Full Press Release Details
Paris, July 28, 2011
Sales growth of 6.9% thanks to Genzyme acquisition
and performance of growth platforms
Positive impact from Genzyme on
| Q2 2011 | Change on a reported basis | Change at constant exchange rates 1 | H1 2011 | Change on a reported basis | Change at constant exchange rates | |||||||||||||||||||
| Net sales | 8,349m | +0.5 | % | +6.9 | % | 16,128m | -0.5 | % | +1.0 | % | ||||||||||||||
| Business net income 1 | 2,150m | -13.2 | % | -7.0 | % | 4,320m | -11.9 | % | -11.5 | % | ||||||||||||||
| Business EPS 1 | 1.64 | -13.7 | % | -7.4 | % | 3.30 | -12.2 | % | -11.7 | % |
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 2011 is provided in Appendix 7. A reconciliation of business net income to consolidated net income is provided in Appendix 6. Consolidated net income in H1 2011 was 2,224 million, compared to
3,421 million in H1 2010. Consolidated earnings per share in H1 2011 was
1.70 versus 2.62 in H1
Commenting on the Group s performance in Q2 2011, Sanofi Chief Executive Officer, Christopher
A. Viehbacher said, As expected, the second quarter is the most challenging this year, given the level of generic competition. Against this, growth platforms2 continue to perform well and strong progress has been achieved in the integration of Genzyme and Merial.
Sanofi : www.sanofi.com
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2011 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 2011, Sanofi generated net sales of 8,349 million, up 0.5% on a reported basis. Exchange rate movements had a negative effect of 6.4 percentage points, of which more than 70% was due to the weakening of the U.S. dollar versus the Euro.
Various currencies from Emerging Markets (notably the Venezuelan Bolivar, Chinese Yuan and the 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 6.9%.
Net sales in the first half of 2011 were 16,128 million, a decrease of 0.5% on a reported basis. Exchange rate movements had an unfavorable effect of 1.5 percentage points. The depreciation of the U.S. dollar, and the Venezuelan Bolivar
against the Euro was partially offset by the favorable effect of the Japanese Yen and the Australian dollar. At constant exchange rates, and after taking into account changes in structure (primarily the consolidation of Genzyme from
April 1st), net sales increased by 1.0%.
Growth Platforms (see Appendix 4)
Group s growth platforms grew by 9.5% and including Genzyme accounted for 65.2% of total consolidated sales in the second quarter of 2011, which is up from 54.9% in the second quarter of 2010. In the first half of 2011, the growth platforms and
Genzyme comprised 62.3% of total consolidated sales compared with 54.4% for the first half of 2010. Over the period, growth platforms grew by 12.3% excluding A/H1N1 vaccines sales.
Second-quarter net sales for the Pharmaceuticals business
were 7,147 million (up 7.7%), which reflects the positive impact ( 796 million) from the consolidation of Genzyme 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. First-half 2011 net sales increased 3.3% to 13,730 million.
| (millions of euros) | Q2 2011 net sales | Change at constant exchange rates | H1 2011 net sales | Change at constant exchange rates | ||||||||||||
| Lantus | 969 | +14.5 | % | 1,894 | +13.9 | % | ||||||||||
| Apidra | 53 | +29.5 | % | 102 | +25.3 | % | ||||||||||
| Lovenox | 536 | -34.8 | % | 1,119 | -30.9 | % | ||||||||||
| Taxotere | 204 | -64.5 | % | 586 | -49.1 | % | ||||||||||
| Plavix | 510 | -2.4 | % | 994 | -8.4 | % | ||||||||||
| Aprovel | 343 | +3.6 | % | 663 | -0.3 | % | ||||||||||
| Eloxatin | 248 | +194.7 | % | 436 | +185.6 | % | ||||||||||
| Multaq | 68 | +89.7 | % | 131 | +114.3 | % | ||||||||||
| Jevtana | 48 | 96 | ||||||||||||||
| Cerezyme | 166 | +58.3 | %* | 166 | +58.3 | %* | ||||||||||
| Myozyme / Lumizyme | 99 | +42.0 | %* | 99 | +42.0 | %* | ||||||||||
| Renvela /Renagel | 137 | +14.6 | %* | 137 | +14.6 | %* | ||||||||||
| Synvisc /Synvisc One | 89 | +17.2 | %* | 89 | +17.2 | %* |
Net sales of the Diabetes division were 1,168 million (up 12.4%) and 2,281 million (up 11.5%) in the second quarter and first half of 2011, respectively. In the second quarter, Lantus , the world s leading diabetes brand, delivered double digit growth (+14.5% to 969 million). Over the period, sales of the product grew by 12.4% in the U.S. reflecting additional sustained promotional effort implemented
from mid-2010. The contribution from Lantus SoloSTAR in the second quarter represented 46.2% of total
Lantus sales in the U.S., an increase of 13.9 percentage points versus the fourth quarter of 2009. The growth of Lantus was also sustained in Japan (+14.9%). Emerging Markets9 grew 29.3% given robust performance in Russia (+55.0%), China (+50.6%) and Latin America (+38.0%). In Western Europe, sales
in the second quarter of 2011 returned to more dynamic growth (+9.3%). First-half sales of Lantus reached 1,894 million, up 13.9%.
BGStar and iBGStarTM, the first range of blood glucose monitoring systems (BGMs) co-developed by Sanofi and its partner AgaMatrix, were launched in
France and Germany in the second quarter.
Net sales of the rapid-acting insulin analog Apidra were
53 million in the second quarter, up 29.5%. Sales in the U.S. accelerated (+17.6%) driven by a new commercial approach.
First-half net sales of Apidra reached 102 million, an increase of 25.3%.
Despite 8.6% growth in Emerging
Markets, net sales of Amaryl decreased 9.5% (to 109 million) due to generic competition in Japan. First-half sales of Amaryl
were 217 million, down 7.7%.
Eloxatin in the second quarter were 248 million (up 194.7%), reflecting recovery of U.S. sales ( 182 million, versus 29 million in the second quarter of 2010). First-half sales of the product were
436 million, an increase of 185.6%, 25.5% of which ( 111 million, up 11.0%) was generated outside the U.S. and Western Europe. Since June 30, 2010, following the settlement of the Eloxatin U.S. patent infringement suits, generic manufacturers remain enjoined by the U.S. District Court for the District of New Jersey from selling their Eloxatin generic products in the U.S. until August 9, 2012 or the earlier entry of a competing generic product. One generic
manufacturer, Sun Pharmaceuticals, sought appellate review of the court s injunction. Following this appeal, Sun s case was remanded to the District Court for further consideration and the trial was held before the District Court on
April 7, 2011. In the event Sun prevails before the District Court, the generic manufacturers could re-enter the market prior to August 9, 2012.
Second-quarter net sales of Taxotere declined by 64.5% to 204 million reflecting rapid generic erosion in the U.S. (sales down 84.0% to
34 million) and in Western Europe (sales down 73.3% to 51 million). First-half sales of Taxotere were 586 million, down 49.1%, 44.2% of which ( 259 million) was generated outside the U.S. and Western Europe.
(cabazitaxel) recorded second-quarter net sales of 48 million. Sales in the U.S. reached 35 million.
Jevtana was launched in Germany and France in Q2 2011 and generated sales in Western Europe of 9 million.
presence1 of Plavix /Iscover
The second quarter worldwide presence of Plavix was 1,767 million, up 11.1%, reflecting strong
growth in the U.S. (sales were 1,215 million, up 16.9% - net sales consolidated by Bristol-Myers Squibb), Japan (+21.7% to 162 million), and China (+28.1% to
72 million). Sales in Europe were
149 million, down 29.8% due to generic competition. The first half worldwide presence of Plavix reached
3,501 million, an increase of 5.9%. Consolidated sales in Japan and China were
132 million (up 29.5%), respectively.
Worldwide presence of Plavix /Iscover : geographic split
| (millions of euros) | Q2 2011 | Change at constant exchange rates | H1 2011 | Change at constant exchange rates | ||||||||||||
| Europe | 149 | -29.8 | % | 302 | -35.3 | % | ||||||||||
| United States | 1,215 | +16.9 | % | 2,415 | +12.2 | % | ||||||||||
| Other Countries | 403 | +16.3 | % | 784 | +13.1 | % | ||||||||||
| TOTAL | 1,767 | +11.1 | % | 3,501 | +5.9 | % |
Worldwide presence1 of
worldwide presence of Aprovel was 469 million, down 8.2%, impacted by growing penetration of losartan generics. The performance in Other Countries was supported by sales of the active ingredient to our Japanese partners.
Consolidated sales of Aprovel in Emerging Markets grew by 11.6% to
95 million in the quarter. The first half worldwide presence of Aprovel was 951 million, a decrease of 8.9%. Consolidated
sales in Emerging Markets increased by 11.4% to 188 million.
Worldwide presence of
/Karvea : geographic split
| (millions of euros) | Q2 2011 | Change at constant exchange rates | H1 2011 | Change at constant exchange rates | ||||||||||||
| Europe | 212 | -13.1 | % | 420 | -14.4 | % | ||||||||||
| United States | 93 | -21.1 | % | 209 | -17.3 | % | ||||||||||
| Other Countries | 164 | +10.2 | % | 321 | +7.3 | % | ||||||||||
| TOTAL | 469 | -8.2 | % | 951 | -8.9 | % |
Other Pharmaceutical Products
Net sales of Lovenox reached
536 million, down 34.8% in the second quarter, reflecting additional loss of market share against generic competition versus the
first quarter of 2011 in the U.S. (U.S. sales were 160 million, down 64.7%). Lovenox delivered sustained performance outside the U.S. as sales increased 9.8% in Western Europe (to 212 million) and 9.6% in Emerging Markets (to 142 million). First-half sales of Lovenox were
1,119 million, down 30.9%, 65.9% of which ( 737 million) was generated outside the U.S (up 7.5%).
Multaq recorded net sales of
68 million in the second quarter, of which 47 million was generated in the U.S. and 17 million in Western Europe. First-half
sales of Multaq were 131 million of which 91 million was generated in the U.S. and 34 million in Western Europe.
In January 2011, Sanofi issued a Dear Health Care Provider Letter worldwide. The regulatory agencies also issued a Drug Safety Communication on hepatic events reported in patients treated with Multaq . The revised product information was updated accordingly. Sanofi announced in July that the company has discontinued the
PALLAS Phase IIIb trial in patients with permanent Atrial Fibrillation (AF). It was a seeking indication trial. Multaq
(dronedarone) is currently approved in non permanent AF patients. The decision follows recommendations from the study s Operations Committee and the Data Monitoring Committee which observed a significant increase in cardiovascular events
in the dronedarone arm. The decision to terminate the study was not related to any hepatic adverse event. The benefit/risk assessment of Multaq by the agencies is ongoing.
Net sales of the Ambien family of products were 116 million in the second
quarter, down 45.5% due to the generic competition of Ambien CR in the U.S (sales decreased by 91.1% to 9 million). In Japan,
Myslee , the leading treatment for insomnia on the market, showed 7.7% growth to 65 million. First-half sales of the Ambien family were 232 million of which 17 million was for
Ambien CR in the U.S. (down 92.1%). Sales of Myslee in Japan reached 129 million, up 10.8%.
Allegra as a prescription drug recorded 119 million
of net sales in the second quarter led by the performance in Japan (up 22.8% to 88 million) sustained locally by a strong allergy season.
Allegra moved to the OTC market in the U.S. in March 2011 (sales booked in CHC). First-half sales of Allegra were
335 million, 81.8% of which
( 274 million) was generated in Japan and increased by 34.1%.
Second-quarter net sales of Copaxone were 119 million, down 9.9%, reflecting the
end of the co-promotion agreement in certain countries notably the U.K in the fourth quarter of 2010. First-half sales of the product reached
233 million, down 11.8%.
In the arbitration proceeding between Sanofi and Warner Chilcott, an arbitration panel decided on July 14, 2011 that the termination by Warner Chilcott of an ancillary agreement did not give rise to the
termination of the Actonel Alliance. Following this decision, the Alliance remains in force until January 1,
In July, Sanofi announced the strategic divestiture of its dermatology business, Dermik, to Valeant Pharmaceuticals
International for a total cash consideration of U.S. $425 million. The scope of this transaction includes Dermik assets, which consist of an aesthetic and therapeutic business in the United States and Canada, as well as an aesthetic business around
the world with sales of U.S. $206 million in 2010. Sanofi decided to divest its dermatology business with the intention of further focusing on its growth platforms. The closing of the transaction is subject to customary conditions, including
clearance by certain antitrust authorities.
| ( million) | Q2 2011 net sales | Change on a constant structure basis and at constant exchange rates | ||||||
| Cerezyme | 166 | +58.3 | % | |||||
| Myozyme / Lumizyme | 99 | +42.0 | % | |||||
| Fabrazyme | 30 | +3.5 | % | |||||
| Renagel /Renvela | 137 | +14.6 | % | |||||
| Synvisc | 89 | +17.2 | % | |||||
| Total Genzyme | 796 | +16.0 | % |
Second-quarter net sales of Genzyme reached 796 million, an increase of 16.0%.