2012 - morning star hc
DESCRIPTION
2012 - Morning Star HCTRANSCRIPT
Morningstar Healthcare Conference
Dr. Paul Chew U.S. Chief Science Officer / Chief Medical Officer, SVP
Chicago, November 7th, 2012
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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 include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements 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 believes that 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 and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include 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 to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual 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.
(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%
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YTD Sales (€m)
YTD 2011 YTD 2012
€26,421m
+1.2% at CER(3)
€24,881m
Results Reflect Generic Competition to Legacy Blockbusters(1)
and Loss of Exclusivity of Plavix® and Avapro® in the U.S.(2)
YTD 2011 YTD 2012
YTD Business EPS (€)
€5.01
-8.4% at CER(4)
€5.09
Growth Platforms Sales (€m and % of Total Sales)
Q2 Q1 Q2 Q3
€6,412m
€5,381m
In Q3 2012 Growth Platforms Represented Over 70% of Sales
(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
Q2 Q1 Q2 Q3
4.4% of Total Sales
€813m €399m
Key Genericized Products Sales(1)
(€m and % of Total Sales)
€752m
€5,753m
70.9% of Total Sales
€3,339m
€2,207m
2012 2009 2012 2009
Growth Platforms Grew by +6.4% in Q3 2012
5 (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®
+17.5%
+0.7%
+5.9%
+3.8%
+22.5%
Innovative Products(2) €154m +7.6%
+6.8%
Vaccines €1,481m
Diabetes Solutions €1,486m
Consumer Health Care €733m
Animal Health €519m
Emerging Markets €2,821m
New Genzyme(1) €470m
Growth at CER
Executing Successful Strategy to Reposition Sanofi
Deliver sustainable growth
and generate improved
shareholder returns Adapt structure for future challenges and opportunities 3
Pursue external growth opportunities 2
Increase innovation in R&D 1
6 6
Several Regulatory Milestones Expected in Next 6 Months
hoFH: Homozygous Familial Hypercholesterolemia heFH: Heterozygous Familial Hypercholesterolemia 7
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
PDUFA: Prescription Drug User Fee Act CHMP: Committee for Medicinal Products for Human Use
Expected Milestones
CHMP Opinion: Q4 2012
Products
® Metastatic Colorectal Cancer
FDA Re-Submission on track(2)
CHMP Opinion: Q2 2013 Relapsing Forms of Multiple Sclerosis
CHMP Opinion: Q4 2012 PDUFA Date: Jan 29, 2013(1)
TM hoFH/severe heFH in EU and hoFH in the U.S
Targeted Indications
CHMP Opinion: Q1 2013 Relapsing Forms of Multiple Sclerosis
®
CHMP Opinion: Q4 2012 FDA Submission: Dec 2012
®
Type 2 Diabetes
(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 f ile
DTP-HepB-Polio-Hib EU Licensure: Q2 2013 New 6-in-1
Paediatric Vaccine
Now Available in the U.S.
8 (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.
Key Facts about MS
● 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
Oncology
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An Exciting New Oral Treatment Now Approved by FDA for Relapsing MS
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(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.
The AUBAGIO® label includes a boxed warning citing the risk of hepatotoxicity and teratogenicity (based on animal data).
● 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 STUDYReduction in Progression of
Disability(2)
Placebo
-29.8%(3)p=0.0279(4)
Aubagio®
14mgPlacebo Aubagio®
14mg
0.273
0.1580.202 0.197
-31.5%(3)p=0.0442(4)
Reduction in Progression of Disability(2)
n=370n=363 n=359 n=388
TEMSO STUDY TOWER STUDYAnnualized Relapse Rate(1)
Placebo
- 31.5%p=0.0005
Aubagio®
14mg
n=370
Placebo Aubagio®
14mg
0.539
0.3190.369
0.501
n=363 n=359 n=388
Annualized Relapse Rate(1)
- 36.3%p=0.0001
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Significantly More Effective at Reducing ARR in Pivotal Trials with Unique Dosing Regimen
Broadening our Diabetes Platform with New Patient Focused Solutions
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® ● Once-daily and pronounced PPG lowering effect
● Use on top of basal insulin
● ELIXA: CV outcome study ongoing
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 Identif ier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142
● Unique flat PK/PD profile and lower injection volume
● 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
NEW INSULIN GLARGINE
FORMULATION
T2D Patients Treated with Basal Insulin(1) (worldwide)
On basal insulin On basal insulin with controlled fasting
glucose control but A1c >7%
4 million on other
basal insulins(2)
4 million on 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 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
Clinical Development Designed to Support Use in Combination with Basal Insulin
®
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Mono Mono Japan
Monotherapy
Placebo-controlled in OAD failure
M (metformin)
F1 (metformin)
M Asia (metformin)
S (sulfonylurea)
P (pioglitazone)
X vs. exenatide Active-controlled
L Asia
L Placebo-controlled
on top of basal insulin Duo 1
Phase III Program
Fix-Flex Device Has Been Developed for Joint Administration 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 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
Lixisenatide
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New Glargine Formulation
● Investigational glargine formulation: ● Flat PK/PD profile ● Lower injection volume
● Phase III trials ongoing in T2D high-dose insulin users(1)
● Targeting ~1,600 patients
● Second set of Phase III studies recently started(2)
EDITION I T2D Patients Basal Bolus
EDITION II T2D Patients Basal + OAD
PK/PD – Pharmacokinetic/Pharmacodynamic OAD – Oral anti-diabetic drugs (1) ClinicalTrials.gov Identif ier: NCT1499082 & NCT01499095 (2) ClinicalTrials.gov Identif ier: NCT01676220 & NCT01683266
New Insulin Glargine Formulation Depot formation after subcutaneous injection
Schematic illustration
Lantus® New Glargine Formulation
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EDITION III T2D Patients Insulin Naïve
EDITION IV T1D Patients
Basal
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Targeting Rare Familial Hypercholesterolemias
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(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
● Four Phase III trials conducted in severe FH forms ● Significant reduction in LDL-C
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)
● FDA Ad Com voted on October 18th recommending approval
HeFH: 1 million patients
HoFH Severe FH
Understanding Rarity
~40,000 patients(1)
On statins: 60 million patients
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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
Otamixaban Regimen 2 (n=1,969)
Otamixaban Regimen 1 (n=1,969)
UFH + Eptifibatide (n=1,969)
R
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Sponsor-blinded interim analysis
Eliglustat(1) - A Novel Oral Therapy in Gaucher Disease
● Potent, novel substrate inhibitor
● Oral therapy ● Eliminating challenges of infusions
● Positive results from ENGAGE, first Phase III study (vs. placebo) ● Primary endpoint and all secondary
endpoints met ● Well tolerated with no serious
adverse events reported
● ENCORE Phase III results (vs. Cerezyme®) expected in early 2013
22 (1) Eliglustat tartrate is an investigational drug (2) Secondary endpoints included improvements in hemoglobin levels and platelet levels, as w ell as liver volumes
+2%
-28%
Placebo Eliglustat
Change in Spleen Volume (% change at 9 months)
30% Absolute
Difference
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Dengue Vaccine: Addressing a Growing Global Threat
First Efficacy Results
● Phase IIb results in ~4,000 patients recently published in the Lancet
● Effective against DENV 1, 3 and 4 (in the range of 60% to 90%), with only DENV 2 appearing to be resistant
● Safe and well-tolerated
Significant Disease Burden
● Estimated 220m dengue infections worldwide per year
● 2m cases of Hemorrhagic Fever
● >500,000 hospitalizations and >20,000 deaths / year
● Dengue: a public health priority in Asia and Latin America
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Ambitious Phase III Program
● Global Phase III program ongoing
● Large scale studies in LatAm and Asia
● 31,000 children and adolescents
● Results expected in 2014
Ensuring R&D Contributes to Sanofi’s Success
Global R&D
Goals
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
Execute on late-stage projects Medical value and translational feasibility to guide early-stage
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
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