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 5
Growth Platforms Collectively Provide a Sustainable Base
+5% at CER
+10% at CER
% of Group sales 63.2% 77.2%
(2)
(2)
Quarterly Sales Growth from Growth Platforms(1)
6
Four New Products Granted Regulatory Approvals
over the Last Year
Key Regulatory Approvals
U.S. (Dec 2014) Protection against four
strains of influenza virus 2
U.S. (Nov 2014) Relapsing forms of
multiple sclerosis 3
U.S. (Aug 2014)
E.U. (Jan 2015)
Oral Therapy for
Gaucher Disease Type 1 4
New once-daily long-
acting basal insulin 1
U.S. (Feb 2015)
Positive CHMP
Opinion (Feb 2015)(1)
(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.
7
Praluent® (alirocumab) is developed in collaboration with Regeneron
(1) Rolling submission process in some endemic countries in Asia initiated in January 2015
Regulatory Filings for Three Major New Medicines
or Vaccines Submitted over the Last Year
Key Regulatory Filings
U.S.
Pediatric hexavalent vaccine
PR5i 6-in-1
Endemic
markets(1)
Dengue
Dengue vaccine
U.S.
E.U.
Hypercholesterolemia
Praluent® alirocumab
● World-class RNAi technology
● Focus on genetically defined
diseases with a clear translational
model for RNA interference
● Market value of 11.8% ownership
of €728m on Dec 31, 2014(3)
8
A Successful Model for Productive R&D Collaborations
● Global strategic collaboration
● Access to highly productive
therapeutic human antibody
platform
● Market value of 22.3% ownership
of €7,724m on Dec 31, 2014(1,2)
(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
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
A rapid-acting inhaled insulin
An innovative and patient friendly
device
Addressing resistance to insulin
initiation and insulin intensification
Launched in the U.S.
in Feb 2015
New Diabetes Launches in 2015
9
Smoother PK/PD profile than Lantus®
Similar HbA1c lowering with lower
hypoglycemia than Lantus®
Improved patient experience
U.S. approval (Feb 2015)
Positive CHMP opinion
(Feb 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
Additional Milestones Expected in 2015
to Further Expand our Diabetes Franchise
Key Milestones for Lixisenatide in 2015
1 2 3
U.S. regulatory submission
expected in Q3 2015
Completion of
CV outcome trial
evaluating lixisenatide in
type 2 diabetic patients
after an ACS event
expected in Q2 2015
10
study
® (2) (1)
11
Praluent® Has the Potential to Transform Management
of Hypercholesterolemic Patients with High CV Risk
● Regulatory applications accepted in the U.S. and EU
● 6-month FDA priority review granted(1)
● 18-month results of odyssey LONG TERM Trial published in
NEJM
● Fewer major CV events observed in post hoc analysis(2)
● 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.
1
2
3
Praluent® alirocumab
On Track to Make Dengue
the Next Vaccine-Preventable Disease
● 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
A Breakthrough Innovation to Help Reduce the Burden of Dengue(1)
12 12
Source of Patients
Expanding Genzyme’s Gaucher Franchise with Cerdelga®
● Oral therapy eliminating infusion
challenges
● Launched in the U.S. in Sep 2014
● 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
13
Other therapies New treatment
starts
Clinical trials
Cerezyme® 37%
40%
19% 4%
(1)
(1) Proportion of patients on Cerdelga® since launch
Robust Growth and Steady Market Share Gains
Achieved by Genzyme’s Aubagio® in 2014
Quarterly Sales (€m)
€146m
● FY 2014 sales of €433m vs. €166m
last year
● 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
15
Lemtrada® Acceleration Expected with FDA Approval
(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.
● FY 2014 sales of €34 million
● FDA approval received in Nov 2014
● Infrastructure to support REMS program fully operational
● First patients infused within 2 weeks of approval
● 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
2
3
16
(1) At CER, 5 years for each product from and including the first full year of launch
(2) Non-risk adjusted sales projections
Returns from R&D Are Expected to Substantially Improve
Potential cumulative
first 5 years sales
~€7.5bn(1,2)
2007 - 2013
2014 - 2020
Potential cumulative
first 5 years sales
>€30bn(1,2)
10 launches achieved
Up to 18 launches expected
Praluent®
alirocumab
Dengue
Vaccine
2015
Expected Regulatory Decisions Q1 Q2 Q3 Q4
● 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 Q1 Q2 Q3 Q4
● Lyxumia® in Diabetes (U.S.)
● LixiLan in Diabetes (U.S. & E.U.)
● Sarilumab in Rheumatoid Arthritis (U.S.)
Expected Headline Phase III Data Releases Q1 Q2 Q3 Q4
● Lyxumia® ELIXA CV outcome study in Diabetes
● LixiLan in Diabetes
● Sarilumab in Rheumatoid Arthritis
Expected Phase III Starts Q1 Q2 Q3 Q4
● Dupilumab in Asthma and Nasal Polyposis
Innovation Momentum Set to Continue in 2015
17
Evolution of Dividend
2013 2014
€2.85 €2.80
2012
€2.77
2011
€2.65
2010
€2.50
2009
€2.40
2008
€2.20
18
● Proposed dividend of €2.85 per share
for 2014 financial year(1)
● Increase of 5 cents per share
● 21st consecutive year of dividend
increase
● Payout of 54.8%
(1) To be submitted for approval by shareholders at the Annual General Meeting on May 4, 2015
Strong Commitment to Shareholder Return
(1)
Buyback Issuance Buyback
Evolution of Share Buyback
19
SBB: Share Buyback
(1) Number of shares outstanding in million on Dec 31st 2012, Dec 31st 2013 and Dec 31st 2014
€645m €680m€823m
€1,801m €1,641m
€1,004m
2012
€178m Net SBB
€637m Net SBB
€1,121m Net SBB
Share count (m) 1,323.2 1,320.7 1,309.9
Issuance
Significant Increase in Share Buyback Program in 2014
2013
Issuance
2014
Buyback
Net share buyback activity was up by €484m in 2014
(1)
Outlook for 2015 - Investing in Future Growth Drivers
(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
• 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)
FY 2015 Guidance(1)
20 20
Our Focus Continues to Be on Excellence in Execution
of Sanofi’s Strategy
21
Adapt structure for future
challenges and opportunities 3
Bring innovative products
to market 2
Grow a global healthcare leader
with synergistic platforms 1
Seize value-enhancing
growth opportunities 4
2015 Focus
Maintain financial discipline
Focus company resources
on must-win priorities
Ensure successful launches
Strategy
Sustain leadership positions