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JP Morgan Healthcare Conference Olivier Brandicourt – Chief Executive Officer
San Francisco - January 12, 2016
2
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 initiatives 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, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Key Accomplishments Since April 2015 On Our Way to Future Success
3
(1) LixiLan (U.S.), sarilumab (U.S.) and lixisenatide (U.S.) (2) BioNTech, Evotec, Google Life Sciences, Hanmi, Lexicon Pharmacuticals, Voyager Therapeutics and Regeneron (3) December 15, 2015 press release: Sanofi and Boehringer Ingelheim enter exclusive negotiations on business swap : Sanofi would
become a global leader in Consumer Healthcare and Boehringer Ingelheim would become second largest Animal Health company Icons designed by Freepik
3 launches of major products – Toujeo®, Praluent® and Dengvaxia®
3 submissions for regulatory review(1)
Accelerated BD(2) activities and strategic alliance in Immuno-oncology
Key first transaction announced to reshape the portfolio(3)
New organizational model to drive focus and simplification
2015-2020 strategic roadmap to create long term value
We Have Four Strategic Priorities
4
Reshape the portfolio
Deliver outstanding
launches
Simplify the organization
Sustain innovation
in R&D
1 2 3
4
● Multiple Sclerosis(1)
● Oncology(1)
● Immunology(1)
● Consumer Healthcare(2)
● Animal Health
● Generics(2) in Europe
● Diabetes/CV
● Vaccines
● Rare Diseases(1)
● Emerging Markets(2)
Reshape the Portfolio
5
1
Explore strategic options C A Sustain
leadership Build competitive positions B
(1) Will be part of Specialty Care Global Business Unit (2) Will be part of General Medicines and Emerging Markets Global Business Unit
Sanofi and Boehringer Ingelheim Enter Exclusive Negotiations on Business Swap
6
Potential exchange of Sanofi Animal Health (Merial) and Boehringer Ingelheim (BI) CHC businesses
● Enterprise value: ● Merial: €11.4bn ● BI CHC: €6.7bn ● Gross cash payment from BI to Sanofi of €4.7bn
(1) Following consultations with the relevant social bodies and subject to appropriate regulatory approvals (2) Taking into account the anticipated CHC results, share buybacks and potential synergies
BI CHC: 7 core brands
Expected CHC pro forma sales of
~€5.1bn in 2015e
Sanofi would
become a Leading player in CHC
Goal is to close the potential transaction in Q4 2016(1)
● Sanofi intends to use a portion of the net proceeds of the transaction to repurchase shares
● The overall transaction is expected to be business EPS neutral in 2017 and accretive in subsequent years(2)
>60% of sales
7
4.6%
4.6%
4.4%
4.3%
3.4%2.5%2.1%1.1%
1.0%
71.9%
Other
Global Categories(2) Segment Size in €bn
Sanofi + BI CHC
VMS(3) 27.6 #3
Cough & Cold Care 17.2 #6
Digestive health 14.4 #1
Pain Care 13.2 #2
Allergy Solutions 3.1 #3
Feminine Care 0.8 #1
Combined Worldwide CHC Market Share(1)
Combined Worldwide CHC Sales - Priority Categories(4)
(pro forma)
Sanofi to Become a Global Leader in CHC
(1) Nicholas Hall & Company, MAT Q3 2015 (2) As per Sanofi definition (3) Vitamins, Minerals and Supplements (4) Source: Nicholas Hall & Company, FY 2014
Taisho
Reckitt Benckiser
Pfizer
J&J
GSK
Takeda P&G
Bayer
+
8
Committed to Diabetes and Cardiovascular Diseases
1 Develop the insulin franchise
4
3 Lead the market shift to managing diabetes outcomes
A
Google Life Sciences
2 Strengthen the pipeline through external opportunities and ambitious research
Transform the management of hypercholesterolemia
Ambition to grow Diabetes franchise beginning in 2019(1) Praluent® multi-blockbuster potential(2)
(1) Diabetes sales are expected to decline at an average annualized rate of -4% to -8% at CER over 2015-2018 (2) As of December 31, 2015, Sell-side analyst consensus for Praluent in 2020 per Vara is € 3,063m Icons designed by Freepik
LixiLan filed in the U.S. with PRV
Lexicon and Hanmi deals closed
Significant U.S. market access achieved
9
Strengthening our R&D Portfolio in Diabetes with Two In-Licensing Agreements
A
(1) SGLT2 (sodium-glucose cotransporter type 2) is a transporter responsible for most of the glucose reabsorption performed by the kidney SGLT1 (sodium-glucose cotransporter type 1) is a transporter responsible for glucose and galactose absorption in the gastrointestinal tract, and to a lesser extent than SGLT2, glucose reabsorption in the kidney
(2) Subject to customary closing conditions (3) LAPS CA-Exendin-4 analog
T1DM: Diabetes mellitus type 1
Sotagliflozin - Phase II in T2 Diabetes Phase III in T1 Diabetes
● Dual SGLT1 and SGLT2 inhibitor(1)
● Limiting meal time glucose absorption and increasing renal glucose excretion
● Oral administration
● Adjunct therapy to insulin in T1DM
● Favorable safety profile
Immunology
Efpeglenatide – Phase II ● Long acting GLP-1(3)
● Diabetes/Obesity
● Weekly/monthly administration
LAPS Insulin 115 (HM12470) – Phase I ● Long acting insulin
● Less side-effects (hypoglycemia, obesity)
● Weekly administration
LAPS Insulin Combo – Pre-clinical ● Long acting insulin + efpeglenatide combination
● Weekly administration
(2)
Growing Faster than Market in Vaccines
10
A
Further develop strong vaccine brands ● Flu vaccines ● Pediatric combinations ● Adult boosters
Successfully launch Dengvaxia®
Expand our manufacturing capacity
Deliver novel high-value vaccines e.g. C. diff vaccine
2015e 2014
€4.0bn
2020e
Pediatric & boosters
Flu
Dengue ~75% of
sales
Projected Sanofi Pasteur Sales 1
2
3
4
High single digit sales CAGR
at CER
Sustaining Leadership in Rare Diseases
11
A
● Sustain market share through patient-centered approach, product differentiation and market access
● Grow market through patient screening and manufacturing expansion
● Advance internal and partnered novel pipeline
Sales CAGR for Rare Diseases expected at high single digit at CER over 2015-2020
1
2
3
Undiagnosed(1) Undiagnosed(1)
Undiagnosed(1)
(1) Genzyme internal analysis. Include China and India
Retaining #1 Position in Emerging Markets through Greater Focus
12
Leader in Emerging Markets(1)
● Increase focus on priority countries/regions
● Prioritize resource allocation
● Adapt industrial footprint
● Redefine scope to exclude Eastern Europe(1)
● Win the emerging middle class
● Innovate specifically for Emerging Markets
● Optimize trade and channel management
#3 in China
#1 in Brazil
#2 in Russia
#4 in India
#2 in Mexico
A
A top 3 MNC player in BRIC-M 1
2
3
4
MNC: Multinational corporation (1) World excluding U.S., Canada, Western & Eastern Europe (except Russia, Ukraine, Georgia, Belarus and Armenia),
Japan, South Korea, Australia, New Zealand and Puerto Rico
Growing our Multiple Sclerosis Franchise
13
● Successfully complete global launches of Aubagio® and Lemtrada®
● Expand LCM activities to maximize support to existing products
● Reinforce presence in “high efficacy” category
● Enter the neuroprotection/ remyelination segment
B
Q12013
Q22013
Q32013
Q42013
Q12014
Q22014
Q32014
Q42014
Q12015
Q22015
Q32015
Série2Série1
Multiple Sclerosis Franchise Reported sales (€m)
€923m
®
1
2
3
4
Ambition to double the size of the MS franchise from 2015 to 2020
LCM: Life Cycle Management
Rebuilding a Competitive Position in Oncology
14
● Maximize clinical assets, particularly isatuximab (anti-CD38 mAb) and Antibody-Drug Conjugates
● Build a transformative pipeline ● Immuno-oncology collaboration with Regeneron ● Collaboration with BioNTech on mRNA therapeutics
● Rebuild critical mass
Oncology Opportunity
Largest therapeutic area for pharmaceuticals
Strong growth driven by unmet need and
groundbreaking science
B
1
2
3
ADCs: Antibody-Drug Conjugates
Sarilumab and Dupilumab Represent Cornerstones of a New Immunology Franchise
15
● Multi-disease, best in class drug targeting Th2 pathway
● Breakthrough treatment for atopic dermatitis
● Further opportunities in asthma and nasal polyposis
● Multi-blockbuster potential across key indications
● FDA submission in AD planned for Q3 2016
Immunology
B
● Entering an €18bn RA market where unmet need is still high ● IL-6 class >€1bn in sales and
growing >20%
● Aim to be preferred 2nd line for TNF-IR patients and preferred monotherapy
● Goal to differentiate through dosing, bone impact
● Filed with FDA in Q4 2015
RA: Rheumatoid Arthritis TNF-IR: TNF inadequate responders AD: Atopic Dermatitis
16
Focus on 6 Products … … and Excel in Execution
New GBU organization with clear accountability, P&L ownership and life cycle management to focus on:
● Delivering differentiated products rapidly
● Shaping the market
● Securing market access
● Driving uptake
Deliver Outstanding Launches 2
Expected combined peak sales of €12bn to €14bn(1)
(1) At CER, non-risk adjusted sales projections through 2025
Global Roll-out Underway for Three Major Products
● Rapid market access obtained in the U.S.(1)
● Showing early promise in key markets ● U.S. uptake trending
favorably compared to diabetes analogues(2)
● Launched globally in 20 countries
● Now accessible on formularies covering ~150m patients in the U.S. ● Only PCSK9 inhibitor
preferred across UnitedHealth Group formularies
● ODYSSEY OUTCOMES interim efficacy analysis expected in H2 2016(3)
● First ever dengue vaccine ● Priority introduction in
large endemic countries
● Approvals recently granted in Mexico, the Philippines and Brazil(4)
● Submitted in over 20 countries
17
Praluent® is developed and commercialized in collaboration with Regeneron (1) As of January 1, 2016, 86% of commercial and 91% of Medicare lives covered (2) Toujeo® analogues include: Bydureon® (AstraZeneca), Farxiga® (AstraZeneca), Invokana® (J&J), Levemir® (Novo Nordisk),
Tanzeum® (GlaxoSmithKline), Tresiba® (Novo Nordisk) and Trulicity® (Eli Lilly) (3) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred (4) The Mexican Federal Commission for the Protection against Sanitary Risks, Philippines' Food and Drug Administration and Brazilian
regulatory authorities ANVISA approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue virus serotypes in individuals from 9-45 years of age living in endemic areas.
18
N New Molecular Entity
Immunology
Rare Diseases
Oncology
Diabetes
Vaccines
Infectious Diseases
Cardiovascular Diseases
Neurodegenerative Diseases
Ophthalmology
Multiple Sclerosis
GZ402668 GLD52 (anti-CD52 mAb)
Relapsing multiple sclerosis
GZ402666 neo GAA
Pompe Disease
SAR113244 Anti-CXCR5 mAb
Systemic lupus erythematosus
SAR339375 Anti-miR21 RNA Alport syndrome
GZ389988 TRKA antagonist
Osteoarthritis
SAR439774 (ALN-AT3) siRNA targeting Anti-Thrombin
Haemophilia
SAR425899 GLP-1R/GCGR dual agonist
Diabetes
SAR228810 Anti-protofibrillar AB mAb
Alzheimer’s disease
SAR438335 GLP-1R/GIPR dual agonist
Diabetes
SAR422459 ABCA4 gene therapy
Stargardt disease
SAR566658 Maytansin-loaded anti-CA6 mAb
Solid tumors
UshStat® Myosin 7A gene therapy
Usher syndrome 1B
SAR408701 Anti-CEACAM5 ADC
Solid tumors
SAR366234 EP2 receptor agonist
Elevated intraocular pressure
SAR439684 PD-1 inhibitor
Cancer
Streptococcus pneumonia Meningitis & pneumonia vaccine
SAR428926 LAMP-1 inhibitor
Cancer
Herpes Simplex Virus Type 2 HSV-2 vaccine
SAR439152 Myosin inhibitor
Hypertrophic cardiomyopathy
Phase I
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
dupilumab Anti-IL4Rα mAb Nasal polyposis;
Eosinophilic oesophagitis
GZ402671 Oral GCS Inhibitor
Fabry Disease
SAR156597 IL4/IL13 Bi-specific Ab
Idiopathic pulmonary fibrosis
olipudase alfa rhASM
Niemann-Pick type B
sarilumab Anti-IL6R mAb
Uveitis
Rabies VRVg Purified vero rabies vaccine
Combination ferroquine / OZ439
Antimalarial
Meningitis ACYW conj. 2nd generation meningococcal
conjugate infant vaccine
isatuximab Anti-CD38 naked mAb
Multiple myeloma
Tuberculosis Recombinant subunit vaccine
Fluzone® QIV HD Quadrivalent inactivated
influenza vaccine - High dose
Phase II N
N
N N
N
LixiLan lixisenatide + insulin glargine Fixed-Ratio / Type 2 diabetes
SAR342434 insulin lispro
Type 1+2 diabetes
sarilumab Anti-IL6R mAb
Rheumatoid arthritis, EU
dupilumab Anti-IL4Rα mAb
Atopic dermatitis, Asthma
patisiran (ALN-TTR02) siRNA inhibitor targeting TTR
Familial amyloidotic polyneuropathy
revusiran (ALN-TTRsc) siRNA inhibitor targeting TTR
Familial amyloidotic cardiomyopathy
Jevtana® cabazitaxel
Metastatic prostate cancer (1L)
Clostridium difficile Toxoid vaccine
Rotavirus Live attenuated tetravalent
Rotavirus oral vaccine
VaxiGrip® QIV IM Quadrivalent inactivated
influenza vaccine (3-36 months)
Phase III
N
N
N
N
N
Registration lixisenatide GLP-1 agonist
Type 2 diabetes, U.S.
sarilumab Anti-IL6R mAb
Rheumatoid arthritis, U.S.
Dengvaxia® Mild-to-severe
dengue fever vaccine
PR5I DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine, U.S., EU
VaxiGrip® QIV IM Quadrivalent inactivated
influenza vaccine (3 years+)
N
N
3 Sustain Innovation in R&D(1)
(1) Pipeline chart as of November 6, 2015
Diabetes
Vaccines
Rare Diseases
1
2
3
4
19
Isatuximab - Multiple Myeloma
Immuno-oncology - Various oncology indications
5
6
7
(1) Patisiran, revusiran and ALN-AT3 developed in collaboration with Alnylam
Potentially Transformative Drugs in Earlier Stages of Development
Selected R&D Assets
Oncology
Immunology
8
Olipudase alfa - Niemann-Pick type B
Patisiran(1) - Familial Amyloidotic Polyneuropathy
Revusiran(1) - Familial Amyloidotic Cardiomyopathy
Dual agonists - Type 2 Diabetes
C. difficile vaccine - Nosocomial infections
IL4/IL13 Bi-specific Ab - Idiopathic Pulmonary Fibrosis
ALN-AT3(1) - Haemophilia
NeoGAA - Pompe 9
10
20
Key R&D Milestones Expected in 2016
20
Expected Regulatory Decisions Q1 Q2 Q3 Q4 ● Lixisenatide in Diabetes (U.S.) ● LixiLan in Diabetes (U.S.) ● Sarilumab in Rheumatoid Arthritis (U.S.) Expected Regulatory Submissions Q1 Q2 Q3 Q4 ● LixiLan in Diabetes (E.U.) ● Dupilumab in Atopic Dermatitis (U.S.) Expected Phase III / IIIb Data Q1 Q2 Q3 Q4 ● Dupilumab in Atopic Dermatitis ● Insulin lispro in Diabetes (SORELLA ) ● Sarilumab in Rheumatoid Arthritis (MONARCH) ● Praluent® ODYSSEY OUTCOMES interim analysis(1)
Expected Phase III Starts Q1 Q2 Q3 Q4 ● Olipudase alfa in Niemann Pick type B(2) ● NeoGAA in Pompe ● Fitusiran in Hemophilia ● Efpeglenatide in Diabetes ● Sotagliflozin in Diabetes ● Isatuximab in Multiple Myeloma
(1) Interim analysis for futility when ~50% of events have occurred; second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred in H2 2016
(2) Pivotal phase II/III trial
Simplify the Organization
21
4
Create one
Sanofi culture
Reshape the plant network
Move to Global Business
Unit organization
The Roadmap for Sanofi
22
● Invest for the future ● Refocus the portfolio ● Execute launches ● Reinforce pipeline through
business development ● Simplify the organization
● Accelerate growth from priority launches
● Continue to build scale in priority businesses
● Capture margin improvement
1
2
2018-20
Accelerate growth
2015-17
Reshape Sanofi