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BofA-ML Global Healthcare Conference
London, September 16, 2016
Olivier Brandicourt, Chief Executive Officer
2
Forward Looking Statements
This presentation contains forward-looking statements as defined in the Private Securities Li...
Executing on our 2020 Strategic Roadmap
3
(1) Including Merial
(2) On a reported basis, H1 2016 Aggregate Sales were down ...
H1 2016FX
Impact
-€0.13
Incremental
EPS at CER
+€0.04
H1 2015
Aggregate(1)
Company Sales Business EPS
Business EPS Increas...
New Launches More than Offset Lantus® Sales Decline
in H1 2016
5
Launches H1 2016
at CER
Lantus®Others Plavix Japan
& Vene...
6
Franchise Sales Driven by Specialty Care, Vaccines and
Animal Health Offset by Established Products
(1) Excluding Venezu...
H1 2015 H1 2016
Rare
Diseases
Multiple
Sclerosis
Oncology
7
Specialty Care Maintains Strong Momentum in H1 2016
● Multiple...
Vaccines Grow due to Strong PPH Franchise in H1 2016
Dengvaxia® Uptake Delayed
8
PPH: Polio, Pertussis, Hib vaccines
(1) A...
9
Diabetes Franchise Performs In-Line with Expectations
● Global Diabetes sales decline -3.8% at CER(1)
to €3,591m in H1 2...
Launch of Praluent® Progressing Globally
● H1 2016 sales of €33m
● Market Access progressing
● Gradual improvement of U.S....
Emerging
Markets
€600m (-11.2%)
or
+1.3% excluding
Venezuela
11
CHC Franchise Grows by +3.4%
Excluding Venezuela Impact an...
4.5%
4.4%
4.3%
4.2%
3.5%
2.5%
2.0%
1.4%
1.0%
Boehringer Ingelheim Asset Swap: A Strong Strategic
Rationale for Our Ambitio...
A Value Creating Transaction Based on Strong Financials
Expected
Transaction
Benefits
● Increased scale in Consumer Health...
First Fully-Human, Subcutaneously
Delivered IL-6R Antibody Studied in RA
14
● Sarilumab efficacy/safety results in moderat...
First IL-4/IL-13 Receptor Antibody to
Show Positive Phase III Results in AD
15
● Dupilumab Phase III data in Atopic Dermat...
Expected Regulatory Decisions Q2 Q3 Q4 Q1
● Dengvaxia® in endemic countries
● Adlyxin™ (lixisenatide) in Diabetes (U.S.)
●...
17
Q&A SESSION
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2016/09 – BoA-ML Healthcare Conference

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2016/09 – BoA-ML Healthcare Conference

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2016/09 – BoA-ML Healthcare Conference

  1. 1. BofA-ML Global Healthcare Conference London, September 16, 2016 Olivier Brandicourt, Chief Executive Officer
  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. Executing on our 2020 Strategic Roadmap 3 (1) Including Merial (2) On a reported basis, H1 2016 Aggregate Sales were down - 3.2%. Excluding Venezuela Aggregate Sales were up +2.5%at CER (3) On a reported basis, H1 2016 Business EPS was down -3.3% (4) Subject to regulatory clearances ● Toujeo® U.S. TRx share reaches 6.4%(5), achieving global sales of €244m in H1 ● Praluent® improved TRx share, now captures half of U.S. PCSK9i market ● Dengvaxia® uptake delayed by political changes and economic volatility in LatAm Launches 3 ● Delivered Aggregate(1) Company Sales of €17,411m, slightly up +0.2% at CER(2) ● Business EPS increased +1.5% at CER(3) Financial Results H1 2016 1 ● Animal Health / CHC asset swap with Boehringer Ingelheim signed in June 2016 and expected to close by year-end(4)Portfolio 2 ● FDA approves Adlyxin™ (lixisenatide), a once-daily mealtime GLP-1R agonist ● FDA Advisory Committee recommends LixiLan(6) for approval in the U.S.(7) ● BLA submission for dupilumab in Atopic Dermatitis(8) completed Innovation 4 (5) IMS data as of August 26th 2016 (6) LixiLan is a project name and is not the intended brand name for the combination of insulin glargine and lixisenatide (7) The members of the Advisory Committee voted 12-2 for an approval of LixiLan (8) Under FDA review for the treatment of Moderate to Severe Atopic Dermatitis in Adult patients
  4. 4. H1 2016FX Impact -€0.13 Incremental EPS at CER +€0.04 H1 2015 Aggregate(1) Company Sales Business EPS Business EPS Increases Slightly in H1 2016 Despite Several Headwinds 4 (1) Including Merial (2) Reflecting reclassification of VaxServe from Sales to Other revenues (3) On a reported basis, H1 2016 Aggregate Sales were down -3.2% and Business EPS was down -3.3% +1.5% at CER(3) H1 2016FX Impact -€610m Venezuela -€390m Incremental Sales at CER +€433m H1 2015 +0.2% at CER(3) €17,978m €17,411m €2.73 €2.64 (2)
  5. 5. New Launches More than Offset Lantus® Sales Decline in H1 2016 5 Launches H1 2016 at CER Lantus®Others Plavix Japan & Venezuela H1 2015 +€748m -€366m +€340m (1) (1) Includes Aubagio®, Lemtrada®, Cerdelga®, Toujeo®, Praluent®, Dengvaxia®, NexGard® +0.2% at CER €17,978m H1 2016 Aggregate Sales €18,021m -€679m
  6. 6. 6 Franchise Sales Driven by Specialty Care, Vaccines and Animal Health Offset by Established Products (1) Excluding Venezuela sales were up +11.8% at CER (2) Excluding Plavix® in Japan, sales were down -5.6% at CER (3) Excluding Venezuela sales were up +4.9% at CER (4) Excluding Venezuela sales were up +1.0% at CER H1 2016 Aggregate Sales by Franchise Developed Markets Emerging Markets Growth at CER Total Sales GrowthSales Animal Health +13.2%€1,485m +25.2%+10.1%€1,177m €308m Specialty Care +19.0%€2,864m +13.3%+20.3%€2,414m €450m Diabetes & Cardiovascular -2.8%€3,794m +5.6%-4.6%€3,102m €692m Sales Growth Vaccines +7.1%€1,422m +20.7%-1.7%€810m €612m Established Rx Products -9.0%€5,208m -5.1%-11.2%€3,343m €1,865m Generics +0.6%€933m +1.4%+0.0%€553m €380m Consumer Healthcare -3.6%€1,705m -11.4%+1.8%€1,105m €600m (1) (3) (4) (6) (5) Excluding Venezuela sales were up +7.7% at CER (6) Reflecting reclassification of VaxServe from Sales to Other revenues from Jan 1, 2016 (5) (2)
  7. 7. H1 2015 H1 2016 Rare Diseases Multiple Sclerosis Oncology 7 Specialty Care Maintains Strong Momentum in H1 2016 ● Multiple Sclerosis franchise ● Aubagio® remains fastest growing oral MS drug in the U.S.(1), up +61.0% at CER globally ● Lemtrada® sales more than double to €196m ● Rare Diseases franchise grows double-digit ● Gaucher Franchise(2) up +11.1% at CER ● Fabrazyme® up +12.2% at CER ● Myozyme®/Lumizyme® up +11.2% at CER ● Olipudase alfa Phase II/III study in ASMD(3) initiated (ASCEND trial) ● Jevtana® up +12.6% at CER to €178m €243m €1,260m €2,864m €1,353m +11.4% at CER €790m +71.6% at CER Global Specialty Care Sales €468m (1) Based on IMS data (2) Cerezyme® and Cerdelga® (3) ASMD – Acid Sphingomyelinase Deficiency previously referred as Niemann Pick type B €747m €721m -1.2% at CER €2,475m +19.0% at CER
  8. 8. Vaccines Grow due to Strong PPH Franchise in H1 2016 Dengvaxia® Uptake Delayed 8 PPH: Polio, Pertussis, Hib vaccines (1) After VaxServe reclassification from the Sales P&L line to the Other revenues P&L line from January 1, 2016 ● PPH franchise growth of +17.1% at CER ● Strong sales in Emerging Markets (+47.5%) and Europe (+56.8%) ● Pentacel® sales down -28.5% in H1 but supply improvement in Q2 2016 ● Dengvaxia® ● Recent political changes and economic volatility in Latin America delaying uptake ● Work progressing towards market access: ● Dengue immunization Public program in Paraná State of Brazil set to achieve WHO 2020 ambition ● Recently approved in Indonesia, Peru and Guatemala ● Approved in a total of 9 countries Sanofi Pasteur Sales(1) H1 2016 €1,422m H1 2015 €1,374m Polio/Pertussis/Hib Influenza Vaccines Other Dengvaxia Travel/Endemic Adult Boosters Meningitis/Pneumo (1) +7.1% at CER
  9. 9. 9 Diabetes Franchise Performs In-Line with Expectations ● Global Diabetes sales decline -3.8% at CER(1) to €3,591m in H1 2016 ● U.S. sales down -9.0% ● Emerging Markets sales up +5.7%(2) ● Toujeo® reached €244m in global sales in H1 2016 and 6.4% TRx U.S. market share(3) ● Adlyxin™ (lixisenatide) FDA approved in July ● LixiLan(4) recommended for approval by FDA Advisory Committee ● Updated information on the pen delivery device submitted to FDA resulting in new PDUFA date in Nov 2016 (1) Growth excluding Venezuela was -2.8% at CER (2) Growth excluding Venezuela +11.8% at CER (3) IMS Rapid weekly as of August 26th 2016 (4) LixiLan is a project name and is not the intended brand name for the combination of insulin glargine and lixisenatide €7m €13m €46m €98m €103m €141m Q1 Q2 Q3 Q4 Q1 Q2 Ex U.S. U.S. Quarterly Sales 2015 2016
  10. 10. Launch of Praluent® Progressing Globally ● H1 2016 sales of €33m ● Market Access progressing ● Gradual improvement of U.S. payer utilization management criteria ● UK NICE issues positive recommendation ● Additional reimbursement achieved in Canada, Spain, Netherlands and Austria ● Praluent approved in Japan early July ● 300mg once-monthly dosing filed in U.S. and EU ● ODYSSEY OUTCOMES second interim data analysis for futility and overwhelming efficacy potentially in Q4 2016(1) U.S. TRx Market Share(2) (1) When 75% of the targeted number of primary events have occurred (2) IMS Rapid data week ending September 2nd 2016 10 0% 10% 20% 30% 40% 50% 60% Jan-16 Mar-16 May-16 Jul-16
  11. 11. Emerging Markets €600m (-11.2%) or +1.3% excluding Venezuela 11 CHC Franchise Grows by +3.4% Excluding Venezuela Impact and at Constant Structure(1) ● Developed Markets ● Europe (+2.7%)(2) driven to Doliprane price cut and mild winter ● U.S. sales (+3.6%) driven by Allegra, Nasacort and Gold bond and despite weak allergy season ● Emerging Markets ● Down -11.2% as a result of Venezuela currency devaluation and challenging economic environment in Russia ● Boehringer Ingelheim asset swap signed in June and expected to close by end of 2016(3) (1) -3.6% at CER including Venezuela and small divested products (2) Including the sales of small divested products in the 2015 base, decline at CER was -3.6% (3) Subject to regulatory clearances (4) Including the sales of small divested products in the 2015 base, growth at CER was +1.8% H1 2016 CHC Sales (growth at CER and constant structure) 35%65% Developed Markets €1,105m (+4.7%)(4)
  12. 12. 4.5% 4.4% 4.3% 4.2% 3.5% 2.5% 2.0% 1.4% 1.0% Boehringer Ingelheim Asset Swap: A Strong Strategic Rationale for Our Ambitions in Consumer Healthcare 12 Other Taisho Reckitt Benckiser Pfizer J&J GSK Takeda P&G Bayer + (1) Nicholas Hall & Company, FY 2015 (2) Excludes BI CHC in China ● Market share of 4.3% in 2015(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 Leading Player in the €109bn OTC Market(1)
  13. 13. A Value Creating Transaction Based on Strong Financials Expected Transaction Benefits ● Increased scale in Consumer Healthcare business ● Combined CHC global sales of approximately €4.9bn in 2015(1) ● Value creation ● Synergies in advertising and promotional activities (e.g. Sanofi medical sales force to support BI brands, pipeline, etc.) ● Stronger global commercial platform for potential OTC launches and Rx switches ● Financial implications ● BOI margin contribution of the CHC business expected to be around 30% in 2018 ● Continue to expect transaction to be business EPS neutral in 2017 and accretive in subsequent years (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 13
  14. 14. First Fully-Human, Subcutaneously Delivered IL-6R Antibody Studied in RA 14 ● Sarilumab efficacy/safety results in moderate to severe RA patients ● Sarilumab 200mg Q2W + MTX(1) in MTX- inadequate responders showed 91% inhibition of structural damage ● Sarilumab + MTX in anti-TNFα-inadequate responders showed consistent impact on symptoms and physical functioning ● Most frequently reported TEAE(2) include serious infections, injection site erythema and neutropenia ● Sarilumab monotherapy shows superior efficacy vs. adalimumab(3) ● Two subcutaneous doses evaluated: 150mg and 200mg Q2W U.S. regulatory decision expected in Q4 2016 and EU dossier filed in Q2 2016 Sarilumab is developed in collaboration with Regeneron RA: Rheumatoid Arthritis Sarilumab is an investigational agent under clinical development and its safety and efficacy has not been fully evaluated by any Regulatory Authority (1) Methotrexate (2) Treatment Emergent Adverse Events (3) Not included in the initial BLA filed with FDA
  15. 15. First IL-4/IL-13 Receptor Antibody to Show Positive Phase III Results in AD 15 ● Dupilumab Phase III data in Atopic Dermatitis to be presented at EADV on October 1st 2016 ● Dupilumab 300mg QW / Q2W demonstrated the following in SOLO 1 and 2 Phase III trials(3) ● 37-36% / 38-36% of patients achieved clearing or near-clearing (IGA 0 or 1) of skin lesions at week 16 ● 72-69% / 72- 67% improvement in EASI(2) ● CHRONOS Phase III results reported in Q2 2016 ● U.S. FDA submission completed in Q3 2016 ● Additional indications: ● Phase III in Asthma enrollment completed ● Phase III in Nasal Polyps to start in Q1 2017 Dupilumab is developed in collaboration with Regeneron AD: Atopic Dermatitis Dupilumab is an investigational agent under clinical development and its safety and efficacy has not been fully evaluated by any Regulatory AuthorityThe SOLO 1 , SOLO 2, CHRONOS and CAFE trials are part of the LIBERTY AD clinical trial program U.S. submission completed in Q3 2016 IGA score 4 (1) For illustration only. While these pictures are from the Phase IIb clinical trial, individual results may vary (2) Eczema Area and Severity Index (3) Most frequently Treatment Emergent Adverse Events include serious and severe infections, injection site reactions and conjunctivitis AFTERBEFORE (1)(1) Images of a patient before and after dupilumab therapy in Phase IIb trial (Individual results did vary) IGA score 0
  16. 16. Expected Regulatory Decisions Q2 Q3 Q4 Q1 ● Dengvaxia® in endemic countries ● Adlyxin™ (lixisenatide) in Diabetes (U.S.) ● LixiLan in Diabetes (U.S.)  ● Sarilumab in Rheumatoid Arthritis (U.S.)  Expected Regulatory Fillings Q2 Q3 Q4 Q1 ● Sarilumab in Rheumatoid Arthritis (EU) ● Dupilumab in Atopic Dermatitis (U.S.)  Expected Phase III / IIIb Topline Data Q2 Q3 Q4 Q1 ● Dupilumab in Atopic Dermatitis (CHRONOS) ● Insulin lispro in Diabetes (SORELLA-1 & 2)  ● Praluent® ODYSSEY OUTCOMES 2nd interim analysis(1)  Expected Phase III Starts Q2 Q3 Q4 Q1 ● PD-1 Inhibitor in advanced CSCC(2) pivotal Phase II ● Olipudase alfa ASCEND in ASMD(3) ● NeoGAA in Pompe ● Efpeglenatide in Diabetes  ● Sotagliflozin in Diabetes  ● Isatuximab in Multiple Myeloma  ● Dupilumab in Nasal Polyposis  ● Fitusiran (ALN-AT3) in Hemophilia  16 Potential Important Regulatory Approvals for Dengvaxia®, LixiLan, Sarilumab and Dupilumab in the Next 12 Months * SORELLA-1 data was presented at ADA 2016 * (1) Second interim data analysis for futility and overwhelming efficacy when ~75% of events have occurred (2) Cutaneous Squamous Cell Carcinoma (3) Pivotal Phase II/III trial. ASMD – Acid Sphingomyelinase Deficiency previously referred as Niemann Pick type B
  17. 17. 17 Q&A SESSION

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