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2012 - Morning Star HC

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2012 - Morning Star HC

2012 - Morning Star HC


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  • 1. Morningstar Healthcare Conference Dr. Paul ChewU.S. Chief Science Officer / Chief Medical Officer, SVP Chicago, November 7th, 2012
  • 2. Forward Looking StatementsThis presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Actof 1995, as amended. Forward-looking statements are statements that are not historical facts. These statementsinclude projections and estimates and their underlying assumptions, statements regarding plans, objectives,intentions and expectations with respect to future financial results, events, operations, services, productdevelopment and potential, and statements regarding future performance. Forward-looking statements aregenerally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similarexpressions. Although Sanofis management believes that the expectations reflected in such forward-lookingstatements are reasonable, investors are cautioned that forward-looking information and statements are subjectto various risks and uncertainties, many of which are difficult to predict and generally beyond the control ofSanofi, that could cause actual results and developments to differ materially from those expressed in, or impliedor projected by, the forward-looking information and statements. These risks and uncertainties include amongother things, the uncertainties inherent in research and development, future clinical data and analysis, includingpost marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and whento approve any drug, device or biological application that may be filed for any such product candidates as wellas their decisions regarding labeling and other matters that could affect the availability or commercial potential ofsuch product candidates, the absence of guarantee that the product candidates if approved will be commerciallysuccessful, the future approval and commercial success of therapeutic alternatives, the Groups ability to benefitfrom 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 asthose discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including thoselisted under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofisannual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law,Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 2
  • 3. Results Reflect Generic Competition to Legacy Blockbusters (1)and Loss of Exclusivity of Plavix® and Avapro® in the U.S. (2) YTD Sales (€m) YTD Business EPS (€) €26,421m €24,881m €5.09 €5.01 +1.2% -8.4% at CER(3) at CER(4) YTD 2011 YTD 2012 YTD 2011 YTD 2012 (1) Eloxatin® and Aprovel® lost their exclusivity in the U.S. and EU, respectively, in August 2012 (2) Avapro® in March 2012 and Plavix ® in May 2012 (3) On a reported basis, YTD 2012 sales w ere up +6.2% (4) On a reported basis, YTD 2012 Business EPS w as down -1.6% 3
  • 4. In Q3 2012 Growth Platforms Represented Over 70% of Sales (1) Key Genericized Products Sales Growth Platforms Sales (€m and % of Total Sales) (€m and % of Total Sales) €6,412m €5,753m €5,381m €3,339m 70.9% of Total €2,207m 4.4% Sales of Total Sales €813m €752m €399m Q2 Q1 Q2 Q3 Q2 Q1 Q2 Q3 2009 2012 2009 2012 (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) 4
  • 5. Growth Platforms Grew by +6.4% in Q3 2012 Growth at CER Emerging Markets €2,821m +6.8% Diabetes Solutions €1,486m +17.5% Vaccines €1,481m +0.7% Consumer Health Care €733m +5.9% Animal Health €519m +3.8% New Genzyme(1) €470m +22.5% Innovative Products(2) €154m +7.6% (1) New Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises (2) Includes new product launches which do not belong to the Grow th Platforms listed above: Multaq®, Jevtana®, Mozobil® and Zaltrap® 5
  • 6. Executing Successful Strategy to Reposition Sanofi 1 Increase innovation in R&D Deliver sustainable growth Pursue external growth 2 opportunities and generate improved shareholder returns Adapt structure for future 3 challenges and opportunities 6 6
  • 7. Several Regulatory Milestones Expected in Next 6 Months Products Targeted Indications Expected Milestones ® Metastatic CHMP Opinion: Q4 2012 Colorectal Cancer ® CHMP Opinion: Q4 2012 Type 2 Diabetes FDA Submission: Dec 2012 TM hoFH/severe heFH in EU CHMP Opinion: Q4 2012 and hoFH in the U.S PDUFA Date: Jan 29, 2013(1) ® Relapsing Forms of CHMP Opinion: Q1 2013 Multiple Sclerosis Relapsing Forms of FDA Re-Submission on track(2) Multiple Sclerosis CHMP Opinion: Q2 2013 New 6-in-1 DTP-HepB-Polio-Hib EU Licensure: Q2 2013 Paediatric Vaccine (1) On October 18th 2012, an FDA AdCom recommended Kynamro™ for hoFH (2) Sanofi w ill make an announcement w hen the FDA makes a decision concerning the acceptance of the file Lyxumia® , Kynamro™ and Lemtrada™ are registered trade names submitted to health authorities for investigational agents Zaltrap® is developed in collaboration w ith Regeneron, Kynamro™ w ith Isis Pharmaceuticals and Lyxumia® is in-licensed from Zealand Pharma Genzyme is developing Lemtrada™ in MS in collaboration w ith Bayer HealthCare hoFH: Homozygous Familial Hypercholesterolemia PDUFA: Prescription Drug User Fee Act 7 heFH: Heterozygous Familial Hypercholesterolemia CHMP: Committee for Medicinal Products for Human Use
  • 8. Now Available in the U.S. Key Facts about MS Oncology● A novel VEGF trap acting on multiple angiogenic targets● Indicated in combination with FOLFIRI in mCRC patients resistant to or progressing on an oxaliplatin-containing regimen● Significant improvement in Overall Survival demonstrated in the VELOUR study(1)● Launch on-track with sales of €7m in Q3 2012 (1) Van Cutsem, et al. Ann Oncol. 2011;22(suppl 5). Abstract O-0024 and presentation at: ESMO 13th WCGIC. June 22-25, 2011; Barcelona, Spain. 8
  • 9. An Exciting New Oral Treatment Now Approved by FDA for Relapsing MS● Aubagio® 14mg is the only oral MS drug to significantly delay disability progression in two Phase III trials(5)● Aubagio® 14mg provided statistically significant reduction in Annualized Relapse Rate● Well-characterized safety profile across placebo-controlled trials (6)● Convenient once-daily oral dosing● Launched October 2012 TEMSO STUDY TOWER STUDY TEMSO STUDY TOWER STUDY Annualized Relapse Rate(1) Annualized Relapse Rate(1) Reduction in Progression of Reduction in Progression of Disability(2) Disability(2) - 31.5% - 36.3% -29.8%(3) p=0.0005 0.501 p=0.0001 p=0.0279(4) 0.539 0.273 -31.5%(3) p=0.0442(4) 0.319 0.197 0.369 0.202 0.158 n=363 n=359 n=388 n=370 n=363 n=359 n=388 n=370 Placebo Aubagio® Placebo Aubagio® Placebo Aubagio® Placebo Aubagio® 14mg 14mg 14mg 14mg (1) Adjusted f or Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment into account (2) At Week 108 (3) Deriv ed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as cov ariates (4) Deriv ed f rom log-rank test with stratif ication of EDSS strata at baseline and region (5) TEMSO and TOWER. Analy sis of the f ull TOWER data is ongoing and results will be presented at a f orthcoming scientif ic meeting; Aubagio® 7mg tablets are also av ailable in the U.S. (6) The most f requent adv erse reactions f or AUBAGIO® in the placebo-controlled studies were ALT increased, alopecia, diarrhea, inf luenza, nausea, and paresthesia. 9 The AUBAGIO® label includes a boxed warning citing the risk of hepatotoxicity and teratogenicity (based on animal data).
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  • 12. Significantly More Effective at Reducing ARRin Pivotal Trials with Unique Dosing Regimen 12
  • 13. Broadening our Diabetes Platformwith New Patient Focused Solutions ® ● Once-daily and pronounced PPG lowering effect ● Use on top of basal insulin ● ELIXA: CV outcome study ongoing NEW ● Unique flat PK/PD profile and lower injection volume INSULIN GLARGINE FORMULATION ● EDITION program: six Phase III trials currently ongoing in T1D and T2D(2) ● First state-of-the art re-usable insulin pen, manufactured by a global company in India ● For use with Sanofi’s insulin portfolio in India and possibly other Emerging Markets Lyxumia® is the proprietary name submitted to the EMA for the company’s investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration. Lixisenatide is not currently approved or licensed anyw here in the w orld. Lixisenatide w as in-licensed from Zealand Pharma A/S. PPG: postprandial glucose PK/PD – Pharmacokinetic/Pharmacodynamic TD1 and TD2: Type 1 and Type 2 diabetes (1) Except for the device intended for Japan (2 steps to maintenance dose w ith one pen) (2) EDITION I, II, III, IV, JPI, JPII - ClinicalTrials.gov Identifier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142 13
  • 14. ® Clinical Development Designed to Support Use in Combination with Basal Insulin T2D Patients Treated Phase III Program with Basal Insulin(1) (worldwide) Mono Monotherapy Mono Japan On basal insulin On basal insulin with controlled fasting F1 (metformin) glucose control S (sulfonylurea)Placebo-controlled but A1c >7% M (metformin) in OAD failure P (pioglitazone) M Asia (metformin) 4 million on Lantus® Active-controlled X vs. exenatide 4 million 4 millionPlacebo-controlled L on other on top of L Asia basal insulins(2) basal insulin Duo 1 Lyxumia® is the proprietary name submitted to the EMA for the company’s investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration. Lixisenatide is not currently approved or licensed anyw here in the w orld. T2D – Type 2 Diabetes A1C – HbA1c or Glycated hemoglobin (1) Adapted from IMS data (2) Includes all types of basal insulins 14
  • 15. Fix-Flex Device Has Been Developed for JointAdministration of Lantus® and Lixisenatide ● Single injection per day coupled with possibility to adjust Lantus® dose ● Entering phases for industrialization, validation, usability and manufacturing + ● Device expected to be available Lixisenatide mid-2013 for Phase III initiation Lyxumia® is the proprietary name submitted to the EMA for the company’s investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration. Lixisenatide is not currently approved or licensed anyw here in the w orld. 15
  • 16. New Glargine Formulation ● Investigational glargine formulation: ● Flat PK/PD profile New Insulin Glargine Formulation ● Lower injection volume Depot formation after subcutaneous injection ● Phase III trials ongoing in T2D high-dose insulin users(1) Lantus® New Glargine ● Targeting ~1,600 patients Formulation EDITION I EDITION II T2D Patients T2D Patients Basal Bolus Basal + OAD ● Second set of Phase III studies recently started(2) EDITION III EDITION IV Schematic illustration T2D Patients T1D Patients Insulin Naïve Basal PK/PD – Pharmacokinetic/Pharmacodynamic OAD – Oral anti-diabetic drugs (1) ClinicalTrials.gov Identifier: NCT1499082 & NCT01499095 (2) ClinicalTrials.gov Identifier: NCT01676220 & NCT01683266 16
  • 17. Targeting Rare Familial Hypercholesterolemias Understanding Rarity● Four Phase III trials conducted in severe FH forms ~40,000 patients(1) ● Significant reduction in LDL-C HoFH Severe FH when added to a regimen of maximally tolerated statin dose and other lipid lowering therapies● Sustained reduction in apo B production decreased LDL and Lp(a) On statins:● FDA Ad Com voted on October 60 million 18th recommending approval patients HeFH: 1 million patients (1) Patients for hoFH and Severe FH in US and EU markets hoFH – Homozygous Familial Hypercholesterolemia Severe FH – Severe Familial Hypercholesterolemia = treated LDL-C CHD – Coronary Heart Disease heFH – Heterozygous familial hypercholesterolemia 17
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  • 21. Otamixaban: Providing Superior Outcomes whileSimplifying Treatment during Interventional Procedures TAO Study ● Despite current therapies, death, MI, and readmission rates remain high Moderate-to-high risk NSTE-ACS with planned early invasive strategy (n=13,220) ● Otamixaban is the first IV direct and selective factor Xa inhibitor with R quick onset/offset ● 27 to 42% risk reduction in ACS complications including death and MI Otamixaban Otamixaban UFH + Regimen 1 Regimen 2 Eptifibatide in Phase Il(1) (n=1,969) (n=1,969) (n=1,969) ● Phase III TAO study ongoing with Sponsor-blinded results expected in Q2 2013 interim analysis Primary endpoint: Death/Myocardial Infarction @ day 7 (1) The Lancet, Volume 374, Issue 9692, Pages 762 - 764, 5 September 2009 NSTE-ACS – Non-ST-Elevation Acute Coronary Syndrome, MI – Myocardial Infarction, UFH – Unfractionated Heparin 21
  • 22. Eliglustat(1) - A Novel Oral Therapy in Gaucher Disease ● Potent, novel substrate inhibitor Change in Spleen Volume (% change at 9 months) ● Oral therapy ● Eliminating challenges of infusions +2% Eliglustat ● Positive results from ENGAGE, Placebo first Phase III study (vs. placebo) ● Primary endpoint and all secondary 30% endpoints met ● Well tolerated with no serious adverse events reported Absolute ● ENCORE Phase III results (vs. Difference Cerezyme®) expected in early 2013 -28% (1) Eliglustat tartrate is an investigational drug (2) Secondary endpoints included improvements in hemoglobin levels and platelet levels, as w ell as liver volumes 22
  • 23. Dengue Vaccine: Addressing a Growing Global Threat Significant Disease Ambitious Phase III First Efficacy Results Burden Program ● Estimated 220m dengue ● Phase IIb results in ~4,000 ● Global Phase III program infections worldwide per year patients recently published ongoing in the Lancet ● 2m cases of Hemorrhagic ● Large scale studies in LatAm Fever ● Effective against DENV 1, 3 and Asia and 4 (in the range of 60% to ● >500,000 hospitalizations and 90%), with only DENV 2 ● 31,000 children and >20,000 deaths / year appearing to be resistant adolescents ● Dengue: a public health ● Safe and well-tolerated ● Results expected in 2014 priority in Asia and Latin America 23 23
  • 24. Ensuring R&D Contributes to Sanofi’s Success An efficient global R&D organization Maximize synergies and convergence around Hub model Exploit economies of scale Improve R&D cost structure Focus on high-value projects Global Execute on late-stage projects R&D Medical value and translational feasibility to guide early-stage Goals portfolio prioritization Establish new models of external innovation Enhance the value of external opportunities and partnerships Create open and creative models with partners across the healthcare ecosystem 24

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