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Q1 2013 RESULTS - Sanofi...2013/05/02  · Q1 2013 RESULTS May 2, 2013 2 Forward Looking Statements...

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Q1 2013 RESULTS May 2, 2013
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  • Q1 2013 RESULTS May 2, 2013

  • 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, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

  • 3 3

    Agenda

    Key Highlights

    ● Christopher A. Viehbacher, Chief Executive Officer

    Business Performance

    ● Hanspeter Spek, President, Global Operations

    Financial Performance

    ● Jérôme Contamine, Executive Vice President, Chief Financial Officer

    Q&A

  • KEY HIGHLIGHTS

    Christopher A. Viehbacher

    Chief Executive Officer

    4

  • Key Genericized Products Represented Only ~€260m of Sales for a Second Quarter in a Row

    Q1 2013

    €259m

    Q4 2012

    €257m

    Q3 2012

    €399m

    Q2 2012

    €752m

    Q1 2012

    €813m

    5

    One quarter to go before the impact of Key Genericized Products(1) becomes minimal

    Key Genericized Products(1) - Quarterly Sales (€m)

    (1) Key genericized products include Lovenox® U.S., Plavix® Western EU, Taxotere® Western EU & U.S., Eloxatin® U.S., Ambien® family U.S., Allegra® U.S., Aprovel® Western EU, Xyzal® U.S., Xatral® U.S., Nasacort® U.S. and BMS Alliance (active ingredients of Plavix® and Avapro® sold to BMS)

    3.2% of sales

  • Growth Platforms Grew by +8.6% in Q1 2013 and Reached 71% of Sales

    6 (1) Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises (2) Includes new product launches which do not belong to the other Growth Platforms listed above: Multaq®, Jevtana®, Mozobil®, Zaltrap® and Auvi-Q™

    +19.6%

    +3.1%

    +15.9%

    -3.1%

    +25.5%

    Other Innovative Products(2) €157m +13.7%

    +6.5%

    Consumer Healthcare

    €811m

    Diabetes Solutions €1,542m

    Vaccines €697m

    Animal Health €554m

    Emerging Markets €2,719m

    Genzyme(1) €493m

    Q1 2013 growth at CER

  • Q1 2013 Sales Were Affected by U.S. Loss of Exclusivity of Eloxatin® in August 2012 and by FX Fluctuations(1)

    €9,040m

    Q4 2012

    €8,526m

    Q3 2012 Q2 2012

    €8,870m

    Q1 2012

    €8,511m

    Q1 2013

    €8,059m

    Sales

    7

    (1) Reported sales of Eloxatin® in the U.S. were €321m in Q1 2012 but only €8m in Q1 2013. (2) On a reported basis, sales in Q1 2013 were down -5.3%.

    The negative currency impact in Q1 2013 was €212m.

    -2.8% at CER(2)

  • Q1 2013 Q1 2012 Q1 2012

    8

    "Other Revenues" "Income from Associates"

    (1) Avapro® on March 30, 2012 and Plavix® on May 17, 2012 (2) At constant exchange rates

    Q1 2013

    €426m

    Loss of Exclusivity of Plavix® & Avapro® in the U.S.(1)

    €297m Impact on Q1 2013

    Business Net Income:

    €562m(2) €98m €18m

    Residual impact(2) on BNI of Plavix® & Avapro® U.S. LoE expected to be around €240m in Q2 2013

    The Loss of U.S. Exclusivity of Plavix® and Avapro® Impacted Business EPS by €0.42 in Q1 2013

  • Q1 2013

    €1.22

    Q4 2012 Q2 2012

    €1.17

    €1.46

    Q3 2012 Q1 2012

    €1.67 €1.83

    As Anticipated, Q1 2013 Business EPS Was Better than Q4 2012 Trough

    Business EPS

    9

    -29.0% at CER(2)

    (1) With the retroactive application of IAS19R (2) On a reported basis, Q1 2013 EPS was down -33.3%

    Sanofi expects to resume Business EPS growth in H2 2013

    (1) (1) (1) (1)

  • ® Type 2 Diabetes EU roll-out starting in late March 2013

    Recent Regulatory Approvals Have Resulted in Six New Product Launches

    10 Zaltrap® is developed in collaboration with Regeneron, Kynamro™ with Isis Pharmaceuticals and Lyxumia® is in-licensed from Zealand Pharma. Sanofi U.S. licensed the North American commercialization rights to AUVI-Q™ from Intelliject Inc.

    Launch Status Products ® Metastatic

    Colorectal Cancer

    Indications

    Launched in the U.S. in August 2012 EU roll-out starting in late March 2013

    Relapsing Forms of Multiple Sclerosis

    ® Launched in the U.S. in October 2012

    Launched in the U.S. in January 2013 Life-Threatening Allergic Reactions

    Prevention of Poliomyelitis Launched in Japan in September 2012

    Homozygous Familial Hypercholesterolemia Launched in the U.S. in late March 2013

  • Several Important Study Releases and Regulatory Milestones Achieved in the Last 4 Months

    11

    Clinical Data Releases

    ● Eliglustat tartrate - Phase III in Gaucher disease (ENCORE)

    ● Dupilumab - PoC in Atopic Dermatitis and Severe Asthma

    ● Lemtrada™ - Phase III in MS (1-year Extension of CARE-MS Program)

    ● Aubagio® - Phase III in Clinically Isolated Syndrome (TOPIC)

    Regulatory Milestones

    ● Lemtrada™ FDA file acceptance in MS

    ● Aubagio® positive CHMP opinion in MS

    ● Lyxumia® FDA file acceptance in type II diabetes

    ● Hexyon® /Hexacima® EC approval (DTaP-IPV-Hib-HepB vaccine)

    ● Quadrivalent Influenza Vaccine accepted for review in EU

    Lemtrada™ is the registered trade name for alemtuzumab in MS submitted to health authorities. Lemtrada™ is developed in collaboration with Bayer HealthCare

  • Additional Phase III Trial Readouts and Regulatory Decisions Expected Throughout 2013

    12

    2013 Expected Headline Phase III Data Releases Q2 Q3 Q4 ● New insulin glargine formulation in Diabetes (EDITION I & II) ● Otamixaban in Acute Coronary Syndrome (TAO) ● JAK2 inhibitor in Myelofibrosis (JAKARTA) ● Iniparib in Squamous Non Small Cell Lung Cancer ● Alirocumab (Anti-PCSK9) in Hypercholesterolemia (ODYSSEY Mono) Expected Regulatory Milestones Q2 Q3 Q4 ● Fluzone® Quadrivalent IM FDA decision in the U.S. ● Lemtrada™ CHMP opinion in Multiple Sclerosis in EU ● Lemtrada™ FDA decision in Multiple Sclerosis in the U.S.

    ● Eliglustat regulatory submission in the U.S. and EU in Gaucher disease

  • Composition of the Executive Committee as of July 1st, 2013

    Karen Linehan Executive VP Legal Affairs & General Counsel

    Christopher A. Viehbacher Chief Executive Officer

    Jérôme Contamine Executive VP Chief Financial Officer

    Elias Zerhouni President Global R&D

    Olivier Charmeil Executive VP Vaccines

    Peter Guenter Executive VP Global Commercial Operations

    Roberto Pucci Executive VP Human Resources

    Philippe Luscan Executive VP Industrial Affairs

    David-Alexandre Gros Executive VP Chief Strategy Officer

    13

    Pascale Witz Executive VP Global Divisions & Strategic Commercial Development

  • BUSINESS PERFORMANCE

    14

    Hanspeter Spek President, Global Operations

  • (1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Holland, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark), Japan, Australia and New Zealand

    Emerging Markets Represented >1/3 of Total Sales and Delivered Solid Sales Growth in Q1 2013

    ● Q1 2013 Emerging Markets sales of €2,719m, up +6.5% at CER ● Strong growth in Diabetes, Vaccines and Genzyme ● Lower sales of Generics and Oncology products

    ● BRIC sales of €975m, up +10.7% at CER

    33.7%

    29.0%

    24.8%

    12.5%

    15

    (1)

    +4.7% +11.9% -0.2% +11.7% Growth at CER

    Q1 2013 Sales (€m)

  • 16

    Double-Digit Growth of our Diabetes Franchise for Nine Consecutive Quarters

    Quarterly Sales (€m)

    16

    €1,338m

    ● Q1 2013 Diabetes sales of €1,542m, up +19.6% at CER

    ● Strong performance of Lantus®, up +21.3% at CER ● SoloSTAR® accounted for 57.0% of

    U.S. sales (vs. 51.1% in Q1 2012)

    ● Strong growth in Emerging Markets with sales up +19.9% at CER

    ● Recovery of Apidra® continues, up +30.8% at CER

    ● Lyxumia® launched in Germany and the UK in March 2013

  • 17

    Consumer Healthcare Showed Steady Performance Except in China in Q1 2013

    €199m

    Q1 2013 Sales (€m) ● Q1 2013 sales of €811m, up +3.1% at CER ● Double-digit sales growth of several

    leading brands (Doliprane®, Dorflex®, Enterogermina®)

    ● Lower sales in China due to reduced trade inventory levels and ongoing rationalization of distributors

    ● Allegra® OTC sales of €99m, up +6.3% at CER driven by recent launch in Japan ● New Allegra® anti-itch cream

    introduced in the U.S. in April

    €177m

    €368m

    €67m

  • 18

    Merial Performance Reflected Lower Sales of Frontline® in Q1 2013

    Q12011

    Q22011

    Q32011

    Q42011

    Q12012

    Q22012

    Q32012

    Q42012

    Q12013

    Quarterly Sales (€m) ● Q1 2013 sales of €554m, down -3.1% at CER

    ● Companion Animals sales of €374m, down -5.3% at CER ● Frontline® impacted by unfavorable

    weather conditions, increased competition and weak economic environment in Europe

    ● Strong sales of Heartgard® benefiting from competitor supply issue

    ● Production Animals sales of €180m, up +1.6% at CER

    €554m

  • €47m

    €112m

    €149m

    €92m€116m

    €171m

    19

    Genzyme Rare Diseases Growth Accelerated in Q1 2013

    &

    Q1 2013

    Q1 2012

    Q1 2013

    Q1 2012

    Q1 2013

    Q1 2012

    ● Q1 2013 Rare Disease sales of €473m, up +20.5% at CER driven by supply recovery and growing number of patients on therapy

    ● Fabrazyme® sales reached €92m doubling in the U.S. as well as in Western Europe

    ● Myozyme® grew +4.5% at CER to €116m

    ● Cerezyme® sales increased +16.8% at CER to €171m driven by strong growth in Emerging Markets and the U.S.

    Quarterly Sales (€m)

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

  • 20 20

    (1) IMS Weekly Total Prescriptions (2) Based on data collected at Genzyme's MS One to One™ Patient and Provider Support Center, Sep 2012-Jan 2013 (3) NAS: New Active Substance (4) Clinical results for 14 mg dose; CDMS = Clinically Definite Multiple Sclerosis

    ®

    ● Aubagio® Q1 2013 sales of €20m

    ● Encouraging U.S. launch trends(1,2) ● TRx broadly tracking Gilenya®

    ● >83% of patients switched to AUBAGIO® were most recently on IFN-beta or Copaxone®

    ● Positive CHMP opinion granted in March 2013 ● Request for CHMP re-examination of

    NAS designation filed(3)

    ● Ongoing regulatory review of Lemtrada™ in EU and the U.S.

    A Promising Entry in the Large MS Market

    Lemtrada™ is the registered trade name for alemtuzumab in MS submitted to health authorities Lemtrada™ is developed in collaboration with Bayer HealthCare

    RELAPSE 31%

    DISABILITY 30%

    TEMSO(4)

    TOWER(4)

    TOPIC(4)

    RELAPSE 36%

    DISABILITY 31%

    REDUCTION IN RISK OF CONVERSION TO CDMS 43%

  • 21

    Q1 2013

    €697m

    Q1 2012

    €617m

    Other Meningitis/Pneumo Travel/Endemic

    Influenza Vaccines Adult Boosters Polio/Pertussis/Hib

    +15.9% at CER

    Quarterly Sales (€m)

    Vaccines Deliver a Strong First Quarter

    ● Q1 2013 sales of €697m, up +15.9% at CER

    ● PPH sales of €270m, +15.9% at CER driven by favorable phasing of Pentaxim® rollout in China and IPV campaign in Japan

    ● Influenza sales of €119m, +34.8% at CER from successful SH campaign and late U.S. sales

    ● Solid sales of Menactra® in the U.S. and LatAm (€67m, +19.6% at CER)

    ● Pentacel® progressive recovery expected to begin as of mid-2013 in the U.S.

    (1) Includes VaxServe, a U.S. healthcare supplier serving primary care physician offices, community immunization providers, immunizing pharmacies, travel clinics and corporations.

    SH: Southern Hemisphere

    (1)

  • FINANCIAL PERFORMANCE

    Jérôme Contamine

    Executive Vice President, Chief Financial Officer

    22

  • €212m

    Q1 2013 FX Impact Growth Platforms

    €464m

    Copaxone and Others

    -€151m

    Key Genericized

    Products

    -€553m

    Q1 2012

    €8,511m

    As Expected, Q1 2013 Sales Were Impacted by the Residual Effect of the Patent Cliff and by FX

    23

    (1) Key genericized products include Lovenox® U.S., Plavix® Western EU, Taxotere® Western EU & U.S., Eloxatin® U.S., Ambien® family U.S., Allegra® U.S., Aprovel® Western EU, Xyzal® U.S., Xatral® U.S., Nasacort® U.S. and BMS Alliance (active ingredients of Plavix® and Avapro® sold to BMS)

    (2) Emerging Markets, Diabetes Solutions, Vaccines, Consumer Healthcare, Animal Health, Genzyme and Other Innovative Products

    Q1 2013 Sales (€m)

    (1)

    (2)

    €8,059m

    ®

  • Q3 2012 Q2 2012 Q1 2012 Q4 2012 Q1 2013

    24

    Q1 2013 Performance Impacted by Unfavorable Currency Headwind in Japan and Latin America

    Currency impact on sales in Q1 2013: JPY / Japanese Yen (-€113.7m); BRL / Brazilian Real (-€36.0m) ; VEF / Venezuelan Bolivar (-€14.3m); USD / US Dollar (-€14.2m); ZAR / South African Rand (-€9.8m)

    Quarterly Currency Impact (in % change)

    Q1 2012 Q1 2013 Q4 2012 Q3 2012 Q2 2012

    +2.4%

    +5.8%

    +4.0%

    +8.0%

    €486m

    €187m

    €235m

    €120m

    +6.4% €561m

    +8.2% €277m

    Sales Business Operating Income

    +1.9% €166m

    +2.1% €61m

    -2.5% -€212m -4.5%

    -€154m

  • 25

    Q1 2013 Reflects the Impact of Plavix®/Avapro® U.S. LoE but also Illustrates Good Cost Control

    €m Q1 2013 Q1 2012 % Change (reported €) % Change

    (CER)

    Net sales 8,059 8,511 -5.3% -2.8%

    Other revenues 98 426 -77.0% -76.5%

    Cost of sales (2,536) (2,608) -2.8% -1.1%

    Gross profit 5,621 6,329 -11.2% -8.5%

    R&D (1,155) (1,172) -1.5% -0.6%

    SG&A (2,129) (2,116) +0.6% +2.7%

    Other current operating income & expenses 30 157 - -

    Share of Profit/Loss of associates 18 297 - -

    Minority interests (41) (54) - -

    Business operating income 2,344 3,441 -31.9% -27.4%

    Business operating margin 29.1% 40.4% - -

    CER: Constant Exchange Rates LoE: Loss of Exclusivity (1) With the retroactive application of IAS19R

    (1)

  • Q1 2013 CoS Ratio Slightly Better than FY 2012 Average(1)

    ● Slightly lower Cost of Sales (CoS) in Q1 2013: €2,536m, down -1.1% at CER

    ● CoS ratio slightly up in Q1 2013 vs. Q1 2012 reflecting: ● Loss of sales from Key Genericized

    Products with relatively low CoS ● Relatively higher vaccines sales

    in Emerging Markets and from VaxServe(1)

    ● Unfavourable currency impact

    26

    Cost of Sales (%)

    2012 2013

    31.5% 30.6%

    (1) FY 2012 CoS ratio was 31.7% (2) VaxServe, a Sanofi Pasteur company, is a U.S. healthcare supplier serving primary care physician

    offices, community immunization providers, immunizing pharmacies, travel clinics and corporations

  • Rigorous Control of R&D Expenses While Significantly Investing in Phase III Trials

    27

    ● Q1 2013 R&D expenses of €1,155m, down -0.6% at CER reflecting: ● Ongoing multiple Phase III trials

    (e.g. alirocumab, new insulin glargine formulation, JAK2, sarilumab)

    ● Lower expenses in research and medical affairs

    ● Quarterly R&D spend in line with guidance

    27

    R&D Expenses (€m)

    2012 2013

    €1,155m €1,172m

  • Increase in SG&A Expenses in Q1 2013 Driven by New Product Launch Costs

    28

    ● Q1 2013 SG&A expenses of €2,129m, up +2.7% at CER reflecting:

    ● Sales & Marketing investment in product launches (e.g. Genzyme MS)

    ● Tight control of G&A expenses down -4.8% at CER

    ● Lower SG&A spend in Europe

    28

    SG&A Expenses (€m)

    2012 2013

    €2,129m €2,116m

  • 29

    €m Q1 2013 Q1 2012 % Change (reported €) % Change

    (CER)

    Business operating income 2,344 3,441 -31.9% -27.4%

    Net financial expenses (140) (169) - -

    Income tax expense (591) (848) - -

    Effective tax rate -26.5% -28.0% - -

    Business net income 1,613 2,424 -33.5% -28.8%

    Net margin 20.0% 28.5% - -

    Business EPS(2) €1.22 €1.83 -33.3% -29.0%

    Average number of shares outstanding (m) 1,322.2 1,321.2 - -

    As Expected, Q1 2013 Business EPS Reflected the Residual Impact of the Patent Cliff(1)

    29

    (1) With the retroactive application of IAS19R (2) Business EPS was down -7.8% at CER in Q1 2013 excluding Plavix® and Avapro®

    Loss of Exclusivity in the U.S. - Avapro® on March 30, 2012 and Plavix® on May 17, 2012

    CER: Constant Exchange Rates

    (1)

  • Net Debt Mar 31, 2013

    Other

    -133

    Share Repurchase

    -401

    Acquisitions & Licensing

    -345

    CapEx

    - 301

    Net Cash from Operating Activities

    Net Debt Dec 31, 2012

    Free Cash Flow Affected by U.S. Loss of Exclusivity of Plavix® and Avapro®

    30

    (1)

    (2)

    -7,719 -7,440

    FCF +1,158

    +1,459

    (1)

    Q1 2013 (€m)

    (3)

    (1) Including derivatives related to the financial debt €431m at Dec 31, 2012 and €420m at Mar 31, 2013 (2) Excluding restructuring costs (3) “Other” include €204m of restructuring costs

    Net debt decreased by €279m in Q1 2013

  • Sanofi Expects to Resume Growth in H2 2013

    Solid performance of our Growth Platforms representing 71% of sales

    As expected, Q1 2013 Business EPS impacted by exclusivity losses in prior year

    Continued good cost control illustrated by Q1 2013 OpEx

    Guidance for FY 2013 reaffirmed

    Significant newsflow related to late stage R&D pipeline

    1

    2

    3

    4

    31

    5

  • APPENDICES R&D Pipeline

    32

  • 33

    Late Stage Pipeline – Pharma & Vaccines

    eliglustat tartrate Glucosylceramide synthetase inhibitor

    Gaucher disease

    Insulin glargine New formulation

    Type 1+2 diabetes

    Quadracel® Diphtheria, tetanus, pertussis & polio vaccine; 4-6 y of age

    Fluzone® QIV IM Quadrivalent inactivated

    influenza vaccine

    iniparib (BSI-201) Squamous NSCLC (1L)

    otamixaban Direct Xa inhibitor

    ACS

    Dengue Mild-to-severe

    dengue fever vaccine

    VaxiGrip® QIV IM Quadrivalent inactivated

    influenza vaccine

    SAR302503 (TG101348) JAK-2 inhibitor

    Myelofibrosis (1L)

    Kynamro™ (mipomersen) Apolipoprotein B-100 antisense

    Severe HeFH, U.S.

    DTP-HepB-Polio-Hib (PR5I) Pediatric hexavalent vaccine

    Aubagio® (teriflunomide) Relapsing forms of Multiple sclerosis

    (RMS) – Monotherapy, EU

    Jevtana® (cabazitaxel) Metastatic prostate cancer (1L)

    alirocumab (SAR236553) Anti-PCSK-9 mAb

    Hypercholesterolemia

    Fluzone® QIV ID Quadrivalent inactivated

    influenza vaccine intradermal

    Lemtrada™ (alemtuzumab) Anti-CD52 mAb

    Multiple sclerosis, EU, U.S.

    SYNVISC-ONE® Medical device Pain in hip OA

    sarilumab (SAR153191) Anti-IL-6R mAb

    Rheumatoid arthritis

    SAR399063 DHA-GLP + vit D Pre-sarcopenia

    Lyxumia® (lixisenatide) GLP-1 agonist

    Type 2 diabetes, U.S., Japan

    MACI® Cell-based treatment

    Articular cartilage defects

    Registration Phase III

    N N

    N

    N

    N

    33

    N

    N

    N New Molecular Entity Immune Mediated Diseases

    Rare Diseases

    Oncology Diabetes Solutions

    Vaccines

    Infectious Diseases

    Cardiovascular Diseases

    Age Related Degenerative Diseases

    Ophthalmology

    N

    Biosurgery

    N

  • Early Stage Pipeline – Pharma & Vaccines

    iniparib (BSI-201) Platinum-resistant ovarian cancer (2L)

    Metastatic triple negative breast cancer (mTNBC)

    FOV1101 FDC prednisolone/cyclosporine

    Allergic conjunctivitis

    fresolumimab TGFβ antagonist

    Fibrosis

    SAR3419 Maytansin-loaded anti-CD19 mAb

    B-cell malignancies refractory/relapsed (NHL, ALL)

    SAR292833 (GRC15300) TRPV3 antagonist

    Neuropathic pain, osteoarthritic pain

    SAR279356 (F598) Anti-PNAG mAb Serious infections

    SAR256212 (MM121) anti-ErbB3 mAb

    Breast cancer (2L, 3L)

    SAR110894 H3 antagonist

    Alzheimer's disease

    ferroquine Antimalarial

    Malaria

    SAR245408 (XL147) Oral PI3K inhibitor

    Breast cancer

    SAR113945 IKK-β inhibitor Osteoarthritis

    SAR97276 Antimalarial

    Malaria

    SAR245409 (XL765) Oral dual inhibitor of PI3K & mTOR

    Non-Hodgkin lymphoma

    Meninge ACYW conj. 2nd generation meningococcal

    conjugate infant vaccine

    dupilumab (SAR231893) Anti-IL4Rα mAb

    Asthma; Atopic dermatitis

    SAR302503 (TG101348) JAK-2 inhibitor

    Polycythemia vera (2L) Ruxolitinib resistant/intolerant MF

    ACAM-Cdiff Clostridium difficile

    Toxoid vaccine

    SAR339658 VLA 2 antagonist

    Inflammatory bowel disease

    Jevtana® (cabazitaxel) Small cell lung cancer (2L)

    Rabies VRVg Purified vero rabies vaccine

    SAR156597 IL4/IL13 Bi-specific mAb

    Idiopathic pulmonary fibrosis

    lixisenatide + Lantus® GLP-1 agonist + insulin glargine

    Fixed-Ratio / Type 2 diabetes

    Rotavirus Live attenuated tetravalent

    Rotavirus oral vaccine

    SAR100842 LPA-1/LPA-3

    Skin manifestation of scleroderma

    Phase II

    N

    N

    N

    N

    N

    N

    N

    N

    N N

    N

    N

    34

    N

    N

    N

    34

    N New Molecular Entity Immune Mediated Diseases

    Rare Diseases

    Oncology Diabetes Solutions

    Vaccines

    Infectious Diseases

    Cardiovascular Diseases

    Age Related Degenerative Diseases

    Ophthalmology

    Biosurgery

    N

  • Early Stage Pipeline – Pharma & Vaccines

    SAR153192 Anti-DLL4 mAb

    Solid tumors

    SAR260301 PI3K β selective

    PTEN – Deficient tumors

    SAR252067 Anti-LIGHT mAb

    Crohn’s disease & Ulcerative colitis

    Streptococcus pneumonia Meningitis & pneumonia vaccine

    GZ402674 Non-camptothecin topo1 inhibitor

    Solid tumors

    SAR405838 (MI-773) HDM2 / p53 antagonist

    Solid tumors

    SAR113244 Anti-CXCRS mAb

    Systemic lupus erythematosus

    Pseudomonas aeruginosa Antibody fragment product

    Prevention of ventilator-associated pneumonia

    SAR650984 Anti-CD38 naked mAb

    Hematological malignancies

    GZ404477 (AAV-hAADC) Gene therapy

    Parkinson's disease

    SAR127963 P75 receptor antagonist

    Trauma brain injury

    Tuberculosis Recombinant subunit vaccine

    SAR566658 Maytansin-loaded anti-CA6 mAb

    Solid tumors

    SAR391786 Rehabilitation post orthopedic surgery

    SAR126119 TAFIa inhibitor

    Acute ischemic stroke

    RetinoStat® Gene therapy

    Wet age-related macular degeneration (AMD)

    SAR307746 Anti-ANG2 mAb

    Solid tumors

    SAR228810 Anti-protofibrillar AB mAb

    Alzheimer’s disease

    SAR407899 Rho kinase inhibitor

    Pulmonary hypertension

    StarGen® Gene therapy

    Stargardt disease

    SAR125844 C-MET kinase inhibitor

    Solid tumors

    SAR404460 DHA-GPL + Vit D Pre-sarcopenia

    GZ402665 (rhASM)

    Niemann-Pick type B

    GZ402663 (sFLT-01) Gene therapy

    Age-related macular degeneration (AMD)

    Combinations SAR245409 / MSC1936369B

    SAR245408/SAR256212 (MM121) Solid tumors

    lixisenatide + Lantus® GLP-1 agonist + insulin glargine

    Fix-Flex / Type 2 diabetes

    GZ402671 GCS Inhibitor Fabry Disease

    UshStat® Gene therapy

    Usher syndrome 1B

    Phase I N

    N

    N

    N

    N

    N

    N

    N N N N

    N N

    N

    N

    N

    N

    N

    N

    N

    N

    N

    35 35

    N New Molecular Entity Immune Mediated Diseases

    Rare Diseases

    Oncology Diabetes Solutions

    Vaccines

    Infectious Diseases

    Cardiovascular Diseases

    Age Related Degenerative Diseases

    Ophthalmology

    Biosurgery

    N

  • 36

    Phase I Phase II Phase III Registration TOTAL

    Oncology 8 4 2 0 14

    Diabetes Solutions 0 0 0 1 1

    Cardiovascular Diseases 3 1 2 0 6

    Immune Mediated Diseases 2 4 1 2 9

    Infectious Diseases 0 3 0 0 3

    Ophthalmology 4 1 0 0 5

    Rare Diseases 2 0 1 0 3

    Age Related Degenerative Diseases 4 3 1 0 8

    Vaccines 3 4 4 2 13

    TOTAL 26 20 11 5

    R&D Pipeline Summary Table(1)

    46 16 NMEs & Vaccines

    62

    36

    49

    (1) Excluding life cycle management programs

  • 37

    Expected R&D Milestones

    37

    Product Event Timing Lemtrada™ (alemtuzumab) Expected CHMP decision in RMS in EU Q2 2013

    Sarilumab Start of additional Phase III studies (COMPARE and ASCERTAIN) in RA Q2 2013

    New insulin glargine formulation First Phase III headline results in diabetes (EDITION I & II) Q2 2013

    Otamixaban Phase III headline results in ACS Q2 2013

    JAK2 inhibitor Phase III headline results in Myelofibrosis Q2 2013

    Iniparib Phase III headline results in 1st line Squamous NSCLC Q2 2013

    Fluzone® Quadrivalent IM Expected FDA decision in the U.S. Q2 2013

    Aubagio® (teriflunomide) Expected CHMP reexamination of NAS status in EU Mid-year

    Dupilumab (anti IL-4Rα mAb) Expected start of Phase IIb studies in Asthma and Atopic Dermatitis Mid-year

    Alirocumab (anti PCSK9 mAb) First Phase III headline results in Hypercholesterolemia Q3 2013

    C. Diff vaccine Expected start of Phase III program Q3 2013

    Eliglustat Expected U.S. and EU regulatory submissions in Gaucher disease Q4 2013

    Lemtrada™ (alemtuzumab) Expected FDA decision in RMS in the U.S. H2 2013

  • APPENDICES FINANCE

    38

  • Business Net Income Statement

    First quarter

    Net sales 8,059 8,511 (5.3%) 6,808 7,316 (6.9%) 697 617 13.0% 554 578 (4.2%)Other revenues 98 426 (77.0%) 83 412 (79.9%) 7 5 40.0% 8 9 (11.1%)Cost of sales (2,536) (2,608) (2.8%) (2,025) (2,178) (7.0%) (345) (262) 31.7% (166) (168) (1.2%)As % of net sales (31.5%) (30.6%) (29.7%) (29.8%) (49.5%) (42.5%) (29.9%) (29.1%)Gross profit 5,621 6,329 (11.2%) 4,866 5,550 (12.3%) 359 360 (0.3%) 396 419 (5.5%)As % of net sales 69.7% 74.4% 71.5% 75.9% 51.5% 58.3% 71.5% 72.5%Research and development expenses

    (1,155) (1,172) (1.5%) (988) (990) (0.2%) (128) (141) (9.2%) (39) (41) (4.9%)

    As % of net sales (14.3%) (13.8%) (14.5%) (13.5%) (18.4%) (22.9%) (7.0%) (7.1%)Selling and general expenses

    (2,129) (2,116) 0.6% (1,828) (1,819) 0.5% (139) (130) 6.9% (162) (167) (3.0%)

    As % of net sales (26.4%) (24.9%) (26.9%) (24.9%) (19.9%) (21.1%) (29.3%) (28.9%)Other current operating income/expenses

    30 157 31 152 2 (1) 1 (2) 4

    Share of profit/loss of associates*

    18 297 19 302 (1) (5)

    Net income attributable to non-controlling interests

    (41) (54) (41) (55)

    Business operating income 2,344 3,441 (31.9%) 2,059 3,140 (34.4%) 93 84 10.7% 194 213 (8.9%) (2) 4

    As % of net sales 29.1% 40.4% 30.2% 42.9% 13.3% 13.6% 35.0% 36.9%Financial income and expenses (140) (169)

    Income tax expense (591) (848)

    Tax rate** 26.5% 28.0%Business net income 1,613 2,424 (33.5%)As % of net sales 20.0% 28.5%Business earnings per share*** (in euros)

    1.22 1.83 (33.3%)

    Group Total

    € million Q1 2013 Q1 2012(1) Q1 2012(1) Q1 2013 Q1 2012(1) Q1 2013change

    Pharmaceuticals

    change

    OtherVaccines Animal health

    Q1 2012(1)change change Q1 2013Q1 2013 Q1 2012(1)

    (1) Including impact of transition to IAS19R * Net of tax ** Determined on the basis of Business income before tax, associates, and non-controlling interests *** Based on an average number of shares outstanding of 1,322.2 million in the first quarter of 2013 and 1,321.2 million in the first quarter of 2012 39

  • 40 40

    Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi

    € million Q1 2013 Q1 2012(1) change

    Business net income 1,613 2,424 (33.5%)Amortization of intangible assets (775) (833)

    Impairment of intangible assets (10) (1)

    Fair value remeasurement of contingent consideration liabilities (41) (33)

    Expenses arising from the impact of acquisitions on inventories (3) (14)

    Restructuring costs (54) (87)

    Tax effect of: 280 360

    amortization of intangib le assets 259 332 fair value remeasurement of contingent consideration liab ilities 4 2 expenses arising from the impact of acquisitions on inventories 1 4 restructuring costs 16 22

    Other tax items

    Share of items listed above attributable to non-controlling interests 1 1

    Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures

    (7) (8)

    Net income attributable to equity holders of Sanofi 1,004 1,809 (44.5%)Consolidated earnings per share (in euros) 0.76 1.37 (44.5%)

    (1) Including impact of transition to IAS19R

  • Consolidated Income Statement

    € million

    Net sales 8,059 8,511

    Other revenues 98 426

    Cost of sales (2,539) (2,622)

    Gross profit 5,618 6,315

    Research and development expenses (1,155) (1,172)

    Selling and general expenses (2,129) (2,116)

    Other operating income 71 206

    Other operating expenses (41) (49)

    Amortization of intangible assets (775) (833)

    Impairment of intangible assets (10) (1)

    Fair value remeasurement of contingent consideration liabilities (41) (33)

    Restructuring costs (54) (87)

    Other gains and losses, and litigation

    Operating income 1,484 2,230

    Financial expenses (157) (189)

    Financial income 17 20

    Income before tax and associates and joint ventures 1,344 2,061

    Income tax expense (311) (488)

    Share of profit / loss of associates and joint ventures 11 289

    Net income 1,044 1,862

    Net income attributable to non-controlling interests 40 53

    Net income attributable to equity holders of Sanofi 1,004 1,809

    Average number of shares outstanding (million) 1,322.2 1,321.2

    Consolidated earnings per share (in euros) 0.76 1.37

    Q1 2012(1)Q1 2013

    41 (1) Including impact of transition to IAS19R

    Q1 2013 RESULTSForward Looking StatementsAgendaDiapositive numéro 4Key Genericized Products Represented Only ~€260m�of Sales for a Second Quarter in a RowGrowth Platforms Grew by +8.6% in Q1 2013�and Reached 71% of SalesQ1 2013 Sales Were Affected by U.S. Loss of Exclusivity �of Eloxatin® in August 2012 and by FX Fluctuations(1)The Loss of U.S. Exclusivity of Plavix® and Avapro® Impacted Business EPS by €0.42 in Q1 2013As Anticipated, Q1 2013 Business EPS Was Better �than Q4 2012 TroughRecent Regulatory Approvals Have Resulted �in Six New Product LaunchesSeveral Important Study Releases and Regulatory Milestones Achieved in the Last 4 MonthsAdditional Phase III Trial Readouts and Regulatory Decisions Expected Throughout 2013Diapositive numéro 13Diapositive numéro 14Diapositive numéro 15Double-Digit Growth of our Diabetes Franchise �for Nine Consecutive QuartersDiapositive numéro 17Merial Performance Reflected Lower Sales of Frontline® �in Q1 2013Diapositive numéro 19Diapositive numéro 20Diapositive numéro 21Diapositive numéro 22As Expected, Q1 2013 Sales Were Impacted �by the Residual Effect of the Patent Cliff and by FXQ1 2013 Performance Impacted by Unfavorable Currency Headwind in Japan and Latin AmericaQ1 2013 Reflects the Impact of Plavix®/Avapro® U.S. LoE �but also Illustrates Good Cost ControlQ1 2013 CoS Ratio Slightly Better than FY 2012 Average(1)Rigorous Control of R&D Expenses While Significantly Investing in Phase III TrialsIncrease in SG&A Expenses in Q1 2013�Driven by New Product Launch CostsAs Expected, Q1 2013 Business EPS Reflected the Residual Impact of the Patent Cliff(1)Free Cash Flow Affected by U.S. Loss of Exclusivity �of Plavix® and Avapro®Sanofi Expects to Resume Growth in H2 2013Diapositive numéro 32Late Stage Pipeline – Pharma & VaccinesEarly Stage Pipeline – Pharma & VaccinesEarly Stage Pipeline – Pharma & VaccinesR&D Pipeline Summary Table(1)Expected R&D MilestonesDiapositive numéro 38Business Net Income StatementReconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of SanofiConsolidated Income Statement


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