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PRESS RELEASE Paris

Key Takeaway: Paris, October 25, 2012 Q3 2012 Business EPS1 reflects patent expirations Growth Platforms2 reached over 70% of sales Q3 2012 Change on a reported basis Change at constant exchange rates 1 9-month 2012 Change on a reported basis Change at constant exchange rates N

Full Press Release Details

Paris, October 25, 2012
Q3 2012 Business EPS1 reflects patent expirations
Growth Platforms2 reached over 70% of sales
Q3 2012 Change on a reported basis Change at constant exchange rates 1 9-month 2012 Change on a reported basis Change at constant exchange rates
Net sales 9,040m +3.3 % -3.1 % 26,421m +6.2 % +1.2 %
Business net income 1 2,221m -7.4 % -15.9 % 6,607m -1.7 % -8.6 %
Business EPS 1 1.68 -6.1 % -14.5 % 5.01 -1.6 % -8.4 %
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 9 months of 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 the first 9 months of
2012 was 4,557 million, compared to 4,254 million for the first 9 months of 2011. Consolidated EPS for the first 9 months of 2012 was 3.45 versus 3.23 for the first 9 months of 2011.
Commenting on the Group s performance in Q3 2012, Sanofi Chief Executive Officer, Christopher A.
The loss of exclusivity for Eloxatin in August in the U.S. marks the final step in the genericization of our legacy blockbusters. The solid performance
of our growth platforms2 which account for over 70% of sales,
coupled with tight cost control, allowed us to limit the impact of the patent cliff on business EPS1 this quarter. Furthermore, we continue to make progress with our pipeline with the launch of Zaltrap and Aubagio in the U.S. and the FDA approval for
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
2012 third-quarter and 9-month 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 2012 reached of 9,040 million, an increase of 3.3% on a reported basis. Exchange rate
movements had a positive effect of 6.4 percentage points reflecting mainly 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 decreased by 1.2%.
In the first nine months of 2012, Sanofi generated net sales of 26,421 million, an increase
of 6.2% on a reported basis. Exchange rate movements had a favorable effect of 5.0 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 0.2%.
Third quarter sales of the Group s growth platforms were 6,412 million, an increase of 6.4%, with double-digit
sales growth achieved by Diabetes and new Genzyme . The Group s growth platforms accounted for 70.9% of total consolidated sales in the third quarter of 2012, up from 64.5% in the third quarter of 2011. Year-to-date sales of growth
platforms (including new Genzyme ) reached 17,546 million, up 9.3 % or 6.6% with Genzyme proforma (sales of Genzyme were not consolidated in the first quarter of 2011). Growth platforms sales comprised 66.4% of total
consolidated sales compared with 61.6% in the first nine months of 2011.
Net sales of Growth Platforms
( million) Q3 2012 net sales Change at constant exchange rates 9-month 2012 net sales Change at constant exchange rates
Emerging Markets */ ** 2,821 +6.8 % 8,268 +8.8 %
Emerging Markets excluding Diabetes, Vaccines, CHC, animal health, new Genzyme and Innovative Products 1,569 +0.3 % 4,734 +2.4 %
Diabetes 1,486 +17.5 % 4,233 +15.2 %
Vaccines 1,481 +0.7 % 2,881 +1.1 %
Consumer Health Care (CHC) 733 +5.9 % 2,276 +9.5 %
Animal Health 519 +3.8 % 1,673 +2.0 %
New Genzyme 470 +22.5 % 1,304 +15.0 %***
Innovative products **** 154 +7.6 % 445 +6.1 %
Total Growth Platforms 6,412 +6.4 % 17,546 +9.3 %
Total Growth Platforms with Genzyme pro forma 6,412 +6.4 % 17,546 +6.6 %
Pharmaceuticals net sales decreased 4.3% (to
7,040 million) in the third quarter of 2012, impacted by the loss of sales of Copaxone (impact of
117 million), disposal of Dermik (impact of 33 million), EU austerity measures and generic competition. In the third quarter, net sales lost to generic competition were 448 million, due mainly to Eloxatin and Lovenox in the U.S. and, to a lesser extent,
Aprovel , Plavix , Taxotere in the
EU. Year-to-date sales for the Pharmaceuticals business were 21,867 million, an increase of 1.2%, which includes the positive contribution from Genzyme (consolidated from April 2011).
(millions of euros) Q3 2012 net sales Change at constant exchange rates 9-month 2012 net sales Change at constant exchange rates
Lantus 1,279 +20.7 % 3,625 +18.1 %
Plavix 505 -10.4 % 1,563 -4.0 %
Lovenox 437 -14.0 % 1,452 -11.7 %
Aprovel 298 -8.3 % 939 -6.7 %
Renvela /Renagel 164 +12.6 % 476 +10.7 %*
Cerezyme 163 +9.9 % 462 -0.2 %*
Eloxatin 129 -62.9 % 888 +10.1 %
Taxotere 129 -36.0 % 438 -46.6 %
Myozyme / Lumizyme 116 +8.9 % 341 +11.6 %*
Synvisc /Synvisc One 89 +0.0 % 273 +5.9 %*
Fabrazyme 87 +146.9 % 208 +107.6 %*
Multaq 65 -9.1 % 192 -9.1 %
Jevtana 56 +17.8 % 175 +18.4 %
Apidra 57 +1.9 % 165 +1.9 %
In the third quarter, the Diabetes business reached sales of 1,486 million, an increase of 17.5%. The performance of
Lantus was particularly strong this quarter with sales up 20.7% (to 1,279 million) driven by the U.S.
(+ 22.1% to 800 million), Emerging Markets (+31.5% to 204 million) and Japan (+22.5% to 39 million). In the U.S., Lantus SoloSTAR
represented 51.5% of total Lantus sales in the quarter, versus 47.2% in the third quarter of 2011. In
the Emerging Markets, Lantus sales growth was particularly strong in China (+27.9%), Brazil (+31.2%),
Mexico (+24.2%) and Russia (+41.3%). Year-to-date sales of Lantus reached 3,625 million, up
Our Diabetes portfolio was further enlarged in the Emerging Markets with the launch of Insuman SoloSTAR in Russia in July and the launch in October in India of AllStar , the first Indian-manufactured, re-usable insulin pen, manufactured by a global company
in India. AllStar has been developed specifically for patients in Emerging Markets. The launch of AllStar is a significant milestone emblematic of Sanofi s leadership in addressing the needs of people with diabetes in India. It
highlights Sanofi s commitment to Diabetes and Emerging Markets and its regionalized approach to finding solutions that are adapted to local market needs. Going forward, Sanofi intends to make AllStar accessible to other Emerging Markets.
Third-quarter and year-to-date sales of Apidra reached 57 million (+1.9%) and 165 million (+1.9%), respectively.
Despite a good performance in Emerging Markets (+14.3% to 68 million), worldwide sales for Amaryl were down 7.5% to 106 million, impacted by generic competition in Japan (where sales decreased 34.1%
to 30 million). Year-to-date sales of Amaryl decreased to 319 million (-6.8%), of which
62% were generated in Emerging Markets ( 198 million) and increased 11.8%.
The Diabetes business recorded year-to-date sales of
4,233 million, an increase of 15.2%.
The third quarter was marked by the approval in the U.S. of
Zaltrap (ziv-aflibercept, collaboration with Regeneron). Zaltrap is indicated for combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), for patients with metastatic
colorectal cancer that is resistant to, or has progressed, following an oxaliplatin-containing regimen. Zaltrap
was launched at the end of August in the U.S. and reached sales of 7 million. This quarter was also marked by the expected loss of market exclusivity of Eloxatin in the U.S. on August 9, 2012 , resulting in a 74.7% decrease in Eloxatin sales to 72 million.
Third-quarter sales of
Taxotere were down 36.0% to 129 million, reflecting generic erosion in the U.S. ( 10
million, -70.4%) and Western Europe ( 12 million, -70.7%). Year-to-date sales of Taxotere were
438 million (down 46.6%), of which 347 million was generated outside the U.S. and Western Europe.
Sales of Jevtana increased 17.8% to 56 million in the third quarter, reflecting the recent launches in Western Europe. Year-to-date Jevtana sales totaled 175 million, an increase of 18.4%.
Sales of Mozobil reached 26 million and 71 million (+9.5%) in the third quarter and (+20.0%*) in the first 9 months, respectively.
Third-quarter sales of the Oncology business decreased 35.7% to 485 million. Year-to-date sales of this business decreased 6.0% to
Worldwide presence1 of
Plavix /Iscover and Aprovel /Avapro /Karvea /Avalide
On October 3, Sanofi
and Bristol-Myers Squibb (BMS) announced a restructuring of their successful long-term alliance following the loss of exclusivity of Plavix and Avapro /Avalide in many major markets (Japan remains excluded from the Alliance). Under the terms of the revised agreement, which
will go into effect January 1, 2013, BMS will return to Sanofi its rights to Plavix and Avapro /Avalide in all markets worldwide with the exception of Plavix in the U.S. and Puerto Rico, giving Sanofi sole control and freedom to operate commercially. In exchange, BMS
will receive royalty payments on Sanofi s sales of branded and unbranded Plavix worldwide, excluding the
U.S. and Puerto Rico, and on sales of branded and unbranded Avapro /Avalide worldwide, in each case through 2018, and will receive a terminal payment of U.S. $200 million from Sanofi in
December 2018. Plavix rights in the U.S. and Puerto Rico will continue unchanged under the terms of the existing agreement through December 2019.
The Worldwide presence of Plavix decreased 70.1% to
568 million in the third quarter, impacted by generic competition in the U.S., following the loss of exclusivity on May 17, 2012 (U.S. sales, consolidated by BMS, declined by 97.5% to 33 million). In Europe, sales were down
29.6% to 102 million, also impacted by generic competition. In Emerging Markets, third-quarter consolidated sales increased 8.0% to 210 million, of which 104 million was generated in China (+28.2 %). In Japan, sales
of Plavix grew 18.1% to 214 million. Year-to-date, the worldwide presence of Plavix was 3,430 million, a decrease of 38.7%.
Worldwide presence of Plavix /Iscover : geographic split
(millions of euros) Q3 2012 Change at constant exchange rates 9-month 2012 Change at constant exchange rates
Europe 102 -29.6 % 347 -22.1 %
United States 33 -97.5 % 1,813 -52.5 %
Other Countries 433 -5.1 % 1,270 -3.3 %
TOTAL 568 -70.1 % 3,430 -38.7 %
The worldwide presence of Aprovel /Avalide was down
26.2% to 334 million in the third quarter, reflecting generic competition in the U.S. and in Europe. In the U.S., where the product lost its exclusivity on March 30, 2012, sales declined 83.7%. Sanofi launched an authorized generic
version in the U.S. (sales are booked in the Generics business). In Europe, where Aprovel faced generic
competition in most countries during the third quarter, sales were down 25.2% to 155 million. Consolidated sales of the product in Emerging Markets were 95 million, down 1.1%. The year-to-date worldwide presence of Aprovel was 1,120 million, a decrease of 22.0%.
Worldwide presence of Aprovel /Avapro /Karvea : geographic split
(millions of euros) Q3 2012 Change at constant exchange rates 9-month 2012 Change at constant exchange rates
Europe 155 -25.2 % 525 -16.5 %
United States 16 -83.7 % 124 -60.8 %
Other Countries 163 +7.3 % 471 -4.8 %
TOTAL 334 -26.2 % 1,120 -22.0 %
Other Pharmaceutical Products
Third-quarter sales of Lovenox decreased 14.0% to 437 million, due to generic pressure in the U.S. where sales declined 63.2% to 55 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 382 million (+4.2%). In Emerging Markets, sales
increased 10.9% to 154 million. In Western Europe, sales of the product were stable at 201 million. Year-to-date sales of Lovenox totaled 1,452 million (-11.7%), of which 81.8% ( 1,188 million) was generated outside the U.S. (+7.6%).
/Renagel recorded sales of 164 million (+12.6%) in the third quarter, driven
by the performance in the U.S. (sales were up 17.2% to 115 million). Year-to-date sales of
Renvela /Renagel were 476 million, up 10.7%*. Genzyme and generic manufacturers settled pending U.S. litigation in the District of Maryland with regard to the production
and sale of generic formulations of Renvela tablets, Renvela for oral suspension and
Renagel . These settlements are subject to review by the U.S. Federal and Trade Commission. According to the
terms of the settlements, the first-filer for each product can enter the U.S. market on March 16, 2014 and second-filers can enter the market on September 16, 2014, or earlier under certain circumstances, pending approval of their generic
The Ambien family of products recorded sales of 126 million, (-5.0%). In Japan, given the entry of generics, sales modestly decreased 5.6% to 72 million.
Year-to-date sales of the Ambien family totaled 380 million, down 0.6%. In Japan,
year-to-date sales of Myslee reached 224 million, up 1.7%.
Third-quarter sales of Allegra as a prescription drug were 110 million (-1.9%). Japan sales were 77 million and declined 8.3% reflecting the recent price decrease.
Year-to-date sales of Allegra as a prescription drug were 418 million (down 11.2%), of which
76.1% ( 318 million, down 17.2%) was generated in Japan. On August 15, 2012, the Japan regulatory agency approved the first three Allegra generics of Esai, Taisho, and Koybashi although the validity of the patents covering the product had been reinstated. On October 5, 2012, Sanofi brought a
patent infringement suit against Elmed-Eisai, Taisho (Teva) and Kobayashi at the Tokyo District Court.
Synvisc /Synvisc One reached 89 million and 273 million (+5.9%*) in the third quarter and the first 9 months, respectively.
Last updated: Oct 25, 2012