EX-99.1 2 d386238dex991.htm EXHIBIT 99.1 Exhibit 99.1

PRESS RELEASE

 

LOGO    Paris, July 26, 2012

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  rates1
 

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 income1   1,944m   -9.6%   -17.6%   4,386m   +1.5%    -4.5%
Business EPS1   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 antibody4.

Q2 2012 Performance

 

  ·   

Total sales5 reached 8,870 million, an increase of 0.4% (2.5% on a constant structure basis). Net sales lost to generic competition were 163 million in the quarter.

 

  ·   

Sales from growth platforms2 were 5,753 million (+7.6%) and accounted for 64.9% of total sales, compared to 60.9% in Q2 2011.

 

  ·   

Emerging Markets6 sales were 2,823 million, an increase of 9.8% (or 10.4% on a constant structure basis).

 

  ·   

Diabetes recorded another quarter of strong double digit growth (+13.7%) driven by the performance of Lantus® (+16.5% to 1,228 million).

 

  ·   

Vaccines sales increased 3.0% supported by another record year for flu sales in the Southern Hemisphere which was partly offset by temporarily order limitations for Pentacel® in the U.S.

 

  ·   

“New Genzyme”7 sales increased 9.1% to 434 million, supported by the recovery of Fabrazyme®.

 

  ·   

Consumer Health Care achieved double digit growth (+11.3%) boosted by Emerging Markets.

 

  ·   

The impact of the Plavix® and Avapro® loss of exclusivity in the U.S. was 331 million on the business net income which is consistent with the Group’s previously announced projected impact of around 1.4 billion in 2012.

 

  ·   

Business EPS1 of 1.48 was down 17.7% at CER.

R&D and Outlook

 

  ·   

LemtradaTM was submitted to regulatory authorities in the U.S. and in Europe in Q2 2012.

 

  ·   

A broad Phase III program for our Anti-PCSK-9 monoclonal antibody has been recently initiated.

 

  ·   

The performance of the first half of 2012 is in line with the full year guidance announced on February 8, 2012. Taking into account the loss of Plavix® and Avapro® exclusivity in the U.S., the performance of growth platforms, contribution from Genzyme and cost controls as well as other generic competition, 2012 business EPS1 is expected to be 12% to 15% lower at CER than 20118, barring unforeseen adverse events.

(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; (8) 6.65

Sanofi: www.sanofi.com

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

 

1


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.

Pharmaceuticals

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).

Flagship Products9

 

  (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

9 See Appendix 2 for a geographical split of consolidated net sales by product

 

2


Diabetes

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 Amaryl® were 213 million, down 6.5%.

Oncology

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%.

Worldwide presence1 of Plavix®/Iscover®

As expected, the 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

 

3


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

Lovenox® 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. (+ 9.2%).

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 indicators

* On a constant structure basis and at constant exchange rates, Genzyme sales were not consolidated in Q1 2011

 

4


Sales of Multaq® were 64 million, down 14.7%, reflecting the impact of updated labeling in the second half of 2011. Sales of the product in the U.S. were 50 million, down 4.3%. First-half sales of Multaq® were 127 million, down 9.2%.

The transfer to Teva of Copaxone® sales was finalized in the first quarter of 2012. As a consequence, Sanofi did not book any sales of the product in the second quarter of 2012 compared to 119 million consolidated in the second quarter of 2011. Sanofi will receive a payment of 6% on sales from Teva for a period of two years, on a country-by-country basis. In the first half of 2012, Sanofi recorded 24 million of Copaxone® sales compared to 233 million in the first half of 2011.

New Genzyme

“New Genzyme” currently consists of Rare Diseases products and future Multiple Sclerosis products (Aubagio® and LemtradaTM).

 

  ( million)   

Q2 2012

net sales

     Change at constant
exchange rates
    

H1 2012

net sales

     Change on a constant
structure basis and at
constant exchange rates
 

  Cerezyme®

     150         -13.9%         299         -4.6%*   

  Myozyme® / Lumizyme®

     113         +9.1%         225         +13.0%*   

  Fabrazyme®

     74         +123.3%         121         +86.7%*   

  Other Rare Disease products

     97         +13.9%         189         +11.2%*   

  Total “new Genzyme”

     434         +9.1%         834         +11.3%*   
                                     

Second-quarter sales of “new Genzyme” were 434 million, an increase of 9.1%. First-half sales of “new Genzyme” reached 834 million, an increase of 11.3%*.

Sales of Cerezyme® were 150 million in the second quarter, a decrease of 13.9%, reflecting the quarterly variability of order patterns and a strong comparable in the second quarter 2011. However, Genzyme remains on track to maintain market share and deliver modest Cerezyme® growth throughout the year. First-half sales of Cerezyme® reached 299 million (-4.6%*).

Second-quarter sales of Myozyme®/Lumizyme® reached 113 million, an increase of 9.1%. First-half sales of Myozyme®/Lumizyme® reached 225 million, an increase of 13.0%*. In May, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved a second operation for filling and finishing product at the Genzyme manufacturing plant at Waterford, Ireland. With this approval, Genzyme has nearly doubled its ability to fill and finish Myozyme® and Lumizyme® produced at the 4,000 liter bioreactor scale. Genzyme will also begin the process to secure FDA and EMA approvals to fill and finish additional products in the second suite, with the long-term goal to use the Waterford site as a filling and finishing platform across its portfolio of products.

Fabrazyme® recovered significantly in the second quarter with sales up 123.3% to 74 million. First-half sales of Fabrazyme® reached 121 million, an increase of 86.7%*. In March 2012, Genzyme began shipping Fabrazyme® produced in its new plant in Framingham MA, which was approved by the FDA and the EMA in January 2012. In March, treated patients in the U.S. returned to full dosing. In addition, new patients in the U.S. are eligible to begin Fabrazyme® treatment, at full dosing levels. In Europe, the process of moving the most severely affected patients to full dose of Fabrazyme® began in March 2012. Globally, the complete return to normal supply levels of Fabrazyme® has begun and will continue throughout the year, as Genzyme works to obtain all global regulatory approvals for the Framingham plant and to build inventory.

During the quarter, Genzyme made significant progress towards building a leading franchise in multiple sclerosis (MS) with the filing of Lemtrada™ (alemtuzumab) in the U.S. and EU in June 2012 and the release of positive top-line results from the TOWER trial with Aubagio® (teriflunomide)10. In addition, Genzyme initiated hiring the U.S. MS sales team.

* On a constant structure basis and at constant exchange rates, Genzyme sales were not consolidated in Q1 2011

10 Aubagio® is the proprietary name submitted to health authorities

 

5


Consumer Health Care

Second-quarter Consumer Health Care (CHC) sales were 738 million, an increase of 11.3%, reflecting the performance in Emerging Markets which included the contribution of Universal Medicare in India. In Emerging Markets, sales of Essentiale®, Lactacyd®, Enterogermina®, Maalox®, NoSpa® and Haowawa® recorded double digit growth. CHC sales in Latin America, Asia and Russia grew by 18.1%, 41.3% and 26.7%, respectively. In Western Europe, Doliprane®, Maalox® and MagneB6® showed good performance resulting from greater promotional focus. In the U.S., sales were 157 million, down 3.4%, due to lower sales of Allegra® OTC (down 23.7% to 54 million) reflecting inventory build at the retail level in the second quarter of 2011 to ensure proper supply during launch. First-half sales of Consumer Health Care reached 1,543 million, an increase of 11.4%.

Generics

Second-quarter sales of generics reached 468 million, up 7.8%, led by the U.S. performance which benefited from the launch of the authorized generics of Lovenox® and Aprovel® (U.S. sales of generic products increased 76.5% to 67 million). In Emerging Markets, sales of generics were 277 million, up 2.5%, despite lower sales in Eastern Europe. First-half sales of generics were 907 million, an increase of 7.2%.

Human Vaccines

Second-quarter consolidated sales of Sanofi Pasteur were 783 million, an increase of 3.0%, supported by another record performance for seasonal influenza vaccines in Southern Hemisphere and despite temporarily order limitations for Pentacel® in the U.S. First-half consolidated net sales for the Human Vaccines business were 1,400 million, an increase of 1.5%.

Sales of seasonal influenza vaccines increased 40.4% to 80 million in the second quarter of 2012, reflecting the positive impact of a later timing of supply than last year in the Southern Hemisphere and strong demand. 2012 was another record performance for seasonal influenza vaccines in the Southern Hemisphere for Sanofi Pasteur. First-half sales of seasonal influenza vaccines reached 167 million compared to 158 million in the first half of 2011. In July 16, 2012, Sanofi Pasteur, announced that the first lots of Fluzone® vaccine began shipping to U.S. health care providers. This initial shipment represents the first of more than 60 million doses of seasonal influenza vaccine the company plans to deliver in the U.S. this influenza season

Second-quarter sales of Polio/Pertussis/Hib vaccines reached 273 million, down 5.2% reflecting some order limitations for the 5-in-1 combination vaccines Pentacel® in the U.S. (sales were 62 million, down 28.6%). Sanofi Pasteur has effectively temporarily implemented order limitations for Pentacel® and Daptacel® vaccines from April 2012 in the U.S. These ordering limitations are likely to remain in effect until the beginning of 2013. This is a necessary step due to a manufacturing delay that will temporarily reduce supply below the level needed to fully satisfy market demand in the U.S. Despite strong growth in China in the second quarter, Pentaxim® sales were impacted by phasing deliveries in Mexico and reached 60 million, down 10.8%. Emerging Markets sales of Polio/Pertussis/Hib vaccines increased 14.4% to 131 million in the second quarter. First-half sales of Polio/Pertussis/Hib vaccines reached 518 million, down 0.4%.

In April, the Japanese Ministry of Health, Labor and Welfare approved the Sanofi Pasteur’s standalone Inactivated Poliovirus Vaccine (Imovax® Polio) against acute flaccid poliomyelitis. Imovax® Polio will be added to the country’s public immunization program on September 1st, 2012.

Furthermore, in June, HexaximTM (DTaP-IPV-Hib-HepB vaccine) received a positive scientific opinion from the European Medicines Agency (EMA), as part of a procedure designed to evaluate medicinal products intended for markets outside the European Union. This is the first time the EMA gave a positive scientific opinion to a vaccine following that procedure.

Second-quarter sales of Menactra® were 111 million, up 2.2% despite competition in the U.S. First-half sales for Menactra® were 167 million, an increase of 10.5%.

Adult booster vaccines sales recorded a 20.9% increase in the second quarter to 146 million, reflecting the strong performance of Adacel® in the U.S. (total sales of Adacel® were up 30.7% to 100 million). First-half consolidated net sales for Adult boosters were 233 million, an increase of 5.3%.

 

6


Second-quarter and first-half sales of travel and other endemic vaccines were 100 million (up 5.6%) and 177 million (stable), respectively.

On July 12, Sanofi Pasteur received a Warning Letter following regular inspections conducted this year at manufacturing facilities in Toronto, Canada and Marcy L’Etoile, France this year. Sanofi Pasteur takes seriously the observations regarding the US licensed products and their related production units. We are working diligently with the FDA to implement a series of immediate and ongoing steps to address the issues identified in the Warning Letter and further strengthen our manufacturing operations and quality systems.

Consolidated vaccines sales

  (millions of euros)   

Q2 2012

net sales

     Change at
constant
exchange rates
    

H1 2012

net sales

     Change at
constant
exchange rates
 

  Influenza Vaccines (incl. Vaxigrip® and Fluzone®)

     80         +40.4%         169         +5.7%   

of which seasonal vaccines

     80         +40.4%         167         +4.4%   

of which pandemic vaccines

     0         -         2         Ns   
                                     

  Polio/Pertussis/Hib Vaccines (incl. Pentacel® and Pentaxim®)

     273         -5.2%         518         -0.4%   

  Meningitis/Pneumonia Vaccines (incl. Menactra®)

     129         -3.3%         202         +2.7%   

  Adult Booster Vaccines (incl. Adacel ®)

     146         +20.9%         233         +5.3%   

  Travel and Other Endemics Vaccines

     100         +5.6%         177         0.0%   

  Other Vaccines

     55         -19.7%         101         -3.1%   
                                     

  TOTAL

     783         +3.0%         1,400         +1.5%   
                                     

Second-quarter sales of Sanofi Pasteur MSD (not consolidated), the joint venture with Merck & Co. in Europe, increased 3.8% to 176 million, driven by travel and other endemic vaccines. Sales of Gardasil® stabilized (down 2.2%) at 46 million. First-half sales of Sanofi Pasteur MSD grew 7.7% to 332 million.

Animal Health

Sales of Merial increased 9.1% to 576 million in the second quarter of 2012, driven by the U.S. (up 17.8% to 261 million) and Emerging Markets (up 10.9% to 143 million). First-half sales of Merial reached 1,154 million, an increase of 1.2%.

Second-quarter sales of the Companion Animals segment were up 10.2% to 385 million, reflecting strong performance of the Frontline®/Fipronil family of products with sales up 11.1% to 228 million driven by the U.S. (sales of Frontline® family products increased by 18.8% to 135 million). First-half sales of the companion animals segment reached 784 million, up 1.0%.

On June 6, 2012, Merial filed a patent infringement complaint against Velcera for its new PetArmor Plus product and requested an hearing for a preliminary injunction. On June 29th, the Court granted the motion enjoining Velcera from selling their new product. Velcera has appealed that decision to the Federal Circuit. The patent infringement trial is scheduled for November 2012.

The Production Animals segment reported sales of 191 million in the second quarter, up 6.9%, driven by the Avian segment (up 10.8%) and the Swine segment (+33.3%) which includes the acquisition of Newport Laboratories in the U.S. and completed in March. First-half sales of the production animals segment were 370 million, up 1.7%.

 

7


Net sales by geographic region

 

  (millions of euros)   

Q2 2012

net sales

     Change at
constant
exchange rates
    

H1 2012

net sales

     Change at
constant
exchange rates
 

  United States

     2,795         +3.0%         5,395         +8.8%   

  Western Europe*

     2,136         -11.0%         4,361         -6.4%   

  Emerging Markets**

     2,823         +9.8%         5,447         +9.9%   

    of which Eastern Europe and Turkey

     670         -0.1%         1,327         +1.0%   

    of which Asia

     716         +12.7%         1,381         +12.2%   

    of which Latin America

     887         +12.7%         1,675         +14.2%   

    of which Africa

     255         +8.4%         507         +9.4%   

    of which Middle East

     267         +25.9%         494         +15.6%   
                                     

  Rest of the world***

     1,116         -2.5%         2,178         -0.7%   
                                     

  of which Japan

     796         -0.1%         1,529         +0.9%   
                                     

  TOTAL

     8,870         +0.4%         17,381         +3.6%   
                                     

* France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark

** World less the U.S. and Canada, Western Europe, Japan, Australia and New Zealand

*** Japan, Canada, Australia and New Zealand

Second-quarter sales in Emerging Markets increased 9.8% to 2,823 million. This performance was supported by the broad geographic footprint of the Group and its diversified portfolio of products in Emerging Markets (Rx drugs, branded generics, CHC, new Genzyme, Vaccines and Animal Health). In the second quarter, in Emerging Markets Diabetes, Vaccines and CHC recorded strong double digit growth, up 19.1%, up 22.9% and up 26.9%, respectively. BRIC (Brazil, Russia, India and China) sales were 995 million, an increase of 15.2%. Sales in China reached 320 million, up 20.9%, reflecting the growth of Plavix®, Lantus® and Vaccines. Brazil sales grew 14.0% to 405 million, up driven by Vaccines and CHC. Sales in Russia were 203 million, an increase of 9.0%, led by the performance of Lantus®, CHC and generics. Emerging Markets reported first-half sales of 5,447 million, up 9.9% (or 7.7% with Genzyme proforma).

In the U.S., sales reached 2,795 million in the second quarter, an increase of 3.0%. The sales growth of Lantus®, Eloxatin® and contribution from authorized generics and Animal Health offset the impact of generic competition for Lovenox®, Taxotere® and the disposal of Dermik. First-half sales in the U.S. increased 8.8% to 5,395 million (or up 1.0% with Genzyme pro forma).

Second-quarter sales in Western Europe decreased 11.0% to 2,136 million. Sales were impacted by the transfer of the Copaxone® business to Teva, generic competition for Taxotere®, Aprovel® and Plavix®, as well as the impact of austerity measures. Excluding the impact of Copaxone®, sales in Western Europe declined 6.6%. First-half sales in Western Europe were 4,361 million, a decline of 6.4%, (or down 6.5% with Genzyme pro forma and excluding Copaxone®).

Sales in Japan were stable at 796 million in the second quarter. Despite good performance from Plavix® and Lantus®, sales in Japan were impacted by biannual price cuts, generic competition to Amaryl®, lower sales in Vaccines and Allegra® due to a mild allergy season. First-half sales in Japan increased 0.9% to 1,529 million (or down 2.6% with Genzyme pro forma).

R&D update

Since the last R&D update on April 27, 2012, there has been important newsflow for Sanofi R&D. Several dossiers were submitted to regulatory authorities; positive clinical trials results were announced; a large Phase III program for the anti-PCSK9 monoclonal antibody (SAR236553, collaboration with Regeneron) was initiated as planned; several compounds entered Phase I and a collaboration with the Joslin Diabetes Center was signed.

 

8


At the end of July, the R&D portfolio comprises 64 NMEs (New Molecular Entities) projects and vaccines in clinical development of which 18 are in Phase III or have been submitted to the health authorities for approval.

Regulatory update

Several regulatory milestones were achieved during the period:

 

   

In April, the Japanese Ministry of Health, Labor and Welfare approved Sanofi Pasteur’s standalone Inactivated Poliovirus Vaccine, Imovax® Polio.

 

   

In May the European Commission granted a marketing authorization in the European Union for the extended use of Lantus® for the treatment of type 1 diabetes in children aged two to five years. Sanofi will request 6-month Pediatric Exclusivity for the existing Supplementary Protection Certificates (SPC) for Lantus® in EU countries. Assuming grant of the pediatric exclusivity, most SPCs in EU would therefore expire in May 2015. In the U.S., a pediatric extension has been granted already which extends the compound patent covering Lantus® to February 2015.

 

   

In June, a supplemental Biologics License Application was submitted to the U.S. FDA and a marketing authorization application was filed with the EMA for Lemtrada™ (alemtuzumab) in the treatment of relapsing multiple sclerosis. Genzyme has requested Priority Review of the sBLA (six month review) and an FDA decision is pending. In the absence of a Fast Track designation, a Standard Review (ten month review) may be assigned.

 

   

In June, the marketing authorization application for Lyxumia® (lixisenatide, licensed from Zealand Pharma), a once-daily GLP-1 receptor agonist has also been submitted for review to the Ministry of Health, Labour and Welfare in Japan.

 

   

In June, HexaximTM (DTaP-IPV-Hib-HepB vaccine) received a positive scientific opinion from the European Medicines Agency, as part of a procedure designed to evaluate medicinal products intended for markets outside the European Union. The EMA scientific opinion is based on the review of a dossier submitted by Sanofi Pasteur through the “Article 58” procedure.

Late stage portfolio

In May, additional positive results from a Phase II trial of SAR236553, a subcutaneously administered, fully-human monoclonal antibody targeting PCSK9, in patients with heterozygous familial hypercholesterolemia (heFH) were presented at the European Atherosclerosis Society Congress. The trial randomized 77 patients with heFH whose LDL-cholesterol (LDL-C) levels remained uncontrolled on statin therapy with or without ezetimibe. Across the four different dosing regimens tested, patients receiving SAR236553 for 12 weeks achieved a mean LDL-C reduction from baseline of 28.9% to 67.9%, compared to 10.7% in patients receiving placebo (p<0.05). The results from this study were also published online in The Lancet. Positive data from two Phase II trials in primary hypercholesterolemia were also presented at the American College of Cardiology’s Annual Scientific Meeting in March.

Several trials of ODYSSEY, the Phase III clinical program of SAR236553, have now initiated patient enrollment. This program will enroll more than 22,000 patients and consists of over ten clinical trials evaluating the effect of SAR236553 on the lowering of LDL cholesterol and an 18,000 patient cardiovascular outcomes study. Internally, Sanofi has also created a dedicated PCSK9 Development & Launch Unit which underscores Sanofi’s commitment to develop this potential first-in-class therapeutic agent.

In June, the results of 2 Phase III trials, GetGoal Duo 1 and GetGoal-L, evaluating Lyxumia® (lixisenatide), a once-daily investigational GLP-1 agonist, in combination with basal insulin plus oral anti-diabetic agents, were presented at ADA Scientific Sessions in June. These two studies achieved the primary efficacy endpoint of HbA1c improvement with an associated significant reduction in post-prandial glucose in people with type 2 diabetes who were either new to insulin therapy (as early as 12 weeks after initiation) or already treated with insulin (for an average of 3.1 years).

In addition, the results of the ORIGIN trial were presented in June at the American Diabetes Association (ADA) Scientific Sessions Scientific Sessions and showed that Lantus® had no statistically significant positive or negative impact on cardiovascular (CV) 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 a large-scale epidemiological program in Europe and the U.S. were also presented at the ADA Scientific Sessions in June.

 

9


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. Lantus® is the most studied basal insulin with over 10 years of scientific data and real life experience.

In June, Genzyme announced top-line results from the TOWER trial that assessed the efficacy and safety of once-daily, oral Aubagio® (teriflunomide) in patients with relapsing forms of multiple sclerosis (MS). In the study, patients receiving teriflunomide 14 mg had a statistically significant reduction of 36.3% in annualized relapse rate and 31.5% reduction in the risk of 12-week sustained accumulation of disability. Analysis of the full TOWER data is ongoing and results will be presented at a forthcoming scientific meeting. These results are consistent with the results observed in the Phase III TEMSO study. Marketing applications for teriflunomide for the treatment of relapsing forms of MS are under review by the FDA, the EMA and other regulatory authorities.

In July, Sanofi Pasteur announced that its tetravalent dengue vaccine candidate demonstrated proof of efficacy against dengue, a threat to almost 3 billion people, in the world’s first ever dengue efficacy trial. The results of this study conducted in Thailand confirm the excellent safety profile of the vaccine. The vaccine generated antibody response for all four dengue virus serotypes. Evidence of protection was demonstrated against three of the four virus serotypes circulating in Thailand. Analyses are ongoing to understand the lack of protection for the fourth serotype in the particular epidemiological context of Thailand. The full data resulting from this first efficacy trial are currently under review by scientific and clinical experts, as well as public health officials. Detailed results of this study will be published in a peer-reviewed journal and presented to the scientific community later this year.Large scale phase III dengue vaccine clinical studies with 31,000 participants are underway in 10 countries of Asia and Latin America. These studies will generate important additional data in a broader population and in a variety of epidemiological settings to demonstrate vaccine efficacy against the four circulating dengue virus serotypes.

On June 20, 2012 semuloparin was reviewed by the U.S. FDA’s Oncologic Drugs Advisory Committee. The committee voted to recommend against approval of semuloparin for the prophylaxis of venous thromboembolism (VTE) in patients receiving chemotherapy for certain type of cancer. In July, Sanofi decided to withdraw all applications for marketing authorization for semuloparin following comments by regulatory agencies.

It has been decided not to pursue registration of clofarabine (Clolar®) in acute myeloid leukemia (AML). A Phase II study, evaluating ombrabulin, a vascular disrupting agent, in non-small cell lung cancer (NSCLC) did not meet its primary endpoint. The recruitment of patients of the Phase III study, evaluating ombrabulin in sarcoma, is now completed. The results of the randomized, open-label, phase II study conducted in Europe evaluating iniparib in association with paclitaxel versus paclitaxel single-agent as neoadjuvant therapy in patients with stage II-IIIA triple negative breast cancer did not show any advantage in efficacy.

Early stage portfolio

Four compounds entered Phase I:

 

   

SAR252067, (collaboration and license agreement with Kyowa Hakko Kirin), an anti-LIGHT fully human monoclonal antibody for ulcerative colitis and Crohn’s disease;

 

   

UshStatTM (collaboration and option license with Oxford BioMedica), a myosin 7A gene therapy for Usher syndrome 1B. At the end of June, Sanofi elected to exercise its options to acquire the exclusive worldwide licence for further development, manufacture and commercialization of UshStatTM as well as StarGen™ (a gene-based therapy for Stargardt disease) already in Phase I;

 

   

SAR405838 (collaboration and license agreement with Ascenta Therapeutics), an oral inhibitor of the HDM2/ p53 protein-protein interaction, in oncology.

 

   

SAR404460 a DHA-GLP & Vitamin D combination for pre sarcopenia (collaboration with CRNH, ASL & 3inature);

A new collaboration to promote the development of new medicines for the treatment of diabetes and related disorders was also signed in June between Sanofi and the Joslin Diabetes Center, a teaching and research affiliate of Harvard Medical School.

Sanofi decided to discontinue the BiTE® antibody project and to terminate its collaboration with Micromet.

 

10


Second-quarter and first-half 2012 financial results

Business Net Income1

Sanofi generated second-quarter net sales of 8,870 million, up 6.2% on a reported basis (+0.4% at constant exchange rates), reflecting the performance of growth platforms, the impact from EU austerity measures, the loss of 163 million of sales due to generic competition and a favorable currency effect. First-half sales were 17,381 million, an increase of 7.8% on a reported basis (+3.6% at constant exchange rates), also reflecting the consolidation of Genzyme from April 2011 and the loss of 398 million of sales due to generic competition.

Other revenues were down 41.5% (or down 45.7% at constant exchange rates) to 247 million in the second quarter due to the loss of exclusivity of Plavix® and Avapro® in the U.S. on May 17 and March 30, respectively. First-half other revenues were down 19.4% to 673 million (or down 23.4% at constant exchange rates).

Gross profit reached 6,387 million in the second quarter, an increase of 3.3% (or a decrease of 3.5% at constant exchange rates). The ratio of cost of sales to net sales was virtually flat at 30.8%, 0.2 percentage points lower versus the second quarter of 2011, reflecting a favorable currency effect and industrial productivity enhancement which offset the negative evolution of the product mix. First-half gross profit reached 12,711 million, up 5.8% (or up 0.8% at constant exchange rates). In the first half of 2012, the ratio of cost of sales to net sales was 30.8%, 0.1 percentage points higher.

Research and development expenses were 1,239 million in the second quarter, an increase of 3.5%. At constant exchange rates, R&D expenses decreased 1.2% due to tight cost control on internal costs, ongoing transformation initiatives, which more than offset significant investment in late-stage portfolio. The ratio of R&D expenses to net sales was 14.0%, down 0.3 percentage points versus the second quarter of 2011. First-half R&D expenses reached 2,415 million, up 5.1% (or down 3.6% with Genzyme proforma and at constant exchange rates). In the first half of 2012, the ratio of R&D expenses to net sales was 13.9%, versus 14.2% in the first half of 2011.

Selling and general expenses were 2,289 million in the second quarter, an increase of 0.9%. At constant exchange rates, SG&A decreased 4.3% due to a tight control especially in mature areas coupled with synergies derived from the Genzyme integration despite continued investment in growth platforms. The ratio of selling and general expenses to net sales was 25.8%, down 1.4 percentage points versus the second quarter of 2011. First-half SG&A expenses reached 4,410 million, up 5.0% (or -4.6% with Genzyme proforma and at constant exchange rates). In the first half of 2012, the ratio of selling and general expenses to net sales was 25.4%, versus 26.0% in the first half of 2011.

Other current operating income net of expenses was a charge of 152 million in the second quarter of 2012 versus income of 7 million in the second quarter of 2011. In 2012, this line included an additional pre-tax reserve of 118 million linked to ramipril litigation in Canada. This line also includes a slight foreign exchange loss compared to a slight gain in the second quarter of 2012. In the first half of 2012, other current operating income net of expenses, which benefited from a settlement of a license litigation booked in the first quarter, was a loss of 5 million compared to an income of 23 million in the first half of 2011.

In the second quarter, the share of profits from associates was 122 million, down 56.1% (or down 60.1% at constant exchange rates) due to the loss of exclusivity of Plavix® and Avapro® in the U.S. The share of after-tax profits from the territories managed by BMS under the Plavix® and Avapro® alliance dropped 55.5% to 122 million. First-half share of profits from associates reached 419 million, down 26.5% (or down 30.4% at constant exchange rates), 417 million of which was attributed to BMS alliance.

Non-controlling interests were 50 million in the second quarter, a decrease of 13.8%, reflecting lower profits paid to BMS from territories managed by Sanofi (44 million versus 53 million in Q2 2011) as a result of generic competition in Europe. In the first half of 2012, non-controlling interests were 104 million, down 23.5%.

Second-quarter Business operating income was 2,779 million, down 5.6% (or down 13.6% at constant exchange rates). The ratio of business operating income to net sales reached 31.3%, compared to 35.3% in the second quarter of 2011. First-half business operating income increased 3.8% (or decreased 2.2% at constant exchange rates) to 6,196 million. The ratio of business operating income to net sales was 35.6%, down 1.4 percentage points compared to the first half of 2011.

1 See Appendix 10 for definitions of financial indicators, and Appendix 6 for reconciliation of business net income to consolidated net income attributable to equity holders of Sanofi

 

11


Net financial expenses reached 108 million, compared to 100 million in the second quarter of 2011. First-half-net financial expenses were 227 million versus 178 million in the first half of 2011 which included the financing of the Genzyme acquisition only for a quarter.

The effective tax rate was 28.0% compared to 26.5% in the second quarter of 2011. The first-half effective tax rate was 28.0% compared to 27.5% in the first half of 2011.

Business net income1 reached 1,944 million in the second quarter, down 9.6% (or down 17.6% at constant exchange rates). First-half business net income1 was 4,386 million, up 1.5% (or down 4.5% at constant exchange rates).

 

In the second quarter of 2012, Business earnings per share1 (EPS) was 1.48, down 9.8% and down 17.7% on a reported basis and at constant exchange rates, respectively. The average number of shares outstanding increased to 1,317.4 million this quarter versus 1,311.6 million in the second quarter of 2011.

In the first half of 2012, Business earnings per share1 (EPS) was 3.32 up 0.6% and down 5.2% on a reported basis and at constant exchange rates, respectively. The average number of shares outstanding increased to 1,319.3 million in the first half of 2012 versus 1,308.6 million in the first half of 2011.

From business net income to consolidated net income (see Appendix 6)

In the first half of 2012, the main reconciling items between business net income and consolidated net income attributable to equity holders of Sanofi were:

 

-

A 1,675 million amortization charge against intangible assets arising on the application of purchase accounting to acquired companies (primarily Aventis: 770 million, Genzyme: 487 million and Merial 196 million) and to acquired intangible assets (licenses/products: 73 million). The second quarter amortization charge against intangible assets was 842 million (primarily Aventis: 395 million, Genzyme 244 million and Merial 99 million), 28 million of which related to acquired intangible assets (licenses/products). This item has no cash impact on the Group.

 

-

An impairment loss against intangible assets of 40 million (of which 39 million in Q2 2012 mainly related to discontinuation of R&D projects). This item has no cash impact on the Group.

 

-

A charge of 106 million mainly reflecting an increase in the fair value of contingent considerations related to the CVRs (56 million, of which 32 million in Q2 2012) and Bayer contingent considerations (39 million, of which 32 million in Q2 2012).

 

-

A charge of 17 million arising from the workdown of inventories of acquired companies remeasured at fair value due to the application of purchase accounting to acquisitions. This item has no cash impact on the Group.

 

-

250 million of restructuring costs (including 163 million in the second quarter related to continuing transformation of R&D and Industrial Affairs in Europe).

 

-

A 714 million tax effect arising from the items listed above, comprising 615 million generated by amortization charged against intangible assets and 77 million associated with restructuring costs. The second quarter tax effect was 354 million, including 283 million of deferred taxes generated by amortization charged against intangible assets and 55 million linked to restructuring costs (see Appendix 6).

 

-

In “Share of profits/losses from associates”, a charge of 15 million, net of tax, mainly relating to the share of amortization of intangible assets (of which 7 million in Q2 2011). This item has no cash impact on the Group.

1 See Appendix 10 for definitions of financial indicators, and Appendix 6 for reconciliation of business net income to consolidated net income attributable to equity holders of Sanofi

 

12


Net Debt (See Appendices 8 and 9)

Net cash generated by operating activities after changes in working capital and before restructuring costs was 4,649 million in the first half of 2012, an increase of 6.6% compared to the first half of 2011. This amount covered a large part of capital expenditures (711 million), dividend paid by Sanofi (3,487 million), repurchasing of shares (454 million), acquisitions and partnerships (254 million) and restructuring costs (504 million). As a consequence, net debt increased from 10,859 million at December 31, 2011 to 11,347 million at June 30, 2012 (debt of 15,654 million, net of 4,307 million cash and cash equivalents).

***********************                

Limited review procedures on the half-year consolidated financial statements are complete. The limited review opinion is currently issuing.

***********************                

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, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

13


Appendices

List of appendices

Appendix 1: 2012 second-quarter and 2012 first-half consolidated net sales by product

Appendix 2: 2012 second-quarter and 2012 first-half consolidated net sales by geographic region and product

Appendix 3: Consolidated net sales by business segment

Appendix 4: Net sales of Growth Platforms

Appendix 5: 2012 second-quarter and 2012 first-half business net income statement

Appendix 6: Reconciliation of business net income to net income attributable to equity holders of Sanofi

Appendix 7: 2012 second-quarter and 2012 first-half consolidated income statement

Appendix 8: Change in net debt

Appendix 9: Simplified consolidated balance sheet

Appendix 10: Definitions of non-GAAP financial indicators

 

14


Appendix 1: 2012 second-quarter and first half consolidated net sales by product

 

  ( million)   

Q2 2012

net sales

     Change at constant
exchange rates
    Change on a reported
basis
 

  Lantus®

     1,228         16.5     26.7%   

  Apidra®

     56         0.0     5.7%   

  Amaryl®

     110         -5.5     0.9%   

  Insuman®

     33         3.0     0.0%   

Total Diabetes

     1,436         13.7     22.9%   

  Taxotere®

     159         -27.9     -22.1%   

  Eloxatin®

     375         35.9     51.2%   

  Jevtana®

     65         27.1     35.4%   

  Other Oncology

     152         0.0     7.0%   

Total Oncology

     751         7.0     17.0%   

  Lovenox®

     489         -11.0     -8.8%   

  Plavix®

     553         -1.0     8.4%   

  Aprovel®

     334         -5.8     -2.6%   

  Allegra®

     126         -2.5     5.9%   

  Stilnox®/Ambien®/Ambien CR®/Myslee®

     129         1.7     11.2%   

  Copaxone®

     0         -100.0     -100.0%   

  Depakine®

     102         0.0     2.0%   

  Tritace®

     93         -2.1     -2.1%   

  Multaq®

     64         -14.7     -5.9%   

  Xatral®

     36         -46.9     -43.8%   

  Actonel®

     36         -18.6     -16.3%   

  Nasacort®

     19         -38.7     -38.7%   

  Renagel®/ Renvela®

     165         10.9     20.4%   

  Synvisc®/ Synvisc one®

     106         9.0     19.1%   
                           

  Cerezyme®

     150         -13.9     -9.6%   

  Myozyme®

     113         9.1     14.1%   

  Fabrazyme®

     74         123.3     146.7%   

  Other Rare Diseases products

     97         13.9     22.8%   

New Genzyme

     434         9.1     16.0%   

  Other Rx Drugs

     1,432         -8.8     -5.5%   

  Consumer Health Care

     738         11.3     14.6%   

  Generics

     468         7.8     7.8%   
                           

  Total Pharmaceuticals

     7,511         -0.4     5.1%   
                           

  Vaccines

     783         3.0     10.9%   
                           

  Animal Health

     576         9.1     16.1%   
                           

  Total

     8,870         0.4     6.2%   
                           

Vaccines

  ( million)    Q2 2012
net sales
     Change at constant
exchange rates
    Change on a reported
basis
 

  Polio/Pertussis/Hib Vaccines

     273         -5.2     2.2%   

  Influenza Vaccines

     80         40.4     40.4%   

  Meningitis/Pneumonia Vaccines

     129         -3.3     6.6%   

  Adult Booster Vaccines

     146         20.9     32.7%   

  Travel and Other Endemics Vaccines

     100         5.6     11.1%   

  Other Vaccines

     55         -19.7     -9.8%   
                           

  Total Vaccines

     783         3.0     10.9%   
                           

Animal Health

  ( million)   

Q2 2012

net sales

     Change at constant
exchange rates
    Change on a reported
basis
 

  Frontline® and other fipronil products

     228         11.1     20.6%   

  Vaccines

     180         8.8     13.2%   

  Avermectin

     107         6.5     15.1%   

  Others

     61         7.3     10.9%   
                           

  Total

     576         9.1     16.1%   
                           

 

15


       
  ( million)   

H1 2012

net sales

    

 

Change at constant
exchange rates

    Change on a reported
basis
 

  Lantus®

     2,346         16.8     23.9

  Apidra®

     108         2.0     5.9

  Amaryl®

     213         -6.5     -1.8

  Insuman®

     65         3.1     1.6

Total Diabetes

     2,747         14.0     20.4

  Taxotere®

     309         -50.0     -47.3

  Eloxatin®

     759         61.9     74.1

  Jevtana®

     119         18.8     24.0

  Other Oncology

     305                

Total Oncology

     1,492         9.9     16.8

  Lovenox®

     1,015         -10.7     -9.3

  Plavix®

     1,058         -0.6     6.4

  Aprovel®

     641         -5.9     -3.3

  Allegra®

     308         -14.0     -8.1

  Stilnox®/Ambien®/Ambien CR®/Myslee®

     254         1.7     9.5

  Copaxone®

     24         -90.1     -89.7

  Depakine®

     202         1.5     3.1

  Tritace®

     180         -6.7     -7.2

  Multaq®

     127         -9.2     -3.1

  Xatral®

     69         -48.1     -46.5

  Actonel®

     72         -23.1     -20.9

  Nasacort®

     38         -50.0     -48.6

  Renagel®/ Renvela®

     312                

  Synvisc®/ Synvisc1®

     184                
                           

  Cerezyme®

     299                

  Myozyme®

     225                

  Fabrazyme®

     121                

  Other Rare Diseases products

     189                

New Genzyme

     834                

  Other Rx Drugs

     2,820         -5.3     -7.4

  Consumer Health Care

     1,543         11.4     13.8

  Generics

     907         7.2     7.0
                           

  Total Pharmaceuticals

     14,827         4.0     8.0
                           

  Vaccines

     1,400         1.5     7.0
                           

  Animal Health

     1,154         1.2     5.9
                           

  Total

     17,381         3.6     7.8
                           

  Vaccines

 

       
  ( million)    H1 2012
net sales
    

 

Change at constant
exchange rates

    Change on a reported
basis
 

  Polio/Pertussis/Hib Vaccines

     518         -0.4     4.9%   

  Influenza Vaccines

     169         5.7     7.0%   

  Meningitis/Pneumonia Vaccines

     202         2.7     10.4%   

  Adult Booster Vaccines

     233         5.3     13.1%   

  Travel and Other Endemics Vaccines

     177         0.0     3.5%   

  Other Vaccines

     101         -3.1     5.2%   
                           

  Total Vaccines

     1,400         1.5     7.0%   
                           

  Animal Health

 

       
  ( million)   

H1 2012

net sales

    

 

Change at constant
exchange rates

     Change on a reported
basis
 

  Frontline® and other fipronil products

     468         -3.5%         2.0%   

  Vaccines

     345         3.4%         6.2%   

  Avermectin

     221         5.1%         11.6%   

  Others

     120         7.4%         11.1%   
                            

  Total

     1,154         1.2%         5.9%   
                            

 

16


Appendix 2: 2012 second-quarter and first half consolidated net sales by geographic region and product

Second-quarter 2012

Pharmaceuticals

 

Q2 net sales ( million)    Western
Europe
     Change at
CER
     United
States
     Change at
CER
     Emerging
Markets
     Change at
CER
     Rest of the
World
     Change at
CER
 

  Lantus®

     194         1.6      760         19.4      198         20.6      76         25.5

  Apidra®

     18         -10.0      18         -16.7      13         18.2      7         75.0

  Amaryl®

     8         -11.1      1         0.0      68         14.0      33         -31.0

  Insuman®

     24         -7.7      0                9         28.6      0         -   
                                                                         

Total Diabetes

     251         0.4      781         18.5      288         19.1      116         5.9

  Taxotere®

     13         -74.5      22         -44.1      73         -2.7      51         -4.3

  Eloxatin®

     3         -60.0      313         53.3      40         -5.0      19         0.0

  Jevtana®

     25         166.7      32         -20.0      8         166.7      0         0.0

  Other Oncology

     36         -5.4      84         0.0      21         -8.7      11         50.0
                                                                         

Total Oncology

     77         -29.0      451         23.1      142         -0.7      81         2.8

  Lovenox®

     219         2.8      87         -52.5      158         12.0      25         9.1

  Plavix®

     89         -20.0      28*         -49.1      202         6.9      234         17.8

  Aprovel®

     170         -15.5      12*         -7.7      107         4.2      45         22.9

  Allegra®

     4         0.0      0         -         35         34.6      87         -13.5

  Stilnox®/Ambien®/Ambien CR®/Myslee®

     12         -7.7      20         -10.0      17         12.5      80         4.5

  Copaxone®

     0         -100.0      0         -         0         -         0         -100.0

  Depakine®

     36         -5.4      0         -         62         3.4      4         0.0

  Tritace®

     41         -6.8      0         -         48         4.3      4         -25.0

  Multaq®

     11         -35.3      50         -4.3      2         0.0      1         -100.0

  Xatral®

     12         -25.0      7         -78.1      15         -6.3      2         -   

  Actonel®

     8         -46.7      0         -         19         -9.5      9         14.3

  Nasacort®

     6         -25.0      5         -75.0      8         33.3      0         0.0

  Renagel®/ and Renvela®

     33         -8.6      111         23.8      14         25.0      7         -40.0

  Synvisc®/ Synvisc one®

     4         -33.3      87         11.6      7         40.0      8         0.0
                                                                         

  Cerezyme®

     54         -11.5      43         -9.5      38         -20.8      15         -13.3

  Myozyme®

     63         6.9      28         4.0      14         40.0      8         0.0

  Fabrazyme®

     11         42.9      39         169.2      12         175.0      12         83.3

  Other Rare Diseases products

     23         27.8      33         0.0      18         30.8      23         10.5

New Genzyme

     151         3.5      143         17.4      82         6.7      58         10.9

  Other Rx Drugs

     561         -8.5      146         -24.1      533         -0.9      192         -17.3

  Consumer Health Care

     161         1.9      157         -3.4      357         26.9      63         -1.7
                                                                         

  Generics

     118         4.5      67         76.5      277         2.5      6         -40.0
                                                                         

  Total Pharma

     1,964         -11.7      2,152         3.0      2,373         8.3      1,022         -0.8
                                                                         

*Sales of active ingredient to the American entity managed by BMS

 

Vaccines

 

  

  

  Q2 net sales ( million)    Western
Europe
     Change at
CER
     United
States
     Change at
CER
     Emerging
Markets
     Change at
CER
     Rest of the
World
     Change at
CER
 

  Polio/Pertussis/Hib Vaccines

     8         28.6      102         -17.4      131         14.4      32         -32.5

  Influenza Vaccines

     0         -         0         -         78         40.0      2         50.0

  Meningitis/Pneumonia Vaccines

     2         100.0      99         -9.4      28         18.2      0         0.0

  Adult Booster Vaccines

     21         -4.5      104         17.9      14         180.0      7         20.0

  Travel and Other Endemics Vaccines

     5         -28.6      32         16.7      52         8.3      11         -9.1

  Other Vaccines

     1         -100.0      45         -16.0      4         25.0      5         -50.0
                                                                         

  Total vaccines

     37         -7.5      382         -5.0      307         22.9      57         -21.9
                                                                         

 

17


 

Animal Health

                       
  Q2 net sales ( million)    Western
Europe
     Change at
CER
     United
States
     Change at
CER
     Emerging
Markets
     Change at
CER
     Rest of the
World
     Change at
CER
 

  Frontline® and other fipronil products

     59         0.0      135         18.8      24         4.3      10         14.3

  Vaccines

     43         2.4      38         9.4      92         11.0      7         33.3

  Avermectin

     12         -15.4      62         19.1      16         6.7      17         -11.1

  Others

     21         5.0      26         23.5      11         33.3      3         -44.4
                                                                         

  Total

     135         0.0      261         17.8      143         10.9      37         -10.8
                                                                         

 

First-half 2012

 

Pharmaceuticals

 

                       
H1 2012 net sales ( million)    Western
Europe
     Change at
CER
     United
States
     Change at
CER
     Emerging
Markets
     Change at
CER
     Rest of the
World
     Change at
CER
 

  Lantus®

     383         4.7      1,444         18.0      379         26.0      140         20.6

  Apidra®

     40         2.6      32         -12.1      24         14.3      12         22.2

  Amaryl®

     16         -5.9      2         0.0      130         10.5      65         -29.8

  Insuman®

     48         -4.0      0                17         21.4      0          
                                                                         

Total Diabetes

     500         5.1      1,480         17.2      550         21.3      217         0.5

  Taxotere®

     32         -74.4      37         -83.2      147         -7.7      93         -19.4

  Eloxatin®

     9         -62.5      634         95.0      81         -2.5      35         3.1

  Jevtana®

     44         290.9      60         -32.1      15         275.0      0         0.0

  Other Oncology

     73                169                43                20          
                                                                         

Total Oncology

     158         -23.2      900         24.6      286         6.1      148         -4.9

  Lovenox®

     444         5.5      209         -49.2      312         15.3      50         6.8

  Plavix®

     180         -18.3      72*         -32.7      393         6.1      413         14.5

  Aprovel®

     339         -14.7      26*         13.0      204         2.7      72         19.3

  Allegra®

     7         -12.5      -1         -120.0      61         27.1      241         -19.3

  Stilnox®/Ambien®/Ambien CR®/Myslee®

     24         -11.1      40         -14.0      36         19.4      154         5.3

  Copaxone®

     19         -91.4      0                0                5         -63.6

  Depakine®

     71         -2.8      0                123         5.2      8         -12.5

  Tritace®

     80         -9.1      0                93         0.0      7         -45.5

  Multaq®

     23         -32.4      99         1.1      4         33.3      1         -100.0

  Xatral®

     25         -19.4      12         -83.1      30         -6.3      2         0.0

  Actonel®

     18         -40.0      0                36         -14.3      18         -15.8

  Nasacort®

     11         -26.7      11         -77.8      14         16.7      2         0.0

  Renagel®/ and Renvela®

     66                213                21            12          

  Synvisc®/ Synvisc one®

     10                153                11                10          
                                                                         

  Cerezyme®

     106                79                84                30          

  Myozyme®

     125                58                26                16          

  Fabrazyme®

     21                62                18                20          

  Other Rare Diseases products

     46                61                38                44          

New Genzyme

     298                260                166                110          

  Other Rx Drugs

     1,132         -10.0      285         -11.4      1,034         -0.7      369         -13.5

  Consumer Health Care

     355         3.2      340         0.3      724         24.3      124         0.0
                                                                         

  Generics

     224         -2.2      141         98.5      529         1.3      13         -33.3
                                                                         

  Total Pharma

     3,984         -6.7      4,240         11.2      4,627         10.8      1,976         -0.7
                                                                         

*Sales of active ingredient to the American entity managed by BMS

  

 

18


 

Vaccines

                       
  H1 2012 net sales ( million)    Western
Europe
     Change at
CER
     United
States
     Change at
CER
     Emerging
Markets
     Change at
CER
     Rest of the
World
     Change at
CER
 
  Polio/Pertussis/Hib Vaccines      26         52.9      210         -7.2      220         0.5      62         5.7
  Influenza Vaccines      0                6                150         1.4      13         9.1
  Meningitis/Pneumonia Vaccines      2         100.0      136         -5.4      62         27.7      2         -40.0
  Adult Booster Vaccines      34         -19.0      166         6.3      22         83.3      11         0.0
  Travel and Other Endemics Vaccines      12         9.1      53         17.1      90         -8.2      22         0.0
  Other Vaccines      5         -16.7      79         -2.6      9         12.5      8         -16.7
                                                                         

  Total vaccines

     79         2.6      650         -0.3      553         3.6      118         0.9
                                                                         

 

  Animal Health

                       
  H1 2012 net sales ( million)    Western
Europe
     Change at
CER
     United
States
     Change at
CER
     Emerging
Markets
     Change at
CER
     Rest of the
World
     Change at
CER
 
  Frontline® and other fipronil products      138         -0.7      262         -5.5      43         4.9      25         -12.0

  Vaccines

     88         -11.1      71         10.0      176         8.8      10         33.3

  Avermectin

     30         -3.3      125         9.4      28         3.7      38         0.0

  Others

     42         -2.3      47         20.0      20         23.5      11         -15.4
                                                                         

  Total

     298         -4.5      505         2.0      267         8.6      84         -3.8
                                                                         

Appendix 3: Consolidated net sales by business segment

 

  Millions of euros    Q2 2012      Q2 2011      H1 2012      H1 2011  

  Pharmaceuticals

     7,511         7,147         14,827         13,730   

  Vaccines

     783         706         1,400         1,308   
                                     

  Merial

     576         496         1,154         1,090   
                                     

  Total

     8,870         8,349         17,381         16,128   
                                     

Appendix 4: Net sales of Growth Platforms

 

  (millions of euros)            Q2 2012              Change at constant
exchange rates
             H1 2012              Change at constant
exchange rates
 

  Emerging Markets1/2

     2,823            9.8%            5,547            9.9%      

Emerging Markets excluding Diabetes, Animal Health, New Genzyme, Vaccines, CHC, and new products

        1,634            3.0%            3,165            3.5%   

  Diabetes

        1,436            13.7%            2,747            14.0%   

  Vaccines

        783            3.0%            1,400            1.5%   

  Consumer Health Care (CHC)

        738            11.3%            1,543            11.4%   

  Animal Health

        576            9.1%            1,154            1.2%   

  New Genzyme

        434            9.1%            834            11.3%3   

  New products4

        152            4.5%            291            5.3%   
                                                                         

  Total Growth Platforms

        5,753            7.6%            11,134            11.0%   
                                                                         

  Total Growth Platforms with Genzyme pro forma

        5,753            7.6%            11,134            6.7%   
                                                                         

1 World excluding the U.S. and Canada, Western Europe, Japan, Australia and New Zealand.

2 Include Diabetes, Vaccines, Consumer Health Care, new Genzyme, Merial and new products sales generated in Emerging Markets;

3 “new Genzyme” on a constant structure basis and at constant exchange rates;

4 Multaq® and Jevtana® and Mobozyl® pro forma

 

19


Appendix 5: Business net income statement

 

Second quarter 2012   Pharmaceuticals     Vaccines     Animal Health     Other     Group Total  
  Millions of euros   Q2 2012     Q2 2011     % change     Q2 2012     Q2 2011     % change     Q2 2012     Q2 2011     % change     Q2 2012     Q2 2011     Q2 2012     Q2 2011     % change  
  Net sales   7,511     7,147     5.1%     783     706     10.9%     576     496     16.1%                   8,870     8,349     6.2%  

    Other revenues

    233        412        (43.4%)        5        5        -        9        5        80.0%            247        422        (41.5%)   

    Cost of sales

    (2,249)        (2,146)        4.8%        (303)        (282)        7.4%        (178)        (160)        11.3%            (2,730)        (2,588)        5.5%   

    As % of net sales

    (29.9%)        (30.0%)          (38.7%)        (39.9%)          (30.9%)        (32.3%)              (30.8%)        (31.0%)     
                                                                                                                 

  Gross profit

    5,495        5,413        1.5%        485        429        13.1%        407        341        19.4%            6,387        6,183        3.3%   

  As % of net sales

    73.2%        75.7%          61.9%        60.8%          70.7%        68.8%              72.0%        74.1%     
                                                                                                                 

    Research and development expenses

    (1,057)        (1,023)        3.3%        (143)        (139)        2.9%        (39)        (35)        11.4%            (1,239)        (1,197)        3.5%   

    As % of net sales

    (14.1%)        (14.3%)          (18.3%)        (19.7%)          (6.8%)        (7.1%)              (14.0%)        (14.3%)     

    Selling and general expenses

    (1,939)        (1,969)        (1.5%)        (158)        (137)        15.3%        (191)        (161)        18.6%        (1)        (1)        (2,289)        (2,268)        0.9%   

    As % of net sales

    (25.8%)        (27.6%)          (20.1%)        (19.4%)          (33.1%)        (32.5%)              (25.8%)        (27.2%)     

    Other current operating income/expenses

    (165)        (20)            (2)            10          13        19        (152)        7     

    Share of profit/loss of associates*

    123        276          (1)        2                    122        278     

    Net income attributable to non-controlling interests

    (49)        (58)                (1)                (50)        (58)     
                                                                                                                 

Business operating income

    2,408        2,619        (8.1%)        183        153        19.6%        176        155        13.5%        12        18        2,779        2,945        (5.6%)   

  As % of net sales

    32.1%        36.6%          23.4%        21.7%          30.6%        31.3%              31.3%        35.3%     
                                                                                                                 

    Financial income and expenses

                          (108)        (100)     

    Income tax expense

                          (727)        (695)     

    Tax rate**

                          28.0%        26.5%     
                                                                                                                 

  Business net income

                          1,944        2,150        (9.6%)   

  As % of net sales

                          21.9%        25.8%     
                                                                                                                 

Business earnings per share*** (in euros)

                          1.48        1.64        (9.8%)   

*    Net of tax

**  Determined on the basis of Business income before tax, associates, and non-controlling interests

*** Based on an average number of shares outstanding of 1,317.4 million in the second quarter of 2012 and 1,311.6 million in the second quarter of 2011

 

20


  First-half 2012   Pharmaceuticals     Vaccines     Animal Health     Other     Group Total  
  Millions of euros   H1 2012     H1 2011     % change     H1 2012     H1 2011     % change     H1 2012     H1 2011     % change     H1 2012     H1 2011     H1 2012     H1 2011     % change  
  Net sales   14,827     13,730     8.0%     1,400     1,308     7.0%     1,154     1,090     5.9%                   17,381     16,128     7.8%  

    Other revenues

    645        816        (21.0%)        10        10        -        18        9        100.0%            673        835        (19.4%)   

    Cost of sales

    (4,431)        (4,073)        8.8%        (566)        (550)        2.9%        (346)        (327)        5.8%            (5,343)        (4,950)        7.9%   

    As % of net sales

    (29.9%)        (29.7%)          (40.4%)        (42.1%)          (30.0%)        (30.0%)              (30.8%)        (30.7%)     
                                                                                                                 

  Gross profit

    11,041        10,473        5.4%        844        768        9.9%        826        772        7.0%            12,711        12,013        5.8%   

  As % of net sales

    74.5%        76.3%          60.3%        58.7%          71.6%        70.8%              73.1%        74.5%     
                                                                                                                 

    Research and development expenses

    (2,051)        (1,963)        4.5%        (284)        (264)        7.6%        (80)        (70)        14.3%            (2,415)        (2,297)        5.1%   

    As % of net sales

    (13.8%)        (14.3%)          (20.3%)        (20.2%)          (6.9%)        (6.4%)              (13.9%)        (14.2%)     

    Selling and general expenses

    (3,763)        (3,614)        4.1%        (288)        (264)        9.1%        (358)        (322)        11.2%        (1)        (1)        (4,410)        (4,201)        5.0%   

    As % of net sales

    (25.4%)        (26.3%)          (20.6%)        (20.2%)          (31.1%)        (29.6%)              (25.4%)        (26.0%)     

    Other current operating income/expenses

    (21)        42          (1)        (1)          1        (7)          16        (11)        (5)        23     

    Share of profit/loss of associates*

    425        559          (6)        (2)                  13        419        570     

Net income attributable to non-controlling interests

    (104)        (136)                          (104)        (136)     
                                                                                                                 

Business operating income

    5,527        5,361        3.1%        265        237        11.8%        389        373        4.3%        15        1        6,196        5,972        3.8%   

  As % of net sales

    37.3%        39.0%          18.9%        18.1%          33.7%        34.2%              35.6%        37.0%     
                                                                                                                 

    Financial income and expenses

                          (227)        (178)     

    Income tax expense

                          (1,583)        (1,474)     

    Tax rate**

                          28.0%        27.5%     
                                                                                                                 

  Business net income

                          4,386        4,320        1.5%   

  As % of net sales

                          25.2%        26.8%     
                                                                                                                 

Business earnings per share*** (in euros)

                          3.32        3.30        0.6%   

*    Net of tax

**  Determined on the basis of Business income before tax, associates, and non-controlling interests

*** Based on an average number of shares outstanding of 1,319.3 million in the first semester of 2012 and 1,308.6 million in the first semester of 2011

 

21


Appendix 6: Reconciliation of Business net income to Net income attributable to equity holders of Sanofi

 

  Millions of euros    Q2 2012      Q2 2011      % change  

  Business net income

     1,944         2,150         (9.6%
                            

  Amortization of intangible assets(1)

     (842)         (965)      

  Impairment of intangible assets

     (39)         (37)      

  Fair value remeasurement of contingent consideration liabilities

     (73)         (20)      

  Expenses arising from the impact of acquisitions on inventories

     (3)         (262)      

  Restructuring costs

     (163)         (345)      

  Other gains and losses, and litigation

        

  Tax effect of :

     354         492      

Amortization of intangible assets

     283         296      

Impairment of intangible assets

     14         10      

Fair value remeasurement of contingent

consideration liabilities

     1         5      

Expenses arising on the workdown of acquired

inventories

     1         78      

Restructuring costs

     55         108      

Other gains and losses, and litigation

        (5)      

  Share of items listed above attributable to non-controlling interests

        

  Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures

     (7)         (7)      
                            

  Net income attributable to equity holders of sanofi

     1,171         1,006         16.4
                            

  Consolidated earnings per share(2) (in euros)

     0.89         0.77         15.6
                            

 

(1) 

Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: 814 million in the second quarter of 2012 and 921 million in the second quarter of 2011.

 

(2) 

Based on an average number of shares outstanding of 1,317.4 million in the second quarter of 2012 and 1,311.6 in the second quarter of 2011.

See page 12 for comments on the reconciliation of business net income to consolidated net income

 

Page 22 of 27


  Millions of euros    H1 2012     H1 2011     % change  

  Business net income

     4,386        4,320        1.5%   
                          

  Amortization of intangible assets(1)

     (1,675     (1,701  

  Impairment of intangible assets

     (40     (69  

  Fair value remeasurement of contingent consideration liabilities

     (106     (66  

  Expenses arising from the impact of acquisitions on inventories

     (17     (264  

  Restructuring costs

     (250     (467  

  Other gains and losses, and litigation

       (517  

  Tax effect of :

     714        1,002     

Amortization of intangible assets

     615        559     

Impairment of intangible assets

     14        20     

Fair value remeasurement of contingent

consideration liabilities

     3        5     

Expenses arising on the workdown of acquired

inventories

     5        78     

Restructuring costs

     77        150     

Other gains and losses, and litigation

       190     

  Share of items listed above attributable to non-controlling interests

     1       

  Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures

     (15     (14  
                          

  Net income attributable to equity holders of sanofi

     2,998        2,224        34.8
                          

  Consolidated earnings per share(2) (in euros)

     2.27        1.70        33.5
                          

 

  (1)

Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: 1,602 million in the first semester of 2012 and 1,607 million in the first semester of 2011.

 

  (2)

Based on an average number of shares outstanding of 1,319.3 million in the first semester of 2012 and 1,308.6 in the first semester of 2011.

 

Page 23 of 27


Appendix 7: Consolidated income statements

 

  Millions of euros    Q2 2012     Q2 2011     H1 2012     H1 2011  

  Net sales

     8,870        8,349        17,381        16,128   
                                  

Other revenues

     247        422        673        835   

Cost of sales

     (2,733     (2,850     (5,360     (5,214
                                  

  Gross profit

     6,384        5,921        12,694        11,749   
                                  

Research and development expenses

     (1,239     (1,197     (2,415     (2,297

Selling and general expenses

     (2,289     (2,268     (4,410     (4,201

Other operating income

     113        73        319        191   

Other operating expenses

     (265     (66     (324     (168

Amortization of intangible assets

     (842     (965     (1,675     (1,701

Impairment of intangible assets

     (39     (37     (40     (69

Fair value remeasurement of contingent consideration liabilities

     (73     (20     (106     (66

Restructuring costs

     (163     (345     (250     (467

Other gains and losses, and litigation

           (517
                                  

  Operating income

     1,587        1,096        3,793        2,454   
                                  

Financial expenses

     (133     (133     (272     (234

Financial income

     25        33        45        56   
                                  

  Income before tax and associates and joint ventures

     1,479        996        3,566        2,276   
                                  

Income tax expenses

     (373     (203     (869     (472

Share of profit/loss of associates and joint ventures

     115        271        404        556   
                                  

  Net income

     1,221        1,064        3,101        2,360   
                                  

Net income attributable to non-controlling interests

     50        58        103        136   
                                  

  Net income attributable to equity holders of sanofi

     1,171        1,006        2,998        2,224   
                                  

Average number of shares outstanding (million)

     1,317.4        1,311.6        1,319.3        1,308.6   
                                  

  Consolidated Earnings per share (in euros)

     0.89        0.77        2.27        1.70   
                                  

 

Page 24 of 27


Appendix 8: Change in net debt

 

  Millions of euros    H1 2012      H1 2011  

  Business net income

     4,386         4,320   
                   

Depreciation, amortization and impairment of property, plant and equipment and intangible assets

     627         555   

  Net gains and losses on disposals of non-current assets, net of tax

     (40)         (35)   

  Other non cash items

     360         276   
                   

  Operating cash flow before changes in working capital (1)

     5,333         5,116   
                   

  Changes in working capital (1)

     (684)         (754)   

  Acquisitions of property, plant and equipment and software

     (711)         (768)   
                   

  Free cash flow (1)

     3,938         3,594   
                   

  Acquisitions of intangibles, excluding software

     (75)         (64)   

  Acquisitions of investments, including assumed debt(2)

     (179)         (13,935)   

  Restructuring costs paid

     (504)         (353)   

  Proceeds from disposals of property, plant and equipment, intangibles, and other non-current assets, net of tax

     71         71   

  Issuance of sanofi shares

     74         28   

  Dividends paid to sanofi shareholders

     (3,487)         (1,372)   

  Acquisition of treasury shares

     (454)         (113)   

  Disposals of treasury shares, net of tax

        1   

  Other items(3)

     128         489   
                   

  Change in net debt

     (488)         (11,654)   
                   

(1) Excluding restructuring costs

(2) In 2011: (13,528) M related to Genzyme acquisition

(3) In 2012: of which foreign exchange effect on net debt (68) M

 

Page 25 of 27


Appendix 9: Simplified consolidated balance sheets

 

  ASSETS

   million

  06/30/2012     12/31/2011(1)     

LIABILITIES & EQUITY

million

  06/30/2012     12/31/2011(1)  

  Property, plant and

  equipment

    10,723        10,750      

Equity attributable to equity-

holders of sanofi

    56,208        56,203   

Intangible assets (including goodwill)

    61,462        62,221      

Equity attributable to

non-controlling interests

    146        170   

  Non-current financial assets, investments in associates, and deferred tax assets

    7,859        6,839       Total equity     56,354        56,373   
       Long-term debt     10,270        12,499   
      

Non-current liabilities related to

business combinations and to non-controlling interests

    1,449        1,336   

  Non-current assets

    80,044        79,810       Provisions and other non-current liabilities     11,175        10,346   
       Deferred tax liabilities     6,398        6,530   

  Inventories, accounts receivable and other current assets

    17,141        16,667       Non-current liabilities     29,292        30,711   

  Cash and cash equivalents

    4,307        4,124       Accounts payable and other current liabilities     10,008        10,404   
      

Current liabilities related to business combinations and

to non-controlling interests

    154        220   
       Short-term debt and current portion of long-term debt     5,912        2,940   

  Current assets

    21,448        20,791       Current liabilities     16,074        13,564   

  Assets held for sale or exchange

    251        67       Liabilities related to assets held for sale or exchange     23        20   
                                      

  Total ASSETS

    101,743        100,668      

Total LIABILITIES &

EQUITY

    101,743        100,668   
                                      

(1) In accordance with IFRS 3, Sanofi has revised during the measurement period, certain provisional amounts recognized in 2011.

 

Page 26 of 27


Appendix 10: Definitions of non-GAAP financial indicators

Net sales at constant exchange rates

When we refer to changes in our net sales “at constant exchange rates”, this means that we exclude the effect of changes in exchange rates.

We eliminate the effect of exchange rates by recalculating net sales for the relevant period at the exchange rates used for the previous period.

Reconciliation of reported net sales to net sales at constant exchange rates for the second quarter and the first half of 2011

 

  (millions of euros)    Q2 2012      H1 2012  

  Net sales

     8,870         17,381   

  Effect of exchange rates

     (486)         (673)   

  Net sales at constant exchange rates

     8,384         16,708   
                   

Net sales on a constant structure basis

We eliminate the effect of changes in structure by restating prior-period net sales as follows:

 

   

by including sales from the acquired entity or product rights for a portion of the prior period equal to the portion of the current period during which we owned them, based on sales information we receive from the party from whom we make the acquisition;

 

   

similarly, by excluding sales in the relevant portion of the prior period when we have sold an entity or rights to a product;

 

   

for a change in consolidation method, by recalculating the prior period on the basis of the method used for the current period.

Worldwide presence of Plavix®/Iscover®, Avapro®/Aprovel®

When we refer to the “worldwide presence” of a product, we mean our consolidated net sales of that product, minus sales of the product to our alliance partners plus non-consolidated sales made through our alliances with Bristol-Myers Squibb on Plavix®/Iscover® (clopidogrel bisulfate) and Aprovel®/Avapro®/Karvea® (irbesartan), based on information provided to us by our alliance partner.

Business net income

Sanofi publishes a key non-GAAP indicator in response to the application of IFRS 8. This indicator “Business net income”, replaced “adjusted net income excluding selected items”.

Business net income is defined as net income attributable to equity holders of Sanofi excluding:

 

   

amortization of intangible assets,

 

   

impairment of intangible assets,

 

   

fair value remeasurement of contingent consideration liabilities related to business combinations,

 

   

other impacts associated with acquisitions (including impacts of acquisitions on associates),

 

   

restructuring costs *,

 

   

other gains and losses (including gains and losses on disposals of non-current assets*),

 

   

costs or provisions associated with litigation*,

 

   

tax effects related to the items listed above as well as effects of major tax disputes,

*Reported in the line items Restructuring costs and Gains and losses on disposals, and litigation, which are defined in Note B.20. to our consolidated financial statements.

 

Page 27 of 27