Transcript of "2012 - 2nd Cowen Annual HC Conference"
COWEN HEALTH CARE CONFERENCE Dr. Elias Zerhouni President, Global Research & Development March 6, 2012
Forward 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 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 Sanofi’s 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 of Sanofi,that could cause actual results and developments to differ materially from those expressed in, or implied orprojected by, the forward-looking information and statements. These risks and uncertainties include among otherthings, the uncertainties inherent in research and development, future clinical data and analysis, including postmarketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when toapprove any drug, device or biological application that may be filed for any such product candidates as well astheir decisions regarding labelling 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 Group’s 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 those listedunder “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annualreport on Form 20-F for the year ended December 31, 2010. Other than as required by applicable law, Sanofidoes not undertake any obligation to update or revise any forward-looking information or statements. 2
Sanofi Grew Sales in 2011 due to Genzyme Acquisitionand Growth Platforms Sales €33,389m €32,367m €29,306m €27,568m +5.3% at CER (1) (1) (2) 2008 2009 2010 2011 (1) In 2008 and 2009, Merial Joint Venture sales w ere not consolidated by Sanofi (2) In 2010, excluding non-consolidated sales from Merial, Sanofi reported sales of €30,384m 3
Sanofi Boosted Sales of its Growth Platforms andSignificantly Reduced its Patent Cliff Exposure in 2011 Sales of Sales of Growth Platforms(1) & Genzyme Key Genericized Products(2) €21,703m €11,783m €7,565m €3,152m 2008 2009 2010 2011 2008 2009 2010 2011% of % of 42.7% 65.0% 27.4% 9.4%Total Total (1) 2010 include sales of Merial. In 2008 and 2009, Merial Joint Venture sales w ere not consolidated by Sanofi (2) Lovenox ® U.S., Plavix ® Western EU, Taxotere® Western EU & U.S., Eloxatin® U.S., Ambien CR® U.S., Allegra® U.S., Aprovel® Western EU, Xyzal® U.S., Xatral® U.S., Nasacort® U.S. - Generic makers of oxaliplatin required to cease selling in the U.S. since June 30, 2010 but judgement is 4 under appeal by Sun.
Patent Cliff Impact on EPS Mitigated in 2011 Business EPS €7.06 €6.61 €6.65 €5.59 -3.8% at CER 2008 2009 2010 2011 5
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
Executing our R&D Strategy 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 model of pharma-biotech partnership e.g. Warp Drive Bio 7
Focusing on Delivering a Promising Development Portfolio Achieve Regulatory Milestones Submitted • Lemtrada™ Short-term • Aubagio™ EU/U.S. opportunities • Lyxumia® (1) EU • Zaltrap® (2) EU/U.S. • Visamerin® EU/U.S. • Kynamro™ (3) EU Next Wave of Late-Stage Projects • New glargine formulation • Otamixaban Mid-term • Glargine-lixisenatide combo • Sarilumab opportunities • Dengue vaccine • JAK-2 inhibitor • Eliglustat • Iniparib • Anti-PCSK-9 mAb • Ombrabulin Lemtrada™, Aubagio™, Lyxumia®, Zaltrap®, Visamerin® and Kynamro™ are registered trade names submitted to health authorities for investigational agents (1) In-licensed from Zealand Pharma A/S (2) Partnership w ith Regeneron 8 (3) In-licensed from Isis Pharmaceuticals
Genzyme - MSEmergence of a Franchise Addressing the Full Spectrumof Patient Needs in Multiple Sclerosis RRMS(2) and RMS(3) severe/ Early MS/CIS(1) early active MS highly active Convenience Convenience Efficacy with & safety & efficacy manageable safety Aubagio™ Aubagio® Rebif® Lemtrada™ Lemtrada™ CIS – Clinically Isolated Syndrome, TOPIC Phase III study presently ongoing RRMS – Relapse Remitting Multiple Sclerosis RMS – Relapsing Multiple Sclerosis 9 9
Genzyme - MS A Unique Value Proposition: Superior Efficacy with Convenient Annual Dosing CARE-MS I CARE-MS II ● Superior efficacy in Phase III vs. Rebif® Patients 581 840 ● Manageable safety: Study Duration 2 years 2 years ● Well-characterized and consistent Patient Treatment Relapsed on across studies Population naïve prior treatment ● Effective risk management when Treatment Alemtuzumab Alemtuzumab events identified early Arms vs. IFNβ 1a vs. IFNβ 1a Relapse Rate Reduction at 2 Years(1) 55% 49% (p<0.0001) (p<0.0001) Sustained Accumulation of Disability Reduction in (ns) 42% 6 Months(1) (p=0.0084) ANN – American Academy of Neurology (1) Co-primary endpoints in CARE-MS I and CARE-MS II 10
Genzyme - MSAubagi A Once-Daily Oral Therapy with Comparable Efficacy to Injectable Interferon TEMSO: Reduction in Adjusted(1) ARR ● Efficacy demonstrated in TEMSO Placebo on both Relapse Rate and Disability Progression at 14mg T. 7 mg RRR: 31.2% p=0.0002 ● No superiority vs. Rebif® in RRR: 31.5% T. 14 mg TENERE but lower rate of TEAE- p=0.0005 related discontinuation 0 0,1 0,2 0,3 0,4 0,5 0,6 ● Manageable safety profile with up TEMSO: Reduction in Disability Progression (% ) to 10 years of follow-up 30% Placebo T. 7 mg HRR: 23.7% T. 14 mg p=ns 20% HRR: 29.8% 10% p=0.0279 0% 0 12 24 36 48 60 72 84 96 108 Week (1) Adjusted for Expanded Disability Status Scale score strata at baseline and takes duration of treatment into account. TEAE – Treatment Emergent Adverse Events, ACTRIMS - Americas Committee for Treatment and Research in Multiple Sclerosis 11 ENS – European Neurological Society, ARR – Annualized Relapse Rate, RRR – Relative risk reduction, HRR – Hazard ratio reduction
Diabetes ® A GLP-1 Agonist with Unique Post-Prandial Effect and One Step Titration Reported Lyxumia® Profile Mono Drug naïve patients Consistent GLP-1 class effects Mono Japan of A1c reduction and weight loss F1 (metformin) S (sulfonylurea) Pronounced effect on Placebo-controlled post-prandial glucose in OAD failure M (metformin) P (pioglitazone) Favorable safety profile with low M Asia (metformin) risk of hypoglycemic events Active-controlled X vs. exenatide OD injection, simple 1 step L Asia to maintenance dose, 1 penPlacebo-controlled on top of basal insulin L per dose Duo 1 (Lantus®) Placebo-controlled Cardiovascular Ongoing Secondary prevention Outcomes Study Lixisenatide w as in-licensed from Zealand Pharma A/S. Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is currently not approved or licensed anyw here in the w orld. 12
Diabetes ® Optimal Complementary Pharmacological Profile with Basal Insulins T2D Patients Treated with Basal Insulin(1) (worldwide) ● 3 positive GetGoal trials with Lyxumia® on top of basal insulin On basal insulin On basal insulin ● A1c target and PPG control with controlled fasting achieved when used on top of glucose control Lantus® in GetGoal-Duo 1(3) but A1c >7% ● Development of injection device for variable Lantus® dose with 4 million on Lantus® fixed Lyxumia® dose on track for Phase III initiation early 4 million 2013 4 million on other basal insulins(2) T2D – Type 2 Diabetes, A1C – Glycated hemoglobin, PPG – Post Prandial Glucose (1) Adapted from IMS data (2) Includes all types of basal insulins 13 (3) Top line results press release (6 Dec 2011) – Full results expected at a forthcoming scientific meeting
DiabetesNew Glargine Formulation with Unique Pharmacokinetics ● New glargine formulation New Insulin Glargine Formulation Depot formation after subcutaneous injection provides ● Unique flat PK/PD profile Lantus® New Glargine ● Lower injection volume Formulation ● Phase III trials recently initiated in T2D high dose insulin users ● Targeting ~1,600 patients Schematic illustration PK/PD: Pharmacokinetic/pharmacodynamic T2D: Type 2 Diabetes 14
OncologyStrenghtening our Portfolio of Oncology Drugs Zaltrap® aflibercept● A novel VEGF trap acting on ● Only ultra-LMWH effective in multiple angiogenic targets reducing VTE risk reduction in chemo-treated cancer patients● Previously treated metastatic colorectal cancer ● Without impact on major bleeding incidence ● VELOUR: Significant improvement in Overall Survival ● Treatment effect consistent across solid tumor types, stages ● Manageable safety profile and geographical regions consistent with previous studies NSCLC – Non Small Cell Lung Cancer VTE – Venous Thrombo Embolism (includes Deep Venous Thrombosis and Pulmonary Embolism) 15
Kynamro™: Targeting Rare Familial Hypercholesterolemias Understanding Rarity● Four Phase III trials conducted in severe forms of hypercholesterolemia ~40,000 patients(1) ● Sustained reduction in apo B production HoFH Severe FH resulting in significant decreases in LDL-C and Lp(a) when added to a regimen of maximally tolerated statin dose and other lipid lowering therapies● Adverse reactions include ISRs, FLS, and elevations in liver transaminases and fat On statins: ● Liver fat stabilized or decreased in some 60 million patients with treatment beyond 12 patients months 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 ISR – Injection Site Reactions 16 heFH – Heterozygous familial hypercholesterolemia FLS – Flu Like Symptoms
Metabolic DisordersPCSK9 mAb: a First in Class Addressing Unmet Needsin Hypercholesterolemias LDL-C Dose Response (Phase Ib) ● Landmark study demonstrated that Atorvastatin Combo-Rx, heFH & Non-FH Combined when PCSK9 is disabled, Mean Percent Change from Baseline cholesterol and risk of CHD are in Calculated LDL-C (%) greatly lowered(1) 10 ● Preliminary Phase II data 0 -10 ● >65% LDL-C reduction in FH and primary hypercholesterolemia on -20 top of baseline statin use -30 ● Generally safe and well tolerated -40 ● Phase II data to be presented at -50 the upcoming ACC medical -60 meeting -70 1 15 29 43 57 71 85 ● Phase III targeted to start Q2 2012 Study Day Série1 Placebo Série2 50 mg Série3 100 mg Série4 150 mg = Dose administered G. Sw ergold et al. Circulation 2011; 124: A16265 CHD – Coronary Heart Disease, heFH – Heterozygous familial hypercholesterolemia , ACC – American College of Cardiology (1) Cohen JC. N Engl J Med 2006;354(12):1264-72 17
ThrombosisOtamixaban: 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 Otamixaban Otamixaban UFH + complications including death and Regimen 1 Regimen 2 Eptifibatide MI in Phase Il(1) (n=1,969) (n=1,969) (n=1,969) ● Phase III TAO study ongoing and Sponsor-blinded expected to complete by end 2012 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 18
Genzyme - Rare DiseasesEliglustat: a Novel Oral Therapy in Gaucher Disease(1) ● Potent, novel substrate inhibitor ● Convenience of oral therapy ● Eliminating challenges of infusing patients ● Clinical profile expected to be similar to Cerezyme® ● 4-year Phase II data at WORLD congress in February 2012 December 2006 December 2009 ● Phase III trials fully recruited pre-treatment (18 years) 3 years post treatment (21 years)(2) (1) Investigational drug (2) Patient from Phase II clinical trial WORLD – World Organization of Research on Lysosomal Diseases 19
Eliglustat Clinical Data Comparable to Cerezyme® Eliglustat Phase 2 Trial Results: Mean Hb Change from Baseline Treatment Changes to 4 Years(1) % Change (g/dL) from Baseline Platelets +95% 4 100% 2 50% Hemoglobin +2.3 g/dL 0 0% Liver -28% -2 -50% Spleen -63% -4 -100% Baseline Year 1 Year 2 Year 3 Year 4 Cerezyme ® Range (1) Cerezyme® Registry Data on File – Upper and Low er 95% Confidence Interval around Mean 20
VaccinesDengue Vaccine: Addressing a Growing Global Threat Significant Disease Burden Ambitious R&D Program ● Estimated 220m dengue ● Global Phase III program infections worldwide per year (43,000 individuals) ● 2m cases of Hemorrhagic ● 1st efficacy results expected Fever by end of 2012 ● >500,000 hospitalizations and ● First submissions planned >20,000 deaths / year in 2013 ● Dengue: a public health priority in Asia and Latin America 21 21
Eighteen Potential New Launches over 2012-2015 Cumulative Number of Projects Pharmaceuticals (excluding LCM) and Vaccines 18 14 8 Vaccines Rare Diseases & MS 5 Ophthalmology Diabetes Oncology Dengue vaccine Other Pharma Aubagio™ (teriflunomide) eliglustat Quadracel® Kynamro™ (mipomersen) SAR302503 DTP-HepB- Lemtrada™ (JAK-2 inhibitor) Lyxumia® Polio-Hib (lixisenatide) (alemtuzumab) ombrabulin FOV1101 Zaltrap® Fluzone® QIV IM (prednisporin) (aflibercept) iniparib Visamerin® Hexaxim® otamixaban SAR236553 (semuloparin) anti-PCSK-9 mAb 2012 2013 2014 2015 Note: Scope includes pharmaceuticals NMEs (excluding LCM – Life cycle management) and vaccines. Only first launches in a given market are mentioned. 22
Multiple Important Catalysts in 2012 2012 Expected Regulatory Submissions Q1 Q2 Q3 Q4 ● Kynamro™ (mipomersen) in hoFH in the U.S. ● Lemtrada™ (alemtuzumab) in RMS in the U.S. and EU ● Lyxumia® (lixisenatide) in Type 2 diabetes in the U.S. Expected Headline Data Releases ● Zaltrap® (aflibercept) - Phase III results in 1st line prostate cancer (VENICE) ● Aubagio™ (teriflunomide) - Phase III results in RMS (TOWER) ● Lantus® - Phase III results in reduction in CV morbidity & mortality (ORIGIN) ● Otamixaban - Phase III study completion in ACS Expected Phase III Study Initiations ● New insulin glargine formulation - Phase III in diabetes (EDITION) ● Anti-PCSK-9 mAb - Phase III trials in hypercholesterolemia hoFH – Homozygous Familial Hypercholesterolemia Zaltrap®, Lemtrada™, Aubagio™ and Kynamro™ are m-CRC – Metastatic Colorectal Cancer registered trade names submitted to health authorities for RMS – Relapsing forms of Multiple Sclerosis investigational agents 23
Continued Execution of Strategy Expected to DeliverSustainable Growth 2012-2015 2012-2015 Sales CAGR At least 5% Diversified sources of growth Scale in businesses with significant barriers to entry Low small molecule patent exposure in mature markets(1) ~6% Large Emerging Markets presence(2) 38-40% Potential new product launches(3) 18 Operating margin evolution Rebounding 2012-2015 Business EPS CAGR > Sales CAGR Increased dividend payout ratio(4) 50% of 2013 results (1) 2012 sales from chemical products exposed to patent expiry in the U.S., Japan and Western Europe over 2012/2015 (2) Based on 2015 internal estimates (3) Over 2012-2015 24 (4) Dividend paid in 2014
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