2013 - citigroup-whitaker hc
DESCRIPTION
2013 - Citigroup-whitaker HCTRANSCRIPT
Citi Healthcare ConferenceAnne Whitaker, President – North America Pharmaceuticals
New York, February 26, 2013
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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 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 Sanofi's 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 Group's 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 Sanofi's 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.
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Building a Company with Sustainable Growth
2009-2012
Transforming while managing the cliff
• Investing in growth platforms• Increasing diversification• Disciplined cost management
2013+
Generatingsustainable growth
• Growing recurring sales• Launching innovative drugs • Optimizing capital allocation
2005-2008
Focusing on Rx blockbusters
• Blockbuster drugs• Patents challenged• R&D setbacks
Sanofi Has Delivered Sales Growth for the Last Four Years Despite the Loss of Several Mega Blockbusters
€32,367m
2011
€33,389m
20102009
€29,306m
2008
€27,568m
2012
€34,947m
Sales
4
(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
+0.5%at CER(1)
(2) (2) (3)
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201220112009 2010
Key Genericized Products(1)
Unlike Many Peers, Sanofi Has Largely Transitioned Through its Patent Cliff
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
(2)
(2)
2008 2009 20112010 2012
% ofTotal
42.7% 67.4%
Sales ofGrowth Platforms(1)
Our Growth Platforms Have Doubled Over Four YearsWhile the Patent Cliff Enters the Rear-view Mirror
2011201020092008 2012
6
% ofTotal
27.4% 6.4%
Sales ofKey Genericized Products(2)
€23,548m
€11,783m
€2,222m
€7,565m
(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)
The U.S. is a Key Region for Sanofi
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(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
(2) In FY 2012, U.S. sales grew +0.7% at Constant Exchange Rates
Western EU€8,355m
Emerging Markets(1)
€11,145m
RoW€4,594m
U.S.€10,873m
FY 2012 U.S. sales were stable(2) despite significant exclusivity losses
U.S. Sales
Genzyme
Animal Health
Renal
Diabetes
Oncology
BiosurgeryLegacy Products
Cardio / Specialty
CHCWinthrop
29%
11%
6%7%
8%
19%
5%
3%
Vaccines
6%4%
19%
5%
2012 Sales by Region
Agenda
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A Leader in Diabetes
New Products to Drive Growth
Oncology - Zaltrap® Launch On Track
Consumer Healthcare
U.S. Sales Have More Than Doubled Since 2008
€2,134m
2011
€2,336m
20102009
€1,909m
2008
€1,452m
2012
€3,087m
Lantus® U.S. Sales
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2008-2012CAGR+20.8%
10
50%+23%
13%+7%
37%+14%
Share by Insulin Type(1)
Market Share (%) Growth vs. prior year (%)
Sanofi
Novo
Lilly
A Leader in the Largest and Fastest Growing Insulin Segment in the U.S.
2012 U.S. Insulin Market
38%+23%
38%+22%
24%+4%
Share by Insulin Player (Value)(1)
Market Share (%) Growth vs. prior year (%)
(1) IMS NSP Dollars, December 2012
Basal
Short-acting
Premix
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(1) Reported Q4 2012 sales(2) IMS NPA Dec 2012; volume measured in Lantus TRx equivalent units
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)
2007 2008 2009 2010 2011 2012
53% 47%
SoloSTAR®
Vial
Cartridge
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
Lixisenatide: A Once-Daily, Complementary GLP-1 with Enhanced PPG Effect
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● 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
Once-a-Day Prandial GLP-1 Receptor Agonist
Key Facts about MST2D Patients Treated with Basal Insulin(1) (worldwide)
On basal insulinOn basal insulinwith controlledfasting glucosebut A1c >7%
4 millionon other
basal insulins(2)
4 millionon Lantus®
4 million
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
Lixisenatide: Clinical Development Designed to Support Use in Combination with Basal Insulin
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MonoMono Japan
Monotherapy
Placebo-controlledin OAD failure
M (metformin)
F1 (metformin)
M Asia (metformin)
S (sulfonylurea)
P (pioglitazone)
X vs. exenatideActive-controlled
L Asia
L Placebo-controlled on top of
basal insulin Duo 1
Phase III Program
Optimal Complementary Pharmacological Profile with Basal Insulins
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Broad Phase III Program Evaluating Potential Clinical Benefitsof Improved PK/PD Profile of New Glargine Formulation
EDITION IT2D PatientsBasal Bolus
EDITION IIT2D PatientsBasal + OAD
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
New Insulin Glargine Formulation Depot formation after subcutaneous injection
Schematic illustration
Lantus® New Glargine Formulation
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EDITION IIIT2D PatientsInsulin Naïve
EDITION IVT1D Patients
Basal
● Two Phase III trials in T2D high-dose insulin users(1)
● 1,600 patients● Headline results expected in Q2 2013
● Second set of four Phase III studies started in H2 2012(1)
● Two new studies also initiated in Japan (JPI and JPII)
Agenda
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A Leader in Diabetes
New Products to Drive Growth
Oncology - Zaltrap® Launch On Track
Consumer Healthcare
U.S. Launch On Track
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Zaltrap® is developed in collaboration with RegeneronZaltrap® 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)](1) Zaltrap® was approved in EU on Feb 1, 2013
● U.S. launch on track followingAugust 2012 FDA approval afterPriority Review● Sales of €25m in 2012
● Overall awareness climbed to 91% and physician “intent to use” jumpedto 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
● Novel selective JAK2 inhibitor
● Promising Phase II response rate in patients with myelofibrosis (MF)
● 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
% patients with ≥35% reductionin spleen volume from baseline
JAK2 Inhibitor - Addressing Treatment Gaps for Patients with Debilitating Hematologic Malignancies
SAR302503 - Phase II trial
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Agenda
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A Leader in Diabetes
New Products to Drive Growth
Oncology - Zaltrap® Launch On Track
Consumer Healthcare
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An Innovative Productwith a Breakthrough Design(1)
(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(4) IMS MAT sales through November 2012
● 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
Alirocumab (PCSK9 mAb): First in Class and Targeting Unmet Needs in Hypercholesterolemia
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LDL-C Change from baseline (Phase II)(2,4,5)
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 receptorsCHD – 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(5) LS mean (SE), using LOCF method - p<0.0001 for % change SAR236553 vs. placebo
● First-in-class fully-human antibody targeting PCSK9
● Landmark study demonstrated that when PCSK9 is disabled, cholesterol and risk of CHD are greatly lowered(1)
● Phase II data(2,3)
● Significantly reduced mean LDL-C by 40% to 72% over8 to 12 weeks in patients with elevated LDL-C on stable dose of statins
● Most common TEAE: mild injection site reaction
-80
-70
-60
-50
-40
-30
-20
-10
0BASELINE WEEK 2 WEEK 4 WEEK 6 WEEK 8 WEEK 10 WEEK 12
SAR236553 100 mg Q2W PlaceboSAR236553 50 mg Q2W SAR236553 150 mg Q2W
∆ - 64.2%
∆ - 5.1%
∆ - 39.6%
∆ - 72.4%
Decrease in LDL-C shown is at week 12.
~21m patients globallyestimated not at goal for LDL-C(1)
(mainly at high cardiovascular risk)
Sanofi Started the First Ever Phase III Program for an Anti-PCSK9 mAb
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● ODYSSEY: a large global Phase III clinical program evaluating the safety and efficacy of alirocumab ● 22,000 patients, including those with
elevated cardiovascular risk, intolerant to statins or patients with FH
● Injected subcutaneously as one single injection every two weeks
● Evaluating a 1mL auto-injector for both Q2W doses, 75mg and 150mg
● Creation of a PCSK9 Development & Launch Unit
(1) Adapted from Decision Resources 2008, Decision Resources 2010 and CVReg 2011(2) heFH: Heterozygous Familial Hypercholesterolemia
Target Population
Statin Intolerant
heFH(2)
SecondaryPrevention
PrimaryPrevention
Alirocumab (SAR236553 / REGN727) is developed in collaboration with Regeneron
Otamixaban: Providing Superior Outcomes while Simplifying Treatment during Interventional Procedures
● Despite current therapies, death, MI, and readmission rates remain high
● Otamixaban is the first IV direct and selective factor Xa inhibitor with quick onset/offset
● 27% to 42% risk reduction in ACS complications including death and MI in Phase Il(1)
● Phase III TAO study ongoing with results expected in Q2 2013
(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
TAO Study
Moderate-to-high risk NSTE-ACS with planned early invasive strategy (n=13,220)
Primary endpoint:Death/Myocardial Infarction @ day 7
OtamixabanRegimen 2(n=1,969)
OtamixabanRegimen 1(n=1,969)
UFH + Eptifibatide(n=1,969)
R
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Sponsor-blinded interim analysis
Sarilumab (Anti IL-6R mAb): Addressing an Unmet Needin Rheumatoid Arthritis
● ~1/3 of RA patients treated with anti-TNFα do not respond to therapy
● Sarilumab is a fully human, high affinity, IL-6R mAb administered subcutaneously in combinationwith methotrexate● Positive Phase II with meaningful
improvements in signs & symptoms of moderate-to-severe RA
● 2 pivotal Phase III trials ongoing● SARIL-RA-MOBILITY fully enrolled
● SARIL-RA-TARGET recruiting
● New studies to start in H1 2013
MOBILITY Trial (Phase IIb Results)
Sarilumab is developed in collaboration with RegeneronRA – Rheumatoid Arthritis IL-6R – Interleukin-6 receptorACR – American College Of Rheumatology (ACR) Scoring System
200 mg q2w
17.3*
40.4*
65.4
150 mg q2w
11.8
35.3
66.7
Placebo
1.9
15.4
46.2
ACR70ACR50ACR20
* p<0.01 versus placebo (only unadjusted p-values <0.01 are considered statistically significant)
ACR response at week 12 (%)
A&R 2011; 63; suppl.10:4041
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Agenda
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A Leader in Diabetes
New Products to Drive Growth
Oncology - Zaltrap® Launch On Track
Consumer Healthcare
Chattem: Successfully Establishing a U.S. OTC Platform
25(1) Chattem was acquired by Sanofi on February 9, 2010(2) Internal estimates (3) Acquisition of worldwide rights to Rolaids® was announced on January 7, 2013
€606m€549m
€320m(1)
®
2010 2011 2012
● Chattem sales have nearly doubled since the acquisition in 2010(1)
● Operating margin estimated to be among best-in-class in OTC(2)
● Successfully switched Allegra® from Rx-to-OTC status
● Acquisition of worldwide rights to Rolaids®(3)
● Further development of the Chattem portfolio
Chattem U.S. Sales
Allegra® – A Very Successful Rx to OTC Switch
● Launched in March 2011 in the U.S.
● OTC sales of €218m in FY 2012
● Strong trade success and speed to market
● Premium merchandising and promotional support
● Successfully building brandawareness
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Claritin® Zyrtec®Allegra®
4 weeks ending
-
2
4
6
8
10
12
14
16
18
(1) A.C. Nielsen xAOC (represents 81% of all outlets); 4-week data through 01/19/2013
Nielsen Unit Share (%)(1)
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
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