2016/01 - JP Morgan HC Conference

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JP Morgan Healthcare Conference Olivier Brandicourt – Chief Executive Officer San Francisco - January 12, 2016

Transcript of 2016/01 - JP Morgan HC Conference

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JP Morgan Healthcare Conference Olivier Brandicourt – Chief Executive Officer

San Francisco - January 12, 2016

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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 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.

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Key Accomplishments Since April 2015 On Our Way to Future Success

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(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

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We Have Four Strategic Priorities

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Reshape the portfolio

Deliver outstanding

launches

Simplify the organization

Sustain innovation

in R&D

1 2 3

4

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● 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

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Sanofi and Boehringer Ingelheim Enter Exclusive Negotiations on Business Swap

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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

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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

+

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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

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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)

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Growing Faster than Market in Vaccines

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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

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Sustaining Leadership in Rare Diseases

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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

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Retaining #1 Position in Emerging Markets through Greater Focus

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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

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Growing our Multiple Sclerosis Franchise

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● 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

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Rebuilding a Competitive Position in Oncology

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● 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

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Sarilumab and Dupilumab Represent Cornerstones of a New Immunology Franchise

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● 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

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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

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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

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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.

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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

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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

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Key R&D Milestones Expected in 2016

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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

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Simplify the Organization

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4

Create one

Sanofi culture

Reshape the plant network

Move to Global Business

Unit organization

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The Roadmap for Sanofi

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● 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