Sanofi: Q1 2013 business EPS(1) impacted by exclusivity losses in prior year

 Sanofi: Q1 2013 business EPS(1) impacted by exclusivity losses in prior year

Growth platforms(2) sales increased 8.6%(3)

PR Newswire

PARIS, May 2, 2013

PARIS, May 2, 2013 /PRNewswire/ -- Sanofi (NYSE: SNY; EURONEXT: SAN)

                        Q1 2013 Change (reported) Change (CER)
Net sales               €8,059m -5.3%             -2.8%
Business net income^(1) €1,613m -33.5%            -28.8%
Business EPS^(1)        €1.22   -33.3%            -29.0%

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 Q1 2013 is
provided in Appendix 4 and a reconciliation of business net income to
consolidated net income in Appendix 3. Consolidated net income for Q1 2013 was
€1,004 million, compared to €1,809 million for Q1 2012. Consolidated EPS for
Q1 2013 was €0.76 versus €1.37 for Q1 2012.

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Commenting on the Group's performance in Q1 2013, Sanofi Chief Executive
Officer, Christopher A. Viehbacher said, "As expected, the loss of exclusivity
of Plavix^®, Avapro^® and Eloxatin^® in the course of 2012 in the U.S. had a
negative impact on Q1 results. However, our growth platforms^(2) continue to
deliver strong results with diabetes, vaccines, and Genzyme all achieving
double-digit growth. The early launch trends for Aubagio^® and Auvi-Q™ in the
U.S. are encouraging, regulatory approvals were granted for Lyxumia^®,
Zaltrap^® and Hexyon™ in the EU, and we received positive CHMP opinion for
Aubagio^®. Moreover, we look forward to the Phase III data releases for
several pipeline projects later this year, including our new insulin glargine
formulation and alirocumab. The Group expects to resume growth in the second
half of 2013."

Q1 2013 Performance

  oTotal sales^(3) were €8,059 million, down 2.8% impacted by sales lost due
    to generic competition (€553 million).
  oSales of growth platforms^(2) reached €5,723 million, an increase of 8.6%
    and accounted for 71% of total sales.
  oEmerging Markets^(4) sales reached €2,719 million, an increase of 6.5%,
    accounting for 33.7% of total Group sales. Sales in BRIC countries
    increased 10.7%.
  oDiabetes recorded another strong quarter with sales growth of 19.6% to
    €1,542 million driven by Lantus^®.
  oConsumer Healthcare sales were €811 million, an increase of 3.1%.
  oVaccines sales increased 15.9% to €697 million driven by pediatric and flu
  oMerial sales decreased 3.1% to €554 million reflecting unfavorable weather
    conditions and increased competition to Frontline^®.
  oGenzyme^(5) sales grew 25.5% to €493 million, reflecting the recovery of
    Fabrazyme^® and the successful launch of Aubagio^®.
  oQ1 2013 business EPS^(1) was €1.22 reflecting the negative impact of €0.42
    at CER related to the Plavix^® and Avapro^® losses of exclusivity in the
    U.S. last year.

R&D Update

  oSince publication of full-year results, the CHMP issued a positive opinion
    regarding the approval of Aubagio^® in multiple sclerosis and EC approval
    was obtained for the 6-in-1 pediatric vaccine Hexyon™/Hexacima^®.
  oPhase III data are expected in Q2 2013 for several development programs
    (new insulin glargine formulation, otamixaban, a JAK2 inhibitor,

2013 Guidance

  oThe performance of the first quarter is in line with the full year
    guidance announced on February 7, 2013. The 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 the late-stage pipeline, launch expenses for new
    products and ongoing cost savings should lead to a 2013 business EPS^(1)
    of flat to 5% lower than 2012^(6) at CER, barring major unforeseen adverse

(1) See Appendix 6 for definitions of financial indicators (page 18 at; (2) See page 2 at; (3) Growth in
net sales is expressed at constant exchange rates (CER) unless otherwise
indicated (see Appendix 6, page 18 at, for a definition);
(4)See definition on page 7 at; (5)  Genzyme consists of
rare diseases products and multiple sclerosis products; (6) 2012 business EPS
with the retroactive application of IAS19R was €6.14.

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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.

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