EX-99.1 2 a13-17716_2ex99d1.htm EX-99.1

Exhibit 99.1

 

PRESS RELEASE

Paris, August 1, 2013

 

Q2 2013: Last Quarter with Significant Negative Impact from the Patent Cliff

 

 

 

Q2 2013

 

Change
(reported)

 

Change
(CER)

 

H1 2013

 

Change
(reported)

 

Change
(CER)

 

Net sales

 

8,003m

 

-9.8

%

-6.3

%

16,062m

 

-7.6

%

-4.6

%

Business net income(1)

 

1,475m

 

-23.4

%

-18.4

%

3,088m

 

-29.0

%

-24.2

%

Business EPS(1)

 

1.11

 

-24.0

%

-18.5

%

2.33

 

-29.4

%

-24.5

%

 

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 H1 2013 is provided in Appendix 4 and a reconciliation of business net income to consolidated net income in Appendix 3. Consolidated net income for H1 2013 was €1,448 million, compared to €2,962 million(2) for H1 2012. Consolidated EPS for H1 2013 was €1.09 versus €2.25(2) for H1 2012.

 

Commenting on the Group’s performance in Q2 2013, Sanofi Chief Executive Officer, Christopher A. Viehbacher said, “The second quarter was a difficult quarter. As expected, this was the last quarter with a tough comparison to the prior year due to the residual impact of the patent cliff. Sales were also affected by our business in Brazil(3) and commercial underperformance in certain business areas. However, sales growth of 7.7%(4) of our growth platforms(5) in the first half of 2013 continues to demonstrate the value of Sanofi’s integrated business model. In addition, we keep on making strong progress in delivering a growing portfolio of high potential R&D assets, as highlighted by the multiple clinical and regulatory milestones reached in the second quarter of 2013. We continue to expect to return to growth in the second half of 2013.”

 

Q2 2013 Performance

 

·         Total sales(6) were €8,003 million, down 6.3% principally impacted by sales lost due to generic competition (€481 million).

·         Sales in Emerging Markets(7) totalled €2,669 million, a decrease of 2.3% (+5.3% excluding Brazil generics); double-digit sales growth was achieved for Diabetes, Vaccines, Genzyme and Animal Health.

·         Diabetes delivered growth of 16.2% to €1,621 million as Lantus® sales reached €1,409 million, an increase of 17.7%.

·         Consumer Healthcare sales were €729 million, an increase of 1.8%.

·         Vaccines sales reached €760 million (+0.4%) and compared to strong Q2 2012 sales which benefited from a later timing of flu vaccines supply in the Southern Hemisphere.

·         Animal Health sales were down 5.7% to €529 million impacted by unfavorable weather conditions and increased competition to Frontline®.

·         Genzyme recorded another strong quarter with sales growth of 25.6% to €525 million, reflecting strong performance of the rare disease franchise and the progression of Aubagio®.

·         Growth platforms(5) sales were €5,718 million, an increase of 2.5% (+6.2% excluding Brazil generics) and accounted for 71.4% of total sales.

·         Q2 2013 business EPS(1) was €1.11, down 18.5% impacted in particular by the Plavix® and Avapro® losses of exclusivity in the U.S. (€0.18) and Brazil generics (€0.17)(8).

 

R&D Update

 

·         Since publication of Q1 2013 results, several positive Phase III trials results have been announced including two Phase III trials for the investigational new insulin U300, and JAKARTA, which examined fedratinib, a selective JAK2 inhibitor, in myelofibrosis. In addition, the C. diff toxoid vaccine is now moving to Phase III.

·         Several major regulatory milestones were also achieved including positive recommendations from the CHMP both on Lemtrada and on a new active substance designation for Aubagio® which is expected to lead to 10-year exclusivity and the FDA approval of the Fluzone® Quadrivalent vaccine.

 

2013 Adjusted Guidance

 

·         Given the impact of Brazil and the year-to-date performance, 2013 business EPS is expected to be 7% to 10% lower than 2012 at CER(9), barring major unforeseen adverse events.

 


(1) See Appendix 8 for definitions of financial indicators; (2) Including impact of transition to IAS 19R; (3) See disclosure on page 2; (4) Excluding Brazil generics; (5) See page 2; (6) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 8 for a definition); (7) See definition on page 7; (8) Operating losses, net sales adjustment and provisions; €0,19 at CER; (9) 2012 business EPS with the retroactive application of IAS19R was €6.14.

 

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 second-quarter and first-half sales

 

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

 

In the second quarter of 2013, Sanofi sales were €8,003 million, a decrease of 9.8% on a reported basis. Exchange rate movements had a negative effect of 3.5 percentage points primarily reflecting the depreciation of the Japanese Yen, U.S. Dollar, Venezuelan Bolivar, and the South African Rand against the Euro.

 

First-half sales reached €16,062 million, a decrease of 7.6% on a reported basis. Exchange rate movements had an unfavorable effect of 3.0 percentage points mainly driven by the depreciation of the Japanese Yen, U.S. Dollar, Venezuelan Bolivar, Brazilian Real, and the South African Rand against the Euro.

 

Growth Platforms

 

Second-quarter sales of the Group’s growth platforms totaled €5,718 million, an increase of 2.5%, driven by the performance of Diabetes (up 16.2%), Genzyme (up 25.6%) and “Other Innovative Products” (up 14.5%). The Group’s growth platforms accounted for 71.4% of total consolidated sales in the second quarter, up from 71.0% in the second quarter of 2012. Excluding Brazil generics, growth platforms grew 6.2% and Emerging Markets grew 5.3%.

 

During the second quarter, Sanofi determined that generic inventory levels in trade channels in Brazil were significantly and inappropriately in excess of volumes needed to satisfy sell out demand. Accordingly, an adjustment has been recorded in the current quarter to reflect product returns, customer discounts and rebates. The net effect of this adjustment was to lower net sales by €122 million. An additional provision of €79 million has also been recorded for the write-off of inventory and other related costs.

 

First-half sales of growth platforms reached €11,441 million, an increase of 5.4%, and accounted for 71.2% of total consolidated sales compared with 70.8% in the first half of 2012. Excluding Brazil generics, growth platforms were up 7.7%.

 

€ million

 

Q2 2013
net sales

 

Change at
CER

 

H1 2013
net sales

 

Change at
CER

 

Diabetes

 

1,621

 

+16.2

%

3,163

 

+17.8

%

Consumer Healthcare (CHC)

 

729

 

+1.8

%

1,540

 

+2.5

%

Vaccines

 

760

 

+0.4

%

1,457

 

+7.2

%

Animal Health

 

529

 

-5.7

%

1,083

 

-4.4

%

Genzyme

 

525

 

+25.6

%

1,018

 

+25.5

%

Other Innovative Products(a)

 

171

 

+14.5

%

328

 

+14.1

%

Emerging Markets(b)

 

2,669

 

-2.3

%(c)

5,388

 

+1.9

%(c)

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

 

1,286

 

+11.9

%

2,536

 

+14.5

%

of which other products

 

1,383

 

-12.6

%

2,852

 

-7.1

%

Total Growth Platforms

 

5,718

 

+2.5

%

11,441

 

+5.4

%

Change excluding Brazil generics

 

 

 

+6.2

%

 

 

+7.7

%

 


(a)         Includes recent product launches 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 Brazil generics, sales in Emerging Markets grew 5.3% in Q2 2013 and 6.6% in H1 2013

 

Pharmaceuticals

 

In the second quarter, sales for the Pharmaceuticals business were €6,714 million, a decrease of 7.1%, which reflected generic competition, EU austerity measures and an adjustment of €122 million related to Brazil. Sales lost due to generic competition on main legacy products in the U.S. and EU were €481 million, primarily due to declining sales of Eloxatin®, Lovenox® and the active ingredient of Plavix® in the U.S. and Aprovel® in the EU.

 

First-half sales for the Pharmaceuticals business reached €13,522 million, a decrease of 5.7%. First-half sales lost due to generic competition on main legacy products in the U.S. and EU were €1,036 million.

 


(1) See Appendix 8 for definitions of financial indicators

 

2



 

Diabetes

 

€ million

 

Q2 2013
net sales

 

Change at
CER

 

H1 2013
net sales

 

Change at
CER

 

Lantus®

 

1,409

 

+17.7

%

2,747

 

+19.4

%

Apidra®

 

68

 

+25.0

%

134

 

+27.8

%

Amaryl®

 

99

 

-1.8

%

193

 

-2.3

%

Insuman®

 

32

 

-3.0

%

65

 

0.0

%

Total Diabetes

 

1,621

 

16.2

%

3,163

 

17.8

%

 

Diabetes division sales totaled €1,621 million in the second quarter, an increase of 16.2%. Lantus® sales grew 17.7% to €1,409 million driven by the U.S. (+20.9% to €903 million). In the U.S., Lantus® SoloSTAR® represented 56.4% of total Lantus® sales in the quarter, versus 51.9% in the second quarter of 2012. In Emerging Markets, Lantus® sales reached €230 million, an increase of 20.2% reflecting good performance in Russia, China, Africa and the Middle East. First-half sales of Lantus® reached €2,747 million, up 19.4%.

 

In February 2013, the European Commission granted marketing authorisation for Lyxumia® (lixisenatide, licensed from Zealand Pharma), a once-daily prandial GLP-1 receptor agonist. The launch of Lyxumia® in the EU began with Germany at the end of the first quarter where the product has achieved 10.3% market share in volume after 18 weeks since launch(10). In the United Kingdom, the company is taking a step-wise approach by first obtaining local access followed by a full commercial launch later in the year. Commercialization in additional countries in the EU is expected in 2013. Second-quarter sales of Lyxumia® were €1 million. In June 2013, Japan’s Ministry of Health, Labour and Welfare approved the manufacturing and distribution of Lyxumia® for the treatment of type 2 diabetes.

 

Apidra® recorded sales of €68 million (up 25.0%) and €134 million (up 27.8%) in the second quarter and first half, respectively. This sales rebound reflects notably the resolution of temporary supply issues experienced last year.

 

Amaryl® generated sales of €99 million (down 1.8%) impacted by generic competition in Japan where sales decreased 21.3% to €21 million. In Emerging Markets, Amaryl® continued to deliver good performance (up 10.3% to €71 million). First-half, sales of Amaryl® were €193 million (down 2.3%), of which 71.5% were generated in Emerging Markets (€138 million) an increase of 10.8%.

 

The Diabetes division recorded sales of €3,163 million, an increase of 17.8% in the first half of 2013.

 

Genzyme

 

€ million

 

Q2 2013
net sales

 

Change at
CER

 

H1 2013
net sales

 

Change at
CER

 

Cerezyme®

 

171

 

+18.0

%

342

 

+17.4

%

Myozyme® / Lumizyme®

 

126

 

+15.0

%

242

 

+9.8

%

Fabrazyme®

 

91

 

+28.4

%

183

 

+56.2

%

Aldurazyme®

 

41

 

+19.4

%

78

 

+12.7

%

Total Rare Diseases

 

492

 

+17.7

%

965

 

+19.1

%

Aubagio®

 

33

 

 

53

 

 

Total Multiple Sclerosis

 

33

 

 

53

 

 

Total Genzyme

 

525

 

+25.6

%

1,018

 

+25.5

%

 

Second-quarter sales of Genzyme reached €525 million, an increase of 25.6%, driven by growth of Cerezyme® and Fabrazyme® and the launch of Aubagio® in the U.S. Genzyme recorded strong performance in the U.S. and Emerging Markets growing 38.5% (€194 million) and 40.2% (€110 million), respectively. First-half sales of Genzyme totaled €1,018 million, an increase of 25.5%.

 

Sales of Cerezyme® increased 18.0% to €171 million in the second quarter driven by restored supply and new patient accruals. Emerging Markets sales increased 60.5% to €57 million. Sales of Cerezyme® grew 7.0% (to €45 million) and 3.7% (to €56 million) in the U.S. and in Western Europe, respectively. First-half sales of Cerezyme® reached €342 million, up 17.4%.

 

In the second quarter, Fabrazyme® continued to deliver strong performance with sales of €91 million, up 28.4% driven by Western Europe (sales grew 90.9% to €21 million) where the product continued to gain market share from the competitive product. In the U.S., sales of Fabrazyme® reached €50 million, an increase of 30.8% resulting from new patient accruals. First-half sales of Fabrazyme® were €183 million, up 56.2%.

 


(10) Source: Insight Health, Weekly Data in Units, MS within GLP-1 market.

 

3



 

Second-quarter sales of Myozyme®/Lumizyme® grew 15.0% to €126 million, driven by Emerging Markets (up 50.0% to €20 million), Western Europe (up 9.5% to €69 million) and the U.S. (up 10.7% to €30 million). First-half sales of Myozyme®/Lumizyme® were €242 million, up 9.8%.

 

Sales of Aubagio®, were €33 million and €53 million in the second quarter and first half, respectively. The product was approved in the U.S. in September 2012 as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis. In March, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA issued a positive opinion recommending the approval of Aubagio® for the treatment of adult patients with relapsing remitting MS. In June, the CHMP issued a positive opinion on new active substance designation for Aubagio® which is expected to provide 10 years of exclusivity.

 

In June, the CHMP also issued a positive opinion for the approval of Lemtrada™ (alemtuzumab, being developed in multiple sclerosis in collaboration with Bayer HealthCare) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. The European Commission is expected to render a final decision to grant marketing authorizations for Lemtrada™ and Aubagio® in the EU in the coming months.

 

Other Innovative Products(11)

 

€ million

 

Q2 2013
net sales

 

Change at
CER

 

H1 2013
net sales

 

Change at
CER

 

Multaq®

 

69

 

+10.9

%

131

 

+4.7

%

Jevtana®

 

54

 

-16.9

%

106

 

-10.1

%

Mozobil®

 

25

 

+13.0

%

51

 

+15.6

%

Zaltrap®

 

14

 

 

25

 

 

Auvi-Q

 

9

 

 

15

 

 

Total Other Innovative Products

 

171

 

+14.5

%

328

 

+14.1

%

 


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

 

Second-quarter and first-half sales of Multaq® were €69 million (up 10.9%) and €131 million (up 4.7%), respectively. Jevtana® sales were €54 million in the second quarter, reflecting lower sales in the U.S. due to a more competitive environment. In Western Europe sales of the product were stable at €25 million. First-half sales of Jevtana® were €106 million (down 10.1%). Second-quarter and first-half sales of Mozobil® reached €25 million (up 13.0%) and €51 million (up 15.6%), respectively. Zaltrap® (aflibercept, collaboration with Regeneron) generated sales of €14 million in the second quarter and €25 million in the first half. In the U.S., where the product was launched at the end of August 2012, sales were €10 million in the second quarter. In February 2013, the European Commission granted marketing authorization in Europe for Zaltrap®. The first launches of Zaltrap® in the European Union started with Germany and the UK at the end of the first quarter. Launches in other EU countries will continue over the course of the year.

 

At the end of January 2013, Sanofi launched Auvi-Q(12) (epinephrine injection) in the U.S. Auvi-Q is the first-and-only epinephrine auto-injector with audio and visual cues for the emergency treatment of life-threatening allergic reactions in people who are at risk or have a history of anaphylaxis. Sales of Auvi-Q were €9 million in the second quarter and €15 million in the first half.

 

Established Pharmaceutical Products

 

€ million

 

Q2 2013
net sales

 

Change at
CER

 

H1 2013
net sales

 

Change at
CER

 

Plavix®

 

493

 

-1.3

%

943

 

-3.0

%

Lovenox®

 

436

 

-9.2

%

864

 

-13.6

%

Aprovel®/Avapro®

 

238

 

-27.5

%

479

 

-24.3

%

Renvela®/Renagel®

 

175

 

+7.9

%

346

 

+12.5

%

Taxotere®

 

114

 

-22.0

%

222

 

-23.0

%

Synvisc® /Synvisc-One®

 

105

 

+0.9

%

182

 

+0.5

%

Myslee®/Ambien®/Stilnox®

 

92

 

-17.8

%

193

 

-15.0

%

Allegra®

 

79

 

-25.4

%

248

 

-6.8

%

Eloxatin®

 

60

 

-83.7

%

119

 

-84.2

%

 


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

 

4



 

Sales of Plavix® were €493 million, down 1.3% in the second-quarter impacted by decreased sales of active ingredient for the U.S. (€5 million versus €28 million in the second quarter of 2012) as the product lost its exclusivity in the U.S. on May 17, 2012. In Japan, sales of Plavix® reached €189 million, an increase of 7.8%. In Emerging Markets, sales grew 10.9% to €219 million driven by China (€113 million) which increased 16.4%, despite a 9.9% price cut in October 2012, and solid performance in the Middle East. In Western Europe, sales of Plavix® were €69 million, a decrease of 22.5%, impacted by generic competition. First-half sales of Plavix® totaled €943 million, down 3.0%.

 

Sales of Lovenox® were €436 million in the second quarter, a decrease of 9.2%, mainly due to generic competition in the U.S. where sales of the branded product declined 43.7% to €48 million. Sales of the product were €148 million (down 2.5%) in Emerging Markets and €215 million (down 1.4%) in Western Europe. First-half sales of Lovenox® were €864 million, a decrease of 13.6%.

 

Second-quarter sales of Aprovel®/Avapro® decreased 27.5% to €238 million, reflecting generic competition in Western Europe where sales decreased 45.3% to €94 million. In France, sales of the product decreased 66.8% due to generic competition on both formulations (monotherapy and combination with a diuretic). In Emerging Markets, sales of Aprovel®/Avapro® grew 2.8% to €108 million. First-half sales of Aprovel®/Avapro ® totaled €479 million, down 24.3%.

 

Renvela®/Renagel® generated sales of €175 million in the second quarter, an increase of 7.9% driven by Emerging Markets (sales were €19 million, up 42.9%), Western Europe (sales were up 9.1% to €36 million) and the U.S. (sales were €115 million, up 6.3%). First-half sales of Renvela®/Renagel® totaled €346 million, an increase of 12.5%.

 

Second-quarter sales of Taxotere® decreased 22.0% to €114 million, impacted by generic competition in Emerging Markets (€54 million, down 24.7%), in the U.S. (€19 million, down 13.6%) and Western Europe (€6 million, down 53.8%). First-half sales of Taxotere® reached €222 million, a decrease of 23.0%.

 

Synvisc®/Synvisc-One® sales were stable at €105 million in the second quarter. First-half sales of the product were €182 million (up 0.5%).

 

Sales of the Ambien® family of products totaled €92 million, a decrease of 17.8% in the second quarter due to generic competition in Japan where sales decreased 26.0% to €46 million. First-half sales of the Ambien® family of products were €193 million, down 15.0%.

 

Sales of Allegra® as a prescription drug were €79 million, down 25.4% in the second quarter. In Japan, sales of Allegra® as a prescription drug were down 35.2% to €46 million reflecting the entry of generics on the market since February and an earlier peak of the pollen season as compared to last year. First-half sales of Allegra® were €248 million, down 6.8%.

 

Second-quarter sales of Eloxatin® were €60 million, a decrease of 83.7%, reflecting generic competition in the U.S. where the product lost its market exclusivity August 9, 2012 and in Emerging Markets (€31 million, down 20.0%). First-half sales of Eloxatin® reached €119 million (down 84.2%). Eloxatin® was recently approved in China for the treatment of hepatocellular carcinoma.

 

Consumer Healthcare

 

€ million

 

Q2 2013
net sales

 

Change at
CER

 

H1 2013
net sales

 

Change at
CER

 

Doliprane®

 

69

 

+7.7

%

151

 

+12.6

%

Allegra®

 

65

 

+8.2

%

164

 

+7.1

%

Essentiale®

 

57

 

+43.9

%

108

 

+20.9

%

Enterogermina®

 

29

 

+13.8

%

68

 

+12.3

%

No Spa®

 

24

 

-7.4

%

54

 

0.0

%

Lactacyd®

 

24

 

-3.8

%

51

 

+1.9

%

Dorflex®

 

20

 

+4.8

%

46

 

+8.5

%

Other CHC Products

 

441

 

-3.6

%

898

 

-2.3

%

Total Consumer Healthcare

 

729

 

+1.8

%

1,540

 

+2.5

%

 

Consumer Healthcare products (CHC) recorded second-quarter sales of €729 million, an increase of 1.8%. Essentiale® and Enterogermina® recorded double-digit growth in sales. Sales of Allegra® OTC increased 8.2% to €65 million, which includes the recent launch in Japan. Sales in Emerging Markets increased 2.8% to €352 million despite lower sales in China and Mexico. A favorable sequential trend in China was observed in the second quarter following changes implemented in distribution network and reduced inventory levels in the first quarter.

 

5



 

First-half sales of CHC reached €1,540 million, an increase of 2.5%. In the U.S., Chattem will re-launch Rolaids® in the third quarter of 2013.

 

Generics

 

Sales of Generics were €300 million in second-quarter, down 36.8%, driven by reduced sales in Brazil, affected by underperformance and an adjustment of €122 million, leading to a negative variation of €212 million. Excluding Brazil, sales of generics increased 10.2% in the second quarter. In the U.S., Generics sales were down 19.4% to €53 million reflecting lower sales of the authorized generic of Aprovel®. In Western Europe, sales of generics grew 22.0% reflecting strong performance in France following local measures taken by the French government to further develop the Generics segment. First-half sales of Generics reached €723 million, a decrease of 19.8% or an increase of 8.2% excluding Brazil.

 

Vaccines

 

€ million

 

Q2 2013
net sales

 

Change at
CER

 

H1 2013
net sales

 

Change at
CER

 

Influenza Vaccines
(incl. Vaxigrip
® and Fluzone®)

 

53

 

-32.5

%

172

 

+3.0

%

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

 

293

 

+12.5

%

563

 

+14.1

%

Meningitis/Pneumonia Vaccines
(incl. Menactra
®)

 

123

 

-2.3

%

203

 

+2.5

%

Adult Booster Vaccines (incl. Adacel ®)

 

124

 

-13.7

%

209

 

-9.0

%

Travel and Other Endemics Vaccines

 

98

 

+1.0

%

172

 

-0.6

%

Other Vaccines

 

69

 

+30.9

%

138

 

+39.6

%

Total Vaccines
(consolidated sales)

 

760

 

+0.4

%

1,457

 

+7.2

%

 

First-half consolidated sales of Sanofi Pasteur were €1,457 million, an increase of 7.2%. Second-quarter consolidated sales of Sanofi Pasteur reached €760 million, up 0.4% reflecting strong performance of Pentaxim® in Emerging Markets partially offset by the unfavorable impact of phasing for seasonal influenza vaccine in the Southern Hemisphere in the second quarter of 2012 and supply limitations for Pentacel® in the U.S.

 

Sales of Polio/Pertussis/Hib vaccines increased 12.5% to €293 million, driven by the performance of Pentaxim® which largely offset supply limitations for Pentacel® in the U.S. Total sales of Pentaxim® grew 48.3% to €87 million driven by good performances in Mexico and China. Sales of Imovax® in Japan were €5 million reflecting the end of the catch-up cohort following the launch in September 2012. In the U.S., as previously announced, Sanofi Pasteur foresees progressive supply recovery of Pentacel® to begin in the third quarter of 2013. First-half sales of Polio/Pertussis/Hib vaccines grew 14.1% to €563 million.

 

Second-quarter sales of influenza vaccines were €53 million, a decrease of 32.5% due to the high level of sales in the second quarter of 2012 which benefited from favorable phasing for seasonal influenza vaccines in the Southern Hemisphere. First-half sales of influenza vaccines were €172 million, up 3.0%. In June, the FDA approved the supplemental biologics license application for licensure of Sanofi Pasteur four-strain influenza vaccine, Fluzone® Quadrivalent vaccine. This vaccine is the newest addition to the Fluzone® family of influenza vaccines. The 2013 influenza season will be the first in which quadrivalent influenza vaccines will be available in the U.S. In July, shipments of the first lots of Fluzone® vaccines to U.S. health care providers began.

 

Second-quarter sales of Menactra® reached €100 million (down 6.3%), reflecting phasing of public orders in the U.S. (sales were €77 million, a decrease of 18.4%) partially offset by good performance in the Middle East and to a lesser extent Latin America. First-half sales of Menactra® were €167 million, an increase of 2.4%.

 

Adult booster vaccines sales were €124 million (down 13.7%) and €209 million (down 9.0%) in the second quarter and the first half, respectively due to lower sales of Adacel®.

 

Sales of travel and other endemic vaccines reached €98 million (up 1.0%) in the second quarter and €172 million (down 0.6%) in the first half, respectively, and were impacted by the temporary production suspension of Theracys®/Immucyst® and BCG vaccines.

 

Second-quarter sales of other vaccines were €69 million, an increase of 30.9%, reflecting growth of VaxServe(13).

 


(13) A Sanofi Pasteur company, US supplier of vaccines.

 

6



 

Sanofi Pasteur MSD (not consolidated), the joint venture with Merck & Co. in Europe, reported sales of €160 million, a decrease of 8.9% (on a reported basis). First-half sales of Sanofi Pasteur MSD were stable (on a reported basis) at €334 million.

 

Animal Health

 

€ million

 

Q2 2013
net sales

 

Change at
CER

 

H1 2013
net sales

 

Change at
CER

 

Companion Animal

 

323

 

-14.0

%

697

 

-9.6

%

Production Animal

 

206

 

+11.1

%

386

 

+6.5

%

Total Animal Health

 

529

 

-5.7

%

1,083

 

-4.4

%

of which fipronil products

 

168

 

-23.7

%

364

 

-20.5

%

of which avermectin products

 

103

 

-1.9

%

245

 

+12.7

%

of which Vaccines

 

197

 

+11.1

%

361

 

+6.1

%

 

Second-quarter sales of Animal Health were €529 million, down 5.7%. Sales in Emerging Markets were €154 million, an increase of 11.2%, driven by vaccines. First-half sales of Animal Health totaled €1,083 million, down 4.4%.

 

Second-quarter sales of the Companion Animals segment were €323 million, a decrease of 14.0% reflecting lower sales of the anti-parasiticide Frontline®/fipronil family of products (down 24.0% to €165 million). Sales of this family of products were impacted by a weak season for fleas and ticks given unfavorable weather conditions, increased competition from prescription-only products in veterinary channels and high promotional spend from fipronil branded generics. In Emerging Markets, sales of the Frontline®/fipronil family of products reached €22 million, an increase of 9.5%.

 

Second-quarter sales of the Production Animals segment grew 11.1% to €206 million driven by the Avian, Ruminant and Veterinary Public Health segments especially due to the performance in Emerging Markets.

 

The acquisition of the animal health division of the Indian company Dosch Pharmaceuticals Private Limited was finalized in the second quarter of 2013. This acquisition creates a market entry for Merial in India’s strategically important and growing animal health sector.

 

Net sales by geographic region

 

€ million

 

Q2 2013
net sales

 

Change at
CER

 

H1 2013
net sales

 

Change at
CER

 

Emerging Markets(a)

 

2,669

 

-2.3

%

5,388

 

+1.9

%

Change in Emerging Markets excluding Brazil generics

 

 

 

+5.3

%

 

 

+6.6

%

of which Latin America

 

642

 

-22.1

%

1,411

 

-9.5

%

Change in Latin America excluding Brazil generics

 

 

 

+2.0

%

 

 

+5.5

%

of which Asia

 

781

 

+9.6

%

1,525

 

+10.7

%

of which Eastern Europe, Russia and Turkey

 

666

 

+1.3

%

1,319

 

+0.6

%

of which Africa

 

250

 

+4.3

%

531

 

+9.9

%

of which Middle East

 

299

 

+14.6

%

538

 

+11.3

%

United States

 

2,463

 

-10.0

%

4,797

 

-9.9

%

Western Europe(b)

 

1,958

 

-7.9

%

3,958

 

-9.0

%

Rest of the world(c)

 

913

 

-4.3

%

1,919

 

+0.8

%

of which Japan

 

594

 

-7.2

%

1,284

 

+1.0

%

TOTAL

 

8,003

 

-6.3

%

16,062

 

-4.6

%

 


(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

 

Second-quarter sales in Emerging Markets totaled €2,669 million, a decrease of 2.3% including a negative variation of generics sales in Brazil (€212 million). Excluding Brazil generics, sales grew 5.3% in the second quarter. Double-digit growth was recorded for Diabetes (up 17.7%), Vaccines (up 10.1%), Genzyme (up 40.2%) and Animal Health (up 11.2%). Despite recent price cuts, sales in China grew 15.3% to €372 million driven by

 

7



 

Plavix®, Aprovel®, Lantus®, Vaccines and Animal Health. Sales in Eastern Europe/Russia and Turkey increased 1.3%, which included good performance of Russia (up 16.3% to €228 million). In Brazil, sales were €154 million reflecting a net sales adjustment of €122m, as well as lower oncology and flu vaccines sales.

 

Genfar S.A., a leading pharmaceuticals manufacturer headquartered in Bogota, Colombia, was consolidated in the second quarter. With this acquisition, Sanofi has become a market leader in Colombia and has further expanded its portfolio of affordable pharmaceuticals in Latin America.

 

Second-quarter sales in the U.S. were €2,463 million, down 10.0% reflecting primarily the loss of exclusivity of Eloxatin® at the beginning of August 2012 (down 97.4%) which was partially offset by the strong performance of Diabetes (up 21.0%) and Genzyme (up 38.5%). First-half sales in the U.S. totaled €4,797 million, down 9.9%.

 

Sales in Western Europe were €1,958 million in the second quarter, a decrease of 7.9%, impacted by generic competition to Aprovel® as well as austerity measures. First-half sales in Western Europe totaled €3,958 million, down 9.0 %.

 

Sales in Japan totaled €594 million, a decrease of 7.2%, primarily reflecting the impact of generic competition to Allegra®, Myslee® and Amaryl® partially offset by the performance of vaccines and Plavix®. First-half sales in Japan were €1,284 million, up 1.0%.

 

R&D update

 

Consult Appendix 7 for full overview of Sanofi’s R&D pipeline

 

Since the publication of the first-quarter 2013 results on May 2, 2013, the regulatory newsflow has been favorable:

 

·                  In June The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for approval of Lemtrada™ (alemtuzumab) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. In addition, the CHMP issued a positive opinion on the new active substance designation for Aubagio® (teriflunomide). In March, the CHMP issued a positive opinion recommending the approval of Aubagio® for the treatment of adult patients with relapsing remitting MS.

 

·                  In June, the Japan’s Ministry of Health, Labour and Welfare approved the manufacturing and distribution of Lyxumia® for the treatment of type 2 diabetes. Lyxumia®, the first once-daily prandial GLP-1 receptor agonist (RA), is also the first GLP-1 RA approved in Japan for use in combination with basal insulin. Lyxumia® is indicated for patients with type 2 diabetes when the following do not provide adequate glycemic control: diet and exercise and sulfonylureas or diet and exercise and soluble prolonged-acting or intermediate-acting insulin.

 

·                  In June, the U.S. Food and Drug Administration approved the supplemental biologics license application for licensure of Sanofi Pasteur’s four-strain influenza vaccine, Fluzone® Quadrivalent vaccine. Fluzone® Quadrivalent vaccine is the newest addition to the Fluzone® family of influenza vaccines. Like Sanofi Pasteur’s Fluzone® vaccine, Fluzone® Quadrivalent vaccine is licensed for use in children six months of age and older, adolescents, and adults. The 2013 influenza season will be the first in which quadrivalent influenza vaccines will be available in the U.S.

 

·                  In June, the CHMP of the European Medicines Agency issued a positive opinion for inclusion in the Lantus® (insulin glargine) product label of safety and efficacy data from the ORIGIN (Outcome Reduction with Initial Glargine INtervention) cardiovascular (CV) outcomes trial.

 

·                  In June, the European market authorization was granted for MACI® (matrix assisted autologous chondrocyte implantation).

 

At the beginning of August 2013, the R&D pipeline contained 60 projects (excluding Life Cycle Management) and vaccine candidates in clinical development of which 14 are in Phase III or have been submitted to the health authorities for approval.

 

8



 

Portfolio update

 

·                  The C. diff toxoid vaccine developed by Sanofi Pasteur for the prevention of primary symptomatic Clostridium difficile infections (CDI), a leading cause of life-threatening, healthcare associated infections worldwide, will move into Phase III in August 2013. The trial will include up to 15,000 volunteers across 200 trial sites in 17 countries and is estimated to take four years to complete, based on the incidence of CDI and necessary follow-up required with patients after vaccination.

 

·                  A trial evaluating alirocumab (a subcutaneous administered, fully human monoclonal antibody targeting PCSK9, collaboration with Regeneron) dosed every four weeks (ODYSSEY CHOICE) is expected to commence by the end of 2013.

 

·                  In June, the first Phase III study results (EDITION I) for the investigational new insulin U300 were presented at the Scientific Sessions of the American Diabetes Association. The EDITION I study evaluated the efficacy and safety of U300, vs. Lantus® in people with type 2 diabetes using basal plus mealtime insulin. In this study, U300 showed equivalent blood sugar control with fewer night-time low blood sugar events compared to Lantus®. Sanofi also announced topline results of a second Phase III study (EDITION II) which evaluated efficacy and safety of U300 in a type 2 diabetes population treated with basal insulin plus oral antidiabetic therapy. The topline results of EDITION II also demonstrated similar blood sugar reduction while fewer patients experienced night-time low blood sugar events compared with Lantus®. EDITION I and EDITION II are part of the EDITION Phase III clinical program evaluating the efficacy and safety of the investigational new insulin U300 in people with diabetes.

 

·                  In May, Sanofi and Regeneron announced that the COMPARE and ASCERTAIN trials of sarilumab, the first fully human monoclonal antibody directed against the IL-6 receptor, which is delivered by subcutaneous injection every other week, enrolled their first patients. These two Phase III studies are part of the broad SARIL-RA clinical development program which focuses on adult populations with moderate to-severe rheumatoid arthritis (RA) who are inadequate responders to either methotrexate or TNF-alpha inhibitor therapy. Furthermore, a Phase II trial (SARIL-NIU-SATURN) of sarilumab in posterior non-infectious uveitis is being initiated.

 

·                  In May, it was announced that the pivotal study, JAKARTA, examining fedratinib, a selective JAK2 inhibitor (SAR302503) for myelofibrosis, met its primary endpoint in both dose groups. The primary endpoint assessed the proportion of patients achieving >35% reduction of spleen volume. Consistent with data reported in previous trials, the most common adverse events were anemia, diarrhea, nausea and vomiting. Full results will be presented at an upcoming medical congress.

 

·                  In May, the New England Journal of Medicine published online the positive Phase IIa study results of dupilumab (SAR231893, partnership with Regeneron) in patients with moderate-to-severe allergic asthma. Dupilumab is an investigational monoclonal antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), which modulates signaling of both IL-4 and IL-13, drivers of Th2 (Type 2 helper T cell) immune response. The study results were presented at a late-breaking clinical trials session at the American Thoracic Society 2013 International Conference. Following the positive proof of concept results in asthma and atopic dermatitis, the Phase IIb program evaluating dupilumab in asthma and the atopic dermatitis began mid-year as planned.

 

·                  One compound from Genzyme (GZ438027, collaboration with Alnylam) entered Phase II for familial amyloid polyneuropathy (FAP).

 

·                  In June, Sanofi announced its decision to terminate the internal development program for iniparib following the announcement that the randomized Phase III trial of iniparib in squamous non-small cell lung cancer did not meet its primary endpoint and also that the topline results of a Phase II study of iniparib in platinum-resistant ovarian cancer did not support further development of iniparib. In June, Sanofi also announced its decision to discontinue the investigational program for otamixaban following the topline results of the TAO study which did not meet its primary endpoint of superiority over current therapy in non-ST elevation acute coronary syndrome patients planned for early invasive strategy.

 

·                  The Phase II program in breast cancer of the current formulation SAR245408 (XL 147), the orally available inhibitor of phosphoinositide-3-kinase (PI3K) licensed from Exelixis, in combination with letrozole or trastuzumab (studies ARD11437 and ARD11439, respectively) has been discontinued, and a trial in combination with SAR256212 (MM121, ErbB3 inhibitor in partnership with Merrimack) is being completed. A Phase I program to evaluate a new formulation is ongoing.

 

·                  One project in Phase I (GZ402674 in solid tumors) has been discontinued.

 

9



 

Second-quarter and first-half 2013 financial results

 

Business Net Income(1)

 

Sanofi generated second-quarter net sales of €8,003 million, a decrease of 9.8% on a reported basis (-6.3% at constant exchange rates). First-half sales were €16,062 million, a decrease of 7.6% on a reported basis (-4.6% at constant exchange rates).

 

Other revenues decreased 66.4% to €83 million in the second quarter, impacted by the loss of exclusivity of Plavix® in the U.S. on May 17, 2012 and the end of royalties on Enbrel® sales in the U.S. In the first half, other revenues were €181 million down 73.1%.

 

Second-quarter Gross profit was €5,414 million, down 15.3% (down 11.7% at constant exchange rates), impacted by lower other revenues and decreased sales from key genericized products with relatively low cost of sales. The ratio of cost of sales to net sales reached 33.4% compared to 30.7% in the second quarter of 2012. Excluding Brazil generics, this ratio was 32.1% reflecting generic competition, the evolution of the Vaccines sales and Animal Health sales mix and unfavorable currency impact partially offset by positive effect from Lantus® and Genzyme. First-half gross profit reached €11,035 million, down 13.3% (or 10.1% at constant exchange rates). In the first half of 2013, the ratio of cost of sales to net sales was 32.4%, or 31.6% excluding Brazil generics.

 

Research and Development expenses were €1,186 million in the second quarter, a decrease of 4.0% (down 2.4% at constant exchange rates) reflecting investment in the late-stage portfolio offset by lower internal research expenses. First-half R&D expenses reached €2,341 million, down 2.7% (or down 1.5% at constant exchange rates). In the first half of 2013, the ratio of R&D to net sales was 14.6%, versus 13.8% in the first half of 2012.

 

Second-quarter selling and general expenses totaled €2,309 million, up 1.1%. At constant exchange rates, SG&A increased 4.3% reflecting the commercial investment of Genzyme in multiple sclerosis and increased marketing efforts in the U.S. Diabetes business. General expenses remained broadly stable (up 0.5% at constant exchange rates) reflecting tight cost control. First-half SG&A expenses reached €4,438 million, up 0.8% (or 3.5% at constant exchange rates). In the first half of 2013, the ratio of selling and general expenses to net sales was 27.6%, versus 25.3% in the first half of 2012.

 

Other current operating income net of expenses was an income of €140 million in the second quarter versus a charge of €141 million in the second quarter of 2012 which included an additional reserve of €118 million linked to ramipril patent litigation in Canada. The second quarter 2013 included a capital gain linked to the sales of the U.S. rights of tail products to Covis Pharma, a competition fine related to Plavix® in France and provisions related to Brazil Generics. In the first half of 2013, other current operating income net of expenses was an income of €170 million compared to an income of €16 million in the same period of 2012.

 

The share of profits from associates was €3 million in the second quarter versus €122 million in the second quarter of 2012 reflecting the loss of exclusivity of Plavix® in the U.S. First-half 2013 share of profits from associates were €21 million versus €419 million in the first half of 2012.

 

Non-controlling interests decreased 10.0% to -€45 million in the second quarter, mainly reflecting lower profit generated by Plavix® and Avapro® mainly in Europe attributable to Bristol-Myers Squibb. In the first half of 2013, non-controlling interests were -€86 million, down 17.3%.

 

Second-quarter business operating income was €2,017 million, down 28.0% (down 23.6% at constant exchange rates) and included a negative impact of €290 million(14) from Brazil generics. The ratio of business operating income to net sales was 25.2%. Excluding Brazil generics, this ratio was 28.4%. First-half business operating income was €4,361 million, a decrease of 30.2% (down 25.7% at constant exchange rates). The ratio of business operating income to net sales was 27.2%, compared to 35.9% in the first half of 2012.

 

Net financial expenses reached €137 million, compared to €156 million in the second quarter of 2012. First-half net financial expenses were €277 million versus €325 million in the first half of 2012.

 

The Group has revised its 2013 effective tax rate forecast and now anticipates a rate of around 24.0%. The first-half effective tax rate has been adjusted to this rate and consequently the effective tax rate for the second quarter was 21.1%. The main reasons for the reduction in the rate are the constant evolution of our geographical mix of earnings as well as recent and ongoing procedures with the tax authorities in a number of countries which have or are expected to have a positive impact in 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

 

(14) Operating losses, net sales adjustment and provisions for inventory write-offs and other related costs

 

10



 

Second-quarter business net income(1) was €1,475 million, a decrease of 23.4% (down 18.4% at constant exchange rates) and included a negative after tax impact of €229 million(14) from Brazil generics. The negative impact related to the Plavix® and Avapro® losses of exclusivity in the U.S. last year was €233 million. First-half business net income was €3,088 million, a decrease of 29.0% (down 24.2% at constant exchange rates). The ratio of business net income to net sales was 19.2%, compared to 25.0% in the first half of 2012.

 

In the second quarter of 2013, Business earnings per share(1) (EPS) was €1.11, down 24.0% and 18.5% on a reported basis and at constant exchange rates, respectively. The negative impact from Brazil generics was €0.17 and the negative impact related to the Plavix® and Avapro® losses of exclusivity in the U.S. last year was €0.18.  The average number of shares outstanding was 1,325.7 million this quarter versus 1,317.4 million in the second quarter of 2012. In the first half of 2013, Business earnings per share(1) was €2.33 down 29.4% and 24.5% on a reported basis and at constant exchange rates, respectively. The average number of shares outstanding was 1,323.9 million in the first half versus 1,319.3 million in the first half of 2012.

 

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

 

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

 

·                  A €1,543 million amortization charge on intangible assets related to fair value remeasurement of acquired companies (primarily Aventis: €680 million, Genzyme: €468 million and Merial €195 million) and to acquired intangible assets (licenses/products: €54 million). A €768 million amortization charge on intangible assets related to fair value remeasurement of acquired companies (primarily Aventis: €338 million, Genzyme €231 million and Merial €98 million), and to acquired intangible assets (licenses/products: €28 million) was booked in the second quarter. These items have no cash impact on the Group.

 

·                  An impairment loss (net of reversals related to intangible assets) against intangible assets of €440 million (of which €430 million in Q2 2013 mainly related to iniparib following the decision announced on June 3, to terminate the internal development program with iniparib). This item has no cash impact on the Group.

 

·                  A charge of €117 million mainly reflecting an increase in the fair value of contingent considerations related to the CVRs (€38 million, of which €21 million in Q2 2013) and contingent considerations related to Bayer (€49 million, of which €29 million in Q2 2013) and Targegen (€33 million).

 

·                  A charge of €6 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.

 

·                  €159 million of restructuring costs (including €105 million in the second quarter mainly related to continuation of transformation in Europe and Japan).

 

·                  A €749 million tax effect arising from the items listed above, comprising €490 million generated by amortization charged against intangible assets, €180 million associated with impairment loss on intangible assets and €57 million associated with restructuring costs. The second quarter tax effect was €469 million, including €231 million of deferred taxes generated by amortization charged against intangible assets, €180 million associated with impairment loss on intangible assets and €41 million linked to restructuring costs (see Appendix 3).

 

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

 

·                  In “Share of profits/losses from associates”, a charge of €17 million, net of tax, mainly relating to the share of amortization of intangible assets (of which €10 million in Q2 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

 

(14) Operating losses, net sales adjustments and provision for inventory write-offs and other related costs

 

11



 

Net Debt

 

In the first half of 2013, net cash generated by operating activities was €2,381 million after changes in working capital (€870 million) and after an exceptional funding of €305 million related to U.S. pension plans. This amount covered part of repurchasing of shares (€890 million) partially offset by proceeds from the issuance of new shares (€741 million), dividend paid by Sanofi (€3,638 million), capital expenditures (€586 million), acquisitions and partnerships net of disposals (€149 million) and restructuring costs (€325 million). As a consequence, net debt increased from €7,719 million at December 31, 2012 to €10,172 million at June 30, 2013 (net of €4,181 million cash and cash equivalents).

 

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

 

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

 

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

 

Forward-Looking Statements

 

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding 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 second-quarter and 2013 first-half consolidated net sales by geographic region and product

 

Appendix 2:                             2013 second-quarter and 2013 first-half business net income statement

 

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

 

Appendix 4:                             2013 second-quarter and 2013 first-half 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 second-quarter and 2013 first-half consolidated net sales by geographic region and product

 

Q2 2013 net sales (€ million)

 

Total

 

% CER

 

% reported

 

Western Europe

 

% CER

 

United States

 

% CER

 

Emerging Markets

 

% CER

 

Rest of the World

 

% CER

 

Lantus

 

1,409

 

17.7

%

14.7

%

203

 

5.2

%

903

 

20.9

%

230

 

20.2

%

73

 

10.5

%

Apidra

 

68

 

25.0

%

21.4

%

21

 

16.7

%

23

 

33.3

%

16

 

23.1

%

8

 

28.6

%

Amaryl

 

99

 

-1.8

%

-10.0

%

6

 

-25.0

%

1

 

0.0

%

71

 

10.3

%

21

 

-21.2

%

Insuman

 

32

 

-3.0

%

-3.0

%

23

 

-4.2

%

1

 

 

8

 

0.0

%

0

 

 

Diabetes

 

1,621

 

16.2

%

12.9

%

266

 

6.4

%

928

 

21.0

%

326

 

17.7

%

101

 

0.9

%

Taxotere

 

114

 

-22.0

%

-28.3

%

6

 

-53.8

%

19

 

-13.6

%

54

 

-24.7

%

35

 

-13.7

%

Jevtana

 

54

 

-16.9

%

-16.9

%

25

 

0.0

%

22

 

-31.3

%

7

 

-12.5

%

0

 

 

Eloxatin

 

60

 

-83.7

%

-84.0

%

1

 

-66.7

%

7

 

-97.4

%

31

 

-20.0

%

21

 

5.3

%

Thymoglobulin

 

52

 

12.8

%

10.6

%

7

 

-12.5

%

26

 

12.5

%

14

 

36.4

%

5

 

0.0

%

Zaltrap

 

14

 

 

 

3

 

 

10

 

 

1

 

 

0

 

 

Mozobil

 

25

 

13.0

%

8.7

%

8

 

14.3

%

14

 

7.7

%

2

 

0.0

%

1

 

100.0

%

Other Oncology

 

64

 

-18.3

%

-22.0

%

12

 

-42.9

%

37

 

-17.0

%

7

 

-12.5

%

8

 

50.0

%

Oncology

 

383

 

-46.9

%

-49.0

%

62

 

-19.5

%

135

 

-69.2

%

116

 

-16.2

%

70

 

-2.5

%

Aubagio

 

33

 

 

 

0

 

 

33

 

 

0

 

 

0

 

 

Cerezyme

 

171

 

18.0

%

14.0

%

56

 

3.7

%

45

 

7.0

%

57

 

60.5

%

13

 

-6.7

%

Myozyme

 

126

 

15.0

%

11.5

%

69

 

9.5

%

30

 

10.7

%

20

 

50.0

%

7

 

12.5

%

Fabrazyme

 

91

 

28.4

%

23.0

%

21

 

90.9

%

50

 

30.8

%

8

 

-25.0

%

12

 

16.7

%

Aldurazyme

 

41

 

19.4

%

13.9

%

15

 

0.0

%

7

 

0.0

%

16

 

66.7

%

3

 

20.0

%

Other Rare Diseases products

 

63

 

8.2

%

3.3

%

9

 

37.5

%

29

 

11.5

%

9

 

0.0

%

16

 

-5.6

%

Genzyme

 

525

 

25.6

%

21.0

%

170

 

13.9

%

194

 

38.5

%

110

 

40.2

%

51

 

3.4

%

Plavix

 

493

 

-1.3

%

-10.8

%

69

 

-22.5

%

5

(1)

-82.1

%

219

 

10.9

%

200

 

6.0

%

Lovenox

 

436

 

-9.2

%

-10.8

%

215

 

-1.4

%

48

 

-43.7

%

148

 

-2.5

%

25

 

0.0

%

Aprovel

 

238

 

-27.5

%

-28.7

%

94

 

-45.3

%

3

 

-58.3

%

108

 

2.8

%

33

 

-24.4

%

Renagel and Renvela

 

175

 

7.9

%

6.1

%

36

 

9.1

%

115

 

6.3

%

19

 

42.9

%

5

 

-42.9

%

Allegra

 

79

 

-25.4

%

-37.3

%

4

 

-25.0

%

0

 

 

31

 

-2.9

%

44

 

-34.5

%

Ambien family

 

92

 

-17.8

%

-28.7

%

10

 

-16.7

%

20

 

5.0

%

14

 

-11.8

%

48

 

-25.0

%

Depakine

 

103

 

3.9

%

1.0

%

34

 

-2.8

%

0

 

 

65

 

8.1

%

4

 

0.0

%

Synvisc / Synvisc-One

 

105

 

0.9

%

-0.9

%

7

 

75.0

%

82

 

-3.4

%

8

 

14.3

%

8

 

0.0

%

Tritace

 

80

 

-10.8

%

-14.0

%

35

 

-14.6

%

0

 

 

43

 

-6.3

%

2

 

-25.0

%

Multaq

 

69

 

10.9

%

7.8

%

11

 

0.0

%

57

 

16.0

%

2

 

0.0

%

-1

 

-100.0

%

Lasix

 

43

 

-16.1

%

-23.2

%

19

 

-13.6

%

0

 

-100.0

%

13

 

-13.3

%

11

 

-16.7

%

Targocid

 

45

 

-11.1

%

-16.7

%

21

 

-8.7

%

0

 

 

21

 

-12.0

%

3

 

-16.7

%

Orudis

 

38

 

-8.2

%

-22.4

%

7

 

-46.2

%

0

 

 

30

 

2.9

%

1

 

100.0

%

Cordarone

 

37

 

-4.7

%

-14.0

%

7

 

-12.5

%

0

 

 

20

 

10.5

%

10

 

-18.8

%

Xatral

 

25

 

-27.8

%

-30.6

%

10

 

-16.7

%

0

 

-100.0

%

15

 

0.0

%

0

 

-50.0

%

Actonel

 

24

 

-30.6

%

-33.3

%

5

 

-37.5

%

0

 

 

10

 

-42.1

%

9

 

0.0

%

Other Rx Drugs

 

1,074

 

-11.0

%

-14.0

%

400

 

-19.6

%

129

 

-13.3

%

418

 

-2.7

%

127

 

-5.3

%

Total Other Rx Drugs

 

3,156

 

-9.9

%

-14.3

%

984

 

-18.2

%

459

 

-15.0

%

1,184

 

0.4

%

529

 

-9.6

%

Consumer Healthcare

 

729

 

1.8

%

-1.2

%

162

 

0.6

%

151

 

-2.5

%

352

 

2.8

%

64

 

9.5

%

Generics

 

300

 

-36.8

%

-35.9

%

143

 

22.0

%

53

 

-19.4

%

95

 

-67.9

%

9

 

50.0

%

Pharmaceuticals

 

6,714

 

-7.1

%

-10.6

%

1,787

 

-8.7

%

1,920

 

-9.0

%

2,183

 

-4.7

%

824

 

-5.6

%

Polio/Pertussis/Hib Vaccines

 

293

 

12.5

%

7.3

%

11

 

37.5

%

81

 

-17.6

%

166

 

29.0

%

35

 

34.4

%

Influenza Vaccines

 

53

 

-32.5

%

-33.8

%

1

 

 

-5

 

 

54

 

-30.8

%

3

 

150.0

%

Meningitis/Pneumonia Vaccines

 

123

 

-2.3

%

-4.7

%

2

 

0.0

%

79

 

-17.2

%

41

 

46.4

%

1

 

 

Adult Booster Vaccines

 

124

 

-13.7

%

-15.1

%

25

 

19.0

%

84

 

-17.3

%

13

 

-7.1

%

2

 

-71.4

%

Travel and Other Endemics Vaccines

 

98

 

1.0

%

-2.0

%

3

 

-40.0

%

25

 

-18.8

%

55

 

7.7

%

15

 

45.5

%

Other Vaccines

 

69

 

30.9

%

25.5

%

0

 

-100.0

%

65

 

46.7

%

3

 

25.0

%

1

 

-80.0

%

Vaccines

 

760

 

0.4

%

-2.9

%

42

 

13.5

%

329

 

-11.5

%

332

 

10.1

%

57

 

19.3

%

Fipronil products

 

168

 

-23.7

%

-26.3

%

49

 

-15.3

%

88

 

-32.6

%

25

 

4.2

%

6

 

-20.0

%

Vaccines

 

197

 

11.1

%

9.4

%

48

 

11.6

%

43

 

15.8

%

101

 

10.9

%

5

 

-14.3

%

Avermectin products

 

103

 

-1.9

%

-3.7

%

12

 

0.0

%

58

 

-4.8

%

16

 

0.0

%

17

 

5.9

%

Others

 

61

 

4.9

%

0.0

%

20

 

0.0

%

25

 

-7.7

%

12

 

45.5

%

4

 

0.0

%

Animal Health

 

529

 

-5.7

%

-8.2

%

129

 

-3.0

%

214

 

-16.5

%

154

 

11.2

%

32

 

-5.4

%

Total Group

 

8,003

 

-6.3

%

-9.8

%

1,958

 

-7.9

%

2,463

 

-10.0

%

2,669

 

-2.3

%

913

 

-4.3

%

 


(1)         Sales of active ingredient to the American entity managed by BMS

 

13



 

H1 2013 net sales (€ million)

 

Total

 

% CER

 

% reported

 

Western Europe

 

% CER

 

United States

 

% CER

 

Emerging Markets

 

% CER

 

Rest of the World

 

% CER

 

Lantus

 

2,747

 

19.4

%

17.1

%

399

 

4.7

%

1,765

 

23.8

%

442

 

20.1

%

141

 

12.9

%

Apidra

 

134

 

27.8

%

24.1

%

40

 

0.0

%

49

 

56.3

%

30

 

29.2

%

15

 

41.7

%

Amaryl

 

193

 

-2.3

%

-9.4

%

12

 

-25.0

%

1

 

-50.0

%

138

 

10.8

%

42

 

-21.5

%

Insuman

 

65

 

0.0

%

0.0

%

45

 

-6.3

%

1

 

 

19

 

17.6

%

0

 

 

Diabetes

 

3,163

 

17.8

%

15.1

%

519

 

4.2

%

1,816

 

24.3

%

630

 

18.4

%

198

 

3.7

%

Taxotere

 

222

 

-23.0

%

-28.2

%

14

 

-56.3

%

30

 

-18.9

%

110

 

-23.8

%

68

 

-11.8

%

Jevtana

 

106

 

-10.1

%

-10.9

%

49

 

11.4

%

42

 

-30.0

%

14

 

-6.7

%

1

 

 

Eloxatin

 

119

 

-84.2

%

-84.3

%

3

 

-66.7

%

15

 

-97.5

%

65

 

-18.5

%

36

 

0.0

%

Thymoglobulin

 

96

 

3.2

%

1.1

%

15

 

-6.3

%

50

 

6.3

%

24

 

4.2

%

7

 

0.0

%

Zaltrap

 

25

 

 

 

4

 

 

20

 

 

1

 

 

0

 

 

Mozobil

 

51

 

15.6

%

13.3

%

16

 

6.7

%

28

 

7.7

%

5

 

66.7

%

2

 

200.0

%

Other Oncology

 

125

 

-22.4

%

-24.2

%

28

 

-33.3

%

72

 

-22.1

%

15

 

-6.3

%

10

 

-8.3

%

Oncology

 

744

 

-48.5

%

-50.1

%

129

 

-18.4

%

257

 

-71.0

%

234

 

-16.8

%

124

 

-5.4

%

Aubagio

 

53

 

 

 

0

 

 

53

 

 

0

 

 

0

 

 

Cerezyme

 

342

 

17.4

%

14.4

%

113

 

6.6

%

88

 

12.7

%

117

 

45.2

%

24

 

-10.0

%

Myozyme

 

242

 

9.8

%

7.6

%

135

 

8.0

%

60

 

5.2

%

34

 

34.6

%

13

 

0.0

%

Fabrazyme

 

183

 

56.2

%

51.2

%

41

 

95.2

%

97

 

58.1

%

24

 

38.9

%

21

 

25.0

%

Aldurazyme

 

78

 

12.7

%

9.9

%

30

 

3.4

%

14

 

7.7

%

27

 

35.0

%

7

 

0.0

%

Other Rare Diseases products

 

120

 

6.8

%

1.7

%

20

 

29.4

%

50

 

6.3

%

18

 

0.0

%

32

 

0.0

%

Genzyme

 

1,018

 

25.5

%

22.1

%

339

 

14.4

%

362

 

41.2

%

220

 

36.7

%

97

 

1.8

%

Plavix

 

943

 

-3.0

%

-10.9

%

134

 

-25.6

%

5

(1)

-93.1

%

425

 

9.7

%

379

 

10.4

%

Lovenox

 

864

 

-13.6

%

-14.9

%

428

 

-3.4

%

97

 

-53.1

%

291

 

-3.5

%

48

 

-2.0

%

Aprovel

 

479

 

-24.3

%

-25.3

%

193

 

-43.1

%

6

 

-73.1

%

211

 

5.4

%

69

 

-2.8

%

Renagel and Renvela

 

346

 

12.5

%

10.9

%

68

 

3.0

%

236

 

12.7

%

32

 

61.9

%

10

 

-25.0

%

Allegra

 

248

 

-6.8

%

-19.5

%

6

 

-14.3

%

0

 

-100.0

%

60

 

6.6

%

182

 

-10.4

%

Ambien family

 

193

 

-15.0

%

-24.0

%

21

 

-12.5

%

39

 

0.0

%

34

 

0.0

%

99

 

-22.7

%

Depakine

 

209

 

5.9

%

3.5

%

67

 

-4.2

%

0

 

 

135

 

12.2

%

7

 

0.0

%

Synvisc / Synvisc-One

 

182

 

0.5

%

-1.1

%

12

 

20.0

%

145

 

-3.3

%

15

 

36.4

%

10

 

0.0

%

Tritace

 

158

 

-10.0

%

-12.2

%

69

 

-13.8

%

0

 

 

84

 

-6.5

%

5

 

-14.3

%

Multaq

 

131

 

4.7

%

3.1

%

21

 

-8.7

%

106

 

8.1

%

4

 

0.0

%

0

 

0.0

%

Lasix

 

83

 

-14.4

%

-20.2

%

37

 

-11.9

%

1

 

-50.0

%

25

 

-10.3

%

20

 

-19.4

%

Targocid

 

88

 

-12.4

%

-16.2

%

43

 

-8.5

%

0

 

 

39

 

-12.8

%

6

 

-27.3

%

Orudis

 

73

 

-10.9

%

-20.7

%

13

 

-48.0

%

0

 

 

58

 

1.5

%

2

 

100.0

%

Cordarone

 

72

 

-4.9

%

-12.2

%

13

 

-13.3

%

0

 

 

39

 

5.3

%

20

 

-13.8

%

Xatral

 

51

 

-24.6

%

-26.1

%

19

 

-24.0

%

2

 

-83.3

%

29

 

-3.3

%

1

 

0.0

%

Actonel

 

52

 

-25.0

%

-27.8

%

11

 

-38.9

%

0

 

 

25

 

-27.8

%

16

 

-5.6

%

Other Rx Drugs

 

2,162

 

-10.6

%

-13.5

%

835

 

-19.0

%

271

 

-7.1

%

816

 

-2.1

%

240

 

-10.2

%

Total Other Rx Drugs

 

6,334

 

-9.4

%

-13.3

%

1,990

 

-18.6

%

908

 

-17.7

%

2,322

 

1.4

%

1,114

 

-5.0

%

Consumer Healthcare

 

1,540

 

2.5

%

-0.2

%

361

 

1.7

%

328

 

-2.6

%

720

 

3.6

%

131

 

12.1

%

Generics

 

723

 

-19.8

%

-20.3

%

281

 

26.3

%

107

 

-23.4

%

320

 

-39.3

%

15

 

15.4

%

Pharmaceuticals

 

13,522

 

-5.7

%

-8.8

%

3,619

 

-8.9

%

3,778

 

-9.7

%

4,446

 

-0.8

%

1,679

 

-2.5

%

Polio/Pertussis/Hib Vaccines

 

563

 

14.1

%

8.7

%

17

 

-34.6

%

123

 

-40.0

%

312

 

43.2

%

111

 

114.5

%

Influenza Vaccines

 

172

 

3.0

%

1.8

%

1

 

 

10

 

66.7

%

147

 

-1.3

%

14

 

15.4

%

Meningitis/Pneumonia Vaccines

 

203

 

2.5

%

0.5

%

3

 

50.0

%

121

 

-8.8

%

76

 

24.2

%

3

 

50.0

%

Adult Booster Vaccines

 

209

 

-9.0

%

-10.3

%

39

 

14.7

%

142

 

-12.7

%

21

 

-4.5

%

7

 

-36.4

%

Travel and Other Endemics Vaccines

 

172

 

-0.6

%

-2.8

%

8

 

-33.3

%

40

 

-22.6

%

97

 

10.0

%

27

 

27.3

%

Other Vaccines

 

138

 

39.6

%

36.6

%

0

 

-100.0

%

128

 

63.3

%

6

 

-11.1

%

4

 

-50.0

%

Vaccines

 

1,457

 

7.2

%

4.1

%

68

 

-13.9

%

564

 

-11.5

%

659

 

20.8

%

166

 

61.0

%

Fipronil products

 

364

 

-20.5

%

-22.2

%

111

 

-18.8

%

189

 

-27.1

%

47

 

14.0

%

17

 

-20.0

%

Vaccines

 

361

 

6.1

%

4.6

%

91

 

3.4

%

76

 

8.5

%

185

 

6.8

%

9

 

0.0

%

Avermectin products

 

245

 

12.7

%

10.9

%

28

 

-6.7

%

149

 

20.8

%

28

 

3.6

%

40

 

7.9

%

Others

 

113

 

-3.3

%

-5.8

%

41

 

0.0

%

41

 

-12.8

%

23

 

30.0

%

8

 

-36.4

%

Animal Health

 

1,083

 

-4.4

%

-6.2

%

271

 

-8.4

%

455

 

-8.9

%

283

 

9.4

%

74

 

-7.1

%

Total Group

 

16,062

 

-4.6

%

-7.6

%

3,958

 

-9.0

%

4,797

 

-9.9

%

5,388

 

1.9

%

1,919

 

0.8

%

 


(1)    Sales of active ingredient to the American entity managed by BMS

 

14



 

Appendix 2: Business net income statement

 

Second quarter 2013

 

Group Total

 

Pharmaceuticals

 

Vaccines

 

Animal Health

 

Others

 

€ million

 

Q2 2013

 

Q2 2012(1)

 

Change

 

Q2 2013

 

Q2 2012(1)

 

Change

 

Q2 2013

 

Q2 2012(1)

 

Change

 

Q2 2013

 

Q2 2012(1)

 

Change

 

Q2 2013

 

Q2 2012(1)

 

Net sales

 

8,003

 

8,870

 

(9.8

)%

6,714

 

7,511

 

(10.6

)%

760

 

783

 

(2.9

)%

529

 

576

 

(8.2

)%

 

 

 

 

Other revenues

 

83

 

247

 

(66.4

)%

72

 

233

 

(69.1

)%

5

 

5

 

 

 

6

 

9

 

(33.3

)%

 

 

 

 

Cost of sales

 

(2,672

)

(2,725

)

(1.9

)%

(2,142

)

(2,246

)

(4.6

)%

(350

)

(301

)

16.3

%

(180

)

(178

)

1.1

%

 

 

 

 

As % of net sales

 

(33.4

)%

(30.7

)%

 

 

(31.9

)%

(29.9

)%

 

 

(46.1

)%

(38.4

)%

 

 

(34.0

)%

(30.9

)%

 

 

 

 

 

 

Gross profit

 

5,414

 

6,392

 

(15.3

)%

4,644

 

5,498

 

(15.5

)%

415

 

487

 

(14.8

)%

355

 

407

 

(12.8

)%

 

 

 

 

As % of net sales

 

67.6

%

72.1

%

 

 

69.2

%

73.2

%

 

 

54.6

%

62.2

%

 

 

67.1

%

70.7

%

 

 

 

 

 

 

Research and development expenses

 

(1,186

)

(1,235

)

(4.0

)%

(1,019

)

(1,054

)

(3.3

)%

(121

)

(142

)

(14.8

)%

(46

)

(39

)

17.9

%

 

 

 

 

As % of net sales

 

(14.8

)%

(13.9

)%

 

 

(15.2

)%

(14.0

)%

 

 

(15.9

)%

(18.1

)%

 

 

(8.7

)%

(6.8

)%

 

 

 

 

 

 

Selling and general expenses

 

(2,309

)

(2,285

)

1.1

%

(1,968

)

(1,936

)

1.7

%

(160

)

(157

)

1.9

%

(181

)

(191

)

(5.2

)%

 

 

(1

)

As % of net sales

 

(28.9

)%

(25.8

)%

 

 

(29.3

)%

(25.8

)%

 

 

(21.1

)%

(20.1

)%

 

 

(34.2

)%

(33.1

)%

 

 

 

 

 

 

Other current operating income/expenses

 

140

 

(141

)

 

 

100

 

(153

)

 

 

5

 

(2

)

 

 

(1

)

 

 

 

 

36

 

14

 

Share of profit/loss of associates(2) and joint ventures

 

3

 

122

 

 

 

8

 

123

 

 

 

(3

)

(1

)

 

 

(2

)

 

 

 

 

 

 

 

 

Net income attributable to non-controlling interests

 

(45

)

(50

)

 

 

(45

)

(49

)

 

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

Business operating income

 

2,017

 

2,803

 

(28.0

)%

1,720

 

2,429

 

(29.2

)%

136

 

185

 

(26.5

)%

125

 

176

 

(29.0

)%

36

 

13

 

As % of net sales

 

25.2

%

31.6

%

 

 

25.6

%

32.3

%

 

 

17.9

%

23.6

%

 

 

23.6

%

30.6

%

 

 

 

 

 

 

Financial income and expenses

 

(137

)

(156

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

(405

)

(721

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax rate(3)

 

21.1

%

28.0

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business net income

 

1,475

 

1,926

 

(23.4

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As % of net sales

 

18.4

%

21.7

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business earnings per share(4) (in euros)

 

1.11

 

1.46

 

(24.0

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


(1) Including impact of transition to IAS19R

(2) Net of tax

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

(4) Based on an average number of shares outstanding of 1,325.7 million in the second quarter of 2013 and 1,317.4 million in the second quarter of 2012

 

15



 

First-half 2013

 

Group Total

 

Pharmaceuticals

 

Vaccines

 

Animal Health

 

Others

 

€ million

 

H1 2013

 

H1 2012(1)

 

Change

 

H1 2013

 

H1 2012(1)

 

Change

 

H1 2013

 

H1 2012(1)

 

Change

 

H1 2013

 

H1 2012(1)

 

Change

 

H1 2013

 

H1 2012(1)

 

Net sales

 

16,062

 

17,381

 

(7.6

)%

13,522

 

14,827

 

(8.8

)%

1,457

 

1,400

 

4.1

%

1,083

 

1,154

 

(6.2

)%

 

 

 

 

Other revenues

 

181

 

673

 

(73.1

)%

155

 

645

 

(76.0

)%

12

 

10

 

20.0

%

14

 

18

 

(22.2

)%

 

 

 

 

Cost of sales

 

(5,208

)

(5,333

)

(2.3

)%

(4,167

)

(4,424

)

(5.8

)%

(695

)

(563

)

23.4

%

(346

)

(346

)

 

 

 

 

 

 

As % of net sales

 

(32.4

)%

(30.7

)%

 

 

(30.8

)%

(29.8

)%

 

 

(47.7

)%

(40.2

)%

 

 

(32.0

)%

(30.0

)%

 

 

 

 

 

 

Gross profit

 

11,035

 

12,721

 

(13.3

)%

9,510

 

11,048

 

(13.9

)%

774

 

847

 

(8.6

)%

751

 

826

 

(9.1

)%

 

 

 

 

As % of net sales

 

68.7

%

73.2

%

 

 

70.3

%

74.5

%

 

 

53.1

%

60.5

%

 

 

69.3

%

71.6

%

 

 

 

 

 

 

Research and development expenses

 

(2,341

)

(2,407

)

(2.7

)%

(2,007

)

(2,044

)

(1.8

)%

(249

)

(283

)

(12.0

)%

(85

)

(80

)

6.3

%

 

 

 

 

As % of net sales

 

(14.6

)%

(13.8

)%

 

 

(14.8

)%

(13.8

)%

 

 

(17.1

)%

(20.2

)%

 

 

(7.8

)%

(6.9

)%

 

 

 

 

 

 

Selling and general expenses

 

(4,438

)

(4,401

)

0.8

%

(3,796

)

(3,755

)

1.1

%

(299

)

(287

)

4.2

%

(343

)

(358

)

(4.2

)%

 

 

(1

)

As % of net sales

 

(27.6

)%

(25.3

)%

 

 

(28.1

)%

(25.3

)%

 

 

(20.5

)%

(20.5

)%

 

 

(31.7

)%

(31.1

)%

 

 

 

 

 

 

Other current operating income/expenses

 

170

 

16

 

 

 

131

 

(1

)

 

 

7

 

(2

)

 

 

(2

)

1

 

 

 

34

 

18

 

Share of profit/loss of associates(2) and joint ventures

 

21

 

419

 

 

 

27

 

425

 

 

 

(4

)

(6

)

 

 

(2

)

 

 

 

 

 

 

 

 

Net income attributable to non-controlling interests

 

(86

)

(104

)

 

 

(86

)

(104

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business operating income

 

4,361

 

6,244

 

(30.2

)%

3,779

 

5,569

 

(32.1

)%

229

 

269

 

(14.9

)%

319

 

389

 

(18.0

)%

34

 

17

 

As % of net sales

 

27.2

%

35.9

%

 

 

27.9

%

37.6

%

 

 

15.7

%

19.2

%

 

 

29.5

%

33.7

%

 

 

 

 

 

 

Financial income and expenses

 

(277

)

(325

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

(996

)

(1,569

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax rate(3)

 

24.0

%

28.0

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business net income

 

3,088

 

4,350

 

(29.0

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As % of net sales

 

19.2

%

25.0

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Business earnings per share(4) (in euros)

 

2.33

 

3.30

 

(29.4

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


(1) Including impact of transition to IAS19R

(2) Net of tax

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

(4) Based on an average number of shares outstanding of 1,323.9 million in the first semester of 2013 and 1,319.3 million in the first semester of 2012

 

16



 

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

 

€ million

 

Q2 2013

 

Q2 2012(4)

 

Change

 

Business net income

 

1,475

 

1,926

 

(23.4

)%

Amortization of intangible assets(1)

 

(768

)

(842

)

 

 

Impairment of intangible assets

 

(430

)

(39

)

 

 

Fair value remeasurement of contingent consideration liabilities

 

(76

)

(73

)

 

 

Expenses arising from the impact of acquisitions on inventories

 

(3

)

(3

)

 

 

Restructuring costs

 

(105

)

(163

)

 

 

Other gains and losses, and litigation

 

 

 

 

 

 

 

Tax effect of items listed above:

 

469

 

354

 

 

 

Amortization of intangible assets

 

231

 

283

 

 

 

Impairment of intangible assets

 

180

 

14

 

 

 

Fair value remeasurement of contingent consideration liabilities

 

16

 

1

 

 

 

Expenses arising from the impact of acquisitions on inventories

 

1

 

1

 

 

 

Restructuring costs

 

41

 

55

 

 

 

Other tax items(2)

 

(109

)

 

 

 

 

Share of items listed above attributable to non-controlling interests

 

1

 

 

 

 

 

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

 

(10

)

(7

)

 

 

Net income attributable to equity holders of Sanofi

 

444

 

1,153

 

(61.5

)%

Consolidated earnings per share(3) (in euros)

 

0.33

 

0.88

 

 

 

 


(1)         Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €740 million in the second quarter of 2013 and €814 million in the second quarter of 2012.

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

(3)         Based on an average number of shares outstanding of 1,325.7 million in the second quarter of 2013 and 1,317.4 in the second quarter  of 2012.

(4)         Impact of transition to IAS19R.

 

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

 

17



 

€ million

 

H1 2013

 

H1 2012(4)

 

Change

 

Business net income

 

3,088

 

4,350

 

(29.0

)%

Amortization of intangible assets(1)

 

(1,543

)

(1,675

)

 

 

Impairment of intangible assets

 

(440

)

(40

)

 

 

Fair value remeasurement of contingent consideration liabilities

 

(117

)

(106

)

 

 

Expenses arising from the impact of acquisitions on inventories

 

(6

)

(17

)

 

 

Restructuring costs

 

(159

)

(250

)

 

 

Other gains and losses, and litigation

 

 

 

 

 

 

 

Tax effect of items listed above:

 

749

 

714

 

 

 

Amortization of intangible assets

 

490

 

615

 

 

 

Impairment of intangible assets

 

180

 

14

 

 

 

Fair value remeasurement of contingent consideration liabilities

 

20

 

3

 

 

 

Expenses arising from the impact of acquisitions on inventories

 

2

 

5

 

 

 

Restructuring costs

 

57

 

77

 

 

 

Other tax items(2)

 

(109

)

 

 

 

 

Share of items listed above attributable to non-controlling interests

 

2

 

1

 

 

 

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

 

(17

)

(15

)

 

 

Net income attributable to equity holders of Sanofi

 

1,448

 

2,962

 

(51.1

)%

Consolidated earnings per share(3) (in euros)

 

1.09

 

2.25

 

 

 

 


(1)         Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €1,489 million in the first semester of 2013 and €1,602 million in the first semester of 2012.

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

(3)         Based on an average number of shares outstanding of 1,323.9 million in the first semester of 2013 and 1,319.3 in the first semester of 2012.

(4)         Including impact of transition to IAS19R.

 

18



 

Appendix 4: Consolidated income statement

 

€ million

 

Q2 2013

 

Q2 2012(1)

 

H1 2013

 

H1 2012(1)

 

Net sales

 

8,003

 

8,870

 

16,062

 

17,381

 

Other revenues

 

83

 

247

 

181

 

673

 

Cost of sales

 

(2,675

)

(2,728

)

(5,214

)

(5,350

)

Gross profit

 

5,411

 

6,389

 

11,029

 

12,704

 

Research and development expenses

 

(1,186

)

(1,235

)

(2,341

)

(2,407

)

Selling and general expenses

 

(2,309

)

(2,285

)

(4,438

)

(4,401

)

Other operating income

 

276

 

113

 

347

 

319

 

Other operating expenses

 

(136

)

(254

)

(177

)

(303

)

Amortization of intangible assets

 

(768

)

(842

)

(1,543

)

(1,675

)

Impairment of intangible assets

 

(430

)

(39

)

(440

)

(40

)

Fair value remeasurement of contingent consideration liabilities

 

(76

)

(73

)

(117

)

(106

)

Restructuring costs

 

(105

)

(163

)

(159

)

(250

)

Other gains and losses, and litigation

 

 

 

 

 

 

 

 

 

Operating income

 

677

 

1,611

 

2,161

 

3,841

 

Financial expense

 

(154

)

(181

)

(311

)

(370

)

Financial income

 

17

 

25

 

34

 

45

 

Income before tax and associates and joint ventures

 

540

 

1,455

 

1,884

 

3,516

 

Income tax expense(2)

 

(45

)

(367

)

(356

)

(855

)

Share of profit/loss of associates and joint ventures

 

(7

)

115

 

4

 

404

 

Net income

 

488

 

1,203

 

1,532

 

3,065

 

Net income attributable to non-controlling interests

 

44

 

50

 

84

 

103

 

Net income attributable to equity holders of Sanofi

 

444

 

1,153

 

1,448

 

2,962

 

Average number of shares outstanding (million)

 

1,325.7

 

1,317.4

 

1,323.9

 

1,319.3

 

Earnings per share (in euros)

 

0.33

 

0.88

 

1.09

 

2.25

 

 


(1) Including impact of transition to IAS19R.

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

 

19



 

Appendix 5: Change in net debt

 

€ million

 

H1 2013

 

H1 2012(1)

 

Business net income

 

3,088

 

4,350

 

Depreciation, amortization and impairment of property, plant and equipment and software

 

594

 

627

 

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

 

(154

)

(40

)

Other non cash items

 

(277

)

396

 

Operating cash flow before changes in working capital(2)

 

3,251

 

5,333

 

Changes in working capital(2)

 

(870

)

(684

)

Acquisitions of property, plant and equipment and software

 

(586

)

(711

)

Free cash flow(2)

 

1,795

 

3,938

 

Acquisitions of intangibles, excluding software

 

(142

)

(75

)

Acquisitions of investments, including assumed debt(2)

 

(273

)

(179

)

Restructuring costs paid

 

(325

)

(504

)

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

 

266

 

71

 

Issuance of Sanofi shares

 

741

 

74

 

Dividends paid to shareholders of Sanofi

 

(3,638

)

(3,487

)

Acquisition of treasury shares

 

(890

)

(454

)

Disposals of treasury shares, net of tax

 

2

 

 

 

Other items(3)

 

11

 

128

 

Change in net debt

 

(2,453

)

(488

)

 


(1) Including impact of transition to IAS19R.

(2)  Excluding restructuring costs.

(3)  Of which foreign exchange effect on net debt €17 million in 2013 and -€68 million in 2012.

 

20



 

Appendix 6: Simplified consolidated balance sheets

 

 

 

06/30/13

 

12/31/12(1)

 

ASSETS
€ million

 

 

 

 

 

Property, plant and equipment

 

10,409

 

10,578

 

Intangible assets (including goodwill)

 

56,410

 

58,265

 

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

 

9,309

 

8,665

 

Non-current assets

 

76,128

 

77,508

 

Inventories, accounts receivable and other current assets

 

16,626

 

16,419

 

Cash and cash equivalents

 

4,181

 

6,381

 

Current assets

 

20,807

 

22,800

 

Assets held for sale or exchange

 

52

 

101

 

Total ASSETS

 

96,987

 

100,409

 

 

 

 

 

 

 

LIABILITIES & EQUITY
€ million

 

 

 

 

 

Equity attributable to equity-holders of Sanofi

 

56,066

 

57,332

 

Equity attributable to non-controlling interests

 

129

 

134

 

Total equity

 

56,195

 

57,466

 

Long-term debt

 

10,689

 

10,719

 

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

 

1,347

 

1,350

 

Provisions and other non-current liabilities

 

9,565

 

11,043

 

Deferred tax liabilities

 

5,547

 

5,932

 

Non-current liabilities

 

27,148

 

29,044

 

Accounts payable and other current liabilities

 

9,549

 

9,948

 

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

 

109

 

100

 

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

 

3,971

 

3,812

 

Current liabilities

 

13,629

 

13,860

 

Liabilities related to assets held for sale or exchange

 

15

 

39

 

Total LIABILITIES & EQUITY

 

96,987

 

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 second quarter and the first half of 2013

 

€ million

 

Q2 2013

 

H1 2013

 

Net sales

 

8,003

 

16,062

 

Effect of exchange rates

 

305

 

517

 

Net sales at constant exchange rates

 

8,308

 

16,579

 

 

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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