Sanofi Sa · EURONEXT:SAN
Sanofi Sa — FY2012 Earnings Presentation
89 slides from Sanofi Sa's earnings presentation, Feb 7, 2013
Slide 1: Annual Results 2012
February 7'° 2013 Annual Results 2012 a J] SANOFI
Slide 2: Forward Looking Statements
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 under
Slide 3: Agenda
Agenda Key Highlights ● Christopher A. Viehbacher, Chief Executive Officer Financial Performance ● Jérôme Contamine, Executive Vice President, Chief Financial Officer Business Performance ● Hanspeter Spek, President, Global Operations ● Olivier Charmeil, Senior Vice President, Vaccines R&D Update ●
Slide 4: Key Highlights
KEY HIGHLIGHTS Christopher A. Viehbacher Chief Executive Officer 4
Slide 5: Our Key Messages for Today
Our Key Messages for Today 1 We have successfully navigated through the patent cliff 2 Since late 2008, Sanofi has been transformed into a stronger company ● Growth platforms account for 70% of sales(1) ● Late-stage pipeline is robust 3 Sanofi is set to resume growth in H2 2013 4 We are on track to
Slide 6: Building a Company with Sustainable Growth
Building a Company with Sustainable Growth 2005-2008 2009-2012 2013+ Focusing on Transforming while Generating Rx blockbusters managing the cliff sustainable growth • Blockbuster drugs • Investing in growth platforms • Growing recurring sales • Patents challenged • Increasing diversification • Launc
Slide 7: Sanofi Has Delivered Sales Growth for the Last Four Years
Sanofi Has Delivered Sales Growth for the Last Four Years Despite the Loss of Several Mega Blockbusters Sales €34,947m €33,389m €32,367m €29,306m €27,568m +0.5% at CER(1) (2) (2) (3) 2008 2009 2010 2011 2012 (1) On a reported basis, FY 2012 sales were up +4.7% (2) In 2008 and 2009, Merial Joint Vent
Slide 8: Sanofi Has Largely Transitioned Through its Patent Cliff
Unlike Many Peers, Sanofi Has Largely Transitioned Through its Patent Cliff Key Genericized Products(1) (2) (2) 2009 2010 2011 2012 Year-on-year impact of 2012 expiries will phase out progressively by mid 2013 (1) Key genericized products include Lovenox® U.S., Plavix® Western EU, Taxotere® Western
Slide 9: Our Growth Platforms Have Doubled Over Four Years
Our Growth Platforms Have Doubled Over Four Years While the Patent Cliff Enters the Rear-view Mirror Sales of Sales of Growth Platforms(1) Key Genericized Products(2) €23,548m €11,783m €7,565m €2,222m 2008 2009 2010 2011 2012 2008 2009 2010 2011 2012 % of 42.7% % of 27.4% 67.4% 6.4% Total Total (1)
Slide 10: Growth Platforms Grew by +9.9% in 2012
Growth Platforms Grew by +9.9%(1) in 2012 and Constitute Long Life Assets to Drive Future Growth 2012 growth at CER Emerging Markets(2) €11,145m +8.3% Diabetes Solutions €5,782m +16.7% Vaccines €3,897m +5.7% Consumer Healthcare €3,008m +9.9% Animal Health €2,179m +3.1% New Genzyme(3,4) €1,785m +16.9
Slide 11: Financially Disciplined M&A Has Been a Significant Growth Enabler
Financially Disciplined M&A Has Been a Significant Growth Enabler Since 2009 Since January 2009: ● Acquired 32 companies(1) Invested a total of including Genzyme ● Completed 91 in-licensing ~€23.7bn agreements(1) in external growth ● Entered 3 joint ventures(1) Sanofi has demonstrated strong integra
Slide 12: 2012 Was a Turning Point for Unleashing the Full Potential of Genzyme
2012 Was a Turning Point for Unleashing the Full Potential of Genzyme ● Regulatory approval of Framingham plant 1 Supply ● All 2012 numbered steps for Consent Decree met Recovery ● Full supply of Cerezyme® & Fabrazyme® ● Double-digit growth of Rare Diseases franchise 2 Business ● Creation of a new M
Slide 13: Loss of U.S. Exclusivity of Plavix and Avapro Impacted BNI
The Loss of U.S. Exclusivity of Plavix® and Avapro® Impacted our BNI by €1.3bn in 2012 Loss of Exclusivity of Plavix® & Avapro® in the U.S.(1) "Other Revenues" "Income from Associates" €1,669m €1,102m Impact on (2) 2012 €1,010m Business Net Income: €424m €1.3bn (3,4)) 2011 2012 2011 2012 Residual im
Slide 14: Successfully Navigating Through the Patent Cliff
Successfully Navigating Through the Patent Cliff Despite a Tougher Environment than Expected Pressure on Rx Pharma in Mature Markets ● U.S. healthcare reform ● EU price containment ● ~$420m impact from measures healthcare reform in 2012 ● ~€300m average annual including ~$112m from excise impact ove
Slide 15: 2012 EPS Was Slightly Better than Originally Anticipated
2012 EPS Was Slightly Better than Originally Anticipated 18 Months Ago Business EPS €7.06 €6.61 €6.65 €6.20 €5.59 -12.8% at CER(1) 2008 2009 2010 2011 2012 (1) On a reported basis, 2012 EPS was down -6.8% 15
Slide 16: 2012 Was a Solid Year for New Approvals and Regulatory Submissions
2012 Was a Solid Year for New Approvals and Regulatory Submissions Key Regulatory Achievements in Last 12 Months 9 Regulatory Approvals 6 New Drugs / Vaccines Submitted ® ® ● Zaltrap (U.S. and EU)(1) ● Aubagio (EU) ® ® ● Aubagio (U.S.) ● Lyxumia (U.S.)(2) ® ● Lyxumia (EU)(2) ● Lemtrada™ (U.S. and EU
Slide 17: Positive Clinical Results and Decisions to Advance Major Programs in 2012
Positive Clinical Results and Decisions to Advance Several Major Development Programs in 2012 Key Data Milestones in 2012 Progress to Phase III Phase III Results Post-Marketing Studies ● PCSK9 inhibitor ● Lemtrada™ ● Lantus® ORIGIN (ODYSSEY) (CARE-MS I & II) CV safety study ● New insulin glargine ●
Slide 18: Multiple Phase III Readouts and Regulatory Decisions Expected in 2013
Multiple Readouts of Phase III Trials and Regulatory Decisions Expected in 2013 2013 Expected Headline Phase III Data Releases Q1 Q2 Q3 Q4 ● Eliglustat tartrate in Gaucher disease (ENCORE) ● JAK2 inhibitor in Myelofibrosis (JAKARTA) ● Otamixaban in ACS (TAO) ● Insulin glargine in Diabetes (EDI
Slide 19: Sanofi Continues to Offer a Solid Dividend Yield
Sanofi Continues to Offer a Solid Dividend Yield Evolution of Dividend ● Proposed dividend(1) of €2.77 €2.65 €2.77 per share for 2012 results €2.50 €2.40 ● Dividend CAGR of 5.9% €2.20 over the 2008-2012 period ● Target payout ratio of 50% Payout for 2013 results(2) 45% ● €822m of shares repurchased
Slide 20: TOTAL Completed its Exit in September 2012
TOTAL Completed its Exit in September 2012 Shares Held by TOTAL 13.1% 0% 20
Slide 21: Sanofi Underwent a Significant Transformation During the Patent Cliff Era
Sanofi Underwent a Significant Transformation During the "Patent Cliff " Era 2008 2012 Sales €27.6bn €34.9bn Key Genericized Products Sales(1) 28.4% 3.0% Growth Platforms(2) 42.8% 70.4% Emerging Markets Sales €6.5bn €11.1bn Biologic NMEs in R&D Pipeline 17% 48% Business EPS €5.59 €6.20 Dividend €2.2
Slide 22: Financial Performance
FINANCIAL PERFORMANCE Jérôme Contamine Executive Vice President, Chief Financial Officer 22
Slide 23: Growth Platforms Overcome Loss of Blockbusters in 2012
Growth Platforms Overcome Loss of Blockbusters, End of Copaxone® Agreement and Divestiture of Dermik in 2012 2012 Sales (€m) €34,947m €1,400m €33,389m -€1,345m €1,640m -€559m €733m -€310m ® 2011 Key Copaxone Others Genzyme Growth FX Impact 2012 (2) (3) Genericized & Dermik Q1 Platforms Products(1) (
Slide 24: Sales and Business Operating Income Lifted by Favorable Currency
Sales and Business Operating Income Lifted by Favorable Currency Tailwind in 2012 Quarterly Currency Impact (in % change) Sales Business Operating Income 2012 2012 +4.2% or €1,400m +5.7% or €693m +8.0% +8.2% €235m €277m +6.4% +5.8% €561m €486m +4.0% €120m +2.4% +2.1% +1.9% €187m €61m €166m Q1 2012 Q
Slide 25: As Expected, Q4 2012 Was our EPS Trough Quarter
As Expected, Q4 2012 Was our EPS Trough Quarter €m Q4 2012 Q4 2011 % Change % Change (reported €) (CER) Net sales 8,526 8,508 +0.2% -1.7% Other revenues 137 415 -67.0% -67.7% Gross profit 5,792 6,202 -6.6% -8.7% Business operating income 2,096 2,828 -25.9% -28.0% Business net income 1,572 2,077 -24.
Slide 26: FY 2012 Reflected a Slightly Better BOI Margin than Anticipated
FY 2012 Reflected a Slightly Better BOI Margin than Anticipated €m FY 2012 FY 2011 % Change % Change (reported €) (CER) Net sales 34,947 33,389 +4.7% +0.5% Other revenues 1,010 1,669 -39.5% -42.4% Cost of sales (11,095) (10,426) +6.4% +3.9% Gross profit 24,862 24,632 +0.9% -3.9% R&D (4,922) (4,811)
Slide 27: Contribution of the BMS Alliance Significantly Reduced by Q4 2012
Contribution of the BMS Alliance Significantly Reduced by Q4 2012 Other Revenues €1,669m €426m €395m €247m €1,010m €200m €478m €1,274m €137m €532m BMS Alliance Income from Associates €1,102m €297m €32m €1,070m €122m €424m €4m €420m BMS €6m Alliance -€1m 2011 Q1 2012 Q2 2012 Q3 2012 Q4 2012 2012 27
Slide 28: CoS Ratio Slightly Up in 2012 Reflecting Change in Mix
CoS Ratio Slightly Up in 2012 Reflecting Change in Mix Cost of Sales (%) ● Slightly higher Cost of Sales (CoS) 31.2% 31.8% in 2012: €11,095m, up +3.9% at CER or up +1.6% at CER with 33.7% 32.0% Genzyme pro forma ● CoS ratio slightly up in 2012 vs. 2011 reflecting: ● Product mix evolution partially c
Slide 29: Rigorous Control of R&D Expenses
Rigorous Control of R&D Expenses to Keep R&D Below €5bn While Significantly Investing in Phase III Trials R&D/Sales Ratio (%) ● 2012 R&D expenses of €4,922m, 14.4% 14.1% down -1.0% at CER or down -3.6% at CER with Genzyme pro forma 15.2% 15.9% reflecting: ● Good internal cost management ● Ongoing tr
Slide 30: Stable SG&A Expenses in 2012 Despite Several New Drug Launches
Stable SG&A Expenses in 2012 Despite Several New Drug Launches SG&A/Sales Ratio (%) ● 2012 SG&A expenses of €8,947m, 25.6% 25.6% up +0.9% at CER or down -1.9% at 27.6% CER with Genzyme pro forma 26.1% reflecting: ● Genzyme integration synergies ● Tight control of G&A expenses(1) ● Investment in prod
Slide 31: Cost Savings Program of €2bn by 2015 Is On Track
Cost Savings Program of €2bn by 2015 Is On Track 2012 ● 60% of the €2bn cost reduction program has been achieved ● Genzyme targeted synergies have been reached Cost ● 1/3 of the savings have been reinvested in growth platforms savings 2013 of ● At least €500m of savings are targeted for 2013 ● A lar
Slide 32: Patent Cliff Impact on BNI Mitigated to ~€600m in 2012
Patent Cliff Impact on BNI Mitigated to ~€600m in 2012 €m FY 2012 FY 2011 % Change % Change (reported €) (CER) Business operating income 11,353 12,144 -6.5% -12.2% Net financial expenses (460) (412) - - Income tax expense (2,714) (2,937) - - Effective tax rate -25.5% -27.0% - - Business net income 8
Slide 33: Modest Impact of IAS19R on Business Net Income
Modest Impact of IAS19R on Business Net Income 2012 2012 Difference €m IAS19 IAS19R Cost of sales (122) (102) 20 R&D expenses (74) (57) 17 SG&A (65) (47) 18 Other operating income 20 60 40 Benefit cost included in BOI (241) (146) 95 Financial expenses(1) (10) (208) (198) Income tax expense 25 Benefi
Slide 34: From Business Net Income to Consolidated Net Income
From Business Net Income to Consolidated Net Income €m 2012 2011 % Change (reported €) Business net income 8,179 8,795 (7.0%) Amortization of intangible assets (3,291) (3,314) Impairment of intangible assets (117) (142) Fair value remeasurement of contingent consideration liabilities (192) 15 Expens
Slide 35: Solid Free Cash Flow Generated in 2012
Solid Free Cash Flow Generated in 2012 Despite the Loss of Exclusivity of Plavix® in the U.S. 2012 (€m) ● Free Cash Flow of €7,375m, down -11.8% - 1,402 in 2012(1) -538 ● CapEx reduced by 14.7% -7,719 to €1,402m ● 2011 dividend of €3,487m -10,859 -4,310 paid in Q2 2012 +8,777 FCF +7,375 +613 ● Share
Slide 36: Business Performance
BUSINESS PERFORMANCE Hanspeter Spek President, Global Operations Olivier Charmeil Senior Vice President, Vaccines 36
Slide 37: Growth Platforms Reached Over 70% of Sales in Q4 2012
Growth Platforms Reached Over 70% of Sales in Q4 2012 Growth Platforms Sales(1) 70.4% Quarterly Sales (€m) of Sales 59.2% of Sales €6,002m Other Innovative Products New Genzyme Animal Health €4,607m CHC Vaccines Diabetes Emerging Markets excluding Growth Platforms above Sanofi has rapidly increased
Slide 38: Sanofi's Exposure to Western Europe Was Further Reduced in 2012
Sanofi’s Exposure to Western Europe Was Further Reduced in 2012 Emerging United Western (3) Markets (1) Europe RoW States €11,145m €10,873m €8,335m €4,594m (2) +8.3% at CER +0.7% at CER -9.3% at CER +2.5% at CER 13.1% 31.1% 31.9% 23.9% (1) World less North America (USA, Canada), Western Europe (Fran
Slide 39: Sanofi Remained the #1 Healthcare Company in Emerging Markets
Sanofi Remained the #1 Healthcare Company in Emerging Markets in 2012 ● Another record year in Emerging Markets(1) in 2012 ● Strong sales in BRIC of €3,896m up +12.0% at CER (35.0% of EM sales) Emerging Markets Sales (€m) €11,145m +14.3% +9.1% €5,037m 2005 2006 2007 2008 2009 2010 2011 2012 (1) IMS
Slide 40: Broad Geographic Presence in Emerging Markets in 2012
Sanofi Benefited from its Broad Geographic Presence in Emerging Markets in 2012 ● Double-digit sales performance in LatAm, Asia and Africa/Middle East ● Eastern Europe growing at a much lower pace given lower GDP growth ● €1bn sales milestone achieved in both Africa and the Middle East Emerging Mark
Slide 41: Double-Digit Growth of our Diabetes Franchise
Double-Digit Growth of our Diabetes Franchise for Eight Consecutive Quarters ● Strong performance of Diabetes with 2012 sales of €5,782m, up +16.7% at CER ● Continued strong performance of Lantus®, up +19.3% at CER ● Recovery of Apidra®, up +16.8% at CER Quarterly Sales (€m) Growth €3,510m €3,916m €
Slide 42: Lyxumia Now Approved in Europe for Type 2 Diabetes
® Now Approved in Europe for the Treatment of Type 2 Diabetes First Once-a-Day Prandial GLP-1 Receptor Agonist ● ~4m patients worldwide on basal insulin with controlled fasting glucose but with A1c >7%(1) ● Pronounced post-prandial glucose lowering effect of Lyxumia® ● Clinical development designed
Slide 43: Zaltrap: U.S. Launch On Track and EC Approval Granted
U.S. Launch On Track and EC Approval Granted ● U.S. launch on track following August 2012 FDA approval after Priority Review ● Sales of €25m in 2012 ● Overall awareness climbed to 91% and physician “intent to use” jumped to a high of 63% in Nov 2012 ● Formulary access continues to improve ● EC appro
Slide 44: Launching the First Voice-Guided Epinephrine Auto-Injector
Launching the First and Only Voice-Guided Epinephrine Auto-Injector(1) ● Up to 6 million people in the U.S. may be at risk for anaphylaxis(2) ● Epinephrine auto-injector market estimated at $665m in 2012(3) ● One main U.S. competitor with >95% market share(4): EpiPen® from Mylan ● Auvi-Q™ offers a u
Slide 45: Merial Showed Steady Performance in 2012
Merial Showed Steady Performance in 2012 Despite Generic Competition ● Solid sales of €2,179m in 2012, Annual Sales (€m) up +3.1% at CER €2,179m €2,030m ● Frontline® still a blockbuster brand(1) €1,983m despite fipronil generic competition Production ● Good U.S. sales of Heartgard® Animals benefitin
Slide 46: Now a Top 3 Player in Consumer Healthcare Globally
Now a Top 3 Player in Consumer Healthcare Globally (1) ● Record sales of €3,008m in 2012, up +9.9% at CER and outpacing peers(1) ● Seven brands(2) with sales >€100m in 2012 ● Strong double-digit growth in EM, up +19.9% at CER driven by local champions ● Acquisition of worldwide rights to Rolaids® by
Slide 47: Sanofi Pasteur Ended 2012 on a High Note
Sanofi Pasteur Ended 2012 on a High Note Annual Sales (€m) ● 2012 sales: €3,897m, up +5.7% €3,897m at CER €3,469m ● Strong Q4 performance with sales +5.7% of €1,016m, up +20.5% at CER at CER ● BOI margin increased to 29.5% in 2012 vs. 28.4% in 2011 ● Recovery of SPMSD in Europe(1) ● Sales €845m, up
Slide 48: Another Solid Seasonal Flu Campaign in 2012
Another Solid Seasonal Flu Campaign in 2012 ● Undisputed leadership in flu segment with sales of €884m globally in 2012 ● Supply of flu vaccines extended into Q4 unlike last year ● Successful differentiation strategy in the U.S. leading to value upgrade ● Sales of €317m in Emerging Markets, up +5.1%
Slide 49: Sanofi Pasteur Delivered Growth in Mature and Emerging Markets
Sanofi Pasteur Delivered Growth in Mature and Emerging Markets in 2012 Despite Supply Constraints Mature Markets Annual Sales (€m) Emerging Markets ● Strong growth of Emerging ● PPH sales of €495m, Menactra® in the U.S. +9.1% Markets up +5.7% at CER, driven up +10.6% at CER at CER €1,241m by Pentaxi
Slide 50: Genzyme Delivered Strong Performance in 2012
Genzyme Delivered Strong Performance in 2012 ● FY 2012 rare disease sales reached Quarterly Sales (€m) €1,785m, up +16.9%(1) ● Fabrazyme® sales almost doubled ● Supply from new Framingham plant ● Shire’s withdrawal of Replagal® BLA(2) in the U.S. in early 2012 ● Myozyme® grew at a double-digit rate
Slide 51: Aubagio: A Platform Therapy in a Pill for Relapsing MS
® A “Platform” Therapy in a Pill for Relapsing MS ● Very encouraging early launch Cumulative U.S. Weekly TRx(2) indicators in the U.S.(1) ● >80% of MS specialists in the U.S. have prescribed AUBAGIO® ● ~1 in 5 patients prescribed AUBAGIO® were treatment-naïve ● >50% of patients switched to AUBAGIO®
Slide 52: R&D Update
R&D UPDATE Dr. Elias Zerhouni President, Global Research & Development 52
Slide 53: Focusing R&D on High-Value Projects in Key Therapeutic Areas
Focusing R&D on High-Value Projects in Key Therapeutic Areas 1 Multiple Sclerosis: Lemtrada™ 2 Diabetes: New insulin glargine formulation 3 Oncology: JAK2 inhibitor 4 Rare Diseases: Eliglustat 5 Cardio-Metabolic Diseases: PCSK9 mAb & Otamixaban 6 Immunology: Sarilumab & Anti IL-4Rα mAb 7 Vaccines: D
Slide 54: Lemtrada: Only Drug Slowing Accumulation of Disability vs. Active Comparator
® Only Drug Slowing Accumulation of Disability Sustained for Six Months vs. Active Comparator(1) CARE-MS I CARE-MS II ● Ground-breaking efficacy results ● Significantly reduces ARR Annualized Relapse Rate ● Significantly slows accumulation of disability sustained for six months ● Manageable safety p
Slide 55: Broad Phase III Program for New Glargine Formulation
Broad Phase III Program Evaluating Potential Clinical Benefits of Improved PK/PD Profile of New Glargine Formulation New Insulin Glargine Formulation Depot formation after subcutaneous injection ● Two Phase III trials in T2D high-dose insulin users(1) New Glargine Lantus® ● 1,600 patients Formulatio
Slide 56: JAK2 Inhibitor - Addressing Treatment Gaps in Hematologic Malignancies
JAK2 Inhibitor - Addressing Treatment Gaps for Patients with Debilitating Hematologic Malignancies % patients with ≥35% reduction ● Novel selective JAK2 inhibitor in spleen volume from baseline ● Promising Phase II response rate in patients with myelofibrosis (MF) SAR302503 - Phase II trial ● Phase
Slide 57: Eliglustat - A Novel Oral Therapy in Gaucher Disease
Eliglustat(1) - A Novel Oral Therapy in Gaucher Disease Change in Spleen Volume ● Potent, novel substrate inhibitor (% change at 9 months) ● Oral therapy +2% ● Eliminating challenges of infusions Eliglustat ● Positive results from ENGAGE, Placebo Phase III study (vs. placebo) ● Primary endpoint and
Slide 58: PCSK9 mAb: First in Class in Hypercholesterolemia
PCSK9 mAb: First in Class and Targeting Unmet Needs in Hypercholesterolemia ● First-in-class fully-human LDL-C Change from baseline (Phase II)(2,4,5) antibody targeting PCSK9 ● Landmark study demonstrated 0 BASELINE WEEK 2 WEEK 4 WEEK 6 WEEK 8 WEEK 10 WEEK 12 that when PCSK9 is disabled, -10 ∆ - 5.1
Slide 59: First Ever Phase III Program for an Anti-PCSK9 mAb
Sanofi Recently Started the First Ever Phase III Program for an Anti-PCSK9 mAb ● ODYSSEY: a large global Phase III Target Population clinical program evaluating the safety and efficacy of SAR236553 ~21m patients globally estimated not at goal for LDL-C(1) ● 22,000 patients, including those with (mai
Slide 60: Otamixaban: Superior Outcomes During Interventional Procedures
Otamixaban: Providing Superior Outcomes While Simplifying Treatment During Interventional Procedures ● Despite current therapies, death, MI, TAO Study and readmission rates remain high Moderate-to-high risk NSTE-ACS with ● Otamixaban is the first IV direct and planned early invasive strategy (n=13,2
Slide 61: Sarilumab: Addressing an Unmet Need in Rheumatoid Arthritis
Sarilumab (Anti IL-6R mAb): Addressing an Unmet Need in Rheumatoid Arthritis ● ~1/3 of RA patients treated with MOBILITY Trial (Phase IIb Results) anti-TNFα do not respond to therapy ACR response at week 12 (%) ACR20 ● Sarilumab is a fully human, high 66.7 ACR50 65.4 affinity, IL-6R mAb administered
Slide 62: Anti IL-4Rα mAb: Targeting Asthma and Atopic Dermatitis
Anti IL-4Rα mAb: Targeting Asthma and Atopic Dermatitis ● Fully human monoclonal antibody IL-4 IL-13 binding to IL-4Rα or ● Targeting the common IL-4Rα subunit ● Dual IL-4/IL-13 cytokine antagonism with a single agent γc IL-4Rα IL-4Rα IL-13Rα1 ● Positive proof of concept data for asthma and atopic d
Slide 63: Dengue Vaccine: Addressing a Growing Global Threat
Dengue Vaccine: Addressing a Growing Global Threat Significant Disease Ambitious Phase III First Efficacy Results Burden(1) Program ● Estimated 220m dengue ● Phase IIb results in ~4,000 ● Global Phase III program infections worldwide per patients recently published ongoing year in the Lancet ● Large
Slide 64: C. Diff Toxoid Vaccine
C. Diff Toxoid Vaccine: Preventing Primary Symptomatic Clostridium Difficile Infections (CDI) CDI – A Growing Healthcare Problem ● Candidate vaccine shown to be ● Most common cause of healthcare safe and immunogenic in Phase I(1) associated infections in developed countries(2) and Phase II trials ●
Slide 65: Up to Eighteen Potential New Launches over 2012-2015
Up to Eighteen Potential New Launches over 2012-2015 18 Cumulative Number of Projects Pharmaceuticals and Vaccines Vaccines 7 Rare Diseases Multiple Sclerosis 5 Diabetes 4 Oncology Lyxumia® Other Pharma (lixisenatide) AUVI-Q™ (epinephrin) New glargine 2 LeGoo® formulation (biopolymer gel) otamixaban
Slide 66: Strengthening the R&D Leadership Team with New Talent
Strengthening the R&D Leadership Team with New Talent Gary Nabel SVP, Chief Scientific Officer Chairman of the Strategic Development and Scientific Advisory Council Andrew Plump Jay Edelberg Deputy of President R&D Head of PCSK9 Launch Unit VP Research and Translational Medicine Eckhard Leifke Phili
Slide 67: Ensuring R&D Contributes to Sanofi's Success
Ensuring R&D Contributes to Sanofi’s Success Create an efficient global R&D organization ●Maximize synergies and convergence around Hub model ●Leverage economies of scale ●Improve R&D cost structure Focus on high-value projects Global ●Execute on late-stage projects R&D ●Guide early-stage portfolio
Slide 68: Conclusion
CONCLUSION Christopher A. Viehbacher Chief Executive Officer 68
Slide 69: Executing a Successful Strategy
Executing a Successful Strategy Grow a global healthcare leader 1 with synergistic platforms 2 Bring innovative products to market Deliver sustainable long-term growth and maximize Seize value-enhancing growth 3 shareholder returns opportunities Adapt structure for future 4 challenges and opportunit
Slide 70: Sanofi Expects to Resume Growth in H2 2013
Sanofi Expects to Resume Growth in H2 2013 Guidance for FY 2013 ● The residual impact from the loss of Plavix® and Avapro® exclusivity in the U.S. in H1 2012 is anticipated to impact business net income in H1 2013 by approximately €800m at CER(1) ● Including this impact, the continued strong perform
Slide 71: Continued Execution of Strategy Expected to Deliver Sustainable Growth
Continued Execution of Strategy Expected to Deliver Sustainable Growth over 2012-2015 2012-2015 Sales CAGR(1) At least 5% Increasing Evolution of Operating Margin over 2012-2015 over time 2012-2015 Business EPS CAGR(1) > Sales CAGR Dividend Payout Ratio for 2013 Results(2) 50% (1) At constant exchan
Slide 72: Q&A Session
Q&A SESSION SANOFI x
Slide 73: Appendices: R&D Pipeline
APPENDICES R&D Pipeline SANOFI x
Slide 74: Late Stage Pipeline – Pharma & Vaccines
Late Stage Pipeline – Pharma & Vaccines Phase III Registration eliglustat tartrate N otamixaban N Quadracel® Hexaxim™ / New hexavalent vaccine Glucosylceramide synthetase inhibitor Direct Xa inhibitor Diphtheria, tetanus, pertussis DTP-HepB-Polio-Hib vaccine Gaucher disease ACS & polio vaccine; 4-6
Slide 75: Early Stage Pipeline – Pharma & Vaccines (Phase II)
Early Stage Pipeline – Pharma & Vaccines Phase II N N FOV1101 SAR231893 iniparib (BSI-201) FDC prednisolone/cyclosporine Anti-IL4Rα mAb Platinum-resistant ovarian cancer (2L) Allergic conjunctivitis Asthma; Atopic dermatitis SAR3419 N N N SAR292833 (GRC15300) ferroquine Maytansin-loaded anti-CD19 mA
Slide 76: Early Stage Pipeline – Pharma & Vaccines (Phase I)
Early Stage Pipeline – Pharma & Vaccines Phase I SAR153192 N SAR260301 N SAR252067 N Rotavirus Anti-DLL4 mAb PI3K β selective Anti-LIGHT mAb Live Attenuated Tetravalent Solid tumors PTEN – Deficient tumors Crohn’s disease & Ulcerative colitis Rotavirus oral vaccine GZ402674 N SAR127963 N SAR100842 N
Slide 77: R&D Pipeline Summary Table
R&D Pipeline Summary Table New Molecular Entities (NMEs) and Vaccines Phase I Phase II Phase III Registration TOTAL Oncology 8 4 2 0 14 Metabolic Disorders 1 0 1 2 4 Thrombosis 1 0 1 0 2 Central Nervous System 2 0 0 2 4 50 Internal Medicine 3 7 1 0 11 Ophthalmology 4 1 0 0 5 Genetic Diseases 2 0 1 0
Slide 78: Expected R&D Milestones – Pharmaceuticals
Expected R&D Milestones – Pharmaceuticals Product Event Timing eliglustat tartrate Phase III results in Gaucher disease (ENCORE) Q1 2013 Lyxumia® (lixisenatide) Expected FDA file acceptance in type 2 diabetes in U.S. Q1 2013 Aubagio® (teriflunomide) Expected CHMP decision in RMS in EU Q1 2013 sarilu
Slide 79: Expected R&D Milestones – Vaccines
Expected R&D Milestones – Vaccines Product Event Timing Vaxigrip® QIV IM Expected submission of regulatory file in EU Q1 2013 6-in-1 paediatric vaccine Expected CHMP opinion in EU Q1 2013 Fluzone® QIV IM Expected FDA decision in the U.S. Q2 2013 C. Diff vaccine Expected start of Phase III study Q3 2
Slide 80: Appendices: Finance
APPENDICES FINANCE SANOFI x
Slide 81: Business Net Income Statements (Q4)
Business Net Income Statements Fourth quarter Pharmaceuticals Vaccines Animal health Other Group Total €m Q4 2012 Q4 2011 % change Q4 2012 Q4 2011 % change Q4 2012 Q4 2011 % change Q4 2012 Q4 2011 Q4 2012 Q4 2011 % change Net sales 7,004 7,220 (3.0%) 1,016 818 24.2% 506 470 7.7% 8,526 8,508 0.2% Oth
Slide 82: Business Net Income Statements (Full Year)
Business Net Income Statements Full year Pharmaceuticals Vaccines Animal health Other Group Total €m FY 2012 FY 2011 % change FY 2012 FY 2011 % change FY 2012 FY 2011 % change FY 2012 FY 2011 FY 2012 FY 2011 % change Net sales 28,871 27,890 3.5% 3,897 3,469 12.3% 2,179 2,030 7.3% 34,947 33,389 4.7%
Slide 83: Reconciliation of Business Net Income to Consolidated Net Income (Q4)
Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi €m Q4 2012 Q4 2011 % change Business net income 1,572 2,077 (24.3%) Amortization of intangible assets (800) (809) Impairment of intangible assets (89) (66) Fair value remeasurement of contingent
Slide 84: Reconciliation of Business Net Income to Consolidated Net Income (FY)
Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi €m FY 2012 FY 2011 % change Business net income 8,179 8,795 (7.0%) Amortization of intangible assets (3,291) (3,314) Impairment of intangible assets (117) (142) Fair value remeasurement of conti
Slide 85: Consolidated Income Statements
Consolidated Income Statements €m Q4 2012 Q4 2011 FY 2012 FY 2011 Net sales 8,526 8,508 34,947 33,389 Other revenues 137 415 1,010 1,669 Cost of sales (2,874) (2,793) (11,118) (10,902) Gross profit 5,789 6,130 24,839 24,156 Research and development expenses (1,358) (1,293) (4,922) (4,811) Selling an
Slide 86: Consolidated Income Statements
Consolidated Income Statements €m Q4 2012 Q4 2011 FY 2012 FY 2011 Operating income 400 943 6,337 5,731 Financial expenses (146) (165) (553) (552) Financial income (3) 52 93 140 Income before tax and associates and joint ventures 251 830 5,877 5,319 Income tax expense 197 415 (1,134) (455) Share of p
Slide 87: Cash Flow Statements
Cash Flow Statements €m 2012 2011 Business net income 8,179 8,795 Depreciation, amortization and impairment of property, plant and equipment and intangible assets 1,278 1,156 Gains and losses on disposals of non-current assets, net of tax (86) (52) Other non cash items (58) 579 Operating cash flow b
Slide 88: Balance Sheets
Balance Sheets ASSETS Dec 31, 2012 Dec 31, 2011(1) LIABILITIES & EQUITY Dec 31, 2012 Dec 31, 2011(1) €m €m Property, plant and equipment 10,578 10,750 Equity attributable to equity holders of sanofi 57,338 56,203 Intangible assets (including goodwill) 58,265 62,221 Equity attributable to non-control
Slide 89: Impact of IAS19R in 2012 on Business Net Income
Impact of IAS19R in 2012 on Business Net Income(1) Impact on Impact on Impact on Impact on Impact on €m Q1 2012 Q2 2012 Q3 2012 Q4 2012 FY 2012 Cost of sales 5 5 4 6 20 R&D expenses 4 4 5 4 17 SG&A 5 4 7 2 18 Other current operating 10 11 9 10 40 income/expenses Business Operating Income 24 24 25 22