PARIS, Oct. 25, 2012 /PRNewswire/ -- Sanofi (NYSE: SNY;
EURONEXT: SAN)
|
Q3
2012
|
Change on
a reported basis
|
Change
at
constant
exchange
rates1
|
9-month
2012
|
Change on
a reported basis
|
Change
at
constant
exchange
rates
|
Net sales
|
€9,040m
|
+3.3%
|
-3.1%
|
€26,421m
|
+6.2%
|
+1.2%
|
Business net income1
|
€2,221m
|
-7.4%
|
-15.9%
|
€6,607m
|
-1.7%
|
-8.6%
|
Business EPS1
|
€1.68
|
-6.1%
|
-14.5%
|
€5.01
|
-1.6%
|
-8.4%
|
In
order to facilitate an understanding of our operational
performance, we comment on our business net income statement.
Business net income1 is a non-GAAP financial measure.
The consolidated income statement for the 9 months of 2012 is
provided in Appendix 7. A reconciliation of business net income to
consolidated net income is provided in Appendix 6. Consolidated net
income for the first 9 months of 2012 was €4,557 million, compared
to €4,254 million for the first 9 months of 2011. Consolidated EPS
for the first 9 months of 2012 was €3.45 versus €3.23 for the first
9 months of 2011.
|
|
Commenting
on the Group's performance in Q3 2012, Sanofi Chief Executive
Officer, Christopher A. Viehbacher said,
"The loss of exclusivity for Eloxatin®
in August in the U.S. marks the final step in the genericization
of our legacy blockbusters. The solid performance of our growth
platforms2 which account for over 70% of
sales, coupled with tight cost control, allowed us to limit
the impact of the patent cliff on business EPS1 this
quarter. Furthermore, we continue to make progress with our
pipeline with the launch of Zaltrap® and
Aubagio® in the U.S. and the FDA approval for
Auvi-Q™ ."
|
(Logo:
http://photos.prnewswire.com/prnh/20110616/NY20158LOGO )
Q3 2012 Performance
- Total sales3 reached €9,040 million, a
decrease of 3.1%. Net sales lost to generic competition were €448
million in the quarter, primarily due to generic competition to
Eloxatin in the U.S.
- Sales from growth platforms2 grew by 6.4% to
€6,412 million and accounted for 70.9% of total sales.
- Diabetes recorded its seventh consecutive quarter of
double-digit sales growth (+17.5% to €1,486 million).
Lantus® recorded strong growth (+20.7% to €1,279
million) driven by the performance in the U.S. (+22.1%) and
Emerging Markets4 (+31.5%).
- "New Genzyme"5 achieved strong double-digit
sales growth (+22.5%) driven by the Fabrazyme®
recovery.
- Emerging Markets4 sales were €2,821 million,
an increase of 6.8% with double-digit growth recorded for Diabetes,
CHC, new Genzyme and Animal Health.
- Vaccines sales reached €1,481 million (+0.7%), reflecting
solid underlying performance impacted by temporary U.S. supply
limitations for Pentacel® and the delivery of Flu
vaccines extending into Q4 2012 unlike last year.
- The impact of the Plavix® and
Avapro® loss of exclusivity in the U.S. was €469
million6 at CER on Business Net Income.
- Business EPS1 of €1.68 was down 14.5% at
CER.
R&D and Guidance
- The FDA approved Zaltrap® for previously
treated metastatic colorectal cancer, Aubagio® for
relapsing multiple sclerosis and Auvi-Q™ for patients
with life-threatening allergies. Plavix® was approved
for two new indications in Japan.
Fluzone® QIV IM and a new hexavalent vaccine were filed
in the U.S. and EU, respectively.
- A second set of Phase III studies for the new glargine
formulation was recently initiated. Eliglustat, an oral compound
for Gaucher disease, met its primary endpoint in the Phase III
ENGAGE study.
- Given the Group's performance in the first nine months of
this year, 2012 business EPS1 is now expected to be
around 12% lower at CER than 20117, barring unforeseen
adverse events.
(1) See Appendix 8 for definitions of financial indicators;
(2) See Appendix 4; (3) Growth in net sales is expressed at
constant exchange rates (CER) unless otherwise indicated (see
Appendix 8 for a definition); (4) See the definition below
"Net sales by geographic region" table; (5) "New Genzyme"
consists of rare diseases products and Multiple Sclerosis products;
(6) Including a one-time payment of $80
million by BMS; (7) €6.65
Sanofi: www.sanofi.com
Media Relations: (+) 33 1 53 77 46 46 - E-mail
: MR@sanofi.com
Investor
Relations: (+) 33 1 53 77 45 45 - E-mail :
IR@sanofi.com
2012 third-quarter and 9-month
sales
Unless
otherwise indicated, all sales growth figures in this press release
are stated at constant exchange
rates1.
|
Net sales in the third quarter of 2012 reached of €9,040
million, an increase of 3.3% on a reported basis. Exchange rate
movements had a positive effect of 6.4 percentage points reflecting
mainly the appreciation of the U.S. dollar and, to a lesser extent,
the appreciation of the Japanese Yen and Chinese Yuan against the
Euro. At constant exchange rates, and adjusting for changes in the
scope of consolidation (primarily the return of
Copaxone® to Teva and the disposal of Dermik),
net sales decreased by 1.2%.
In the first nine months of 2012, Sanofi generated net sales of
€26,421 million, an increase of 6.2% on a reported basis. Exchange
rate movements had a favorable effect of 5.0 percentage points
driven by the appreciation of the U.S. dollar, Japanese Yen and
Chinese Yuan against the Euro. At constant exchange rates, and
after taking into account changes in structure (primarily the
consolidation of Genzyme from the second quarter of 2011), net
sales increased by 0.2%.
Growth Platforms
Third quarter sales of the Group's growth platforms were €6,412
million, an increase of 6.4%, with double-digit sales growth
achieved by Diabetes and "new Genzyme". The Group's growth
platforms accounted for 70.9% of total consolidated sales in the
third quarter of 2012, up from 64.5% in the third quarter of 2011.
Year-to-date sales of growth platforms (including "new Genzyme")
reached €17,546 million, up 9.3 % or 6.6% with Genzyme proforma
(sales of Genzyme were not consolidated in the first quarter of
2011). Growth platforms sales comprised 66.4% of total consolidated
sales compared with 61.6% in the first nine months of 2011.
Net sales of Growth Platforms
(€
million)
|
Q3
2012
net
sales
|
Change at constant
exchange rates
|
9-month
2012
net
sales
|
Change at
constant
exchange rates
|
Emerging
Markets*/**
|
2,821
|
+6.8%
|
8,268
|
+8.8%
|
Emerging Markets excluding
Diabetes, Vaccines, CHC,
animal health, new Genzyme
and Innovative Products
|
1,569
|
+0.3%
|
4,734
|
+2.4%
|
Diabetes
|
1,486
|
+17.5%
|
4,233
|
+15.2%
|
Vaccines
|
1,481
|
+0.7%
|
2,881
|
+1.1%
|
Consumer Health Care (CHC)
|
733
|
+5.9%
|
2,276
|
+9.5%
|
Animal
Health
|
519
|
+3.8%
|
1,673
|
+2.0%
|
New
Genzyme
|
470
|
+22.5%
|
1,304
|
+15.0%***
|
Innovative
products****
|
154
|
+7.6%
|
445
|
+6.1%
|
Total
Growth Platforms
|
6,412
|
+6.4%
|
17,546
|
+9.3%
|
Total
Growth Platforms with Genzyme pro forma
|
6,412
|
+6.4%
|
17,546
|
+6.6%
|
*
|
World
excluding the U.S. and Canada, Western Europe, Japan, Australia and
New Zealand.
|
**
|
Includes
Diabetes, Vaccines, Consumer Health Care, new Genzyme, Animal
Health and new products sales generated in Emerging
Markets;
|
***
|
"new
Genzyme" on a constant structure basis and at constant exchange
rates;
|
****
|
Includes
recent product launches which do not belong to the other Growth
Platforms listed above: Multaq® and
Jevtana®, Zaltrap®, and Mozobil®
pro forma
|
Pharmaceuticals
Pharmaceuticals net sales decreased 4.3% (to €7,040 million) in
the third quarter of 2012, impacted by the loss of sales of
Copaxone® (impact of €117 million), disposal of
Dermik (impact of €33 million), EU austerity measures and generic
competition. In the third quarter, net sales lost to generic
competition were €448 million, due mainly to
Eloxatin® and Lovenox® in the
U.S. and, to a lesser extent, Aprovel®,
Plavix®, Taxotere® in the EU.
Year-to-date sales for the Pharmaceuticals business were €21,867
million, an increase of 1.2%, which includes the positive
contribution from Genzyme (consolidated from April 2011).
1 See Appendix 8 for definitions of financial
indicators
Flagship Products8
(millions
of euros)
|
Q3
2012
net
sales
|
Change at
constant
exchange rates
|
9-month 2012
net sales
|
Change at
constant
exchange rates
|
Lantus®
|
1,279
|
+20.7%
|
3,625
|
+18.1%
|
Plavix®
|
505
|
-10.4%
|
1,563
|
-4.0%
|
Lovenox®
|
437
|
-14.0%
|
1,452
|
-11.7%
|
Aprovel®
|
298
|
-8.3%
|
939
|
-6.7%
|
Renvela®/Renagel®
|
164
|
+12.6%
|
476
|
+10.7%*
|
Cerezyme®
|
163
|
+9.9%
|
462
|
-0.2%*
|
Eloxatin®
|
129
|
-62.9%
|
888
|
+10.1%
|
Taxotere®
|
129
|
-36.0%
|
438
|
-46.6%
|
Myozyme® / Lumizyme®
|
116
|
+8.9%
|
341
|
+11.6%*
|
Synvisc®/Synvisc
One®
|
89
|
+0.0%
|
273
|
+5.9%*
|
Fabrazyme®
|
87
|
+146.9%
|
208
|
+107.6%*
|
Multaq®
|
65
|
-9.1%
|
192
|
-9.1%
|
Jevtana®
|
56
|
+17.8%
|
175
|
+18.4%
|
Apidra®
|
57
|
+1.9%
|
165
|
+1.9%
|
* On a
constant structure basis and at constant exchange rates
|
1 See Appendix 8 for definitions of
financial indicators
|
8 See Appendix 2 for a geographical
split of consolidated net sales by product
|
Diabetes
In the third quarter, the Diabetes business reached sales of
€1,486 million, an increase of 17.5%. The performance of
Lantus® was particularly strong this
quarter with sales up 20.7% (to €1,279 million) driven by the U.S.
(+ 22.1% to €800 million), Emerging Markets (+31.5% to €204
million) and Japan (+22.5% to €39
million). In the U.S., Lantus®
SoloSTAR® represented 51.5% of total
Lantus® sales in the quarter, versus 47.2% in the
third quarter of 2011. In the Emerging Markets,
Lantus® sales growth was particularly strong in
China (+27.9%), Brazil (+31.2%), Mexico (+24.2%) and Russia (+41.3%). Year-to-date sales of
Lantus® reached €3,625 million, up 18.1%.
Our Diabetes portfolio was further enlarged in the Emerging
Markets with the launch of Insuman®
SoloSTAR® in Russia
in July and the launch in October in India of AllStar™, the first
Indian-manufactured, re-usable insulin pen, manufactured by a
global company in India. AllStar™
has been developed specifically for patients in Emerging Markets.
The launch of AllStar™ is a significant milestone emblematic of
Sanofi's leadership in addressing the needs of people with diabetes
in India. It highlights Sanofi's
commitment to Diabetes and Emerging Markets and its regionalized
approach to finding solutions that are adapted to local market
needs. Going forward, Sanofi intends to make AllStar™ accessible to
other Emerging Markets.
Third-quarter and year-to-date sales of
Apidra® reached €57 million (+1.9%) and €165
million (+1.9%), respectively.
Despite a good performance in Emerging Markets (+14.3% to €68
million), worldwide sales for Amaryl® were
down 7.5% to €106 million, impacted by generic competition in
Japan (where sales decreased 34.1%
to €30 million). Year-to-date sales of Amaryl®
decreased to €319 million (-6.8%), of which 62% were generated in
Emerging Markets (€198 million) and increased 11.8%.
The Diabetes business recorded year-to-date sales of €4,233
million, an increase of 15.2%.
Oncology
The third quarter was marked by the approval in the U.S. of
Zaltrap® (ziv-aflibercept, collaboration with
Regeneron). Zaltrap® is indicated for combination with
5-fluorouracil, leucovorin, irinotecan (FOLFIRI), for patients with
metastatic colorectal cancer that is resistant to, or has
progressed, following an oxaliplatin-containing regimen.
Zaltrap® was launched at the end of August in the U.S.
and reached sales of €7 million. This quarter was also marked by
the expected loss of market exclusivity of
Eloxatin® in the U.S. on August 9, 2012 , resulting in a 74.7% decrease in
Eloxatin® sales to €72 million.
Third-quarter sales of Taxotere® were down
36.0% to €129 million, reflecting generic erosion in the U.S. (€10
million, -70.4%) and Western
Europe (€12 million, -70.7%). Year-to-date sales of
Taxotere® were €438 million (down 46.6%), of
which €347 million was generated outside the U.S. and Western Europe.
Sales of Jevtana® increased 17.8% to €56
million in the third quarter, reflecting the recent launches in
Western Europe. Year-to-date
Jevtana® sales totaled €175 million, an increase of
18.4%.
Sales of Mozobil® reached €26 million
and €71 million (+9.5%) in the third quarter and (+20.0%*) in the
first 9 months, respectively.
Third-quarter sales of the Oncology business decreased
35.7% to €485 million. Year-to-date sales of this business
decreased 6.0% to €1,977 million.
Worldwide presence1 of
Plavix®/Iscover® and
Aprovel®/Avapro®/Karvea®/Avalide®
On October 3, Sanofi and
Bristol-Myers Squibb (BMS) announced a restructuring of their
successful long-term alliance following the loss of exclusivity of
Plavix® and Avapro®/Avalide® in
many major markets (Japan remains
excluded from the Alliance). Under the terms of the revised
agreement, which will go into effect January
1, 2013, BMS will return to Sanofi its rights to
Plavix® and Avapro®/Avalide® in
all markets worldwide with the exception of Plavix in the U.S. and
Puerto Rico, giving Sanofi sole
control and freedom to operate commercially. In exchange, BMS will
receive royalty payments on Sanofi's sales of branded and unbranded
Plavix® worldwide, excluding the U.S. and Puerto Rico, and on sales of branded and
unbranded Avapro®/Avalide® worldwide, in each
case through 2018, and will receive a terminal payment of U.S.
$200 million from Sanofi in
December 2018. Plavix rights in the
U.S. and Puerto Rico will continue
unchanged under the terms of the existing agreement through
December 2019.
The Worldwide presence of Plavix® decreased
70.1% to €568 million in the third quarter, impacted by generic
competition in the U.S., following the loss of exclusivity on
May 17, 2012 (U.S. sales,
consolidated by BMS, declined by 97.5% to €33 million). In
Europe, sales were down 29.6% to
€102 million, also impacted by generic competition. In Emerging
Markets, third-quarter consolidated sales increased 8.0% to €210
million, of which €104 million was generated in China (+28.2 %). In Japan, sales of Plavix® grew 18.1%
to €214 million. Year-to-date, the worldwide presence of
Plavix® was €3,430 million, a decrease of 38.7%.
Worldwide presence of Plavix®/Iscover®:
geographic split
(millions
of euros)
|
Q3
2012
|
Change at constant
exchange rates
|
9-month
2012
|
Change at constant
exchange rates
|
Europe
|
102
|
-29.6%
|
347
|
-22.1%
|
United
States
|
33
|
-97.5%
|
1,813
|
-52.5%
|
Other
Countries
|
433
|
-5.1%
|
1,270
|
-3.3%
|
TOTAL
|
568
|
-70.1%
|
3,430
|
-38.7%
|
The worldwide presence of
Aprovel®/Avalide® was down
26.2% to €334 million in the third quarter, reflecting generic
competition in the U.S. and in Europe. In the U.S., where the product lost
its exclusivity on March 30, 2012,
sales declined 83.7%. Sanofi launched an authorized generic version
in the U.S. (sales are booked in the Generics business). In
Europe, where
Aprovel® faced generic competition in most
countries during the third quarter, sales were down 25.2% to €155
million. Consolidated sales of the product in Emerging Markets were
€95 million, down 1.1%. The year-to-date worldwide presence of
Aprovel® was €1,120 million, a decrease of 22.0%.
Worldwide presence of
Aprovel®/Avapro®/Karvea®:
geographic split
(millions
of euros)
|
Q3
2012
|
Change at constant
exchange rates
|
9-month
2012
|
Change at constant
exchange rates
|
Europe
|
155
|
-25.2%
|
525
|
-16.5%
|
United
States
|
16
|
-83.7%
|
124
|
-60.8%
|
Other
Countries
|
163
|
+7.3%
|
471
|
-4.8%
|
TOTAL
|
334
|
-26.2%
|
1,120
|
-22.0%
|
1 See Appendix 8 for definitions of
financial indicators
|
*
On a constant structure basis and at constant exchange rates,
Genzyme sales were not consolidated in Q1 2011
|
Other Pharmaceutical Products
Third-quarter sales of Lovenox® decreased
14.0% to €437 million, due to generic pressure in the U.S. where
sales declined 63.2% to €55 million. Sanofi commercializes an
authorized generic of Lovenox® in the U.S. (sales are
booked in the Generics business). Outside the U.S.,
Lovenox® recorded another quarter of growth with sales
of €382 million (+4.2%). In Emerging Markets, sales increased 10.9%
to €154 million. In Western
Europe, sales of the product were stable at €201 million.
Year-to-date sales of Lovenox® totaled €1,452
million (-11.7%), of which 81.8% (€1,188 million) was generated
outside the U.S. (+7.6%).
Renvela®/Renagel®
recorded sales of €164 million (+12.6%) in the third quarter,
driven by the performance in the U.S. (sales were up 17.2% to €115
million). Year-to-date sales of
Renvela®/Renagel® were €476 million, up
10.7%*. Genzyme and generic manufacturers settled pending U.S.
litigation in the District of Maryland with regard to the production and
sale of generic formulations of Renvela® tablets,
Renvela® for oral suspension and Renagel®.
These settlements are subject to review by the U.S. Federal and
Trade Commission. According to the terms of the settlements, the
first-filer for each product can enter the U.S. market on
March 16, 2014 and second-filers can
enter the market on September 16,
2014, or earlier under certain circumstances, pending
approval of their generic application.
The Ambien® family of products recorded sales
of €126 million, (-5.0%). In Japan, given the entry of generics, sales
modestly decreased 5.6% to €72 million. Year-to-date sales of the
Ambien® family totaled €380 million, down 0.6%.
In Japan, year-to-date sales of
Myslee® reached €224 million, up 1.7%.
Third-quarter sales of Allegra® as a
prescription drug were €110 million (-1.9%). Japan sales were €77 million and declined 8.3%
reflecting the recent price decrease. Year-to-date sales of
Allegra® as a prescription drug were €418 million
(down 11.2%), of which 76.1% (€318 million, down 17.2%) was
generated in Japan. On
August 15, 2012, the Japan regulatory agency approved the first
three Allegra® generics of Esai, Taisho, and
Koybashi although the validity of the patents covering the product
had been reinstated. On October 5,
2012, Sanofi brought a patent infringement suit against
Elmed-Eisai, Taisho (Teva) and Kobayashi at the Tokyo District Court.
Sales of Synvisc®/Synvisc
One® reached €89 million and €273 million
(+5.9%*) in the third quarter and the first 9 months,
respectively.
Third-quarter sales of Multaq® were €65
million, down 9.1%, reflecting the impact of updated labeling in
the second half of 2011. Sales of the product in the U.S. reached
€51 million, down 2.2%. Year-to-date sales of
Multaq® decreased 9.1% to €192 million.
The transfer of Copaxone® sales to Teva was
finalized in the first quarter of 2012. As a consequence, Sanofi
did not book any sales of the product in the third quarter of 2012
compared to €117 million consolidated in the third quarter of 2011.
Sanofi will receive a payment of 6% on sales from Teva for a period
of two years, on a country-by-country basis. Year-to-date
consolidated sales of Copaxone® were €24 million
compared to €350 million for the same period in 2011.
New Genzyme
"New Genzyme" currently consists of Rare Disease products and
Multiple Sclerosis products (Aubagio® and the
investigational agent Lemtrada™).
(€ million)
|
Q3
2012
net
sales
|
Change at constant
exchange rates
|
9-month
2012
net
sales
|
Change on a constant
structure basis and at
constant exchange rates
|
Cerezyme®
|
163
|
+9.9%
|
462
|
-0.2%*
|
Myozyme® / Lumizyme®
|
116
|
+8.9%
|
341
|
+11.6%*
|
Fabrazyme®
|
87
|
+146.9%
|
208
|
+107.6%*
|
Other Rare
Disease products
|
104
|
+12.8%
|
293
|
+12.2%*
|
Total
"new Genzyme"
|
470
|
+22.5%
|
1,304
|
+15.0%*
|
Third-quarter sales of "new Genzyme" reached €470
million, an increase of 22.5%, driven by the recovery of
Fabrazyme®. Year-to-date sales of "new Genzyme"
totaled €1,304 million, an increase of 15.0%*.
* On a constant structure basis and at constant exchange
rates, Genzyme sales were not consolidated in Q1 2011
Third quarter sales of Cerezyme®
increased 9.9% to €163 million, driven by the performance in
Western Europe (+20.5%).
Year-to-date sales of Cerezyme® reached €462 million
(-0.2%*). Genzyme manufacturing recovery for
Cerezyme® remains on track. Significant progress
in recent months has been made as all existing patients in major
markets have been returned to normal dosing. This includes U.S.,
Japan and the majority of the EU.
Cerezyme® is expected to maintain market share and
deliver modest growth throughout the year.
Sales of
Myozyme®/Lumizyme®
grew 8.9% to €116 million supported by the performance in
Western Europe (+12.5%) in the
third quarter. Year-to-date sales of
Myozyme®/Lumizyme® were €341 million,
an increase of 11.6%*.
The strong recovery of Fabrazyme®
continued in the third quarter with sales up 146.9% to €87 million.
The approval of the new Framingham plant in January, stable
production runs and the return of all existing patients in all
markets to full dose strengthened Fabrazyme sales. In the U.S.,
third-quarter sales (€44 million, up 290.0%) also benefited from
Shire's withdrawal of Replagal® BLA in the U.S.
earlier this year. Year-to-date sales of Fabrazyme®
reached €208 million, an increase of 107.6%*. Genzyme anticipates
approval of Fabrazyme® manufactured in our
Framingham facility for the majority of remaining markets by the
end of 2013.
A key milestone was achieved in the third quarter towards
building a leading franchise in multiple sclerosis (MS) with the
FDA approval of Aubagio® (teriflunomide) in
September as a new once-daily, oral treatment indicated for
patients with relapsing forms of multiple sclerosis.
Aubagio® was launched in the U.S. in October
through the new MS sales team recently hired by Genzyme.
Consumer Health Care
Consumer Health Care (CHC) sales reached €733 million in the
third quarter, an increase of 5.9%. Sales in Emerging Markets
increased 16.1% to €374 million with Lactacyd®,
Dorflex®, Enterogermina®, NoSpa®,
and Maalox® recording double digit growth. U.S. sales of
Allegra® OTC were €44 million (down 11.6%). Year-to-date
sales of Consumer Health Care were €2,276 million, an increase of
9.5%.
Generics
Third-quarter sales of generics were €479 million, up 14.9%,
driven by the authorized generics of Lovenox® and
Aprovel® in the U.S. (U.S. sales of generic products
increased 110.3% to €70 million). In Emerging Markets, sales of
generics were €262 million, up 0.8%. Year-to-date sales of generics
totaled €1,386 million, an increase of 9.7%.
Human Vaccines
Consolidated sales of Sanofi Pasteur were €1,481 million (+0.7%)
in the third quarter, impacted by temporary supply limitations for
Pentacel® in the U.S. and the timing of Flu vaccines
supply. Year-to-date consolidated sales of the Human Vaccines
business totaled €2,881 million, an increase of 1.1%.
Sales of Polio/Pertussis/Hib vaccines recorded a 16.0%
increase to €320 million in the third quarter, boosted by the sales
of Imovax® Polio (against acute flaccid poliomyelitis;
sales of €65 million) in Japan
which was added to the country's public immunization program on
September 1st, 2012. Third-quarter
Emerging Markets sales of Polio/Pertussis/Hib vaccines increased
32.7% to €139 million, driven by Pentaxim® sales which
grew 27.0% (to €83 million) reflecting good performance in
Latin America and in China. Sales of U.S. Polio/Pertussis/Hib
franchise were down 45.0% to €69 million reflecting supply
limitations for Pentacel®. As previously announced,
Sanofi Pasteur temporarily implemented supply limitations for
Pentacel® and Daptacel® vaccines in
April 2012 in the U.S. This is a
necessary step due to a manufacturing delay that will temporarily
reduce supply below the level needed to fully satisfy market demand
in the U.S. These supply limitations are likely to remain in effect
until the beginning of 2013. Year-to-date sales of
Polio/Pertussis/Hib vaccines totaled €838 million, up 5.2%.
* On a constant structure basis and at constant exchange
rates, Genzyme sales were not consolidated in Q1 2011
Sales of seasonal influenza vaccines were €608 million in
the third quarter, down 8.0%, reflecting a tough comparison from
the high level of supply in the U.S. in the third quarter of 2011.
In the U.S., third-quarter sales of influenza vaccines decreased
8.3% to €428 million. Sanofi Pasteur expects to deliver around 60
million doses of seasonal influenza vaccine in the U.S. this
season. The full commercial launch of Fluzone®
Intradermal (the first influenza vaccine licensed in the U.S. that
uses a novel microinjection system for intradermal delivery)
occurred in the third quarter 2012 in the U.S. Year-to-date sales
of seasonal influenza vaccines totaled €777million, down 5.1%.
Sales of Menactra® were €208 million, down
4.9% in the third quarter, reflecting a tough comparison from the
high level of sales in the Middle-East in the third quarter of 2011. In
the U.S., sales reached €195 million (+0.6%) despite continued
competition. Year-to-date sales of Menactra®
totaled €375 million, up 1.5%.
Third-quarter sales of Adult booster vaccines were €140
million, up 4.9%. Sales of Adacel® increased 4.5% to
€108 million. Year-to-date sales of Adult boosters totaled €373
million, an increase of 5.2%.
Third-quarter travel and other endemic vaccines were €83
million (-20.4%) impacted by the temporary suspension of production
of Theracys®/Immucyst® and BCG vaccines.
Year-to-date sales of travel and other endemic vaccines totaled
€260 million (-7.4%).
Following a Warning Letter received on July 12, Sanofi Pasteur continues to work
diligently with the FDA to implement steps to address the issues
identified in the Warning Letter.
Consolidated vaccines sales
(millions of euros)
|
Q3
2012
net
sales
|
Change at
constant exchange rates
|
9-month
2012
net sales
|
Change at
constant exchange rates
|
Influenza
Vaccines (incl. Vaxigrip® and
Fluzone®)
|
608
|
-8.0%
|
777
|
-5.1%
|
of which seasonal vaccines
|
608
|
-8.0%
|
775
|
-5.4%
|
of which pandemic vaccines
|
0
|
-
|
2
|
Ns
|
Polio/Pertussis/Hib Vaccines (incl.
Pentacel® and
Pentaxim®)
|
320
|
+16.0%
|
838
|
+5.2%
|
Meningitis/Pneumonia Vaccines (incl.
Menactra®)
|
230
|
-3.3%
|
432
|
-0.5%
|
Adult
Booster Vaccines (incl. Adacel
®)
|
140
|
+4.9%
|
373
|
+5.2%
|
Travel and
Other Endemics Vaccines
|
83
|
-20.4%
|
260
|
-7.4%
|
Other
Vaccines
|
100
|
+69.8%
|
201
|
+22.8%
|
TOTAL
|
1,481
|
+0.7%
|
2,881
|
+1.1%
|
Third-quarter sales of Sanofi Pasteur MSD (not
consolidated), the joint venture with Merck & Co. in
Europe, increased 3.8% to €270
million, driven by Gardasil® (+61.6% to €66 million) and
pediatric vaccines. Year-to-date sales of Sanofi Pasteur MSD grew
5.9% to €602 million.
Sanofi Pasteur MSD announced plans to license and commercialize
an innovative 6-in-1 pediatric vaccine in its European territories.
The new hexavalent vaccine, developed by Sanofi Pasteur, is the
only fully liquid, ready to use 6-in-1 vaccine to protect infants
against diphtheria, tetanus, pertussis, Hepatitis B, poliomyelitis
and Haemophilus influenzae type b. The vaccine has been submitted
by Sanofi Pasteur MSD to the European Medicines Agency for license
within the European Union and upon approval the company will
commercialize it in its European territories under its own brand
name.
Animal Health
Third-quarter sales of Merial recorded a 3.8% increase to
€519 million, driven by Emerging Markets (+21.1% to €140 million).
Year-to-date sales of Merial reached €1,673 million, an increase of
2.0%.
Sales of the Companion Animals segment increased
3.1% to €330 million in the third quarter, supported by
double-digit-sales increase of Heartgard® in the U.S.
Despite good performance in Western
Europe (+7.9% to €42 million) and Emerging Markets (+23.8%
to €26 million), sales of the Frontline®/fipronil family
of products were down 3.5% to €178 million, impacted by competitive
pressure in the U.S. (-13.0% to €96 million). The launch of a new
combination parasiticide by Merial, Frontline® TRITAK,
at the beginning of September 2012
partially compensated the increased fipronil generic competition in
the U.S. Year-to-date sales of the companion animals segment
totaled €1,112 million, up 1.6%.
Merial has settled all its outstanding litigation with Velcera
during the third quarter. The infringement action filed by Merial
has been withdrawn as have the appeals filed by Velcera. The
injunction against sales of PetArmor® Plus remains in
effect and the generic product is not on the market.
Third-quarter sales of the Production Animals segment
were €189 million, up 5.1%, driven by the Veterinary Public Health
segment (+46.2%) and the Swine segment (+22.2%) which includes the
acquisition of Newport Laboratories in the U.S. completed in March.
The Veterinary Public Health segment benefited from sales of
Foot-and-Mouth vaccines following outbreaks of the disease in some
Emerging Markets. Year-to-date sales of the Production Animals
segment were €561 million, up 2.8%.
Net sales by geographic region
(millions
of euros)
|
Q3
2012
net sales
|
Change at
constant exchange rates
|
9-month
2012
net sales
|
Change at
constant exchange rates
|
United
States
|
2,998
|
-8.5%
|
8,393
|
+2.1%
|
Emerging Markets*
|
2,821
|
+6.8%
|
8,268
|
+8.8%
|
of which Eastern Europe and Turkey
|
667
|
+1.1%
|
1,994
|
+1.0%
|
of which Asia
|
751
|
+9.4%
|
2,132
|
+11.2%
|
of which Latin America
|
892
|
+11.3%
|
2,567
|
+13.2%
|
of which Africa
|
247
|
+2.9%
|
754
|
+7.2%
|
of which Middle East
|
231
|
+2.8%
|
725
|
+11.2%
|
Western
Europe**
|
2,045
|
-11.6%
|
6,406
|
-8.1%
|
Rest of
the world***
|
1,176
|
+6.5%
|
3,354
|
+1.7%
|
of which Japan
|
832
|
+14.2%
|
2,361
|
+5.2%
|
TOTAL
|
9,040
|
-3.1%
|
26,421
|
+1.2%
|
* World
less the U.S., Canada, Western Europe, Japan, Australia and New
Zealand
|
** France,
Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium,
Luxembourg, Portugal, Netherlands, Austria, Switzerland, Sweden,
Ireland, Finland,
Norway, Iceland, Denmark
|
*** Japan,
Canada, Australia and New Zealand
|
Emerging Markets sales reached €2,821 million, an
increase of 6.8% in the third quarter with double digit growth
recorded for Diabetes (+26.5%), Animal Health (+21.1%) and CHC
(+16.1%). BRIC (Brazil,
Russia, India and China) sales totaled €1,000 million, an
increase of 10.4%. Sales in China
reached €341 million, up 11.9%, which includes strong double digit
growth of Plavix®, Lantus® and
vaccines and weaker sales for the CHC business. Despite strong
growth of Lantus®, Lovenox® and
Animal Health, Brazil sales
increased 2.9% to €385 million, reflecting lower sales of Generics
and vaccines. Sales in Russia
increased 20.6% to €204 million, particularly driven by
Lantus®, Lovenox®,
Plavix® and vaccines. Year-to-date sales in
Emerging Markets totaled €8,268 million, up 8.8% (or 7.4% with
Genzyme proforma).
In October Sanofi announced that it has signed an agreement to
acquire Genfar S.A., a leading pharmaceuticals manufacturer
headquartered in Bogota, Colombia.
In 2011, Genfar's total sales were USD 133
million, with 30% of sales generated outside of Colombia. With this acquisition, Sanofi will
become a market leader in Colombia
and expand its portfolio of affordable pharmaceuticals in
Latin America. The closing of the
transaction is subject to certain conditions precedent and is
expected to occur in the first quarter of 2013.
Third quarter sales in the U.S. were €2,998 million, down
8.5% mainly reflecting the loss of exclusivity of
Eloxatin® (sales declined 74.7%) on August 9, 2012, and further generic competition
on Lovenox® (-63.2%). Sanofi delivered strong
growth of Lantus®, "new Genzyme" and Generics
this quarter. Year-to-date sales in the U.S. increased 2.1% to
€8,393 million (or down 2.5 % with Genzyme pro forma).
Third-quarter sales in Western
Europe decreased 11.6% to €2,045 million accounting for
22.6% of Group sales compared to 26.2% in the third quarter of
2011. Sales were impacted by the transfer of the
Copaxone® business to Teva, generic competition
to Taxotere®, Aprovel® and
Plavix®, as well as the impact of austerity
measures. Excluding the impact of Copaxone®,
sales in Western Europe declined
7.1%. Year-to-date sales in Western Europe decreased 8.1% (or 6.7% with
Genzyme pro forma and excluding Copaxone®) to €6,406
million.
Japan reported
third-quarter sales of €832 million, an increase of 14.2%, driven
by good performance from Plavix® and
Lantus®, and the inclusion of
Imovax® Polio vaccine in the country's public
immunization program on September
1st. Year-to-date sales in Japan increased 5.2% to €2,361 million (or
2.7% with Genzyme pro forma).
R&D update
Since the last R&D update on July 26,
2012, Sanofi has had favorable regulatory newsflow including
the approvals of Zaltrap®, Aubagio® and
Auvi-QTM in the U.S.; new indications obtained in
Japan for Plavix®; the
registration filing for a new hexavalent vaccine in Europe, and the Fluzone® QIV IM
filing in the U.S. In parallel, four new Phase III studies
evaluating the new formulation of insulin glargine started, and the
first positive Phase III trial results of the oral therapy for
Gaucher disease, eliglustat, were announced. Several compounds also
entered Phase I and Phase II.
At the end of October, the R&D portfolio comprises 65 NMEs
(New Molecular Entities) projects and vaccines in clinical
development of which 17 are in Phase III or have been submitted to
the health authorities for approval.
Regulatory update
Several regulatory milestones were achieved during the
period:
In August:
- The FDA approved Zaltrap® (ziv-aflibercept,
collaboration with Regeneron) for intravenous infusion, in
combination with 5-fluorouracil leucovorin irinotecan (FOLFIRI),
for patients with metastatic colorectal cancer that is resistant to
or has progressed following an oxaliplatin-containing regimen.
- The FDA approved Auvi-QTM (epinephrine
injection, USP) for the emergency treatment of life-threatening
allergic reactions in people who are at risk for or have a history
of anaphylaxis.
- The Japanese Ministry of Health, Labor and Welfare granted
approval for a Supplemental New Drug Application for
Plavix® for patient with ST-elevation myocardial
infarction. In September, the Japanese authorities granted
approval, for a Supplemental New Drug Application for
Plavix® for patients with Peripheral Arterial
Disease;
- A new hexavalent vaccine (the only fully liquid, ready to
use 6-in-1 vaccine to protect infants against diphtheria, tetanus,
pertussis, Hepatitis B, poliomyelitis and invasive infections
caused by Haemophilus influenzae type b), developed by Sanofi
Pasteur, has been submitted by Sanofi Pasteur MSD to the European
Medicines Agency for license within the European Union.
In September:
- The FDA approved Aubagio® (teriflunomide) a
new once-daily, oral treatment indicated for patients with
relapsing forms of multiple sclerosis.
- Fluzone® QIV IM, a quadrivalent
intramuscular flu Vaccine, was filed in the U.S.
In October:
- The Endocrinologic and Metabolic Drugs Advisory Committee of
the FDA recommended Kynamro™ (mipomersen sodium, partnership
with Isis Pharmaceuticals) for the treatment of patients with
Homozygous Familial Hypercholesterolemia.
In August, Genzyme received a Refuse to File letter from the FDA
in response to the supplemental Biologics License Application
(sBLA) for the approval of Lemtrada™ (alemtuzumab) as a treatment
for relapsing multiple sclerosis. After collaborative consultations
with the FDA, the agency requested that the company modify the
presentation of the data sets to enable the agency to better
navigate the application. The FDA has not requested additional data
or further studies. The refilling of Lemtrada™ is on track and we
will make an announcement when the FDA makes a decision concerning
the acceptance of the file.
Late stage portfolio
In October, top line data for ENGAGE, the first Phase III trial
of the oral therapy, eliglustat, was announced. This trial
which evaluated eliglustat, in previously untreated patients with
Gaucher disease type 1, met its primary endpoint. Patients treated
with eliglustat had a statistically significant reduction in spleen
size of 30% at nine months, compared with placebo. The initial
safety analysis from ENGAGE suggests that eliglustat was well
tolerated. Full results from the ENGAGE study are planned for
presentation at the Lysosomal Disease Network WORLD meeting in
February 2013. Top-line data from the
second Phase III registration trial, ENCORE, are expected in early
2013.
Four new Phase III trials evaluating the new formulation of
insulin glargine started in during quarter.
- The EDITION III trial, compares the new formulation of insulin
glargine with Lantus® in patients with Type 2 diabetes
on non-insulin antidiabetic therapy. The targeted number of
patients to enroll in this study is 800.
- The EDITION IV trial compares the new formulation of insulin
glargine with Lantus® in patients with Type 1 diabetes.
The targeted number of patients to enroll in this study is
500.
- The EDITION JPI & JPII trials compare the new formulation
of insulin glargine with Lantus® in Japanese patients
with Type 1 and Type 2 diabetes.
The implementation of these four new studies, in addition to
EDITION I and II trials, which started recruitment at the end of
2011, demonstrated full engagement of Sanofi in a large Phase III
program to evaluate the new glargine formulation.
The results of the international study of insulin and cancer,
ISICA, were presented at the EASD (European Association for the
Study of Diabetes) Congress on October 3,
2012. ISICA assessed the relative risk for breast cancer in
women with diabetes. No change in the background risk for breast
cancer was demonstrated for the users of insulin glargine.
Furthermore neither dose, nor duration of treatment altered such
neutral effect of insulin glargine.
Detailed results from the pivotal Phase III VELOUR study
evaluating Zaltrap® injection for intravenous
infusion for the treatment of patients with previously treated
metastatic colorectal cancer were published in the October 2012 edition of the Journal of Clinical
Oncology. In this trial evaluating metastatic, patients previously
treated with an oxaliplatin-containing regimen, Zaltrap®
in combination with the FOLFIRI chemotherapy regimen
(5-fluorouracil, leucovorin, irinotecan) showed a statistically
significant improvement in overall survival, progression-free
survival, and the overall tumor response rate versus placebo plus
FOLFIRI.
The global phase III program of sarilumab (collaboration
with Regeneron, the first fully-human subcutaneously administered
monoclonal antibody targeting the interleukin-6 receptor with high
affinity) in rheumatoid arthritis (RA) is moving forward with two
pivotal efficacy and safety trials, Saril-RA-Mobility and
Saril-RA-Target. The Saril-RA-Mobility is now fully enrolled
(N=1197) and will evaluate sarilumab in combination with
methotrexate in adult moderate-to-severe active RA patients with an
inadequate response to methotrexate. The SARIL-RA- Mobility results
are anticipated in 2014. The Saril-RA-Target trial will evaluate
sarilumab in combination with non-biologic, disease-modifying
anti-rheumatic drugs in adult moderate-to-severe active RA
patients with inadequate response to, or intolerant of, one or
more TNF-alpha (tumor necrosis factor alpha) inhibitors. In
addition, a long-term safety study of sarilumab, Saril-RA Extend,
is open for patients who complete the ongoing studies. Additional
phase III studies will be announced in 2013.
In September, the JAKARTA Phase
III study of SAR302503, an
investigational JAK2 inhibitor for the treatment of myelofibrosis,
completed patient enrollment.
Recruitment of the Phase III evaluating
Synvisc-One™ for the treatment of pain in
osteoarthritis of the hip has started.
In September, the detailed results of the Phase IIb study
conducted in Thailand evaluating
the Dengue vaccine candidate were published in the online
publication in The Lancet. The results show the ability of
the vaccine candidate to protect against dengue fever caused by
three dengue virus types. The full analysis of vaccine efficacy
against each serotype, reflecting real-life conditions showed
vaccine efficacy to be 61.2% against dengue virus type 1, 81.9%
against type 3 and 90.0% against type 4. One of the dengue virus
types (serotype 2) eluded the vaccine. Analyses are ongoing to
understand the lack of protection for serotype 2 in the particular
epidemiological context of Thailand. The results of the world's first
efficacy study confirm the excellent safety profile of Sanofi
Pasteur's dengue vaccine candidate. Large-scale phase III clinical
studies of Sanofi Pasteur's dengue vaccine candidate are underway
with 31,000 children and adolescents in 10 countries in
Asia and Latin America. These studies will generate
important additional data in a broader population and in a variety
of epidemiological settings to define the best conditions to set up
vaccination programs in order to protect people at risk of
dengue.
One project in Phase II (FOV2304 –a bradykinin B1 antagonist
evaluated in diabetic macular edema) has been discontinued. Based
on the review of Phase IIb results for FOV-1101 (a FDC
prednisolone/cyclosporine), which led to a reassessment of the
commercial perspectives for this compound, Sanofi has made the
decision to continue the development of FOV1101 under a sublicense
agreement to be entered into with an outside party still to be
identified. It has also been decided not to pursue the development
of SAR245409 (oral dual inhibitor of
PI3K & mTOR) in breast cancer, but to focus its development in
Non-Hodgkin Lymphoma (Phase II).
Early stage portfolio
Two project entered Phase II
- SAR156597, an
interleukin-4/interleukin13 bi-specific monoclonal antibody for
Idiopathic Pulmonary Fibrosis;
- SAR339658, a monoclonal antibody
- anti-VLA2 for the treatment of Ulcerative Colitis.
Three compounds entered Phase I:
- SAR260301, a PI3K beta selective
inhibitor, in oncology;
- SAR113244, a monoclonal antibody
anti-CXCR5, in Systemic Lupus Erythematosus (SLE);
- GZ402671, a GCS inhibitor for the treatment of Fabry
disease.
Third-quarter and first nine months 2012 financial
results
Business Net Income1
Sanofi generated third-quarter net sales of €9,040
million, up 3.3% on a reported basis (-3.1% at constant exchange
rates), reflecting the performance of growth platforms, impact from
EU austerity measures, loss of €448 million of sales (at constant
exchange rates) due to generic competition and a favorable currency
effect. Year-to-date sales were €26,421 million, an increase of
6.2% on a reported basis (+1.2% at constant exchange rates), also
reflecting the consolidation of Genzyme from April 2011 and the loss of €846 million of sales
due to generic competition.
Other revenues decreased 52.3% (or down 55.1% at constant
exchange rates) to €200 million in the third quarter due to the
loss of exclusivity of Plavix® and
Avapro® in the U.S. on May
17 and March 30, respectively.
In the third quarter, other revenues included €45 million
representing most of the one-time payment of $80 million paid by Bristol-Myers Squibb in
relation to the Avalide® supply disruption in the U.S.
in 2011. In the first nine months of 2012, other revenues were down
30.4% (or down 34.0% at constant exchange rates) to €873
million.
Third-quarter Gross profit was €6,359 million, a decrease
of 0.9% (or a decrease of 8.1% at constant exchange rates). The
ratio of cost of sales to net sales was 31.9%, an increase of 0.4
percentage points versus the third quarter of 2011 mainly
reflecting the negative evolution of the product mix partially
offset by industrial productivity and currency effect. Year-to-date
gross profit totaled €19,070 million, up 3.5% (or down 2.3% at
constant exchange rates). In the first nine months of 2012, the
ratio of cost of sales to net sales was 31.1%, 0.2 percentage
points higher than in the same period of 2011.
Third-quarter Research and Development expenses decreased
5.9% to €1,149 million. Despite the investment in late-stage
portfolio, R&D expenses decreased 10.7% at constant exchange
rates reflecting good internal cost management, ongoing
transforming initiatives and a reimbursement from the SPMSD
joint-venture related to a new hexavalent vaccine. The ratio of
R&D expenses to net sales reached 12.7%, versus 13.9% in the
third quarter of 2011. Year-to-date R&D expenses were €3,564
million, up 1.3% (or down 6.0% with Genzyme proforma and at
constant exchange rates). Year-to-date ratio of R&D expenses to
net sales was 13.5%, down 0.6 percentage points versus the same
period of 2012
Selling and general expenses reached €2,183 million in
the third quarter, an increase of 3.3%. At constant exchange rates,
SG&A decreased 2.7% driven by a 4.1% reduction in general
expenses reflecting tight cost control and synergies derived from
the Genzyme integration. Despite continued investment in growth
platforms and launch costs for Zaltrap® and
Aubagio®, marketing expenses also decreased at constant
exchange rate. The ratio of selling and general expenses to net
sales was 24.1%, 0.1 percentage points lower than the third quarter
of 2011. Year-to-date SG&A expenses were €6,593 million, up
4.4% (or -4.0% with Genzyme proforma and at constant exchange
rates). The year-to-date ratio of selling and general expenses to
net sales was 25.0%, versus 25.4% in the same period of 2011.
Other current operating income net of expenses was an
income of €67 million in the third quarter versus an income of €40
million in the third quarter of 2011. In the first nine months of
2012, other current operating income net of expenses was an income
of €62 million compared to an income of €63 million in the same
period of 2011. This line included a settlement of a license
litigation booked in the first quarter, and an additional pre-tax
reserve of €118 million linked to Ramipril litigation in
Canada in the second quarter.
The share of profits from associates dropped 97.8% to €6
million in the third quarter due to the loss of exclusivity of
Plavix® and Avapro® in the U.S.
The share of after-tax profits from the territories managed by BMS
under the Plavix® and Avapro® alliance was €9
million versus €264 million in the third quarter of 2011.
Year-to-date profits from associates were €425 million, down 49.8%
(or down 52.1% at constant exchange rates), and were attributed to
BMS alliance.
Non-controlling interests were €39 million in the third
quarter, down 27.8%, reflecting lower profits paid to BMS from
territories managed by Sanofi (€34 million versus €51 million in Q3
2011) as a result of generic competition in Europe. Year-to-date, non-controlling
interests were €143 million, down 24.7%.
1 See Appendix 8 for definitions of financial
indicators, and Appendix 6 for reconciliation of business net
income to consolidated net income attributable to equity holders of
Sanofi
Business operating income was €3,061 million in the third
quarter, down 8.5% (or down 16.7% at constant exchange rates). The
ratio of business operating income to net sales was 33.9%, 4.3
percentage points lower than the same period of 2011.Year-to-date
business operating income decreased 0.6% (or decreased 7.4% at
constant exchange rates) to €9,257 million. The ratio of business
operating income to net sales was 35.0%, down 2.4 percentage points
compared to the same period of 2011.
Net financial expenses reached €84 million, compared to
€121 million in the third quarter of 2011. This line included a
capital gain linked to the divestment of the stake in the Yves
Rocher Group. Year-to-date net financial expenses were €311 million
versus €299 million in the same period of 2011 which included the
financing of the Genzyme acquisition only for two quarters.
The effective tax rate was 25.1% compared to 27.5% in the
third quarter of 2011. Following agreement with Japanese tax
authorities, the Group has revised its forecast effective tax rate
for 2012 from 28% to 27%. Year-to-date effective tax rate was 27.0%
compared to 27.5% in the same period of 2011.
Business net income1 reached €2,221
million in the third quarter, down 7.4% (or down 15.9% at constant
exchange rates). Year-to-date business net
income1 was €6,607 million, down 1.7% (or down
8.6% at constant exchange rates).
In the
third quarter of 2012, Business earnings per
share1 (EPS) was €1.68, down 6.1% and 14.5%
on a reported basis and at constant exchange rates, respectively.
The average number of shares outstanding was 1,318.4 million this
quarter versus 1,339.4 million in the third quarter of
2011.
|
|
Year-to-date Business earnings per
share1 (EPS) was €5.01, down 1.6% and 8.4% on
a reported basis and at constant exchange rates, respectively. The
average number of shares outstanding was 1,319.0 million in the
first nine months of 2012 versus 1,318.9 million in the first nine
months of 2011.
|
From business net income to consolidated net income (see
Appendix 6)
In the first nine months of 2012, the main reconciling items
between business net income and consolidated net income
attributable to equity holders of Sanofi were:
- A €2,491 million amortization charge related to fair value
remeasurement on intangible asset of acquired companies
(primarily Aventis: €1,131 million, Genzyme: €735 million and
Merial €297 million) and to acquired intangible assets
(licenses/products: €102 million). The third quarter amortization
charge related to fair value remeasurement on intangible asset was
€816 million (primarily Aventis: €361 million, Genzyme €248 million
and Merial €101 million, €29 million of which related to acquired
intangible assets (licenses/products)). This item has no cash
impact on the Group.
- An impairment loss (net of reversals related to intangible
assets) against intangible assets of €28 million (of which a
reversal of €12 million in Q3 2012 related to a product in
launching phase). This item has no cash impact on the Group.
- A charge of €192 million mainly reflecting an increase in the
fair value of contingent considerations related to the CVRs
(€121 million, of which €65 million in Q3 2012) and Bayer
contingent considerations (€51 million, of which €12 million in Q3
2012).
- A charge of €20 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.
- €307 million of restructuring costs (including €57 million in
the third quarter related Industrial Affairs in Europe and commercial operations).
- A €1,008 million tax effect arising from the items listed
above, comprising €892 million generated by amortization charged
against intangible assets and €94 million associated with
restructuring costs. The third quarter tax effect was €294 million,
including €277 million of deferred taxes generated by amortization
charged against intangible assets and €17 million linked to
restructuring costs (see Appendix 6).
1 See Appendix 8 for definitions of financial
indicators, and Appendix 6 for reconciliation of business net
income to consolidated net income attributable to equity holders of
Sanofi
- In "Share of profits/losses from associates", a charge of €22
million, net of tax, mainly relating to the share of amortization
of intangible assets (of which €7 million in Q3 2012). This item
has no cash impact on the Group.
Net Debt
Year-to-date net cash generated by operating activities after
changes in working capital, after capital expenditures (€991
million), and before restructuring costs was €5,812 million, a
decrease of 10.7% compared to the same period of 2011. This amount
covered dividend paid by Sanofi (€3,487 million), repurchasing of
shares (€825 million), acquisitions and partnerships (€348 million)
and restructuring costs (€635 million). Over the period, disposals
accounted for €286 million (especially the stake in Yves Rocher). As a consequence, net debt
decreased from €10,859 million at December
31, 2011 to €9,304 million at the end of the third quarter
2012 (debt of €14,164 million, net of €4,860 million cash and cash
equivalents).
Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words "expects", "anticipates", "believes", "intends",
"estimates", "plans" and similar expressions. Although Sanofi's
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
the Group's ability to benefit from external growth opportunities,
trends in exchange rates and prevailing interest rates, the impact
of cost containment policies and subsequent changes thereto, the
average number of shares outstanding as well as those discussed or
identified in the public filings with the SEC and the AMF made by
Sanofi, including those listed under "Risk Factors" and "Cautionary
Statement Regarding Forward-Looking Statements" in Sanofi's annual
report on Form 20-F for the year ended December 31, 2011. 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:
|
2012
third-quarter and 2012 9-month consolidated net sales by
product
|
Appendix
2:
|
2012
third-quarter and 2012 9-month consolidated net sales by geographic
region and product
|
Appendix
3:
|
Consolidated net sales by business segment
|
Appendix
4:
|
Net sales
of Growth Platforms
|
Appendix
5:
|
2012
third-quarter and 2012 9-month business net income
statement
|
Appendix
6:
|
Reconciliation of business net income to net income
attributable to equity holders of Sanofi
|
Appendix
7:
|
2012
third-quarter and 2012 9-month consolidated income
statement
|
Appendix
8:
|
Definitions of non-GAAP financial
indicators
|
Appendix 1: 2012 third-quarter and 9-month consolidated
net sales by product
(€
million)
|
Q3
2012
net
sales
|
Change at constant exchange
rates
|
Change on a reported
basis
|
|
|
|
|
|
|
|
|
Lantus®
|
1,279
|
20.7%
|
32.1%
|
Apidra®
|
57
|
1.9%
|
7.5%
|
Amaryl®
|
106
|
-7.5%
|
0.0%
|
Insuman®
|
34
|
6.3%
|
6.3%
|
Total
Diabetes
|
1,486
|
17.5%
|
28.0%
|
Taxotere®
|
129
|
-36.0%
|
-30.6%
|
Eloxatin®
|
129
|
-62.9%
|
-58.4%
|
Jevtana®
|
56
|
17.8%
|
24.4%
|
Other Oncology
|
171
|
7.0%
|
20.4%
|
Total
Oncology
|
485
|
-35.7%
|
-29.0%
|
Lovenox®
|
437
|
-14.0%
|
-11.5%
|
Plavix®
|
505
|
-10.4%
|
-2.3%
|
Aprovel®
|
298
|
-8.3%
|
-5.1%
|
Allegra®
|
110
|
-1.9%
|
6.8%
|
Stilnox®/Ambien®/Ambien CR®/Myslee®
|
126
|
-5.0%
|
4.1%
|
Copaxone®
|
0
|
-100.0%
|
-100.0%
|
Depakine®
|
105
|
9.9%
|
15.4%
|
Tritace®
|
83
|
-11.8%
|
-10.8%
|
Multaq®
|
65
|
-9.1%
|
-1.5%
|
Xatral®
|
32
|
-8.8%
|
-5.9%
|
Actonel®
|
32
|
-17.9%
|
-17.9%
|
Nasacort®
|
15
|
0.0%
|
7.1%
|
Renagel®/ Renvela®
|
164
|
12.6%
|
21.5%
|
Synvisc®/ Synvisc-oneTM
|
89
|
0.0%
|
12.7%
|
Cerezyme®
|
163
|
9.9%
|
15.6%
|
Myozyme®
|
116
|
8.9%
|
14.9%
|
Fabrazyme®
|
87
|
146.9%
|
171.9%
|
Other Rare Diseases products
|
104
|
12.8%
|
20.9%
|
New
Genzyme
|
470
|
22.5%
|
30.6%
|
Other Rx Drugs
|
1,326
|
-11.5%
|
-8.2%
|
Consumer Health Care
|
733
|
5.9%
|
10.2%
|
Generics
|
479
|
14.9%
|
16.8%
|
Total Pharmaceuticals
|
7,040
|
-4.3%
|
1.4%
|
Vaccines
|
1,481
|
0.7%
|
10.3%
|
Animal Health
|
519
|
3.8%
|
10.4%
|
Total
|
9,040
|
-3.1%
|
3.3%
|
|
|
Vaccines
|
(€
million)
|
Q3 2012
net sales
|
Change at constant exchange
rates
|
Change on a reported basis
|
Polio/Pertussis/Hib Vaccines
|
320
|
16.0%
|
25,0%
|
Influenza Vaccines
|
608
|
-8.0%
|
1.0%
|
Meningitis/Pneumonia Vaccines
|
230
|
-3.3%
|
8.5%
|
Adult Booster Vaccines
|
140
|
4.9%
|
14.8%
|
Travel and Other Endemics Vaccines
|
83
|
-20.4%
|
-15.3%
|
Other Vaccines
|
100
|
69.8%
|
88.7%
|
Total
|
1,481
|
0.7%
|
10.3%
|
|
|
Animal
Health
|
(€
million)
|
Q3
2012 net
sales
|
Change at constant
exchange rates
|
Change on a reported basis
|
Frontline® and other fipronil
products
|
178
|
-3.5%
|
2.9%
|
Vaccines
|
172
|
12.2%
|
17.0%
|
Avermectin
|
109
|
14.8%
|
23.9%
|
Others
|
60
|
-11.3%
|
-3.2%
|
Total
|
519
|
3.8%
|
10.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
(€
million)
|
9-month
2012
net sales
|
Change at constant exchange
rates
|
Change on a reported basis
|
|
|
|
|
|
|
|
|
Lantus®
|
3,625
|
18.1%
|
26.7%
|
Apidra®
|
165
|
1.9%
|
6.5%
|
Amaryl®
|
319
|
-6.8%
|
-1.2%
|
Insuman®
|
99
|
4.2%
|
3.1%
|
Total
Diabetes
|
4,233
|
15.2%
|
23.0%
|
Taxotere®
|
438
|
-46.6%
|
-43.3%
|
Eloxatin®
|
888
|
10.1%
|
19.0%
|
Jevtana®
|
175
|
18.4%
|
24.1%
|
Other Oncology
|
476
|
46.8%
|
58.1%
|
Total
Oncology
|
1,977
|
-6.0%
|
0.9%
|
Lovenox®
|
1,452
|
-11.7%
|
-10.0%
|
Plavix®
|
1,563
|
-4.0%
|
3.4%
|
Aprovel®
|
939
|
-6.7%
|
-3.9%
|
Allegra®
|
418
|
-11.2%
|
-4.6%
|
Stilnox®/Ambien®/Ambien CR®/Myslee®
|
380
|
-0.6%
|
7.6%
|
Copaxone®
|
24
|
-93.4%
|
-93.1%
|
Depakine®
|
307
|
4.2%
|
7.0%
|
Tritace®
|
263
|
-8.4%
|
-8.4%
|
Multaq®
|
192
|
-9.1%
|
-2.5%
|
Xatral®
|
101
|
-39.9%
|
-38.0%
|
Actonel®
|
104
|
-21.5%
|
-20.0%
|
Nasacort®
|
53
|
-42.0%
|
-39.8%
|
Renagel®/ Renvela®
|
476
|
-
|
-
|
Synvisc®/ Synvisc-oneTM
|
273
|
-
|
-
|
Cerezyme®
|
462
|
-
|
-
|
Myozyme®
|
341
|
-
|
-
|
Fabrazyme®
|
208
|
-
|
-
|
Other Rare Diseases products
|
293
|
-
|
-
|
New
Genzyme
|
1,304
|
-
|
-
|
Other Rx Drugs
|
4,146
|
-8.7%
|
-6.2%
|
Consumer Health Care
|
2,276
|
9.5%
|
12.6%
|
Generics
|
1,386
|
9.7%
|
10.2%
|
Total Pharmaceuticals
|
21,867
|
1.2%
|
5.8%
|
Vaccines
|
2,881
|
1.1%
|
8.7%
|
Animal Health
|
1,673
|
2.0%
|
7.2%
|
Total
|
26,421
|
1.2%
|
6.2%
|
|
|
Vaccines
|
(€
million)
|
9-month
2012 net sales
|
Change at constant exchange
rates
|
Change on a reported basis
|
Polio/Pertussis/Hib Vaccines
|
838
|
5.2%
|
11.7%
|
Influenza Vaccines
|
777
|
-5.1%
|
2.2%
|
Meningitis/Pneumonia Vaccines
|
432
|
-0.5%
|
9.4%
|
Adult Booster Vaccines
|
373
|
5.2%
|
13.7%
|
Travel and Other Endemics Vaccines
|
260
|
-7.4%
|
-3.3%
|
Other Vaccines
|
201
|
22.8%
|
34.9%
|
Total
|
2,881
|
1.1%
|
8.7%
|
|
|
Animal
Health
|
(€
million)
|
9-month
2012
net
sales
|
Change at constant exchange
rates
|
Change on a reported basis
|
Frontline® and other fipronil
products
|
646
|
-3.5%
|
2.2%
|
Vaccines
|
517
|
6.1%
|
9.5%
|
Avermectin
|
330
|
8.0%
|
15.4%
|
Others
|
180
|
0.6%
|
5.9%
|
Total
|
1,673
|
2.0%
|
7.2%
|
Appendix 2: 2012 third-quarter and 9-month consolidated
net sales by geographic region and product
Third-quarter 2012
Pharmaceuticals
Q3 2012
net sales (€ million)
|
Western
Europe
|
Change at CER
|
United
States
|
Change at CER
|
Emerging Markets
|
Change at CER
|
Rest of
the World
|
Change at CER
|
|
|
|
|
Lantus®
|
197
|
6.6%
|
800
|
22.1%
|
204
|
31.5%
|
78
|
22.8%
|
|
Apidra®
|
19
|
11.8%
|
17
|
-25.0%
|
13
|
18.2%
|
8
|
40.0%
|
|
Amaryl®
|
6
|
-25.0%
|
1
|
-100.0%
|
68
|
14.3%
|
31
|
-31.7%
|
|
Insuman®
|
25
|
-3.8%
|
1
|
-
|
9
|
28.6%
|
-1
|
-100.0%
|
|
Total
Diabetes
|
255
|
7.2%
|
820
|
20.6%
|
294
|
26.5%
|
117
|
2.9%
|
|
Taxotere®
|
12
|
-70.7%
|
10
|
-70.4%
|
61
|
-23.0%
|
46
|
-4.5%
|
|
Eloxatin®
|
2
|
-71.4%
|
72
|
-74.7%
|
37
|
-16.7%
|
18
|
0.0%
|
|
Jevtana®
|
21
|
46.7%
|
26
|
-7.7%
|
8
|
100.0%
|
1
|
-
|
|
Other
Oncology
|
32
|
0.0%
|
99
|
10.3%
|
28
|
30.0%
|
12
|
-33.3%
|
|
Total
Oncology
|
67
|
-28.4%
|
207
|
-52.1%
|
134
|
-10.0%
|
77
|
-9.7%
|
|
Lovenox®
|
201
|
0.0%
|
55
|
-63.2%
|
154
|
10.9%
|
27
|
0.0%
|
|
Plavix®
|
65
|
-37.1%
|
4*
|
-93.0%
|
210
|
8.0%
|
226
|
13.4%
|
|
Aprovel®
|
143
|
-20.6%
|
11*
|
-26.7%
|
95
|
-1.1%
|
49
|
51.6%
|
|
Allegra®
|
3
|
-33.3%
|
0
|
-100.0%
|
30
|
15.4%
|
77
|
-8.0%
|
|
Stilnox®/Ambien®/Ambien CR®/Myslee®
|
12
|
-15.4%
|
24
|
0.0%
|
17
|
-5.9%
|
73
|
-4.3%
|
|
Copaxone®
|
0
|
-100.0%
|
0
|
-
|
0
|
-
|
0
|
-100.0%
|
|
Depakine®
|
36
|
-2.8%
|
0
|
-
|
65
|
17.0%
|
4
|
50.0%
|
|
Tritace®
|
35
|
-16.7%
|
0
|
-
|
44
|
-2.3%
|
4
|
-42.9%
|
|
Multaq®
|
12
|
-29.4%
|
51
|
-2.2%
|
2
|
-50.0%
|
0
|
100.0%
|
|
Xatral®
|
10
|
-28.6%
|
5
|
25.0%
|
17
|
7.1%
|
0
|
-50.0%
|
|
Actonel®
|
8
|
-38.5%
|
0
|
-
|
16
|
-15.8%
|
8
|
14.3%
|
|
Nasacort®
|
4
|
0.0%
|
4
|
-25.0%
|
6
|
0.0%
|
1
|
100.0%
|
|
Renagel®/ and Renvela®
|
29
|
-6.5%
|
115
|
17.2%
|
16
|
33.3%
|
4
|
0.0%
|
|
Synvisc®/ Synvisc-oneTM
|
4
|
0.0%
|
74
|
0.0%
|
6
|
25.0%
|
5
|
-20.0%
|
|
Cerezyme®
|
54
|
20.5%
|
45
|
-2.4%
|
46
|
7.0%
|
18
|
23.1%
|
|
Myozyme®
|
64
|
12.5%
|
30
|
0.0%
|
14
|
8.3%
|
8
|
14.3%
|
|
Fabrazyme®
|
14
|
100.0%
|
44
|
290.0%
|
15
|
180.0%
|
14
|
20.0%
|
|
Other Rare Diseases products
|
23
|
21.1%
|
33
|
3.6%
|
21
|
16.7%
|
27
|
14.3%
|
|
New
Genzyme
|
155
|
21.4%
|
152
|
27.6%
|
96
|
20.5%
|
67
|
17.6%
|
|
Other Rx Drugs
|
490
|
-14.6%
|
139
|
-24.7%
|
507
|
-4.0%
|
190
|
-10.9%
|
|
Consumer Health Care
|
151
|
-0.7%
|
140
|
-3.1%
|
374
|
16.1%
|
68
|
-10.3%
|
|
Generics
|
138
|
23.6%
|
70
|
110.3%
|
262
|
0.8%
|
9
|
14.3%
|
|
Total
Pharma
|
1,818
|
-12.4%
|
1,871
|
-9.9%
|
2,345
|
6.3%
|
1,006
|
0.4%
|
|
*Sales of
active ingredient to the American entity managed by BMS
|
|
|
Vaccines
|
Q3 2012
net sales (€
million)
|
Western
Europe
|
Change at CER
|
United
States
|
Change at CER
|
Emerging Markets
|
Change at CER
|
Rest of
the World
|
Change at CER
|
Polio/Pertussis/Hib Vaccines
|
14
|
18.2%
|
69
|
-45.0%
|
139
|
32.7%
|
98
|
169.7%
|
Influenza Vaccines
|
74
|
-5.1%
|
428
|
-8.3%
|
102
|
-8.3%
|
4
|
-20.0%
|
Meningitis/Pneumonia Vaccines
|
2
|
100.0%
|
197
|
0.6%
|
27
|
-20.6%
|
4
|
-50.0%
|
Adult Booster Vaccines
|
14
|
7.7%
|
111
|
2.0%
|
10
|
28.6%
|
5
|
25.0%
|
Travel and Other Endemics Vaccines
|
3
|
-57.1%
|
15
|
-53.6%
|
54
|
-3.6%
|
11
|
12.5%
|
Other Vaccines
|
2
|
-60.0%
|
88
|
92.5%
|
4
|
-25.0%
|
6
|
100.0%
|
Total vaccines
|
109
|
-6.1%
|
908
|
-6.9%
|
336
|
5.2%
|
128
|
101.7%
|
|
|
Animal
Health
|
Q3 2012
net sales (€ million)
|
Western
Europe
|
Change at CER
|
United
States
|
Change at CER
|
Emerging Markets
|
Change at CER
|
Rest of
the World
|
Change at CER
|
|
|
|
|
Frontline® and other fipronil
products
|
42
|
7.9%
|
96
|
-13.0%
|
26
|
23.8%
|
14
|
-7.1%
|
|
Vaccines
|
42
|
-2.4%
|
40
|
6.1%
|
85
|
23.9%
|
5
|
20.0%
|
|
Avermectin
|
12
|
-23.5%
|
60
|
32.5%
|
19
|
18.8%
|
18
|
6.7%
|
|
Others
|
22
|
-4.8%
|
23
|
-25.0%
|
10
|
0.0%
|
5
|
33.3%
|
|
Total
|
118
|
-2.5%
|
219
|
-2.5%
|
140
|
21.1%
|
42
|
5.4%
|
|
|
|
|
|
|
|
9-month
2012
|
|
|
|
|
|
Pharmaceuticals
|
|
|
9-month
2012 net sales (€ million)
|
Western
Europe
|
Change at CER
|
United
States
|
Change at CER
|
Emerging Markets
|
Change at CER
|
Rest of
the World
|
Change at CER
|
|
|
|
|
Lantus®
|
580
|
5.3%
|
2,244
|
19.4%
|
583
|
27.9%
|
218
|
21.3%
|
|
Apidra®
|
59
|
5.4%
|
49
|
-17.0%
|
37
|
15.6%
|
20
|
28.6%
|
|
Amaryl®
|
22
|
-12.0%
|
3
|
-33.3%
|
198
|
11.8%
|
96
|
-30.4%
|
|
Insuman®
|
73
|
-3.9%
|
1
|
-
|
26
|
23.8%
|
-1
|
-200.0%
|
|
Total
Diabetes
|
755
|
5.8%
|
2,300
|
18.4%
|
844
|
23.1%
|
334
|
1.3%
|
|
Taxotere®
|
44
|
-73.5%
|
47
|
-81.7%
|
208
|
-12.6%
|
139
|
-15.0%
|
|
Eloxatin®
|
11
|
-64.5%
|
706
|
18.9%
|
118
|
-7.4%
|
53
|
2.1%
|
|
Jevtana®
|
65
|
150.0%
|
86
|
-26.2%
|
23
|
187.5%
|
1
|
-
|
|
Other
Oncology
|
105
|
38.7%
|
268
|
49.4%
|
71
|
58.1%
|
32
|
33.3%
|
|
Total
Oncology
|
225
|
-24.8%
|
1,107
|
-3.1%
|
420
|
0.5%
|
225
|
-6.5%
|
|
Lovenox®
|
645
|
3.7%
|
264
|
-52.8%
|
466
|
13.9%
|
77
|
4.3%
|
|
Plavix®
|
245
|
-24.4%
|
76*
|
-54.0%
|
603
|
6.7%
|
639
|
14.1%
|
|
Aprovel®
|
482
|
-16.5%
|
37*
|
-2.6%
|
299
|
1.4%
|
121
|
30.7%
|
|
Allegra®
|
10
|
-18.2%
|
-1
|
-125.0%
|
91
|
23.0%
|
318
|
-16.9%
|
|
Stilnox®/Ambien®/Ambien CR®/Myslee®
|
36
|
-12.5%
|
64
|
-9.4%
|
53
|
10.4%
|
227
|
2.0%
|
|
Copaxone®
|
19
|
-94.3%
|
0
|
-
|
0
|
-
|
5
|
-75.0%
|
|
Depakine®
|
107
|
-2.8%
|
0
|
-
|
188
|
8.9%
|
12
|
-0.0%
|
|
Tritace®
|
115
|
-11.5%
|
0
|
-
|
137
|
-0.7%
|
11
|
-44.4%
|
|
Multaq®
|
35
|
-31.4%
|
150
|
0.0%
|
6
|
0.0%
|
1
|
-50.0%
|
|
Xatral®
|
35
|
-22.2%
|
17
|
-76.8%
|
47
|
-2.2%
|
2
|
-33.3%
|
|
Actonel®
|
26
|
-39.5%
|
0
|
-
|
52
|
-14.8%
|
26
|
-7.7%
|
|
Nasacort®
|
15
|
-21.1%
|
15
|
-73.5%
|
20
|
11.8%
|
3
|
33.3%
|
|
Renagel®/ and Renvela®
|
95
|
-
|
28
|
-
|
37
|
-
|
16
|
-
|
|
Synvisc®/ Synvisc-oneTM
|
14
|
-
|
227
|
-
|
17
|
-
|
15
|
-
|
|
Cerezyme®
|
160
|
-
|
124
|
-
|
130
|
-
|
48
|
-
|
|
Myozyme®
|
189
|
-
|
88
|
-
|
40
|
-
|
24
|
-
|
|
Fabrazyme®
|
35
|
-
|
106
|
-
|
33
|
-
|
34
|
-
|
|
Other Rare Diseases products
|
69
|
-
|
94
|
-
|
59
|
-
|
71
|
-
|
|
New
Genzyme
|
453
|
-
|
412
|
-
|
262
|
-
|
177
|
-
|
|
Other Rx Drugs
|
1,622
|
-11.5%
|
424
|
-16.2%
|
1,541
|
-1.8%
|
559
|
-12.6%
|
|
Consumer Health Care
|
506
|
2.0%
|
480
|
-0.7%
|
1,098
|
21.4%
|
192
|
-3.8%
|
|
Generics
|
362
|
6.2%
|
211
|
102.1%
|
791
|
1.1%
|
22
|
-20.0%
|
|
Total
Pharma
|
5,802
|
-8.6%
|
6,111
|
4.0%
|
6,972
|
9.2%
|
2,982
|
-0.3%
|
|
*Sales of
active ingredient to the American entity managed by BMS
|
|
|
Vaccines
|
9-month
2012 net sales (€ million)
|
Western
Europe
|
Change at CER
|
United
States
|
Change at CER
|
Emerging Markets
|
Change at CER
|
Rest of
the World
|
Change at CER
|
|
|
|
|
Polio/Pertussis/Hib Vaccines
|
40
|
39.3%
|
279
|
-20.3%
|
359
|
10.8%
|
160
|
68.6%
|
|
Influenza Vaccines
|
74
|
-5.1%
|
434
|
-6.8%
|
252
|
-2.7%
|
17
|
0.0%
|
|
Meningitis/Pneumonia Vaccines
|
4
|
100.0%
|
333
|
-2.0%
|
89
|
7.4%
|
6
|
-44.4%
|
|
Adult Booster Vaccines
|
48
|
-12.7%
|
277
|
4.6%
|
32
|
63.2%
|
16
|
7.1%
|
|
Travel and Other Endemics Vaccines
|
15
|
-16.7%
|
68
|
-11.6%
|
144
|
-6.5%
|
33
|
3.4%
|
|
Other Vaccines
|
7
|
-36.4%
|
167
|
30.2%
|
13
|
0.0%
|
14
|
30.0%
|
|
Total
|
188
|
-2.6%
|
1,558
|
-4.2%
|
889
|
4.2%
|
246
|
36.6%
|
|
|
|
|
|
|
|
Animal
Health
|
|
|
9-month
2012 net sales (€ million)
|
Western
Europe
|
Change at
CER
|
United
States
|
Change at
CER
|
Emerging Markets
|
Change at CER
|
Rest of
the
World
|
Change at
CER
|
|
|
|
|
Frontline® and other fipronil
products
|
180
|
1.1%
|
358
|
-7.6%
|
69
|
11.3%
|
39
|
-10.3%
|
|
Vaccines
|
130
|
-8.5%
|
111
|
8.6%
|
261
|
13.2%
|
15
|
27.3%
|
|
Avermectin
|
42
|
-10.6%
|
185
|
15.8%
|
47
|
9.3%
|
56
|
2.0%
|
|
Others
|
64
|
-3.1%
|
70
|
0.0%
|
30
|
14.8%
|
16
|
-6.3%
|
|
Total
|
416
|
-4.0%
|
724
|
0.6%
|
407
|
12.5%
|
126
|
-0.9%
|
|
Appendix 3: Consolidated net sales by business
segment
Millions of euros
|
Q3
2012
|
Q3
2011
|
9-month
2012
|
9-month
2011
|
Pharmaceuticals
|
7,040
|
6,940
|
21,867
|
20,670
|
Vaccines
|
1,481
|
1,343
|
2,881
|
2,651
|
Merial
|
519
|
470
|
1,673
|
1,560
|
Total
|
9,040
|
8,753
|
26,421
|
24,881
|
Appendix 4: Net sales of Growth Platforms
Net sales of Growth
Platforms
(€
million)
|
Q3
2012
net
sales
|
Change at
constant
exchange rates
|
9-month
2012
net
sales
|
Change at
constant
exchange rates
|
Emerging
Markets1/2
|
2,821
|
+6.8%
|
8,268
|
+8.8%
|
Emerging Markets excluding
Diabetes, Vaccines, CHC,
animal health, new Genzyme
and Innovative Products
|
1,569
|
+0.3%
|
4,734
|
+2.4%
|
Diabetes
|
1,486
|
+17.5%
|
4,233
|
+15.2%
|
Vaccines
|
1,481
|
+0.7%
|
2,881
|
+1.1%
|
Consumer Health Care (CHC)
|
733
|
+5.9%
|
2,276
|
+9.5%
|
Animal
Health
|
519
|
+3.8%
|
1,673
|
+2.0%
|
New
Genzyme
|
470
|
+22.5%
|
1,304
|
15.0%3
|
Innovative
products4
|
154
|
+7.6%
|
445
|
+6.1%
|
Total
Growth Platforms
|
6,412
|
+6.4%
|
17,546
|
+9.3%
|
Total
Growth Platforms with Genzyme pro forma
|
6,412
|
+6.4%
|
17,546
|
+6.6%
|
1
|
World
excluding the U.S. and Canada, Western Europe, Japan, Australia and
New Zealand.
|
2
|
Includes
Diabetes, Vaccines, Consumer Health Care, new Genzyme, Animal
Health and new products sales generated in Emerging
Markets;
|
3
|
"new
Genzyme" on a constant structure basis and at constant exchange
rates;
|
4
|
Includes
recent product launches which do not belong to the other Growth
Platforms listed above: Multaq® and
Jevtana®, Zaltrap®, and Mozobil®
pro forma
|
Appendix 5: Business net income statement
Third
quarter 2012
|
Pharmaceuticals
|
Vaccines
|
Animal
health
|
Other
|
Group Total
|
Millions of euros
|
Q3
2012
|
Q3 2011
|
% change
|
Q3
2012
|
Q3 2011
|
%
change
|
Q3
2012
|
Q3 2011
|
% change
|
Q3
2012
|
Q3 2011
|
Q3
2012
|
Q3 2011
|
% change
|
Net
sales
|
7,040
|
6,940
|
1.4%
|
1,481
|
1,343
|
10.3%
|
519
|
470
|
10.4%
|
|
|
9,040
|
8,753
|
3.3%
|
Other revenues
|
184
|
406
|
(54.7%)
|
7
|
8
|
(12.5%)
|
9
|
5
|
80.0%
|
|
|
200
|
419
|
(52.3%)
|
Cost of sales
|
(2,133)
|
(2,094)
|
1.9%
|
(578)
|
(502)
|
15.1%
|
(170)
|
(159)
|
6.9%
|
|
|
(2,881)
|
(2,755)
|
4.6%
|
As % of net sales
|
(30.3%)
|
(30.2%)
|
|
(39.1%)
|
(37.4%)
|
|
(32.7%)
|
(33.9%)
|
|
|
|
(31.9%)
|
(31.5%)
|
|
Gross
profit
|
5,091
|
5,252
|
(3.1%)
|
910
|
849
|
7.2%
|
358
|
316
|
13.3%
|
|
|
6,359
|
6,417
|
(0.9%)
|
As %
of net sales
|
72.3%
|
75.7%
|
|
61.4%
|
63.2%
|
|
69.0%
|
67.2%
|
|
|
|
70.3%
|
73.3%
|
|
Research and
development expenses
|
(1,016)
|
(1,031)
|
(1.5%)
|
(97)
|
(154)
|
(37.0%)
|
(36)
|
(36)
|
0.0%
|
|
|
(1,149)
|
(1,221)
|
(5.9%)
|
As % of net sales
|
(14.4%)
|
(14.9%)
|
|
(6.5%)
|
(11.5%)
|
|
(6.9%)
|
(7.7%)
|
|
|
|
(12.7%)
|
(13.9%)
|
|
Selling and general
expenses
|
(1,874)
|
(1,827)
|
2.6%
|
(153)
|
(140)
|
9.3%
|
(156)
|
(147)
|
6.1%
|
|
|
(2,183)
|
(2,114)
|
3.3%
|
As % of net sales
|
(26.6%)
|
(26.3%)
|
|
(10.3%)
|
(10.4%)
|
|
(30.1%)
|
(31.2%)
|
|
|
|
(24.1%)
|
(24.2%)
|
|
Other current operating
income/expenses
|
58
|
(1)
|
|
(2)
|
2
|
|
7
|
(4)
|
|
4
|
43
|
67
|
40
|
|
Share of profit/loss of
associates*
|
10
|
269
|
|
(4)
|
7
|
|
|
|
|
|
|
6
|
276
|
|
Net income
attributable to
non-controlling interests
|
(39)
|
(55)
|
|
|
|
|
|
1
|
|
|
|
(39)
|
(54)
|
|
Business operating income
|
2,230
|
2,607
|
(14.5%)
|
654
|
564
|
16.0%
|
173
|
130
|
33.1%
|
4
|
43
|
3,061
|
3,344
|
(8.5%)
|
As %
of net sales
|
31.7%
|
37.6%
|
|
44.2%
|
42.0%
|
|
33.3%
|
27.7%
|
|
|
|
33.9%
|
38.2%
|
|
Financial income and
expenses
|
|
|
|
|
|
|
|
|
|
|
|
(84)
|
(121)
|
|
Income tax expense
|
|
|
|
|
|
|
|
|
|
|
|
(756)
|
(825)
|
|
Tax rate**
|
|
|
|
|
|
|
|
|
|
|
|
25.1%
|
27.5%
|
|
Business net income
|
|
|
|
|
|
|
|
|
|
|
|
2,221
|
2,398
|
(7.4%)
|
As %
of net sales
|
|
|
|
|
|
|
|
|
|
|
|
24.6%
|
27.4%
|
|
Business earnings per
share*** (in euros)
|
|
|
|
|
|
|
|
|
|
|
|
1.68
|
1.79
|
(6.1%)
|
|
|
*
|
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 1,318.4 million in the
third quarter of 2012 and 1,339.4 million in the third quarter of
2011
|
Nine
months 2012
|
Pharmaceuticals
|
Vaccines
|
Animal
health
|
Other
|
Group Total
|
Millions of euros
|
9M
2012
|
9M
2011
|
% change
|
9M
2012
|
9M
2011
|
%
change
|
9M
2012
|
9M
2011
|
% change
|
9M
2012
|
9M
2011
|
9M
2012
|
9M
2011
|
% change
|
Net
sales
|
21,867
|
20,670
|
5.8%
|
2,881
|
2,651
|
8.7%
|
1,673
|
1,560
|
7.2%
|
|
|
26,421
|
24,881
|
6.2%
|
Other revenues
|
829
|
1,222
|
(32.2%)
|
17
|
18
|
(5.6%)
|
27
|
14
|
92.9%
|
|
|
873
|
1,254
|
(30.4%)
|
Cost of sales
|
(6,564)
|
(6,167)
|
6.4%
|
(1,144)
|
(1,052)
|
8.7%
|
(516)
|
(486)
|
6.2%
|
|
|
(8,224)
|
(7,705)
|
6.7%
|
As % of net sales
|
(30.0%)
|
(29.8%)
|
|
(39.7%)
|
(39.7%)
|
|
(30.8%)
|
(31.2%)
|
|
|
|
(31.1%)
|
(30.9%)
|
|
Gross
profit
|
16,132
|
15,725
|
2.6%
|
1,754
|
1,617
|
8.5%
|
1,184
|
1,088
|
8.8%
|
|
|
19,070
|
18,430
|
3.5%
|
As %
of net sales
|
73.8%
|
76.1%
|
|
60.9%
|
61.0%
|
|
70.8%
|
69.7%
|
|
|
|
72.2%
|
74.1%
|
|
Research and
development expenses
|
(3,067)
|
(2,994)
|
2.4%
|
(381)
|
(418)
|
(8.9%)
|
(116)
|
(106)
|
9.4%
|
|
|
(3,564)
|
(3,518)
|
1.3%
|
As % of net sales
|
(14.0%)
|
(14.5%)
|
|
(13.2%)
|
(15.8%)
|
|
(6.9%)
|
(6.8%)
|
|
|
|
(13.5%)
|
(14.1%)
|
|
Selling and general
expenses
|
(5,637)
|
(5,441)
|
3.6%
|
(441)
|
(404)
|
9.2%
|
(514)
|
(469)
|
9.6%
|
(1)
|
(1)
|
(6,593)
|
(6,315)
|
4.4%
|
As % of net sales
|
(25.8%)
|
(26.3%)
|
|
(15.3%)
|
(15.2%)
|
|
(30.7%)
|
(30.1%)
|
|
|
|
(25.0%)
|
(25.4%)
|
|
Other current operating
income/expenses
|
37
|
41
|
|
(3)
|
1
|
|
8
|
(11)
|
|
20
|
32
|
62
|
63
|
|
Share of profit/loss of
associates*
|
435
|
828
|
|
(10)
|
5
|
|
|
|
|
|
13
|
425
|
846
|
|
Net income
attributable to
non-controlling interests
|
(143)
|
(191)
|
|
|
|
|
|
1
|
|
|
|
(143)
|
(190)
|
|
Business operating
income
|
7,757
|
7,968
|
(2.6%)
|
919
|
801
|
14.7%
|
562
|
503
|
11.7%
|
19
|
44
|
9,257
|
9,316
|
(0.6%)
|
As %
of net sales
|
35.5%
|
38.5%
|
|
31.9%
|
30.2%
|
|
33.6%
|
32.2%
|
|
|
|
35.0%
|
37.4%
|
|
Financial income and
expenses
|
|
|
|
|
|
|
|
|
|
|
|
(311)
|
(299)
|
|
Income tax expense
|
|
|
|
|
|
|
|
|
|
|
|
(2,339)
|
(2,299)
|
|
Tax rate**
|
|
|
|
|
|
|
|
|
|
|
|
27.0%
|
27.5%
|
|
Business net income
|
|
|
|
|
|
|
|
|
|
|
|
6,607
|
6,718
|
(1.7%)
|
As %
of net sales
|
|
|
|
|
|
|
|
|
|
|
|
25.0%
|
27.0%
|
|
Business earnings per
share*** (in euros)
|
|
|
|
|
|
|
|
|
|
|
|
5.01
|
5.09
|
(1.6%)
|
|
|
*
|
Net of
tax
|
**
|
Determined
on the basis of Business income before tax, associates, and
non-controlling interests
|
***
|
Based on
an average number of shares outstanding of 1,319 million in the
first nine months of 2012 and 1,318.9 million in the first nine
months of 2011
|
Appendix 6: Reconciliation of Business net income to Net
income attributable to equity holders of sanofi
Millions of euros
|
Q3
2012
|
Q3
2011
|
%
change
|
Business net income
|
2,221
|
2,398
|
(7.4%)
|
Amortization of intangible
assets(1)
|
(816)
|
(804)
|
|
Impairment
of intangible assets
|
12
|
(7)
|
|
Fair value
remeasurement of contingent
consideration liabilities
|
(86)
|
233
|
|
Expenses
arising from the impact of acquisitions on
inventories
|
(3)
|
(140)
|
|
Restructuring costs
|
(57)
|
(70)
|
|
Other
gains and losses, and litigation
|
|
|
|
Tax effect
of items listed above:
|
294
|
427
|
|
Amortization of intangible
assets
|
277
|
354
|
|
Impairment of intangible
assets
|
(4)
|
2
|
|
Fair value remeasurement of
contingent
consideration
liabilities
|
3
|
5
|
|
Expenses arising on the workdown of
acquired
inventories
|
1
|
42
|
|
Restructuring costs
|
17
|
24
|
|
Other gains and
losses, and litigation
|
|
|
|
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
|
(7)
|
(7)
|
|
Net
income attributable to equity holders of sanofi
|
1,559
|
2,030
|
(23.2%)
|
Consolidated earnings per share(2)
(in euros)
|
1.18
|
1.52
|
(22.4%)
|
(1)
|
Of which
related to amortization expense generated by the remeasurement of
intangible assets as part of business combinations: € 787
million in the third quarter of 2012 and € 760 million in the third
quarter of 2011.
|
(2)
|
Based on
an average number of shares outstanding of 1,318.4 million in the
third quarter of 2012 and 1,339.4 million in the third quarter
of 2011.
|
See previous "From business net income to consolidated net
income (see Appendix 6)" section for comments on the reconciliation
of business net income to consolidated net income.
Millions of euros
|
9M
2012
|
9M
2011
|
%
change
|
Business net income
|
6,607
|
6,718
|
(1.7%)
|
Amortization of intangible
assets(1)
|
(2,491)
|
(2,505)
|
|
Impairment
of intangible assets
|
(28)
|
(76)
|
|
Fair value
remeasurement of contingent
consideration liabilities
|
(192)
|
167
|
|
Expenses
arising from the impact of acquisitions on
inventories
|
(20)
|
(404)
|
|
Restructuring costs
|
(307)
|
(537)
|
|
Other
gains and losses, and litigation
|
|
(517)
|
|
Tax effect
of items listed above:
|
1,008
|
1,429
|
|
Amortization of intangible
assets
|
892
|
913
|
|
Impairment of intangible
assets
|
10
|
22
|
|
Fair value remeasurement of
contingent
consideration
liabilities
|
6
|
10
|
|
Expenses arising on the workdown of
acquired
inventories
|
6
|
120
|
|
Restructuring costs
|
94
|
174
|
|
Other gains and
losses, and litigation
|
|
190
|
|
Share of
items listed above attributable to non-controlling
interests
|
2
|
|
|
Restructuring costs of associates and joint
ventures,
and
expenses arising from the impact of acquisitions
on
associates and joint ventures
|
(22)
|
(21)
|
|
Net
income attributable to equity holders of sanofi
|
4,557
|
4,254
|
7.1%
|
Consolidated earnings per share(2)
(in euros)
|
3.45
|
3.23
|
6.8%
|
|
|
(1)
|
Of which
related to amortization expense generated by the remeasurement of
intangible assets as part of business combinations: € 2,389 million
in the first nine months of 2012 and € 2,367 million in the first
nine months of 2011.
|
(2)
|
Based on
an average number of shares outstanding of 1,319 million in the
first nine months of 2012 and 1,318.9 million in the
first nine months of 2011.
|
Appendix 7: Consolidated income statements
Millions of euros
|
Q3
2012
|
Q3
2011
|
9M
2012
|
9M
2011
|
Net
sales
|
9,040
|
8,753
|
26,421
|
24,881
|
Other revenues
|
200
|
419
|
873
|
1,254
|
Cost of sales
|
(2,884)
|
(2,895)
|
(8,244)
|
(8,109)
|
Gross
profit
|
6,356
|
6,277
|
19,050
|
18,026
|
Research and development
expenses
|
(1,149)
|
(1,221)
|
(3,564)
|
(3,518)
|
Selling and general expenses
|
(2,183)
|
(2,114)
|
(6,593)
|
(6,315)
|
Other operating income
|
117
|
90
|
436
|
281
|
Other operating expenses
|
(50)
|
(50)
|
(374)
|
(218)
|
Amortization of intangible assets
|
(816)
|
(804)
|
(2,491)
|
(2,505)
|
Impairment of intangible assets
|
12
|
(7)
|
(28)
|
(76)
|
Fair value remeasurement of
contingent consideration liabilities
|
(86)
|
233
|
(192)
|
167
|
Restructuring costs
|
(57)
|
(70)
|
(307)
|
(537)
|
Other gains and losses, and litigation
|
|
|
|
(517)
|
Operating income
|
2,144
|
2,334
|
5,937
|
4,788
|
Financial expenses
|
(135)
|
(153)
|
(407)
|
(387)
|
Financial income
|
51
|
32
|
96
|
88
|
Income
before tax and associates
and
joint ventures
|
2,060
|
2,213
|
5,626
|
4,489
|
Income tax expenses
|
(462)
|
(398)
|
(1,331)
|
(870)
|
Share of profit/loss of associates and
joint ventures
|
(1)
|
269
|
403
|
825
|
Net
income
|
1,597
|
2,084
|
4,698
|
4,444
|
Net income attributable to non-
controlling interests
|
38
|
54
|
141
|
190
|
Net
income attributable to equity
holders
of sanofi
|
1,559
|
2,030
|
4,557
|
4,254
|
Average
number of shares outstanding
(million)
|
1,318.4
|
1,339.4
|
1,319.0
|
1,318.9
|
Earnings per share (in euros)
|
1.18
|
1.52
|
3.45
|
3.23
|
Appendix 8: Definitions of non-GAAP financial
indicators
Net sales at constant exchange rates
When we refer to changes in our net sales "at constant exchange
rates", this means that we exclude the effect of changes in
exchange rates.
We eliminate the effect of exchange rates by recalculating net
sales for the relevant period at the exchange rates used for the
previous period.
Reconciliation of reported net sales to net sales at constant
exchange rates for the third quarter and the first half of
2011
(millions
of euros)
|
Q3
2012
|
9-month
2012
|
Net
sales
|
9,040
|
26,421
|
Effect of
exchange rates
|
(561)
|
(1,234)
|
Net
sales at constant exchange rates
|
8,479
|
25,187
|
Net sales on a constant structure basis
We eliminate the effect of changes in structure by restating
prior-period net sales as follows:
- by including sales from the acquired entity or product rights
for a portion of the prior period equal to the portion of the
current period during which we owned them, based on sales
information we receive from the party from whom we make the
acquisition;
- similarly, by excluding sales in the relevant portion of the
prior period when we have sold an entity or rights to a
product;
- for a change in consolidation method, by recalculating the
prior period on the basis of the method used for the current
period.
Worldwide presence of
Plavix®/Iscover®,
Avapro®/Aprovel®
When we refer to the "worldwide presence" of a product, we mean
our consolidated net sales of that product, minus sales of the
product to our alliance partners plus non-consolidated sales made
through our alliances with Bristol-Myers Squibb on
Plavix®/Iscover® (clopidogrel bisulfate) and
Aprovel®/Avapro®/Karvea®
(irbesartan), based on information provided to us by our alliance
partner.
Business net income
Sanofi publishes a key non-GAAP indicator. This indicator
"Business net income", replaced "adjusted net income excluding
selected items".
Business net income is defined as net income attributable to
equity holders of Sanofi excluding:
- amortization of intangible assets,
- impairment of intangible assets,
- fair value remeasurement of contingent consideration
liabilities related to business combinations,
- other impacts associated with acquisitions (including impacts
of acquisitions on associates),
- restructuring costs *,
- other gains and losses (including gains and losses on disposals
of non-current assets*),
- costs or provisions associated with litigation*,
- tax effects related to the items listed above as well as
effects of major tax disputes,
*Reported in the line items Restructuring costs and
Gains and losses on disposals, and litigation, which are
defined in Note B.20. to our consolidated financial statements.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers,
develops and distributes therapeutic solutions focused on patients'
needs. Sanofi has core strengths in the field of healthcare with
seven growth platforms: diabetes solutions, human vaccines,
innovative drugs, rare diseases, consumer healthcare, emerging
markets, animal health and the new Genzyme. Sanofi is listed in
Paris (EURONEXT: SAN) and in
New York (NYSE: SNY).
Sanofi is the holding company of a consolidated group of
subsidiaries and operates in the United
States as Sanofi US. For more information on Sanofi US,
please visit http://www.sanofi.us or call 1-800-981-2491.
Sanofi US is also on Twitter and Facebook. Visit us at
https://twitter.com/SanofiUS and
http://www.facebook.com/sanofiUS.
SOURCE Sanofi