Q1 2014 Results par Sanofi

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Q1 2014 Results par Sanofi

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<ul><li> 1. Q1 2014 RESULTS April 29, 2014 </li> <li> 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. </li> <li> 3. 33 Agenda Key Highlights Christopher A. Viehbacher, Chief Executive Officer Financial Performance Jrme Contamine, Executive Vice President, Chief Financial Officer Conclusion Christopher A. Viehbacher, Chief Executive Officer Q&amp;A </li> <li> 4. KEY HIGHLIGHTS 4 Christopher A. Viehbacher Chief Executive Officer </li> <li> 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&amp;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 </li> <li> 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) </li> <li> 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 &amp; Turkey: +4.0% at CER Middle East &amp; 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 </li> <li> 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 </li> <li> 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 </li> <li> 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 &gt;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 </li> <li> 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 &amp; Immunology) - Annual Meeting, March 4 2014 - Atopic Dermatitis / Asthma Alirocumab and dupilumab are developed in collaboration with Regeneron - Hypercholesterolemia - Diabetes - Multiple Sclerosis 3 R&amp;D </li> <li> 12. Strengthened Relationship with Regeneron 12 A model of global strategic R&amp;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 </li> <li> 13. 13 Genzymes 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 Alnylams 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%. Alnylams 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 Alnylams 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 Amylod Polyneuropathy FAC: Familial Amylod Cardiomyopathy Program Rights* *subject to opt-in 4 </li> <li> 14. New R&amp;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 Crohns 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 </li> <li> 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. &amp; 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. &amp; 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 </li> <li> 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 </li> <li> 17. FINANCIAL PERFORMANCE Jrme Contamine Executive Vice President, Chief Financial Officer 17 </li> <li> 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) </li> <li> 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 (-29...</li></ul>