Last updated on April 18, 2014 at 5:30 EDT

Sanofi Q3 2013 Marks the End of the Patent Cliff Period

October 30, 2013

PARIS, Oct. 30, 2013 /PRNewswire/ — Sanofi (NYSE: SNY; EURONEXT: SAN)

                                                        Q3 2013               Change               Change              9-month 2013                  Change          Change
                                                                              (reported)             (CER)                                           (reported)         (CER)

    Net sales                                          EUR8,432m                        -6.7%            +0.6%          EUR24,494m                             -7.3%        -2.8%

    Business net income(1)                             EUR1,789m                       -18.7%            -8.9%           EUR4,877m                            -25.6%       -19.1%

    Business EPS(1)                                     EUR1.35                        -19.2%            -9.0%            EUR3.68                             -26.0%       -19.3%

    In order to facilitate an understanding of our operational performance, we comment on our business net income statement. Business net income(1) is a non-
     GAAP financial measure. The consolidated income statement for the first 9 months of 2013 is provided in Appendix 4 and a reconciliation of business net
     income to consolidated net income in Appendix 3. Consolidated net income for the first 9 months of 2013 was EUR2,661 million, compared to EUR4,501
     million(2) for the first 9 months of 2012. Consolidated EPS for the first 9 months of 2013 was EUR2.01 versus EUR3.41(2) for the first 9 months of 2012.

Commenting on the Group’s performance in Q3 2013, Sanofi Chief Executive Officer, Christopher A. Viehbacher said,

“The third quarter marks an inflection point for Sanofi as the impact of the patent cliff ended in August. As a result, we returned to sales growth((3) )in September. Our growth platforms((4)) grew 5.5% in the third quarter despite the shortage of pertussis-containing vaccines in the U.S. until mid-October, the impact of the market slowdown in China and our recovering generics business in Brazil. Growth platforms now represent 75% of our sales. We continue to make strong progress in R&D with recent approvals for Aubagio(®) and Lemtrada(TM) in EU, Nasacort(®) Allergy 24HR for OTC use and NexGard(TM) in the U.S. We also released positive results for the first Phase III with alirocumab and for a large study with Fluzone(®) High-Dose.”

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Q3 2013 Performance

    --  Total sales((3) )increased for the first time in five quarters by 0.6%
        to EUR8,432 million.
    --  Emerging Markets((5)) sales were EUR2,652 million, an increase of 2.8%
        and were impacted by lower growth in the Chinese pharmaceutical market
        and lower sales of Brazil generics.
    --  Diabetes sales grew 20.1% to EUR1,670 million and Lantus(®) sales
        reached EUR1,456 million (+21.2%).
    --  Vaccines sales were EUR1,300 million (-7.2%) affected by supply
        limitations of Pentacel(®) and Adacel(®) in the U.S. and the quarterly
        phasing of U.S. flu vaccines sales. Sanofi expects record flu sales in
        the Northern Hemisphere in H2 2013 resulting from its differentiated
        vaccines offerings.
    --  Consumer Healthcare achieved strong sales growth (+9.8%) reflecting
        notably the launch of Rolaids(®) in the U.S. and the improvement of our
        CHC business in China.
    --  Genzyme grew +21.1% to EUR529 million driven by the 11.1% growth of the
        rare disease franchise and the launch of Aubagio(®).
    --  Animal Health sales were EUR458 million, down 6.4% due to increased
        competition to Frontline(®). In September, the FDA approved
        NexGard(TM), a new chewable anti-parasiticide for the treatment and
        prevention of fleas and ticks in dogs.
    --  Growth platforms((4)) sales reached EUR6,298 million, an increase of
        5.5% and accounted for 74.7% of total sales.
    --  Q3 2013 business EPS((1)) was EUR1.35, down 9.0%

R&D Update

    --  Positive results for the first Phase III trial with alirocumab and for a
        large study with Fluzone(®) High-Dose were recently announced. We
        anticipate the release of the EDITION III and IV studies for U300 in the
        fourth quarter.
    --  Multiple approvals were also granted including: Lemtrada(TM) and
        Aubagio(®) in the EU for multiple sclerosis; NexGard(TM), a new
        anti-parasiticide for dogs in the U.S., and Nasacort(®) Allergy 24HR
        for Over-the-Counter use in the U.S. The EU filing for Cerdelga(TM)
        (eliglustat) has also been accepted for review.

2013 Guidance

    --  Taking into account the expected return to growth in the fourth quarter
        and including the impact of extended vaccines shortage in the third
        quarter, the outlook for 2013 is now expected to be at the lower end of
        previous guidance range. 2013 business EPS is therefore expected to be
        around 10% lower than 2012 at CER((6)), barring major unforeseen adverse

(1) See Appendix 6 for definitions of financial indicators (page 22 at http://bit.ly/1cq7R2O); (2) Including impact of transition to IAS 19R; (3) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 6 on page 22 at http://bit.ly/1cq7R2O for a definition); (4) See page 2 at http://bit.ly/1cq7R2O; (5) See definition on page 7 at http://bit.ly/1cq7R2O; (6) 2012 business EPS with the retroactive application of IAS19R was EUR6.14

To access the full press release of the Q3 2013 results, please click here: http://en.sanofi.com/Images/34723_20131030_Q32013_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 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, 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.

Sanofi US is also on Twitter and Facebook. Visit us at https://twitter.com/SanofiUS and http://www.facebook.com/sanofiUS.


Source: PR Newswire