Citi Healthcare ConferenceAnne Whitaker, President – North America Pharmaceuticals                  New York, February 26,...
Forward Looking StatementsThis presentation contains forward-looking statements as defined in the Private Securities Litig...
Building a Company with Sustainable Growth        2005-2008                 2009-2012                           2013+    F...
Sanofi Has Delivered Sales Growth for the Last Four YearsDespite the Loss of Several Mega Blockbusters                    ...
Unlike Many Peers, Sanofi Has Largely TransitionedThrough its Patent Cliff   Key Genericized Products(1)                  ...
Our Growth Platforms Have Doubled Over Four YearsWhile the Patent Cliff Enters the Rear-view Mirror                  Sales...
The U.S. is a Key Region for Sanofi             2012 Sales by Region                                                      ...
Agenda   A Leader in Diabetes   Oncology - Zaltrap® Launch On Track   New Products to Drive Growth   Consumer Healthcare  ...
U.S. Sales Have More Than Doubled Since 2008               Lantus® U.S. Sales                                         €3,0...
A Leader in the Largest and Fastest Growing InsulinSegment in the U.S.                                          2012 U.S. ...
SoloSTAR® Continues to Drive Growth and        is the Majority of U.S. Lantus® Sales% of U.S. Lantus® Sales(1)            ...
Lixisenatide: A Once-Daily, Complementary GLP-1 withEnhanced PPG Effect                  Once-a-Day Prandial GLP-1 Recepto...
Lixisenatide: Clinical Development Designed to SupportUse in Combination with Basal Insulin                               ...
Broad Phase III Program Evaluating Potential Clinical Benefitsof Improved PK/PD Profile of New Glargine Formulation       ...
Agenda   A Leader in Diabetes   Oncology - Zaltrap® Launch On Track   New Products to Drive Growth   Consumer Healthcare  ...
U.S. Launch On Track● U.S. launch on track following  August 2012 FDA approval after  Priority Review   ● Sales of €25m in...
JAK2 Inhibitor - Addressing Treatment Gaps for Patientswith Debilitating Hematologic Malignancies                         ...
Agenda   A Leader in Diabetes   Oncology - Zaltrap® Launch On Track   New Products to Drive Growth   Consumer Healthcare  ...
An Innovative Product                             with a Breakthrough Design(1)● Nearly 6 million people in the U.S.  may ...
Alirocumab (PCSK9 mAb): First in Class and Targeting UnmetNeeds in Hypercholesterolemia  ● First-in-class fully-human     ...
Sanofi Started the First Ever Phase III                                 Program for an Anti-PCSK9 mAb● ODYSSEY: a large gl...
Otamixaban: Providing Superior Outcomes whileSimplifying Treatment during Interventional Procedures  ● Despite current the...
Sarilumab (Anti IL-6R mAb): Addressing an Unmet Needin Rheumatoid Arthritis  ● ~1/3 of RA patients treated with           ...
Agenda   A Leader in Diabetes   Oncology - Zaltrap® Launch On Track   New Products to Drive Growth   Consumer Healthcare  ...
Chattem: Successfully Establishing a U.S. OTC Platform                                                                    ...
Allegra® – A Very Successful Rx to OTC Switch● Launched in March 2011 in the U.S.                                         ...
Growing Our Presence in a Key Region● The U.S. Pharmaceutical market is a significant business and  innovation hub    ● Co...
Upcoming SlideShare
Loading in …5
×

2013 - Citigroup-whitaker HC

1,132 views

Published on

2013 - Citigroup-whitaker HC

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
1,132
On SlideShare
0
From Embeds
0
Number of Embeds
325
Actions
Shares
0
Downloads
3
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

2013 - Citigroup-whitaker HC

  1. 1. Citi Healthcare ConferenceAnne Whitaker, President – North America Pharmaceuticals New York, February 26, 2013
  2. 2. Forward Looking StatementsThis 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 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, andstatements regarding future performance. Forward-looking statements are generally identified by the words "expects","anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofis management believesthat 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 andgenerally beyond the control of Sanofi, that could cause actual results and developments to differ materially from thoseexpressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertaintiesinclude 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 toapprove any drug, device or biological application that may be filed for any such product candidates as well as theirdecisions regarding labeling and other matters that could affect the availability or commercial potential of such productcandidates, the absence of guarantee that the product candidates if approved will be commercially successful, the futureapproval and commercial success of therapeutic alternatives, the Groups ability to benefit from external growthopportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies andsubsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in thepublic filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "CautionaryStatement Regarding Forward-Looking Statements" in Sanofis annual report on Form 20-F for the year ended December31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise anyforward-looking information or statements. 2
  3. 3. 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 • Launching innovative drugs • R&D setbacks • Disciplined cost management • Optimizing capital allocation 3
  4. 4. Sanofi Has Delivered Sales Growth for the Last Four YearsDespite 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 Venture sales were not consolidated by Sanofi (3) In 2010, excluding non-consolidated sales from Merial, Sanofi reported sales of €30,384m 4
  5. 5. Unlike Many Peers, Sanofi Has Largely TransitionedThrough 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 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) Plavix® U.S., and Avapro® U.S. sales were consolidated by BMS 5
  6. 6. Our Growth Platforms Have Doubled Over Four YearsWhile 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) 2010 include sales of Merial. In 2008 and 2009, Merial Joint Venture sales were not consolidated by Sanofi (2) 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) 6
  7. 7. The U.S. is a Key Region for Sanofi 2012 Sales by Region U.S. Sales RoW U.S. €4,594m €10,873m Vaccines Diabetes 19% 19%Western EU €8,355m 29% Genzyme 5%5% 8% Animal Health 11% 3% Winthrop 6% Oncology CHC 7% 6% 4% Legacy Products Renal Emerging Markets(1) Biosurgery €11,145m Cardio / Specialty FY 2012 U.S. sales were stable(2) despite significant exclusivity losses (1) World less North America (USA, 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 7 (2) In FY 2012, U.S. sales grew +0.7% at Constant Exchange Rates
  8. 8. Agenda A Leader in Diabetes Oncology - Zaltrap® Launch On Track New Products to Drive Growth Consumer Healthcare 8
  9. 9. U.S. Sales Have More Than Doubled Since 2008 Lantus® U.S. Sales €3,087m €2,336m €2,134m 2008-2012 €1,909m CAGR +20.8% €1,452m 2008 2009 2010 2011 2012 9
  10. 10. A Leader in the Largest and Fastest Growing InsulinSegment in the U.S. 2012 U.S. Insulin Market Share by Insulin Player (Value)(1) Share by Insulin Type(1) Market Share (%) Market Share (%) Growth vs. prior year (%) Growth vs. prior year (%) 24% +4% 38% 37% +23% +14% 50% +23% 38% +22% 13% +7% Sanofi Basal Lilly Premix Novo Short-acting (1) IMS NSP Dollars, December 2012 10
  11. 11. SoloSTAR® Continues to Drive Growth and is the Majority of U.S. Lantus® Sales% of U.S. Lantus® Sales(1) Volume by Method of Delivery(2) 53% 47% 2007 2008 2009 2010 2011 2012 SoloSTAR® Vial Cartridge (1) Reported Q4 2012 sales (2) IMS NPA Dec 2012; volume measured in Lantus TRx equivalent units 11
  12. 12. Lixisenatide: A Once-Daily, Complementary GLP-1 withEnhanced PPG Effect Once-a-Day Prandial GLP-1 Receptor Agonist ● Pronounced post-prandial glucose lowering effect of Lyxumia® ● Clinical development designed to support use on top of basal insulin ● cardiovascular outcomes study ongoing ● NDA file accepted in February 2013 ● European launch roll-out planned to start in late Q1 2013 The proprietary name for lixisenatide in the U.S. is under consideration. Lixisenatide was in-licensed from Zealand Pharma A/S. A1C – HbA1c or Glycated hemoglobin 12
  13. 13. Lixisenatide: Clinical Development Designed to SupportUse in Combination with Basal Insulin T2D Patients Treated Key Facts about MS Phase III Program with Basal Insulin(1) (worldwide) Mono Monotherapy On basal insulin Mono Japan On basal insulin with controlled F1 (metformin) fasting glucose S (sulfonylurea) but A1c >7% Placebo-controlled M (metformin) in OAD failure P (pioglitazone) 4 million M Asia (metformin) on Lantus® Active-controlled X vs. exenatide 4 million 4 million L on other Placebo-controlled basal insulins(2) on top of L Asia basal insulin Duo 1 Optimal Complementary Pharmacological Profile with Basal Insulins 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 anywhere in the world. T2D – Type 2 Diabetes A1C – HbA1c or Glycated hemoglobin (1) Adapted from IMS data (2) Includes all types of basal insulins 13
  14. 14. Broad Phase III Program Evaluating Potential Clinical Benefitsof 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 Formulation ● Headline results expected in Q2 2013 EDITION I EDITION II T2D Patients T2D Patients Basal Bolus Basal + OAD ● Second set of four Phase III studies started in H2 2012(1) EDITION III EDITION IV T2D Patients T1D Patients Insulin Naïve Basal Schematic illustration ● Two new studies also initiated in Japan (JPI and JPII) PK/PD – Pharmacokinetic/Pharmacodynamic T1D and T2D: Type 1 and Type 2 diabetes OAD – Oral anti-diabetic drugs (1) EDITION I, II, III, IV, JPI, JPII - ClinicalTrials.gov Identifier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142 14
  15. 15. Agenda A Leader in Diabetes Oncology - Zaltrap® Launch On Track New Products to Drive Growth Consumer Healthcare 15
  16. 16. U.S. Launch On Track● 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 approval recently granted(1) ● European launch roll-out planned to start in Q1 2013 Zaltrap® is developed in collaboration with Regeneron Zaltrap® is indicated in combination with FOLFIRI in metastatic colorectal cancer (mCRC) patients resistant to or progressing on an oxaliplatin-containing regimen [FOLFIRI: FOL (folinic acid), F (fluorouracil) and IRI (irinotecan)] 16 (1) Zaltrap® was approved in EU on Feb 1, 2013
  17. 17. JAK2 Inhibitor - Addressing Treatment Gaps for Patientswith 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 III in MF (JAKARTA) ● Two doses (400 mg and 500 mg) selected ● Enrollment completed ● Headline results expected in Q2 2013 ● Two Phase II studies ongoing ● Polycythemia vera ● Myelofibrosis patients previously treated with ruxolitinib 17
  18. 18. Agenda A Leader in Diabetes Oncology - Zaltrap® Launch On Track New Products to Drive Growth Consumer Healthcare 18
  19. 19. An Innovative Product with a Breakthrough Design(1)● Nearly 6 million people in the U.S. may be at risk for anaphylaxis(2)● One main U.S. competitor with >95% market share(3): EpiPen® from Mylan ● Estimated U.S. sales of ~$700m(4)● Auvi-Q™ offers a unique compact size and shape ● Audio and visual cues guide users through the injection process ● Retractable needle mechanism● Launched in the U.S. in Jan 2013 (1) Sanofi U.S. licensed the North American commercialization rights to the epinephrine auto-injector from Intelliject, Inc., (2) Source: 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Practice Parameters (3) Source: Mylan Form 10-K for the period ending Dec 31, 2011 and Mylan Investor Day on Feb 21, 2012 19 (4) IMS MAT sales through November 2012
  20. 20. Alirocumab (PCSK9 mAb): First in Class and Targeting UnmetNeeds 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 cholesterol and risk of CHD ∆ - 5.1% -20 are greatly lowered(1) -30 ∆ - 39.6% ● Phase II data(2,3) -40 ● Significantly reduced mean -50 ∆ - 64.2% LDL-C by 40% to 72% over -60 8 to 12 weeks in patients with -70 elevated LDL-C on stable dose ∆ - 72.4% -80 of statins SAR236553 100 mg Q2W Placebo SAR236553 50 mg Q2W SAR236553 150 mg Q2W ● Most common TEAE: mild injection site reaction Decrease in LDL-C shown is at week 12. Alirocumab (SAR236553 / REGN727) is developed in collaboration with Regeneron PCSK9: proprotein convertase subtilisin/kexin type 9, an enzyme that can contribute to elevated LDL-C levels through degradation of LDL-C receptors CHD – Coronary Heart Disease LDL-C : Low Density Lipoprotein-Cholesterol TEAE : Treatment-Emergent Adverse Event (1) Cohen JC. N Engl J Med 2006;354(12):1264-72 (2) McKenney, et al JACC published online March 28 2012 (3) Roth et al JACC Volume 59, Issue 13, Supplement, 27 March 2012, E1620 (4) Patients with primary hypercholesterolemia receiving stable atorvastatin therapy; change from baseline to week 12 20 (5) LS mean (SE), using LOCF method - p<0.0001 for % change SAR236553 vs. placebo
  21. 21. Sanofi 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 alirocumab ~21m patients globally estimated not at goal for LDL-C(1) ● 22,000 patients, including those with (mainly at high cardiovascular risk) elevated cardiovascular risk, intolerant to statins or patients with FH Primary ● Injected subcutaneously as one single Secondary Prevention injection every two weeks Prevention ● Evaluating a 1mL auto-injector for both Q2W doses, 75mg and 150mg● Creation of a PCSK9 Development heFH(2) & Launch Unit Statin  Intolerant Alirocumab (SAR236553 / REGN727) is developed in collaboration with Regeneron (1) Adapted from Decision Resources 2008, Decision Resources 2010 and CVReg 2011 (2) heFH: Heterozygous Familial Hypercholesterolemia 21
  22. 22. Otamixaban: Providing Superior Outcomes whileSimplifying 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=13,220) selective factor Xa inhibitor with quick onset/offset R ● 27% to 42% risk reduction in ACS complications including death and MI in Phase Il(1) Otamixaban Otamixaban UFH + Regimen 1 Regimen 2 Eptifibatide (n=1,969) (n=1,969) (n=1,969) ● Phase III TAO study ongoing with results expected in Q2 2013 Sponsor-blinded 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 22
  23. 23. Sarilumab (Anti IL-6R mAb): Addressing an Unmet Needin 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 ACR70 subcutaneously in combination with methotrexate 46.2 40.4* ● Positive Phase II with meaningful 35.3 improvements in signs & symptoms of moderate-to-severe RA 15.4 17.3* 11.8 ● 2 pivotal Phase III trials ongoing 1.9 ● SARIL-RA-MOBILITY fully enrolled Placebo 150 mg q2w 200 mg q2w ● SARIL-RA-TARGET recruiting * p<0.01 versus placebo (only unadjusted p-values <0.01 are considered statistically significant) ● New studies to start in H1 2013 A&R 2011; 63; suppl.10:4041 Sarilumab is developed in collaboration with Regeneron RA – Rheumatoid Arthritis IL-6R – Interleukin-6 receptor ACR – American College Of Rheumatology (ACR) Scoring System 23
  24. 24. Agenda A Leader in Diabetes Oncology - Zaltrap® Launch On Track New Products to Drive Growth Consumer Healthcare 24
  25. 25. Chattem: Successfully Establishing a U.S. OTC Platform Chattem U.S. Sales● Chattem sales have nearly doubled since the acquisition in 2010(1) €606m● Operating margin estimated to be €549m among best-in-class in OTC(2) ®● Successfully switched Allegra® from Rx-to-OTC status (1) €320m● Acquisition of worldwide rights to Rolaids®(3)● Further development of the Chattem portfolio 2010 2011 2012 (1) Chattem was acquired by Sanofi on February 9, 2010 (2) Internal estimates 25 (3) Acquisition of worldwide rights to Rolaids® was announced on January 7, 2013
  26. 26. Allegra® – A Very Successful Rx to OTC Switch● Launched in March 2011 in the U.S. Nielsen Unit Share (%)(1)● OTC sales of €218m in FY 2012 18 16● Strong trade success 14 and speed to market 12 10● Premium merchandising and 8 promotional support 6● Successfully building brand 4 awareness 2 - 4 weeks ending Allegra® Claritin® Zyrtec® (1) A.C. Nielsen xAOC (represents 81% of all outlets); 4-week data through 01/19/2013 26
  27. 27. Growing Our Presence in a Key Region● The U.S. Pharmaceutical market is a significant business and innovation hub ● Complex market undergoing significant change ● Largest pharmaceutical market and rewards investment in innovation ● Sanofi U.S. is adapting to a changing environment● Sanofi is well positioned to expand its presence in the U.S. ● Develop integrated diabetes solutions around Lantus® ● Bring to market innovative and differentiated pharmaceuticals and devices and execute on product launches ● Enhance Consumer Healthcare offerings 27

×