Q1 2014 Results par Sanofi

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Q1 2014 Results par Sanofi

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Q1 2014 Results par Sanofi

  1. 1. Q1 2014 RESULTS April 29, 2014
  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 policies 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, 2013. 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. 33 Agenda Key Highlights ● Christopher A. Viehbacher, Chief Executive Officer Financial Performance ● Jérôme Contamine, Executive Vice President, Chief Financial Officer Conclusion ● Christopher A. Viehbacher, Chief Executive Officer Q&A
  4. 4. KEY HIGHLIGHTS 4 Christopher A. Viehbacher Chief Executive Officer
  5. 5. Key Highlights for Q1 2014 Top and bottom line growth in line with expectations – Net sales up +3.5% at CER – Business EPS up +5.8% at CER New product launches – Nasacort® Allergy 24HR nasal spray in the U.S. – NexGard™ chewables in the U.S. Late stage R&D pipeline progress – Dengue vaccine met primary endpoint in 1st Phase III study – Significant advances with Lemtrada™, alirocumab, LixiLan, dupilumab 5 Increased value of open innovation – Strengthened collaborations with Regeneron and Alnylam – New collaborations with UCB and SK Chemical 1 2 3 4
  6. 6. Pharmaceuticals Delivered +4.7% Sales Growth at CER 6 (1) Q1 2014 sales were down -2.7% on a reported basis (2) Q1 2014 sales for Pharmaceuticals were up +4,9% at CER and on a constant perimeter basis €628m €6,697m €7,842m €697m €8,059m Q1 2014 €6,808m €517m Q1 2013 €554m Pharmaceuticals Vaccines Animal Health +4.7% at CER -4.2% at CER -1.6% at CER Q1 2014 Net Sales (1) 1 (2)
  7. 7. 7 (1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Holland, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark), Japan, Australia, and New Zealand (2) Western Europe: France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Holland, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark Q1 2014 Net Sales (1) (2) Latin America: +13.1% at CER Asia: +4.0% at CER Eastern EU, Russia & Turkey: +4.0% at CER Middle East & Africa: -1.0% at CER €2,590m +5.5% at CER €2,415m +7.5% at CER €1,998m -0.3% at CER €839m -4.0% at CER Continued Solid Growth in our Two Largest Geographies1 Emerging Markets United States Western EU RoW
  8. 8. +18.6%Consumer Healthcare(1) €885m Vaccines -4.2%€628m Genzyme(2) Growth Platforms Grew by +7.9% Reaching 73.7% of Sales 8 (1) Some products recorded in prescription pharmaceuticals in Q1 2013 were transferred as Consumer Healthcare products and totaled €68m in Q1 2014. Excluding this change of perimeter, sales of Consumer Healthcare grew 9.4% in Q1 2014. (2) Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises (3) Includes products launched since 2009 which do not belong to the Growth Platforms listed above: Multaq®, Jevtana®, Auvi-Q™, Mozobil® and Zaltrap® +13.2% -4.2% +21.5% -1.6% Other Innovative Products(3) €190m +22.6% +5.5% Diabetes Solutions €1,662m Animal Health €566m Emerging Markets €2,590m €517m Q1 2014 Growth at CER 1
  9. 9. New Launches Executed in Q1 2014 9 ● First and only 24 HR full Rx strength nasal allergy spray available OTC in the U.S. ● Up to 60m people in U.S. with allergies and up to 28m people using nasal sprays ● €36m sales in Q1 2014 in the U.S. ● First and only beef-flavored chew treating fleas and ticks in dogs in the U.S. ● Launched in the U.S. and France ● €23m sales in Q1 2014 2
  10. 10. 10 First-in-Class Dengue Vaccine Met Primary Endpoint in Phase III Trial in Asia Significant Disease Burden(1) ● 2.5bn people at risk ● 100m symptomatic dengue cases worldwide per year ● 500,000 people with severe dengue requiring hospitalization ● 2.5% of people with severe dengue die ● Dengue is a public health priority in Asia and Latin America (1) Dengue and severe dengue; WHO Fact Sheet No. 117 updated Sep. 2013 http://www.who.int/mediacentre/factsheets/fs117/en/index.html Dengue is under-reported and thus the burden is likely underestimated (Bhatt S et al. Nature. 2013 Apr 25;496(7446):504-7) (2) Sabchareon A et al. Lancet. 2012 Nov 3;380(9853):1559-67. Ambitious Development Program ● 1st Phase III in Asia (~10,000 children) ● 3 vaccinations at 0, 6, and 12 months ● 56% reduction of dengue disease cases from first available data ● Good safety profile ● 2nd Phase III trial ongoing in LatAm ● >20,000 children and adolescents ● Results expected in Q3 2014 3 WHO objectives: Reduce dengue mortality by 50% and morbidity by at least 25% by 2020
  11. 11. Innovation - Significant Advances in Q1 2014 11 ● Planned sBLA resubmission in Q2 2014 ● FDA review timeframe: 2 or 6 months once filing is accepted(1) ● 2 Phase III studies initiated in Q1 2014 ● LixiLan-O: patients insufficiently controlled on OADs ● LixiLan-L: patients not at goal on basal insulin ● Positive Phase III monotherapy trial results presented at ACC in Mar 2014 ● 9 additional Phase III top-line readouts expected from June through Q3 2014 ● Strong Phase IIa results in AD presented at AAAAI in March 2014(2) ● Phase IIb top-line results in AD expected in Q2 2014 and in Asthma in Q1 2015 (1) FDA will assign a 2 month or 6 month review cycle within 14 calendar days of receipt of the resubmission (2) Phase IIa presented at AAAAI (American Academy of Allergy, Asthma & Immunology) - Annual Meeting, March 4 2014 - Atopic Dermatitis / Asthma Alirocumab and dupilumab are developed in collaboration with Regeneron - Hypercholesterolemia - Diabetes - Multiple Sclerosis 3 R&D
  12. 12. Strengthened Relationship with Regeneron 12 ● A model of global strategic R&D collaboration ● Secured access to therapeutic human antibody platform ● Sanofi ownership of Regeneron recently reached 20% ● Robert A. Ingram nominated by Sanofi and appointed as a member of Regeneron's Board of Directors ● “Significant influence” under IFRS rules allows Sanofi to account for its investment in Regeneron using the Equity method from April 4, 2014 4
  13. 13. 13 Genzyme’s Leadership in Rare Diseases Increases through Expansion of Alnylam Collaboration (1) Proprietary technology that conjugates a sugar molecule called “GalNAc” to the siRNA (small interfering RNA) (2) In January 2014, Genzyme purchased $700m of Alnylam common stock. On March 25, 2014, Genzyme exercised its right to purchase additional shares of Alnylam for $23m as a result of Alnylam’s issuance of shares to Merck in connection with the acquisition of Sirna Therapeutics. The exercise of this right to purchase the maximum number of additional shares under the terms of the investor rights agreement allows Genzyme to maintain its current ownership level of Alnylam common stock of approximately 12%. ● Alnylam’s RNAi technology to provide a platform for sustained drug development for rare genetic diseases for Genzyme ● Focus is on genetically defined diseases with a clear translational model for RNAi ● Delivery platform enabling subcutaneous administration of drug candidates targeting hepatocytes(1) ● Genzyme now one of Alnylam’s main shareholders with 12% stake(2) PC P1 P2 P3 Patisiran (TTR-FAP) in expanded territory AS1 (Hepatic Porphyria) TTRsc (FAC) Unnamed AT3 (Hemophilia) TTR-FAP: Transthyretin-Familial Amyloïd Polyneuropathy FAC: Familial Amyloïd Cardiomyopathy Program Rights* *subject to opt-in 4
  14. 14. New R&D Collaborations Signed in Q1 2014 14 ● A scientific and strategic collaboration for the discovery and development of innovative anti-inflammatory small molecules ● Focused on immune-mediated diseases currently treated by biologic agents such as rheumatoid arthritis, ulcerative colitis and Crohn’s disease, etc. ● A long-term strategic cooperation to co-develop an innovative pneumococcal conjugate vaccine (PCV) with enhanced serotype coverage ● Potential access to the large and growing global PCV market 4
  15. 15. Multiple Regulatory and Phase III Development Milestones Are Expected in 2014 15 2014 Expected Regulatory Decisions Q1 Q2 Q3 Q4 ● Shan5® 5-in-1 pediatric vaccine WHO pre-qualification  ● Cerdelga™ in Gaucher disease (U.S. & EU) ● Lemtrada™ in Multiple Sclerosis (U.S.) ● Fluzone® QIV Intradermal (U.S.)  Expected Regulatory Submissions Q1 Q2 Q3 Q4 ● Fluzone® QIV Intradermal (U.S.) ● Lemtrada™ in Multiple Sclerosis (U.S.)  ● Toujeo™ (U300) in Diabetes (U.S. & EU)  ● 6-in-1 pediatric vaccine PR5i (U.S.)  ● Alirocumab in Hypercholesterolemia (EU)  Expected Headline Phase III Data Releases Q1 Q2 Q3 Q4 ● Dengue vaccine 1st Phase III trial in Asia ● Alirocumab in Hypercholesterolemia (multiple ODYSSEY trials) ● Dengue vaccine 2nd Phase III trial in Latin America  Expected Phase III Starts Q1 Q2 Q3 Q4 ● LixiLan (lixisenatide + insulin glargine) in Diabetes ● Dupilumab in Atopic Dermatitis  ● Rotavirus vaccine  4
  16. 16. SI SBB 16 (1) Cumulated 2014 share buyback of €583m (7.8m shares) by April 25, 2014 (€355m by end of March). (2) Cumulated 2014 proceeds from share issuance of €58m (1.6m shares) by April 25, 2014 (€37m by end of March) (3) Cumulated 2014 shares acquired net of shares created of €525m (6.2m shares) by April 25, 2014 Evolution of Share Buyback (1,2,3) €583m €58m €1,641m €1,004m €823m €646m 2012 : Share issuance : Share buybackSBB SI ● Opportunistic share buyback in Q1 2014 above and beyond anti-dilution purpose ● Share buyback of €583m in YTD 2014(1) ● Proceeds from share issuance of €58m in YTD 2014(2) Sanofi Continued Share Buyback in 2014 SI SBB 2013 SI SBB 2014
  17. 17. FINANCIAL PERFORMANCE Jérôme Contamine Executive Vice President, Chief Financial Officer 17
  18. 18. Q1 2014 -€0.11 FX ImpactIncremental EPS at CER Q1 2013 +€0.07 Net Sales Business EPS Sanofi Delivered Top and Bottom Line Growth at CER, in Line with Expectations 18 (1) On a reported basis, Q1 2014 sales were down -2.7% and Business EPS was down -3.3% (2) With retroactive application of IFRIC21 +5.8% at CER(1) Incremental Sales at CER Q1 2014Q1 2013 FX Impact +€280m -€497m +3.5% at CER(1) €8,059m €7,842m €1.21 €1.17 (2)
  19. 19. Net Sales(1) Business EPS 19 Negative FX Impact given Strength of the Euro vs. Other Currencies (1) Main currency impact on sales in Q1 2014: U.S. Dollar (-€96m); Japanese Yen (-€87m); Brazilian Real (-€62m); Russian Ruble (-€39m); Argentine Peso (-€29m); Turkish Lira(-€27m) and Australian Dollar (-€26m) (2) Difference between variation on reported basis and variation at constant exchange rates Quarterly Currency Impact -2.5% -€212m -4.4% -€0.08 -3.5% -€305m 2013 -€0.08 -5.5% -7.3% -€662m -€0.17 -10.2% Q4Q3Q2Q1 -7.3% -€627m 2014 Q1 -€0.16 -13.7% -6.2% -€497m -9.1% -€0.11 2013 Q4Q3Q2Q1 2014 Q1 Assuming Q1 2014 exchange rates for 2014, negative FX impact on 2014 Business EPS would be ~6%(2)
  20. 20. Sequential Improvement in Gross Margin in Q1 2014 vs. Q4 2013 ● Cost of Sales (CoS) in Q1 2014: €2,516m, up +4.3% at CER ● CoS ratio up 0.5 ppt in Q1 2014: ● CoS ratio improvement for Pharmaceuticals (positive impact of 0.4 ppt at CER on the variation of the Group CoS ratio) ● Dilutive impact of Vaccines and Animal Health (negative impact of 0.3 ppt at CER on the Group CoS ratio for each) ● Unfavorable currency variations 20 Gross Margin (%) 2013 2014 69.0%69.6% 67.7% 67.0% 66.8%
  21. 21. Stable R&D Expenses despite Significant Investment in Phase III Trials 21 ● Q1 2014 R&D expenses of €1,139m, up +1.1% at CER ● Ongoing multiple Phase III trials ● Slight increase in R&D spend in line with guidance 21 R&D Expenses (€m) 2013 2014 €1,139m€1,157m (1) With retroactive application of IFRIC21 (1)
  22. 22. Modest Increase in SG&A Expenses in Q1 2014 Despite New Product Launch Costs 22 ● Q1 2014 SG&A expenses of €2,078m, up +2.5% at CER ● Sales & Marketing investment in product launches (Aubagio®, Lemtrada™, Nasacort® OTC, NexGard™) ● Lower increase in SG&A than Sales 22 SG&A Expenses (€m) 2013 2014 €2,078m€2,140m (1) (1) With retroactive application of IFRIC21
  23. 23. CER: Constant Exchange Rates 23 €m Q1 2014 Q1 2013 % Change (reported €) % Change (CER) Business operating income 2,145 2,321 -7.6% +0.6% Net financial expenses (76) (140) - - Income tax expense (522) (583) - - Effective tax rate -25.0% -26.5% - - Business net income 1,547 1,598 -3.2% +5.6% Net margin 19.7% 19.8% - - Business EPS(2) €1.17 €1.21 -3.3% +5.8% Average number of shares outstanding (m) 1,319.9 1,322.2 - - Business EPS Growth of +5.8% in Line with Full Year Financial Guidance 23 (1) With the retroactive application of IFRIC21 (2) Business EPS was down -7.8% at CER in Q1 2013 excluding Plavix® and Avapro® Loss of Exclusivity in the U.S. - Avapro® on March 30, 2012 and Plavix® on May 17, 2012 (1)
  24. 24. Proceeds from Issuance of Shares Share Repurchase €355m Other Net Debt Mar 31, 2014 €1,556m Acquisitions, Licensing, Net of Disposals €176m €37m CapEx €279m Net Cash from Operating Activities Net Debt Dec 31, 2013 FCF Increased by 20.6% and Sanofi Made Significant Investments in Regeneron and Alnylam in Q1 2014 24 (1) (2) €6,043m €6,697m€1,675m (1)(4) Net Debt (in €m) FCF €1,396m (1) Including derivatives related to the financial debt +€290m at December 31st 2013 and +€317m at March 31st 2014 (2) Excluding Restructuring costs (3) Including €954m in Regeneron and €530m in Alnylam (4) Other including Restructuring costs (3)
  25. 25. OWNERSHIP / INVESTOR AGREEMENT Contribution of Regeneron Reflects Growing Importance of Strategic Relationship ● Regeneron 20% ownership accounted for under the Equity method from April 4, 2014 ● Limited differences between U.S. GAAP and IFRS BNI expected to benefit by ~€45m in 2014(4) ● Sanofi funds clinical development cost(1) ● Regeneron funds 20% of Phase III costs incurred after receipt of the first positive results in a Phase III trial ● Sanofi retains 50% of profits in U.S. and 55% to 65% of profits ex-U.S.(2) ● Regeneron repays Sanofi for 50% of development costs out of profits(3) License and Collaboration Agreement (Post Opt-In) COMMERCIALIZATIONDEVELOPMENT (1) 100% development funding by Sanofi for all opted-in antibodies except 80% of an antibody’s Phase III costs incurred after receipt of the first positive results in a Phase III trial for that antibody (2) Regeneron has co-promotion rights in U.S. and other major market countries (3) Repayment is capped in any year at 10% of Regeneron share of total antibody profits (4) Based on Regeneron consensus estimates for US GAAP net income in FY2014; EUR/USD rate of $1.38 25
  26. 26. CONCLUSION 26 Christopher A. Viehbacher Chief Executive Officer
  27. 27. Good start into 2014 Q1 2014 results in line with expectations and guidance Key pipeline assets in pre-launch phase External R&D collaborations extended Continued buyback of shares in Q1 2014 27
  28. 28. APPENDICES R&D Pipeline 28
  29. 29. 29 Late Stage Pipeline – Pharma & Vaccines Toujeo™ (U300) Insulin glargine Type 1+2 diabetes alirocumab Anti-PCSK-9 mAb Hypercholesterolemia Dengue Mild-to-severe dengue fever vaccine Lemtrada™ (alemtuzumab) Anti-CD52 mAb Multiple sclerosis, U.S. Lyxumia® (lixisenatide) GLP-1 agonist Type 2 diabetes, U.S. Kynamro® (mipomersen) Apolipoprotein B-100 antisense Severe HeFH, U.S. Clostridium difficile Toxoid vaccine Cerdelga™ (eliglustat tartrate) Glucosylceramide synthetase inhibitor Gaucher disease, U.S., EU LixiLan lixisenatide + insulin glargine Fixed-Ratio / Type 2 diabetes sarilumab Anti-IL-6R mAb Rheumatoid arthritis DTP-HepB-Polio-Hib (PR5I) Pediatric hexavalent vaccine Quadracel® Diphtheria, tetanus, pertussis & polio vaccine; 4-6 y of age patisiran SAR438037 mRNA inhibitor Familial amyloid polyneuropathy Jevtana® (cabazitaxel) Metastatic prostate cancer (1L) VaxiGrip® QIV IM Quadrivalent inactivated influenza vaccine Fluzone® QIV ID Quadrivalent inactivated influenza vaccine intradermal SYNVISC-ONE® Medical device Pain in hip OA N 29 N N N N New Molecular Entity Immune Mediated Diseases Rare Diseases Oncology Diabetes Solutions Vaccines Infectious Diseases Cardiovascular / Renal Diseases Age Related Degenerative Diseases Ophthalmology Biosurgery N Phase III Registration N
  30. 30. Early Stage Pipeline – Pharma & Vaccines dupilumab Anti-IL4Rα mAb Atopic dermatitis; Asthma; Nasal polyposis SAR391786 GDF8 mAb Sarcopenia SAR438714 (ALN-TTRsc) RNAi Familial amyloid cardiomyopathy SAR339658 Anti-VLA 2 mAb Multiple sclerosis SAR3419 Maytansin-loaded anti-CD19 mAb B-cell refractory/relapsed malignancies (NHL) Rotavirus Live attenuated tetravalent Rotavirus oral vaccine SAR156597 IL4/IL13 Bi-specific mAb Idiopathic pulmonary fibrosis SAR256212 (MM121) anti-ErbB3 mAb Breast cancer (2L, 3L) Rabies VRVg Purified vero rabies vaccine SAR100842 LPA-1 receptor antagonist Systemic sclerosis Combination SAR245409 (XL765) / MSC1936369B Oral dual inhibitor of PI3K & mTOR / pimasertib Ovarian cancer Meningitis ACYW conj. 2nd generation meningococcal conjugate infant vaccine sarilumab Anti-IL-6R mAb Uveitis SAR279356 (F598) Anti-PNAG mAb Serious infections Tuberculosis Recombinant subunit vaccine fresolimumab TGFβ antagonist Focal segmental glomerulosclerosis Combination ferroquine / OZ439 Antimalarial Malaria Phase II N N N N NN 30 N 30 N N New Molecular Entity Immune Mediated Diseases Rare Diseases Oncology Diabetes Solutions Vaccines Infectious Diseases Cardiovascular / Renal Diseases Age Related Degenerative Diseases Ophthalmology Biosurgery N N N N
  31. 31. Early Stage Pipeline – Pharma & Vaccines SAR650984 Anti-CD38 naked mAb Hematological malignancies SAR245408 (XL147) Oral PI3K inhibitor Solid tumors GZ402663 (sFLT-01) Gene therapy Age-related macular degeneration (AMD) Streptococcus pneumonia Meningitis & pneumonia vaccine SAR405838 (MI-773) HDM2 / p53 antagonist Solid tumors Combination SAR405838 / MSC1936369B Solid tumors StarGen® Gene therapy Stargardt disease Pseudomonas aeruginosa Antibody fragment product Prevention of ventilator-associated pneumonia SAR153192 Anti-DLL4 mAb Solid tumors SAR228810 Anti-protofibrillar AB mAb Alzheimer’s disease UshStat® Gene therapy Usher syndrome 1B Herpes Simplex Virus Type 2 HSV-2 vaccine SAR566658 Maytansin-loaded anti-CA6 mAb Solid tumors SAR252067 Anti-LIGHT mAb Crohn’s disease GZ402665 (rhASM) Niemann-Pick type B SAR125844 C-MET kinase inhibitor Solid tumors SAR113244 Anti-CXCR5 mAb Systemic lupus erythematosus GZ402671 Oral GCS Inhibitor Fabry Disease SAR307746 Anti-ANG2 mAb Solid tumors Insulin Biosimilar Program Diabetes GZ402666 neo GAA Pompe Disease SAR260301 PI3K β selective inhibitor PTEN – Deficient tumors SAR438151 Undisclosed target SAR438584 Undisclosed target Phase I N N N N N N N N N N N N 3131 N N N N N New Molecular Entity Immune Mediated Diseases Rare Diseases Oncology Diabetes Solutions Vaccines Infectious Diseases Cardiovascular / Renal Diseases Age Related Degenerative Diseases Ophthalmology Biosurgery N NN
  32. 32. 32 Phase I Phase II Phase III Registration TOTAL Oncology 8 3 0 0 11 Diabetes Solutions 0 0 2 0 2 Cardiovascular / Renal Diseases 0 1 1 0 2 Immune Mediated Diseases 2 4 1 0 7 Infectious Diseases 0 2 0 0 2 Ophthalmology 3 0 0 0 3 Rare Diseases 3 1 1 1 6 Age Related Degenerative Diseases 1 1 0 0 2 Vaccines 3 4 4 2 13 TOTAL 22(2) 16 9 3 R&D Pipeline Summary Table(1) 38 12 NMEs & Vaccines 50 32 37(2) (1) Excluding life cycle management programs (2) Includes 2 Phase I projects addressing an undisclosed target
  33. 33. 33 Expected R&D Milestones in 2014 33 Product Event Timing Dengue vaccine Expected 1st Phase III results (Asia) Q2 2014 Shan5® 5-in-1 pediatric vaccine Expected WHO pre-qualification Q2 2014 Lemtrada™ (alemtuzumab) Expected U.S. regulatory submissions in Multiple Sclerosis Q2 2014 Toujeo™ (U300) Expected U.S. and EU regulatory submissions in Diabetes Q2 2014 Alirocumab (anti-PCSK9 mAb) Expected multiple Phase III readouts in Hypercholesterolemia Jun to Q3 2014 DTP-HepB-Polio-Hib (PR5i) Expected U.S. regulatory submission Q3 2014 Dengue vaccine Expected 2nd Phase III results (Latin America) Q3 2014 Dupilumab (anti-IL4Rα mAb) Expected start of Phase III trial in Atopic Dermatitis Q3 2014 Cerdelga™ (eliglustat tartrate) Expected U.S. and EU regulatory decisions in Gaucher disease H2 2014 Lemtrada™ (alemtuzumab) Expected U.S. regulatory decision in Multiple Sclerosis H2 2014 Rotavirus vaccine Expected start of Phase III trial Q4 2014 Fluzone® QIV ID Expected U.S. regulatory decision Q4 2014 Alirocumab (anti-PCSK9 mAb) Expected EU regulatory submission in Hypercholesterolemia Q4 2014
  34. 34. APPENDICES FINANCE 34
  35. 35. 35 Business Net Income Statement * 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 1,319.9 million in the first quarter of 2014 and 1,322.2 million in the first quarter of 2013. (1) Including impact of transition to IFRIC 21. First quarter Group Total Pharmaceuticals Vaccines Animal Health Others € million Q1 2014 Q1 2013(1) Change Q1 2014 Q1 2013(1) Change Q1 2014 Q1 2013(1) Change Q1 2014 Q1 2013(1) Change Q1 2014 Q1 2013(1) Net sales 7,842 8,059 (2.7%) 6,697 6,808 (1.6%) 628 697 (9.9%) 517 554 (6.7%) Other revenues 83 98 (15.3%) 68 83 (18.1%) 7 7 - 8 8 - Cost of sales (2,516) (2,545) (1.1%) (1,988) (2,034) (2.3%) (350) (345) 1.4% (178) (166) 7.2% As % of net sales (32.1%) (31.6%) (29.7%) (29.9%) (55.7%) (49.5%) (34.4%) (29.9%) Gross profit 5,409 5,612 (3.6%) 4,777 4,857 (1.6%) 285 359 (20.6%) 347 396 (12.4%) As % of net sales 69.0% 69.6% 71.3% 71.3% 45.4% 51.5% 67.1% 71.5% Research and development expenses (1,139) (1,157) (1.6%) (995) (990) 0.5% (107) (128) (16.4%) (37) (39) (5.1%) As % of net sales (14.5%) (14.4%) (14.9%) (14.5%) (17.0%) (18.4%) (7.2%) (7.0%) Selling and general expenses (2,078) (2,140) (2.9%) (1,791) (1,836) (2.5%) (129) (141) (8.5%) (158) (163) (3.1%) As % of net sales (26.5%) (26.6%) (26.7%) (27.0%) (20.6%) (20.2%) (30.5%) (29.5%) Other current operating income/expenses (25) 29 (23) 30 (2) 2 6 (1) (6) (2) Share of profit/loss of associates* and joint ventures 13 18 8 19 5 (1) Net income attributable to non-controlling interests (35) (41) (35) (41) Business operating income 2,145 2,321 (7.6%) 1,941 2,039 (4.8%) 52 91 (42.9%) 158 193 (18.1%) (6) (2) As % of net sales 27.4% 28.8% 29.0% 30.0% 8.3% 13.1% 30.6% 34.8% Financial income and expenses (76) (140) Income tax expense (522) (583) Tax rate** 25.0% 26.5% Business net income 1,547 1,598 (3.2%) As % of net sales 19.7% 19.8% Business earnings per share*** (in euros) 1.17 1.21 (3.3%)
  36. 36. Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi € million Q1 2014 Q1 2013 (1) Change Business net income 1,547 1,598 (3.2%) Amortization of intangible assets (2) (677) (775) Impairment of intangible assets (3) (10) Fair value remeasurement of contingent consideration liabilities (8) (41) Expenses arising from the impact of acquisitions on inventories - (3) Restructuring costs (51) (54) Other gains and losses, litigation 35 (3) - Tax effect of items listed above: 248 280 Amortization of intangible assets 244 259 Impairment of intangible assets 1 - Fair value remeasurement of contingent consideration liabilities 1 4 Expenses arising from the impact of acquisitions on inventories - 1 Restructuring costs 15 16 Other gains and losses, and litigations (13) - 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 (8) (7) Net income attributable to equity holders of Sanofi 1,084 989 Consolidated earnings per share (4) (in euros) 0.82 0.75 9.3% (1) Including impact of transition to IFRIC 21. (2) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €657 million in the first quarter of 2014 and €749 million in the first quarter of 2013. (3) Day one profit on Alnylam shares in Financial result. (4) Based on an average number of shares outstanding of 1,319.9 million in the first quarter of 2014 and 1,322.2 million in the first quarter of 2013. 36
  37. 37. Consolidated Income Statement 37 37 (1) Including impact of transition to IFRIC 21. € million Q1 2014 Q1 2013(1) Net sales 7,842 8,059 Other revenues 83 98 Cost of sales (2,516) (2,548) Gross profit 5,409 5,609 Research and development expenses (1,139) (1,157) Selling and general expenses (2,078) (2,140) Other operating income 10 71 Other operating expenses (35) (42) Amortization of intangible assets (677) (775) Impairment of intangible assets (3) (10) Fair value remeasurement of contingent consideration liabilities (8) (41) Restructuring costs (51) (54) Other gains and losses, and litigation - - Operating income 1,428 1,461 Financial expense (147) (157) Financial income 106 17 Income before tax and associates and joint ventures 1,387 1,321 Income tax expense (274) (303) Share of profit/loss of associates and joint ventures 5 11 Net income 1,118 1,029 Net income attributable to non-controlling interests 34 40 Net income attributable to equity holders of Sanofi 1,084 989 Average number of shares outstanding (million) 1,319.9 1,322.2 Earnings per share (in euros) 0.82 0.75
  38. 38. Business EPS Currency Sensitivity Currency Exposure on Q1 2014 Sales Currency Average Rates 2014 Currency Sensitivity 38 ● 1% variation in €/$ corresponds to an impact of 0.5% on 2014 Business EPS ● 1% variation in €/Yen corresponds to an impact of 0.1% on 2014 Business EPS Q1’13 Q1’14 % change €/$ 1.32 1.37 3.7% €/Yen 121.91 140.76 15.5% €/Real 2.63 3.24 23.0% €/Ruble 40.15 48.08 19.7%

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