Sanofi: Sanofi Delivers Business EPS Growth of 10.3% at CER

PARIS, Oct. 28, 2014 /PRNewswire/ -- Sanofi (NYSE: SNY; EURONEXT: SAN)

In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income⁽¹⁾ is a non-GAAP financial measure. ⁽²⁾(EPS) Earnings Per Share

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Commenting on the Group's performance in Q3 2014, Sanofi Chief Executive Officer, Christopher A. Viehbacher said, "We are pleased with our performance in the third quarter. We achieved solid Business EPS growth driven by continued strong contribution from our growth platforms, allowing us to confirm 2014 outlook. Growth platforms reached over 78% of sales and grew 10%. We have recently seen a more challenging U.S. diabetes price environment which will impact our diabetes sales throughout 2015, while growth platforms globally are expected to continue to show solid growth. At the same time, our pipeline delivered strong results, with the release of exciting Phase III data for alirocumab and our Dengue vaccine, the entry of dupilumab in Phase III as well as the FDA approval of Cerdelga™ and the licensing of Afrezza^®."

Q3 2014 Performance

• In the third quarter of 2014, Sanofi generated sales of €8,781 million, an increase of 4.1% on a reported basis. Exchange rate movements had a negative effect of 1.0 percentage point primarily reflecting the strength of the euro versus other currencies, in particular the Argentine Peso, Japanese Yen and Russian Ruble.
• Third-quarter sales of the Diabetes division reached €1,799 million, an increase of 8.3%. Year-to-date sales of the Diabetes division increased 12.5% to €5,249 million. Lantus^® sales increased 8.1% to €1,567 million in the third quarter.
• Sales of Consumer Healthcare products (CHC) were €819 million in the third quarter, an increase of 12.9%. Several products (amounting to €64 million in sales) previously recorded in prescription pharmaceuticals in the third quarter of 2013 were transferred to Consumer Healthcare products.
• Sales of Genzyme increased 24.6% to €649 million in the third quarter driven by the growth of Aubagio^® and Fabrazyme^®. Sales grew 28.2% to €259 million in the U.S., 25.0% to €207 million in Western Europe and 19.8% to €124 million in Emerging Markets. Year-to-date sales of Genzyme reached €1,858 million, an increase of 25.1%.
• Other Innovative Products increased 18.0% to €227 million in the third quarter and 17.9% to €606 million in the first nine months.
• Sales of Plavix^® grew 9.0% to €450 million in the third quarter, driven by strong performance in Emerging Markets (up 21.3% to €203 million) and Japan (up 8.7% to €190 million). The performance of the product in Emerging Markets was driven by China where sales grew 47.1% to €125 million. Year-to-date sales of Plavix^® increased 5.8% to €1,362 million.
• Third-quarter sales of Generics increased 8.3% to €451 million reflecting the recovery in Brazil where sales were €76 million. Third-quarter sales of Generics decreased 3.9% in Western Europe (to €125 million) and 24.3% in the U.S. (to €28 million). In Emerging Markets, sales of Generics grew 19.8% to €287 million driven by the recovery in Brazil. Year-to-date sales of Generics increased 23.2% to €1,338 million.
• Third-quarter consolidated sales of Sanofi Pasteur increased 11.2% to €1,451 million driven by strong performance of influenza vaccines in the U.S. and in Emerging Markets as well as continued gradual recovery of Pentacel^® and Adacel^® in the U.S. Year-to-date consolidated sales of Sanofi Pasteur increased 4.1% to €2,797 million.
• Third-quarter sales of Animal Health increased 12.7% to €515 million driven by the launch of NexGard™ and the strong performance of the production animal segment. In the U.S., Animal Health sales grew 23.2% to €220 million. Year-to-date sales of Animal Health increased 5.3% to €1,569 million.

R&D Update

Regulatory updates since the publication of the second-quarter 2014 results on July 31, 2014 include the following:

• In August, the U.S. Food and Drug Administration (FDA) approved Cerdelga™ (eliglustat) capsules, the only first-line oral therapy for certain adult Gaucher disease type 1 patients.
• The sBLA for Lumizyme^® label expansion and 4,000L manufacturing process was also approved in August by the FDA. Lumizyme^® is now indicated for all patients with Pompe disease regardless of age or phenotype.
• In September, the BLA for a pediatric hexavalent vaccine PR5i (DTP-Hep B-Polio-Hib) was submitted in the U.S.
• At the end of July, Sanofi and Regeneron announced that the companies intend to use a U.S. Food and Drug Administration rare pediatric disease priority review voucher in connection with the Biologics License Application (BLA) submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited 6-month review from the filing date instead of the standard 10-month review. Sanofi and Regeneron expect to submit U.S. and EU regulatory submissions for alirocumab before year end.
• At the end of October 2014, the R&D pipeline contained 46 projects (excluding Life Cycle Management) and vaccine candidates in clinical development of which 14 are in Phase III or have been submitted to the regulatory authorities for approval.

To access the full press release of the Q3 2014 results, please click here.

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 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 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.

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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