2012 - bofa-merrill lynch hc conference
DESCRIPTION
2012 - Merril Lynch HC ConferenceTRANSCRIPT
BofA MERRILL LYNCH HEALTHCARE CONFERENCE Dr. Paul Chew
U.S. Chief Science Officer / Chief Medical Officer, SVP
May 15, 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.
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€1.66
Q1 2011 Q1 2012
Total Sales (€m)
2012 - A Good Start to the Year
€7,779m
Q1 2011 Q1 2012
Business EPS (€)
€1.85
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€8,511m
+7.2% at CER
+7.0% at CER
Growth Platforms Accounted for 63.2% of Sales in Q1 2012
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Growth is at CER (Constant Exchange Rates)(1) With Genzyme pro forma in Q1 2011, Emerging Market sales grew by 5.6%, and by 7.9% excluding vaccines(2) New Genzyme perimeter include Rare Diseases and Multiple Sclerosis franchises(3) Change on a constant structure basis and at constant exchange rates(4) Multaq®, Jevtana®, and Mozobil®
+14.4% +14.4%
+11.4%+11.4%
-0.2%-0.2%
-5.4%-5.4%
+13.7%(3) +13.7%(3)
Innovative Products(4) €139m +6.3%(3)+6.3%(3)
+9.9%(1) +9.9%(1)
Consumer Health Care €805m
Diabetes Solutions €1,311m
Vaccines €617m
Animal Health €578m
Emerging Markets €2,624m
New Genzyme(2) €400m
Growth at CER
Executing Successful Strategy to Reposition Sanofi
Deliver sustainable growth
and generate improved
shareholder returnsAdapt structure for future challenges and opportunities3
Pursue external growth opportunities2
Increase innovation in R&D1
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Executing our R&D Strategy
GlobalR&D
Goals
An efficient global R&D organization Maximize synergies and convergence around Hub modelExploit economies of scale Improve R&D cost structure
Focus on high-value projects Execute on late-stage projectsMedical value and translational feasibility to guide early-stage
portfolio prioritization
Establish new models of external innovationEnhance the value of external opportunities and partnershipsCreate open and creative model of pharma-biotech partnership
e.g. Warp Drive Bio
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Focusing on Delivering a Promising Development Portfolio
Achieve Regulatory Milestones
• Lemtrada™• Aubagio™• Lyxumia® (1)
• Zaltrap™(2)
• Semuloparin• Kynamro™ (3)
Next Wave of Late-Stage Projects
• New glargine formulation• Glargine-lixisenatide combo• Dengue vaccine• Eliglustat• Anti-PCSK-9 mAb
EU/U.S.
EU
EU/U.S.
EU/U.S.
EU/U.S.
• Otamixaban• Sarilumab• JAK-2 inhibitor• Iniparib• Ombrabulin
Short-term opportunities
Mid-term opportunities
Submitted
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Lemtrada™, Aubagio™, Lyxumia®, Zaltrap™, and Kynamro™ are registered trade names submitted to health authorities for investigational agents(1) In-licensed from Zealand Pharma A/S(2) Partnership with Regeneron(3) In-licensed from Isis Pharmaceuticals
Efficacy with manageable safety
Convenience & efficacy
Early MS/CIS(1) RRMS(2) and early active MS
RMS(3) severe/ highly active
Emergence of a Franchise Addressing the Full Spectrum of Patient Needs in Multiple Sclerosis
Lemtrada™
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Aubagio®
Convenience & safety
Rebif®
Lemtrada™
Aubagio™
CIS – Clinically Isolated Syndrome, TOPIC Phase III study presently ongoing RRMS – Relapse Remitting Multiple SclerosisRMS – Relapsing Multiple Sclerosis
Genzyme - MS
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9Coles A ECTRIMS 2011; platform presentation
CARE-MS I - Strong Effect on Relapse
Proportion of Relapse-Free Patients at Year 2
59%
78%
Lemtrada™ 12 mg/day Rebif®
HR 0.45 P<0.001
CARE-MS II - Reversing Disability in Some Patients
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Mean EDSS Change from Baseline
p<0.0001
0.24 p=0.0064
‒0.17 p=0.0044
Rebif®Lemtrada™ 12 mg/day
EDSS – Expanded Disability Status ScoreCohen J AAN 2012; platform presentation
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Aubagi A Once-Daily Oral Therapy with Comparable Efficacy to Injectable Interferon
●
Efficacy demonstrated in TEMSO on both Relapse Rate and Disability Progression at 14mg
●
No superiority vs. Rebif® in TENERE but lower rate of TEAE- related discontinuation
●
Manageable safety profile with up to 10 years of follow-up
(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 SclerosisENS – European Neurological Society, ARR – Annualized Relapse Rate, RRR – Relative risk reduction, HRR – Hazard ratio reduction
TEMSO: Reduction in Adjusted(1) ARR
RRR: 31.2%p=0.0002
RRR: 31.5%p=0.0005
0%
20%
10%
HRR: 23.7%p=ns
HRR: 29.8%p=0.0279
30%PlaceboT. 7 mgT. 14 mg
Week
TEMSO: Reduction in Disability Progression (%)
Genzyme - MS
0 0,1 0,2 0,3 0,4 0,5 0,6
T. 14 mg
T. 7 mg
Placebo
0 12 24 36 48 60 72 84 96 108
A GLP-1 Agonist with Unique Post-Prandial Effect and One Step Titration
MonoMono Japan
Drug naïve patients
Placebo-controlledin OAD failure
M (metformin)
F1 (metformin)
M Asia (metformin)
S (sulfonylurea)
P (pioglitazone)
X vs. exenatideActive-controlled
L
L AsiaPlacebo-controlled on
top of basal insulin
Placebo-controlled Secondary prevention
Cardiovascular Outcomes Study
Reported
Lixisenatide was in-licensed from Zealand Pharma A/S. Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is currently not approved or licensed anywhere in the world. 12
Duo 1 (Lantus®)
Consistent GLP-1 class effects of A1c reduction and weight loss
Pronounced effect on post-prandial glucose
Favorable safety profile with low risk of hypoglycemic events
OD injection, simple 1 step to maintenance dose, 1 pen per dose
Lyxumia® Profile
®Diabetes
Ongoing
●
3 positive GetGoal trials with Lyxumia® on top of basal insulin
●
A1c target and PPG control achieved when used on top of Lantus® in GetGoal-Duo 1(3)
●
Development of injection device for variable Lantus® dose with fixed Lyxumia® dose on track for Phase III initiation early 2013
T2D Patients Treated with Basal Insulin(1)
(worldwide)
On basal insulin On basal insulinwith controlled fasting
glucose controlbut A1c >7%
4 million
T2D – Type 2 Diabetes, A1C – Glycated hemoglobin, PPG – Post Prandial Glucose(1) Adapted from IMS data(2) Includes all types of basal insulins(3) Top line results press release (6 Dec 2011) – Full results expected at a forthcoming scientific meeting
Optimal Complementary Pharmacological Profile with Basal Insulins
Diabetes®
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4 million on other
basal insulins(2)
4 million on Lantus®
New Glargine Formulation with Unique Pharmacokinetics
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New Insulin Glargine Formulation Depot formation after subcutaneous injection
PK/PD – Pharmacokinetic/pharmacodynamicT2D – Type 2 Diabetes
Schematic illustration
●
New glargine formulation provides
●
Unique flat PK/PD profile
●
Lower injection volume
●
Phase III trials recently initiated in T2D high dose insulin users
●
Targeting ~1,600 patients
Diabetes
Lantus® New Glargine Formulation
Strengthening our Portfolio of Oncology Drugs
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●
A novel VEGF trap acting on multiple angiogenic targets
●
Previously treated metastatic colorectal cancer
●
VELOUR: Significant improvement in Overall Survival
●
Manageable safety profile consistent with previous studies
Zaltrap® aflibercept
Mulsevo™ is a registered trade name submitted to health authorities for an investigational agentNSCLC – Non Small Cell Lung Cancer VTE – Venous Thrombo Embolism (includes Deep Venous Thrombosis and Pulmonary Embolism)
Oncology
●
Only ultra-LMWH effective in reducing VTE risk reduction in chemo-treated cancer patients
●
Without impact on major bleeding incidence
●
Treatment effect consistent across solid tumor types, stages and geographical regions
™
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Kynamro™: Targeting Rare Familial Hypercholesterolemias
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(1) Patients for HoFH and Severe FH in US and EU marketsHoFH – Homozygous Familial HypercholesterolemiaSevere FH – Severe Familial Hypercholesterolemia = treated LDL-C CHD – Coronary Heart DiseaseHeFH – Heterozygous familial hypercholesterolemiaISR – Injection Site ReactionsFLS – Flu Like Symptoms
●
Four Phase III trials conducted in severe forms of hypercholesterolemia●
Sustained reduction in apo B production 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●
Liver fat stabilized or decreased in some patients with treatment beyond 12 months
HeFH: 1 million patients
HoFH Severe FH
Understanding Rarity
~40,000 patients(1)
On statins: 60 million patients
PCSK9 mAb: First in Class and Addressing Unmet Needs in Hypercholesterolemia
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LDL-C Change from baseline (Phase II)(2,4,5)
CHD – Coronary Heart Disease(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
Metabolic Disorders
●
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% over 8 to 12 weeks in patients with elevated LDL-C in patients on stable dose of statins
●
Generally safe and well tolerated
●
Phase III targeted to start Q2 2012
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Eliglustat: 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
●
Phase III trials fully recruited
(1) Investigational drug (2) Patient from Phase II clinical trialWORLD – World Organization of Research on Lysosomal Diseases
December 2006pre-treatment (18 years)
December 20093 years post treatment (21 years)(2)
Genzyme - Rare Diseases
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Eliglustat Clinical Data Comparable to Cerezyme®
Platelets +95%
Hemoglobin +2.3 g/dL
-4
-2
0
2
4
Hb Change from Baseline
(g/dL)
-100%
-50%
0%
50%
100%
Mean % Change
from Baseline
Liver -28%
Spleen -63%
Year 1 Year 2 Year 3 Year 4Baseline
(1) Cerezyme® Registry Data on File – Upper and Lower 95% Confidence Interval around Mean
Eliglustat Phase 2 Trial Results: Treatment Changes to 4 Years(1)
Cerezyme® Range
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Dengue Vaccine: Addressing a Growing Global Threat
Ambitious R&D Program
●
Global Phase III program (43,000 individuals)
●
1st efficacy results expected by end of 2012
●
First submissions planned in 2013
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
Vaccines
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Rare Diseases & MS
DiabetesOncologyOther Pharma
Ophthalmology
Vaccines
Eighteen Potential New Launches over 2012-2015
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Kynamro™ (mipomersen)
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Lemtrada™ (alemtuzumab)
Aubagio™ (teriflunomide)
Lyxumia®
(lixisenatide)
Zaltrap™ (aflibercept)
semuloparin Hexaxim®
ombrabulin
Dengue vaccine
eliglustat
SAR302503 (JAK-2 inhibitor)
otamixaban
DTP-HepB- Polio-Hib
FOV1101 (prednisporin)
SAR236553 anti-PCSK-9 mAb
iniparib
2012 2013 2014 2015
Cumulative Number of Projects Pharmaceuticals (excluding LCM) and Vaccines
Fluzone® QIV IM
Quadracel®
Note: Scope includes pharmaceuticals NMEs (excluding LCM – Life cycle management) and vaccines. Only first launches in a given market are mentioned.21
Key R&D Milestones for the Remainder of 2012
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Lemtrada™, Aubagio™ and Lyxumia® are registered trade names submitted to health authorities for investigational agents
2012
Expected Regulatory Submissions Q2 Q3 Q4●
Lemtrada™ (alemtuzumab) in RMS(1) in the U.S. and EU
●
Lyxumia® (lixisenatide) in Type 2 diabetes in the U.S.(2)
Expected Headline Data Releases
●
Lantus® - ORIGIN study results
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Lantus® - Retrospective cohort studies results
●
Aubagio™ (teriflunomide) – TOWER headline Phase III results in RMS
●
Dengue vaccine - Phase IIb efficacy results
Expected Phase III Study Initiations
●
Anti-PCSK-9 mAb - Phase III program in hypercholesterolemia
●
Sarilumab (Anti-IL-6R mAb) - Second Phase III trial
(1) RMS: Relapsing Forms of Multiple Sclerosis(2) Partnership with Zealand Pharma(3) Mid year 2012
(3)
Continued Execution of Strategy Expected to Deliver Sustainable Growth 2012-2015
2012-2015 Sales CAGR
Diversified sources of growth
Scale in businesses with significant barriers to entry
Low small molecule patent exposure in mature markets(1)
Large Emerging Markets presence(2)
Potential new product launches(3)
Operating margin evolution
2012-2015 Business EPS CAGR
Increased dividend payout ratio(4)
(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(4) Dividend paid in 2014
~6%
50% of 2013 results
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38-40%
Rebounding
> Sales CAGR
At least 5%
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