Q1 2013 Results


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Q1 2013 Results

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Q1 2013 Results

  1. 1. Q1 2013 RESULTSMay 2, 2013
  2. 2. 2Forward Looking StatementsThis presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of1995, as amended. Forward-looking statements are statements that are not historical facts. These statements includeprojections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions andexpectations 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 Sanofismanagement believes that the expectations reflected in such forward-looking statements are reasonable, investors arecautioned that forward-looking information and statements are subject to various risks and uncertainties, many of whichare difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments todiffer 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 theEMA, regarding whether and when to approve any drug, device or biological application that may be filed for any suchproduct candidates as well as their decisions regarding labeling and other matters that could affect the availability orcommercial potential of such product candidates, the absence of guarantee that the product candidates if approved willbe commercially successful, the future approval and commercial success of therapeutic alternatives, the Groups abilityto benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of costcontainment policies and subsequent changes thereto, the average number of shares outstanding as well as thosediscussed 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 Sanofis annual report on Form20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake anyobligation to update or revise any forward-looking information or statements.
  3. 3. 33AgendaKey Highlights● Christopher A. Viehbacher, Chief Executive OfficerBusiness Performance● Hanspeter Spek, President, Global OperationsFinancial Performance● Jérôme Contamine, Executive Vice President, Chief Financial OfficerQ&A
  4. 4. KEY HIGHLIGHTSChristopher A. ViehbacherChief Executive Officer4
  5. 5. Key Genericized Products Represented Only ~€260mof Sales for a Second Quarter in a RowQ1 2013€259mQ4 2012€257mQ3 2012€399mQ2 2012€752mQ1 2012€813m5One quarter to go before the impact ofKey Genericized Products(1) becomes minimalKey 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
  6. 6. Growth Platforms Grew by +8.6% in Q1 2013and Reached 71% of Sales6(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 €811mDiabetes Solutions €1,542mVaccines €697mAnimal Health €554mEmerging Markets €2,719mGenzyme(1)€493mQ1 2013 growth at CER
  7. 7. Q1 2013 Sales Were Affected by U.S. Loss of Exclusivityof Eloxatin® in August 2012 and by FX Fluctuations(1)€9,040mQ4 2012€8,526mQ3 2012Q2 2012€8,870mQ1 2012€8,511mQ1 2013€8,059mSales7(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)
  8. 8. Q1 2013Q1 2012 Q1 20128"Other Revenues" "Income from Associates"(1) Avapro® on March 30, 2012 and Plavix® on May 17, 2012(2) At constant exchange ratesQ1 2013€426mLoss of Exclusivity of Plavix® & Avapro® in the U.S.(1)€297mImpact onQ1 2013Business NetIncome:€562m(2)€98m€18mResidual impact(2)on BNI of Plavix® & Avapro® U.S. LoEexpected to be around €240m in Q2 2013The Loss of U.S. Exclusivity of Plavix® and Avapro®Impacted Business EPS by €0.42 in Q1 2013
  9. 9. Q1 2013€1.22Q4 2012Q2 2012€1.17€1.46Q3 2012Q1 2012€1.67€1.83As Anticipated, Q1 2013 Business EPS Was Betterthan Q4 2012 TroughBusiness EPS9-29.0%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)
  10. 10. ®Type 2 Diabetes EU roll-out starting in late March 2013Recent Regulatory Approvals Have Resultedin Six New Product Launches10Zaltrap® is developed in collaboration with Regeneron, Kynamro™ with Isis Pharmaceuticals and Lyxumia® is in-licensedfrom Zealand Pharma. Sanofi U.S. licensed the North American commercialization rights to AUVI-Q™ from Intelliject Inc.Launch StatusProducts®MetastaticColorectal CancerIndicationsLaunched in the U.S. in August 2012EU roll-out starting in late March 2013Relapsing Formsof Multiple Sclerosis®Launched in the U.S. in October 2012Launched in the U.S. in January 2013Life-Threatening AllergicReactionsPrevention of Poliomyelitis Launched in Japan in September 2012Homozygous FamilialHypercholesterolemiaLaunched in the U.S. in late March 2013
  11. 11. Several Important Study Releases and RegulatoryMilestones Achieved in the Last 4 Months11Clinical Data Releases● Eliglustat tartrate - Phase III inGaucher disease (ENCORE)● Dupilumab - PoC in Atopic Dermatitisand Severe Asthma● Lemtrada™ - Phase III in MS (1-yearExtension of CARE-MS Program)● Aubagio® - Phase III in ClinicallyIsolated Syndrome (TOPIC)Regulatory Milestones● Lemtrada™ FDA file acceptance in MS● Aubagio® positive CHMP opinion inMS● Lyxumia®FDA file acceptance in type IIdiabetes● Hexyon®/Hexacima®EC approval(DTaP-IPV-Hib-HepB vaccine)● Quadrivalent Influenza Vaccineaccepted 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
  12. 12. Additional Phase III Trial Readouts and RegulatoryDecisions Expected Throughout 2013122013Expected 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 
  13. 13. Composition of the Executive Committeeas of July 1st, 2013Karen LinehanExecutive VPLegal Affairs &General CounselChristopher A. ViehbacherChief Executive OfficerJérôme ContamineExecutive VPChief Financial OfficerElias ZerhouniPresidentGlobal R&DOlivier CharmeilExecutive VPVaccinesPeter GuenterExecutive VPGlobal CommercialOperationsRoberto PucciExecutive VPHuman ResourcesPhilippe LuscanExecutive VPIndustrial AffairsDavid-Alexandre GrosExecutive VPChief Strategy Officer13Pascale WitzExecutive VPGlobal Divisions &Strategic CommercialDevelopment
  14. 14. BUSINESS PERFORMANCE14Hanspeter SpekPresident, Global Operations
  15. 15. (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 ZealandEmerging Markets Represented >1/3 of Total Salesand 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 CER33.7%29.0%24.8%12.5%15(1)+4.7% +11.9% -0.2% +11.7%Growthat CERQ1 2013 Sales (€m)
  16. 16. 16Double-Digit Growth of our Diabetes Franchisefor Nine Consecutive QuartersQuarterly 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% ofU.S. sales (vs. 51.1% in Q1 2012)● Strong growth in Emerging Marketswith sales up +19.9% at CER● Recovery of Apidra® continues, up+30.8% at CER● Lyxumia® launched in Germany andthe UK in March 2013
  17. 17. 17Consumer Healthcare Showed Steady PerformanceExcept in China in Q1 2013€199mQ1 2013 Sales (€m)● Q1 2013 sales of €811m, up +3.1%at CER● Double-digit sales growth of severalleading brands (Doliprane®, Dorflex®,Enterogermina®)● Lower sales in China due to reducedtrade inventory levels and ongoingrationalization of distributors● Allegra® OTC sales of €99m, up+6.3% at CER driven by recentlaunch in Japan● New Allegra® anti-itch creamintroduced in the U.S. in April€177m€368m€67m
  18. 18. 18Merial Performance Reflected Lower Sales of Frontline®in Q1 2013Q12011Q22011Q32011Q42011Q12012Q22012Q32012Q42012Q12013Quarterly 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 unfavorableweather conditions, increasedcompetition and weak economicenvironment in Europe● Strong sales of Heartgard® benefitingfrom competitor supply issue● Production Animals sales of €180m,up +1.6% at CER€554m
  19. 19. €47m€112m€149m€92m€116m€171m19Genzyme Rare Diseases Growth Accelerated in Q1 2013&Q12013Q12012Q12013Q12012Q12013Q12012● Q1 2013 Rare Disease sales of€473m, up +20.5% at CER driven bysupply recovery and growingnumber of patients on therapy● Fabrazyme® sales reached €92mdoubling in the U.S. as well as inWestern Europe● Myozyme® grew +4.5% at CER to€116m● Cerezyme® sales increased +16.8%at CER to €171m driven by stronggrowth in Emerging Markets and theU.S.Quarterly Sales (€m)
  20. 20. 2020(1) IMS Weekly Total Prescriptions(2) Based on data collected at Genzymes 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 toAUBAGIO® were most recentlyon IFN-beta or Copaxone®● Positive CHMP opinion granted inMarch 2013● Request for CHMP re-examination ofNAS designation filed(3)● Ongoing regulatory review ofLemtrada™ in EU and the U.S.A Promising Entry in the Large MS MarketLemtrada™ is the registered trade name for alemtuzumab in MS submitted to health authoritiesLemtrada™ is developed in collaboration with Bayer HealthCareRELAPSE 31%DISABILITY 30%TEMSO(4)TOWER(4)TOPIC(4)RELAPSE 36%DISABILITY 31%REDUCTION IN RISK OFCONVERSION TO CDMS43%
  21. 21. 21Q1 2013€697mQ1 2012€617mOtherMeningitis/PneumoTravel/EndemicInfluenza VaccinesAdult BoostersPolio/Pertussis/Hib+15.9%at CERQuarterly Sales (€m)Vaccines Deliver a Strong First Quarter● Q1 2013 sales of €697m, up +15.9%at CER● PPH sales of €270m, +15.9% atCER driven by favorable phasing ofPentaxim® rollout in China and IPVcampaign in Japan● Influenza sales of €119m, +34.8% atCER from successful SH campaignand late U.S. sales● Solid sales of Menactra® in the U.S.and LatAm (€67m, +19.6% at CER)● Pentacel® progressive recoveryexpected to begin as of mid-2013in the U.S.(1) Includes VaxServe, a U.S. healthcare supplier serving primary care physician offices, communityimmunization providers, immunizing pharmacies, travel clinics and corporations.SH: Southern Hemisphere(1)
  22. 22. FINANCIAL PERFORMANCEJérôme ContamineExecutive Vice President, Chief Financial Officer22
  23. 23. €212mQ1 2013FX ImpactGrowthPlatforms€464mCopaxoneand Others-€151mKeyGenericizedProducts-€553mQ1 2012€8,511mAs Expected, Q1 2013 Sales Were Impactedby the Residual Effect of the Patent Cliff and by FX23(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 ProductsQ1 2013 Sales (€m)(1)(2)€8,059m®
  24. 24. Q3 2012Q2 2012Q1 2012 Q4 2012 Q1 201324Q1 2013 Performance Impacted by Unfavorable CurrencyHeadwind in Japan and Latin AmericaCurrency 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 2013Q4 2012Q3 2012Q2 2012+2.4%+5.8%+4.0%+8.0%€486m€187m€235m€120m+6.4%€561m+8.2%€277mSales Business Operating Income+1.9%€166m+2.1%€61m-2.5%-€212m -4.5%-€154m
  25. 25. 25Q1 2013 Reflects the Impact of Plavix®/Avapro® U.S. LoEbut 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)
  26. 26. 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 2013vs. Q1 2012 reflecting:● Loss of sales from Key GenericizedProducts with relatively low CoS● Relatively higher vaccines salesin Emerging Markets and fromVaxServe(1)● Unfavourable currency impact26Cost of Sales (%)2012 201331.5%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 physicianoffices, community immunization providers, immunizing pharmacies, travel clinics and corporations
  27. 27. Rigorous Control of R&D Expenses While SignificantlyInvesting in Phase III Trials27● Q1 2013 R&D expenses of€1,155m, down -0.6% at CERreflecting:● Ongoing multiple Phase III trials(e.g. alirocumab, new insulin glargineformulation, JAK2, sarilumab)● Lower expenses in research andmedical affairs● Quarterly R&D spend in line withguidance27R&D Expenses (€m)2012 2013€1,155m€1,172m
  28. 28. Increase in SG&A Expenses in Q1 2013Driven by New Product Launch Costs28● Q1 2013 SG&A expenses of€2,129m, up +2.7% at CERreflecting:● Sales & Marketing investment inproduct launches (e.g. Genzyme MS)● Tight control of G&A expensesdown -4.8% at CER● Lower SG&A spend in Europe28SG&A Expenses (€m)2012 2013€2,129m€2,116m
  29. 29. 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 theResidual 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, 2012CER: Constant Exchange Rates(1)
  30. 30. Net DebtMar 31, 2013Other-133Share Repurchase-401Acquisitions& Licensing-345CapEx- 301Net Cash fromOperatingActivitiesNet DebtDec 31, 2012Free Cash Flow Affected by U.S. Loss of Exclusivityof Plavix® and Avapro®30(1)(2)-7,719-7,440FCF+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 costsNet debt decreased by €279m in Q1 2013
  31. 31. Sanofi Expects to Resume Growth in H2 2013Solid performance of our Growth Platforms representing 71% of salesAs expected, Q1 2013 Business EPS impacted by exclusivity lossesin prior yearContinued good cost control illustrated by Q1 2013 OpExGuidance for FY 2013 reaffirmedSignificant newsflow related to late stage R&D pipeline1234315
  32. 32. APPENDICESR&D Pipeline32
  33. 33. 33Late Stage Pipeline – Pharma & Vaccineseliglustat tartrateGlucosylceramide synthetase inhibitorGaucher diseaseInsulin glargineNew formulationType 1+2 diabetesQuadracel®Diphtheria, tetanus, pertussis& polio vaccine; 4-6 y of ageFluzone® QIV IMQuadrivalent inactivatedinfluenza vaccineiniparib (BSI-201)Squamous NSCLC (1L)otamixabanDirect Xa inhibitorACSDengueMild-to-severedengue fever vaccineVaxiGrip® QIV IMQuadrivalent inactivatedinfluenza vaccineSAR302503 (TG101348)JAK-2 inhibitorMyelofibrosis (1L)Kynamro™ (mipomersen)Apolipoprotein B-100 antisenseSevere HeFH, U.S.DTP-HepB-Polio-Hib (PR5I)Pediatric hexavalent vaccineAubagio® (teriflunomide)Relapsing forms of Multiple sclerosis(RMS) – Monotherapy, EUJevtana® (cabazitaxel)Metastatic prostate cancer (1L)alirocumab (SAR236553)Anti-PCSK-9 mAbHypercholesterolemiaFluzone® QIV IDQuadrivalent inactivatedinfluenza vaccine intradermalLemtrada™ (alemtuzumab)Anti-CD52 mAbMultiple sclerosis, EU, U.S.SYNVISC-ONE®Medical devicePain in hip OAsarilumab (SAR153191)Anti-IL-6R mAbRheumatoid arthritisSAR399063DHA-GLP + vit DPre-sarcopeniaLyxumia® (lixisenatide)GLP-1 agonistType 2 diabetes, U.S., JapanMACI®Cell-based treatmentArticular cartilage defectsRegistrationPhase IIIN NNNN33NNN New Molecular EntityImmune Mediated DiseasesRare DiseasesOncologyDiabetes SolutionsVaccinesInfectious DiseasesCardiovascular DiseasesAge Related DegenerativeDiseasesOphthalmologyNBiosurgeryN
  34. 34. Early Stage Pipeline – Pharma & Vaccinesiniparib (BSI-201)Platinum-resistant ovarian cancer (2L)Metastatic triple negative breast cancer (mTNBC)FOV1101FDC prednisolone/cyclosporineAllergic conjunctivitisfresolumimabTGFβ antagonistFibrosisSAR3419Maytansin-loaded anti-CD19 mAbB-cell malignancies refractory/relapsed(NHL, ALL)SAR292833 (GRC15300)TRPV3 antagonistNeuropathic pain, osteoarthritic painSAR279356 (F598)Anti-PNAG mAbSerious infectionsSAR256212 (MM121)anti-ErbB3 mAbBreast cancer (2L, 3L)SAR110894H3 antagonistAlzheimers diseaseferroquineAntimalarialMalariaSAR245408 (XL147)Oral PI3K inhibitorBreast cancerSAR113945IKK-β inhibitorOsteoarthritisSAR97276AntimalarialMalariaSAR245409 (XL765)Oral dual inhibitor of PI3K & mTORNon-Hodgkin lymphomaMeninge ACYW conj.2nd generation meningococcalconjugate infant vaccinedupilumab (SAR231893)Anti-IL4Rα mAbAsthma; Atopic dermatitisSAR302503 (TG101348)JAK-2 inhibitorPolycythemia vera (2L)Ruxolitinib resistant/intolerant MFACAM-CdiffClostridium difficileToxoid vaccineSAR339658VLA 2 antagonistInflammatory bowel diseaseJevtana® (cabazitaxel)Small cell lung cancer (2L)Rabies VRVgPurified vero rabies vaccineSAR156597IL4/IL13 Bi-specific mAbIdiopathic pulmonary fibrosislixisenatide + Lantus®GLP-1 agonist + insulin glargineFixed-Ratio / Type 2 diabetesRotavirusLive attenuated tetravalentRotavirus oral vaccineSAR100842LPA-1/LPA-3Skin manifestation of sclerodermaPhase IINNNNNNNNN NNN34NNN34N New Molecular EntityImmune Mediated DiseasesRare DiseasesOncologyDiabetes SolutionsVaccinesInfectious DiseasesCardiovascular DiseasesAge Related DegenerativeDiseasesOphthalmologyBiosurgeryN
  35. 35. Early Stage Pipeline – Pharma & VaccinesSAR153192Anti-DLL4 mAbSolid tumorsSAR260301PI3K β selectivePTEN – Deficient tumorsSAR252067Anti-LIGHT mAbCrohn’s disease & Ulcerative colitisStreptococcus pneumoniaMeningitis & pneumonia vaccineGZ402674Non-camptothecin topo1 inhibitorSolid tumorsSAR405838 (MI-773)HDM2 / p53 antagonistSolid tumorsSAR113244Anti-CXCRS mAbSystemic lupus erythematosusPseudomonas aeruginosaAntibody fragment productPrevention of ventilator-associated pneumoniaSAR650984Anti-CD38 naked mAbHematological malignanciesGZ404477(AAV-hAADC)Gene therapyParkinsons diseaseSAR127963P75 receptor antagonistTrauma brain injuryTuberculosisRecombinant subunit vaccineSAR566658Maytansin-loaded anti-CA6 mAbSolid tumorsSAR391786Rehabilitation post orthopedic surgerySAR126119TAFIa inhibitorAcute ischemic strokeRetinoStat®Gene therapyWet age-related macular degeneration (AMD)SAR307746Anti-ANG2 mAbSolid tumorsSAR228810Anti-protofibrillar AB mAbAlzheimer’s diseaseSAR407899Rho kinase inhibitorPulmonary hypertensionStarGen®Gene therapyStargardt diseaseSAR125844C-MET kinase inhibitorSolid tumorsSAR404460DHA-GPL + Vit DPre-sarcopeniaGZ402665(rhASM)Niemann-Pick type BGZ402663 (sFLT-01)Gene therapyAge-related macular degeneration(AMD)CombinationsSAR245409 / MSC1936369BSAR245408/SAR256212 (MM121)Solid tumorslixisenatide + Lantus®GLP-1 agonist + insulin glargineFix-Flex / Type 2 diabetesGZ402671GCS InhibitorFabry DiseaseUshStat®Gene therapyUsher syndrome 1BPhase INNNNNNNN N N NNNNNNNNNNNN3535N New Molecular EntityImmune Mediated DiseasesRare DiseasesOncologyDiabetes SolutionsVaccinesInfectious DiseasesCardiovascular DiseasesAge Related DegenerativeDiseasesOphthalmologyBiosurgeryN
  36. 36. 36Phase I Phase II Phase III Registration TOTALOncology 8 4 2 0 14Diabetes Solutions 0 0 0 1 1Cardiovascular Diseases 3 1 2 0 6Immune MediatedDiseases2 4 1 2 9Infectious Diseases 0 3 0 0 3Ophthalmology 4 1 0 0 5Rare Diseases 2 0 1 0 3Age RelatedDegenerative Diseases4 3 1 0 8Vaccines 3 4 4 2 13TOTAL 26 20 11 5R&D Pipeline Summary Table(1)46 16NMEs & Vaccines623649(1) Excluding life cycle management programs
  37. 37. 37Expected R&D Milestones37Product Event TimingLemtrada™ (alemtuzumab) Expected CHMP decision in RMS in EU Q2 2013Sarilumab Start of additional Phase III studies (COMPARE and ASCERTAIN) in RA Q2 2013New insulin glargine formulation First Phase III headline results in diabetes (EDITION I & II) Q2 2013Otamixaban Phase III headline results in ACS Q2 2013JAK2 inhibitor Phase III headline results in Myelofibrosis Q2 2013Iniparib Phase III headline results in 1st line Squamous NSCLC Q2 2013Fluzone® Quadrivalent IM Expected FDA decision in the U.S. Q2 2013Aubagio® (teriflunomide) Expected CHMP reexamination of NAS status in EU Mid-yearDupilumab (anti IL-4Rα mAb) Expected start of Phase IIb studies in Asthma and Atopic Dermatitis Mid-yearAlirocumab (anti PCSK9 mAb) First Phase III headline results in Hypercholesterolemia Q3 2013C. Diff vaccine Expected start of Phase III program Q3 2013Eliglustat Expected U.S. and EU regulatory submissions in Gaucher disease Q4 2013Lemtrada™ (alemtuzumab) Expected FDA decision in RMS in the U.S. H2 2013
  39. 39. Business Net Income StatementFirst quarterNet 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 developmentexpenses(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 generalexpenses(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 operatingincome/expenses30 157 31 152 2 (1) 1 (2) 4Share of profit/loss ofassociates* 18 297 19 302 (1) (5)Net income attributable tonon-controlling interests(41) (54) (41) (55)Business operatingincome2,344 3,441 (31.9%) 2,059 3,140 (34.4%) 93 84 10.7% 194 213 (8.9%) (2) 4As % of net sales 29.1% 40.4% 30.2% 42.9% 13.3% 13.6% 35.0% 36.9%Financial income andexpenses(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 pershare***(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 2013changePharmaceuticalschangeOtherVaccines Animal healthQ1 2012(1)changechange 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. 4040Reconciliation of Business Net Income to ConsolidatedNet Income Attributable to Equity Holders of Sanofi€ million Q1 2013 Q1 2012(1)changeBusiness 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 360amortization of intangible assets 259 332fair value remeasurement of contingent consideration liabilities 4 2expenses arising from the impact of acquisitions on inventories 1 4restructuring costs 16 22Other tax itemsShare of items listed above attributable to non-controlling interests 1 1Restructuring costs of associates and joint ventures, and expenses arising from the impactof 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
  41. 41. Consolidated Income Statement€ millionNet sales 8,059 8,511Other revenues 98 426Cost of sales (2,539) (2,622)Gross profit 5,618 6,315Research and development expenses (1,155) (1,172)Selling and general expenses (2,129) (2,116)Other operating income 71 206Other 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 litigationOperating income 1,484 2,230Financial expenses (157) (189)Financial income 17 20Income before tax and associates and joint ventures 1,344 2,061Income tax expense (311) (488)Share of profit / loss of associates and joint ventures 11 289Net income 1,044 1,862Net income attributable to non-controlling interests 40 53Net income attributable to equity holders of Sanofi 1,004 1,809Average number of shares outstanding (million) 1,322.2 1,321.2Consolidated earnings per share (in euros) 0.76 1.37Q1 2012(1)Q1 201341(1) Including impact of transition to IAS19R