Full Press Release Details
As expected, Q2 2012 Business EPS1 impacted by the loss of exclusivity
of Plavix and Avapro in the U.S.
| Q2 2012 | Change on a reported basis | Change at constant exchange rates 1 | H1 2012 | Change on a reported basis | Change at constant exchange rates | |||||||
| Net sales | 8,870m | +6.2% | +0.4% | 17,381m | +7.8% | +3.6% | ||||||
| Business net income 1 | 1,944m | -9.6% | -17.6% | 4,386m | +1.5% | -4.5% | ||||||
| Business EPS 1 | 1.48 | -9.8% | -17.7% | 3.32 | +0.6% | -5.2% |
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 H1 2012 is provided in Appendix 7. A reconciliation of business net income to consolidated net income is
provided in Appendix 6. Consolidated net income for H1 2012 was 2,998 million, compared to 2,224 million for H1 2011. Consolidated EPS for H1 2012 was 2.27 versus 1.70 for H1 2011.
Commenting on the Group s performance in Q2 2012, Sanofi Chief Executive Officer,
Christopher A. Viehbacher said, This quarter, we faced the anticipated loss of exclusivity of Plavix and Avapro in the U.S. The strategy initiated at the end of 2008 focusing on the development of our growth platforms2, coupled with continuous tight cost control and value-creating acquisitions allowed
Sanofi to limit the impact on business EPS1. In addition, we made progress in
advancing our pipeline with the submission of LemtradaTM (alemtuzumab)3 to the U.S. and EU regulatory agencies as well as the recent initiation of a
comprehensive Phase III program for an Anti-PCSK-9 monoclonal
(1) See Appendix 10 for definitions of financial indicators; (2) See Appendix 4; (3) LemtradaTM is being developed in Multiple Sclerosis in collaboration with Bayer HealthCare, LemtradaTM is the
proprietary name submitted to health authorities; (4) Collaboration with Regeneron; (5) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 10 for a definition); (6) See
definition on page 8; (7) New Genzyme consists of rare diseases products and future Multiple Sclerosis products;
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2012 second-quarter and first-half sales
Unless otherwise indicated, all sales growth figures in this press release are stated at constant exchange rates1.
In the second quarter of 2012, Sanofi generated net sales of 8,870 million, up 6.2% on a reported basis. Exchange rate movements had a positive effect of 5.8 percentage points reflecting the appreciation of the U.S. dollar and, to a lesser extent, the
appreciation of the Japanese Yen and Chinese Yuan against the Euro. At constant exchange rates, and adjusting for changes in the scope of consolidation (primarily the return of Copaxone to Teva and the disposal of Dermik), net sales increased by 2.5%.
Net sales in the first half of 2012 reached 17,381 million, an increase of 7.8% on a reported
basis. Exchange rate movements had a favorable effect of 4.2 percentage points driven by the appreciation of the U.S. dollar, Japanese Yen and Chinese Yuan against the Euro. At constant exchange rates, and after taking into account changes in
structure (primarily the consolidation of Genzyme from the second quarter of 2011), net sales increased by 1.0%.
Growth Platforms (see Appendix 4)
In the second quarter of 2012, sales of the Group s growth platforms (including new Genzyme ) were 5,753 million, an increase of 7.6%, with double digit growth achieved by Diabetes and CHC, while Emerging Markets grew 9.8%. The Group s growth platforms accounted for 64.9% of total consolidated
sales in the second quarter 2012, up from 60.9% in the second quarter of 2011. In the first half of 2012, growth platforms sales (including new Genzyme ) reached 11,134 million, an increase of 11.0% or 6.7% with Genzyme proforma (sales of Genzyme were not consolidated in the first quarter of 2011). Growth platforms sales comprised 64.1% of total consolidated
sales compared with 60.1% for the first half of 2011.
Sales for the Pharmaceuticals business were 7,511 million in the second quarter of 2012, a decrease of 0.4%. The performance of growth platforms broadly offset the loss of sales of Copaxone (impact of 119 million), disposal of Dermik
(impact of 29 million), EU austerity measures and generic competition (resulting in
163 million impact, mainly to Lovenox , Xatral and Taxotere in the U.S.; Taxotere , Plavix and Aprovel in the EU). First-half 2012 sales for the Pharmaceuticals business were
14,827 million, an increase of 4.0%, which reflects the positive contribution from Genzyme (consolidated from April 2011).
| (millions of euros) | Q2 2011 net sales | Change at constant exchange rates | H1 2012 net sales | Change at constant exchange rates | ||||||||||||
| Lantus | 1,228 | +16.5% | 2,346 | +16.8% | ||||||||||||
| Apidra | 56 | 0.0% | 108 | +2.0% | ||||||||||||
| Plavix | 553 | -1.0% | 1,058 | -0.6% | ||||||||||||
| Lovenox | 489 | -11.0% | 1,015 | -10.7% | ||||||||||||
| Eloxatin | 375 | +35.9% | 759 | +61.9% | ||||||||||||
| Aprovel | 334 | -5.8% | 641 | -5.9% | ||||||||||||
| Taxotere | 159 | -27.9% | 309 | -50.0% | ||||||||||||
| Multaq | 64 | -14.7% | 127 | -9.2% | ||||||||||||
| Jevtana | 65 | +27.1% | 119 | +18.8% | ||||||||||||
| Cerezyme | 150 | -13.9% | 299 | -4.6%* | ||||||||||||
| Myozyme / Lumizyme | 113 | +9.1% | 225 | +13.0%* | ||||||||||||
| Fabrazyme | 74 | +123.3% | 121 | +86.7%* | ||||||||||||
| Renvela /Renagel | 165 | +10.9% | 312 | +9.7%* | ||||||||||||
| Synvisc /Synvisc One | 106 | +9.0% | 184 | +8.9%* |
*On a constant structure basis and at constant exchange rates
1 See Appendix 10 for definitions of
financial indicators
See Appendix 2 for a geographical split of consolidated net sales by product
The Diabetes business recorded another quarter of double-digit growth (up 13.7%) to 1,436 million driven by the strong performance of Lantus . Sales of Lantus increased
16.5% to 1,228 million supported by strong growth in the U.S. (sales +19.4% to
760 million), Emerging Markets (+20.6% to 198 million) and Japan (+25.9% to 40 million). In the U.S., Lantus
SoloSTAR represented 51.9% of total Lantus sales in the quarter, versus 46.2% in the second quarter of 2011. In the Emerging Markets, Lantus sales growth were particularly strong in China (+34.9%), Mexico (+25.8%) and Russia (+14.0%). In May, Sanofi inaugurated a new assembling and packaging line
to produce Lantus SoloSTAR at its Beijing plant in China. First-half sales of Lantus reached 2,346 million, up 16.8%.
The results from the ORIGIN trial were presented in June at the American Diabetes Association (ADA) Scientific Sessions and
showed that Lantus had no statistically significant positive or negative impact on cardiovascular outcomes versus
standard care during the study period. The results also showed that insulin glargine delayed progression from pre-diabetes to type 2 diabetes and there was no association between insulin glargine use and increased risk of any cancer.
Results of large-scale epidemiological studies, conducted by independent researchers in Northern Europe and in the United States
were also presented at the ADA Scientific Sessions in June. These results provide further evidence that there was no increased risk of cancer in people with diabetes treated with Lantus , compared to those treated with other insulins.
Second-quarter sales of Apidra were stable at 56 million, reflecting the improvement in supply of Apidra 3mL cartridges. First-half net sales of
Apidra reached 108 million, an increase of 2.0%.
Sales of Amaryl decreased 5.5% to
110 million in the second quarter, reflecting generic competition in Japan (where sales decreased 28.6% to 34 million). In Emerging Markets, sales of Amaryl increased 14.0% to 68 million. First-half sales of
213 million, down 6.5%.
Sales from the Oncology business increased
7.0% to 751 million in the second quarter, largely attributable to another strong quarter for Eloxatin in the U.S. with sales of 313 million (up 53.3%). The U.S. market exclusivity of Eloxatin will
expire on August 9, 2012. First-half sales of the oncology business were 1,492 million, an increase of 9.9%.
Second-quarter Taxotere sales stabilized (at 159 million) versus the previous
quarter, but decreased 27.9%, versus the second quarter of 2011, reflecting generic erosion in the U.S. ( 22 million, -44.1%) and Western
Europe ( 13 million, -74.5%). First-half sales of Taxotere were 309 million (down 50.0%), 77.7% of which
( 240 million) was generated outside the U.S. and Western Europe.
Second-quarter sales of Jevtana increased 27.1% to 65 million, supported by
the commercial roll-out in Western Europe. First-half sales of the product reached 119 million, an increase of 18.8%.
presence1 of Plavix /Iscover
Worldwide presence of Plavix decreased 43.3% to 1,100 million in the second quarter, reflecting the loss of its exclusivity in the U.S. on May 17, 2012. During the period, sales in the U.S. (consolidated by Bristol-Myers Squibb) declined by
59.9% to 536 million. In Europe, where Plavix also faces generic competition, sales were down 18.5% to
121 million. Second-quarter consolidated sales in Emerging Markets increased 6.9% to
202 million, of which
96 million was generated in China (up 25.2%). In Japan, sales of Plavix recorded another quarter of double digit growth (up 19.0%) to
220 million. In the first half of 2012, the Worldwide presence of Plavix reached 2,862 million, a decrease of 23.1%.
1 See Appendix 10 for definitions of
financial indicators
Worldwide presence of Plavix /Iscover : geographic split
| (millions of euros) | Q2 2012 | Change at constant exchange rates | H1 2012 | Change at constant exchange rates | ||||||||||||
| Europe | 121 | -18.5% | 245 | -18.6% | ||||||||||||
| United States | 536 | -59.9% | 1,780 | -30.4% | ||||||||||||
| Other Countries | 443 | -2.3% | 837 | -2.4% | ||||||||||||
| TOTAL | 1,100 | -43.3% | 2,862 | -23.1% |
Worldwide presence1 of Aprovel /Avapro /Karvea /Avalide
In the second quarter,
the worldwide presence of Aprovel decreased 22.3% to
382 million, due to generic competition. In the U.S., sales declined 69.6% reflecting the loss of exclusivity on March 30,
2012. Sanofi launched an authorized generic version in the U.S. Consolidated sales of the product in Emerging Markets reached
107 million, up 4.2%. In the first half of 2012, the worldwide presence of Aprovel reached 786 million, down 20.2%.
Worldwide presence of Aprovel /Avapro /Karvea : geographic split
| (millions of euros) | Q2 2012 | Change at constant exchange rates | H1 2012 | Change at constant exchange rates | ||||||||||||
| Europe | 185 | -13.5% | 370 | -12.2% | ||||||||||||
| United States | 32 | -69.6% | 108 | -51.4% | ||||||||||||
| Other Countries | 165 | -6.9% | 308 | -10.2% | ||||||||||||
| TOTAL | 382 | -22.3% | 786 | -20.2% |
Other Pharmaceutical Products
sales were 489 million in the second quarter, down 11.0%, reflecting generic pressure in the U.S. where sales declined
52.5% to 87 million. Sanofi commercializes an Authorized Generic of Lovenox in the U.S. (sales are booked in the Generics business). Outside the U.S., Lovenox recorded another quarter of growth with sales of
402 million (+6.6%). In Emerging Markets, sales increased 12.0% to 158 million. In Western Europe sales of the product reached 219 million, up 2.8%.
First-half sales of Lovenox were 1,015 million (-10.7%), 79.4% of which ( 806 million) was generated outside the U.S. (+
Second-quarter sales of Renvela /Renagel recorded double digit
growth rate (up 10.9%) to 165 million, driven by a good performance in the U.S. (sales were up 23.8% to 111 million). First-half sales of Renvela /Renagel were 312 million, up 9.7%*.
Synvisc /Synvisc One sales were 106 million, an increase of 9.0%
in the second quarter, driven by the Synvisc One franchise in the U.S. (where sales of Synvisc /Synvisc
One increased 11.6% to 87 million). First-half sales of Synvisc /Synvisc One reached
184 million, an increase of 8.9%*.
Second-quarter sales of the Ambien family of products were 129 million, (+1.7%), 60.5% of which ( 78 million) was generated in Japan (+6.2%). First-half sales of the
Ambien family were 254 million, up 1.7%. In Japan, first-half sales of Myslee reached 151 million, up 5.4%.
Allegra sales as a prescription drug were 126 million in the second quarter, down 2.5%, reflecting the impact in Japan of a mild allergy season compared to 2011 (sales of the
product in Japan were down 12.5% to 88 million). First-half sales of Allegra were 308 million (down 14.0%), 78.2% of which
( 241 million, down 19.7%) was generated in Japan. In July 2012, Sanofi entered into settlements in Japan with generic manufacturers
regarding Allegra . Sanofi does not expect the entry of generics before March 2014.
1 See Appendix 10 for definitions of financial
* On a constant structure basis and at constant exchange rates, Genzyme sales were not consolidated in Q1 2011