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JP Morgan Healthcare Conference
Olivier Brandicourt – Chief Executive Officer
San Francisco - January 10, 2017
2
Forward Looking Statements
This presentation contains forward-looking statements as defined in the Private Securities Li...
3
Agenda
Reshaping the portfolio
Progress on our strategic roadmap in 2016
Focused on key product launches
Sustain innovat...
Focused on key launches: Toujeo®, Soliqua™, Praluent®, Dengvaxia®
2016: Sanofi Progressing on its Strategic Priorities
4
V...
5
Agenda
Reshaping the portfolio
Progress on our strategic roadmap in 2016
Focused on key product launches
Sustain innovat...
Sanofi
Genzyme
(Specialty Care)
● Rare diseases
● Multiple Sclerosis
● Immunology
● Oncology
Shaping a Leading Portfolio o...
4.4%
4.4%
4.4%
4.2%
3.5%
2.4%
1.9%
1.0%
73.8%
BI Asset Swap: A Strong Strategic Rationale for Our
Ambitions in Consumer He...
A Value Creating Transaction Based on Strong Financials
● Combined CHC global sales
of around €4.9bn in 2015(1)
● Focus on...
9
BI Transaction Increases Scale of Sanofi CHC Portfolio in
Attractive Categories and Important Geographies
● Highly compl...
10
Agenda
Reshaping the portfolio
Progress on our strategic roadmap in 2016
Focused on key product launches
Sustain innova...
11
®
Focus on 6 Major Launches to Drive Future Growth
12
- Capturing Share in Key Markets
(1) IMS Rapid weekly as of December 21th, 2016
(2) Market Share of the Basal insulin m...
13
- Important Addition to our Diabetes Franchise
● U.S. FDA approval of Soliqua™ 100/33
● Once-daily fixed-ratio combinat...
14
Praluent® is developed and commercialized in collaboration with Regeneron
(1) Internal estimates
(2) IMS Health
● Sanof...
Re-submission for Regulatory Review in
the U.S. expected in Q1 2017
15
U.S. launch preparation activities ongoing
Sariluma...
16
First-in-Class Biologic for Adults with
Moderate to Severe Atopic Dermatitis
Atopic Dermatitis (AD)
● Characterized by ...
Launch Focused on Patients with the
Highest Unmet Medical Need
17
Physician Focus
Target physicians
with experience
prescr...
18
A Pipeline in One Product - Clinical Studies in Multiple
Indications Underway
Nasal polyposis
 Phase 3 started in Q4 2...
19
- Update on Launches in Endemic Countries
(1) Bolivia, Brazil, Cambodia, Costa Rica, El Salvador, Guatemala, Indonesia,...
20
Agenda
Reshaping the portfolio
Progress on our strategic roadmap in 2016
Focused on key product launches
Outlook
Sustai...
21
Expanding Pipeline in Leadership Categories:
Diabetes and Rare Diseases
Sotagliflozin
● Dual SGLT1 and SGLT2
inhibitor(...
22
Re-Building a Competitive Position in Oncology
MoA: Mechanism of Action
(1) HDeckert, et al. Clin Cancer Res 2014;20:45...
23
Agenda
Reshaping the portfolio
Progress on our strategic roadmap in 2016
Focused on key product launches
Sustain innova...
Driving Financial Performance on our 2020 Roadmap
 Deliver stated financial objectives
● FY2016 EPS guidance raised in Oc...
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2017/01 - JP Morgan HC Conference

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2017/01 - JP Morgan HC Conference

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2017/01 - JP Morgan HC Conference

  1. 1. JP Morgan Healthcare Conference Olivier Brandicourt – Chief Executive Officer San Francisco - January 10, 2017
  2. 2. 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 labelling 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 Company’s ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, 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, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
  3. 3. 3 Agenda Reshaping the portfolio Progress on our strategic roadmap in 2016 Focused on key product launches Sustain innovation in R&D Outlook
  4. 4. Focused on key launches: Toujeo®, Soliqua™, Praluent®, Dengvaxia® 2016: Sanofi Progressing on its Strategic Priorities 4 Vaccines JV in Europe discontinued(2); EU Generics to be carved out 5 NMEs(3) start Ph 3: isatuximab, PD-1, sotagliflozin, olipudase alfa, NeoGAA Priority review granted for Dupixent® in Atopic Dermatitis Streamlined GBU organization driving financial performance Simplify Reshape Innovation Launches BI asset swap makes Sanofi a global leader in Consumer Healthcare(1) (1) Sanofi and Boehringer Ingelheim confirm closing of business swap on January 1st, 2017 (2) Sanofi Pasteur and MSD end joint vaccines business in Europe on January 2nd, 2017 (3) NME: New Molecular Entity Icons designed by Freepik
  5. 5. 5 Agenda Reshaping the portfolio Progress on our strategic roadmap in 2016 Focused on key product launches Sustain innovation in R&D Outlook
  6. 6. Sanofi Genzyme (Specialty Care) ● Rare diseases ● Multiple Sclerosis ● Immunology ● Oncology Shaping a Leading Portfolio of Diversified Businesses with an Attractive Long-term Growth Profile 6 (1) YTD September at constant exchange rates (CER) (2) Excluding Venezuela and Consumer Healthcare (CHC) (3) On a comparable structure basis and excluding Venezuela (4) BI sales for YTD September 2016 General Medicines & Emerging Markets ● Leader in EM ● EU Generics (YTD Sep sales €610m) carve-out expected to take 12-24 months Consumer Healthcare ● Allergy ● Cough & Cold ● Digestive ● Pain ● VMS €3,684m +19.1% Diabetes & Cardiovascular ● Leading basal insulin franchise ● PCSK9 9 Months 2016 Sales by Global Business Unit(1) Sanofi Pasteur (Vaccines) ● Flu vaccine ● Polio/Pertussis/Hib ● Meningitis/ Pneumonia ● Dengue €3,225m +11.0% €10,853m(2) -1.8% €4,687m -3.9% €2,496m +2.3%(3) + Boehringer Ingelheim(4) €1,132m
  7. 7. 4.4% 4.4% 4.4% 4.2% 3.5% 2.4% 1.9% 1.0% 73.8% BI Asset Swap: A Strong Strategic Rationale for Our Ambitions in Consumer Healthcare (CHC) 7 Other Reckitt Benckiser Pfizer J&J GSK Takeda P&G Bayer + (1) Nicholas Hall & Company, MAT Q3 2016 (2) Excludes BI CHC in China ● Market share of 4.4% in 2016(1,2) ● Leverage scale in a fragmented market ● Opportunity for strategic consolidation ● Expand global footprint ● Brand equity offers more sustainable revenue streams ● No patent cliff ● ‘Ever-lasting’ brands Sanofi to Become a Top Player in the €113bn OTC Market(1) Reinforces ambition to be a diversified global healthcare leader focused on human health
  8. 8. A Value Creating Transaction Based on Strong Financials ● Combined CHC global sales of around €4.9bn in 2015(1) ● Focus on a portfolio of high-value self medications (1) Excludes Boehringer Ingelheim CHC in China; value of CHC sales in Venezuela have been reduced to nearly zero due to revision of foreign exchange rates by both companies ● Synergies in advertising and promotional activities ● Global commercial platform for OTC launches and Rx switches ● BOI margin contribution expected to be around 30% in 2018 ● Expect transaction to be business EPS neutral in 2017 and accretive in subsequent years BI Consumer Healthcare €6.7bn plus gross cash payment €4.7bn Sanofi Animal Health €11.4bn 8 Financial implications Increased Scale in CHC Business Value creation
  9. 9. 9 BI Transaction Increases Scale of Sanofi CHC Portfolio in Attractive Categories and Important Geographies ● Highly complementary portfolio boosts market position in priority categories ● 6 iconic brands generate 60% of BI CHC sales in 2015 ● BI footprint complementary in strategically important countries(2) ● Japan (€299m), U.S. (€186m) and Germany (€162m) (1) Nicholas Hall & Company, MAT Q3 2016 (2) BI sales in 2015 Global size in €bn(1) 33.1 #5 #3 19.6 #10 #6 16.2 #5 #1 15.4 #4 #2 3.8 #3 #2 1.0 #1 #1 + Market Rank(1,2) Sanofi Global Categories /
  10. 10. 10 Agenda Reshaping the portfolio Progress on our strategic roadmap in 2016 Focused on key product launches Sustain innovation in R&D Outlook
  11. 11. 11 ® Focus on 6 Major Launches to Drive Future Growth
  12. 12. 12 - Capturing Share in Key Markets (1) IMS Rapid weekly as of December 21th, 2016 (2) Market Share of the Basal insulin market in International Units for France, Germany, Spain, UK and Japan, in TRx for the U.S.; Toujeo® Market Share(1,2) Top EU Countries, Japan and the U.S. ● Toujeo® generated sales €411m YTD September 2016 ● 6.8% TRx market share in the U.S.(1) ● Launched in 35 countries ● U.S. formulary status remains favorable ● >3/4 commercial lives covered in 2017 ● Solid performance in top EU countries despite introduction of biosimilar glargine ● Strong rebound in Japan following the lifting of the 2-week prescription limitation in September 2016 0% 5% 10% 15% 20% W0 W10 W20 W30 W40 W50 W60 W70 W80 W90 France Germany UK Spain Japan U.S. Week since launch
  13. 13. 13 - Important Addition to our Diabetes Franchise ● U.S. FDA approval of Soliqua™ 100/33 ● Once-daily fixed-ratio combination of Lantus® and GLP-1 receptor agonist Adlyxin® (lixisenatide) ● Indicated for adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide ● Administered with the SoloStar® pen device ● SOLIQUA™ 100/33 U.S. product profile ● Wide dosing range (15 to 60 units of insulin) in a single pen ● Flexible switching regimen with recommended starting dose of 15 or 30 units ● Positive CHMP opinion on SULIQUA™ in Nov 16; EU regulatory decision anticipated in Jan 17 >50% of people with diabetes remain uncontrolled on basal insulin(1) (1) Banegas JR, et al. Eur Heart J. 2011;32(17):2143-52, DOI: 10.1093/eurheartj/ehr080; Stark Casagrande S, et al. Diabetes Care. 2013;36(8):2271-9, DOI: 10.2337/dc12-2258; Vouri SM, et al. J Manag Care Pharm. 2011;17(4):304-12, http://www.ncbi.nlm.nih.gov/pubmed/21534641 Launched in the U.S. January 4, 2017
  14. 14. 14 Praluent® is developed and commercialized in collaboration with Regeneron (1) Internal estimates (2) IMS Health ● Sanofi and Regeneron will appeal the District Court’s rulings in the Federal Circuit Court of Appeals, including requesting a stay of the injunction during the pendency of the appeal ● Will vigorously defend our case through the appeal process as we believe that Amgen’s asserted patent claims are invalid and the facts and controlling law support our position ● Praluent® continues to be available to patients ● More than 18,000 patients in the U.S. treated(1) ● Approximately 85% of prescriptions are dispensed at the low 75mg dose(2) ● ODYSSEY OUTCOMES trial expected to complete in late 2017 as planned ● DMC will continue to monitor study ● Focused on patients with the highest medical need - Litigation and Product Update
  15. 15. Re-submission for Regulatory Review in the U.S. expected in Q1 2017 15 U.S. launch preparation activities ongoing Sarilumab is developed in collaboration with Regeneron Pharmaceuticals, Inc. Sarilumab is an investigational agent under clinical development and its safety and efficacy has not been fully evaluated by any Regulatory Authority (1) Subject to successful FDA prelicense inspection related to dupilumab (2) Most frequently reported Treatment Emergent Adverse Events include serious infections, injection site erythema and neutropenia (3) Based on one head to head superiority study comparing sarilumab and Humira in improving signs and symptoms of RA in adults (MONARCH). A second confirmatory study has not been conducted. Neutropenia, which was not associated with infections, was more common with sarilumab than Humira®. Not included in the initial BLA filed with FDA; Humira® (adalimumab) is an AbbVie brand ● Based on review of responses to the FDA 483 as well as proposed corrective actions, the FDA has classified the Le Trait ‘fill and finish’ facility as “acceptable” ● Expect FDA inspection of Le Trait and re-submission of sarilumab BLA in Q1 2017(1) ● IL-6 plays key roles in the local joint symptoms and systemic manifestations of rheumatoid arthritis (RA) ● Positive Phase 3 efficacy/safety data in methotrexate-inadequate responder (IR) and difficult-to-treat TNF-IR populations(2) ● Positive sarilumab monotherapy efficacy data compared to Humira® monotherapy(3)
  16. 16. 16 First-in-Class Biologic for Adults with Moderate to Severe Atopic Dermatitis Atopic Dermatitis (AD) ● Characterized by intense itching and recurrent eczematous lesions ● Multifactorial etiology involving immune-mediated inflammation, genetic factors, and environmental triggers ● Although it often starts in infancy, it is also highly prevalent in adults IGA 4 IGA 1 ● BSA affected: 86.5% ● EASI score: 51.5 ● Pruritus NRS: 7 ● AD duration: 48 years ● BSA affected: 2.5% ● EASI score: 3.1 ● Pruritus NRS: 1.6 BLA accepted for priority review by the FDA with PDUFA date of March 29, 2017 ® Pictures from Phase 3 clinical trial provided for illustration purposes only to show how the clinical parameters above may correlate to the clinical presentation of a patient.(1) Dupixent® is developed in collaboration with Regeneron Pharmaceuticals, Inc. Dupixent® is an investigational agent under clinical development and its safety and efficacy has not been fully evaluated by any Regulatory Authority IGA: Investigator Global Assessment BSA: Body Surface Area EASI: Eczema Area and Severity Index NRS: Numerical Rating Scale (1) Images are taken from one patient at baseline (left) and at 16 weeks (right). Results were not representative of all patients and individual results did vary. In phase 3 clinical trials, the percentage of patients achieving an IGA score of 0 or 1 ranged from 36%-38%. Adverse events that were higher for Dupixent® vs placebo included injection site reactions and conjunctivitis; Photo used with permission
  17. 17. Launch Focused on Patients with the Highest Unmet Medical Need 17 Physician Focus Target physicians with experience prescribing biologics (i.e. Psoriasis) Up to 7,000 doctors in the U.S. Patient Focus Intolerant to or inadequate response to an existing therapy (e.g. Topicals, Oral/systemic steroids, Immuno-suppressants) Around 300,000 adult patients in the U.S. Dupixent® is developed in collaboration with Regeneron Pharmaceuticals, Inc. Dupixent® is an investigational agent under clinical development and its safety and efficacy has not been fully evaluated by any Regulatory Authority ®
  18. 18. 18 A Pipeline in One Product - Clinical Studies in Multiple Indications Underway Nasal polyposis  Phase 3 started in Q4 2016 Asthma  Phase 3 fully enrolled and U.S. submission expected in Q4 2017 Atopic dermatitis (AD)  Phase 3, March 29 FDA PDUFA Date  Accepted for review by EMA in Dec 2016 Type 2, including Th-2 mediated diseases DUPILUMAB Eosinophilic esophagitis  Ph 2 data exp. H2 17 Food allergy  Phase 2 expected to start 2017 Additional Indications Pediatric expansion in AD(1) and Asthma  Ph 3 studies in AD (age 6-11 and 12-17) and Asthma (age 6-11) expected to start Q1 2017 (1) FDA Breakthrough designation for adults and pediatric moderate to severe atopic dermatitis
  19. 19. 19 - Update on Launches in Endemic Countries (1) Bolivia, Brazil, Cambodia, Costa Rica, El Salvador, Guatemala, Indonesia, Mexico, Paraguay, Peru, the Philippines, Thailand and Singapore (2) http://www.who.int/wer/2016/wer9130.pdf?ua=1 ● Dengvaxia® approved in 13 countries(1) ● License application filed in 31 endemic countries including the U.S. FDA in Dec 2016 ● ~750,000 people administered to date ● Sales of €50m in first 9 months of 2016 ● Sales largely from Philippines and Paraná state in Brazil ● Working on roll-out of immunization program in other states of Brazil WHO recommends vaccination in high disease burden geographies(2)
  20. 20. 20 Agenda Reshaping the portfolio Progress on our strategic roadmap in 2016 Focused on key product launches Outlook Sustain innovation in R&D
  21. 21. 21 Expanding Pipeline in Leadership Categories: Diabetes and Rare Diseases Sotagliflozin ● Dual SGLT1 and SGLT2 inhibitor(1) ● Limiting meal time glucose absorption and increasing renal glucose excretion ● Oral administration ● Favorable safety profile ● Positive Phase 3 data in Type 1 diabetes announced ● Phase 3 program in Type 2 diabetes started in 2016 Olipudase alfa NeoGAA ● Rare genetic lysosomal storage disorder: Second-generation therapy for Pompe disease ● NeoGAA(3) glycan structure could potentially have efficacy, safety and convenience advantages ● First patient enrolled in pivotal Phase 3 COMET study in November 2016 ● Rare genetic lysosomal storage disorder: Acid sphingomyelinase deficiency, ASMD(2) ● FDA Breakthrough Therapy designation ● Leveraging Sanofi Genzyme’s strong presence in hematology ● Pivotal Phase 2/3 trial started in July 2016 (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) Also known as Niemann-Pick Type B (3) GAA: Genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase
  22. 22. 22 Re-Building a Competitive Position in Oncology MoA: Mechanism of Action (1) HDeckert, et al. Clin Cancer Res 2014;20:4574–83. (2) ICARIA-MM: A phase 3 randomized, open-label, multicenter study comparing Isatuximab (SAR650984) in Combination with Pomalidomide And Low- Dose Dexamethasone verRsus Pomalidomide and Low-Dose Dexamethasone In patients with refractory or relapsed and refractory Multiple Myeloma Isatuximab (anti-CD38) ● Pivotal Phase 2/3 study in cutaneous squamous cell carcinoma ongoing ● Phase 2 study in basal cell carcinoma expected to start in H1 2017 ● Start of Phase 2 study in non-small cell lung cancer planned for H1 2017 PD-1 (REGN2810) Sanofi’s Antibody Drug Conjugates (ADCs) in Phase 1 complementary to our multi-specific antibody platform and IO strategy ● Product profile potentially differentiated ● Targets unique epitope with a distinct combination MoA(1) ● Phase 3 study in relapsed/refractory multiple myeloma initiated in December(2) ● Potential indications beyond multiple myeloma being explored
  23. 23. 23 Agenda Reshaping the portfolio Progress on our strategic roadmap in 2016 Focused on key product launches Sustain innovation in R&D Outlook
  24. 24. Driving Financial Performance on our 2020 Roadmap  Deliver stated financial objectives ● FY2016 EPS guidance raised in October ● FY2017 guidance to be released on Feb 8th, 2017  Achieve targeted cost savings ● At least €1.5bn by 2018 ● Re-investment of savings will be scaled  €3.5bn buy-back commitment by year-end 2017 ● €1.7bn shares repurchased since Q3 results ● Potential additional opportunistic SBB Financial Targets 2016 - 2017  Accelerate growth from priority launches  Continue to build scale in priority businesses  Capture margin improvement 2018 - 2020 24 Accelerate Growth

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