Sanofi (France): Q1 2013 Business EPS(1) Impacted by Exclusivity Losses in Prior Year

PARIS, May 2, 2013 /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⁽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

• Total sales⁽³⁾ were 8,059 million, down 2.8% impacted by sales lost due to generic competition (553 million).
• Sales of growth platforms⁽²⁾ reached 5,723 million, an increase of 8.6% and accounted for 71% of total sales.
• Emerging 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%.
• Diabetes recorded another strong quarter with sales growth of 19.6% to 1,542 million driven by Lantus^®.
• Consumer Healthcare sales were 811 million, an increase of 3.1%.
• Vaccines sales increased 15.9% to 697 million driven by pediatric and flu vaccines.
• Merial sales decreased 3.1% to 554 million reflecting unfavorable weather conditions and increased competition to Frontline^®.
• Genzyme⁽⁵⁾ sales grew 25.5% to 493 million, reflecting the recovery of Fabrazyme^® and the successful launch of Aubagio^®.
• Q1 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

• Since 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^®.
• Phase III data are expected in Q2 2013 for several development programs (new insulin glargine formulation, otamixaban, a JAK2 inhibitor, iniparib).

2013 Guidance

• The 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 events.

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

To access the full press release of the Q1 2013 results, please click here: http://en.sanofi.com/Images/32910_20130502_Q1RESULTS_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.

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SOURCE Sanofi