Ce diaporama a bien été signalé.
Nous utilisons votre profil LinkedIn et vos données d’activité pour vous proposer des publicités personnalisées et pertinentes. Vous pouvez changer vos préférences de publicités à tout moment.
Q1 2016 RESULTS
April 29, 2016
2
Forward Looking Statements
This presentation contains forward-looking statements as defined in the Private Securities Li...
3
Agenda
3
Q1 2016 Key Highlights
● Olivier Brandicourt - Chief Executive Officer
Q1 2016 Financial Results
● Jérôme Conta...
Q1 2016 KEY HIGHLIGHTS
4
Olivier Brandicourt
Chief Executive Officer
● Toujeo® continues to capture TRx share in the U.S. reaching 5.0%(4)
● Progressive launch of Praluent® while awaiting out...
Q1 2016Incremental
EPS at CER
+€0.07
Q1 2015 FX Impact
-€0.05
Aggregate Group Sales Business EPS
As Expected, Aggregate Sa...
7
Growth
at CER
New Organization by Global Business Unit
in Place as of January 1st 2016
(1) Does not include Emerging Mar...
8
Q1 2016 Sales Up 3% excluding Venezuela at CER
Driven by Specialty Care, Vaccines and Animal Health
(1) Excluding Venezu...
Q1 2015 Q1 2016
Other
Rare Disease Franchise Shows High-Single Digit Growth
in Q1 2016
● Comparable franchise growth
in De...
10
Multiple Sclerosis Franchise Continues to Deliver
Strong Growth in Q1 2016
● Aubagio® continues to expand oral
segment ...
Vaccines Franchise Up 8.2% at CER in Q1 2016
11
PPH: Polio, Pertussis, Hib vaccines
(1) After VaxServe reclassification fr...
12
Diabetes Franchise Reflected Lower U.S. Glargine(1)
Average Net Price, Moderated by Growth in EU and China
● Sales of €...
13
Praluent® is developed and commercialized in collaboration with Regeneron
Progressive Launch Underway
Awaiting Outcomes...
14
CHC Franchise Grows by +4.1%
Excluding Venezuela Impact and at Constant Structure(1)
● Strong U.S. performance up +7.7%...
+15.6%
CER: Constant Exchange Rates
(1) World excluding U.S., Canada, Europe, Japan, South Korea, Australia, New Zealand a...
16
Expected Regulatory Decisions Q1 Q2 Q3 Q4
● Dengvaxia® in endemic countries
● Lixisenatide in Diabetes (U.S.) 
● LixiL...
First Fully-Human, Subcutaneously
Delivered IL-6R Antibody Studied in RA
17
● Sarilumab efficacy/safety results in moderat...
First IL-4/IL-13 Receptor Antibody to
Show Positive Phase III Results in AD
18
● Dupilumab Phase IIb data in Atopic Dermat...
FINANCIAL RESULTS
Jérôme Contamine
Executive Vice President, Chief Financial Officer
19
20
FX Headwind on Top and Bottom Line in Q1 2016
(1) Main currency impact on sales in Q1 2016: Brazilian Real (-€70.3m), A...
CER: Constant Exchange Rates
(1) Reflecting reclassification of VaxServe from Sales to Other revenues. VaxServe sales of n...
22
€m Q1 2016 Q1 2015
% Change
(reported €)
% Change
(CER)
Aggregate Business operating income 2,384 2,398 -0.6% +3.0%
Agg...
Stable Gross Margin Ratio in Q1 2016
● Stable Cost of Sales (CoS) of
€2,693m in Q1 2016
● Gross margin of 70.3% in Q1 2016...
Limited OpEx Growth Mostly Driven by R&D in Q1 2016
24
● Q1 2016 OpEx of €3,696m, up
+3.0% at CER
● R&D expenses of €1,278...
Share Repurchase
-€1,403m
CapEx
-€325m
Net Cash from
Operating
Activities
Net Debt
Dec 31, 2015
Net Debt
Mar 31, 2016
Othe...
26
(1) Barring major unforeseen adverse events
(2) FY 2015 Business EPS of €5.64
(3) Difference between variation on a rep...
CLOSING REMARKS
27
Olivier Brandicourt
Chief Executive Officer
28
Delivering on our Strategic Priorities
● Solid financial results in Q1 2016
● Reshaping the portfolio
● CHC/Animal Heal...
29
Q&A SESSION
30
APPENDICES
R&D Pipeline
Immunology
Infectious Diseases
Neurodegenerative Diseases
Ophthalmology
Multiple Sclerosis
R&D Pipeline – Pharma & Vaccine...
32
Phase I Phase II Phase III Registration TOTAL
Oncology 4 1 0 0 5
Diabetes 4 1 2 2 9
Cardiovascular Diseases 2 0 0 0 2
I...
33
Expected R&D Milestones (1/2)
33
Product Event Timing
Dengvaxia® Expected regulatory decision in endemic countries Thro...
34
Expected R&D Milestones (2/2)
34
Product Event Timing
Praluent® Expected results of ODYSSEY OUTCOMES 2nd interim analys...
APPENDICES
FINANCE
35
Business EPS Currency Sensitivity
Currency Exposure on Q1 2016 Sales Currency Average Rates
2016 - Currency Sensitivity
36...
2016 - Headwinds and Tailwinds
● Residual impact of Plavix® generic
erosion in Japan
● Biosimilar insulin glargine launche...
38
Q1 2016 - Business Net Income Statement
First quarter 2016 Pharmaceuticals Vaccines Others Total Group Animal Health(1)...
Q1 2016 - Reconciliation of Business Net Income to
Consolidated Net Income Attributable to Equity Holders of Sanofi
39
(1)...
40
Q1 2016 - Consolidated Income Statements
(1) Including Animal Health business which is reported on a single line in the...
Prochain SlideShare
Chargement dans…5
×

Q1 2016 Results by Sanofi

33 837 vues

Publié le

Q1 2016 Results by Sanofi

Publié dans : Santé & Médecine
  • Soyez le premier à commenter

Q1 2016 Results by Sanofi

  1. 1. Q1 2016 RESULTS April 29, 2016
  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 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, 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 3 Q1 2016 Key Highlights ● Olivier Brandicourt - Chief Executive Officer Q1 2016 Financial Results ● Jérôme Contamine - Executive Vice President, Chief Financial Officer Q&A Session ● Olivier Charmeil - Executive Vice President, Sanofi Pasteur ● Peter Guenter - Executive Vice President, General Medicines & Emerging Markets ● Carsten Hellmann - Executive Vice President, Merial ● David P. Meeker - Executive Vice President, Sanofi Genzyme ● Pascale Witz - Executive Vice President, Diabetes & Cardiovascular ● Elias Zerhouni - President, Global R&D
  4. 4. Q1 2016 KEY HIGHLIGHTS 4 Olivier Brandicourt Chief Executive Officer
  5. 5. ● Toujeo® continues to capture TRx share in the U.S. reaching 5.0%(4) ● Progressive launch of Praluent® while awaiting outcomes data ● SAGE recommends Dengvaxia® use in endemic countries to WHO First public immunization program launched in the Philippines Launches Q1 2016 – Progressing on our 2020 Roadmap 5 RA: Rheumatoid Arthritis / AD: Atopic Dermatitis (1) On a reported basis, Q1 2016 Aggregate Sales were down -1.9% (2) On a reported basis, Q1 2016 Business EPS was up +1.5% (3) Subject to regulatory clearances (4) IMS data as of April 1st 2016 (5) LixiLan is a project name and is not the intended brand name for the combination of insulin glargine and lixisenatide ● Exclusive Boehringer Ingelheim asset swap expected to be signed mid-year and closed by year-end(3) ● Sanofi Pasteur targeting to manage European vaccine portfolio independently by year-end Portfolio ● Aggregate Sales reached €8,543m (after VaxServe reclassification), up +0.7% or +3.0% excluding Venezuela at CER(1) ● Solid Business EPS growth of +5.3% at CER(2) to €1.34 Financial Results ● Sarilumab monotherapy showed superior efficacy vs. adalimumab in RA ● Dupilumab met primary endpoints in 2 Phase III studies in AD ● LixiLan(5) combination submitted to EMA Innovation 3 1 2 4
  6. 6. Q1 2016Incremental EPS at CER +€0.07 Q1 2015 FX Impact -€0.05 Aggregate Group Sales Business EPS As Expected, Aggregate Sales Up Slightly in Q1 2016 Given High Base for Comparison in Venezuela & Japan 6 (1) Including Merial (2) Reflecting reclassification of VaxServe from Sales to Other revenues (3) On a reported basis, Q1 2016 Aggregate Sales were down -1.9% and Business EPS was up +1.5% +5.3% at CER(3) Q1 2015 FX Impact -€228m +€61m Incremental Sales at CER Q1 2016 +0.7% at CER(3) €8,710m €8,543m €1.32 €1.34 (2) Aggregate Group Sales +3.0% at CER excluding Venezuela (1)
  7. 7. 7 Growth at CER New Organization by Global Business Unit in Place as of January 1st 2016 (1) Does not include Emerging Markets sales (2) Includes Emerging Markets sales for Diabetes & Cardiovascular and Sanofi Genzyme (3) Emerging Markets: World excluding U.S., Canada, Western & Eastern Europe (except Eurasia), Japan, South Korea, Australia, New Zealand and Puerto Rico (4) Excluding Venezuela: -0.3% at CER (5) Reflecting reclassification of VaxServe from Sales to Other revenues from Jan 1, 2016. Pictures by Freepik Q1 2016 Aggregate Sales by Global Business Unit Group Aggregate Sales €8,543m +0.7% €760mAnimal Health +17.5% €1,499mDiabetes & Cardiovascular -5.8% (1) €1,169mSanofi Genzyme +20.5% (1) €4,490mGeneral Medicines & Emerging Markets -4.3% (4)(2,3) €625mVaccines +8.2% (5)
  8. 8. 8 Q1 2016 Sales Up 3% excluding Venezuela at CER Driven by Specialty Care, Vaccines and Animal Health (1) Excluding Venezuela sales were up +12.3% at CER (2) Excluding Plavix® in Japan, sales were down -6.3% at CER (3) Excluding Venezuela sales were up +8.8% at CER (4) Excluding Venezuela sales were up +3.8% at CER Q1 2016 Aggregate Sales by Franchise Developed Markets Emerging Markets Growth at CER Total Sales GrowthSales Animal Health +17.5%€760m +37.5%+13.0%€612m €148m Specialty Care +18.4%€1,371m +9.3%+20.5%€1,169m €202m Diabetes & Cardiovascular -3.5%€1,832m +6.7%-5.8%€1,499m €333m Sales Growth Vaccines +8.2%€625m +37.0%-8.1%€347m €278m Established Rx Products -8.2%€2,591m -2.1%-11.5%€1,667m €924m Generics +3.3%€459m 0.0%+6.0%€282m €177m Consumer Healthcare -3.1%€905m -9.9%+1.5%€594m €311m (1) (3) (4) (6) (5) Excluding Venezuela sales were up +7.1% at CER (6) Reflecting reclassification of VaxServe from Sales to Other revenues from Jan 1, 2016 (7) Excluding Pentacel® in the U.S., sales were up +9.3% at CER (5) (2) (7)
  9. 9. Q1 2015 Q1 2016 Other Rare Disease Franchise Shows High-Single Digit Growth in Q1 2016 ● Comparable franchise growth in Developed and Emerging Markets (+8.5% / +8.3% at CER, respectively) ● Sales split Developed / Emerging: 83% / 17% ● Growth driven by patient accruals ● Gaucher franchise grew +10.1% at CER ● Market share of 73% in value(1) ● Cerdelga® sales in the U.S. almost double(2) ● Fabrazyme® sales up +6.4% at CER following strong Q4 2015(3) ● Myozyme® / Lumizyme® sales up +8.3% at CER €646m +8.5% at CER €613m 9 & €182m €23m €166m €149m €126m (1) Cerezyme® + Cerdelga® value share is 73% based on Q1 2016 reported sales by Sanofi and Shire (2) Cerdelga® sales were €23m in Q1 2016 and €10m in Q1 2015 (3) Fabrazyme® Q4 2015 sales were up +20.3% at CER Global Rare Diseases Sales
  10. 10. 10 Multiple Sclerosis Franchise Continues to Deliver Strong Growth in Q1 2016 ● Aubagio® continues to expand oral segment with sales up +64.1% at CER ● Remains fastest growing oral MS drug ● Sales now annualizing at more than €1bn ● U.S. weekly TRx share increased to 7.2%(1) ● Progressively overcoming barriers to Lemtrada® use with sales more than doubling in Q1 2016 ● Lemtrada® demonstrated significant slow down in brain volume loss at 3 years and increase in retinal nerve fiber layer thickness over 2 years(2) €243m Q1 2015 Q1 2016 €208m €367m +76.9% at CER €88m +134.2% at CER €279m +64.1% at CER (1) IMS data for the week ending April 1st 2016 (2) Presentation at American Academy of Neurology Annual Meeting 2016 Global Multiple Sclerosis Sales
  11. 11. Vaccines Franchise Up 8.2% at CER in Q1 2016 11 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. VaxServe sales from third parties were €100m in Q1 2015 (2) Strategic Advisory Group of Experts on Immunization to the World Health Organization ● PPH vaccines up +6.0% at CER ● Strong sales in Emerging Markets driven by Hexaxim® ● Low U.S. sales given expected Pentacel® supply constraint ● Menactra® performance more than offsets softness in Booster vaccine ● Menactra® sales up +29.9% ● Adult boosters decline -15.8% due to Adacel® buying pattern in the U.S. ● First sales of Dengvaxia® of €19m ● SAGE(2) recommends use in endemic countries to WHO ● Dossier submitted to EMA Sanofi Pasteur Sales Q1 2016 €625m Q1 2015 €597m Other Dengvaxia® Travel/Endemic Adult Boosters Meningitis/Pneumo Polio/Pertussis/Hib Influenza Vaccines (1) +8.2% at CER (1)
  12. 12. 12 Diabetes Franchise Reflected Lower U.S. Glargine(1) Average Net Price, Moderated by Growth in EU and China ● Sales of €1,734m, down -4.5%(2) at CER ● U.S. sales down by -11.1% reflecting expected lower Glargine average net price ● Europe up +4.0% despite biosimilar competition ● Emerging Markets up +12.0%(3) excluding Venezuela ● Glargine TRx U.S. market share relatively stable year over year at 68.4%(4) ● Toujeo® expected to be launched in over 40 countries by end 2016 ● LixiLan(5) and lixisenatide FDA Advisory Committee scheduled for May 25th 2016 Q1 2015 Q1 2016 Other €1,734m -4.5% at CER (1) Lantus® and Toujeo® (2) Diabetes sales declined by -3.6% when excluding Venezuela (3) Diabetes sales in Emerging Markets increased by +6.4% when including Venezuela (4) IMS Rapid weekly as of April 1st 2016, -0.4% vs same period in 2015 (5) LixiLan is a project name and is not the intended brand name for the combination of insulin glargine and lixisenatide (6) Includes Apidra®, Amaryl®, Insuman®, Lyxumia® and Blood Glucose Monitoring €1,837m (6) Global Diabetes Sales
  13. 13. 13 Praluent® is developed and commercialized in collaboration with Regeneron Progressive Launch Underway Awaiting Outcomes Study Results ● Q1 2016 sales of €12m reflecting current payer restrictions limiting uptake ● ODYSSEY OUTCOMES first interim data analysis for futility conducted and study continues ● Second interim analysis for futility and overwhelming efficacy potentially in H2 2016 when 75% of the targeted number of primary events have occurred ● 300mg monthly dosing expected to be filed with FDA in Q2 2016 ● Sanofi and Regeneron strongly disagree with U.S. jury verdict in ongoing patent litigation and will appeal
  14. 14. 14 CHC Franchise Grows by +4.1% Excluding Venezuela Impact and at Constant Structure(1) ● Strong U.S. performance up +7.7% at CER driven by Allegra®, Nasacort® and Gold Bond® ● Europe declines -7.3% at CER due to Doliprane® price cuts and mild winter ● Emerging Markets were up +3.8% at CER excluding Venezuela(2) (1) Excluding minor divestments (2) Including Venezuela sales were down -9.9% at CER (3) Subject to regulatory clearances CHC Franchise Global Sales Fx Impact Q1 2016Organic Growth Q1 2015 Adjusted Base Venezuela & Minor Divestments -€67m Q1 2015 €979m €912m +€37m -€44m €905m +4.1% at CER CHC asset swap on track for signing in mid 2016 and closing by end 2016(3)
  15. 15. +15.6% CER: Constant Exchange Rates (1) World excluding U.S., Canada, Europe, Japan, South Korea, Australia, New Zealand and Puerto Rico (2) RoW: Japan, South Korea, Canada, Australia, New Zealand and Puerto Rico (3) Eurasia: Russia, Ukraine, Georgia, Belarus, Armenia and Turkey Sanofi Continues to Show a Balanced Geographic Profile 15 Q1 2016 Aggregate Group Sales by Geography (€m) 27.8% 34.7% 27.8% 9.7% (1) €833m €571m €259m €668m Asia Africa Middle East and South Asia Latin America Eurasia Growth at CER Emerging Markets Sales by Region Emerging Markets €2,373m +4.2% at CER or +13.1% at CER excluding VenezuelaU.S. €2,966m +1.5% at CER Europe €2,372m +1.7% at CER RoW €832m -13.3% at CER (2) Growth at CER excluding Venezuela +9.9%-14.9% +11.0% +11.8% (3)
  16. 16. 16 Expected Regulatory Decisions Q1 Q2 Q3 Q4 ● Dengvaxia® in endemic countries ● 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.)  ● Sarilumab in Rheumatoid Arthritis (EU)  Expected Phase III / IIIb Topline Data Q1 Q2 Q3 Q4 ● Dupilumab in Atopic Dermatitis (SOLO 1 & 2 / CHRONOS)  ● Sarilumab in Rheumatoid Arthritis (MONARCH) ● Insulin lispro in Diabetes (SORELLA)  ● Praluent® ODYSSEY OUTCOMES 2nd interim analysis(1) Expected Phase III Starts Q1 Q2 Q3 Q4 ● Olipudase alfa in Niemann Pick type B(2)  ● NeoGAA in Pompe  ● PD-1 Inhibitor in CSCC(3) pivotal Phase II  ● Fitusiran in Hemophilia  ● Efpeglenatide in Diabetes  ● Sotagliflozin in Diabetes  ● Isatuximab in Multiple Myeloma  Seven Registrational Studies Expected to Start in 2016 (1) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred in H2 2016 (2) Pivotal phase II/III trial (3) Cutaneous Squamous Cell Carcinoma
  17. 17. First Fully-Human, Subcutaneously Delivered IL-6R Antibody Studied in RA 17 ● 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 early Q4 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
  18. 18. First IL-4/IL-13 Receptor Antibody to Show Positive Phase III Results in AD 18 ● Dupilumab Phase IIb data in Atopic Dermatitis published in The Lancet ● 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 expected in Q2 2016 ● European pivotal study initiated in Q1 2016 (CAFE) ● Phase III study in Asthma ongoing 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 in AD planned for 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
  19. 19. FINANCIAL RESULTS Jérôme Contamine Executive Vice President, Chief Financial Officer 19
  20. 20. 20 FX Headwind on Top and Bottom Line in Q1 2016 (1) Main currency impact on sales in Q1 2016: Brazilian Real (-€70.3m), Argentine Peso (-€39.6m), South African Rand (-€20.4m), Turkish New Lira (-€19.7m), Russian Ruble (-€18.9m) and Mexican Peso (-€18.9m); U.S. Dollar (+€50.6m) , Japanese Yen (+€22.2m) (2) Excluding Vaxserve in Aggregate Sales (3) Adverse impact of Venezuela on Q1 2016 Business EPS was €0.09, which includes €197m lower sales vs Q1 2015 and €102m Fx loss recorded in Other operating income P&L line +9.8% +€764m +11.1% +€888m +5.6% +€487m -2.6% -€228m Q1 2016 Q1 2015 Q2 2015 Q3 2015 Q4 2015 +3.7% +€332m Q1 2016 Q1 2015 Q2 2015 Q3 2015 Q4 2015 +10.2% +€0.12 +15.4% +€0.18 +€0.05 +3.4% +7.1% +€0.10 -3.8% -€0.05 Currency Impact Aggregate Group Sales(1,2) Business EPS Currency impact excluding Venezuela(3)
  21. 21. CER: Constant Exchange Rates (1) Reflecting reclassification of VaxServe from Sales to Other revenues. VaxServe sales of non-Group products were €100m in Q1 2015 and €83m in Q1 2016 (2) Includes an indemnity amount of €192m pursuant to a final arbitration as consequence of a contractual dispute and an Fx loss of €102m in Venezuela 21 Aggregate BOI Increased +3.0% at CER in Q1 2016 €m Q1 2016 Q1 2015 % Change (reported €) % Change (CER) Aggregate Group sales 8,543 8,710 -1.9% +0.7% Aggregate Other revenues 155 180 -13.9% -15.0% Aggregate Cost of sales (2,693) (2,786) -3.3% -0.1% Aggregate Gross profit 6,005 6,104 -1.6% +0.6% Aggregate R&D (1,278) (1,199) +6.6% +6.5% Aggregate SG&A (2,418) (2,438) -0.8% +1.3% Aggregate Other current operating income & expenses 79 (67) - - Aggregate Share of profit/loss of associates 23 31 - - Aggregate Minority interests (27) (33) - - Aggregate Business operating income 2,384 2,398 -0.6% +3.0% Aggregate Business operating margin 27.9% 27.5% - - (1) (2)
  22. 22. 22 €m Q1 2016 Q1 2015 % Change (reported €) % Change (CER) Aggregate Business operating income 2,384 2,398 -0.6% +3.0% Aggregate Net financial expenses (118) (97) - - Income tax expense (544) (575) - - Effective tax rate 24.0% 25.0% - - Business net income 1,722 1,726 -0.2% +3.5% Net margin 20.2% 19.8% - - Business EPS €1.34 €1.32 +1.5% +5.3% Average number of shares outstanding (m) 1,288.4 1,308.4 - - A Good Start to 2016 with Mid-Single Digit Growth of Business EPS at CER 22 CER: Constant Exchange Rates (1) Number of shares outstanding on March 31st, 2016: 1,286.7m (1)
  23. 23. Stable Gross Margin Ratio in Q1 2016 ● Stable Cost of Sales (CoS) of €2,693m in Q1 2016 ● Gross margin of 70.3% in Q1 2016 reflects: ● Positive impact from Specialty Care franchise and Vaccines more than offsetting the impact from lower Glargine average net price in the U.S. and Plavix® LoE(2) in Japan ● Slight positive currency impact 23 Q1 Q2 Q3 Q4 Q1 2015 2016 70.3%70.1% Aggregate Gross Margin(1) Gross Margin is calculated as the ratio of Aggregate Gross profit over Aggregate Group sales (excluding Aggregate Other revenues) (1) Historical values adjusted for VaxServe reclassification (2) Loss of Exclusivity 70.4% 70.7% 69.0%
  24. 24. Limited OpEx Growth Mostly Driven by R&D in Q1 2016 24 ● Q1 2016 OpEx of €3,696m, up +3.0% at CER ● R&D expenses of €1,278m up 6.5% at CER mainly due to: ● Immuno-Oncology activities ● Dupilumab Phase III program ● SG&A expenses of €2,418m, slightly up (+1.3% at CER) showing: ● Reallocation of resources behind key products launches ● Lower G&A expenses 24 Q1 Q2 Q3 Q4 Q1 €3,696m€3,637m 2015 2016 €1,278m€1,199m €2,418m€2,438m R&D SG&A Operating Expenses
  25. 25. Share Repurchase -€1,403m CapEx -€325m Net Cash from Operating Activities Net Debt Dec 31, 2015 Net Debt Mar 31, 2016 Other -€569m Acquisitions, Licensing, Net of Disposals -€25m €1.4bn of Share Repurchase Completed in Q1 2016 25 (1) (2) €7,254m €8,373m €1,203m (4) (1) FCF €878m (3) FCF: Free Cash Flow (1) Including derivatives related to the financial debt +€152m at December 31st 2015 and +€196m at March 31st 2016 (2) Excluding Restructuring costs (3) Including Hanmi Pharmaceuticals of €400m, Verily JV of €165m and Regeneron anti-dilutive share purchase of €94m (4) Other including Restructuring costs and Fx impact Net Debt 25
  26. 26. 26 (1) Barring major unforeseen adverse events (2) FY 2015 Business EPS of €5.64 (3) Difference between variation on a reported basis and variation at CER when applying March 2016 average exchange rates to the remaining quarters of the year Confirmed 2016 Business EPS Growth at CER Business EPS Growth Around -3%(3) based on March 2016 average exchange rates Broadly stable at CER(1,2) FY 2016 FX impact on Business EPS
  27. 27. CLOSING REMARKS 27 Olivier Brandicourt Chief Executive Officer
  28. 28. 28 Delivering on our Strategic Priorities ● Solid financial results in Q1 2016 ● Reshaping the portfolio ● CHC/Animal Health asset swap ● End joint Vaccines operations in Europe ● Focus on execution of launches ● New wave of innovation with seven pivotal trials expected to start in 2016 1 2 3 4
  29. 29. 29 Q&A SESSION
  30. 30. 30 APPENDICES R&D Pipeline
  31. 31. Immunology Infectious Diseases Neurodegenerative Diseases Ophthalmology Multiple Sclerosis R&D Pipeline – Pharma & Vaccines GZ402668 GLD52 (anti-CD52 mAb) Relapsing multiple sclerosis GZ402666 neoGAA Pompe Disease GZ389988 TRKA antagonist Osteoarthritis SAR339375 Anti-miR21 RNA Alport syndrome SAR425899 GLP-1R/GCGR dual agonist Type 2 diabetes fitusiran (ALN-AT3) siRNA targeting Anti-Thrombin Hemophilia SAR438335 GLP-1R/GIPR dual agonist Type 2 diabetes UshStat® Myosin 7A gene therapy Usher syndrome 1B SAR438544 Stable glucagon analog Diabetes SAR228810 Anti-protofibrillar AB mAb Alzheimer’s disease SAR440067 (LAPS Insulin 115)nn Long acting insulin analog Type 2 diabetes SAR439152 Myosin inhibitor Hypertrophic cardiomyopathy SAR566658 Maytansin-loaded anti-CA6 mAb Solid tumors SAR407899 rho kinase Microvascular angina 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 Phase I N N N N N N N N N N N N N N N dupilumab Anti-IL4Rα mAb Nasal polyposis; Eosinophilic oesophagitis olipudase alfa rhASM Niemann-Pick type B SAR156597 IL4/IL13 Bi-specific mAb Idiopathic pulmonary fibrosis GZ402671 Oral GCS inhibitor Fabry Disease SAR100842 LPA1 receptor antagonist Scleroderma SAR422459 ABCA4 gene therapy Stargardt disease SAR439954 (sotagliflozin) Oral SGLT-1&2 inhibitor Type 2 diabetes Combination ferroquine / OZ439 Antimalarial SAR439977 (efpeglenatide)n Long-acting GLP-1 receptor agonist Type 2 diabetes Rabies VRVg Purified vero rabies vaccine sarilumab Anti-IL6R mAb Uveitis Tuberculosis Recombinant subunit vaccine isatuximab Anti-CD38 naked mAb Multiple myeloma Fluzone® QIV HD Quadrivalent inactivated influenza vaccine - High dose Phase II N N N N N SAR342434 insulin lispro Type 1+2 diabetes SAR439954 (sotagliflozin) n Oral SGLT-1&2 inhibitor Type 1 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 VaxiGrip® QIV IM Quadrivalent inactivated influenza vaccine (6-35 months) Pediatric pentavalent vaccine DTP-Polio-Hib Japan Men Quad TT 2nd generation meningococcal ACYW conjugate vaccine Phase III N N N N Registration lixisenatide GLP-1 agonist Type 2 diabetes, U.S. LixiLan Fixed-Ratio insulin glargine+lixisenatide Type 2 diabetes, U.S., EU sarilumab Anti-IL6R mAb Rheumatoid arthritis, U.S. Dengvaxia®(1) Mild-to-severe dengue fever vaccine PR5i DTP-HepB-Polio-Hib Pediatric hexav. vaccine, U.S. VaxiGrip® QIV IM Quadrivalent inactivated influenza vaccine (3 years+) N N N N (1) Approved in Brazil, Mexico, the Philippines and El Salvador 31 N N N N New Molecular Entity Rare Diseases Oncology Diabetes Vaccines Cardiovascular Diseases N N N
  32. 32. 32 Phase I Phase II Phase III Registration TOTAL Oncology 4 1 0 0 5 Diabetes 4 1 2 2 9 Cardiovascular Diseases 2 0 0 0 2 Immune Mediated Diseases 1 2 1 1 5 Infectious Diseases 0 1 0 0 1 Ophthalmology 1 0 0 0 1 Rare Diseases 4 3 2 0 9 Multiple Sclerosis 1 0 0 0 1 Neurodegenerative Diseases 1 0 0 0 1 Vaccines 2 3 4 3 12 TOTAL 20 11 9 6 R&D Pipeline Summary Table(1) 31 15 NMEs & Vaccines 46 32 34 (1) Excluding life cycle management programs
  33. 33. 33 Expected R&D Milestones (1/2) 33 Product Event Timing Dengvaxia® Expected regulatory decision in endemic countries Throughout 2016 Lixisenatide and LixiLan FDA Advisory Committee May 25, 2016 Men Quad TT Expected start of Phase III trial Q2 2016 insulin lispro Expected SORELLA Phase III top line results in Diabetes Q2 2016 dupilumab Expected CHRONOS Phase III interim results in Atopic Dermatitis Q2 2016 NeoGAA (GZ402666) Expected start of Phase III trial in Pompe Disease Q2 2016 olipudase alfa Expected start of pivotal Phase II/III trial in Niemann Pick type B Q2 2016 SAR439684 (PD-1 Inhibitor) Expected start of pivotal Phase II trial in Cutaneous Squamous Cell Carcinoma Q2 2016 sarilumab Expected EU regulatory submission in Rheumatoid Arthritis Q3 2016 Lixisenatide Expected U.S. regulatory decision in Type 2 Diabetes Q3 2016 LixiLan Expected U.S. regulatory decision in Type 2 Diabetes Q3 2016 dupilumab Expected U.S. regulatory submission in Atopic Dermatitis Q3 2016 fitusiran Expected start of Phase III trial in Hemophilia Q3 2016
  34. 34. 34 Expected R&D Milestones (2/2) 34 Product Event Timing Praluent® Expected results of ODYSSEY OUTCOMES 2nd interim analysis(1) H2 2016 sarilumab Expected U.S. regulatory decision in Rheumatoid Arthritis Q4 2016 VaxiGrip® QIV IM (3 years+) Expected EU regulatory decision Q4 2016 sotagliflozin Expected start of Phase III trial in Type 2 Diabetes Q4 2016 efpeglenatide Expected start of Phase III trial in Type 2 Diabetes Q4 2016 isatuximab (anti-CD38) Expected start of Phase III trial in Multiple Myeloma Q4 2016 (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
  35. 35. APPENDICES FINANCE 35
  36. 36. Business EPS Currency Sensitivity Currency Exposure on Q1 2016 Sales Currency Average Rates 2016 - Currency Sensitivity 36 Q1 2015 Q1 2016 % change EUR/USD 1.13 1.10 -2.2% EUR/JPY 134.19 127.02 -5.3% EUR/CNY 7.03 7.21 +2.6% EUR/BRL 3.22 4.31 +33.7% EUR/RUB 71.09 82.47 +16.0% Currency Variation Business EPS Sensitivity U.S. Dollar -0.05 USD/EUR +EUR 0.13 Japanese Yen +5 JPY/EUR -EUR 0.02 Chinese Yuan +0.2 CNY/EUR -EUR 0.02 Brazilian Real +0.4 BRL/EUR -EUR 0.01 Russian Ruble +10 RUB/EUR -EUR 0.04 € 24.9% US $ 35.9% Chinese Yuan 5.9% Japanese Yen 5.0% Brazilian Real 2.5% British £ 1.9% Australian $ 1.5% Canadian $ 1.4% Russian Ruble 1.3% Mexican Peso 1.2% Others 18.5%
  37. 37. 2016 - Headwinds and Tailwinds ● Residual impact of Plavix® generic erosion in Japan ● Biosimilar insulin glargine launched in Japan & EU in H2 2015 ● Potential generic competition for Renagel®/Renvela® in the U.S. and Lovenox® in the EU ● Launch expenses for Toujeo®, Praluent®, Dengvaxia®, LixiLan(1) and sarilumab ● Immuno-Oncology related expenses ● Low tax rate in H2 2015 creating unfavorable base for comparison 3737 Headwinds ● Easier base for comparison for Diabetes and Venezuela(2) in H2 2016 ● Stronger Vaccines outlook in H2 2016 ● Q4 2015 negatively impacted by Auvi-Q® and Afrezza® Tailwinds (1) LixiLan is a project name and is not the intended brand name for the combination of insulin glargine and lixisenatide (2) €200m sales in Q2 2015 and €56m in H2 2015
  38. 38. 38 Q1 2016 - Business Net Income Statement First quarter 2016 Pharmaceuticals Vaccines Others Total Group Animal Health(1) Total: aggregate basis(4) € million Q1 2016 Q1 2015 Change Q1 2016 Q1 2015(3) Change Q1 2016 Q1 2015 Q1 2016 Q1 2015 Q1 2016 Q1 2015 Change Q1 2016 Q1 2015 Change Net sales 7,158 7,455 (4.0%) 625 597 4.7% 7,783 8,052 760 658 15.5% 8,543 8,710 (1.9%) Other revenues 54 62 (12.9%) 91 106 (14.2%) 145 168 10 12 (16.7%) 155 180 (13.9%) Cost of sales (2,097) (2,190) (4.2%) (350) (376) (6.9%) (2,447) (2,566) (246) (220) 11.8% (2,693) (2,786) (3.3%) As % of net sales (29.3%) (29.4%) (56.0%) (63.0%) (31.4%) (31.9%) (32.4%) (33.4%) (31.5%) (32.0%) Gross profit 5,115 5,327 (4.0%) 366 327 11.9% 5,481 5,654 524 450 16.4% 6,005 6,104 (1.6%) As % of net sales 71.5% 71.5% 58.6% 54.8% 70.4% 70.2% 68.9% 68.4% 70.3% 70.1% Research and development expenses (1,108) (1,039) 6.6% (127) (120) 5.8% (1,235) (1,159) (43) (40) 7.5% (1,278) (1,199) 6.6% As % of net sales (15.5%) (13.9%) (20.3%) (20.1%) (15.9%) (14.4%) (5.7%) (6.1%) (15.0%) (13.8%) Selling and general expenses (2,046) (2,094) (2.3%) (166) (156) 6.4% (2,212) (2,250) (206) (188) 9.6% (2,418) (2,438) (0.8%) As % of net sales (28.6%) (28.1%) (26.6%) (26.1%) (28.4%) (27.9%) (27.1%) (28.6%) (28.3%) (28.0%) Other current operating income/expenses 107 (28) 1 (14) (40) 93 (67) (14) 79 (67) Share of profit/loss of associates* and joint ventures 16 32 7 (1) 23 31 - 23 31 Net income attributable to non-controlling interests (27) (33) - (27) (33) - (27) (33) Business operating income 2,057 2,165 (5.0%) 80 51 56.9% (14) (40) 2,123 2,176 261 222 17.6% 2,384 2,398 (0.6%) As % of net sales 28.7% 29.0% 12.8% 8.5% 27.3% 27.0% 34.3% 33.7% 27.9% 27.5% Financial income and expenses(2) (118) (97) Income tax expense(2) (544) (575) Tax rate** 24.0% 25.0% Business net income 1,722 1,726 (0.2%) As % of net sales 20.2% 19.8% Business earnings per share*** (in euros) 1.34 1.32 1.5% * Net of tax ** Determined on the basis of Business income before tax, associates and non-controlling interests. *** Based on an average number of shares outstanding of 1,288.4 million in the first quarter of 2016 and 1,308.4 million in the first quarter of 2015. (1) Pursuant to IFRS5 presentation requirement as "discontinued operations”, Animal Health business net result is reported on the single income statement line Net income from the held-for-exchange Animal Health business for 2015 and prior years. Until the closing of the transaction, Animal Health remains an operating segment of the Group (2) Including Animal Health business which is reported on a single line in the consolidated income statements in accordance with IFRS5 (Non-Current Held for Sale and Discontinued Operations) (3) As per a change in accounting presentation, Vaxserve sales of non Group products are reported in Other revenues from 2016 onwards. Prior period Net sales and Other revenues have been restated accordingly. . (4) Aggregate amount including Animal Health business
  39. 39. Q1 2016 - Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi 39 (1) Animal Health reported separately in accordance with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations) (2) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €410 million in the first quarter of 2016 and €471 million in the first quarter of 2015 (3) Includes the following items: Impact of the discontinuation of depreciation and impairment of Property, Plant & Equipment starting at IFRS 5 application (Non-current held for sale and discontinued operations), impact of the amortization and impairment of intangible assets until IFRS 5 application, costs incurred as a result of the divestment as well as tax effect of these items, and outside basis deferred tax impact (4) Based on an average number of shares outstanding of 1,288.4 million in the first quarter of 2016 and 1,308.4 million in the first quarter of 2015 € million Q1 2016(1) Q1 2015 (1) Change Business net income 1,722 1,726 (0.2%) Amortization of intangible assets(2) (444) (499) Impairment of intangible assets - (27) Fair value remeasurement of contingent consideration liabilities (29) 1 Restructuring costs (500) (353) Tax effect of items listed above: 338 312 Amortization of intangible assets 156 174 Impairment of intangible assets - 10 Fair value remeasurement of contingent consideration liabilities 11 7 Other gains and losses, and litigation - - Restructuring costs 171 121 Share of items listed above attributable to non-controlling interests 1 1 Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures 70 (62) Animal Health items(3) (71) (76) Net income attributable to equity holders of Sanofi 1,087 1,023 6.3% Consolidated earnings per share(4) (in euros) 0.84 0.78
  40. 40. 40 Q1 2016 - Consolidated Income Statements (1) Including Animal Health business which is reported on a single line in the consolidated income statements in accordance with IFRS5 (Non-Current Held for Sale and Discontinued Operations). (2) As per a change in accounting presentation, Vaxserve sales of non-Group products are reported in Other revenues from 2016 onwards. Prior period Net sales and Other revenues have been restated accordingly. . € million Q1 2016(1) Q1 2015(1)(2) Net sales 7,783 8,052 Other revenues 145 168 Cost of sales (2,447) (2,566) Gross profit 5,481 5,654 Research and development expenses (1,235) (1,159) Selling and general expenses (2,212) (2,250) Other operating income 217 34 Other operating expenses (124) (101) Amortization of intangible assets (444) (499) Impairment of intangible assets - (27) Fair value remeasurement of contingent consideration liabilities (29) 1 Restructuring costs (500) (353) Operating income 1,154 1,300 Financial expenses (129) (131) Financial income 12 36 Income before tax and associates and joint ventures 1,037 1,205 Income tax expense (117) (184) Share of profit/loss of associates and joint ventures 93 (31) Net income excluding the held for exchange Animal Health business 1,013 990 Net income from the held for exchange Animal Health business 100 65 Net income 1,113 1,055 Net income attributable to non-controlling interests 26 32 Net income attributable to equity holders of Sanofi 1,087 1,023 Average number of shares outstanding (million) 1,288.4 1,308.4 Earnings per share (in euros) excluding the held for exchange Animal Health business 0.77 0.73 Earnings per share (in euros) 0.84 0.78

×