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Net sales up 10.1% and Business net income 1 up 4.1% at CER 2 - Performance driven by growth platforms, Genzyme acquisition and cost savings - Q3 2011 Change on a reported basis Change at constant exchange rates 9 months

Key Takeaway: Net sales up 10.1% and Business net income1 up 4.1% at - Performance driven by growth platforms, Genzyme acquisition and cost savings - Q3 2011 Change on a reported basis Change at constant exchange rates 9 months 2011 Change on a reported basis Change at constant e

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Net sales up 10.1% and Business net income1 up 4.1% at
- Performance driven by growth platforms, Genzyme acquisition and cost savings -
Q3 2011 Change on a reported basis Change at constant exchange rates 9 months 2011 Change on a reported basis Change at constant exchange rates
Net sales 8,753 m +5.0 % +10.1 % 24,881 m +1.4 % +4.1 %
Business net income 1 2,398 m -3.0 % +4.1 % 6,718 m -8.9 % -6.3 %
Business EPS 1 1.79 -5.3 % +1.6 % 5.09 -9.9 % -7.3 %
In order to facilitate an understanding of our operational performance, we comment on our business
net income statement. Business net income1 is a non-GAAP
financial measure. The consolidated income statement for the first 9 months of 2011 is provided in Appendix 7. A reconciliation of business net income to consolidated net income is provided in Appendix 6. Consolidated net income for the first 9
months of 2011 was 4,254 million, compared to 5,030 million for the first 9 months of 2010. Consolidated EPS for the first 9 months of 2011 was 3.23.versus 3.85 for the first 9 months of 2010.
Commenting on the Group s performance in Q3 2011, Sanofi Chief Executive
Officer, Christopher A. Viehbacher said, The return to growth in sales and earnings in the third quarter reflects an important milestone as the company progressively puts the patent cliff behind it. The integration of Genzyme is progressing
well. Our growth platforms3 again achieved double digit growth
and more than compensated for generic erosion. We continue to make strong progress in R&D with the submission of five new products and also in the tight control of our costs.
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
2011 third quarter and 9-month net sales
Unless otherwise indicated, all sales growth figures in this press release are
stated at constant exchange rates1.
Net sales in the third quarter of 2011 were 8,753 million, an increase of 5.0% on a reported basis. Exchange rate
movements had a negative effect of 5.1 percentage points, mainly due to a less favorable euro/U.S. dollar parity. Various currencies from Emerging Markets (notably the Venezuelan Bolivar and Turkish Lira) also had an unfavorable impact. At constant
exchange rates, and including changes in structure (primarily the consolidation of Genzyme from
April 1st), net sales increased by 10.1%.
In the first 9 months of 2011, net sales were 24,881 million, up 1.4% on a reported basis. Exchange rate movements had an
unfavorable effect of 2.7 percentage points. The impact of the depreciation of the U.S. dollar, Venezuelan Bolivar and Turkish Lira against the Euro was reduced by the favorable effect of the Japanese Yen and Australian dollar. At constant exchange
rates, and accounting for changes in structure (primarily the consolidation of Genzyme from April 1st), net sales increased by 4.1%.
Growth Platforms (see Appendix 4)
Third-quarter sales of the Group s growth platforms grew by 10.4% or 11.1% excluding A/H1N1 vaccines sales. Including Genzyme, the Group s
growth platforms accounted for 68.5% of total consolidated sales, which is up from 60.2% in the third quarter of 2010. In the first 9 months, the growth platforms and Genzyme comprised 64.5% of total consolidated sales compared with 56.4% over the
same period of 2010. Year-to-date sales growth of growth platforms was 11.9% excluding A/H1N1 vaccines sales.
Pharmaceuticals net sales reached 6,940 million (up 10.0%) in the third quarter, which reflects the
positive contribution ( 768 million) from Genzyme (consolidated from April 1st, 2011) as well as generic competition to Lovenox ,
Ambien CR and Taxotere in the U.S.,
Plavix and Taxotere in the EU and the impact of U.S. healthcare reform and EU austerity measures. Year-to-date 2011 net sales were 20,670 million, an increase of 5.5%.
(millions of euros) Q3 2011 net sales Change at constant exchange rates 9-month 2011 net sales Change at constant exchange rates
Lantus 968 +14.6 % 2,862 +14.1 %
Apidra 53 +22.2 % 155 +24.2 %
Plavix 517 +3.8 % 1,511 -4.5 %
Lovenox 494 -12.7 % 1,613 -26.1 %
Aprovel 314 -5.6 % 977 -2.1 %
Eloxatin 310 +179.2 % 746 +182.9 %
Taxotere 186 -64.8 % 772 -54.1 %
Multaq 66 +52.2 % 197 +88.1 %
Jevtana 45 +14.6 % 141 +256.1 %
Cerezyme 141 +7.0 %* 307 ** +29.9 %*
Myozyme / Lumizyme 101 +27.2 %* 200 ** +34.5 %*
Renagel /Renvela 135 +6.7 %* 272 ** +10.5 %*
Synvisc 80 +11.3 %* 169 ** +14.5 %*
Third-quarter sales of the Diabetes division grew 12.4% to 1,161 million reflecting strong growth of Lantus in the U.S. (+14.6% to 580 million) and Emerging Markets (+23.4% to 149 million). In Western Europe, Lantus sales increased by 7.1% ( 182 million). In the third quarter, Lantus SoloSTAR represented 47.2% of total
Lantus sales in the U.S., an increase of 14.9 percentage points versus the fourth quarter of 2009. The
growth of Lantus in Japan (+15.1%) was also strong. In Emerging Markets, sales of Lantus doubled in China (+103.5%) and benefited from the inclusion into the reimbursement scheme of the largest
provincial markets, Shanghai (December 2010) and Beijing (July 2011). In Latin America, sales of Lantus were up
31.4%. Year-to-date sales of Lantus reached 2,862 million, up 14.1%.
Net sales of the rapid-acting insulin analog Apidra were 53 million in the third quarter, up 22.2%. Sales in the U.S. increased by 40% ( 20 million) reflecting the benefit of our new commercial
approach. Year-to-date net sales of Apidra reached 155 million, an increase of 24.2%. A
temporary shortage of Apidra 3mL cartridges, will impact supplies potentially until early 2012 in some
markets. Apidra vials are not impacted.
Despite 10.9% growth in Emerging Markets, net sales of Amaryl decreased 7.4% (to 106 million) due to generic competition in Japan. Year-to-date sales of Amaryl were 323 million, down 7.6%.
sales of the Diabetes division increased by 11.8% to 3,442 million.
achieved net sales of 310 million (up 179.2%) in the third quarter, reflecting the full recovery of U.S. sales ( 245 million, versus 56 million in the third quarter of 2010). Year-to-date sales of the
product were 746 million, an increase of 182.9%. In September, the U.S. District Court for the District of New Jersey ruled against Sun Pharmaceuticals in favor of Sanofi U.S. with respect to a contractual dispute arising from the
resolution of the Eloxatin patent litigation. This ruling, which Sun Pharmaceuticals is contesting, maintains
the U.S. market exclusivity of Eloxatin through August 9, 2012.
As expected, net sales of Taxotere decreased by 64.8% to 186 million in the third quarter reflecting generic erosion in the U.S. (sales down 85.3% to 27 million) and in Western Europe
(sales down 78.4% to 41 million). Year-to-date sales of Taxotere were 772 million, down
54.1%. Over the period, Taxotere sales generated outside the U.S. and Western Europe amounted to 377 million.
Third-quarter net sales of Jevtana were 45 million. Sales in the U.S. and in Western Europe reached 26 million and 15 million, respectively. Commercialization of
Jevtana is now underway in most Western European countries. Year-to-date sales of Jevtana were 141 million.
presence1 of Plavix /Iscover
The worldwide presence of
Plavix was 1,738 million, up 6.5%, in the third quarter. Sales in the U.S. (consolidated by
Bristol-Myers Squibb) were 1,185 million, up 9.0%. In Japan and China, Plavix continued to show
strong growth of 20.1% (to 162 million) and 28.5% (to 72 million), respectively. Sales in Europe declined by 21.0% to 143 million, due to generic competition. In the first 9 months of 2011, the worldwide presence of Plavix totaled 5,240 million, an increase of 6.1%. Year-to-date consolidated sales in Japan and China were
463 (up 23.0%) and 203 million (up 29.1%), respectively. On October 18, 2011, in the damages phase of the Plavix patent infringement case against Apotex, the U.S. Court of Appeals upheld the damages award granted to Sanofi and BMS in the amount of $442.2 million.
Worldwide presence of Plavix /Iscover : geographic split
(millions of euros) Q3 2011 Change at constant exchange rates 9-month 2011 Change at constant exchange rates
Europe 143 -21.0 % 445 -31.3 %
United States 1,185 +9.0 % 3,600 +11.1 %
Other Countries 410 +11.9 % 1,195 +12.7 %
TOTAL 1,738 +6.5 % 5,240 +6.1 %
Worldwide presence1 of Aprovel /Avapro /Karvea /Avalide
The worldwide presence of
Aprovel was 434 million, down 15.2% in the third quarter reflecting the growing penetration
of Losartan generics. In the first 9 months of 2011, the worldwide presence of Aprovel totaled
1,384 million, a decrease of 11.0%. Year-to-date consolidated sales of the product in Emerging Markets reached 276 million, up 8.6%.
Worldwide presence of Aprovel /Avapro /Karvea : geographic split
(millions of euros) Q3 2011 Change at constant exchange rates 9-month 2011 Change at constant exchange rates
Europe 207 -9.6 % 627 -12.8 %
United States 86 -28.5 % 295 -21.0 %
Other Countries 141 -12.5 % 462 +0.2 %
TOTAL 434 -15.2 % 1,384 -11.0 %
Other Pharmaceutical Products
Third quarter net sales of Lovenox ( 494 million, down
12.7%) were impacted by generic competition in the U.S. ( 133 million, down 42.4%). Lovenox continued to
show solid performance outside the U.S. with a sales increase of 8.7% in Western Europe (to 199 million) and 11.6% in Emerging Markets (to 137 million). Year-to-date sales of Lovenox were 1,613 million, down 26.1%. Sales generated outside the U.S. were 1,098 million (up 8.3%), or 68.1% of total Lovenox sales. In September
2011, the FDA approved Amphastar Pharmaceuticals version of enoxaparin. In October, Sanofi, through its generic business Winthrop, launched an authorized generic of Lovenox in the U.S.
Net sales of Multaq reached 66 million in the third quarter, of which 46 million was generated in the U.S. and
17 million in Western Europe. Year-to-date sales of Multaq were 197 million. Following
its review, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed in September that the benefits of Multaq continue to outweigh the risks with a revised indication for the treatment of a newly defined population of paroxysmal and persistent Atrial Fibrillation
patients. Multaq is indicated for the maintenance of sinus rhythm after successful cardioversion in
adult clinically stable patients with paroxysmal or persistent atrial fibrillation. Due to its safety profile,
Multaq should only be prescribed after alternative treatment options have been considered and should not
be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure. The benefit/risk assessment of Multaq by other regulatory agencies is ongoing.
Third-quarter net sales of the Ambien family of products
decreased by 43.6% (to 121 million), due to generic competition to Ambien CR in the U.S. (Ambien sales in the U.S. were down 81.0%). In Japan, Myslee , showed 7.3% growth to 69 million in the third quarter. Year-to-date sales of the Ambien family were 353 million of which 64 million was for Ambien CR in the U.S.
(Ambien sales in the U.S. were down 82.5%). Year-to-date sales of Myslee in Japan totaled 198 million, up 9.5%.
Third quarter net sales of Allegra as a prescription drug, were 103 million of which 75 million (up 4.0%) was generated in Japan. Allegra moved to the OTC market in the U.S. in March 2011 (sales reported in CHC). Year-to-date sales of Allegra as a prescription drug, were 438 million, 80% of which ( 349 million) was generated in Japan and
Net sales of Copaxone were 117 million, down 6.4% in the third-quarter, reflecting the end of the co-promotion agreement in certain countries notably the U.K in the fourth
quarter of 2010. Year-to-date sales of the product reached 350 million, down 10.1%.
(millions of euros) Q3 2011 net sales Change on a constant structure basis and at constant exchange rates Net sales since April 1 st 2011 Change on a constant structure basis and at constant exchange rates
Cerezyme 141 +7.0 % 307 +29.9 %
Myozyme / Lumizyme 101 +27.2 % 200 +34.5 %
Fabrazyme 32 +24.9 % 62 +14.0 %
Renagel /Renvela 135 +6.7 % 272 +10.5 %
Synvisc 80 +11.3 % 169 +14.5 %
Total Genzyme 768 +6.9 % 1,564 +11.5 %
Third quarter sales of Genzyme reached 768 million, an increase of 6.9% over the third quarter of 2010.
Net sales of Cerezyme were 141 million in the third quarter, an increase of 7.0%. Quarterly sales were impacted by reduced product availability during the quarter.
Net sales of Myozyme /Lumizyme were
101 million, an increase of 27.2%. Growth in the third quarter was driven by continued expansion of
Lumizyme in the U.S. and volume growth across all geographies.
Net sales of Fabrazyme in the third quarter were 32 million, up 24.9% from the third quarter of 2010. The increase was driven by greater availability of the product compared
to the third quarter of 2010.
Sales of Renvela /Renagel were
135 million in the third quarter, an increase of 6.7%. Growth in the third quarter was driven by continued U.S. market share growth, which reached an all time high of 53.1% in September, and European adoption of Renvela , particularly in the chronic kidney disease segment.
Net sales of Synvisc /Synvisc One were
80 million, up 11.3% due to continued growth in the U.S. and in Japan.
Genzyme announced in early October that
a temporary decrease in Cerezyme production yields, and changes to product release processes and
Last updated: Nov 3, 2011