Sanofi Q2 2013: Last Quarter with Significant Negative Impact from the Patent Cliff

PARIS, Aug. 1, 2013 /PRNewswire/ -- Sanofi (NYSE: SNY; EURONEXT: SAN)

Q2 2013

Change (reported)

Change (CER)

H1 2013

Change (reported)

Change (CER)

Net sales







Business net income(1)







Business 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 H1 2013 is provided in Appendix 4 and a reconciliation of business net income to consolidated net income in Appendix 3. Consolidated net income for H1 2013 was €1,448 million, compared to €2,962 million(2) for H1 2012. Consolidated EPS for H1 2013 was €1.09 versus €2.25(2) for H1 2012

Commenting on the Group's performance in Q2 2013, Sanofi Chief Executive Officer, Christopher A. Viehbacher said,

"The second quarter was a difficult quarter. As expected, this was the last quarter with a tough comparison to the prior year due to the residual impact of the patent cliff. Sales were also affected by our business in Brazil(3) and commercial underperformance in certain business areas. However, sales growth of 7.7%(4) of our growth platforms(5) in the first half of 2013 continues to demonstrate the value of Sanofi's integrated business model. In addition, we keep on making strong progress in delivering a growing portfolio of high potential R&D assets, as highlighted by the multiple clinical and regulatory milestones reached in the second quarter of 2013. We continue to expect to return to growth in the second half of 2013."

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Q2 2013 Performance

  • Total sales(6) were €8,003 million, down 6.3% principally impacted by sales lost due to generic competition (€481 million).
  • Sales in Emerging Markets(7) totalled €2,669 million, a decrease of 2.3% (+5.3% excluding Brazil generics); double-digit sales growth was achieved for Diabetes, Vaccines, Genzyme and Animal Health.
  • Diabetes delivered growth of 16.2% to €1,621 million as Lantus® sales reached €1,409 million, an increase of 17.7%.
  • Consumer Healthcare sales were €729 million, an increase of 1.8%.
  • Vaccines sales reached €760 million (+0.4%) and compared to strong Q2 2012 sales which benefited from a later timing of flu vaccines supply in the Southern Hemisphere.
  • Animal Health sales were down 5.7% to €529 million impacted by unfavorable weather conditions and increased competition to Frontline®.
  • Genzyme recorded another strong quarter with sales growth of 25.6% to €525 million, reflecting strong performance of the rare disease franchise and the progression of Aubagio®.
  • Growth platforms(5) sales were €5,718 million, an increase of 2.5% (+6.2% excluding Brazil generics) and accounted for 71.4% of total sales.
  • Q2 2013 business EPS(1) was €1.11, down 18.5% impacted in particular by the Plavix® and Avapro® losses of exclusivity in the U.S. (€0.18) and Brazil generics (€0.17)(8).

R&D Update

  • Since publication of Q1 2013 results, several positive Phase III trials results have been announced including two Phase III trials for the investigational new insulin U300, and JAKARTA, which examined fedratinib, a selective JAK2 inhibitor, in myelofibrosis. In addition, the C. diff toxoid vaccine is now moving to Phase III.
  • Several major regulatory milestones were also achieved including positive recommendations from the CHMP both on Lemtrada™ and on a new active substance designation for Aubagio® which is expected to lead to 10-year exclusivity and the FDA approval of the Fluzone® Quadrivalent vaccine.

2013 Adjusted Guidance

  • Given the impact of Brazil and the year-to-date performance, 2013 business EPS is expected to be 7% to 10% lower than 2012 at CER(9), barring major unforeseen adverse events.

(1) See Appendix 8 for definitions of financial indicators (page 24 at ); (2) Including impact of transition to IAS 19R; (3) See disclosure on page 2 at ; (4) Excluding Brazil generics; (5) See page 2 at ; (6) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 8 for a definition at; (7) See definition on page 7 at; (8) Operating losses, net sales adjustment and provisions; €0,19 at CER; (9) 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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