Sanofi delivers solid 2012 results despite patent expirations

        Sanofi delivers solid 2012 results despite patent expirations

PR Newswire

PARIS, Feb. 7, 2013

PARIS, Feb. 7, 2013 /PRNewswire/ -- Sanofi (NYSE: SNY; EURONEXT: SAN)

                  Change on a Change at                  Change on a Change at
          Q4 2012 reported    constant exchange FY 2012  reported    constant
                  basis       rates^1                    basis       exchange
                                                                     rates
Net sales €8,526m +0.2%       -1.7%             €34,947m +4.7%       +0.5%
Business
net       €1,572m -24.3%      -27.1%            €8,179m  -7.0%       -12.9%
income^1
Business  €1.19   -23.7%      -26.3%            €6.20    -6.8%       -12.8%
EPS^1

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 2012 is
provided in Appendix 6 and a reconciliation of business net income to
consolidated net income in Appendix 5. Consolidated net income for 2012 was
€4,967 million, compared to €5,693 million for 2011. Consolidated EPS for 2012
was €3.76 versus €4.31 for 2011.

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Commenting on the Group's performance in 2012, Sanofi Chief Executive Officer,
Christopher A. Viehbacher said, "2012 was a turning point for Sanofi with the
loss of exclusivity in the U.S. for several significant legacy drugs. Despite
the effect of the patent cliff, Sanofi was able to grow sales and mitigate the
impact on Business EPS^1. At the same time, Sanofi was able to obtain nine
significant regulatory approvals and submit six new files with regulatory
agencies. Although the financial results in the first half will experience a
residual effect from patent expirations, we expect to resume growth in the
second half of 2013. This will be driven primarily by continued strong
performance from our growth platforms^2 which now represent more than 70% of
our sales and rose nearly 10%^3 in 2012. We are on track to meet our 2012-2015
objectives for sustainable growth."

2012 Performance

  oTotal sales^4 grew 0.5% to €34,947 million. Net sales lost due to generic
    competition were €1,345 million.
  oGrowth platforms^2 recorded sales of €23,548 million, an increase of
    9.9%^3 and accounted for 70.4% of total sales in Q4 2012.
  oDiabetes recorded very strong sales growth of 16.7% to €5,782 million
    driven by Lantus^®. In Q4 2012, Diabetes grew +20.9%, representing the
    eighth consecutive quarter of double-digit sales growth.
  o"New Genzyme"^5 delivered pro forma sales growth of 16.9% with Fabrazyme^®
    sales almost doubling.
  oEmerging Markets^6 sales were €11,145 million, an increase of 8.3% with
    double-digit growth recorded in Latin America, Asia and Africa/Middle
    East.
  oConsumer Health Care sales reached €3,008 million, an increase of 9.9%,
    giving Sanofi the # 3 global rank in CHC.
  oVaccines delivered 5.7% sales growth to €3,897 million, ending 2012 on a
    high note with 20.5% growth in Q4.
  oMerial grew 3.1% with Frontline showing continued resilience.
  o2012 business EPS^1 was €6.20 versus €6.65 in 2011 reflecting the negative
    impact of €1.3 billion at CER on the business net income related to the
    Plavix^® and Avapro^® losses of exclusivity in the U.S.
  oThe proposed dividend of €2.77 per share corresponds to a payout ratio of
    45% of business EPS^1.

R&D Update

  oSince the beginning of the year, Lyxumia^® (lixisenatide) and Zaltrap^®
    (aflibercept) were approved in Europe and Kynamro™ (mipomersen) in the
    U.S. In addition, the Lemtrada™ (alemtuzumab) application for multiple
    sclerosis was accepted for review by the FDA, and the ENCORE Phase III
    study with eliglustat met its primary efficacy endpoint.
  oPhase III data is expected in 2013 for otamixaban for ACS patients with
    planned early invasive strategy, our JAK2 inhibitor in myelofibrosis, the
    new glargine formulation in diabetes and anti-PCSK9 mAb in monotherapy for
    hypercholesterolemia.

2013 Guidance

  oThe residual impact from the loss of Plavix^® and Avapro^® exclusivity in
    the U.S. is anticipated to impact business net income in H1 2013 by
    approximately €800m at CER^1. Including this impact, the continued strong
    performance of growth platforms, investments in late-stage pipeline,
    launch expenses for new products and ongoing cost savings should lead to a
    2013 business EPS flat to 5% lower than 2012^7 at CER, barring major
    unforeseen adverse events.

(1) See Appendix 9 (on page 26 at http://bit.ly/XQOjJ4) for definitions of
financial indicators; (2) See page 2 at  http://bit.ly/XQOjJ4; (3) 7.8% with
Genzyme pro forma; (4) Growth in net sales is expressed at constant exchange
rates (CER) unless otherwise indicated (see Appendix 9 on page 26, at
http://bit.ly/XQOjJ4, for a definition); (5) "New Genzyme" consists of rare
diseases products and Multiple Sclerosis products; (6) See definition on page
8 at http://bit.ly/XQOjJ4; (7) 2012 business EPS with the retroactive
application of IAS19R: €6.14.

To access the full press release of the 2012 annual results, please click
here:

http://en.sanofi.com/events/2012_Results/docs/2013-02-07_Results-2012_PR_EN.pdf.

Sanofi: www.sanofi.com
Media Relations: (+) 33 1 53 77 46 46 - E-mail : MR@sanofi.com
Investor Relations: (+) 33 1 53 77 45 45 - E-mail : IR@sanofi.com

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, 2011. Other than as
required by applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.

SOURCE Sanofi

Website: http://www.sanofi.us
 
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