EX-99.1 2 a14-23195_1ex99d1.htm EX-99.1

Exhibit 99.1

 

PRESS RELEASE

 

 

 

 

Paris, October 28, 2014

 

Sanofi delivers Business EPS(1) growth of 10.3% at CER in Q3 2014

 

Solid sales and business EPS(1) growth at CER in the third quarter

 

·         Group sales(2) up 5.1% to €8,781 million

·         Growth platforms(3) increased 10.0% to €6,862 million, representing 78.1% of total sales

·         Business net income(1) grew 9.4% at CER to €1,935 million (+7.8% on a reported basis)

·         Business EPS(1) increased 10.3% at CER to €1.47

 

Steady sales increase in growth platforms

 

·         Diabetes grew 8.3% to €1,799 million despite increased price competition in the U.S.

·         Vaccines sales grew 11.2% driven by strong performance of flu vaccine and progressive supply recovery

·         Genzyme continued to deliver with sales growth of 24.6%

·         Animal Health grew 12.7% due to strong sales in the U.S. market

 

Significant advances in bringing new medicines to market

 

·         Cerdelga™, the only oral therapy for adult Gaucher disease type 1 patients, approved in the U.S.

·         Detailed results from four pivotal Phase III alirocumab trials presented at the ESC congress

·         Final landmark Phase III efficacy study in Latin America for Dengue vaccine successfully completed

·         Dupilumab, an investigational therapy for moderate-to-severe atopic dermatitis, entered Phase III

·         Investigational rotavirus vaccine for Emerging Markets entered Phase III

·         Global licensing agreement announced for Afrezza®, a new rapid-acting inhaled insulin

 

Financial guidance for 2014 confirmed

 

·         2014 business EPS(1) is expected to be between 6% to 8% higher than 2013 at CER, barring major unforeseen adverse events

 

Sanofi Chief Executive Officer, Christopher A. Viehbacher commented:

 

“We are pleased with our performance in the third quarter. We achieved solid Business EPS growth driven by continued strong contribution from our growth platforms, allowing us to confirm 2014 outlook. Growth platforms reached over 78% of sales and grew 10%. We have recently seen a more challenging U.S. diabetes price environment which will impact our diabetes sales throughout 2015, while growth platforms globally are expected to continue to show solid growth. At the same time, our pipeline delivered strong results, with the release of exciting Phase III data for alirocumab and our Dengue vaccine, the entry of dupilumab in Phase III as well as the FDA approval of Cerdelgaand the licensing of Afrezza®.”

 


(1) See Appendix 8 for definitions of financial indicators; (2) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 8 for a definition); (3) See page 2

 

Investor Relations: (+) 33 1 53 77 45 45 - E-mail: IR@sanofi.com  -  Media Relations: (+) 33 1 53 77 46 46 - E-mail: MR@sanofi.com

Web site: www.sanofi.com  Mobile app : SANOFI IR available on the App Store and Google Play

 



 

2014 third-quarter and 9-month figures

 

 

 

Q3 2014

 

Change
(reported)

 

Change
(CER)

 

9M 2014

 

Change
(reported)

 

Change
(CER)

 

Net sales

 

8,781

m

+4.1

%

+5.1

%

24,698

m

+0.8

%

+5.0

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business net income(1)

 

1,935

m

+7.8

%

+9.4

%

5,019

m

+3.0

%

+9.3

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business EPS(1)

 

1.47

 

+8.1

%

+10.3

%

3.81

 

+3.5

%

+10.1

%

 

In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income(1) is a non-GAAP financial measure. The consolidated income statement for 9M 2014 is provided in Appendix 4 and a reconciliation of business net income to consolidated net income in Appendix 3. Consolidated net income for 9M 2014 was €3,051 million compared to €2,656 million for 9M 2013. Consolidated EPS for 9M 2014 was €2.32 versus €2.01 for 9M 2013. Consolidated EPS for Q3 2014 was €0.91 versus €0.92 for Q3 2013.

 

2014 third-quarter and 9-month sales

 

Unless otherwise indicated, all sales growth figures in this press release are stated at constant exchange rates(1).

 

In the third quarter of 2014, Sanofi generated sales of €8,781 million, an increase of 4.1% on a reported basis. Exchange rate movements had a negative effect of 1.0 percentage point primarily reflecting the strength of the euro versus other currencies, in particular the Argentine Peso, Japanese Yen and Russian Ruble.

 

Year-to-date sales increased 0.8% to €24,698 million on a reported basis. Exchange rate movements had an unfavorable effect of 4.2 percentage points.

 

Growth Platforms

 

In the third quarter, sales of the Group’s growth platforms increased 10.0% to €6,862 million, driven by the performance of Genzyme (up 24.6%), Vaccines (up 11.2%), Animal Health (up 12.7%) and Other Innovative Products (up 18.0%). The Group’s growth platforms accounted for 78.1% of total consolidated sales in the third quarter, up from 74.7% in the third quarter of 2013. Year-to-date sales of growth platforms reached €18,801 million, an increase of 10.8%, and accounted for 76.1% of total consolidated sales compared with 72.5% in the first nine month of 2013.

 

€ million

 

Q3 2014
net sales

 

Change
(CER)

 

9M 2014
net sales

 

Change
(CER)

 

Diabetes

 

1,799

 

+8.3

%

5,249

 

+12.5

%

Vaccines

 

1,451

 

+11.2

%

2,797

 

+4.1

%

Consumer Healthcare (CHC)

 

819

 

+12.9

%

2,520

 

+17,3

%

Genzyme

 

649

 

+24.6

%

1,858

 

+25.1

%

Animal Health

 

515

 

+12.7

%

1,569

 

+5.3

%

Other Innovative Products(a)

 

227

 

+18.0

%

606

 

+17.9

%

Emerging Markets(b)

 

2,776

 

+7.6

%

8,221

 

+9.9

%(c)

of which Diabetes, Vaccines, CHC, Animal Health, Genzyme and Other Innovative Products

 

1,374

 

+14.0

%

4,019

 

+14.8

%

of which other products

 

1,402

 

+2.0

%

4,202

 

+5.5

%

Total Growth Platforms

 

6,862

 

+10.0

%

18,801

 

+10.8

%

 


(a)         Includes product launches since 2009 which do not belong to the other Growth Platforms listed above: Multaq®, Jevtana®, Zaltrap®, Auvi-Q and Mozobil®.

(b)         World excluding the U.S. and Canada, Western Europe, Japan, Australia and New Zealand.

(c)          Excluding generics in Brazil, sales in Emerging Markets grew 6.1% in 9M 2014.

 

(1) See Appendix 8 for definitions of financial indicators.

 

2



 

Pharmaceuticals

 

Third-quarter sales for the Pharmaceuticals business grew 3.4% to €6,815 million, driven by Emerging Markets. Year-to-date sales for Pharmaceuticals increased 5.1% to €20,332 million.

 

Diabetes

 

€ million

 

Q3 2014
net sales

 

Change
(CER)

 

9M 2014
net sales

 

Change
(CER)

 

Lantus®

 

1,567

 

+8.1

%

4,572

 

+12.5

%

Amaryl®

 

87

 

-2.2

%

269

 

+0.7

%

Apidra®

 

88

 

+21.9

%

240

 

+20.3

%

Insuman®

 

34

 

0.0

%

99

 

+3.0

%

BGM (Blood Glucose Monitoring)

 

14

 

+25.0

%

46

 

+34.3

%

Lyxumia®

 

8

 

 

19

 

 

Total Diabetes

 

1,799

 

+8.3

%

5,249

 

+12.5

%

 

Third-quarter sales of the Diabetes division reached €1,799 million, an increase of 8.3%. Year-to-date sales of the Diabetes division increased 12.5% to €5,249 million. Lantus® sales increased 8.1% to €1,567 million in the third quarter. In the U.S., third-quarter sales of Lantus® reached €1,042 million, an increase of 5.8%, reflecting increasing competitive pressure at the payor level. Lantus® SoloSTAR® represented 62.2% of total Lantus® sales, versus 57.4% for the same period in 2013. In Emerging Markets, Lantus® sales grew 19.7% to €232 million in the third quarter, reflecting good performance in China, Turkey, Middle East, Mexico and Africa. In Western Europe, sales of Lantus® recorded a strong performance with sales up 9.5% to €222 million driven by Germany, France and Italy. Year-to-date sales of Lantus® reached €4,572 million, up 12.5%.

 

Sanofi has recently concluded payor negotiations in the U.S. and has secured favorable formulary positions for Lantus® with key payors. The level of rebates required to maintain these positions has increased significantly due to aggressive discounting by competitors. The rebates will not change the Group’s Business EPS guidance for 2014. The increased rebates in the U.S. and the impact of the Affordable Care Act will continue in 2015. Sanofi expects to mitigate this impact on the Diabetes division in 2015 through the launches of Toujeo® and Afrezza® as well as continued strong growth in Emerging Markets. Therefore, global sales of the Diabetes division are expected to be broadly stable in 2015.

 

Third-quarter sales of Amaryl® were €87 million, down 2.2%. In Emerging Markets, Amaryl® sales increased 6.2% to €68 million. Year-to-date sales of Amaryl® were €269 million (up 0.7%).

 

Apidra® sales increased 21.9% to €88 million. The product recorded strong growth in all territories. In the U.S., sales were up 20.7% to €35 million. In Emerging Markets, sales were up 25.0% to €19 million and in Western Europe, sales grew 19.0% to €26 million. Year-to-date sales of Apidra® grew 20.3% to €240 million.

 

Third-quarter and year-to-date sales of Lyxumia® were €8 million and €19 million, respectively.

 

In August, Sanofi and MannKind entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza®, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. The companies plan to launch Afrezza® in the United States in the first quarter of 2015. Under the collaboration and license agreement, Sanofi will be responsible for global commercial, regulatory and development activities.

 

3



 

Consumer Healthcare

 

€ million

 

Q3 2014
net sales

 

Change
(CER)

 

9M 2014
net sales

 

Change
(CER)

 

Allegra®

 

78

 

+31.7

%

276

 

+30.4

%

Doliprane®

 

74

 

+4.2

%

232

 

+5.4

%

Essentiale®

 

53

 

+46.2

%

174

 

+32.0

%

Enterogermina®

 

48

 

+53.1

%

122

 

+28.0

%

No Spa®

 

31

 

+6.3

%

84

 

+9.3

%

Lactacyd®

 

24

 

-3.7

%

81

 

+15.4

%

Nasacort®

 

23

 

 

91

 

 

Maalox®

 

23

 

+9.5

%

73

 

+11.6

%

Dorflex®

 

18

 

-25.0

%

68

 

+10.0

%

Other CHC Products

 

447

 

+4.1

%

1,319

 

+8.6

%

Total Consumer Healthcare

 

819

 

+12.9

%

2,520

 

+17.3

%

 

Sales of Consumer Healthcare products (CHC) were €819 million in the third quarter, an increase of 12.9%. Several products (amounting to €64 million in sales) previously recorded in prescription pharmaceuticals in the third quarter of 2013 were transferred to Consumer Healthcare products. Excluding this category change, sales of CHC grew 4.0% driven by the success of the Nasacort® Rx-to-OTC switch in the U.S. and good performance in Emerging Markets (+7.8%). Sales of Nasacort® Allergy 24HR nasal spray, which has been available over-the-counter (OTC) in the U.S. since February, were €18 million in the third quarter in the U.S.

 

Year-to-date sales of CHC were €2,520 million, an increase of 17.3%. Excluding the category change mentioned above (€205 million in the first nine month of 2013), CHC sales grew 7.6%.

 

Genzyme

 

€ million

 

Q3 2014
net sales

 

Change
(CER)

 

9M 2014
net sales

 

Change
(CER)

 

Cerezyme®

 

175

 

+9.1

%

518

 

+8.3

%

Myozyme® / Lumizyme®

 

138

 

+9.4

%

392

 

+9.2

%

Fabrazyme®

 

116

 

+21.9

%

337

 

+26.2

%

Aldurazyme®

 

41

 

+7.9

%

127

 

+13.8

%

Total Rare Diseases

 

530

 

+10.9

%

1,553

 

+11.8

%

Aubagio®

 

112

 

+156.8

%

287

 

+205.2

%

Lemtrada

 

7

 

 

18

 

 

Total Multiple Sclerosis

 

119

 

+175.0

%

305

 

+224.7

%

Total Genzyme

 

649

 

+24.6

%

1,858

 

+25.1

%

 

Sales of Genzyme increased 24.6% to €649 million in the third quarter driven by the growth of Aubagio® and Fabrazyme®. Sales grew 28.2% to €259 million in the U.S., 25.0% to €207 million in Western Europe and 19.8% to €124 million in Emerging Markets. Year-to-date sales of Genzyme reached €1,858 million, an  increase of 25.1%.

 

Third quarter-sales of Cerezyme® grew 9.1% to €175 million, reflecting double digit-growth in Western Europe (up 15.4% to €60 million). Sales of Cerezyme® grew 7.0% to €56 million and 4.3% to €48 million in Emerging Markets and the U.S., respectively. Year-to-date sales of Cerezyme® grew 8.3% to €518 million. In August, the FDA approved Cerdelga™, the only first-line oral therapy for Gaucher disease type 1 patients (GD1). The vast majority of adult GD1 patients should be eligible for Cerdelga™, which is now available in the U.S.

 

Fabrazyme® continued its strong performance with sales of €116 million, up 21.9% in the third quarter driven by Western Europe (up 40.0% to €28 million) and Emerging Markets (up 33.3% to €15 million). In the U.S., sales of Fabrazyme® reached €58 million, an increase of 14.0%. Year-to-date sales of Fabrazyme® grew 26.2% to €337 million.

 

Third-quarter sales of Myozyme®/Lumizyme® increased 9.4% to €138 million, driven by Emerging Markets (up 42.1% to €25 million). In the U.S. and Western Europe, sales were €35 million (up 9.4%) and €69 million (up 1.5%), respectively. Year-to-date sales of Myozyme®/Lumizyme® grew 9.2% to €392 million.

 

4



 

Third-quarter sales of Aubagio® reached €112 million versus €44 million in the third quarter of 2013. In the U.S., sales of Aubagio® were €87 million versus €44 million in the third quarter of 2013. In Western Europe, where the launch of the product started in the fourth quarter of 2013, sales reached €18 million in the third quarter. The product is mainly commercially available in the U.S., Germany, Switzerland, Nordic countries, Canada, Argentina and Australia. Year-to-date sales of Aubagio® totaled €287 million, up 205.2%.

 

In October, the Food and Drug Administration (FDA) approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of Aubagio® in the product’s U.S. label. Aubagio® is the only oral treatment to significantly slow progression of disability in two Phase III studies of patients with relapsing multiple sclerosis (TEMSO and TOWER), and to have positive data on early multiple sclerosis in its label.

 

Third quarter and year-to-date sales of Lemtrada™ were €7 million and €18 million, respectively. In May, the U.S. Food and Drug Administration (FDA) accepted for review the resubmission of the supplemental Biologics License Application (sBLA) seeking approval of Lemtrada™ for the treatment of relapsing forms of multiple sclerosis. A six-month review period has been assigned for the Lemtrada™ sBLA.

 

Other Innovative Products(4)

 

€ million

 

Q3 2014
net sales

 

Change
(CER)

 

9M 2014
net sales

 

Change
(CER)

 

Multaq®

 

76

 

+13.4

%

215

 

+11.1

%

Jevtana®

 

67

 

+15.3

%

199

 

+23.6

%

Auvi-Q

 

37

 

+26.7

%

63

 

+32.7

%

Mozobil®

 

29

 

+20.0

%

80

 

+7.9

%

Zaltrap®

 

18

 

+30.8

%

49

 

+28.9

%

Total Other Innovative Products

 

227

 

+18.0

%

606

 

+17.9

%

 

Other Innovative Products increased 18.0% to €227 million in the third quarter and 17.9% to €606 million in the first nine months.

 

Sales of Multaq® were €76 million, up 13.4% in the third quarter. Year-to-date sales of the product increased 11.1% to €215 million.

 

Third-quarter sales of Jevtana® increased 15.3% to €67 million driven by launches in Western Europe and Emerging Markets. Year-to-date sales of Jevtana® grew 23.6% to €199 million.

 

Third-quarter sales of Auvi-Q™ were €37 million (up 26.7%). Year-to-date sales of the product were €63 million (up 32.7%).

 

In the third quarter, sales of Zaltrap® reached €18 million, an increase of 30.8% driven by recent launches in Western Europe which offset lower sales in the U.S. Year-to-date sales of the product were €49 million (up 28.9%).

 

Other Pharmaceutical Products

 

€ million

 

Q3 2014
net sales

 

Change
(CER)

 

9M 2014
net sales

 

Change
(CER)

 

Plavix®

 

450

 

+9.0

%

1,362

 

+5.8

%

Lovenox®

 

426

 

+7.2

%

1,263

 

+2.9

%

Aprovel®/Avapro®

 

178

 

-14.8

%

550

 

-17.9

%

Renvela®/Renagel®

 

162

 

-13.4

%

471

 

-9.0

%

Synvisc® /Synvisc-One®

 

88

 

-2.2

%

251

 

-4.8

%

Myslee®/Ambien®/Stilnox®

 

78

 

-16.0

%

229

 

-15.3

%

Taxotere®

 

59

 

-28.6

%

195

 

-31.7

%

Eloxatin®

 

43

 

-12.0

%

136

 

-14.2

%

Allegra®

 

32

 

-52.1

%

151

 

-47.6

%

 


(4) Includes new product launches which do not belong to the other Growth Platforms

 

5



 

Sales of Plavix® grew 9.0% to €450 million in the third quarter, driven by strong performance in Emerging Markets (up 21.3% to €203 million) and Japan (up 8.7% to €190 million). The performance of the product in Emerging Markets was driven by China where sales grew 47.1% to €125 million. Year-to-date sales of Plavix® increased 5.8% to €1,362 million.

 

Third-quarter sales of Lovenox® were up 7.2% to €426 million sustained by the strong performance in Emerging Markets where sales increased 16.9% to €147 million driven by China and Latin America. In Western Europe, sales of the product grew 5.8% to €221 million. Year-to-date sales of Lovenox® totaled €1,263 million, an increase of 2.9%.

 

Aprovel®/Avapro® generated sales of €178 million in the third quarter, down 14.8%, reflecting generic competition in Western Europe where sales decreased 47.4% to €41 million. In Emerging Markets, sales of Aprovel®/Avapro® increased 9.3% to €105 million driven by China. Year-to-date sales of Aprovel®/Avapro® were €550 million, down 17.9%.

 

Third-quarter sales of Renvela®/Renagel® were €162 million in the third quarter, down 13.4%. In the U.S., sales of the product decreased 22.0% to €103 million reflecting the impact of the agreement with Impax which was granted a license to sell a limited allotment of bottles of an authorized generic version of Renvela® tablets in the U.S. starting from April 2014. The specific allotment corresponds to up to 10% of the total 2013 sevelamer sales in the U.S. In Emerging Markets, sales of Renvela®/Renagel® increased 22.2% to €22 million. In Western Europe sales were stable at €32 million. Year-to-date sales of Renvela®/Renagel® were €471 million, a decrease of 9.0%.

 

In the third quarter, sales of Allegra® as a prescription drug were €32 million, down 52.1% (excluding the change of category, sales decreased 19.0%) and sales of the Ambien® family of products were €78 million, down 16.0%, reflecting generic competition in Japan for both products. Year-to-date sales of Allegra® and the Ambien® family of products were €151 million and €229 million, respectively.

 

Third-quarter and year-to-date sales of Taxotere® decreased 28.6% (€59 million) and 31.7% (€195 million), respectively, mainly due to generic erosion. Third-quarter and year-to-date sales of Eloxatin® decreased 12.0% (€43 million) and 14.2% (€136 million), respectively.

 

Generics

 

Third-quarter sales of Generics increased 8.3% to €451 million reflecting the recovery in Brazil where sales were €76 million. Third-quarter sales of Generics decreased 3.9% in Western Europe (to €125 million) and 24.3% in the U.S. (to €28 million). In Emerging Markets, sales of Generics grew 19.8% to €287 million driven by the recovery in Brazil. Year-to-date sales of Generics increased 23.2% to €1,338 million.

 

Vaccines

 

€ million

 

Q3 2014
net sales

 

Change
(CER)

 

9M 2014
net sales

 

Change
(CER)

 

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

 

259

 

+7.4

%

754

 

-2.4

%

Influenza Vaccines
(incl. Vaxigrip
® and Fluzone®)

 

650

 

+15.0

%

844

 

+16.0

%

Meningitis/Pneumonia Vaccines
(incl. Menactra
®)

 

191

 

-10.0

%

362

 

-10.4

%

Adult Booster Vaccines
(incl. Adacel
®)

 

131

 

+54.8

%

295

 

+3.1

%

Travel and Other Endemic Vaccines

 

99

 

-3.0

%

277

 

+5.9

%

Other Vaccines

 

121

 

+21.8

%

265

 

+14.2

%

Total Vaccines

(consolidated sales)

 

1,451

 

+11.2

%

2,797

 

+4.1

%

 

Third-quarter consolidated sales of Sanofi Pasteur increased 11.2% to €1,451 million driven by strong performance of influenza vaccines in the U.S. and in Emerging Markets as well as continued gradual recovery of Pentacel® and Adacel® in the U.S. Year-to-date consolidated sales of Sanofi Pasteur increased 4.1% to €2,797 million.

 

6



 

Third-quarter sales of Influenza vaccines grew 15.0% to €650 million due to strong influenza vaccines sales in the U.S. and in Emerging Markets. In the U.S., Sanofi Pasteur’s strategy to offer differentiating vaccines leads to a strong uptake of Fluzone® High-Dose for elderly people and Fluzone® Quadrivalent vaccine, a four-strain influenza vaccine. Year-to-date sales of influenza vaccines increased 16.0% to €844 million.

 

Sales of Polio/Pertussis/Hib vaccines increased 7.4% to €259 million in the third quarter. In the U.S., Polio/Pertussis/Hib vaccines sales were €97 million, an increase of 94.0% sustained by the continued gradual recovery of Pentacel®. In Emerging Markets sales of Polio/Pertussis/Hib vaccines decreased 20.6% to €120 million reflecting lower sales of Pentaxim® and Polio vaccines in Asia. Year-to-date sales of Polio/Pertussis/Hib vaccines were €754 million, down 2.4%.

 

Third-quarter sales of Menactra® were €174 million, down 10.3%. In the U.S., lower sales of Menactra® reflected phasing of public orders while strong market share was maintained. Year-to-date sales of Menactra® were €327 million down 6.9%.

 

Sales of Travel and Other Endemic vaccines were down 3.0% to €99 million and up 5.9% to €277 million in the third quarter and the first nine months of 2014, respectively.

 

Third-quarter sales of Adult Booster vaccines increased 54.8% to €131 million, reflecting supply improvement and positive phasing of Adacel® sales. Year-to-date sales of Adult booster vaccines were €295 million, an increase of 3.1%.

 

Sanofi Pasteur MSD (not consolidated), the joint venture with Merck & Co. in Europe, reported stable sales at €295 million. Increased sales of Zostavax® were offset by lower sales of Gardasil®. Year-to-date sales of Sanofi Pasteur MSD were €608 million, down 3.4% on a reported basis.

 

Animal Health

 

€ million

 

Q3 2014
net sales

 

Change
(CER)

 

9M 2014
net sales

 

Change
(CER)

 

Companion Animal

 

317

 

+13.3

%

1,006

 

+5.9

%

Production Animal

 

198

 

+11.7

%

563

 

+4.2

%

Total Animal Health

 

515

 

+12.7

%

1,569

 

+5.3

%

of which fipronil products

 

143

 

-5.3

%

483

 

-3.3

%

of which NexGard

 

27

 

 

85

 

 

of which avermectin products

 

101

 

+11.1

%

313

 

-3.3

%

of which Vaccines

 

176

 

+11.3

%

510

 

+1.7

%

 

Third-quarter sales of Animal Health increased 12.7% to €515 million driven by the launch of NexGard™ and the strong performance of the production animal segment. In the U.S., Animal Health sales grew 23.2% to €220 million. Year-to-date sales of Animal Health increased 5.3% to €1,569 million.

 

Third-quarter sales of the Companion Animals segment increased 13.3% to €317 million, reflecting the NexGard™ launch as well as performance of pet vaccines and Heartgard®. Merial launched, its next generation flea and tick product for dogs, NexGard™, in the U.S. in the first quarter and in several European countries during the first nine months of the year. Third-quarter sales of NexGard™ reached €27 million of which €23 million was generated in the U.S. Sales of the Companion Animals segment increased 19.5% in the U.S. to €185 million. Year-to-date sales of the Companion Animals segment increased 5.9% to €1,006 million.

 

Third-quarter sales of the Production Animals segment increased 11.7% to €198 million driven by double-digit growth of products for ruminants and swine. Furthermore, favorable phasing for tenders of Veterinary Public Health products had a positive impact in the quarter. Sales of the Production Animals segment increased 4.2% to €563 million year-to-date.

 

7



 

Net sales by geographic region

 

€ million

 

Q3 2014
net sales

 

Change
(CER)

 

9M 2014
 net sales

 

Change
(CER)

 

Emerging Markets(a)

 

2,776

 

+7.6

%

8,221

 

+9.9

%

of which Latin America

 

811

 

+8.0

%

2,429

 

+23.7

%

of which Asia

 

814

 

+9.6

%

2,333

 

+6.8

%

of which Eastern Europe, Russia and Turkey

 

629

 

+4.8

%

1,868

 

+4.7

%

of which Africa

 

257

 

+13.9

%

743

 

+2.5

%

of which Middle East

 

236

 

+3.5

%

756

 

+1.7

%

United States

 

3,208

 

+7.2

%

8,192

 

+8.0

%

Western Europe(b)

 

2,003

 

+3.1

%

5,909

 

+0.0

%

Rest of the world(c)

 

794

 

-5.4

%

2,376

 

-6.8

%

of which Japan

 

507

 

-7.2

%

1,569

 

-7.4

%

TOTAL

 

8,781

 

+5.1

%

24,698

 

+5.0

%

 


(a)         World less the U.S., Canada, Western Europe, Japan, Australia and New Zealand;

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

(c)          Japan, Canada, Australia and New Zealand

 

In the third quarter, sales in Emerging Markets grew 7.6% to €2,776 million. Pharmaceuticals sales increased 9.2% driven by Diabetes (up 17.5%), Genzyme (up 19.8%), and Generics (up 19.8%). Sales in China grew 10.5% to €386 million reflecting strong performance of Pharmaceuticals (up 20.1%) partially offset by Vaccines notably due to lower sales of Pentaxim®. In China, the Pharmaceuticals sales growth was driven by Plavix®, Lantus® and Aprovel®. Sales in Eastern Europe, Russia and Turkey were up 4.8%, supported by good performance in Turkey and Hungary. Sales in Russia reached €195 million, an increase of 4.3%. In the Middle-East, sales grew 3.5% to €236 million. In Brazil, sales increased 17.5% to €318 million sustained by the performance of generics. Year-to-date sales in Emerging Markets increased 9.9% to €8,221 million. Excluding Brazil generics, sales in Emerging Markets grew 6.1%.

 

In the U.S., sales were up 7.2% to €3,208 million in the third quarter, due largely to strong performance of Genzyme (up 28.2%), Vaccines (up 15.8%) and Animal Health (up 23.2%). Year-to-date sales in the U.S. increased 8.0% to €8,192 million.

 

Western Europe returned to growth in the third-quarter with sales increasing 3.1% to €2,003 million. Strong performance of Genzyme (up 25.0%) was offset by the impact of generic competition to Aprovel®. Year-to-date sales in Western Europe were stable at €5,909 million.

 

Third-quarter sales in Japan were €507 million, a decrease of 7.2%, reflecting the impact of generic competition to Allegra®, Myslee®, Amaryl® and Taxotere® partially offset by the performance of Plavix® and Vaccines. Year-to-date sales in Japan were €1,569 million (down 7.4%).

 

R&D update

 

Consult Appendix 6 for full overview of Sanofi’s R&D pipeline

 

Regulatory update

 

Regulatory updates since the publication of the second-quarter 2014 results on July 31, 2014 include the following:

 

·                  In August, the U.S. Food and Drug Administration (FDA) approved Cerdelga™ (eliglustat) capsules, the only first-line oral therapy for certain adult Gaucher disease type 1 patients.

 

·                  The sBLA for Lumizyme® label expansion and 4,000L manufacturing process was also approved in August by the FDA. Lumizyme® is now indicated for all patients with Pompe disease regardless of age or phenotype.

 

8



 

·                  In September, the BLA for a pediatric hexavalent vaccine PR5i (DTP-Hep B-Polio-Hib) was submitted in the U.S.

 

·                  At the end of July, Sanofi and Regeneron announced that the companies intend to use a U.S. Food and Drug Administration rare pediatric disease priority review voucher in connection with the Biologics License Application (BLA) submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited 6-month review from the filing date instead of the standard 10-month review. Sanofi and Regeneron expect to submit U.S. and EU regulatory submissions for alirocumab before year end.

 

At the end of October 2014, the R&D pipeline contained 46 projects (excluding Life Cycle Management) and vaccine candidates in clinical development of which 14 are in Phase III or have been submitted to the regulatory authorities for approval.

 

Portfolio update

 

Phase III:

 

·                  In October, dupilumab, (an investigational monoclonal antibody that blocks IL-4 and IL-13 signaling, in collaboration with Regeneron), entered into Phase III in adults with moderate-to-severe atopic dermatitis that is not adequately controlled with topical atopic dermatitis medications.

 

·                  In October, Sanofi Pasteur announced the start of a phase III clinical trial in India for its investigational rotavirus vaccine, developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad, India.

 

·                  In September, positive interim results from the second year of the extension study of Lemtrada™ (alemtuzumab) for multiple sclerosis were announced. In this analysis, relapse rates and sustained accumulation of disability remained low among patients who had previously received Lemtrada in either of the Phase III CARE-MS I and CARE-MS II studies. In these pivotal studies, Lemtrada™ was given as two annual courses, at the start of the study and 12 months later. Approximately 70% of patients who received Lemtrada™ in the pivotal studies did not receive further treatment with Lemtrada™ through the second year of the extension study (corresponding to year 4). No new safety signals were identified.

 

·                  In September, Sanofi Pasteur, announced that the final landmark phase III efficacy study of its dengue vaccine candidate in Latin America successfully achieved its primary clinical endpoint. Results showed an overall significant reduction of 60.8%* of dengue disease cases in children and adolescents 9-16 years old after a three-dose vaccination schedule. Importantly, efficacy was observed against each of the four dengue serotypes. Additional observations of the results showed a clinically important reduction by 80.3% in the risk of hospitalization due to dengue during the study. The results also showed in the study population an efficacy against dengue haemorrhagic fever, the severe form of dengue, which is consistent with the results released from Sanofi’s Phase III dengue study in Asia. Lastly, the results suggest better protection in case of prior exposure to dengue. A full analysis of the efficacy and safety data from the phase III study will be presented at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting, 2-6 November 2014, in New Orleans, U.S.

 

·                  In August, detailed positive results from four Phase III ODYSSEY trials (ODYSSEY LONG TERM, ODYSSEY COMBO II, FH I and FH II) of alirocumab, an investigational monoclonal antibody targeting PCSK9, (collaboration with Regeneron), in people with hypercholesterolemia were presented at a Hot Line session at the ESC Congress 2014. All of these four studies met their primary endpoint. Alirocumab showed significant and sustained reductions in LDL-C over one year on top of standard-of-care statin therapy across different patient types. Futhermore, in a post hoc safety analysis of ODYSSEY LONG TERM trial, (designed to evaluate the long-term safety and efficacy of 150 mg alirocumab every two weeks versus placebo in patients with hypercholesterolemia who are at high or very-high cardiovascular risk) there was a lower rate of adjudicated major cardiovascular events (cardiac death, myocardial infarction, stroke, and unstable angina requiring hospitalization) in the alirocumab group compared to placebo (1.4 percent compared to 3.0 percent, nominal p-value <0.01). These cardiovascular events comprise the composite primary endpoint of the ongoing 18,000-patient ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential of alirocumab to demonstrate CV benefit.

 


*95 percent CIs overall efficacy [52.0 percent, 68.0 percent]; Efficacy per serotype (ST1 50.3%, ST2 42.3%, ST3 74.0%, ST4 77.7%); 95 percent CIs reduction of the risk of hospitalization [64.7 percent, 89.5 percent]

 

9



 

·                  In August, The New England Journal of Medicine published positive results from a large-scale, multi-center efficacy trial, which found that Fluzone® High-Dose (Influenza Vaccine) was more efficacious in preventing influenza in adults 65 years of age and older compared to standard-dose Fluzone® vaccine.  Fluzone® High-Dose vaccine was found to be 24.2 percent (95% CI, 9.7 to 36.5) more effective in preventing influenza relative to standard-dose Fluzone® vaccine for the primary endpoint.

 

Phase II:

 

·                  In September, Sanofi and Regeneron announced that a Phase IIa proof-of-concept study of dupilumab, an investigational monoclonal antibody that blocks IL-4 and IL-13 signaling (in collaboration with Regeneron), met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps who did not respond to intranasal corticosteroids. In the study, dupilumab resulted in a statistically-significant improvement in the size of nasal polyps, as measured by endoscopic Nasal Polyp Score, the primary endpoint of the study. The safety profile was consistent with previous studies. The most common adverse events with dupilumab were injection site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness.

 

·                  Valetizumab (an anti-VLA2 monoclonal antibody) entered into Phase IIb in multiple sclerosis.

 

·                  Sanofi and Alopexx have agreed to let Alopexx take primary responsibility for development of SR279356 (an anti-PNAG monoclonal antibody). As a consequence both parties have agreed to terminate their agreement relating to the development of SAR279356.

 

Phase I:

 

·                  Sanofi and Regeneron have disclosed that the project SAR 438584 (REGN2222) currently in Phase I is a fully human anti-RSV F protein monoclonal antibody under evaluation for the prevention of Respiratory Sincytial Virus—related disease, a leading cause of respiratory morbidity in infants.

 

·                  SAR408701, an anti-CEACAM5 ADC, entered into Phase I in solid tumors during the quarter.

 

New Collaborations:

 

·                  In October, Sanofi Pasteur and Immune Design Corp., a clinical-stage immunotherapy company, announced that they have entered into a broad collaboration for the development of a herpes simplex virus (HSV) immune therapy

 

·                  In August Sanofi and MannKind announced that they have entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza®, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes.

 

·                  In September, Sanofi and MyoKardia, Inc., a privately-held company leading the development of precision therapies for genetic heart disease, announced a worldwide collaboration to discover and develop first-of-its-kind targeted therapeutics for heritable heart diseases known as cardiomyopathies, the most common forms of heart muscle disease.

 

10



 

Third-quarter and first 9-months 2014 financial results

 

Business Net Income(1)

 

In the third quarter, Sanofi generated net sales of €8,781 million, an increase of 4.1% on a reported basis (up 5.1% at constant exchange rates). Year-to-date sales were €24,698 million, an increase of 0.8% on a reported basis (up 5.0% at constant exchange rates).

 

Other revenues were €87 million (up 1.2%) and €241 million (down 9.7%) in the third quarter and the first nine months, respectively, reflecting the end of royalties on Enbrel® sales in the U.S during Q1 2013.

 

Gross profit was €6,004 million in the third quarter, an increase of 6.3% (up 7.3% at constant exchange rates). The ratio of cost of sales to net sales (CoS ratio) improved by 1.4 percentage points to 32.6%, versus the third quarter of 2013. This reflected the resolution of Toronto manufacturing issues, improved industrial performance of Genzyme combined with higher sales in multiple sclerosis and positive mix effect in the U.S. and China. Year-to-date gross profit was €16,951 million, up 1.6% (or up 6.1% at constant exchange rates). In the first nine months, the ratio of cost of sales to net sales improved by 0.6 percentage points to 32.4% versus the same period of 2013.

 

Research and Development expenses were down 3.0% at €1,146 million in the third quarter. At constant exchange rates, R&D expenses decreased by 2.6% reflecting lower spend in oncology and completion of the Toujeo® EDITION program more than offsetting higher spend on dupilumab. Year-to-date R&D expenses were down 1.4% to €3,473 million (or up 0.6% at constant exchange rates), the ratio of R&D to net sales was 0.3 percentage points lower at 14.1% compared with the same period of 2013.

 

Third-quarter selling and general expenses increased 9.0% to €2,193 million. At constant exchange rates, SG&A increased 10.0% reflecting a rebound of commercial activity in China, higher Advertising & Promotional expenses in the U.S. on NexGard™ and Frontline® as well as Genzyme’s launch investments in multiple sclerosis and Rare Diseases. The ratio of selling and general expenses to net sales was 1.1 percentage points higher to 25.0% compared with the third quarter of 2013. Year-to-date SG&A expenses increased 1.1% to €6,526 million (an increase of 4.9% at constant exchange rates). In the first nine months, the ratio of selling and general expenses to net sales was stable at 26.4%.

 

Other current operating income net of expenses was €39 million in the third quarter versus €28 million in the third quarter of 2013. This quarter included a €40 million gain associated with the termination of a licence of a U.S. product.

 

The share of profits from associates was €43 million in the third quarter (versus €38 million in the third quarter of 2013) and included our share in Regeneron profit recorded under the equity method since the beginning of April as well as our share of profit in Sanofi Pasteur MSD (the Vaccines joint venture with Merck & Co. in Europe).

 

Non-controlling interests were -€31 million in the third quarter versus -€36 million in the third quarter of 2013.

 

In the third-quarter, business operating income increased 9.3% to €2,716 million. At constant exchange rates, business operating income grew 11.0%. The ratio of business operating income to net sales improved by 1.4 percentage points to 30.9%. Year-to-date business operating income grew 2.6% to €7,006 million (up 8.6% at constant exchange rates). The ratio of business operating income to net sales was 28.4%, compared to 27.9% in the same period of 2013.

 

Net financial expenses were €139 million in the third quarter compared to €123 million in the third quarter of 2013). Year-to-date net financial expenses were €309 million versus €400 million in the same period of 2013.

 

The third quarter and year-to-date effective tax rate was 25% (versus 24% in the third quarter of 2013).

 

Third-quarter business net income(1) increased 7.8% to €1,935 million. At constant exchange rates, the growth was 9.4%. The ratio of business net income to net sales improved by 0.7 percentage points to 22.0% in the third quarter of 2014 compared to the third quarter of 2013. Year-to-date business net income grew 3.0% to €5,019 million (an increase of 9.3% at constant exchange rates). The ratio of business net income to net sales improved by 0.4 percentage points to 20.3% compared to the first nine months of 2013.

 


(1)         See Appendix 8 for definitions of financial indicators, and Appendix 3 for reconciliation of business net income to consolidated net income attributable to equity holders of Sanofi

 

11



 

In the third quarter of 2014, business earnings per share(1) (EPS) was €1.47, up 8.1% on a reported basis and up 10.3% at constant exchange rates. The average number of shares outstanding was 1,313.0 million this quarter versus 1,323.5 million in the third quarter of 2013. In the first nine months of 2014, business earnings per share(1) was €3.81, up 3.5% on a reported basis and up 10.1% at constant exchange rates. The average number of shares outstanding was 1,315.8 million in the first nine months of 2014 versus 1,323.8 million in the first nine months of 2013.

 

From business net income to consolidated net income (see Appendix 3)

 

In the first nine months of 2014, the main reconciling items between business net income and consolidated net income attributable to equity holders of Sanofi were:

 

·                  A €1,862 million amortization charge related to fair-value re-measurement on intangible assets of acquired companies (primarily Aventis: €689 million, Genzyme: €608 million and Merial: €294 million) and to acquired intangible assets (licenses/products: €64 million). A €561 million amortization charge on intangible assets related to fair-value re-measurement of acquired companies (primarily Aventis: €182 million, Genzyme: €188 million and Merial: €100 million), and to acquired intangible assets (licenses/products: €21 million) was booked in the third quarter. These items have no cash impact on the Group.

 

·                  An impairment loss against intangible assets of €109 million (of which €35 million in Q3 2014 mainly related to SAR 279356). This item has no cash impact on the Group.

 

·                  A charge of €177 million mainly reflecting an increase in the fair value of contingent considerations related to the CVRs (€21 million, of which a gain of €7 million in Q3 2014) and Bayer contingent considerations (€155 million, of which €51 million in Q3 2014) linked to Lemtrada™.

 

·                  Restructuring costs of €298 million (including €163 million in Q3 2014 mainly related to transformation in France).

 

·                  A €35 million gain on Alnylam shares. This item has no cash impact on the Group.

 

·                  An annual fee of €116 million related to 2013 sales in the U.S. following the final IRS regulation issued in July 2014 that has changed the timing of liability recognition and leads to a one-time “double” expense in 2014.

 

·                  A €783 million tax effect arising from the items listed above, comprising €639 million generated by amortization charged against intangible assets, €99 million associated with restructuring costs and €39 million associated with impairment against intangible assets. The third quarter tax effect was €261 million, including €188 million of deferred taxes generated by amortization charged against intangible assets, €55 million linked to restructuring costs and €13 million associated with impairment loss on intangible assets (see Appendix 3).

 

·                  A tax of €110 million on dividends paid to shareholders of Sanofi.

 

·                  In “Share of profits/losses from associates”, a charge of €118 million, net of tax, mainly relating to the share of the fair-value re-measurements on assets and liabilities as part of the acquisition of associates and to the share of amortization of intangible assets of joint-ventures (of which €86 million in Q3 2014). This item has no cash impact on the Group.

 

Capital Allocation

 

In the first nine months of 2014, net cash generated by operating activities increased 15.8% to €4,239 million after capital expenditures of €802 million and an increase in working capital by €577 million. This net Cash Flow has contributed to finance a share repurchase (€1,102 million) partially offset by proceeds from the issuance of new shares (€635 million), dividend paid by Sanofi (€3,676 million), acquisitions and partnerships net of disposals (€2,220 million of which €1,492 million was related to Regeneron and €535 million was related to Alnylam) and restructuring costs (€603 million).

 


(1)         See Appendix 8 for definitions of financial indicators, and Appendix 3 for reconciliation of business net income to consolidated net income attributable to equity holders of Sanofi

 

12



 

As a consequence, net debt increased from €6,043 million at December 31, 2013 to €9,228 million at the end of September 2014 (amount net of €6,526 million cash and cash equivalents).

 

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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

Appendices

 

List of appendices

 

Appendix 1:                             2014 third-quarter and 2014 9-month of consolidated net sales by geographic region and product

 

Appendix 2:                             2014 third-quarter and 2014 9-month business net income statement

 

Appendix 3:                             Reconciliation of business net income to net income attributable to equity holders of Sanofi

 

Appendix 4:                             2014 third-quarter and 2014 9-month consolidated income statement

 

Appendix 5:                             2014 currency sensitivity

 

Appendix 6:                             R&D pipeline

 

Appendix 7:                             Expected R&D milestones in H2 2014 / 9M 2015

 

Appendix 8:                             Definitions

 

13



 

Appendix 1: 2014 Third-quarter and 9-month consolidated net sales by geographic region and product

 

Q3 2014 net sales
(€ million)

 

Total

 

% CER

 

% reported

 

Western
Europe

 

% CER

 

United
States

 

% CER

 

Emerging
Markets

 

% CER

 

Rest of the
World

 

% CER

 

Lantus

 

1,567

 

8.1

%

7.6

%

222

 

9.5

%

1,042

 

5.8

%

232

 

19.7

%

71

 

4.2

%

Apidra

 

88

 

21.9

%

20.5

%

26

 

19.0

%

35

 

20.7

%

19

 

25.0

%

8

 

28.6

%

Amaryl

 

87

 

-2.2

%

-4.4

%

5

 

0.0

%

2

 

 

68

 

6.2

%

12

 

-38.1

%

Insuman

 

34

 

0.0

%

0.0

%

21

 

-4.5

%

0

 

 

13

 

8.3

%

0

 

 

Lyxumia

 

8

 

166.7

%

166.7

%

4

 

100.0

%

0

 

 

2

 

 

2

 

100.0

%

Diabetes

 

1,799

 

8.3

%

7.7

%

292

 

10.3

%

1,079

 

6.4

%

336

 

17.5

%

92

 

-3.9

%

Taxotere

 

59

 

-28.6

%

-29.8

%

3

 

-40.0

%

2

 

-33.3

%

35

 

-23.9

%

19

 

-33.3

%

Jevtana (*)

 

67

 

15.3

%

13.6

%

34

 

22.2

%

23

 

9.5

%

8

 

12.5

%

2

 

0.0

%

Eloxatine

 

43

 

-12.0

%

-14.0

%

2

 

0.0

%

-4

 

-500.0

%

31

 

-3.1

%

14

 

0.0

%

Thymoglobulin

 

54

 

3.8

%

3.8

%

8

 

0.0

%

28

 

7.7

%

14

 

-12.5

%

4

 

100.0

%

Mozobil (*)

 

29

 

20.0

%

16.0

%

10

 

12.5

%

17

 

21.4

%

2

 

0.0

%

0

 

 

Zaltrap (*)

 

18

 

30.8

%

38.5

%

9

 

100.0

%

6

 

-25.0

%

2

 

 

1

 

 

Other Oncology

 

61

 

-6.3

%

-4.7

%

14

 

7.7

%

34

 

-12.2

%

8

 

-14.3

%

5

 

33.3

%

Oncology

 

331

 

-4.0

%

-4.6

%

80

 

16.2

%

106

 

-5.3

%

100

 

-10.7

%

45

 

-13.2

%

Aubagio

 

112

 

156.8

%

154.5

%

18

 

 

87

 

97.7

%

3

 

300.0

%

4

 

-500.0

%

Lemtrada

 

7

 

 

 

6

 

 

0

 

 

1

 

 

0

 

 

Cerezyme

 

175

 

9.1

%

6.1

%

60

 

15.4

%

48

 

4.3

%

56

 

7.0

%

11

 

10.0

%

Myozyme

 

138

 

9.4

%

8.7

%

69

 

1.5

%

35

 

9.4

%

25

 

42.1

%

9

 

0.0

%

Fabrazyme

 

116

 

21.9

%

20.8

%

28

 

40.0

%

58

 

14.0

%

15

 

33.3

%

15

 

14.3

%

Aldurazyme

 

41

 

7.9

%

7.9

%

16

 

14.3

%

8

 

28.6

%

12

 

0.0

%

5

 

-20.0

%

Other Rare Diseases products

 

60

 

3.4

%

1.7

%

10

 

-10.0

%

23

 

0.0

%

12

 

20.0

%

15

 

6.3

%

Genzyme

 

649

 

24.6

%

22.7

%

207

 

25.0

%

259

 

28.2

%

124

 

19.8

%

59

 

19.2

%

Plavix

 

450

 

9.0

%

6.4

%

52

 

-17.5

%

0

 

 

203

 

21.3

%

195

 

6.8

%

Lovenox

 

426

 

7.2

%

6.2

%

221

 

5.8

%

34

 

-12.8

%

147

 

16.9

%

24

 

0.0

%

Aprovel

 

178

 

-14.8

%

-15.2

%

41

 

-47.4

%

4

 

0.0

%

105

 

9.3

%

28

 

-9.7

%

Renagel And Renvela

 

162

 

-13.4

%

-13.4

%

32

 

0.0

%

103

 

-22.0

%

22

 

22.2

%

5

 

0.0

%

Allegra

 

32

 

-52.1

%

-54.9

%

2

 

0.0

%

0

 

-100.0

%

1

 

-96.7

%

29

 

-24.4

%

Stilnox

 

78

 

-16.0

%

-17.0

%

10

 

-9.1

%

19

 

-5.0

%

16

 

0.0

%

33

 

-27.7

%

Depakine

 

100

 

-1.0

%

-2.0

%

36

 

0.0

%

0

 

 

61

 

0.0

%

3

 

-25.0

%

Synvisc / Synvisc One

 

88

 

-2.2

%

-2.2

%

6

 

0.0

%

69

 

-4.2

%

11

 

10.0

%

2

 

0.0

%

Tritace

 

69

 

-5.3

%

-8.0

%

31

 

-8.8

%

0

 

 

38

 

0.0

%

0

 

-33.3

%

Multaq (*)

 

76

 

13.4

%

13.4

%

11

 

10.0

%

62

 

17.0

%

3

 

0.0

%

0

 

-50.0

%

Lasix

 

42

 

2.3

%

-2.3

%

19

 

0.0

%

1

 

0.0

%

13

 

18.2

%

9

 

-8.3

%

Targocid

 

40

 

8.1

%

8.1

%

20

 

17.6

%

0

 

 

17

 

5.9

%

3

 

-33.3

%

Orudis

 

33

 

-8.3

%

-8.3

%

4

 

0.0

%

0

 

 

28

 

-12.9

%

1

 

 

Cordarone

 

31

 

-3.0

%

-6.1

%

6

 

0.0

%

0

 

 

17

 

6.3

%

8

 

-18.2

%

Xatral

 

22

 

-15.4

%

-15.4

%

9

 

-10.0

%

0

 

-100.0

%

13

 

-14.3

%

0

 

0.0

%

Actonel

 

21

 

-8.7

%

-8.7

%

4

 

-33.3

%

0

 

 

11

 

0.0

%

6

 

0.0

%

Auvi-Q / Allerject (*)

 

37

 

26.7

%

23.3

%

1

 

 

33

 

22.2

%

0

 

 

3

 

33.3

%

Other Rx Drugs

 

881

 

-12.1

%

-13.1

%

382

 

-3.3

%

75

 

-37.8

%

324

 

-12.1

%

100

 

-16.1

%

Total Other Rx Drugs

 

2,766

 

-5.4

%

-6.6

%

887

 

-5.4

%

400

 

-14.4

%

1,030

 

-0.6

%

449

 

-7.2

%

Consumer Healthcare

 

819

 

12.9

%

10.4

%

157

 

0.0

%

158

 

3.3

%

452

 

26.2

%

52

 

-11.9

%

Generics

 

451

 

8.3

%

6.4

%

125

 

-3.9

%

28

 

-24.3

%

287

 

19.8

%

11

 

0.0

%

Pharmaceuticals

 

6,815

 

3.4

%

2.1

%

1,748

 

1.3

%

2,030

 

2.3

%

2,329

 

9.2

%

708

 

-5.7

%

Polio Pertussis

 

259

 

7.4

%

6.1

%

8

 

0.0

%

97

 

94.0

%

120

 

-20.6

%

34

 

9.7

%

Influenza Vaccines

 

650

 

15.0

%

16.3

%

89

 

15.6

%

456

 

11.7

%

99

 

31.6

%

6

 

25.0

%

Meningite/Pneumonie

 

191

 

-10.0

%

-9.5

%

2

 

100.0

%

168

 

-6.1

%

19

 

-34.5

%

2

 

-50.0

%

Adult Booster Vaccines

 

131

 

54.8

%

56.0

%

28

 

107.7

%

90

 

58.9

%

11

 

-8.3

%

2

 

0.0

%

Travel And Other Andemics Vaccines

 

99

 

-3.0

%

-2.0

%

6

 

50.0

%

31

 

-18.4

%

50

 

6.3

%

12

 

-9.1

%

Other Vaccines

 

121

 

21.8

%

19.8

%

0

 

-50.0

%

116

 

21.3

%

5

 

300.0

%

0

 

0.0

%

Vaccines

 

1,451

 

11.2

%

11.6

%

133

 

26.7

%

958

 

15.8

%

304

 

-4.0

%

56

 

3.6

%

Fipronil products

 

143

 

-5.3

%

-5.3

%

39

 

-4.9

%

67

 

-9.6

%

28

 

16.0

%

9

 

-25.0

%

Nexgard

 

27

 

 

 

3

 

 

23

 

 

1

 

 

0

 

 

Vaccines

 

176

 

11.3

%

10.0

%

47

 

23.7

%

40

 

11.1

%

84

 

6.1

%

5

 

0.0

%

Avermectin products

 

101

 

11.1

%

12.2

%

11

 

0.0

%

61

 

27.1

%

14

 

7.1

%

15

 

-25.0

%

Others

 

68

 

21.1

%

19.3

%

22

 

-5.0

%

29

 

45.0

%

16

 

15.4

%

1

 

50.0

%

Animal Health

 

515

 

12.7

%

12.4

%

122

 

8.1

%

220

 

23.2

%

143

 

9.7

%

30

 

-13.9

%

Total Group

 

8,781

 

5.1

%

4.1

%

2,003

 

3.1

%

3,208

 

7.2

%

2,776

 

7.6

%

794

 

-5.4

%

 

14


 


 

9 months net sales
(€ million)

 

Total

 

% CER

 

% reported

 

Western
Europe

 

% CER

 

United
States

 

% CER

 

Emerging
Markets

 

% CER

 

Rest of the
World

 

% CER

 

Lantus

 

4,572

 

12.5

%

8.8

%

643

 

6.5

%

3,028

 

13.3

%

700

 

17.8

%

201

 

4.2

%

Apidra

 

240

 

20.3

%

15.9

%

73

 

18.0

%

90

 

17.9

%

54

 

28.3

%

23

 

18.2

%

Amaryl

 

269

 

0.7

%

-5.3

%

15

 

-11.8

%

3

 

200.0

%

210

 

9.9

%

41

 

-28.6

%

Insuman

 

99

 

3.0

%

0.0

%

61

 

-9.0

%

1

 

0.0

%

37

 

29.0

%

0

 

 

Lyxumia

 

19

 

375.0

%

375.0

%

11

 

266.7

%

0

 

 

3

 

 

5

 

400.0

%

Diabetes

 

5,249

 

12.5

%

8.6

%

846

 

7.7

%

3,122

 

13.5

%

1,007

 

17.5

%

274

 

1.0

%

Taxotere

 

195

 

-31.7

%

-36.3

%

11

 

-42.1

%

7

 

-78.8

%

110

 

-25.0

%

67

 

-24.5

%

Jevtana (*)

 

199

 

23.6

%

20.6

%

106

 

38.2

%

65

 

6.3

%

25

 

27.3

%

3

 

0.0

%

Eloxatine

 

136

 

-14.2

%

-19.5

%

4

 

-20.0

%

-3

 

-118.8

%

90

 

-3.1

%

45

 

-2.0

%

Thymoglobulin

 

160

 

11.5

%

8.1

%

24

 

4.3

%

78

 

5.3

%

49

 

27.5

%

9

 

11.1

%

Mozobil (*)

 

80

 

7.9

%

5.3

%

26

 

4.2

%

44

 

7.1

%

8

 

12.5

%

2

 

50.0

%

Zaltrap (*)

 

49

 

28.9

%

28.9

%

25

 

177.8

%

20

 

-28.6

%

4

 

300.0

%

0

 

 

Other Oncology

 

192

 

3.7

%

1.6

%

43

 

4.9

%

112

 

3.5

%

23

 

4.5

%

14

 

0.0

%

Oncology

 

1,011

 

-3.8

%

-7.3

%

239

 

20.3

%

323

 

-10.2

%

309

 

-5.8

%

140

 

-13.0

%

Aubagio

 

287

 

205.2

%

195.9

%

56

 

 

218

 

130.9

%

6

 

700.0

%

7

 

-900.0

%

Lemtrada

 

18

 

 

 

16

 

 

0

 

 

1

 

 

1

 

 

Cerezyme

 

518

 

8.3

%

2.2

%

179

 

8.5

%

138

 

6.0

%

171

 

12.1

%

30

 

-2.9

%

Myozyme

 

392

 

9.2

%

6.2

%

199

 

-2.5

%

99

 

10.9

%

71

 

47.2

%

23

 

19.0

%

Fabrazyme

 

337

 

26.2

%

20.8

%

81

 

32.8

%

164

 

14.3

%

51

 

58.3

%

41

 

31.4

%

Aldurazyme

 

127

 

13.8

%

9.5

%

48

 

6.8

%

24

 

19.0

%

43

 

20.5

%

12

 

8.3

%

Other Rare Diseases products

 

179

 

3.4

%

0.0

%

31

 

3.3

%

63

 

-11.0

%

37

 

39.3

%

48

 

4.2

%

Genzyme

 

1,858

 

25.1

%

20.1

%

610

 

20.9

%

706

 

28.7

%

380

 

28.4

%

162

 

18.8

%

Plavix

 

1,362

 

5.8

%

-0.3

%

168

 

-14.7

%

1

 

-80.0

%

629

 

10.4

%

564

 

8.8

%

Lovenox

 

1,263

 

2.9

%

-0.2

%

672

 

5.3

%

95

 

-27.9

%

430

 

10.0

%

66

 

-1.4

%

Aprovel

 

550

 

-17.9

%

-20.2

%

147

 

-45.8

%

13

 

30.0

%

306

 

3.9

%

84

 

-14.0

%

Renagel And Renvela

 

471

 

-9.0

%

-11.6

%

97

 

-3.0

%

305

 

-14.7

%

55

 

20.0

%

14

 

-6.7

%

Allegra

 

151

 

-47.6

%

-52.7

%

8

 

0.0

%

0

 

-100.0

%

4

 

-95.6

%

139

 

-30.5

%

Stilnox

 

229

 

-15.3

%

-20.2

%

31

 

-3.1

%

53

 

-8.5

%

48

 

0.0

%

97

 

-26.0

%

Depakine

 

291

 

-2.6

%

-6.4

%

103

 

0.0

%

0

 

 

178

 

-3.5

%

10

 

-9.1

%

Synvisc / Synvisc One

 

251

 

-4.8

%

-7.7

%

20

 

11.1

%

196

 

-7.4

%

28

 

20.0

%

7

 

-33.3

%

Tritace

 

212

 

-5.6

%

-9.0

%

96

 

-6.8

%

0

 

 

112

 

-2.5

%

4

 

-37.5

%

Multaq (*)

 

215

 

11.1

%

8.6

%

33

 

6.5

%

174

 

12.6

%

7

 

16.7

%

1

 

-50.0

%

Lasix

 

123

 

3.2

%

-2.4

%

59

 

5.4

%

2

 

0.0

%

38

 

16.7

%

24

 

-15.6

%

Targocid

 

115

 

-5.6

%

-8.0

%

61

 

0.0

%

0

 

 

48

 

-7.1

%

6

 

-33.3

%

Orudis

 

116

 

14.7

%

6.4

%

14

 

-16.7

%

0

 

 

99

 

20.2

%

3

 

50.0

%

Cordarone

 

96

 

-1.9

%

-8.6

%

18

 

-5.3

%

0

 

 

53

 

3.6

%

25

 

-9.7

%

Xatral

 

69

 

-7.8

%

-10.4

%

28

 

-3.4

%

0

 

-100.0

%

40

 

-2.3

%

1

 

-50.0

%

Actonel

 

62

 

-12.0

%

-17.3

%

13

 

-23.5

%

0

 

 

32

 

-5.6

%

17

 

-13.6

%

Auvi-Q / Allerject (*)

 

63

 

32.7

%

28.6

%

2

 

0.0

%

54

 

31.0

%

0

 

 

7

 

60.0

%

Other Rx Drugs

 

2,717

 

-10.5

%

-13.9

%

1,156

 

-5.9

%

272

 

-25.1

%

1,015

 

-9.0

%

274

 

-16.6

%

Total Other Rx Drugs

 

8,356

 

-6.3

%

-10.1

%

2,726

 

-7.0

%

1,165

 

-12.8

%

3,122

 

-1.6

%

1,343

 

-9.3

%

Consumer Healthcare

 

2,520

 

17.3

%

10.4

%

518

 

0.0

%

536

 

15.0

%

1,321

 

32.4

%

145

 

-16.8

%

Generics

 

1,338

 

23.2

%

16.7

%

400

 

-3.2

%

94

 

-32.6

%

815

 

56.4

%

29

 

22.2

%

Pharmaceuticals

 

20,332

 

5.1

%

0.7

%

5,339

 

-0.2

%

5,946

 

6.1

%

6,954

 

12.9

%

2,093

 

-6.8

%

Polio Pertussis

 

754

 

-2.4

%

-6.6

%

20

 

-20.0

%

263

 

56.1

%

361

 

-19.1

%

110

 

-15.5

%

Influenza Vaccines

 

844

 

16.0

%

15.5

%

90

 

15.4

%

477

 

14.1

%

259

 

20.2

%

18

 

11.1

%

Meningite/Pneumonie

 

362

 

-10.4

%

-12.6

%

2

 

-50.0

%

299

 

1.3

%

56

 

-42.9

%

5

 

0.0

%

Adult Booster Vaccines

 

295

 

3.1

%

0.7

%

44

 

-15.4

%

213

 

10.1

%

30

 

-6.1

%

8

 

-10.0

%

Travel And Other Andemics Vaccines

 

277

 

5.9

%

1.5

%

19

 

58.3

%

77

 

1.3

%

144

 

4.1

%

37

 

5.3

%

Other Vaccines

 

265

 

14.2

%

10.9

%

1

 

-50.0

%

248

 

14.0

%

10