21
Exane Healthcare Conference Jérôme Contamine, Executive Vice President, Chief Financial Officer Paris, March 18, 2015

2015 - Exane BNP Paribas Healthcare Conference

  • Upload
    sanofi

  • View
    436

  • Download
    2

Embed Size (px)

Citation preview

Page 1: 2015 - Exane BNP Paribas Healthcare Conference

Exane Healthcare Conference Jérôme Contamine, Executive Vice President, Chief Financial Officer

Paris, March 18, 2015

Page 2: 2015 - Exane BNP Paribas Healthcare Conference

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.

Page 3: 2015 - Exane BNP Paribas Healthcare Conference

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)

Page 4: 2015 - Exane BNP Paribas Healthcare Conference

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%

Page 5: 2015 - Exane BNP Paribas Healthcare Conference

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)

Page 6: 2015 - Exane BNP Paribas Healthcare Conference

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.

Page 7: 2015 - Exane BNP Paribas Healthcare Conference

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

Page 8: 2015 - Exane BNP Paribas Healthcare Conference

● 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

Page 9: 2015 - Exane BNP Paribas Healthcare Conference

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)

Page 10: 2015 - Exane BNP Paribas Healthcare Conference

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)

Page 11: 2015 - Exane BNP Paribas Healthcare Conference

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

Page 12: 2015 - Exane BNP Paribas Healthcare Conference

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

Page 13: 2015 - Exane BNP Paribas Healthcare Conference

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

Page 14: 2015 - Exane BNP Paribas Healthcare Conference

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

Page 15: 2015 - Exane BNP Paribas Healthcare Conference

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

Page 16: 2015 - Exane BNP Paribas Healthcare Conference

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

Page 17: 2015 - Exane BNP Paribas Healthcare Conference

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

Page 18: 2015 - Exane BNP Paribas Healthcare Conference

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)

Page 19: 2015 - Exane BNP Paribas Healthcare Conference

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)

Page 20: 2015 - Exane BNP Paribas Healthcare Conference

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

Page 21: 2015 - Exane BNP Paribas Healthcare Conference

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