Sanofi Returns to Growth in Q4 2013

PARIS, Feb. 6, 2014 /PRNewswire/ -- Sanofi (NYSE: SNY; EURONEXT: SAN)

Commenting on the Group's performance in Q4 2013, Sanofi Chief Executive Officer, Christopher A. Viehbacher said,
"Sanofi's growth profile emerged in Q4 2013 with total sales growing 6.5% at CER and growth platforms⁽³⁾, which represented 72.9% of sales, increasing 10.0% at CER.  Furthermore, new product launches are underway or imminent in most of Sanofi's core businesses and several high potential R&D projects progressed in 2013, including alirocumab, sarilumab and U300."

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Q4 2013 and 2013 Performance

• Sales increased 6.5%⁽⁴⁾ in Q4 2013. In 2013, total sales were stable (-0.5%) at €32,951 million.
• Growth platforms⁽³⁾ increased 10.0% in Q4 2013. In 2013, sales from growth platforms reached €23,905 million (+6.6%) and accounted for 72.5% of total sales.
• In Q4 2013, Emerging Markets⁽⁵⁾ sales recorded double digit growth (+10.4%). In 2013, Emerging Markets sales were €10,957 million, an increase of 4.4% (+7.1% excluding Brazil generics).
• Diabetes sales were up 19.0% in Q4 2013. Diabetes recorded strong double digit growth (+18.7%) to €6,568 million in 2013 driven by the performance of Lantus^® (+20.0% to €5,715 million).
• Vaccines sales were stable in Q4 2013 as supply improved for Pentacel^® and Adacel^® in the U.S. from mid-October. In 2013, Vaccines sales were stable at €3,716 million as record flu vaccines sales offset U.S. supply constraints on Pentacel^® and Adacel^®.
• CHC sales were up 6.1% in Q4 2013. Sales of Consumer Healthcare exceeded €3 billion in 2013, an increase of +5.2%.
• Genzyme recorded a robust performance in Q4 2013 with sales up 31.4%. In 2013, Genzyme recorded sales of
  €2,142 million, up 25.9% driven by 16.6% growth of the rare disease franchise and by Aubagio^® (€166 million).
• Animal Health sales were down 6.3% in Q4 2013. Sales of Animal Health decreased 5.3% to €1,985 million in 2013 reflecting increased competition to Frontline^®. Broadline™, a unique product in the fight against internal and external parasites for cats, was approved in the EU in December.
• In Q4 2013, business EPS⁽¹⁾ was €1.37 (+ 30.8% at CER). 2013 business EPS was €5.05 (-9.8% at CER).
• Board proposes dividend of €2.80.

R&D Update

• In Q4 2013, positive top line results in Phase III trials for U300 (EDITION III, IV and EDITION JP I) and for sarilumab (SARIL-RA-MOBILITY) were announced. The Phase III program for the Fixed-Ratio combination of Lantus^®/Lyxumia^® was recently initiated.
• The FDA accepted the New Drug Application of Cerdelga™ (eliglustat) for review and granted it a Priority Review designation.

2014 Guidance

(1) See Appendix 8 for definitions of financial indicators at http://bit.ly/N6tJ8M; (2) Including impact of transition to IAS 19R; (3) See page 2 at http://bit.ly/N6tJ8M; (4) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 8 for a definition
at http://bit.ly/N6tJ8M); (5) See definition on page 7 at http://bit.ly/N6tJ8M

• The continued performance of growth platforms, investments in new product launches and in late-stage pipeline should lead to a 2014 business EPS⁽¹⁾ growth between 4% and 7% at CER, barring major unforeseen adverse events.

To access the full press release of the Annual 2013 results, please click here: http://en.sanofi.com/events/2013_Results/docs/2014-02-06_Results-2013_PR_EN.pdf

Forward-Looking Statements
This press release 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, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.

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SOURCE Sanofi