Sanofi Announces Q2 2016 Results
(Thomson Reuters ONE) -
Paris, July 29, 2016
Sanofi Announces Q2 2016 Results
Q2 2016 Change Change (CER) H1 2016 Change Change (CER)
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IFRS net sales ?8,143m -5.1% -0.9% ?15,926m -4.2% -0.8%
reported
IFRS net income ?1,158m -11.1% ?2,245m -3.4%
reported
IFRS EPS reported ?0.90 -10.0% ?1.74 -2.2%
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Aggregate Company ?8,868m -4.3% -0.2% ?17,411m -3.2% +0.2%
sales((1))
Business net ?1,680m -8.7% -3.3% ?3,402m -4.6% 0.0%
income((2))
Business EPS((2)) ?1.31 -7.1% -2.1% ?2.64 -3.3% +1.5%
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Following the announcement of exclusive negotiations with Boehringer Ingelheim
and as per the IFRS 5 presentation requirement for discontinued operations, net
income for Sanofi's Animal Health business (Merial) will be reported on a
separate line ("Net income from the held for exchange Animal Health Business")
in the Consolidated Income Statement for Q2 2016 and for H1 2016, and the prior
year. Until the closing of the transaction, Sanofi will continue to manage and
report the performance of the Animal Health business, which will remain an
operating segment consistent with IFRS 8 and be included in the key performance
indicators of the Company.
+------------------------------------------------------------------------------+
|Second quarter financial results and 2016 guidance confirmed |
| * Aggregate Company sales((1)) decreased 0.2%((3)) (down 4.3% at 2016 |
| exchange rates) to ?8,868 million. Excluding Venezuela, Aggregate Company |
| sales grew 1.9% |
| * IFRS EPS reported was down 10.0% to ?0.90 |
| * Business EPS((2)) was down 2.1% at CER to ?1.31 and down 7.1% on a |
| reported basis |
| * Sanofi continues to expect 2016 Business EPS((2)) to be broadly |
| stable((4)) at CER, barring unforeseen major adverse events |
|Performance of Global Business Units (GBU) led by Sanofi Genzyme |
| * Strong double-digit growth of Sanofi Genzyme (+20.1%) across multiple |
| sclerosis and rare disease franchises |
| * Sanofi Pasteur sales increased +6.3%, despite anticipated supply |
| constraints of Pentacel(®) in the U.S. |
| * General Medicines & Emerging Markets((5)) sales declined 5.6%, or down |
| 1.9% excluding Venezuela. |
| * Diabetes and Cardiovascular sales were down 3.5%. Global diabetes |
| franchise sales declined 3.2% |
| * Animal Health sales were up 9.1% to ?725 million, driven by the success of|
| the NexGard(®) family of products |
| * Aggregate sales in Emerging Markets grew 6.7% excluding Venezuela |
|Major launches update |
| * Toujeo(®) generated worldwide sales of ?141 million |
| * Praluent(®) launch advancing globally with approval in Japan and market |
| share improvement in the U.S. |
| * Dengvaxia(® )uptake delayed by recent political changes and economic |
| volatility in Latin America |
|Key R&D milestones achieved |
| * Positive CHRONOS data for dupilumab in atopic dermatitis |
| * Adlyxin(TM) (lixisenatide) approved in the U.S. |
| * FDA Advisory Committee recommended approval of LixiLan |
+------------------------------------------------------------------------------+
Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"Our second quarter financial performance was in-line with expectations and
reflected anticipated headwinds. Sanofi Genzyme grew 20% and Sanofi Pasteur
performed well despite a delay in Dengvaxia® uptake. Recent highlights
included the signing of the CHC asset swap, the approval of Praluent® in
several countries and positive Phase III CHRONOS data for dupilumab. Following
our first half performance, we confirm our broadly stable 2016 Business EPS
guidance at CER."
(1) Including Merial (see Appendix 10 for definition of Aggregate Company sales)
which is reported on a single line in the consolidated income statements in
accordance with IFRS 5 (Non-current assets held for sale and discontinued
operations). Additionally, Sanofi comments include Merial for every income
statement line using the term "Aggregate"; (2) In order to facilitate an
understanding of operational performance, Sanofi comments on the business net
income statement. Business net income is a non-GAAP financial measure (see
Appendix 10 for definitions). The consolidated income statement for Q2 2016 and
H1 2016 is provided in Appendix 4 and a reconciliation of business net income to
IFRS net income reported is set forth in Appendix 3; (3) Percentage changes in
net sales and Aggregate sales are expressed at constant exchange rates (CER)
unless otherwise indicated (see Appendix 10); (4) 2015 Business EPS was
?5.64;(5) See page 8
Investor Relations: (+) 33 1 53 77 45 45 - E-mail: IR(at)sanofi.com - Media
Relations: (+) 33 1 53 77 46 46 - E-mail: MR(at)sanofi.com
Web site: www.sanofi.com Mobile app: SANOFI IR available on the App Store and
Google Play
2016 second-quarter and first-half Aggregate Sanofi sales
Unless otherwise indicated, all percentage changes in sales in this press
release are stated at CER((7)).
In the second quarter of 2016, Aggregate Company sales were ?8,868 million, down
4.3% at 2016 exchange rates. Exchange rate movements had a negative effect of
4.1 percentage points with the adverse evolution of the U.S. dollar as well as
several emerging market currencies more than offsetting the positive effects
from the Japanese Yen. At CER, Aggregate Company sales decreased 0.2%. First-
half Aggregate Company sales reached ?17,411 million, down 3.2% at 2016 exchange
rates. Exchange rate movements had an unfavorable effect of 3.4 percentage
points.
This performance included a negative currency impact related to the change of
exchange rate applied for the translation of Venezuela operations, resulting
from the evolution of the exchange system in February 2016 as well as from the
persistent inability to exchange Venezuelan bolivars for U.S. dollars at the
privileged official rate((8)). In addition, in the second quarter of 2015,
Sanofi benefited from a significant increase in product demand in Venezuela, due
to buying patterns associated with local market conditions. As a consequence,
sales in Venezuela were ?6 million in the second quarter of 2016 compared to
?199 million in the second quarter of 2015. Excluding Venezuela, Aggregate
Company sales increased 1.9% and 2.5% in the second quarter and in the first
half of 2016, respectively.
Global Business Units
The table below presents sales by Global Business Units (GBU) and reflects the
organization of the Sanofi which became effective as of January 1, 2016. In this
organizational structure, all Pharmaceutical sales in Emerging Markets are now
included in the General Medicines and Emerging Markets GBU. This new reporting
structure simplifies Sanofi, deepens specialization and allows clear focus on
growth drivers.
Net Sales by GBU Q2 2016 Change H1 2016 Change
(? million) (CER) (CER)
------------------------------------------------------------- -----------
Sanofi Genzyme (Specialty Care)((a)) 1,245 +20.1% 2,414 +20.3%
Diabetes & Cardiovascular((a)) 1,603 -3.5% 3,102 -4.6%
General Medicines & Emerging 4,498 -5.6%((c)) 8,988 -4.9%((d))
Markets((b))
Sanofi Pasteur (Vaccines) 797 +6.3%((e)) 1,422 +7.1%((f))
Merial (Animal Health) 725 +9.1% 1,485 +13.2%
Total Aggregate Company sales 8,868 -0.2%((g)) 17,411 +0.2%((h))
(a) Does not include Emerging Markets sales- see definition page 8; (b) Includes
Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care; (c)
Excluding Venezuela:-1.9%; (d) Excluding Venezuela: -1.1%; (e) Excluding
Venezuela:+7.0%; (f) Excluding Venezuela: +7.8%; (g) Excluding Venezuela:+1.9%;
(h) Excluding Venezuela: +2.5%.
Global Franchises
The table below presents sales by global franchises. The performance by
franchise provides a bridge to our previous reporting methodology and allows
straightforward peer comparisons. Appendix 1 provides a reconciliation of sales
by GBU and by franchise.
Net sales by Change Developed Change Emerging Change
Franchise Q2 2016 (CER) Markets (CER) Markets (CER)
(? million)
------------------------------------------ ---------------------
Specialty Care 1,493 +19.5%((a)) 1,245 +20.1% 248 +16.8%((b))
Diabetes & 1,962 -2.0%((c)) 1,603 -3.5% 359 +4.7%((d))
Cardiovascular
Established Products 2,617 -9.7%((e)) 1,676 -10.9% 941 -7.7%((f))
Consumer Healthcare 800 -4.3%((g)) 511 +2.1% 289 -13.0%((h))
(CHC)
Generics 474 -1.9%((i)) 271 -5.5% 203 +2.6%((j))
Vaccines 797 +6.3%((k)) 463 +3.8% 334 +9.8%((l))
Animal Health 725 +9.1% 565 +7.3% 160 +15.6%
Total Aggregate net 8,868 -0.2%((m)) 6,334 0.0% 2,534 -0.5%((n))
sales
(a) Excluding Venezuela : +20.3%; (b) Excluding Venezuela : +21.1%; (c)
Excluding Venezuela : -0.9%; (d) Excluding Venezuela : +11.4%; (e) Excluding
Venezuela :
-6.6%; (f) Excluding Venezuela: +1.5%; (g) Excluding Venezuela: +0.6%; (h)
Excluding Venezuela:-1.8%; (i) Excluding Venezuela: +0.4%; (j) Excluding
Venezuela: +8.2%; (k) Excluding Venezuela: +7.0%; (l) Excluding Venezuela:
+11.5%; (m) Excluding Venezuela: +1.9%; (n) Excluding Venezuela: +6.7%.
(7) See Appendix 10 for definitions of financial indicators. (8) In Q2 2016, the
exchange rate used was the DICOM rate (628VEF per USD) versus the privileged
official CENCOEX rate of 6.3VEF per USD in Q2 2015.
The table below presents sales for global franchise for the first half of 2016.
Net sales by Change Developed Change Emerging Change
Franchise H1 2016 (CER) Markets (CER) Markets (CER)
(? million)
------------------------------------------ ---------------------
Specialty Care 2,864 +19.0%((a)) 2,414 +20.3% 450 +13.3%((b))
Diabetes & 3,794 -2.8%((c)) 3,102 -4.6% 692 +5.6%((d))
Cardiovascular
Established Products 5,208 -9.0%((e)) 3,343 -11.2% 1,865 -5.1%((f))
Consumer Healthcare 1,705 -3.6%((g)) 1,105 +1.8% 600 -11.4%((h))
(CHC)
Generics 933 +0.6%((i)) 553 0.0% 380 +1.4%((j))
Vaccines 1,422 +7.1%((k)) 810 -1.7% 612 +20.7%((l))
Animal Health 1,485 +13.2% 1,177 +10.1% 308 +25.2%
Total Aggregate net 17,411 +0.2%((m)) 12,504 -0.4% 4,907 +1.7%((n))
sales
(a) Excluding Venezuela : +19.7%; (b) Excluding Venezuela : +17.3%; (c)
Excluding Venezuela : -1.8%; (d) Excluding Venezuela : +11.8%; (e) Excluding
Venezuela :
-5.7%; (f) Excluding Venezuela : +4.9%; (g) Excluding Venezuela: +1.5%; (h)
Excluding Venezuela: +1.0%; (i) Excluding Venezuela: +3.3%; (j) Excluding
Venezuela: +7.7%; (k) Excluding Venezuela: +7.8%; (l) Excluding Venezuela:
+22.7%; (m) Excluding Venezuela: +2.5%; (n) Excluding Venezuela: +9.7%.
Pharmaceuticals
Second-quarter sales for Pharmaceuticals were down 1.7% to ?7,346 million
impacted by a decrease in Diabetes, CHC and Established Rx Products sales that
was partially offset by the Multiple Sclerosis and Rare Disease franchises.
Excluding Venezuela, second-quarter sales for Pharmaceuticals were up 0.8%.
First-half sales for Pharmaceuticals decreased 1.5% to ?14,504 million.
Excluding Venezuela, first-half sales for Pharmaceuticals increased 1.0%.
Rare Diseases franchise
Net sales (? million) Q2 2016 Change H1 2016 Change
(CER) (CER)
Cerezyme(®) 199 +8.0%((a)) 381 +5.9%((b))
Myozyme(® )/ Lumizyme(®) 182 +13.9% 348 +11.2%
Fabrazyme(®) 167 +17.8% 316 +12.2%
Aldurazyme(®) 50 +6.0% 98 +5.1%
Cerdelga(®) 26 +62.5% 49 +88.5%
Total Rare Diseases 707 +14.2%((c)) 1,353 +11.4%((d))
(a) Excluding Venezuela: +9.2%; (b) Excluding Venezuela: +7.9%; (c) Excluding
Venezuela: +15.5%; (d) Excluding Venezuela: +12.7%;
In the second quarter, Gaucher (Cerezyme(®) and Cerdelga(®)) sales increased
12.1% to ?225 million, sustained by Cerezyme(®) in Emerging Markets (up 27.3% to
?70 million) and the increasing contribution of Cerdelga(®) (?26 million versus
?16 million in the second quarter of 2015). In the U.S., second-quarter sales of
the Gaucher franchise increased 4.7% to ?65 million reflecting declining
Cerezyme(®) sales (?45 million, down 4.1%) which were more than offset by
increasing Cerdelga(®) sales (?20 million, up 33.3%). In Europe, where
Cerdelga(®) is now available in Germany, France, Denmark, and Nordic countries,
sales of the Gaucher franchise were ?76 million, up 5.5%. In the first-half,
Gaucher sales were up 11.1% to ?430 million. First half sales of Cerezyme(®) and
Cerdelga(®) increased 5.9% (to ?381 million) and 88.5% to ?49 million,
respectively.
Sales of Fabrazyme(®) were up 17.8% to ?167 million in the second quarter driven
by the U.S. (up 14.5% to ?85 million), Europe (up 14.3% to ?40 million), Japan
and Emerging Markets (up 23.5% to ?16 million). First-half sales of Fabrazyme(®)
increased 12.2% to ?316 million.
Second-quarter sales of Myozyme(®)/Lumizyme(®) increased 13.9% to ?182 million,
driven by the U.S. (up 15.7% to ?58 million) and Europe (up 11.7% to ?84
million). In Emerging Markets, sales were up 7.1% to ?26 million. First-half
sales of Myozyme(®)/Lumizyme(®) increased 11.2% to ?348 million.
Multiple Sclerosis franchise
Net sales (? million) Q2 2016 Change H1 2016 Change
(CER) (CER)
Aubagio(®) 315 +58.3% 594 +61.0%
Lemtrada(®) 108 +100.0% 196 +113.8%
Total Multiple Sclerosis 423 +67.3% 790 +71.6%
In the second quarter, sales of Aubagio(®) increased 58.3% to ?315 million
driven by the U.S. (up 55.6% to ?216 million) and Europe (up 68.8% to ?80
million). First-half sales of Aubagio(®) increased 61.0% to ?594 million.
Second-quarter sales of Lemtrada(®) were ?108 million (versus ?56 million in the
second quarter of 2015), including ?56 million in the U.S. (up 96.6%), and ?40
million in Europe (versus ?21 million in the second quarter of 2015), mainly in
the UK and Germany. First-half sales of Lemtrada(®) were ?196 million (versus
?94 million in the first half of 2015).
Oncology franchise
Net sales (? million) Q2 2016 Change H1 2016 Change
(CER) (CER)
Jevtana(®) 88 +8.5% 178 +12.6%
Thymoglobulin(®) 69 +4.3% 134 +10.5%
Taxotere(®) 46 -21.0% 92 -16.5%
Eloxatin(®) 44 -15.8% 86 -17.1%
Mozobil(®) 37 +11.4% 72 +7.2%
Zaltrap(®) 17 -15.0% 34 -15.0%
Total Oncology 363 -3.6% 721 -1.2%
Second-quarter Oncology sales were ?363 million, down 3.6% due to lower sales of
Taxotere(®) and Eloxatin(®). First-half sales of Oncology were ?721 million,
down 1.2%.
Sales of Jevtana(®) (cabazitaxel) increased 8.5% to ?88 million in the second
quarter led by the U.S. (up 12.1% to ?37 million) and Japan. First-half sales of
Jevtana(®) were up 12.6% to ?178 million.
Second-quarter Thymoglobulin(®) sales increased 4.3% to ?69 million supported by
the U.S. performance (up 7.9% to ?39 million). First-half sales of
Thymoglobulin(®) increased 10.5% to ?134 million.
Second-quarter sales of Eloxatin(® )were down 15.8% to ?44 million reflecting
generic competition in Canada more than offsetting the performance in China.
Over the same period, sales of Taxotere(®) (docetaxel) decreased 21.0% (to ?46
million), impacted by generic competition especially in Japan more than
offsetting the performance in China. First-half sales of Taxotere(®) and
Eloxatin(®) were down 16.5% (?92 million) and down 17.1% (?86 million),
respectively.
Diabetes franchise
Net sales (? million) Q2 2016 Change H1 2016 Change
(CER) (CER)
Lantus(®) 1,465 -11.2% 2,860 -11.1%
Toujeo(®) 141 ns 244 ns
Total glargine 1,606 -3.5% 3,104 -4.3%
Amaryl(®) 93 -9.2% 181 -7.3%
Apidra(®) 93 +3.2% 178 0.0%
Insuman(®) 34 +8.8% 66 +4.5%
BGM (Blood Glucose Monitoring) 17 +6.3% 34 +6.3%
Lyxumia(®) 8 -10.0% 17 0.0%
Total Diabetes 1,857 -3.2%((a)) 3,591 -3.8%((b))
(a) Excluding Venezuela: -2.0%; (b) Excluding Venezuela:-2.8%
In the second quarter, Diabetes franchise sales were down 3.2% to ?1,857
million, reflecting lower sales of Lantus(®) in the U.S. Second-quarter U.S.
Diabetes sales were down 7.1% to ?1,033 million. Outside the U.S., sales were
?824 million, an increase of 2.0% driven by Emerging Markets (up 5.0% to ?358
million; excluding Venezuela up 11.7%). Sales in Europe were ?338 million, an
increase of 0.9% reflecting the performance of Toujeo(®) which offset lower
sales of Lantus(®). First-half sales for the Diabetes franchise were ?3,591
million down 3.8%.
Second-quarter sales of Sanofi's glargine (Lantus(®) and Toujeo(®)) were ?1,606
million, down 3.5%. In the U.S., Sanofi's glargine sales of ?1,002 million were
down 6.7%. In Europe, sales of Sanofi's glargine increased 1.2% to ?255 million
despite the launch of a biosimilar glargine in several European markets. First-
half sales of Sanofi's glargine were ?3,104 million down 4.3%.
Over the quarter, sales of Lantus(®) were ?1,465 million down 11.2%. In the
U.S., as anticipated, sales of Lantus(®) decreased 15.7% to ?896 million mainly
reflecting lower average net price and patients switching to Toujeo(®). In
Europe, second-quarter Lantus(®) sales were ?228 million, down 9.1% while in
Emerging Markets, sales were ?250 million, up 5.3% (up 9.8% excluding
Venezuela), driven by China. First-half sales of Lantus(®) were ?2,860 million,
down 11.1%.
Second-quarter sales of Toujeo(®) were ?141 million of which ?106 million were
recorded in the U.S. and ?27 million were from Europe. The global roll-out of
this product continues and Sanofi expects Toujeo(®) to be available in over 40
countries by the end of 2016. First-half sales of Toujeo(®) were ?244 million.
Sales of Amaryl(®) were ?93 million (down 9.2%, up 2.1% excluding Venezuela) in
the second-quarter of which ?74 million were generated in Emerging Markets (down
6.9%). Excluding Venezuela, sales of Amaryl in Emerging Markets increased 8.0%.
First-half sales of Amaryl(®) were ?181 million, down 7.3%.
Second-quarter sales of Apidra(®) were up 3.2% to ?93 million, reflecting lower
sales in the U.S. (down 11.8% to ?30 million), which were more than offset by
the performance in Emerging Markets (up 27.8% to ?20 million). First-half sales
of Apidra(®) were stable at ?178 million.
Cardiovascular franchise
Praluent(®) (alirocumab, collaboration with Regeneron) was launched in the U.S.
in 2015 and in a number of European markets in 2015 and 2016. Second-quarter
sales of Praluent(®) were ?21 million of which ?18 million were in the U.S. and
?3 million in Europe, where the product has recently become commercially
available in a few countries (including the UK, Germany, Spain, Netherlands, and
Nordic countries). First-half sales of Praluent(®) were ?33 million reflecting
current payer restrictions limiting uptake.
Second-quarter sales and first-half sales of Multaq(®) were ?84 million (down
1.1%) and ?170 million (up 0.6%), respectively.
Established Rx Products
Net sales (? million) Q2 2016 Change H1 2016 Change
(CER) (CER)
Plavix(®) 392 -25.7% 780 -22.2%
Lovenox(®) 414 +0.5% 818 -1.7%
Renvela(®)/Renagel(®) 208 -7.4% 442 -2.4%
Aprovel(®)/Avapro(®) 175 -16.1%((a)) 344 -14.6%((b))
Synvisc(® )/Synvisc-One(®) 109 -3.4% 197 0.0%
Myslee(®)/Ambien(®)/Stilnox(®) 78 +5.4% 148 0.0%
Allegra(®) 39 -2.7% 114 -7.7%
Other 1,202 -7.4%((c)) 2,365 -7.7%((d))
Total Established Rx Products 2,617 -9.7%((e)) 5,208 -9.0%((f))
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(a) Excluding Venezuela: -1.1%; (b) Excluding Venezuela: -1.9%; (c) Excluding
Venezuela: -4.5%; (d) Excluding Venezuela: -4.1%; (e) Excluding Venezuela:
-6.6%; (f) Excluding Venezuela: -5.7%;
Second-quarter sales of Established Rx Products were ?2,617 million, down 9.7%,
reflecting lower sales in Venezuela and generic competition to Plavix(®) in
Japan. Excluding Venezuela, sales of Established Rx Products were down 6.6%. In
Emerging Markets, sales of Established Rx Products were ?941 million, down 7.7%
and up 1.5% excluding Venezuela. In Europe and the U.S., sales of Established Rx
Products were down 3.0% (to ?942 million) and 8.3% (to ?374 million),
respectively. First-half sales of Established Rx Products decreased 9.0% to
?5,208 million and down 5.7% excluding Venezuela.
Second-quarter sales of Lovenox(®) increased 0.5% to ?414 million and 1.6%
excluding Venezuela. In Emerging Markets, sales of Lovenox(®) were up 2.4% to
?113 million, and up 6.6% excluding Venezuela. In Europe, sales of the product
were down 0.8% to ?262 million. In July, two biosimilars containing enoxaparin
sodium received positive opinion from the CHMP (European Medicines Agency's
Committee for Medicinal Products for Human Use). First-half sales of Lovenox(®)
were ?818 million down 1.7% and down 0.7% excluding Venezuela.
In the second quarter, Plavix(®) sales declined 25.7% to ?392 million due to
generic competition in Japan that started in June 2015 (sales in Japan were down
59.1% to ?93 million), which was partially offset by the growth in China (up
10.4% to ?177 million). First-half sales of Plavix(®) decreased 22.2% to ?780
million.
Second-quarter sales of Renvela(®)/Renagel(®) decreased 7.4% to ?208 million. In
the U.S., sales of the product were ?170 million (down 0.6%). Generics of the
product are currently marketed in a number of European countries, which resulted
in Europe sales of Renvela(®)/Renagel(®) down 32.3% to ?21 million. Sanofi
expects generic competition in the U.S. in 2016. First-half sales of
Renvela(®)/Renagel(®) were down 2.4% to ?442 million.
Sales of Aprovel(®)/Avapro(®) were down 16.1% to ?175 million in the second
quarter. Excluding Venezuela, sales of Aprovel(®)/Avapro(®) were down 1.1%.
First-half sales of Aprovel(®)/Avapro(®) decreased 14.6% to ?344 million and
1.9% excluding Venezuela.
In the second quarter and the first half of 2015, sales of Auvi-Q(®) and
Allerject(®) were ?35 million and ?52 million, respectively. Sanofi no longer
commercializes this product in the U.S. where no sales were recorded in 2016.
Consumer Healthcare
Net sales (? million) Q2 2016 Change H1 2016 Change
(CER) (CER)
Allegra(®) 97 -11.2% 237 -5.0%
Doliprane(®) 77 +11.4% 154 0.0%
Enterogermina(®) 43 +27.8% 85 -3.2%
Essentiale(®) 32 -22.2% 71 -17.9%
Nasacort(®) 23 -25.0% 68 -6.8%
Lactacyd(®) 22 -42.9% 41 -32.4%
Maalox(®) 21 -15.4% 45 -11.1%
No Spa(®) 19 0.0% 40 +2.3%
Magne B6(®) 16 -19.0% 36 -4.9%
Dorflex(®) 15 -15.0% 34 -2.3%
Other CHC Products 435 +0.9% 894 0.0%
Total Consumer Healthcare 800 -4.3%((a)) 1,705 -3.6%((b))
(a) Excluding Venezuela: +0.6%; (b) Excluding Venezuela: +1.5%;
Second-quarter Consumer Healthcare (CHC) sales were ?800 million, down 4.3%.
Excluding Venezuela and the divestiture of smaller products, CHC sales were up
2.7% driven by the strong performance in Australia, Mexico and Argentina, which
was partially offset by Russia. Second-quarter sales of CHC in the U.S. were
down 0.8% to ?229 million reflecting a mild allergy season impacting sales of
Allegra(®) (down 18.3% to ?56 million). In Emerging Markets, sales were down
13.0% to ?289 million (down 1.8% excluding Venezuela) impacted by lower sales in
Russia. In the Rest of the World, second-quarter sales grew 18.0% to ?69 million
sustained by the allergy franchise and the vitamins business in Australia. Over
the quarter, in Europe, sales increased 0.9% to ?213 million (impacted by
divestitures of small products), buoyed by a strong Doliprane(®) performance due
to a successful DTC campaign. First-half sales of CHC reached ?1,705 million,
down 3.6% and up 3.4% excluding Venezuela and the divestiture of several small
products.
On June 27, 2016, Sanofi and Boehringer Ingelheim announced the signing of
contracts to secure the strategic transaction initiated in December 2015 which
consists of an exchange of Sanofi's animal health business and Boehringer
Ingelheim's consumer healthcare business. This step marks a major milestone
before closing of the transaction which is expected by year-end 2016 and remains
subject to approval by all regulatory authorities in different territories.
Generics
Second-quarter sales of Generics were down 1.9% to ?474 million. Excluding
Venezuela, sales were up 0.4% driven by Emerging Markets (up 8.2%) offsetting
lower sales of the Plavix authorized generic in Japan. First-half sales of
Generics increased 0.6% to ?933 million (up 3.3% excluding Venezuela).
Vaccines
Net sales (? million) Q2 2016 Change H1 2016 Change
(CER) (CER)
Polio/Pertussis/Hib Vaccines
(incl. Pentacel(®), Pentaxim(® )and 339 +28.6% 627 +17.1%
Imovax(®))
Meningitis/Pneumonia Vaccines 139 -1.4% 261 +10.3%
(incl. Menactra(®))
Adult Booster Vaccines (incl. Adacel 104 -9.3% 184 -12.2%
(®))
Influenza Vaccines 96 -10.5% 116 -8.1%
(incl. Vaxigrip(®) and Fluzone(®))
Travel and Other Endemic Vaccines 101 +7.2% 184 +6.1%
Dengvaxia(®) 1 - 20
Other Vaccines 17 -36.7% 30 -34.7%
Total Vaccines (consolidated sales) 797 +6.3%(*(a)) 1,422 +7.1%(*(b))
*Comparability based on the new presentation of VaxServe sales (see below)
(a) Excluding Venezuela: +7.0%; (b) Excluding Venezuela: +7.8%;
VaxServe sales
VaxServe is a U.S. entity of the Vaccines segment. VaxServe activities include
products distribution in the U.S. in channels that are not the primary focus of
Sanofi Pasteur. VaxServe complements its Sanofi Pasteur products offering by
distributing vaccines and other products from third party manufacturers. All
VaxServe sales were reported on the line Net sales in the past.
In order to provide more relevant published information, VaxServe sales of non-
Sanofi products are reported on the line Other revenues in the income statement
from January 1, 2016. Accordingly, prior period comparative net sales have been
reclassified to the line Other revenues.
The 2015 quarterly and full-year 2015 business P&L as well as sales of GBUs and
franchises by geographic region reflecting this reclassification are available
on the Investors section of Sanofi's website.
In the second quarter of 2015 and in full-year 2015, sales of VaxServe((9)) of
non-Sanofi products were ?110 million and ?482 million, respectively.
Vaccines
In the second quarter, consolidated vaccines sales were up 6.3% to ?797 million
driven by the Polio/Pertussis/Hib Vaccines franchise in Emerging Markets and
Travel and other endemics vaccines. In the U.S., sales of vaccines decreased
2.3% to ?331 million due to increased competitive pressure on Adacel(® )and
lower sales of Menactra(® )reflecting favorable CDC order phasing in the U.S
during the first quarter of 2016. In Emerging Markets sales of vaccines
increased 9.8% driven by Pentaxim(®) and Hexaxim(®) growth. First-half sales of
Sanofi Pasteur were up 7.1% to ?1,422 million.
Second quarter sales of Polio/Pertussis/Hib Vaccines were up 28.6% to ?339
million. In Emerging Markets, sales of the franchise increased 43.6% to ?178
million driven by the growth of Pentaxim(®) and Hexaxim(®) in the Middle-East,
Africa, Turkey and Mexico. This performance more than offset lower sales of
Pentaxim(®) and Polio vaccines in China due to local market disruption. In the
U.S., sales of Polio/Pertussis/Hib Vaccines were down 1.1% to ?88 million
reflecting a slight decrease in sales of IPV vaccines. Pentacel(®) sales in the
U.S. were ?56 million, up 1.8%. As previously communicated, Sanofi Pasteur is
experiencing Pentacel(®) manufacturing delays and is not meeting all current
demand. Supply improvements are expected in the second half of 2016. First-half
sales of Polio/Pertussis/Hib vaccines increased 17.1% to ?627 million.
Dengvaxia(®), the world's first dengue vaccine is now approved in five countries
(Mexico, the Philippines, Brazil, El Salvador and Costa Rica). Dengvaxia(®) was
launched in the Philippines in the first quarter and in El Salvador in July.
Additionally, a public vaccination program in Paraná State in Brazil was
announced in late July and is expected to cover half a million people. Despite
these developments, the overall uptake of Dengvaxia(®) is delayed by recent
political changes and economic volatility in Latin America. With only a limited
number of public immunization programs confirmed to date in endemic countries
and the majority of regulatory approvals still pending in Asia, Dengvaxia(®) is
unlikely to meet Sanofi's prior sales expectations for 2016. Dengvaxia(®) sales
in the second quarter were limited to private market sales in the Philippines.
First-half sales of Dengvaxia(®) were ?20 million corresponding to the sales of
the first dose of the first public dengue immunization program in the
Philippines in the first quarter of 2016.
Sales of Influenza Vaccines were ?96 million, a decrease of 10.5% reflecting
lower sales in Brazil due to increased supply of the Butantan Institute.
(9) Sales of VaxServe in Q2 2016 and first-half 2016 are provided in the
Financial Results
Menactra(®) sales were ?126 million, a decrease of 3.0% due to favorable CDC
order phasing in the U.S in the first quarter of 2016. First-half sales of
Menactra(®) increased 10.0% to ?237 million.
Second-quarter Adult Booster Vaccines sales were down 9.3% to ?104 million
reflecting increased Adacel(®) competitive pressure in the U.S. First-half sales
of Adult Booster vaccines decreased 12.2% to ?184 million.
Second-quarter sales of Travel and Other Endemic Vaccines increased 7.2% to ?101
million driven by increased sales of rabies and typhoid vaccines. First-half
sales of Travel and Other Endemic Vaccines were up 6.1% to ?184 million.
Sales of Sanofi Pasteur MSD (not consolidated), the joint venture with Merck &
Co. in Europe, increased 9.0% (on a reported basis) to ?175 million and 13.4%
(on a reported basis) to ?340 million in the second quarter and first half of
2016, respectively. In March, Sanofi Pasteur and Merck announced their intent to
end their joint vaccines operations in Europe, Sanofi Pasteur MSD, to pursue
their own distinct growth strategies in Europe. Sanofi Pasteur and Merck expect
the project to be completed by the end of 2016, subject to local labor laws and
regulations and regulatory approvals.
Animal Health((10))
Net sales (? million) Q2 2016 Change H1 2016 Change
(CER) (CER)
Companion Animal 493 +8.6% 1,022 +14.2%
Production Animal 232 +10.1% 463 +11.1%
Total Animal Health 725 +9.1% 1,485 +13.2%
of which Vaccines 205 +4.9% 417 +11.3%
of which fipronil products 169 -10.3% 350 -7.5%
of which avermectin products 142 +12.2% 312 +10.4%
-----------------------------------------------------------------------
In the second quarter, Animal Health sales were up 9.1% to ?725 million driven
by the success of NexGard(®) family of products, Merial's next generation flea
and tick products for dogs, in the U.S., Europe and Japan.
Second-quarter sales of the Companion Animals segment increased 8.6% to ?493
million boosted by the success of NexGard(®) and NexGard(®) Spectra which more
than offset the decline in the Frontline(®) family of products. HeartGard(®)
also contributed to growth in the Companion Animals segment.
Sales of the Production Animals segment increased 10.1% to ?232 million in the
second quarter reflecting strong performance of the Avian business in Emerging
Markets as well as Ruminant business in the U.S. and Europe.
Aggregate Company sales by geographic region
Aggregate Sanofi sales (? million) Q2 2016 Change H1 2016 Change
(CER) (CER)
United States 3,118 +1.3% 6,084 +1.4%
Emerging Markets((a)) 2,534 -0.5% 4,907 +1.7%
of which Latin America 698 -15.1% 1,269 -15.0%
of which Asia 804 +5.3% 1,637 +10.2%
of which Africa, Middle East and South 736 +10.3% 1,404 +11.0%
Asia((b))
of which Eurasia((c)) 270 +4.3% 529 +6.9%
Europe((d)) 2,360 +3.3% 4,732 +2.5%
Rest of the world((e)) 856 -12.3% 1,688 -12.8%
of which Japan 446 -24.4% 893 -24.9%
Total Aggregate Sanofi sales 8,868 -0.2% 17,411 +0.2%
a. World excluding U.S., Canada, Western & Eastern Europe (except Eurasia),
Japan, South Korea, Australia, New Zealand and Puerto Rico
b. India, Pakistan, Bangladesh, Sri Lanka
c. Russia, Ukraine, Georgia, Belarus, Armenia and Turkey
d. Western Europe + Eastern Europe except Eurasia
e. Japan, South Korea, Canada, Australia, New Zealand, Puerto Rico
In the second quarter, sales in the U.S. increased 1.3% to ?3,118 million. The
strong performance of the multiple sclerosis franchise (up 62.6%), rare disease
franchise (up 12.3%) and Animal Health (up 4.6%) more than offset lower sales of
the diabetes franchise (down 7.1%), Vaccines (down 2.3%) and the Auvi-Q(®)
impact.
(10) Merial is reported on a single line in the consolidated income statements
in accordance with IFRS 5 (Non-current assets held for sale and discontinued
operations). Sanofi will continue to manage and report the performance of
Merial, which will remain an operating segment consistent with IFRS 8.
First-half sales in the U.S. increased 1.4% to ?6,084 million.
Aggregate sales in Emerging Markets were down 0.5% to ?2,534 million in the
second quarter. Excluding Venezuela, Aggregate sales in Emerging Markets grew
6.7% driven by Diabetes (up 11.7%), Rare Diseases (up 28.2%), Vaccines (up
11.5%) and Animal Health (up 15.6%). In the Asia region, Aggregate sales were up
5.3% to ?804 million in the second quarter. Over the quarter, sales in China
increased 2.6% to ?512 million; the strong performance of Pharmaceuticals (up
11.7%) was partially offset by lower vaccines sales (-84.9%). In Latin America,
second-quarter Aggregate sales were down 15.1% to ?698 million and up 5.7%
excluding Venezuela driven by sales in Argentina, Colombia and Mexico. Aggregate
sales in Brazil were down 3.3% to ?280 million impacted by lower sales of Flu
vaccines and Renagel(®). Aggregate sales in the Eurasia region increased 4.3% to
?270 million driven by Turkey. Sales in Russia were down 12.6% to ?110 million
associated with the CHC business. In Africa, the Middle-East and South Asia,
Aggregate sales were up 10.3% to ?736 million sustained by the strong
performance in Africa (up 16.6%). In the Emerging Markets, first-half sales
increased 1.7% to ?4,907 million. Excluding Venezuela, Aggregate first-half
sales in Emerging Markets grew 9.7%.
Aggregate sales in Europe were up 3.3% to ?2,360 million in the second quarter.
The performance of Multiple Sclerosis (up 78.3%), Rare Diseases (up 10.7%) and
Vaccines (up 34.9%) franchises was partially offset by lower sales of
Established Rx products (down 3.0%) mainly impacted by generic competition to
Renagel(®). In Europe, first-half sales increased 2.5% to ?4,732 million.
Aggregate second-quarter sales in Japan decreased 24.4% to ?446 million,
impacted by generic competition to Plavix(®) (down 59.1%). In Japan, first-half
sales decreased 24.9% to ?893 million.
R&D update
Consult Appendix 8 for full overview of Sanofi's R&D pipeline
Regulatory update
Regulatory updates since the publication of the first quarter results on April
29, 2016 include the following:
* In July, the Ministry of Health, Labor and Welfare in Japan granted
marketing authorization for Praluent(®) (alirocumab) for the treatment of
uncontrolled low-density lipoprotein cholesterol in certain adult patients
with hypercholesterolemia at high cardiovascular risk. The 300mg once-
monthly dosing of Praluent(®) was also filed in U.S. and EU.
* In July, the file for the Marketing Authorization Application for sarilumab
in Rheumatoid Arthritis was accepted for review by the European Medicines
Agency (EMA).
* In May, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of
the FDA recommended the approval((11)) of the New Drug Application (NDA) for
Adlyxin(®) (lixisenatide) and for the fixed-ratio combination of basal
insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for
the treatment of adults with type 2 diabetes. The fixed-ratio combination of
basal insulin glargine and GLP-1 receptor agonist lixisenatide is undergoing
FDA review, with decisions anticipated in August 2016. Adlyxin(®)
(lixisenatide) was approved in the U.S. at the end of July.
At the end of July 2016, the R&D pipeline contained 44 pharmaceutical new
molecular entities (excluding Life Cycle Management) and vaccine candidates in
clinical development of which 14 are in Phase III or have been submitted to the
regulatory authorities for approval.
Portfolio update
Phase III:
* In June, the results of the pivotal Phase III LixiLan-O and LixiLan-L
clinical trials with the investigational titratable fixed-ratio combination
of basal insulin glargine 100 Units/mL and lixisenatide in adults with type
2 diabetes were presented at the American Diabetes Association scientific
Sessions. Both studies met their primary endpoints, demonstrating
statistically superior reduction of HbA1c with the titratable fixed-ratio
combination versus comparators (lixisenatide and insulin glargine 100
Units/mL, respectively).
(11) The members of the Advisory Committee voted 12-2 for an approval of LixiLan
* In June, Sanofi and Regeneron announced that a one-year Phase III study,
known as LIBERTY AD CHRONOS, evaluating investigational dupilumab met its
primary and key secondary endpoints. In the study, dupilumab with topical
corticosteroids (TCS) was compared to TCS alone in moderate-to-severe atopic
dermatitis adult patients. Patients enrolled in the study were inadequately
controlled by TCS with or without topical calcineurin inhibitor. Dupilumab
with TCS significantly improved measures of overall disease severity at 16
and 52 weeks, when compared to placebo with TCS.
* Based on the results of the FIRSTANA Phase III study comparing Jevtana(®)
(cabazitaxel) versus Taxotere(®) (docetaxel) in chemotherapy-naïve
metastatic castration resistant prostate cancer, the decision was made not
to submit a first line indication for Jevtana(®) as the results did not
provide the level of benefit that is needed for claiming new indication.
Jevtana(®) currently has a second line indication and FIRSTANA was conducted
as part of the post marketing commitment with the FDA.
Phase II:
* SAR439684, a PD-1 inhibitor (alliance with Regeneron), entered Phase II in
advanced cutaneous squamous cell carcinoma.
Phase I:
* It has been decided not to pursue the development of SAR438544, a stable
glucagon analog, in diabetes.
2016 second-quarter and first-half Aggregate financial results((12))
Business Net Income((12))
In the second quarter of 2016, Sanofi generated Aggregate sales of ?8,868
million, a decrease of 4.3% (down 0.2% at CER). First-half Aggregate sales were
?17,411 million, down 3.2% on a reported basis (up 0.2% at CER).
Aggregate other revenues decreased 10.4% to ?173 million and include VaxServe
sales of non-Sanofi products (down 19.1% to ?89 million) following the change in
presentation as of January 1, 2016((13)). At CER, Aggregate other revenues were
down 8.3%. First-half Aggregate other revenues decreased 12.1% to ?328 million
of which ?172 million were generated by VaxServe (down 18.1%)
Aggregate gross profit was ?6,276 million, down 3.8% and up 0.2% at CER in the
second quarter. The Aggregate gross margin ratio improved by 0.4 percentage
points to 70.8% versus the second quarter of 2015. The positive impact from the
multiple sclerosis franchise, pharmaceuticals in China and industrial
productivity largely offset the negative impact of U.S. Diabetes, and Plavix(®)
generic competition in Japan. Sanofi expects its 2016 Aggregate gross margin
ratio to be above 69% and below 70% at CER. In the first half of 2016, the
Aggregate gross margin ratio improved by 0.3 percentage points to 70.5% versus
the first half of 2015.
Second-quarter Aggregate Research and Development expenses were ?1,325 million,
an increase of 2.7%. At CER, Aggregate R&D expenses were up 4.6% reflecting in
particular the new immuno-oncology alliance with Regeneron. In the first half of
2016, the ratio of Aggregate R&D to Aggregate sales was 1.2 percentage points
higher at 15.0% compared to the same period of 2015.
Aggregate selling general and administrative expenses (SG&A) increased 0.1% to
?2,650 million in the second quarter. At CER, Aggregate SG&A was up 3.9% mainly
reflecting the U.S. launch expenses of Praluent(®), and pre-launch costs for
sarilumab and dupilumab. The ratio of Aggregate SG&A to Aggregate sales
increased 1.3 percentage points to 29.9% compared with the second quarter of
2015. In the first half of 2016, the ratio of Aggregate selling and general
expenses to Aggregate sales was 0.8 percentage points higher to 29.1% compared
with the first half of 2015.
Second-quarter Aggregate other current operating income net of expenses was -?23
million versus -?20 million for the same period of 2015. In the second quarter
of 2015, this line included a foreign exchange loss of ?34 million booked in
connection with Sanofi's Venezuelan operations. First-half Aggregate other
current operating income net of expenses was ?56 million versus -?87 million in
the first half of 2015.
The Aggregate share of profits from associates was stable at ?30 million in the
second quarter. The Aggregate share of profits from associates included Sanofi's
share in Regeneron profit as well as Sanofi's share of profit in Sanofi Pasteur
MSD (the Vaccines joint venture with Merck & Co. in Europe). In the first half,
the share of profits from associates was ?53 million versus ?61 million for the
same period of 2015.
Aggregate non-controlling interests were -?23 million in the second quarter
versus -?29 million in the second quarter of 2015. First-half non-controlling
interests were -?50 million versus -?62 million for the same period of 2015.
Aggregate business operating income was ?2,285 million, down 11.0%. At CER,
Aggregate business operating income decreased 5.8%. The ratio of Aggregate
business operating income to Aggregate net sales decreased 1.9 percentage points
to 25.8% versus the same period of 2015. First-half Aggregate business operating
income was ?4,669 million, down 5.9% (or down 1.6% at CER). In the first half of
2016, the ratio of Aggregate business operating income to Aggregate sales
decreased 0.8 percentage points to 26.8%.
Net Aggregate financial expenses were ?76 million in the second quarter versus
?112 million in the second quarter of 2015. In the second quarter of 2016, this
line included a limited capital gain on a minor asset sale. First-half net
financial expenses were ?194 million versus ?209 million in the first half of
2015.
Second-quarter and first-half 2016 effective tax rate (including Animal Health)
were 24.0% compared with 25.0% in the same periods of 2015.
Second-quarter business net income((12)) decreased 8.7% to ?1,680 million (down
3.3% at CER). The ratio of business net income to Aggregate sales was 18.9%, a
decrease of 1.0 percentage points compared with the second quarter of 2015.
First-half business net income decreased 4.6% to ?3,402 million, (stable at
CER). The ratio of business net income to net sales decreased 0.3 percentage
points to 19.5% compared to the first half of 2015.
(12) See Appendix 4 for 2016 second-quarter and 2016 first-half Consolidated
income statement; see Appendix 10 for definitions of financial indicators, and
Appendix 3 for reconciliation of business net income to IFRS net income reported
(13) See page 7, chapter on Vaccines
+------------------------------------------------------------------------------+
|In the second quarter of 2016, business earnings per share((12)) (EPS) was|
|?1.31, a decrease of 7.1% on a reported basis and 2.1% at CER. The average|
|number of shares outstanding was 1,286.8 million in the second quarter of|
|2016 versus 1,305.9 million in the second quarter of 2015. In the first half|
|of 2016, business earnings per share((12)) was ?2.64, down 3.3% on a reported|
|basis and up 1.5% at CER. The average number of shares outstanding was|
|1,287.6 million in the first half versus 1,307.2 million in the first half of|
|2015. |
+------------------------------------------------------------------------------+
2016 guidance
Sanofi continues to expect 2016 Business EPS to be broadly stable at CER,
barring unforeseen major adverse events. In addition, the currency impact on
2016 full-year business EPS is estimated to be around -4%, applying June 2016
average rates to the two remaining quarters of 2016.
From business net income to IFRS net income reported (see Appendix 3)
In the first half of 2016, the main reconciling items between business net
income and IFRS net income reported were:
* A ?877 million amortization charge related to fair value remeasurement on
intangible assets of acquired companies (primarily Aventis: ?276 million and
Genzyme: ?431 million) and to acquired intangible assets (licenses/products:
?68 million). A ?433 million amortization charge on intangible assets
related to fair value remeasurement of acquired companies (primarily
Aventis: ?136 million and, Genzyme: ?213 million), and to acquired
intangible assets (licenses/products: ?34 million) was booked in the second
quarter. These items have no cash impact on the Company.
* An impairment of intangible assets of ?52 million recorded in the second
quarter linked to small products. This item has no cash impact on the
Company.
* A charge of ?67 million (of which ?38 million in the second quarter)
reflecting an increase of Bayer contingent considerations linked to
Lemtrada(®) (charge of ?41 million, of which ?12 million on the second
quarter) and CVR fair value adjustment.
* Restructuring costs of ?627 million (including ?127 million in the second
quarter mainly related to transformation in Europe and North America).
* A ?548 million tax effect arising from the items listed above, comprising
?307 million of deferred taxes generated by amortization charged against
intangible assets, ?210 million associated with restructuring costs, ?16
million associated with impairment of intangible assets and ?15 million
associated with fair value remeasurement of contingent consideration
liabilities The second quarter tax effect was ?210 million, including ?151
million of deferred taxes generated by amortization charged against
intangible assets, ?39 million associated with restructuring costs and a
charge of ?16 million associated with impairment of intangible asset (see
Appendix 3).
* In "Share of profits/losses from associates and joint-ventures", an income
of ?54 million net of tax (which included a charge of ?16 million related to
second quarter of 2016), mainly relating to the share of fair-value re-
measurement on asset and liabilities of associates and the share of
amortization of intangible assets of acquired associates and joint-ventures.
This item has no cash impact on the Company.
* A tax of ?113 million on dividends paid to shareholders of Sanofi.
* In Animal Health items, a net expense of ?13 million (which included an
income of ?58 million related to the second quarter of 2016), mainly
relating to a change in deferred tax charge resulting from taxable temporary
differences relating to investments in subsidiaries since it is likely that
these differences will reverse.
(12) See Appendix 4 for 2016 second-quarter and 2016 first-half Consolidated
income statement; see Appendix 10 for definitions of financial indicators, and
Appendix 3 for reconciliation of business net income to IFRS net income reported
Capital Allocation
In the first half of 2016, net cash generated by operating activities decreased
by 17.6% to ?2,541 million after capital expenditures of ?700 million and an
increase in working capital of ?753 million. This net Cash Flow has contributed
to finance a share repurchase (?1,403 million), dividend paid by Sanofi (?3,759
million), acquisitions and partnerships net of disposals (?663 million) and
restructuring costs and similar items (?347 million). As a consequence, net debt
increased from ?7,254 million at December 31, 2015 to ?11,001 million at the end
of June 2016 (amount net of ?6,076 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, Sanofi's ability to benefit from external growth opportunities
and/or obtain regulatory clearances, risks associated with intellectual property
and any related pending or future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest rates, volatile
economic conditions, the impact of cost containment initiatives 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, 2015. 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: 2016 second-quarter and 2016 first-half net sales and Aggregate
Company sales by GBU, by franchise, by geographic region and
product
Appendix 2: 2016 second-quarter and 2016 first-half Business income
statement
Appendix 3:
Reconciliation of Business net income to IFRS net income
reported
Appendix 4 2016 second-quarter and 2016 first-half Consolidated income
statement
Appendix 5:
Change in net debt
Appendix 6:
Simplified consolidated balance sheet
Appendix 7: 2016 currency sensitivity
Appendix 8: R&D pipeline
Appendix 9: Expected R&D milestones
Appendix 10: Definitions of non-GAAP financial indicators
Appendix 1: 2016 second-quarter net sales and Aggregate Company sales by GBU, by
franchise by geographic region and product
Q2 % Rest Emer- Total %
2016 Total % re- Eu- % United % of % ging % Fran- % re-
(? GBUs CER ported rope CER States CER the CER Mar- CER chises CER ported
million) World kets
Aubagio 306 57.6% 54.5% 80 68.8% 216 55.6% 10 25.0% 9 83.3% 315 58.3% 54.4%
Lemtrada 103 100.0% 94.3% 40 100.0% 56 96.6% 7 133.3% 5 100.0% 108 100.0% 92.9%
Total MS 409 66.5% 62.9% 120 78.3% 272 62.6% 17 54.5% 14 88.9% 423 67.3% 62.7%
Cerezyme 129 -1.5% -3.0% 71 0.0% 45 -4.1% 13 0.0% 70 27.3% 199 8.0% 0.0%
Cerdelga 26 62.5% 62.5% 5 400.0% 20 33.3%
Unternehmensinformation / Kurzprofil:
Datum: 29.07.2016 - 07:31 Uhr
Sprache: Deutsch
News-ID 486226
Anzahl Zeichen: 65576
contact information:
Town:
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