Press Releases

PARIS, April 29, 2014 /PRNewswire/ -- Sanofi (NYSE: SNY; EURONEXT: SAN)

In order to facilitate an understanding of our operational performance, we comment on our business net income statement. Business net income⁽²⁾ is a non-GAAP financial measure. The consolidated income statement for Q1 2014 is provided in Appendix 4 and a reconciliation of business net income to consolidated net income in Appendix 3. Consolidated net income for Q1 2014 was €1,084 million, compared to €989 million for Q1 2013. Consolidated EPS for Q1 2014 was €0.82 versus €0.75 for Q1 2013.

Commenting on the Group's performance in Q1 2014, Sanofi Chief Executive Officer, Christopher A. Viehbacher said, "The Group's financial performance in the first-quarter continued the growth trajectory that emerged at the end of 2013.  Our Business EPS(1) grew 5.8% at CER which is in line with our full-year financial guidance.  Importantly, our pipeline showed steady progress.  We presented study results for alirocumab, dupilumab, initiated the LixiLan Phase III program and announced plans to resubmit the sBLA for Lemtrada™. In addition, the first dengue vaccine Phase III study met its primary endpoint. During the next three quarters of 2014, we expect important development milestones for multiple high potential pipeline projects including Toujeo™ (U300), the Dengue vaccine, alirocumab, Cerdelga® and dupilumab."

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Q1 2014 Performance

• In the first quarter of 2014, Sanofi generated sales of €7,842 million, a decrease of 2.7% on a reported basis. Exchange rate movements had a negative effect of 6.2 percentage points primarily reflecting the depreciation of the U.S. Dollar, Japanese Yen, Brazilian Real, Russian Ruble, Argentine Peso, Turkish Lira and the Australian Dollar against the Euro.
• Sales of the Group's growth platforms totaled €5,776 million, an increase of 7.9%, driven by the performance of Diabetes (up 13.2%), CHC (up 18.6%), Genzyme (up 21.5%) and "Other Innovative Products" (up 22.6%). The Group's growth platforms accounted for 73.7% of total consolidated sales in the first quarter, up from 71.0% in the first quarter of 2013.
• The Diabetes division generated sales of €1,662 million in the first quarter, an increase of 13.2%.
• First-quarter sales of Consumer Healthcare products (CHC) grew 18.6% to €885 million.
• Genzyme first-quarter sales increased 21.5% to €566 million, driven by Aubagio^® with sales of €78 million versus €20 million in the first quarter of 2013.
• First-quarter consolidated sales of Sanofi Pasteur were €628 million, a decrease of 4.2%, reflecting a phasing effect in Pentaxim^® deliveries in Emerging Markets and strong sales for Imovax^® in Japan and Menactra^® in the previous year period.
• First-quarter sales of Animal Health were €517 million, down 1.6%. In Emerging Markets, sales grew 3.9% to €121 million.
• First-quarter sales in Emerging Markets were €2,590 million, an increase of 5.5%. Double-digit growth was recorded for Diabetes (+16.1%), CHC and Genzyme (+18.2%).

R&D Update                  

• In April, Sanofi and its subsidiary Genzyme announced that following constructive discussions with the U.S. Food and Drug Administration (FDA) the company plans to resubmit in the second quarter its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada^™ (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. The resubmission will provide information to specifically address issues noted by the FDA in its December 2013 Complete Response Letter. Once the filing is accepted, the FDA will assign either a two month or six month review timeframe. Genzyme had previously announced its intention to appeal the FDA's Complete Response Letter. In light of the planned resubmission, the company does not expect to pursue an appeal at this time.
• In March, SAR650984, a monoclonal antibody anti-CD38, obtained a designation as an orphan medicinal product from the European Medicines Agency for the treatment of myeloma.
• In February, the European Commission approved NexGard^™ (afoxolaner) for the treatment of flea and tick infestations in dogs. NexGard^™ can also be used as part of a treatment strategy for the control of Flea Allergy Dermatitis.
• At the end of April 2014, the R&D pipeline contained 50 projects (excluding Life Cycle Management) and vaccine candidates in clinical development of which 12 are in Phase III or have been submitted to the health authorities for approval.

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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(1)  (EPS) Earnings Per Share
(2) Business net income is a non-GAAP financial measure

SOURCE Sanofi