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Transcript of Sanofi, a global leader in healthcare - Q1 2016 RESULTS 2016-04-29¢  Q1 2016...

  • Q1 2016 RESULTS April 29, 2016

  • 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 initiatives 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, 2015. Other than as required by applicable law, Sanofi does not undertake any

    obligation to update or revise any forward-looking information or statements.

  • 3

    Agenda

    3

    Q1 2016 Key Highlights

    ● Olivier Brandicourt - Chief Executive Officer

    Q1 2016 Financial Results

    ● Jérôme Contamine - Executive Vice President, Chief Financial Officer

    Q&A Session

    ● Olivier Charmeil - Executive Vice President, Sanofi Pasteur

    ● Peter Guenter - Executive Vice President, General Medicines & Emerging Markets

    ● Carsten Hellmann - Executive Vice President, Merial

    ● David P. Meeker - Executive Vice President, Sanofi Genzyme

    ● Pascale Witz - Executive Vice President, Diabetes & Cardiovascular

    ● Elias Zerhouni - President, Global R&D

  • Q1 2016 KEY HIGHLIGHTS

    4

    Olivier Brandicourt

    Chief Executive Officer

  • ● Toujeo® continues to capture TRx share in the U.S. reaching 5.0%(4)

    ● Progressive launch of Praluent® while awaiting outcomes data

    ● SAGE recommends Dengvaxia® use in endemic countries to WHO First public immunization program launched in the Philippines

    Launches

    Q1 2016 – Progressing on our 2020 Roadmap

    5

    RA: Rheumatoid Arthritis / AD: Atopic Dermatitis

    (1) On a reported basis, Q1 2016 Aggregate Sales were down -1.9%

    (2) On a reported basis, Q1 2016 Business EPS was up +1.5%

    (3) Subject to regulatory clearances

    (4) IMS data as of April 1st 2016

    (5) LixiLan is a project name and is not the intended brand name for the combination of insulin glargine and lixisenatide

    ● Exclusive Boehringer Ingelheim asset swap expected to be signed mid-year and closed by year-end(3)

    ● Sanofi Pasteur targeting to manage European vaccine portfolio independently by year-end

    Portfolio

    ● Aggregate Sales reached €8,543m (after VaxServe reclassification), up +0.7% or +3.0% excluding Venezuela at CER(1)

    ● Solid Business EPS growth of +5.3% at CER(2) to €1.34

    Financial Results

    ● Sarilumab monotherapy showed superior efficacy vs. adalimumab in RA

    ● Dupilumab met primary endpoints in 2 Phase III studies in AD

    ● LixiLan(5) combination submitted to EMA

    Innovation

    3

    1

    2

    4

  • Q1 2016 Incremental EPS at CER

    +€0.07

    Q1 2015 FX Impact

    -€0.05

    Aggregate Group Sales Business EPS

    As Expected, Aggregate Sales Up Slightly in Q1 2016

    Given High Base for Comparison in Venezuela & Japan

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    (1) Including Merial

    (2) Reflecting reclassification of VaxServe from Sales to Other revenues

    (3) On a reported basis, Q1 2016 Aggregate Sales were down -1.9% and Business EPS was up +1.5%

    +5.3% at CER(3)

    Q1 2015 FX Impact

    -€228m

    +€61m

    Incremental

    Sales at CER Q1 2016

    +0.7% at CER(3)

    €8,710m

    €8,543m €1.32

    €1.34

    (2)

    Aggregate Group Sales +3.0% at CER excluding Venezuela

    (1)

  • 7

    Growth

    at CER

    New Organization by Global Business Unit

    in Place as of January 1st 2016

    (1) Does not include Emerging Markets sales

    (2) Includes Emerging Markets sales for Diabetes & Cardiovascular and Sanofi Genzyme

    (3) Emerging Markets: World excluding U.S., Canada, Western & Eastern Europe (except Eurasia), Japan,

    South Korea, Australia, New Zealand and Puerto Rico

    (4) Excluding Venezuela: -0.3% at CER

    (5) Reflecting reclassification of VaxServe from Sales to Other revenues from Jan 1, 2016. Pictures by Freepik

    Q1 2016 Aggregate Sales by Global Business Unit

    Group Aggregate Sales €8,543m

    +0.7%

    €760m

    Animal Health

    +17.5%

    €1,499m

    Diabetes & Cardiovascular -5.8% (1)

    €1,169m

    Sanofi Genzyme +20.5% (1)

    €4,490m

    General Medicines & Emerging Markets -4.3% (4) (2,3)

    €625m

    Vaccines

    +8.2% (5)

  • 8

    Q1 2016 Sales Up 3% excluding Venezuela at CER

    Driven by Specialty Care, Vaccines and Animal Health

    (1) Excluding Venezuela sales were up +12.3% at CER

    (2) Excluding Plavix® in Japan, sales were down -6.3% at CER

    (3) Excluding Venezuela sales were up +8.8% at CER

    (4) Excluding Venezuela sales were up +3.8% at CER

    Q1 2016 Aggregate Sales by Franchise

    Developed Markets Emerging Markets

    Growth

    at CER

    Total

    Sales Growth Sales

    Animal Health

    +17.5% €760m +37.5% +13.0% €612m €148m

    Specialty Care +18.4% €1,371m

    +9.3% +20.5% €1,169m

    €202m

    Diabetes & Cardiovascular -3.5% €1,832m

    +6.7% -5.8% €1,499m

    €333m

    Sales Growth

    Vaccines

    +8.2% €625m

    +37.0% -8.1% €347m

    €278m

    Established Rx Products -8.2% €2,591m

    -2.1% -11.5% €1,667m

    €924m

    Generics +3.3% €459m 0.0% +6.0% €282m €177m

    Consumer Healthcare -3.1% €905m

    -9.9% +1.5% €594m

    €311m

    (1)

    (3)

    (4)

    (6)

    (5) Excluding Venezuela sales were up +7.1% at CER

    (6) Reflecting reclassification of VaxServe from Sales to Other revenues from Jan 1, 2016

    (7) Excluding Pentacel® in the U.S., sales were up +9.3% at CER

    (5)

    (2)

    (7)

  • Q1 2015 Q1 2016

    Other

    Rare Disease Franchise Shows High-Single Digit Growth

    in Q1 2016

    ● Comparable franchise growth

    in Developed and Emerging Markets

    (+8.5% / +8.3% at CER, respectively)

    ● Sales split Developed / Emerging: 83% / 17%

    ● Growth driven by patient accruals

    ● Gaucher franchise grew +10.1% at CER

    ● Market share of 73% in value(1)

    ● Cerdelga® sales in the U.S. almost double(2)

    ● Fabrazyme® sales up +6.4% at CER

    following strong Q4 2015(3)

    ● Myozyme® / Lumizyme® sales up +8.3% at

    CER

    €646m +8.5% at CER

    €613m

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    &

    €182m

    €23m

    €166m

    €149m

    €126m

    (1) Cerezyme® + Cerdelga® value share is 73% based on Q1 2016 reported sales by Sanofi and Shire

    (2) Cerdelga® sales were €23m in Q1 2016 and €10m in Q1 2015

    (3) Fabrazyme® Q4 2015 sales were up +20.3% at CER

    Global Rare Diseases Sales

    http://www.fabrazyme.com/default.asp

  • 10

    Multiple Sclerosis Franchise Continues to Deliver