EX-99.1 2 a14-5194_1ex99d1.htm EX-99.1

Exhibit 99.1

 

PRESS RELEASE

Paris, February 6, 2014

 

Sanofi Returns to Growth in Q4 2013

 

 

 

Q4 2013

 

Change
(reported)

 

Change
(CER)

 

2013

 

Change
(reported)

 

Change
(CER)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

8,457

m

-0.8

%

+6.5

32,951

m

-5.7

%

-0.5

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business net income(1)

 

1,810

m

+16.8

%

+30.5

%

6,687

m

-17.5

%

-9.6

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business EPS(1)

 

1.37

 

+17.1

%

+30.8

%

5.05

 

-17.8

%

-9.8

%

 

In order to facilitate an understanding of our operational performance, we comment on our business net income statement. Business net income(1) is a non-GAAP financial measure. The consolidated income statement for 2013 is provided in Appendix 4 and a reconciliation of business net income to consolidated net income in Appendix 3. Consolidated net income for 2013 was €3,717 million, compared to €4,889 million(2) for 2012. Consolidated EPS for 2013 was €2.81 versus €3.71(2) for 2012.

 

Commenting on the Group’s performance in Q4 2013, Sanofi Chief Executive Officer, Christopher A. Viehbacher said, “Sanofi’s growth profile emerged in Q4 2013 with total sales growing 6.5% at CER and growth platforms(3), which represented 72.9% of sales, increasing 10.0% at CER.  Furthermore, new product launches are underway or imminent in most of Sanofi’s core businesses and several high potential R&D projects progressed in 2013, including alirocumab, sarilumab and U300.”

 

Q4 2013 and 2013 Performance

 

·                  Sales increased 6.5%(4) in Q4 2013. In 2013, total sales were stable (-0.5%) at €32,951 million.

·                  Growth platforms(3) increased 10.0% in Q4 2013. In 2013, sales from growth platforms reached €23,905 million (+6.6%) and accounted for 72.5% of total sales.

·                  In Q4 2013, Emerging Markets(5) sales recorded double digit growth (+10.4%). In 2013, Emerging Markets sales were €10,957 million, an increase of 4.4% (+7.1% excluding Brazil generics).

·                  Diabetes sales were up 19.0% in Q4 2013. Diabetes recorded strong double digit growth (+18.7%) to €6,568 million in 2013 driven by the performance of Lantus® (+20.0% to €5,715 million).

·                  Vaccines sales were stable in Q4 2013 as supply improved for Pentacel® and Adacel® in the U.S. from mid-October. In 2013, Vaccines sales were stable at €3,716 million as record flu vaccines sales offset U.S. supply constraints on Pentacel® and Adacel®.

·                  CHC sales were up 6.1% in Q4 2013. Sales of Consumer Healthcare exceeded €3 billion in 2013, an increase of +5.2%.

·                  Genzyme recorded a robust performance in Q4 2013 with sales up 31.4%. In 2013, Genzyme recorded sales of €2,142 million, up 25.9% driven by 16.6% growth of the rare disease franchise and by Aubagio® (€166 million).

·                  Animal Health sales were down 6.3% in Q4 2013. Sales of Animal Health decreased 5.3% to €1,985 million in 2013 reflecting increased competition to Frontline®. Broadline™, a unique product in the fight against internal and external parasites for cats, was approved in the EU in December.

·                  In Q4 2013, business EPS(1) was €1.37 (+ 30.8% at CER). 2013 business EPS was €5.05 (-9.8% at CER).

·                  Board proposes dividend of €2.80.

 

R&D Update

 

·                  In Q4 2013, positive top line results in Phase III trials for U300 (EDITION III, IV and EDITION JP I) and for sarilumab (SARIL-RA-MOBILITY) were announced. The Phase III program for the Fixed-Ratio combination of Lantus®/Lyxumia® was recently initiated.

·                  The FDA accepted the New Drug Application of Cerdelga™ (eliglustat) for review and granted it a Priority Review designation.

 

2014 Guidance

 

·                  The continued performance of growth platforms, investments in new product launches and in late-stage pipeline should lead to a 2014 business EPS(1) growth between 4% and 7% at CER, barring major unforeseen adverse events.

 


(1) See Appendix 8 for definitions of financial indicators; (2) Including impact of transition to IAS 19R; (3) See page 2; (4) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 8 for a definition); (5) See definition on page 7;

 

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

 

1



 

2013 fourth-quarter and full-year sales

 

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

 

In the fourth quarter of 2013, Sanofi generated sales of €8,457 million, a decrease of 0.8% on a reported basis. Exchange rate movements had a negative effect of 7.3 percentage points largely due to the depreciation of the Japanese Yen, U.S. Dollar, Brazilian Real, Venezuelan Bolivar, Australian Dollar and Russian Ruble against the Euro.

 

Full-year 2013 sales were €32,951 million, a decrease of 5.7% on a reported basis. Exchange rate movements had an unfavorable effect of 5.2 percentage points mainly driven by the depreciation of the Japanese Yen, U.S. Dollar, Brazilian Real, Venezuelan Bolivar, Australian dollar, South African Rand and Russian Ruble against the Euro.

 

Growth Platforms

 

In the fourth quarter of 2013, sales of the Group’s growth platforms reached €6,166 million, an increase of 10.0%, driven by double digit-growth of Emerging Markets (+10.4%), Diabetes (+19.0%), Genzyme (+31.4%) and Innovative Products (+15.7%). The Group’s growth platforms accounted for 72.9% of total consolidated sales in the fourth quarter up from 70.4% in the fourth quarter of 2012.

 

In 2013, growth platforms recorded sales of €23,905 million and accounted for 72.5% of total consolidated sales compared with 67.4% in 2012.

 

€ million

 

Q4 2013
net sales

 

Change at
CER

 

2013
net sales

 

Change at
CER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diabetes

 

 

 

1,735

 

 

 

+19.0

%

 

 

6,568

 

 

 

+18.7

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaccines

 

 

 

959

 

 

 

+0.1

%

 

 

3,716

 

 

 

-0.1

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consumer Healthcare (CHC)

 

 

 

722

 

 

 

+6.1

%

 

 

3,004

 

 

 

+5.2

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genzyme

 

 

 

595

 

 

 

+31.4

%

 

 

2,142

 

 

 

+25.9

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Animal Health

 

 

 

444

 

 

 

-6.3

%

 

 

1,985

 

 

 

-5.3

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Innovative Products(a)

 

 

 

186

 

 

 

+15.7

%

 

 

705

 

 

 

+18.8

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Emerging Markets(b)

 

2,917

 

 

 

+10.4

%

 

 

10,957

 

 

 

+4.4

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

1,392

 

 

 

+13.8

%

 

 

5,172

 

 

 

+12.7

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

of which other products

 

 

 

1,525

 

 

 

+7.5

%

 

 

5,785

 

 

 

-2.1

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Growth Platforms

 

 

 

6,166

 

 

 

+10.0

%

 

 

23,905

 

 

 

+6.6

%

 


(a)         Includes products launched 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

 

Pharmaceuticals

 

Fourth-quarter sales for the Pharmaceuticals business reached €7,054 million, an increase of 8.4% driven by Diabetes, Genzyme and Generics.

 

2013 sales for the Pharmaceuticals business were stable at €27,250 million (-0.2%). In 2013, sales lost to generic competition on key legacy products in the U.S. and EU were €1,253 million.

 

Diabetes

 

€ million

 

Q4 2013
net sales

 

Change at
CER

 

2013
net sales

 

Change at
CER

 

 

 

 

 

 

 

 

 

 

 

Lantus®

 

1,512

 

+19.9

%

5,715

 

+20.0

%

 

 

 

 

 

 

 

 

 

 

Apidra®

 

81

 

+33.8

%

288

 

+31.7

%

 

 

 

 

 

 

 

 

 

 

Amaryl®

 

91

 

+2.0

%

375

 

-1.0

%

 

 

 

 

 

 

 

 

 

 

Insuman®

 

33

 

-2.8

%

132

 

+0.0

%

 

 

 

 

 

 

 

 

 

 

Total Diabetes

 

1,735

 

19.0

%

6,568

 

18.7

%

 

The Diabetes division recorded its twelfth quarter of double-digit growth (up 19.0%) to €1,735 million. Lantus® sales were €1,512 million, an increase of 19.9% driven by the U.S. (€997 million, an increase of 24.1%) and Emerging Markets (€234 million, an increase of 21.4%).

 


(1) See Appendix 8 for definitions of financial indicators

 

2



 

In the U.S., Lantus® SoloSTAR® sales represented 58.0% of total Lantus® sales in the quarter, versus 53.4% in the fourth quarter of 2012. Lantus® sales in Western Europe were €204 million, an increase of 4.0%. In 2013, sales of Lantus® totaled €5,715 million, up 20.0% driven by the U.S. (+25.6%) and Emerging Markets (+16.8% to €874 million).

 

Sanofi filed a patent infringement suit against Eli Lilly on January 30, 2014 in the United States District Court for the District of Delaware. In its suit Sanofi alleges infringement of four patents. The suit was triggered by notifications received from Lilly starting in mid-December, in which Lilly stated that it had filed a NDA (505(b)(2) New Drug Application) with FDA for an insulin glargine drug product. Lilly also stated that its NDA included a paragraph IV certification challenging six of the seven Sanofi patents listed in the FDA Orange Book for Sanofi’s Lantus® and Lantus® SoloStar® products.

 

Sales of Apidra® reached €81 million (up 33.8%) and €288 million (up 31.7%) in the fourth quarter and 2013, respectively.

 

In the fourth quarter, sales of Amaryl® were €91 million, an increase of 2.0%. In Emerging Markets, sales of the product grew 10.8% to €66 million. In 2013, sales of Amaryl® were €375 million (-1.0%), reflecting 9.9% growth (to €269 million) in Emerging Markets and generic competition in Japan where sales decreased 18.4% to €81 million.

 

Lyxumia® (lixisenatide), a once-daily prandial GLP-1 receptor agonist is commercialized in several countries in Europe (including the UK, Germany, Spain), Japan and Mexico. Fourth-quarter and 2013 sales of Lyxumia® were €5 million and €9 million, respectively.

 

Full-year sales of the Diabetes division reached €6,568 million, an increase of 18.7%.

 

Consumer Healthcare

 

€ million

 

Q4 2013
net sales

 

Change at
CER

 

2013
net sales

 

Change at
CER

 

 

 

 

 

 

 

 

 

 

 

Doliprane®

 

68

 

0.0

%

290

 

+9.0

%

 

 

 

 

 

 

 

 

 

 

Allegra®

 

40

 

-8.7

%

264

 

+7.4

%

 

 

 

 

 

 

 

 

 

 

Essentiale®

 

60

 

+25.0

%

207

 

+21.9

%

 

 

 

 

 

 

 

 

 

 

Enterogermina®

 

30

 

+30.8

%

130

 

+21.8

%

 

 

 

 

 

 

 

 

 

 

No Spa®

 

31

 

+23.1

%

117

 

+10.0

%

 

 

 

 

 

 

 

 

 

 

Lactacyd®

 

27

 

+6.9

%

105

 

+3.6

%

 

 

 

 

 

 

 

 

 

 

Dorflex®

 

23

 

+3.8

%

93

 

+5.0

%

 

 

 

 

 

 

 

 

 

 

Other CHC Products

 

443

 

+4.1

%

1,798

 

+1.4

%

 

 

 

 

 

 

 

 

 

 

Total Consumer Healthcare

 

722

 

+6.1

%

3,004

 

+5.2

%

 

Sales of Consumer Healthcare (CHC) products increased 6.1% to €722 million in the fourth-quarter, driven by the U.S. and Emerging Markets. In the U.S., CHC sales grew 11.9% reflecting a strong performance from the Chattem portfolio as well as 9.1% increase in Allegra® sales. In Emerging Markets, the performance (+12.6% to €388 million) was sustained by strong growth recorded in Russia (+26.6%). In the fourth quarter of 2013, several CHC flagship brands recorded strong performance: Essentiale® (+25.0%), Enterogermina® (+30.8%) and No Spa® (+23.1%). Full-year sales of CHC totaled €3,004 million, an increase of 5.2%, with seven major brands accounting for 40% of sales.

 

In September, Sanofi re-introduced the antacid Rolaids® to retail stores across the U.S. In October, the U.S. Food and Drug Administration approved Nasacort® Allergy 24HR nasal spray as an over-the-counter (OTC) treatment for seasonal and year-round nasal allergies in adults and children 2 years of age and older. Nasacort® Allergy 24HR nasal spray was recently introduced in the U.S.

 

3



 

Genzyme

 

€ million

 

Q4 2013
net sales

 

Change at
CER

 

2013
net sales

 

Change at
CER

 

Cerezyme®

 

181

 

+12.9

%

688

 

+13.9

%

Myozyme® / Lumizyme®

 

131

 

+13.2

%

500

 

+11.9

%

Fabrazyme®

 

104

 

+34.5

%

383

 

+39.0

%

Aldurazyme®

 

43

 

+12.2

%

159

 

+11.3

%

Total Rare Diseases

 

524

 

+17.7

%

1,974

 

+16.6

%

Aubagio®

 

69

 

 

166

 

 

LemtradaTM

 

2

 

 

2

 

 

Total Multiple Sclerosis

 

71

 

 

168

 

 

Total Genzyme

 

595

 

+31.4

%

2,142

 

+25.9

%

 

In the fourth quarter of 2013, Genzyme sales grew 31.4% to €595 million driven by the uptake of Aubagio® and the performance of rare disease products. Genzyme recorded double digit growth in all regions with +47.4% in the U.S. (€213 million), +33.6% in Emerging Markets (€130 million), +21.5% in Western Europe (€196 million) and +13.6% in the rest of the world (€56 million). Full-year sales of Genzyme totaled €2,142 million, an increase of 25.9%.

 

Fourth-quarter sales of Cerezyme®, the leading therapy for Gaucher disease, increased 12.9% to €181 million, reflecting new patient accruals and strong growth in Emerging Markets (€67 million, up 23.3%) and the U.S. (€44 million, up 11.9%). In Western Europe, sales of the product were €60 million, an increase of 9.1%. In 2013, sales of Cerezyme® were €688 million, up 13.9%.

 

Sales of Myozyme®/Lumizyme® grew 13.2% to €131 million in the fourth quarter, driven by the addition of new patients. In Emerging Markets, the product continued to deliver strong performance with sales up 53.3% to €21 million. Sales in the U.S. and Western Europe were €31 million (up 13.8%) and €71 million (up 5.9%), respectively. Full-year sales of Myozyme®/Lumizyme® grew 11.9% to €500 million.

 

Fourth-quarter sales of Fabrazyme® increased 34.5% to €104 million. In Western Europe, sales grew 52.9% to €26 million reflecting market share gains from the competitor product. In the U.S., sales of Fabrazyme® were up 13.0% to €49 million, largely due to the addition of new patients. In Emerging Markets, sales of the product doubled reaching €15 million. In 2013, Fabrazyme® regained its market leadership with sales of €383 million, up 39.0%.

 

Sales of Aubagio® were €69 million in the fourth quarter of which €55 million were in the U.S. The launch of the product in the first Western European countries (specifically Germany and Scandinavia) started in the fourth quarter and sales reached €12 million. In 2013, sales of Aubagio® totaled €166 million.

 

Following its approval by the European Commission in September, Lemtrada™ (alemtuzumab, developed in collaboration with Bayer HealthCare to treat relapsing forms of multiple sclerosis) was launched in Germany in October. Fourth-quarter sales of the product were €2 million. Lemtrada™ is also approved in Canada, Australia, in Nordic countries and Mexico. In December 2013, Genzyme received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of Lemtrada for the treatment of relapsing forms of multiple sclerosis. Genzyme is preparing its appeal to the agency. The CVR milestone of U.S. approval of Lemtrada™ by March 31, 2014 will not be met.

 

Other Innovative Products(6)

 

€ million

 

Q4 2013
net sales

 

Change at
CER

 

2013
net sales

 

Change at
CER

 

Multaq®

 

71

 

+15.9

%

269

 

+8.2

%

Jevtana®

 

66

 

+13.3

%

231

 

+1.3

%

Auvi-Q®

 

9

 

 

51

 

 

Mozobil®

 

25

 

+4.0

%

101

 

+8.3

%

Zaltrap®

 

15

 

-16.7

%

53

 

+116.0

%

Total Other Innovative Products

 

186

 

+15.7

%

705

 

+18.8

%

 


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

 

4



 

Sales of Multaq® were €71 million (up 15.9%) and €269 million (up 8.2%) in the fourth quarter and 2013, respectively. Jevtana® sales increased 13.3% in the fourth quarter to €66 million driven by Western Europe (up 30.8%). In 2013, sales of Jevtana® were €231 million (up 1.3%). Sales of Auvi-Q® (7) which was launched in the U.S. in January 2013, were €9 million and €51 million in the fourth quarter and 2013, respectively. Fourth-quarter and 2013 sales of Mozobil® were €25 million (up 4.0%) and €101 million (up 8.3%), respectively. Sales of Zaltrap® (aflibercept, developed in collaboration with Regeneron) were €15 million in the fourth quarter and €53 million in 2013.

 

Established Pharmaceutical Products

 

€ million

 

Q4 2013
net sales

 

Change at
CER

 

2013
net sales

 

Change at
CER

 

Plavix®

 

491

 

+12.5

%

1,857

 

+1.1

%

Lovenox®

 

438

 

+4.1

%

1,703

 

-7.2

%

Aprovel®/Avapro®

 

193

 

-4.2

%

882

 

-20.9

%

Renvela®/Renagel®

 

217

 

+28.8

%

750

 

+19.0

%

Taxotere®

 

103

 

-6.4

%

409

 

-19.5

%

Allegra®

 

87

 

-19.3

%

406

 

-12.1

%

Myslee®/Ambien®/Stilnox®

 

104

 

+3.4

%

391

 

-9.5

%

Synvisc® /Synvisc-One®

 

99

 

+14.4

%

371

 

+6.1

%

Eloxatin®

 

52

 

-19.1

%

221

 

-76.0

%

 

Sales of Plavix® increased 12.5% to €491 million in the fourth quarter, driven by China (+39.8% to €114 million) following a market slowdown in the third quarter, and Japan (+15.7% to €209 million). In 2013, sales of Plavix® reached €1,857 million, up 1.1%.

 

Fourth-quarter sales of Lovenox® increased 4.1% to €438 million, reflecting 6.7% growth in Western Europe (€222 million) and generic competition in the U.S. (-3.6% to €51 million). Full-year sales of Lovenox® were €1,703 million, a decrease of 7.2%.

 

Sales of Aprovel®/Avapro® were €193 million, down 4.2% in the fourth-quarter, reflecting generic competition in Western Europe (-9.3% to €67 million) and strong performance in Emerging Markets (+14.6% to €102 million). In 2013, sales of Aprovel®/Avapro® decreased 20.9% to €882 million of which €410 million was generated in Emerging Markets (up 9.1%).

 

Sales of Renvela®/Renagel® recorded strong growth (+28.8% to €217 million) in the fourth-quarter driven by the U.S. (+39.0% to €163 million). In 2013, sales of Renvela®/Renagel® were €750 million, up 19.0%.

 

Fourth-quarter sales of the Ambien® family of products were €104 million, an increase of 3.4% despite generic competition in Japan (-8.8% to €48 million). Full-year sales of the Ambien® family of products totaled €391 million, down 9.5%.

 

Sales of Synvisc®/Synvisc-One® were €99 million (up 14.4%) and €371 million (up 6.1%), in the fourth-quarter and 2013, respectively.

 

Sales of Taxotere® were €103 million in the fourth-quarter, a decrease of 6.4%, reflecting generic competition globally. In 2013, sales of Taxotere® were €409 million, down 19.5%.

 

Fourth-quarter sales of Allegra® as a prescription drug decreased 19.3% to €87 million reflecting generic competition in Japan (sales were down 30.5% to €56 million). 2013 sales of Allegra® were €406 million, down 12.1%.

 

Sales of Eloxatin® decreased 19.1% to €52 million in the fourth-quarter. Full-year sales of Eloxatin® were down 76.0% to €221 million reflecting the loss of the product market exclusivity in the U.S. in August, 2012.

 

Generics

 

Sales of Generics increased 12.0% to €478 million in the fourth-quarter, reflecting strong improvement in Brazil where sales grew 23.6% (€59 million). In the U.S., Generics sales decreased 41.0% to €35 million due to reduced sales of the authorized generic of Lovenox® and Taxotere®. In 2013, sales of Generics were €1,625 million a decrease of 8.2% reflecting challenges in Brazil and lower sales of authorized generics in the U.S. Excluding Brazil, sales of Generics grew 8.6% in 2013.

 


(8) Sanofi U.S. licensed the North America commercialization rights to Auvi-Q from Intelliject.Inc.

 

5



 

Vaccines

 

€ million

 

Q4 2013
net sales

 

Change at
CER

 

2013
net sales

 

Change at
CER

 

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

 

341

 

+5.8

%

1,148

 

+3.2

%

Influenza Vaccines (incl. Vaxigrip® and Fluzone®)

 

198

 

+94.4

%

929

 

+9.3

%

Meningitis/Pneumonia Vaccines (incl. Menactra®)

 

82

 

-60.6

%

496

 

-20.8

%

Travel and Other Endemics Vaccines

 

109

 

+10.6

%

382

 

+9.9

%

Adult Booster Vaccines (incl. Adacel ®)

 

98

 

-16.3

%

391

 

-18.5

%

Other Vaccines

 

131

 

+17.8

%

370

 

+21.0

%

Total Vaccines (consolidated sales)

 

959

 

+0.1

%

3,716

 

-0.1

%

 

Consolidated sales of Sanofi Pasteur were stable at €959 million the fourth quarter reflecting strong influenza vaccines sales and a progressive supply improvement of Pentacel®, Adacel® and Daptacel® from mid-October in the U.S. Full-year consolidated sales of Sanofi Pasteur were also stable at €3,716 million.

 

Sales of Polio/Pertussis/Hib vaccines were €341 million, an increase of 5.8%, reflecting progressive improvement of supply for Pentacel® in the U.S. and continued strong Pentaxim® penetration, coupled with lower sales of Imovax® in Japan due to the end of the catch-up cohort following its launch in September 2012. In Emerging Markets, sales of Polio/Pertussis/Hib vaccines grew 36.0%. The rollout of Hexaxim® in Emerging Markets continued. Full-year sales of Polio/Pertussis/Hib vaccines totaled €1,148 million, up 3.2%.

 

Fourth-quarter sales of influenza vaccines grew 94.4% to €198 million. Sales in the U.S. were €121 million (3 times more than in Q4 2012), reflecting a positive phasing of supply and the success of Sanofi Pasteur’s differentiation strategy. Differentiated vaccines such as Fluzone® High-Dose for elderly people, Fluzone® Quadrivalent vaccine, a four-strain influenza vaccine and Fluzone® ID (which uses a novel microinjection system for intradermal delivery) represented 41% of flu vaccines sales in the U.S. for Sanofi Pasteur in 2013 (versus 26% in 2012). Full-year sales of influenza vaccines reached of new record level at €929 million, up 9.3%. In the U.S., Flu vaccines sales in 2013 were €533 million, an increase of 20.4%.

 

Menactra® sales were €63 million, a decrease of 64.0% in the fourth-quarter, reflecting a high comparison basis in the fourth quarter of 2012 which included CDC (Centers for Disease Control and Prevention) stock piling in the U.S. and strong sales in Latin America associated with a meningitis outbreak. Full-year sales of Menactra® were €424 million, down 21.5%. In the U.S., Menactra® maintained a strong market share of 78% in 2013.

 

Fourth-quarter sales of Adult booster vaccines were €98 million, a decrease of 16.3%, reflecting progressive improvement of supply for Adacel® in the U.S. Full-year sales of Adult booster vaccines were €391 million (-18.5%).

 

Sales of travel and other endemic vaccines reached €109 million, up 10.6%, in the fourth quarter and €382 million, up 9.9%, in 2013, reflecting higher Avaxim® sales in Emerging Markets.

 

Sales of other vaccines were €131 million (up 17.8%) in the fourth quarter and €370 million (up 21.0%) in 2013, respectively, and reflected the expansion of VaxServe (a Sanofi Pasteur company, U.S. supplier of vaccines).

 

Sales of Sanofi Pasteur MSD (not consolidated), the joint venture with Merck & Co. in Europe were €247 million, an increase of 1.4% (on a reported basis). The rollout of Hexyon® (DTaP-IPV-Hib-HepB vaccine) began in Germany and additional launches are expected in 2014. Full-year sales of Sanofi Pasteur MSD increased 3.7% (on a reported basis) to €876 million driven by Gardasil® (up 6.7% on a reported basis to €219 million) and the launch of Zostavax® (€51 million).

 

6



 

Animal Health

 

€ million

 

Q4 2013
net sales

 

Change at
CER

 

2013
net sales

 

Change at
CER

 

Companion Animal

 

218

 

-10.0

%

1,195

 

-9.8

%

Production Animal

 

226

 

-2.4

%

790

 

+2.1

%

Total Animal Health

 

444

 

-6.3

%

1,985

 

-5.3

%

of which fipronil products

 

96

 

-18.6

%

611

 

-17.8

%

of which avermectin products

 

78

 

-8.6

%

413

 

+1.7

%

of which Vaccines

 

206

 

+1.9

%

727

 

+3.0

%

 

Fourth-quarter sales of Animal Health products were €444 million, a decrease of 6.3%. Full-year sales of Animal Health products were €1,985 million, down 5.3%.

 

Sales of the Companion Animals franchise were €218 million, a decrease of 10.0% in the fourth-quarter reflecting increased Frontline® competition from prescription-only products and branded generics of fipronil. Full-year sales of the Companion Animals franchise were €1,195 million, down 9.8%.

 

In September, the U.S. FDA approved NexGard™ (afoxolaner) Chewables for the treatment and prevention of flea infestations, and treatment and control of the American Dog tick in adult dogs and puppies. The launch of NexGard™ began in the U.S. in the first quarter of 2014. In December, the European Medicines Agency (EMA) approved Broadline™, a unique product in the fight against external and internal parasite for cats and kittens. Broadline™ will be a prescription-only product and is expected to be launched in Europe in the first quarter of 2014.

 

Fourth-quarter sales of the Production Animals franchise totaled €226 million, down 2.4%. Full-year sales of the Production Animals franchise were €790 million, an increase of 2.1%.

 

Net sales by geographic region

 

€ million

 

Q4 2013
 net sales

 

Change at
CER

 

2013
 net sales

 

Change at
CER

 

Emerging Markets(a)

 

2,917

 

+10.4

%

10,957

 

+4.4

%

of which Latin America

 

825

 

+10.1

%

3,013

 

-1.5

%

of which Asia

 

776

 

+15.4

%

3,040

 

+10.1

%

of which Eastern Europe, Russia and Turkey

 

712

 

+5.2

%

2,673

 

+2.2

%

of which Africa

 

266

 

+8.3

%

1,028

 

+7.7

%

of which Middle East

 

302

 

+14.1

%

1,071

 

+10.6

%

United States

 

2,654

 

+12.3

%

10,433

 

-0.7

%

Western Europe(b)

 

1,943

 

+1.2

%

7,831

 

-5.6

%

Rest of the world(c)

 

943

 

-5.6

%

3,730

 

-2.9

%

of which Japan

 

650

 

-8.4

%

2,507

 

-4.3

%

TOTAL

 

8,457

 

+6.5

%

32,951

 

-0.5

%

 


(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

 

Emerging Markets recorded double-digit growth in the fourth quarter to €2,917 million, driven by Diabetes (+19.3%), Genzyme (+33.6%), Generics (+26.8%) and CHC (+12.6%). Fourth-quarter sales in China recorded strong performance (+35.1% to €400 million) reflecting the progressive recovery of the Pharmaceuticals business. Sales in Eastern Europe, Russia and Turkey were up 5.2% to €712 million, driven by Russia (+10.4%) to €250 million, Turkey (+16.0%) and Hungary (+11.5%). Latin America sales increased 10.1% to €825 million. In Brazil, sales grew 6.8% to €337 million driven by the performance of Generics (+23.6%) and Genzyme (+66.7%) despite lower sales of vaccines. Full-year sales in Emerging Markets were €10,957 million, an increase of 4.4% (+7.1% excluding Brazil Generics). Full-year sales in China, Brazil and Russia were €1,471 million (+18.6%), €1,111 million (-18.2%) and €901 million (+12.0%), respectively.

 

7



 

Sales trends in the U.S. have been gradually improving in recent quarters Fourth-quarter sales in the U.S. delivered 12.3% growth to €2,654 million driven by strong performances from Diabetes (up 24.9%), Genzyme (up 47.4%) and CHC (up 11.9%). Full-year sales in the U.S. were €10,433 million, down 0.7%.

 

Sales trends in Western Europe have also been gradually improving in recent quarters. In the fourth quarter sales in this region were €1,943 million, an increase of 1.2%, reflecting the impact of austerity measures, generic competition and 9.2% growth in Germany which benefited from the launch of Aubagio® and Lemtrada™. Full-year sales in Western Europe totaled €7,831 million, down 5.6%.

 

Sales in Japan were €650 million, a decrease of 8.4% in the fourth quarter primarily reflecting the impact of generic competition to Allegra®, Myslee®, Amaryl® and lower sales of the active ingredient of Aprovel® to local partners as well as lower sales of Imovax® Polio. In 2013, sales in Japan were €2,507 million, down 4.3%.

 

R&D update

 

Consult Appendix 5 for full overview of Sanofi’s R&D pipeline

 

Regulatory update

 

Regulatory updates since the publication of the third-quarter 2013 results on October 30, 2013 include the following:

 

·                  In December, Sanofi and its subsidiary Genzyme announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of LemtradaTM (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. Genzyme is preparing its appeal to the agency.

 

·                  In December the FDA granted a Priority Review designation to the New Drug Application (NDA) for Cerdelga™ (eliglustat), an investigational oral therapy for adult patients with Gaucher disease type 1. The European Medicines Agency (EMA) accepted Genzyme’s marketing authorization application for eliglustat in the EU in late October 2013.

 

·                  In December, Merial announced the approval by the European Medicines Agency of Broadline™, a unique product in the fight against external and internal parasite for cats and kittens.

 

·                  Sanofi Pasteur made the decision to withdraw the Quadrivalent Influenza Vaccine marketing authorization application submitted in Europe through a decentralized procedure early this year to update the pharmaceutical section at the request of the regulatory authorities. Sanofi Pasteur will take the opportunity of this update to extend the target group to 36 month of age (vs. 9 years of age in the initial submission). A phase III study will start in 2014 with the objective of providing the necessary data.

 

At the beginning of February 2014, the R&D pipeline contained 49 projects (excluding Life Cycle Management) and vaccine candidates in clinical development of which 12 are in Phase III or have been submitted to the health authorities for approval. Biologics constitute 80% of pipeline projects(8) in development. Sanofi currently has nine high-potential late-stage projects(9).

 

Portfolio update

 

Phase III:

 

·                  The Phase III program for LixiLan, the Fixed-Ratio combination of Lantus® / Lyxumia®, started. LixiLan-O will evaluate LixILan in patients insufficiently controlled on oral antidiabetics drugs (OADs) and LixiLan-L will evaluate LixiLan in patients not at goal on basal insulin.

 

·                  Patisiran (SAR438027/ALN-TTR02), a mRNA inhibitor, entered into Phase III, for familial amyloid polyneuropathy.

 

·                  The full results from the EDITION II study were presented at the International Diabetes Federation 2013 World Diabetes Congress in December. These results showed that investigational new insulin U300 demonstrated similar blood sugar control with 23% fewer patients experiencing night-time low blood sugar compared with Lantus® (insulin glargine injection).

 


(8) 39 NMEs and vaccines out of a total of 49

(9) U300, 6-in-1 vaccine PR5I (U.S.), alirocumab, Dengue vaccine, lixisenatide (U.S.), sarilumab, LixiLan, dupilumab, C. Diff vaccine

 

8



 

The full EDITION II results are consistent with those from EDITION I. Both studies were conducted in patients with type 2 diabetes already using basal insulin (with mealtime insulin or oral medication). Sanofi also announced additional top-line results from the EDITION Phase 3 clinical program. The primary endpoint was met in the 6-month EDITION III, EDITION IV and EDITION JP I studies. Consistent with the results of the EDITION I and II studies, the rates of severe or nocturnal confirmed hypoglycemia in EDITION III from month 3 to 6 (main secondary endpoint) were lower with U300, but unlike EDITION I and II, the reduction was not statistically significant. Full results of these studies are expected to be presented at scientific meetings in 2014.

 

·                  In December, Sanofi announced the results of a 24-week Phase IIIb clinical study showing that Lyxumia® (lixisenatide) met the primary endpoint of non-inferiority in blood sugar lowering (HbA1c) when administered either before breakfast or the main meal of the day. These results indicate that lixisenatide can effectively lower blood sugar at either time of administration.

 

·                  In November, Sanofi and Regeneron announced positive results with sarilumab (the first fully-human anti-IL-6R monoclonal antibody) in the first Phase III rheumatoid arthritis trial. In the SARIL-RA-MOBILITY Phase III clinical trial in adult patients with active rheumatoid arthritis (RA) who were inadequate responders to methotrexate (MTX) therapy, sarilumab treatment in combination with MTX improved disease signs and symptoms as well as physical function, and inhibited progression of joint damage. Both sarilumab groups showed clinically relevant and statistically significant improvements compared to the placebo group in all three co-primary endpoints. Additional analyses of efficacy and safety data from the SARIL-RA-MOBILITY study will be presented at a future medical conference.

 

·                  In November, Sanofi announced the decision to halt all clinical trials and cancel plans for regulatory filings with its investigational JAK2 inhibitor, fedratinib (SAR302503). Following a thorough risk-benefit analysis, including consultation with the FDA, study investigators, independent expert neurologists and neuro-radiologists, Sanofi determined that the risk to patient safety outweighed the benefit that fedratinib would bring to patients.

 

Phase II:

 

·                  SAR391786, a monoclonal antibody GDF8, entered into Phase II for sarcopenia.

 

·                  One project in Phase II (SAR292833 in chronic disabling pain) has been discontinued

 

·                  The Phase IIa study of dupilumab in asthma was named “Clinical Advance of the Year” by Scrip Intelligence at the 9th annual Scrip Awards. The award was announced in November by Scrip, a leading pharmaceutical industry publication. Dupilumab is a fully-human monoclonal antibody that is in clinical development for treatment of asthma, atopic dermatitis, and nasal polyposis. Dupilumab is being developed by Regeneron and Sanofi.

 

In January, Genzyme and Alnylam Pharmaceuticals(10), Inc. announced that they significantly expanded their strategic agreement to develop and commercialize treatments for rare genetic diseases. Genzyme will have significant rights to Alnylam’s portfolio of clinical and pre-clinical stage drug candidates. Alnylam will retain most product rights in North America and Western Europe, and will have significantly expanded development and commercial opportunities for its genetic medicine pipeline through Genzyme’s established global infrastructure in rare diseases.

 

In December, Sanofi and Regeneron announced an innovative collaboration with the American College of Cardiology (ACC) focused on enhancing clinical research with alirocumab, an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). PCSK9 is known to contribute to circulating low-density lipoprotein cholesterol (LDL-C) levels. Alirocumab is being co-developed by Sanofi and Regeneron. Under the terms of the agreement, the ACC will apply its expertise in clinical research and utilize its extensive registries to identify patients who might be appropriate candidates for the Phase 3 ODYSSEY OUTCOMES clinical trial.

 


(10) This transaction has been approved by the boards of both companies, and is subject to customary closing conditions and clearances under the Hart-Scott Rodino Antitrust Improvements Act

 

9


 


 

Fourth-quarter and 2013 financial results

 

Business Net Income(1)

 

In the fourth quarter, Sanofi net sales decreased 0.8% (+6.5% at constant exchange rates) to €8,457 million. In 2013, Sanofi net sales were €32,951 million, a decrease of 5.7% on a reported basis (-0.5% at constant exchange rates).

 

Other revenues decreased 35.8% to €88 million in the fourth quarter, impacted by the end of royalties on Enbrel® sales in the U.S. In 2013, other revenues were €355 million, a decrease of 64.9%, mainly reflecting the loss of exclusivity of Plavix® in the U.S. in 2012.

 

In the fourth quarter, Gross profit was €5,644 million, a decrease of 2.7% (up 5.3% at constant exchange rates). The ratio of cost of sales to net sales was 34.3% compared to 33.6% in the fourth quarter of 2012. This increase reflects the impact of vaccine manufacturing issues, the mix effect from lower sales of high margin companion animal brands and unfavorable currency variation and was partially offset by the enhanced margin of Diabetes and Genzyme. In 2013, gross profit reached €22,324 million, down 10.3% (or -4.8% at constant exchange rates). In 2013, the ratio of cost of sales to net sales was 33.4% versus 31.7% in 2012, mainly reflecting the impact of vaccine manufacturing issues, challenges in Brazil generics and unfavourable currency variation.

 

Research and Development expenses were €1,246 million in the fourth-quarter, a decrease of 8.0%. At constant exchange rates, R&D expenses decreased 4.8% reflecting lower internal fixed costs, less spend on post-marketing studies and decreased vaccines expenses following the conclusion of the 30,000 patient study with Fluzone® High-Dose in Q3 2013. In 2013, R&D expenses were €4,770 million, down 2.8% (-0.3% at constant exchange rates) reflecting significant reduction in internal fixed costs and higher investments supporting late-stage R&D pipeline projects. In 2013, the ratio of R&D to net sales was 14.5% versus 14.0% in 2012.

 

Fourth-quarter selling and general expenses were €2,148 million, a decrease of 8.7%. At constant exchange rates, SG&A decreased 3.1% due to lower sales force costs in Europe, decreased European and U.S. Pharma Advertising and Promotion costs, and lower Vaccines spend in the U.S. This decreased spend offset higher commercial investment of Genzyme in multiple sclerosis and investments in the Diabetes business. General expenses increased 2.6% at constant exchange rates. In 2013, SG&A expenses were €8,602 million, a decrease of 3.7% (or an increase of 0.7% at constant exchange rates) mainly reflecting tight control over sales and marketing costs, flat general expenses and investment in new multiple sclerosis franchise. In 2013, the ratio of selling and general expenses to net sales was 26.1% versus 25.6% in 2012.

 

Other current operating income net of expenses was an income of €251 million in the fourth quarter versus an income of €56 million in the fourth quarter of 2012 and included a payment of €92 million before tax received following the amendment of the Actonel agreement with Warner Chilcott and an income of €93 million before tax resulting from the Rituxan arbitration between Hoechst and Genentech. In 2013, other current operating income net of expenses was an income of €449 million.

 

The share of profits from associates was €26 million in the fourth quarter (versus -€1 million in the fourth quarter of 2012). In 2013, share of profits from associates was €85 million versus €424 million in 2012, impacted by the loss of exclusivity of Plavix® in the U.S. in May 2012.

 

In the fourth quarter, non-controlling interests were -€40 million compared to -€29 million in the fourth quarter of 2012. In 2013, non-controlling interests were -€162 million, down 5.8%.

 

Business operating income grew 17.4% to €2,487 million in the fourth quarter (up 30.6% at constant exchange rates). The ratio of business operating income to net sales was 29.4% compared to 24.8% in the fourth quarter of 2012. In 2013, business operating income was €9,324 million, a decrease of 18.6% (down 11.1% at constant exchange rates). In 2013, the ratio of business operating income to net sales was 28.3%, compared to 32.8% in 2012.

 

Fourth-quarter Net financial expenses were €103 million, compared to €198 million in the fourth quarter of 2012 and included a capital gain (€29 million) linked to the partial sale of a financial investment. Full-year net financial expenses were €503 million versus €658 million in 2012. In 2013, interest cost of net defined benefit liability was €159 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

 

10



 

The effective tax rate was 23.9% in the fourth quarter compared to 19.0% in the fourth quarter of 2012. The 2013 effective tax rate was 24.0% versus 25.5% in 2012 mainly due to the constant evolution of our geographical mix of earnings as well as recent procedures with the tax authorities in a number of countries which had a positive impact in 2013.

 

Business net income(1) grew 16.8% (up 30.5% at constant exchange rates) to €1,810 million in the fourth-quarter. In 2013, business net income decreased 17.5% (or -9.6% at constant exchange rates) to €6,687 million. The ratio of business net income to net sales was 20.3%, compared to 23.2% in 2012.

 

In the fourth quarter of 2013, Business earnings per share(1) (EPS) was €1.37, up 17.1% and 30.8% on a reported basis and at constant exchange rates, respectively. The average number of shares outstanding was 1,321.1 million this quarter versus 1,320.9 million in the fourth quarter of 2012. In 2013, Business earnings per share(1) was €5.05, down 17.8% and 9.8% on a reported basis and at constant exchange rates, respectively. In 2013, currency fluctuations impacted Business EPS by €0.49 or 8.0 percentage points. The average number of shares outstanding was 1,323.1 million 2013 versus 1,319.5 million in 2012.

 

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

 

In 2013, the main reconciling items between business net income and consolidated net income attributable to equity holders of Sanofi were:

 

·                  A €2,914 million amortization charge on intangible assets related to fair value remeasurement of acquired companies (primarily Aventis: €1,199 million, Genzyme: €930 million and Merial €387 million) and to acquired intangible assets (licenses/products: €110 million). A €682 million amortization charge on intangible assets related to fair value remeasurement of acquired companies (primarily Aventis: €258 million, Genzyme €234 million and Merial €95 million), and to acquired intangible assets (licenses/products: €25 million) was booked in the fourth quarter. These items have no cash impact on the Group.

 

·                  An impairment loss against intangible assets of €1,387 million (of which €919 million in Q4 2013 mainly related to the reassessment of LemtradaTM in the U.S. (€612 million) following the FDA complete response letter and TargeGen (€170 million). This item has no cash impact on the Group.

 

·                  An income of €314 million mainly reflecting a decrease in the fair value of contingent considerations related to the CVRs (€246 million, of which €306 million in Q4 2013) and TargeGen (€127 million, of which €161 million in Q4 2013) and an increase of contingent considerations related to Bayer (€60 million, including an income of €34 million in Q4 2013).

 

·                  A charge of €8 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.

 

·                  €300 million of restructuring costs (including €70 million in the fourth quarter mainly related to plans in France).

 

·                  A €1,480 million tax effect arising from the items listed above, comprising €939 million generated by amortization charged against intangible assets, €527 million associated with impairment loss on intangible assets, €97 million associated with restructuring costs and €85 million of reversal of differed tax related to the change of fair value remeasurement of consideration liabilities. The fourth quarter tax effect was €442 million, including €216 million of deferred taxes generated by amortization charged against intangible assets, €338 million associated with impairment loss on intangible assets, €16 million linked to restructuring costs and €128 million of reversal of differed tax related to the change of fair value remeasurement of consideration liabilities (see Appendix 3).

 

·                  A €109 million tax (3%) on dividends paid to Sanofi shareholders.

 

·                  In “Share of profits/losses from associates”, a charge of €50 million, net of tax, mainly relating to the share of amortization of intangible assets (of which €24 million in Q4 2013). This item has no cash impact on the Group.

 


(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



 

Net Debt

 

In 2013, net cash generated by operating activities was €7,655 million after changes in working capital (€124 million). This amount covered part of a share repurchase (€1,641 million) partially offset by proceeds from the issuance of new shares (€1,004 million), dividend paid by Sanofi (€3,638 million), capital expenditures (€1,198 million), acquisitions and partnerships net of disposals (€151 million) and restructuring costs (€659 million). As a consequence, net debt decreased from €7,719 million at December 31, 2012 to €6,043 million at December 31, 2013 (net of €8,257 million cash and cash equivalents). Net debt decreased from €8,788 million at September 30, 2013 to €6,043 million at December 31, 2013.

 

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 labeling 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, 2012. 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:

 

2013 fourth-quarter and 2013 consolidated net sales by geographic region and product

 

 

 

Appendix 2:

 

2013 fourth-quarter and 2013 business net income statement

 

 

 

Appendix 3:

 

Reconciliation of business net income to net income attributable to equity holders of Sanofi

 

 

 

Appendix 4:

 

2013 fourth-quarter and 2013 consolidated income statement

 

 

 

Appendix 5:

 

Change in net debt

 

 

 

Appendix 6:

 

Simplified consolidated balance sheet

 

 

 

Appendix 7:

 

R&D pipeline

 

 

 

Appendix 8:

 

Definitions

 

12



 

 

Appendix 1: 2013 fourth-quarter and 2013 consolidated net sales by geographic region and product

 

Q4 2013 net sales (€ million)

 

Total

 

% CER

 

% reported

 

Western
Europe

 

% CER

 

United States

 

% CER

 

Emerging
Markets

 

% CER

 

Rest of the
World

 

% CER

 

Lantus

 

1,512

 

19.9

%

13.3

%

204

 

4.0

%

997

 

24.1

%

234

 

21.4

%

77

 

10.7

%

Apidra

 

81

 

33.8

%

24.6

%

23

 

21.1

%

34

 

50.0

%

17

 

28.6

%

7

 

25.0

%

Amaryl

 

91

 

2.0

%

-10.8

%

5

 

-16.7

%

1

 

 

66

 

10.8

%

19

 

-16.1

%

Insuman

 

33

 

-2.8

%

-8.3

%

23

 

-8.0

%

0

 

 

11

 

9.1

%

-1

 

 

Diabetes

 

1,735

 

19.0

%

12.0

%

270

 

5.8

%

1,032

 

24.9

%

329

 

19.3

%

104

 

4.8

%

Taxotere

 

103

 

-6.4

%

-17.6

%

3

 

-55.6

%

9

 

50.0

%

55

 

-3.2

%

36

 

-8.3

%

Jevtana

 

66

 

13.3

%

10.0

%

34

 

30.8

%

23

 

0.0

%

9

 

0.0

%

0

 

0.0

%

Eloxatin

 

52

 

-19.1

%

-23.5

%

1

 

-50.0

%

3

 

-75.0

%

30

 

-8.6

%

18

 

0.0

%

Thymoglobulin

 

50

 

1.9

%

-3.8

%

8

 

14.3

%

26

 

16.7

%

13

 

-17.6

%

3

 

-25.0

%

Mozobil

 

25

 

4.0

%

0.0

%

8

 

0.0

%

14

 

0.0

%

2

 

0.0

%

1

 

 

Zaltrap

 

15

 

-16.7

%

-16.7

%

6

 

 

8

 

-55.6

%

1

 

 

0

 

 

Other Oncology

 

63

 

0.0

%

-8.7

%

13

 

0.0

%

36

 

8.3

%

8

 

-16.7

%

6

 

-14.3

%

Oncology

 

374

 

-3.4

%

-10.3

%

73

 

13.6

%

119

 

-6.7

%

118

 

-6.5

%

64

 

-6.3

%

Aubagio

 

69

 

928.6

%

885.7

%

12

 

 

55

 

728.6

%

1

 

 

1

 

 

Lemtrada

 

2

 

 

 

2

 

 

0

 

 

0

 

 

0

 

 

Cerezyme

 

181

 

12.9

%

5.8

%

60

 

9.1

%

44

 

11.9

%

67

 

23.3

%

10

 

-14.3

%

Myozyme

 

131

 

13.2

%

8.3

%

71

 

5.9

%

31

 

13.8

%

21

 

53.3

%

8

 

0.0

%

Fabrazyme

 

104

 

34.5

%

23.8

%

26

 

52.9

%

49

 

13.0

%

15

 

100.0

%

14

 

46.2

%

Aldurazyme

 

43

 

12.2

%

4.9

%

16

 

21.4

%

8

 

14.3

%

15

 

6.7

%

4

 

0.0

%

Other Rare Diseases products

 

65

 

21.1

%

14.0

%

9

 

0.0

%

26

 

23.8

%

11

 

44.4

%

19

 

16.7

%

Genzyme

 

595

 

31.4

%

23.7

%

196

 

21.5

%

213

 

47.4

%

130

 

33.6

%

56

 

13.6

%

Plavix

 

491

 

12.5

%

-2.4

%

60

 

-4.8

%

0

 

 

213

 

14.8

%

218

 

15.1

%

Lovenox

 

438

 

4.1

%

-0.7

%

222

 

6.7

%

51

 

-3.6

%

142

 

4.0

%

23

 

0.0

%

Aprovel

 

193

 

-4.2

%

-9.0

%

67

 

-9.3

%

7

 

-12.5

%

102

 

14.6

%

17

 

-45.5

%

Renagel and Renvela

 

217

 

28.8

%

22.6

%

33

 

0.0

%

163

 

39.0

%

17

 

18.8

%

4

 

0.0

%

Allegra

 

87

 

-19.3

%

-35.6

%

2

 

100.0

%

-1

 

 

30

 

20.7

%

56

 

-30.5

%

Stilnox

 

104

 

3.4

%

-11.1

%

10

 

0.0

%

29

 

47.6

%

15

 

0.0

%

50

 

-8.7

%

Depakine

 

94

 

-2.9

%

-8.7

%

36

 

2.8

%

0

 

 

54

 

-6.3

%

4

 

0.0

%

Synvisc / Synvisc-One

 

99

 

14.4

%

10.0

%

7

 

16.7

%

78

 

8.0

%

8

 

42.9

%

6

 

150.0

%

Tritace

 

74

 

-3.7

%

-9.8

%

33

 

-5.7

%

0

 

 

38

 

-2.3

%

3

 

0.0

%

Multaq

 

71

 

15.9

%

12.7

%

12

 

0.0

%

57

 

18.0

%

2

 

50.0

%

0

 

 

Lasix

 

46

 

-5.5

%

-16.4

%

19

 

5.6

%

1

 

0.0

%

14

 

-6.3

%

12

 

-15.0

%

Targocid

 

41

 

0.0

%

-6.8

%

19

 

0.0

%

0

 

 

19

 

10.5

%

3

 

-33.3

%

Orudis

 

35

 

0.0

%

-14.6

%

6

 

-45.5

%

0

 

 

28

 

21.4

%

1

 

-50.0

%

Cordarone

 

36

 

-2.4

%

-12.2

%

6

 

0.0

%

0

 

 

19

 

5.3

%

11

 

-12.5

%

Xatral

 

24

 

-10.3

%

-17.2

%

10

 

0.0

%

0

 

-100.0

%

15

 

0.0

%

-1

 

0.0

%

Actonel

 

25

 

-10.0

%

-16.7

%

5

 

-28.6

%

0

 

 

12

 

-7.1

%

8

 

0.0

%

Auvi-Q

 

9

 

 

 

0

 

 

9

 

 

0

 

 

0

 

 

Other Rx Drugs

 

1,066

 

-5.1

%

-11.5

%

416

 

-3.9

%

122

 

-12.2

%

402

 

-0.9

%

126

 

-12.4

%

Total Other Rx Drugs

 

3,150

 

1.7

%

-6.4

%

963

 

-1.8

%

516

 

12.0

%

1,130

 

5.1

%

541

 

-5.9

%

Consumer Healthcare

 

722

 

6.1

%

-1.4

%

147

 

-8.1

%

135

 

11.9

%

388

 

12.6

%

52

 

-7.6

%

Generics

 

478

 

12.0

%

4.4

%

143

 

4.3

%

35

 

-41.0

%

291

 

26.8

%

9

 

120.0

%

Pharmaceuticals

 

7,054

 

8.4

%

0.7

%

1,792

 

1.9

%

2,050

 

17.9

%

2,386

 

11.1

%

826

 

-3.1

%

Polio/Pertussis/Hib Vaccines

 

341

 

5.8

%

-1.4

%

10

 

-26.7

%

102

 

12.6

%

177

 

36.0

%

52

 

-37.0

%

Influenza Vaccines

 

198

 

94.4

%

85.0

%

5

 

0.0

%

121

 

296.9

%

68

 

10.8

%

4

 

-20.0

%

Meningitis/Pneumonia Vaccines

 

82

 

-60.6

%

-62.4

%

1

 

 

52

 

-61.4

%

27

 

-61.8

%

2

 

0.0

%

Adult Booster Vaccines

 

98

 

-16.3

%

-20.3

%

8

 

-18.2

%

70

 

-22.1

%

15

 

23.1

%

5

 

0.0

%

Travel and Other Endemics Vaccines

 

109

 

10.6

%

4.8

%

6

 

0.0

%

19

 

-28.6

%

70

 

28.1

%

14

 

23.1

%

Other Vaccines

 

131

 

17.8

%

11.0

%

1

 

-150.0

%

125

 

19.1

%

4

 

-20.0

%

1

 

400.0

%

Vaccines

 

959

 

0.1

%

-5.6

%

31

 

-20.5

%

489

 

2.6

%

361

 

7.7

%

78

 

-24.8

%

Fipronil products

 

96

 

-18.6

%

-25.6

%

25

 

-7.1

%

27

 

-47.2

%

27

 

29.2

%

17

 

-16.7

%

Vaccines

 

206

 

1.9

%

-3.3

%

53

 

3.9

%

40

 

2.4

%

107

 

0.9

%

6

 

0.0

%

Avermectin products

 

78

 

-8.6

%

-16.1

%

18

 

-15.0

%

28

 

-21.1

%

17

 

5.6

%

15

 

11.8

%

Others

 

64

 

-5.6

%

-9.9

%

24

 

4.2

%

20

 

-16.7

%

19

 

18.8

%

1

 

-57.1

%

Animal Health

 

444

 

-6.3

%

-12.3

%

120

 

-1.6

%

115

 

-23.1

%

170

 

7.0

%

39

 

-10.9

%

Total Group

 

8,457

 

6.5

%

-0.8

%

1,943

 

1.2

%

2,654

 

12.3

%

2,917

 

10.4

%

943

 

-5.6

%

 

13



 

2013 net sales (€ million)

 

Total

 

% CER

 

% reported

 

Western
Europe

 

% CER

 

United States

 

% CER

 

Emerging
Markets

 

% CER

 

Rest of the
World

 

% CER

 

Lantus

 

5,715

 

20.0

%

15.2

%

804

 

4.1

%

3,747

 

25.6

%

874

 

16.8

%

290

 

12.3

%

Apidra

 

288

 

31.7

%

25.2

%

84

 

7.7

%

112

 

58.9

%

63

 

31.4

%

29

 

28.6

%

Amaryl

 

375

 

-1.0

%

-10.9

%

22

 

-21.4

%

2

 

-33.3

%

269

 

9.9

%

82

 

-18.1

%

Insuman

 

132

 

0.0

%

-2.2

%

90

 

-8.2

%

1

 

0.0

%

42

 

18.9

%

-1

 

-100.0

%

Diabetes

 

6,568

 

18.7

%

13.6

%

1,051

 

4.4

%

3,862

 

26.1

%

1,250

 

16.1

%

405

 

5.7

%

Taxotere

 

409

 

-19.5

%

-27.4

%

22

 

-56.6

%

42

 

-18.9

%

211

 

-18.5

%

134

 

-10.7

%

Jevtana

 

231

 

1.3

%

-1.7

%

110

 

22.0

%

86

 

-19.3

%

31

 

3.0

%

4

 

150.0

%

Eloxatin

 

221

 

-76.0

%

-76.9

%

6

 

-53.8

%

19

 

-97.4

%

127

 

-14.4

%

69

 

1.4

%

Thymoglobulin

 

198

 

7.3

%

2.6

%

31

 

6.9

%

102

 

8.2

%

53

 

10.0

%

12

 

-6.3

%

Mozobil

 

101

 

8.3

%

5.2

%

32

 

6.7

%

56

 

3.6

%

10

 

42.9

%

3

 

33.3

%

Zaltrap

 

53

 

116.0

%

112.0

%

15

 

 

36

 

54.2

%

2

 

 

0

 

-100.0

%

Other Oncology

 

252

 

-18.7

%

-22.7

%

54

 

-26.7

%

149

 

-15.8

%

30

 

-28.9

%

19

 

4.3

%

Oncology

 

1,465

 

-35.3

%

-38.8

%

270

 

-6.2

%

490

 

-59.3

%

464

 

-13.3

%

241

 

-5.3

%

Aubagio

 

166

 

2371.4

%

2271.4

%

12

 

 

152

 

2157.1

%

2

 

 

0

 

 

Lemtrada

 

2

 

 

 

2

 

 

0

 

 

0

 

 

0

 

 

Cerezyme

 

688

 

13.9

%

8.7

%

225

 

5.1

%

178

 

10.8

%

241

 

36.3

%

44

 

-16.1

%

Myozyme

 

500

 

11.9

%

8.2

%

274

 

7.4

%

123

 

9.4

%

74

 

43.6

%

29

 

3.0

%

Fabrazyme

 

383

 

39.0

%

31.2

%

87

 

69.2

%

196

 

33.6

%

51

 

31.7

%

49

 

29.8

%

Aldurazyme

 

159

 

11.3

%

6.0

%

60

 

5.2

%

29

 

15.4

%

54

 

21.3

%

16

 

0.0

%

Other Rare Diseases products

 

244

 

8.7

%

1.2

%

39

 

14.7

%

99

 

5.2

%

39

 

13.9

%

67

 

8.0

%

Genzyme

 

2,142

 

25.9

%

20.0

%

699

 

14.3

%

777

 

42.6

%

461

 

33.3

%

205

 

5.1

%

Plavix

 

1,857

 

1.1

%

-10.1

%

257

 

-16.3

%

5

*

-93.4

%

807

 

4.6

%

788

 

12.1

%

Lovenox

 

1,703

 

-7.2

%

-10.0

%

858

 

0.9

%

187

 

-39.5

%

563

 

-2.6

%

95

 

-1.9

%

Aprovel

 

882

 

-20.9

%

-23.4

%

338

 

-39.1

%

17

 

-60.0

%

410

 

9.1

%

117

 

-20.8

%

Renagel and Renvela

 

750

 

19.0

%

14.9

%

133

 

4.7

%

531

 

22.0

%

67

 

35.8

%

19

 

0.0

%

Allegra

 

406

 

-12.1

%

-26.6

%

10

 

-9.1

%

-3

 

200.0

%

120

 

12.5

%

279

 

-18.7

%

Stilnox

 

391

 

-9.5

%

-21.3

%

42

 

-8.7

%

88

 

7.1

%

65

 

0.0

%

196

 

-16.6

%

Depakine

 

405

 

2.7

%

-1.2

%

138

 

-2.1

%

0

 

 

252

 

5.6

%

15

 

0.0

%

Synvisc / Synvisc-One

 

371

 

6.1

%

2.2

%

25

 

25.0

%

295

 

1.0

%

33

 

45.8

%

18

 

17.6

%

Tritace

 

307

 

-7.2

%

-11.0

%

136

 

-9.3

%

0

 

 

160

 

-4.4

%

11

 

-20.0

%

Multaq

 

269

 

8.2

%

5.5

%

43

 

-6.5

%

216

 

11.5

%

8

 

12.5

%

2

 

0.0

%

Lasix

 

172

 

-9.5

%

-18.1

%

75

 

-5.1

%

3

 

0.0

%

50

 

-11.3

%

44

 

-13.6

%

Targocid

 

166

 

-11.1

%

-16.2

%

79

 

-8.1

%

0

 

 

75

 

-10.0

%

12

 

-27.3

%

Orudis

 

144

 

-9.8

%

-21.7

%

24

 

-52.9

%

0

 

 

117

 

7.8

%

3

 

-25.0

%

Cordarone

 

141

 

-4.3

%

-13.5

%

25

 

-10.7

%

0

 

 

74

 

2.6

%

42

 

-10.2

%

Xatral

 

101

 

-20.0

%

-22.3

%

39

 

-13.3

%

3

 

-85.0

%

58

 

-3.2

%

1

 

-33.3

%

Actonel

 

100

 

-20.1

%

-25.4

%

22

 

-33.3

%

0

 

 

48

 

-22.7

%

30

 

-2.9

%

Auvi-Q

 

51

 

 

 

0

 

 

51

 

 

0

 

 

0

 

 

Other Rx Drugs

 

4,230

 

-8.1

%

-12.8

%

1,645

 

-13.1

%

497

 

-12.0

%

1,607

 

-0.3

%

481

 

-11.1

%

Total Other Rx Drugs

 

12,446

 

-5.5

%

-11.5

%

3,889

 

-13.0

%

1,890

 

-6.1

%

4,514

 

1.8

%

2,153

 

-5.4

%

Consumer Healthcare

 

3,004

 

5.2

%

-0.1

%

664

 

-0.2

%

616

 

4.8

%

1,482

 

7.9

%

242

 

3.9

%

Generics

 

1,625

 

-8.2

%

-11.9

%

552

 

11.4

%

179

 

-32.4

%

858

 

-12.8

%

36

 

51.9

%

Pharmaceuticals

 

27,250

 

-0.2

%

-5.6

%

7,125

 

-5.4

%

7,814

 

1.8

%

9,029

 

3.2

%

3,282

 

-2.6

%

Polio/Pertussis/Hib Vaccines

 

1,148

 

3.2

%

-3.0

%

35

 

-34.5

%

275

 

-23.8

%

644

 

33.9

%

194

 

-8.5

%

Influenza Vaccines

 

929

 

9.3

%

5.1

%

83

 

5.1

%

533

 

20.4

%

291

 

-5.7

%

22

 

4.5

%

Meningitis/Pneumonia Vaccines

 

496

 

-20.8

%

-23.7

%

5

 

25.0

%

352

 

-22.4

%

132

 

-17.6

%

7

 

-12.5

%

Adult Booster Vaccines

 

391

 

-18.5

%

-21.2

%

60

 

3.4

%

268

 

-25.3

%

48

 

11.1

%

15

 

-25.0

%

Travel and Other Endemics Vaccines

 

382

 

9.9

%

4.9

%

18

 

-14.3

%

97

 

5.2

%

215

 

11.4

%

52

 

23.9

%

Other Vaccines

 

370

 

21.0

%

16.0

%

3

 

-88.9

%

347

 

30.0

%

11

 

-33.3

%

9

 

-13.3

%

Vaccines

 

3,716

 

-0.1

%

-4.6

%

204

 

-10.1

%

1,872

 

-5.2

%

1,341

 

11.5

%

299

 

-4.9

%

Fipronil products

 

611

 

-17.8

%

-21.2

%

177

 

-13.9

%

289

 

-28.0

%

99

 

16.1

%

46

 

-14.3

%

Vaccines

 

727

 

3.0

%

-0.4

%

182

 

1.1

%

152

 

3.3

%

374

 

4.3

%

19

 

-4.5

%

Avermectin products

 

413

 

1.7

%

-2.4

%

58

 

-6.5

%

225

 

3.6

%

59

 

-1.5

%

71

 

5.5

%

Others

 

234

 

-2.8

%

-6.8

%

85

 

-2.3

%

81

 

-11.7

%

55

 

28.3

%

13

 

-30.4

%

Animal Health

 

1,985

 

-5.3

%

-8.9

%

502

 

-6.1

%

747

 

-12.8

%

587

 

7.4

%

149

 

-7.2

%

Total Group

 

32,951

 

-0.5

%

-5.7

%

7,831

 

-5.6

%

10,433

 

-0.7

%

10,957

 

4.4

%

3,730

 

-2.9

%

 


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

 

14



 

Appendix 2: Business net income statement

 

Fourth quarter 2013

 

Group Total

 

Pharmaceuticals

 

Vaccines

 

Animal Health

 

Others

 

€ million

 

Q4 2013

 

Q4 2012(1)

 

Change

 

Q4 2013

 

Q4 2012(1)

 

Change

 

Q4 2013

 

Q4 2012(1)

 

Change

 

Q4 2013

 

Q4 2012(1)

 

Change

 

Q4 2013

 

Q4 2012(1)

 

Net sales

 

8,457

 

8,526

 

(0.8

)%

7,054

 

7,004

 

0.7

%

959

 

1,016

 

(5.6

)%

444

 

506

 

(12.3

)%

 

 

 

 

Other revenues

 

88

 

137

 

(35.8

)%

71

 

104

 

(31.7

)%

9

 

27

 

(66.7

)%

8

 

6

 

33.3

%

 

 

 

 

Cost of sales

 

(2,901

)

(2,865

)

1.3

%

(2,214

)

(2,191

)

1.0

%

(501

)

(489

)

2.5

%

(186

)

(185

)

0.5

%

 

 

 

 

As % of net sales

 

(34.3

)%

(33.6

)%

 

 

(31.4

)%

(31.3

)%

 

 

(52.2

)%

(48.2

)%

 

 

(41.9

)%

(36.6

)%

 

 

 

 

 

 

Gross profit

 

5,644

 

5,798

 

(2.7

)%

4,911

 

4,917

 

(0.1

)%

467

 

554

 

(15.7

)%

266

 

327

 

(18.7

)%

 

 

 

 

As % of net sales

 

66.7

%

68.0

%

 

 

69.6

%

70.2

%

 

 

48.7

%

54.5

%

 

 

59.9

%

64.6

%

 

 

 

 

 

 

Research and development expenses

 

(1,246

)

(1,354

)

(8.0

)%

(1,068

)

(1,148

)

(7.0

)%

(136

)

(158

)

(13.9

)%

(42

)

(48

)

(12.5

)%

 

 

 

 

As % of net sales

 

(14.7

)%

(15.9

)%

 

 

(15.1

)%

(16.4

)%

 

 

(14.2

)%

(15.6

)%

 

 

(9.5

)%

(9.5

)%

 

 

 

 

 

 

Selling and general expenses

 

(2,148

)

(2,352

)

(8.7

)%

(1,857

)

(2,028

)

(8.4

)%

(133

)

(169

)

(21.3

)%

(158

)

(155

)

1.9

%

 

 

 

 

As % of net sales

 

(25.4

)%

(27.6

)%

 

 

(26.3

)%

(29.0

)%

 

 

(13.9

)%

(16.6

)%

 

 

(35.6

)%

(30.6

)%

 

 

 

 

 

 

Other current operating income/expenses

 

251

 

56

 

 

 

258

 

71

 

 

 

(4

)

(5

)

 

 

2

 

(5

)

(5

)

(5

)

 

 

Share of profit/loss of associates* and joint ventures

 

26

 

(1

)

 

 

18

 

(3

)

 

 

9

 

9

 

 

 

(1

)

(7

)

 

 

 

 

 

 

Net income attributable to non-controlling interests

 

(40

)

(29

)

 

 

(39

)

(28

)

 

 

 

 

 

 

 

 

(1

)

(1

)

 

 

 

 

 

 

Business operating income

 

2,487

 

2,118

 

17.4

%

2,223

 

1,781

 

24.8

%

203

 

231

 

(12.1

)%

66

 

111

 

(40.5

)%

(5

)

(5

)

As % of net sales

 

29.4

%

24.8

%

 

 

31.5

%

25.4

%

 

 

21.2

%

22.7

%

 

 

14.9

%

21.9

%

 

 

 

 

 

 

Financial income and expenses

 

(103

)

(198

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

(574

)

(370

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax rate**

 

23.9

%

19.0

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business net income

 

1,810

 

1,550

 

16.8

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As % of net sales

 

21.4

%

18.2

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business earnings per share*** (in euros)

 

1.37

 

1.17

 

17.1

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


*

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 1,321.1 million in the fourth quarter of 2013 and 1,320.9 million in the fourth quarter of 2012.

(1)

Including impact of transition to IAS19R.

 

15



 

Full year 2013

 

Group Total

 

Pharmaceuticals

 

Vaccines

 

Animal Health

 

Others

 

€ million

 

2013

 

2012(1)

 

Change

 

2013

 

2012(1)

 

Change

 

2013

 

2012(1)

 

Change

 

2013

 

2012(1)

 

Change

 

2013

 

2012(1)

 

Net sales

 

32,951

 

34,947

 

(5.7

)%

27,250

 

28,871

 

(5.6

)%

3,716

 

3,897

 

(4.6

)%

1,985

 

2,179

 

(8.9

)%

 

 

 

 

Other,revenues

 

355

 

1,010

 

(64.9

)%

295

 

933

 

(68.4

)%

30

 

44

 

(31.8

)%

30

 

33

 

(9.1

)%

 

 

 

 

Cost of sales

 

(10,982

)

(11,075

)

(0.8

)%

(8,517

)

(8,745

)

(2.6

)%

(1,776

)

(1,629

)

9.0

%

(689

)

(701

)

(1.7

)%

 

 

 

 

As % of net sales

 

(33.4

)%

(31.7

)%

 

 

(31.3

)%

(30.3

)%

 

 

(47.8

)%

(41.8

)%

 

 

(34.7

)%

(32.2

)%

 

 

 

 

 

 

Gross profit

 

22,324

 

24,882

 

(10.3

)%

19,028

 

21,059

 

(9.6

)%

1,970

 

2,312

 

(14.8

)%

1,326

 

1,511

 

(12.2

)%

 

 

 

 

As % of net sales

 

67.7

%

71.2

%

 

 

69.8

%

72.9

%

 

 

53.0

%

59.3

%

 

 

66.8

%

69.3

%

 

 

 

 

 

 

Research and development expenses

 

(4,770

)

(4,905

)

(2.8

)%

(4,087

)

(4,203

)

(2.8

)%

(518

)

(538

)

(3.7

)%

(165

)

(164

)

0.6

%

 

 

 

 

As % of net sales

 

(14.5

)%

(14.0

)%

 

 

(15.0

)%

(14.6

)%

 

 

(13.9

)%

(13.8

)%

 

 

(8.3

)%

(7.5

)%

 

 

 

 

 

 

Selling and general expenses

 

(8,602

)

(8,929

)

(3.7

)%

(7,361

)

(7,650

)

(3.8

)%

(588

)

(609

)

(3.4

)%

(653

)

(669

)

(2.4

)%

 

 

(1

)

As % of net sales

 

(26.1

)%

(25.6

)%

 

 

(27.0

)%

(26.5

)%

 

 

(15.8

)%

(15.6

)%

 

 

(32.9

)%

(30.7

)%

 

 

 

 

 

 

Other current operating income/expenses

 

449

 

148

 

 

 

421

 

134

 

 

 

3

 

(7

)

 

 

(1

)

3

 

 

 

26

 

18

 

Share of profit/loss of associates* and joint ventures

 

85

 

424

 

 

 

48

 

432

 

 

 

41

 

(1

)

 

 

(4

)

(7

)

 

 

 

 

 

 

Net income attributable to non-controlling interests

 

(162

)

(172

)

 

 

(162

)

(171

)

 

 

1

 

 

 

 

 

(1

)

(1

)

 

 

 

 

 

 

Business operating income

 

9,324

 

11,448

 

(18.6

)%

7,887

 

9,601

 

(17.9

)%

909

 

1,157

 

(21.4

)%

502

 

673

 

(25.4

)%

26

 

17

 

As % of net sales

 

28.3

%

32.8

%

 

 

28.9

%

33.3

%

 

 

24.5

%

29.7

%

 

 

25.3

%

30.9

%

 

 

 

 

 

 

Financial income and expenses

 

(503

)

(658

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

(2,134

)

(2,689

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax rate**

 

24.0

%

25.5

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business net income

 

6,687

 

8,101

 

(17.5

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As % of net sales

 

20.3

%

23.2

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business earnings per share*** (in euros)

 

5.05

 

6.14

 

(17.8

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


*

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 1,323.1 million in 2013 and 1,319.5 million in 2012.

(1)

Including impact of transition to IAS19R.

 

16



 

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

 

€ million

 

Q4 2013

 

Q4 2012(3)

 

Change

 

Business net income

 

1,810

 

1,550

 

16.8

%

Amortization of intangible assets(1)

 

(682

)

(800

)

 

 

Impairment of intangible assets

 

(919

)

(89

)

 

 

Fair value remeasurement of contingent consideration liabilities

 

499

 

 

 

 

Expenses arising from the impact of acquisitions on inventories

 

(1

)

(3

)

 

 

Restructuring costs

 

(70

)

(834

)

 

 

Tax effect of items listed above:

 

442

 

572

 

 

 

Amortization of intangible assets

 

216

 

267

 

 

 

Impairment of intangible assets

 

338

 

32

 

 

 

Fair value remeasurement of contingent consideration liabilities

 

(128

)

(4

)

 

 

Expenses arising from the impact of acquisitions on inventories

 

 

1

 

 

 

Restructuring costs

 

16

 

276

 

 

 

Other tax items

 

 

 

 

 

Share of items listed above attributable to non-controlling interests

 

1

 

1

 

 

 

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

 

(24

)

(9

)

 

 

Net income attributable to equity holders of Sanofi

 

1,056

 

388

 

172.2

%

Consolidated earnings per share(2) (in euros)

 

0.80

 

0.29

 

 

 

 


(1)

Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €657 million in the fourth quarter of 2013 and €770 million in the fourth quarter of 2012.

(2)

Based on an average number of shares outstanding of 1,321.1 million in the fourth quarter of 2013 and 1,320.9 in the fourth quarter of 2012.

(3)

Impact of transition to IAS19R.

 

See page 11 for comments on the reconciliation of business net income to consolidated net income.

 

17



 

€ million

 

2013

 

2012(4)

 

Change

 

Business net income

 

6,687

 

8,101

 

(17.5

)%

Amortization of intangible assets(1)

 

(2,914

)

(3,291

)

 

 

Impairment of intangible assets

 

(1,387

)

(117

)

 

 

Fair value remeasurement of contingent consideration liabilities

 

314

 

(192

)

 

 

Expenses arising from the impact of acquisitions on inventories

 

(8

)

(23

)

 

 

Restructuring costs

 

(300

)

(1,141

)

 

 

Tax effect of items listed above:

 

1,480

 

1,580

 

 

 

Amortization of intangible assets

 

939

 

1,159

 

 

 

Impairment of intangible assets

 

527

 

42

 

 

 

Fair value remeasurement of contingent consideration liabilities

 

(85

)

2

 

 

 

Expenses arising from the impact of acquisitions on inventories

 

2

 

7

 

 

 

Restructuring costs

 

97

 

370

 

 

 

Other tax items(2)

 

(109

)

 

 

 

Share of items listed above attributable to non-controlling interests

 

4

 

3

 

 

 

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

 

(50

)

(31

)

 

 

Net income attributable to equity holders of Sanofi

 

3,717

 

4,889

 

(24.0

)%

Consolidated earnings per share(3) (in euros)

 

2.81

 

3.71

 

 

 

 


(1)

Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations:€2,804 million in 2013 and €3,159 million in 2012.

 

 

(2)

Tax on dividends paid to shareholders of Sanofi.

 

 

(3)

Based on an average number of shares outstanding of 1,323.1 million in 2013 and 1,319.5 million in 2012.

 

 

(4)

Including impact of transition to IAS19R.

 

18



 

Appendix 4: Consolidated income statement

 

€ million

 

Q4 2013

 

Q4 2012(1)

 

2013

 

2012(1)

 

Net sales

 

8,457

 

8,526

 

32,951

 

34,947

 

Other revenues

 

88

 

137

 

355

 

1,010

 

Cost of sales

 

(2,902

)

(2,868

)

(10,990

)

(11,098

)

Gross profit

 

5,643

 

5,795

 

22,316

 

24,859

 

Research and development expenses

 

(1,246

)

(1,354

)

(4,770

)

(4,905

)

Selling and general expenses

 

(2,148

)

(2,352

)

(8,602

)

(8,929

)

Other operating income

 

288

 

126

 

691

 

562

 

Other operating expenses

 

(37

)

(70

)

(242

)

(414

)

Amortization of intangible assets

 

(682

)

(800

)

(2,914

)

(3,291

)

Impairment of intangible assets

 

(919

)

(89

)

(1,387

)

(117

)

Fair value remeasurement of contingent consideration liabilities

 

499

 

 

314

 

(192

)

Restructuring costs

 

(70

)

(834

)

(300

)

(1,141

)

Other gains and losses, and litigation

 

 

 

 

 

Operating income

 

1,328

 

422

 

5,106

 

6,432

 

Financial expense

 

(154

)

(195

)

(612

)

(751

)

Financial income

 

51

 

(3

)

109

 

93

 

Income before tax and associates and joint ventures

 

1,225

 

224

 

4,603

 

5,774

 

Income tax expense(2)

 

(132

)

202

 

(763

)

(1,109

)

Share of profit/loss of associates and joint ventures

 

2

 

(10

)

35

 

393

 

Net income

 

1,095

 

416

 

3,875

 

5,058

 

Net income attributable to non-controlling interests

 

39

 

28

 

158

 

169

 

Net income attributable to equity holders of Sanofi

 

1,056

 

388

 

3,717

 

4,889

 

Average number of shares outstanding (million)

 

1,321.1

 

1,320.9

 

1,323.1

 

1,319.5

 

Earnings per share (in euros)

 

0.80

 

0.29

 

2.81

 

3.71

 

 


(1)

Including impact of transition to IAS19R.

(2)

In 2013, including a tax on dividends paid to shareholders of Sanofi: (109) M€.

 

19



 

Appendix 5: Change in net debt

 

€ million

 

2013

 

2012(1)

 

Business net income

 

6,687

 

8,101

 

Depreciation amortization and impairment of property plant and equipment and software

 

1,211

 

1,278

 

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

 

(261

)

(86

)

Other non-cash items

 

(106

)

20

 

Operating cash flow before changes in working capital(2)

 

7,531

 

9,313

 

Changes in working capital(2)

 

124

 

(536

)

Acquisitions of property, plant and equipment and software

 

(1,198

)

(1,402

)

Free cash flow(2)

 

6,457

 

7,375

 

Acquisitions of intangibles, excluding software

 

(200

)

(210

)

Acquisitions of investments, including assumed debt(2)

 

(319

)

(328

)

Restructuring costs paid

 

(659

)

(791

)

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

 

368

 

358

 

Issuance of Sanofi shares

 

1,004

 

645

 

Dividends paid to shareholders of Sanofi

 

(3,638

)

(3,487

)

Acquisition of treasury shares

 

(1,641

)

(823

)

Disposals of treasury shares, net of tax

 

2

 

1

 

Other items(3)

 

302

 

400

 

Change in net debt

 

1,676

 

3,140

 

 


(1)         Including impact of transition to IAS19R.

(2)         Excluding restructuring costs.

(3)         Of which foreign exchange effect on net debt €355M in 2013 and €281M in 2012.

 

20



 

Appendix 6: Simplified consolidated balance sheets

 

ASSETS
€ million

 

31/12/13

 

31/12/12(1)

 

LIABILITIES
€ million

 

31/12/13

 

31/12/12(1)

 

Property, plant and equipment

 

10,182

 

10,578

 

Equity attributable to equity holders of Sanofi

 

56,885

 

57,332

 

Intangible assets (including goodwill)

 

52,529

 

58,265

 

Equity attributable to non-controlling interests

 

129

 

134

 

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

 

9,428

 

8,665

 

Total equity

 

57,014

 

57,466

 

 

 

 

 

 

 

Long-term debt

 

10,414

 

10,719

 

 

 

 

 

 

 

Non-current liabilities related to business combinations and to non-controlling interests

 

884

 

1,350

 

Non-current assets

 

72,139

 

77,508

 

Provisions and other non-current liabilities

 

8,735

 

11,043

 

 

 

 

 

 

 

Deferred tax liabilities

 

5,060

 

5,932

 

Inventories, accounts receivable and other current assets

 

15,655

 

16,419

 

Non-current liabilities

 

25,093

 

29,044

 

Cash and cash equivalents

 

8,257

 

6,381

 

Accounts payable and other current liabilities

 

9,757

 

9,948

 

 

 

 

 

 

 

Current liabilities related to business combinations and to non-controlling interests

 

24

 

100

 

 

 

 

 

 

 

Short-term debt and current portion of long-term debt

 

4,176

 

3,812

 

Current assets

 

23,912

 

22,800

 

Current liabilities

 

13,957

 

13,860

 

Assets held for sale or exchange

 

14

 

101

 

Liabilities related to assets held for sale or exchange

 

1

 

39

 

Total ASSETS

 

96,065

 

100,409

 

Total LIABILITIES & EQUITY

 

96,065

 

100,409

 

 


(1)   Including impact of transition to IAS19R.

 

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Appendix 7: R&D Pipeline

 

 

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Appendix 8: Definitions of non-GAAP financial indicators

 

Net sales at constant exchange rates (CER)

 

When we refer to changes in our net sales “at constant exchange rates” (CER), 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 fourth quarter and the full-year 2013

 

€ million

 

Q4 2013

 

2013

 

Net sales

 

8,457

 

32,951

 

Effect of exchange rates

 

627

 

1,806

 

Net sales at constant exchange rates

 

9,084

 

34,757

 

 

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.

 

Business net income

 

Sanofi publishes a key non-GAAP indicator. 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(1),

·                  other gains and losses (including gains and losses on disposals of non-current assets(1)),

·                  costs or provisions associated with litigation(1),

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

·                  Tax (3%) on dividends paid to Sanofi shareholders.

 


(1)         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.

 

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