Sanofi : Q3 2017 Business EPS up 1.1% at CER FY 2017 Guidance Confirmed
(Thomson Reuters ONE) -
Paris, November 2, 2017
Q3 2017 Business EPS((1)) up 1.1% at CER((2))
FY 2017 Guidance Confirmed
Change Change Change Change
Q3 2017 Change at CER at 9M 2017 Change at CER at
CER/CS((3)) CER/CS((3))
IFRS net
sales ?9,053m +0.3% +4.7% -0.2% ?26,364m +5.7% +6.2% +1.2%
reported
IFRS net
income ?1,567m -6.4% - - ?8,305m +111.9% - -
reported
IFRS EPS ?1.25 -3.8% - - ?6.60 +117.1% - -
reported
----------------------------------------------------------------------------------
Business
net ?2,141m -6.9% -1.1% - ?5,632m -1.2% -0.3% -
income((1))
Business ?1.71 -4.5% +1.1% - ?4.48 +1.1% +2.0% -
EPS((1))
----------------------------------------------------------------------------------
Third-quarter and first nine months 2017 accounts reflect the acquisition of the
former Boehringer Ingelheim Consumer Healthcare (CHC) business and the disposal
of the Animal Health business (completed on January 1, 2017((4))). In accordance
with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations),
Animal Health results in 2016 and gain on disposal in 2017 are reported
separately. Third-quarter and first nine months 2017 income statements also
reflect the consolidation of European operations related to Sanofi vaccine
portfolio, following the termination of the Sanofi Pasteur MSD joint venture
(SPMSD JV) with Merck at the end of 2016.
+------------------------------------------------------------------------------+
|Q3 2017 sales performance supported by Sanofi Genzyme, Sanofi Pasteur and |
|Emerging Markets |
| * Net sales were ?9,053 million, up 0.3% on a reported basis and 4.7%((2)) |
| at CER reflecting the change in scope of the CHC and Vaccines Global |
| Business Units (GBUs). At CER and CS((3)), net sales were stable (-0.2%). |
| * Sanofi Genzyme grew 13.9% at CER due to the strong U.S. launch of |
| Dupixent(®) and good growth in Multiple Sclerosis. |
| * Sanofi Pasteur grew 7.2% at CER and CS largely driven by pediatric |
| combinations and booster vaccines. |
| * CHC sales were up 1.0% at CER and CS impacted by increased competition in |
| developed markets. |
| * Diabetes and Cardiovascular sales declined 14.8% at CER. Given increased |
| visibility on sales performance, Sanofi refines its global Diabetes |
| franchise outlook to -6% to -8% CAGR over 2015-2018 at CER. |
| * Emerging Markets((5)) sales increased 7.3% at CER and CS driven by strong |
| contributions from China and Russia. |
|Q3 2017 business EPS consistent with the full-year guidance |
| * Q3 2017 business operating income of ?2,911 million, up 5.1% at CER and |
| +1.7% at CS. |
| * Q3 2017 business EPS((1)) grew 1.1% at CER to ?1.71 and decreased 4.5% on |
| a reported basis. |
| * Sanofi continues to expect 2017 business EPS((1)) to be broadly |
| stable((6)) at CER, barring unforeseen major adverse events. |
| * Currency impact on 2017 business EPS is estimated to be -1% to -2% at the |
| average September 2017 exchange rates. |
|Sustaining Innovation in R&D |
| * Dupixent(®) approved in the EU in moderate to severe atopic dermatitis. |
| * Positive topline results of the Phase 3 QUEST and VENTURE studies |
| confirmed the safety and efficacy profile of dupilumab in asthma; U.S. |
| filing in persistent uncontrolled asthma expected to take place in Q4. |
| * In immuno-oncology, FDA granted Breakthrough Therapy designation status to|
| cemiplimab((7)) (anti PD-1). |
+------------------------------------------------------------------------------+
Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"The strong launch of Dupixent(®) in the U.S., the continued double-digit
growth of our Multiple Sclerosis franchise and the performance of our
pediatric vaccines were important drivers in the quarter. These positive
dynamics, accompanied by robust growth in Emerging Markets and disciplined
expense management, offset the decline of our Diabetes franchise. We are
pleased by the progress in R&D demonstrated by the positive phase 3 topline
results in asthma for Dupixent(®) and the recent advances of cemiplimab, our
anti PD-1, in oncology."
(1) 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 8 for definitions). The consolidated income
statement for Q3 2017 and 9M 2017 is provided in Appendix 3 and a reconciliation
of IFRS net income reported to business net income is set forth in Appendix 4;
(2) changes in net sales are expressed at constant exchange rates (CER) unless
otherwise indicated (see Appendix 8); (3) CS: constant structure: adjusted for
BI CHC business, termination of SPMSD and others; (4) The closing of the
disposal of Merial in Mexico is expected in 2017; (5) See definition page 8; (6)
2016 Business EPS was ?5.68; (7) Collaboration with Regeneron.
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
Website: www.sanofi.com Mobile app: SANOFI IR available on the App Store and
Google Play
2017 third-quarter and nine-months Sanofi sales
Unless otherwise indicated, all percentage changes in sales in this press
release are stated at CER((8)).
In the third quarter of 2017, Company sales were ?9,053 million, up 0.3% on a
reported basis. Exchange rate movements had a negative effect of 4.4 percentage
points mainly reflecting the movement of the U.S. Dollar, Japanese Yen, Egyptian
Pound, Chinese Yuan and Turkish Lira. Company sales benefited from the
acquisition of Boehringer Ingelheim's CHC business and full consolidation of
Sanofi's European vaccines operations leading to an increase of 4.7% at CER. At
CER and constant structure, Company sales were down 0.2%.
First nine months Company sales reached ?26,364 million, up 5.7% on a reported
basis. Exchange rate movements had a negative effect of 0.5 percentage points.
At CER and constant structure, Company sales were up 1.2%.
Global Business Units
The table below presents sales by Global Business Unit (GBU) and reflects the
organization of Sanofi. This structure drives deeper specialization, simplifies
reporting and provides a clear focus on growth drivers. Please note that
Emerging Markets sales for Specialty Care and Diabetes and Cardiovascular are
included in the General Medicines and Emerging Markets GBU.
Net Sales by GBU Q3 2017 Change Change 9M 2017 Change Change
(? million) (CER) CER/CS* (CER) CER/CS*
Sanofi Genzyme (Specialty 1,390 +13.9% +13.9% 4,208 +14.5% +14.6%
Care)((a))
Diabetes and 1,298 -14.8% -14.8% 4,103 -12.6% -12.6%
Cardiovascular((a))
General Medicines & Emerging 3,317 -2.7% -3.1% 10,701 -0.6% -0.8%
Markets((b))
Consumer Healthcare (CHC) 1,132 +48.5% +1.0% 3,636 +44.5% +2.0%
Total Pharmaceuticals 7,137 +3.2% -2.1% 22,648 +4.6% -0.3%
Sanofi Pasteur (Vaccines) 1,916 +11.0% +7.2% 3,716 +17.0% +11.4%
Total net sales 9,053 +4.7% -0.2% 26,364 +6.2% +1.2%
(a) Does not include Emerging Markets sales- see definition page 7; (b) Includes
Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care
*CS: constant structure
Global Franchises
The tables below present third-quarter and first nine months of 2017 sales by
global franchise, including Emerging Markets sales, to facilitate comparisons.
Appendix 1 provides a reconciliation of sales by GBU and franchise.
Net sales by Change Change Developed Change Emerging Change
Franchise Q3 2017 (CER) at Markets at Markets at
(? million) CER/CS* CER/CS* CER/CS*
--------------------------------- ------------------
Specialty Care 1,633 +12.5% +12.5% 1,390 +13.9% 243 +5.3%
Diabetes and 1,675 -9.1% -9.1% 1,298 -14.8% 377 +17.2%
Cardiovascular
Established Rx 2,264 -6.5% -7.1% 1,338 -13.8% 926 +4.3%
Products
Consumer 1,132 +48.5% +1.0% 721 -2.0% 411 +6.7%
Healthcare (CHC)
Generics 433 -0.9% -0.9% 247 -1.9% 186 +0.5%
Vaccines 1,916 +11.0% +7.2% 1,542 +6.2% 374 +11.6%
Total net sales 9,053 +4.7% -0.2% 6,536 -2.9% 2,517 +7.3%
*CS: constant structure
(8) See Appendix 8 for definitions of financial indicators.
Net sales by Change Change Developed Change Emerging Change
Franchise 9M 2017 (CER) at Markets at Markets at
(? million) CER/CS* CER/CS* CER/CS*
--------------------------------- ------------------
Specialty Care 4,964 +13.8% +13.9% 4,208 +14.6% 756 +10.0%
Diabetes and 5,242 -8.0% -8.0% 4,103 -12.6% 1,139 +12.6%
Cardiovascular
Established Rx 7,463 -2.7% -3.1% 4,564 -7.9% 2,899 +5.4%
Products
Consumer 3,636 +44,5% +2.0% 2,420 +0.8% 1,216 +4.3%
Healthcare (CHC)
Generics 1,343 -3.7% -3.5% 768 -4.6% 575 -1.9%
Vaccines 3,716 +17.0% +11.4% 2,612 +9.9% 1,104 +15.1%
Total net sales 26,364 +6.2% +1.2% 18,675 -1.2% 7,689 +7.4%
*CS: constant structure
Pharmaceuticals
Third-quarter Pharmaceuticals sales were up 3.2% to ?7,137 million. At constant
structure, Pharmaceuticals sales were down 2.1% primarily due to Diabetes and
Established Rx Products. First nine months sales for Pharmaceuticals increased
4.6% to ?22,648 million (down 0.3% at constant structure).
Rare Disease franchise
Net sales (? million) Q3 2017 Change 9M 2017 Change
(CER) (CER)
Myozyme(® )/ Lumizyme(®) 191 +5.9% 584 +9.6%
Cerezyme(®) 178 +1.6% 547 -1.8%
Fabrazyme(®) 175 +4.5% 542 +10.4%
Aldurazyme(®) 50 -1.9% 159 +6.0%
Cerdelga(®) 31 +14.3% 93 +20.8%
Others Rare Diseases 73 -7.2% 237 -2.9%
Total Rare Diseases 698 +2.7% 2,162 +5.3%
In the third quarter, Rare Disease sales increased 2.7% to ?698 million. Rare
Disease sales grew 1.9% in the U.S., 1.5% in Emerging Markets and 1.7% in
Europe. Year-to-date Rare Disease sales increased 5.3% to ?2,162 million.
Gaucher (Cerezyme(®) and Cerdelga(®)) sales were up 3.3% at ?209 million in the
third quarter. Cerezyme(®) sales were up 1.6% to ?178 million and Cerdelga(®)
sales increased 14.3% to ?31 million of which ?23 million were generated in the
U.S. (up 4.3%) in the third quarter. Year-to-date Gaucher sales increased 0.9%
to ?640 million.
Third-quarter Fabrazyme(®) sales were up 4.5% to ?175 million. Year-to-date
Fabrazyme(®) sales were up 10.4% to ?542 million.
Third-quarter Myozyme(®)/Lumizyme(®) sales grew 5.9% to ?191 million, mainly due
to new patient accruals. Year-to-date Myozyme(®)/Lumizyme(®) sales increased
9.6% to ?584 million.
Multiple Sclerosis franchise
Net sales (? million) Q3 2017 Change 9M 2017 Change
(CER) (CER)
Aubagio(®) 382 +19.2% 1,178 +26.9%
Lemtrada(®) 113 +5.4% 362 +18.5%
Total Multiple Sclerosis 495 +15.7% 1,540 +24.8%
Third-quarter Multiple Sclerosis (MS) sales grew 15.7% to ?495 million, driven
by Aubagio(® )performance in the U.S. and Europe. Year-to-date MS sales
increased 24.8% to ?1,540 million.
Third-quarter Aubagio(® )sales increased 19.2% to ?382 million driven by the
U.S. (up 20.9% to ?274 million). In Europe sales of Aubagio were up 16.0% to ?86
million. Year-to-date Aubagio(®) sales increased 26.9% to ?1,178 million.
In the third quarter Lemtrada(®) sales were up 5.4% to ?113 million, including
?60 million in the U.S. (stable) and ?40 million in Europe (up 10.8%). Year-to-
date Lemtrada(®) sales increased 18.5% to ?362 million.
Immunology franchise
Net sales (? million) Q3 2017 Change 9M 2017 Change
(CER) (CER)
Dupixent(®) 75 - 101 -
Kevzara(®) 2 - 3 -
Total Immunology 77 - 104 -
Dupixent(®) (collaboration with Regeneron) which was launched in the U.S. in
March for the treatment of moderate to severe adult atopic dermatitis (AD)
generated sales of ?75 million in the third quarter. Since launch, over 7,100
physicians in the U.S. have prescribed Dupixent(®) and cumulatively over 23,000
patients have been prescribed Dupixent(®). In Europe, Dupixent(®) was approved
at the end of September 2017 for use in adults with moderate-to-severe AD who
are candidates for systemic therapy. Launch of the product is planned by end
2017 in Germany.
Kevzara(®) (collaboration with Regeneron) was launched for rheumatoid arthritis
in June in the U.S. and in Europe in Germany and the Netherlands during the
third quarter. Year-to-date Kevzara(®) sales were ?3 million.
Oncology franchise
Net sales (? million) Q3 2017 Change 9M 2017 Change
(CER) (CER)
Jevtana(®) 90 +6.8% 287 +8.3%
Thymoglobulin(®) 71 +5.7% 219 +7.4%
Taxotere(®) 42 +2.2% 133 -0.7%
Eloxatin(®) 45 +11.6% 135 +6.2%
Mozobil(®) 43 +12.8% 123 +10.8%
Zaltrap(®) 19 +18.8% 53 +6.0%
Others 53 -9.7% 208 +11.2%
Total Oncology 363 +5.0% 1,158 +7.4%
Third-quarter and year-to-date Oncology sales increased 5.0% to ?363 million and
7.4% to ?1,158 million, respectively.
Jevtana(® )sales were up 6.8% to ?90 million in the third quarter supported by
the performance in the U.S. and Japan. Year-to-date Jevtana(®) sales increased
8.3% to ?287 million.
In the third quarter, Thymoglobulin(®) sales increased 5.7% to ?71 million
driven by Emerging Markets (up 28.6% to ?17 million). Year-to-date
Thymoglobulin( ®) sales increased 7.4% to ?219 million.
Eloxatin(®) sales increased 11.6% to ?45 million in the third quarter driven by
China. Third-quarter Taxotere(®) sales increased 2.2% to ?42 million. Year-to-
date sales of Taxotere(®) and Eloxatin(®) were down 0.7% (to ?133 million) and
up 6.2% (to ?135 million), respectively.
Diabetes franchise
Net sales (? million) Q3 2017 Change 9M 2017 Change
(CER) (CER)
Lantus(®) 1,123 -15.5% 3,546 -16.3%
Toujeo(®) 198 +23.4% 600 +45.0%
Total glargine 1,321 -11.3% 4,146 -10.9%
Apidra(®) 89 0.0% 280 +3.7%
Amaryl(®) 82 -3.3% 256 -1.1%
Insuman(®) 26 -18.8% 81 -16.3%
BGM (Blood Glucose Monitoring) 14 -12.5% 47 -6.0%
Lyxumia(®) 7 -22.2% 21 -19.2%
Soliqua(®) 8 - 17 -
Total Diabetes 1,552 -10.0% 4,862 -9.5%
In the third quarter, global Diabetes sales decreased 10.0% to ?1,552 million,
reflecting lower Lantus(®) sales in the U.S. Third-quarter U.S. Diabetes sales
were down 22.4% to ?745 million. Year-to-date U.S. Diabetes sales decreased
20.2% to ?2,398 million. As previously indicated, Sanofi expects an accelerated
decline of U.S. diabetes sales in the fourth quarter of 2017 relative to the
year-to-date performance. This reflects the phased impact of exclusions in
commercial formularies at CVS and United Health as well as a high basis of
comparison in the fourth quarter of 2016. Third-quarter sales in Emerging
Markets increased 17.3% to ?375 million. Third-quarter sales in Europe decreased
3.1% to ?313 million reflecting market share gains which were more than offset
by net price adjustments in Italy and Spain. Year-to-date global Diabetes sales
decreased 9.5% to ?4,862 million.
In the third quarter, Sanofi glargine (Lantus(®) and Toujeo(®)) sales decreased
11.3% to ?1,321 million. U.S. Sanofi glargine sales were down 23.1% to ?716
million, reflecting the impact of the exclusion from the CVS commercial
formulary from January 1, 2017 as well as from the United Health commercial
formulary which became effective on April 1, 2017. In Europe, Sanofi glargine
sales decreased 3.2% to ?238 million due to biosimilar competition in several
European markets. Year-to-date Sanofi glargine sales decreased 10.9% to ?4,146
million.
In the third quarter, Lantus(®) sales were ?1,123 million down 15.5%. In the
U.S., Lantus(®) sales decreased 25.4% to ?608 million mainly reflecting lower
average net price and the aforementioned impact of formulary exclusions. In
Europe, third-quarter Lantus(®) sales were ?184 million (down 14.0%) due to
biosimilar competition and patients switching to Toujeo(®). In Emerging Markets,
third-quarter sales were up 17.2% to ?256 million. Year-to-date Lantus(®) sales
decreased 16.3% to ?3,546 million.
In August, Sanofi filed a patent infringement suit against Merck in the United
States District Court for the District of New Jersey. In its suit Sanofi alleges
infringement of two patents. The suit was triggered by a notification received
from Merck in late June in which Merck stated that it had filed an NDA
(505(b)(2) New Drug Application) with FDA for an insulin glargine vial drug
product. Merck also stated that its NDA included a paragraph IV certification
challenging all of the Sanofi patents then listed in the FDA Orange Book for
Sanofi's Lantus(®) and Lantus(®) SoloStar(®) products.
In October, Sanofi filed a patent infringement suit against Mylan in the United
States District Court for the District of New Jersey. In its suit Sanofi alleges
infringement of 18 patents. The suit was triggered by notifications received
from Mylan beginning in mid-September, in which Mylan stated that it had filed a
NDA (505(b)(2) New Drug Application) with the FDA for insulin glargine pre-
filled pen and vial drug products. Mylan also stated that its NDA included a
paragraph IV certification challenging all of the Sanofi patents then listed in
the FDA Orange Book for Sanofi's Lantus(®) (insulin glargine injection, 100
Units/mL) and Lantus(®) SoloStar(®) products.
Third-quarter Toujeo(®) sales were ?198 million (up 23.4%) of which ?108 million
(down 6.6%) were recorded in the U.S., ?54 million in Europe (up 66.7%) and ?19
million in Emerging Markets (versus ?3 million in the third quarter of 2016).
Year-to-date Toujeo(®) sales increased 45.0% to ?600 million.
Amaryl(®) sales were ?82 million, down 3.3% in the third quarter, of which ?70
million were generated in Emerging Markets (up 4.1%). Year-to-date Amaryl(®)
sales were down 1.1% to ?256 million.
Third-quarter Apidra(®) sales were stable at ?89 million. Lower sales in the
U.S. (down 25.8% to ?21 million) were offset by strong growth in Emerging
Markets (up 26.3%% to ?22 million) and in Europe (up 9.4% to ?35 million). Year-
to-date Apidra(®) sales increased 3.7% to ?280 million.
Soliqua(®) 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL
injection) was launched in the U.S. in January 2017 and Suliqua(TM) recently
launched in the first European country, the Netherlands. In the U.S., payer
coverage is improving and access was secured for 65% of commercial lives by the
close of the third quarter. Soliqua(®) 100/33 / Suliqua(TM) sales were ?8
million in the third quarter and ?17 million in the first nine months.
Following contracting negotiations with U.S. payers, Sanofi has secured coverage
for Lantus(®) and Toujeo(®) on the vast majority of formularies in the U.S. for
2018. Given the increased visibility on sales performance, Sanofi refines its
global Diabetes franchise outlook and now expects a sales decline at an average
annualized rate of between 6% and 8% at CER over the 2015-2018 time frame.
Cardiovascular franchise
Third-quarter Praluent(®) sales (collaboration with Regeneron) were ?42 million
of which ?28 million was in the U.S. and ?12 million in Europe. This reflected
significant payer utilization management restrictions in the U.S. and limited
market access in Europe. First nine months Praluent(®) sales were ?118 million
versus ?68 million in the first nine months of 2016.
In October 2017, the U.S. Court of Appeals for the Federal Circuit ordered a new
trial and vacated the permanent injunction in the dispute concerning Amgen's
asserted patent claims for antibodies targeting PCSK9. This ruling means that
Sanofi and Regeneron will continue marketing, selling and manufacturing
Praluent(®) in the U.S.
Third-quarter and year-to-date Multaq(®) sales were ?81 million (down 4.5%) and
?262 million (up 0.8%), respectively.
Established Rx Products
Net sales (? million) Q3 2017 Change 9M 2017 Change
(CER) (CER)
Lovenox(®) 370 -5.4% 1,187 -1.9%
Plavix(®) 358 -4.7% 1,123 -2.3%
Renvela(®)/Renagel(®) 153 -35.1% 647 -6.7%
Aprovel(®)/Avapro(®) 150 -9.8% 533 +4.1%
Synvisc(® )/Synvisc-One(®) 95 -2.0% 301 +0.7%
Myslee(®)/Ambien(®)/Stilnox(®) 63 -13.0% 200 -11.6%
Allegra(®) 24 -16.1% 126 -13.8%
Other 1,051 -0.4% 3,346 -2.6%
Total Established Rx Products 2,264 -6.5% 7,463 -2.7%
In the third quarter, Established Rx Products sales decreased 6.5% to ?2,264
million. This reflected a decline in sales in Europe (down 4.4% to ?816
million), the onset of generic competition to Renvela(®)/Renagel(®) in the U.S.
and the impact of generic competition to Plavix(®) in Japan, which more than
offset a solid Emerging Markets performance (up 4.4% to ?926 million). Year-to-
date Established Rx Products sales decreased 2.7% to ?7,463 million.
Lovenox(® )sales decreased 5.4% to ?370 million in the third quarter, reflecting
increased competition in Europe (down 10.9% to ?220 million) which more than
offset the growth in Emerging Markets (up 2.5% to ?112 million). As of
September, biosimilars have been introduced in the UK and Germany. Year-to-date
Lovenox(®) sales decreased 1.9% to ?1,187 million.
In the third quarter, Plavix(® )sales were down 4.7% to ?358 million due to
generic competition in Japan that started in June 2015 (sales in Japan were down
31.8% to ?53 million). In Emerging Markets, third-quarter Plavix sales increased
5.0% to ?254 million sustained by the performance in China. Year-to-date
Plavix(®) sales decreased 2.3% to ?1,123 million.
Third-quarter Renvela(®)/Renagel(® )sales decreased 35.1% to ?153 million due to
generic competition in the U.S. (down 42.7% to ?112 million). In October, Sanofi
launched an authorized generic of Renvela(®)/Renagel(®) on the U.S. market. In
Europe, third-quarter Renvela(®)/Renagel(® )sales were down 10.0% to ?18 million
also reflecting generic competition. Year-to-date Renvela(®)/Renagel(® )sales
decreased 6.7% to ?647 million.
Aprovel(®)/Avapro(®) sales were down 9.8% to ?150 million reflecting lower sales
to Sanofi's partner in Japan which offset the growth in China. Year-to-date
Aprovel(®)/Avapro(®) sales increased 4.1% to ?533 million.
Consumer Healthcare
CHC sales by geography and category are provided in Appendix 1.
Net sales (? million) Q3 2017 Change Change 9M 2017 Change Change
(CER) at CER/CS* (CER) at CER/CS*
Allergy Cough & Cold 264 +52.8% -4.8% 933 +52.3% +3.0%
of which Allegra(®) 87 -2.1% -2.1% 338 +0.9% +0.9%
of which Mucosolvan(®) 32 na na 85 na na
of which Xyzal(®) 7 - - 58 - -
Pain 309 +50.5% +7.0% 930 +44.0% +5.1%
of which Doliprane(®) 72 +5.8% +5.8% 228 +3.1% +3.1%
of which Buscopan(®) 60 na na 140 na na
Digestive 220 +97.4% +2.7% 688 +77.8% -1.3%
of which Dulcolax(®) 52 na na 155 na na
of which 38 +2.6% +2.6% 127 +3.3% +3.3%
Enterogermina(®)
of which Essentiale(®) 31 +6.9% +6.9% 106 0.0% 0.0%
of which Zantac(®) 31 na na 88 na na
Nutritionals 162 +38.0% -5.1% 496 +42.5% -2.6%
of which Pharmaton(®) 29 na na 77 na na
Other 177 +14.3% +4.5% 589 +12.5% +3.4%
of which Gold Bond(®) 45 +9.1% +9.1% 145 +5.1% +5.1%
Total Consumer Healthcare 1,132 +48.5% +1.0% 3,636 +44.5% +2.0%
*CS: constant structure
In the third quarter, Consumer Healthcare (CHC) sales increased 48.5% to ?1,132
million reflecting the closing of the acquisition of Boehringer Ingelheim CHC
business on January 1, 2017. At constant structure, Sanofi CHC sales increased
1.0% in the third quarter driven by Emerging Markets (up 6.7% to ?411 million),
offset by lower sales in Europe (down 1.2% to ?321 million) and the U.S. (down
3.8% to ?241 million). At constant structure, year-to-date CHC sales increased
2.0% to ?3,636 million.
In Europe, third-quarter CHC sales were up 65.1% to ?321 million. At constant
structure, sales decreased 1.2% due to lower sales of Allergy Cough & Cold
products (down 9.0%) which offset the growth of the Pain category (up 5.3%). At
constant structure, year-to-date CHC sales in Europe increased 0.7% to ?1,035
million.
In the U.S., third-quarter CHC sales increased 17.6% to ?241 million. At
constant structure, CHC sales were down 3.8% reflecting increasing competition
from private label in this category specifically for Nasacort(®). Third quarter
Xyzal(®) Allergy 24HR sales (approved in February as an over-the-counter
treatment for the relief of symptoms associated with seasonal and year-round
allergies) were ?7 million. Third-quarter sales of the Digestive category were
down 7.4% reflecting lower Zantac(®) sales. In the U.S., at constant structure,
year-to-date CHC sales increased 0.6% to ?882 million.
In Emerging Markets, third-quarter CHC sales increased 37.5% to ?411 million. At
constant structure, CHC sales were up 6.7% reflecting continued recovery in
Russia. Year-to-date Emerging Markets CHC sales increased 4.3% to ?1,216 million
at constant structure.
Generics
In the third quarter, Generics sales decreased 0.9% to ?433 million reflecting
lower sales in Europe (down 7.1% to ?183 million). Year-to-date Generics sales
decreased 3.7% to ?1,343 million.
Vaccines
Net sales (? million) Q3 2017 Change Change 9M 2017 Change Change
(CER) at CER/CS* (CER) at CER/CS*
Polio/Pertussis/Hib
vaccines
(incl. Hexaxim(®) / 433 +38.6% +20.7% 1,334 +40.4% +29.5%
Hexyon(®) Pentacel(®),
Pentaxim(® )and Imovax(®))
Meningitis/Pneumonia
vaccines 252 +3.9% +3.5% 542 +6.4% +6.2%
(incl. Menactra(®))
Adult Booster vaccines 143 +42.3% +26.5% 337 +18.1% 0.0%
(incl. Adacel (®))
Travel and other endemic 114 +53.2% +34.1% 333 +28.0% +12.8%
vaccines
Influenza vaccines
(incl. Vaxigrip(®), 951 +1.0% +1.8% 1,087 +2.4% +3.2%
Fluzone HD(®) &
Fluzone(®))
Dengvaxia(®) 4 -90.0% -90.0% 22 -56.0% -56.0%
Other vaccines 19 -16.0% -12.5% 61 +10.9% +8.9%
Total Vaccines 1,916 +11.0% +7.2% 3,716 +17.0% +11.4%
*CS: constant structure
Third-quarter Vaccines sales were up 11.0% to ?1,916 million and reflected the
termination of the Sanofi Pasteur MSD joint venture in Europe from December
31, 2016. At constant structure, sales were up 7.2% mainly driven by the
Polio/Pertussis/Hib franchise. In the U.S., sales were up 5.5% to ?1,263
million. In Emerging Markets, sales grew 11.9% to ?374 million. In Europe, sales
were up 68.9% to ?199 million and up 9.8% at constant structure. Year-to-date
Vaccines sales grew 11.4% at constant structure to ?3,716 million.
In the third quarter, Polio/Pertussis/Hib (PPH) vaccines sales increased 38.6%
to ?433 million. At constant structure, PPH sales grew 20.7% reflecting
increased Pentaxim(®) sales in China, strong performance of Pentacel(®) in the
U.S., and Hexaxim(®) in Europe and in Emerging markets. At constant structure,
year-to-date Polio/Pertussis/Hib vaccines sales increased 29.5% to ?1,334
million.
Third-quarter and year-to-date Menactra(®) sales increased 8.3% to ?250 million
and 10.0% to ?521 million, respectively.
Influenza vaccines sales increased 1.8% at constant structure to ?951 million in
the third quarter (1.0% at CER) reflecting a competitive environment and the
high level of penetration for Fluzone HD in the over 65 years old population.
The quadrivalent influenza vaccine, VaxigripTetra(TM), was launched in several
countries outside the U.S. Year-to-date influenza vaccines sales were ?1,087
million, up 3.2% at constant structure.
In August, the acquisition of Protein Sciences was completed. Through this
acquisition, Sanofi Pasteur added Flublok(®) to its influenza vaccine portfolio.
Flublok(® )is the only recombinant protein-based influenza vaccine approved by
the U.S. FDA. Flublok(®) QIV has demonstrated in a recent clinical study in
adults 50 years of age and older that it reduced the incidence of laboratory-
confirmed influenza by 30% (relative to comparator).
Third-quarter Adult Booster vaccines sales were ?143 million, up 42.3% and
26.5% at constant structure driven by Adacel(®) in the U.S and improved supply
of Repevax(®) in Europe. At constant structure, year-to-date Adult Booster
vaccines sales were stable at ?337 million.
Third-quarter Travel and other endemic vaccines sales were ?114 million up
53.2% and 34.1% at constant structure reflecting improved supply of Rabies and
Hepatitis A vaccines. At constant structure, year-to-date Travel and other
endemic vaccines sales were up 12.8% to ?333 million.
Third-quarter and first nine months Dengvaxia(®) sales were ?4 million and ?22
million, respectively. This performance resulted from challenges regarding
operational implementation of large public vaccination programs, in a difficult
political and economic environment and a context of low disease incidence, in
particular in Latin America.
Company sales by geographic region
Sanofi sales (? million) Q3 2017 Change Change 9M 2017 Change Change
(CER) (CER/CS) (CER) (CER/CS)
United States 3,442 -2.4% -3.7% 9,004 -0.5% -2.0%
Emerging Markets((a)) 2,517 +11.4% +7.3% 7,689 +10.9% +7.4%
of which Latin America 676 +9.0% +1.6% 2,081 +12.1% +5.3%
of which Asia (including 941 +10.9% +9.5% 2,858 +12.0% +10.6%
South Asia((b)))
of which Africa, Middle East 572 +7.8% +4.0% 1,744 +4.8% +1.6%
of which Eurasia((c)) 303 +32.1% +25.5% 913 +21.3% +16.8%
Europe((d)) 2,297 +8.2% -1.6% 7,058 +8.4% -0.3%
Rest of the World((e)) 797 +9.1% -3.1% 2,613 +11.4% -0.7%
of which Japan 386 +6.8% -12.0% 1,387 +12.3% -6.7%
Total Sanofi sales 9,053 +4.7% -0.2% 26,364 +6.2% +1.2%
*CS : constant structure
(a) World excluding U.S., Canada, Western & Eastern Europe (except
Eurasia), Japan, South Korea, Australia, New Zealand and Puerto Rico
(b) India, 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
Third-quarter sales in the U.S. were ?3,442 million, a decrease of 2.4% or 3.7%
at constant structure impacted by the decline of Diabetes sales (down 22.4%) and
generic competition to Renvela(®)/Renagel(®) which were partially offset by the
performance of the Multiple Sclerosis franchise (up 16.5%), Vaccines (up 5.5%)
as well as the launch of Dupixent(®). In the U.S., at constant structure, year-
to-date sales decreased 2.0% to ?9,004 million.
Third-quarter sales in Emerging Markets were ?2,517 million, up 11.4% or 7.3% at
constant structure driven by Vaccines (up 11.6%), Established Rx Products (up
4.3%) and Diabetes (up 17.3%). In Asia, third-quarter sales were up 10.9% (up
9.5% at constant structure) to ?941 million reflecting strong performance in
China (up 12.3% at constant structure to ?546 million), driven by the recovery
in Vaccines and growth of Established Rx Products and Diabetes. In Latin
America, third-quarter sales increased 9.0% (up 1.6% at constant structure) to
?676 million. Third-quarter sales in Brazil decreased 3.8% at constant structure
to ?269 million due to lower Rare Disease sales arising from order phasing and
to lower Dengvaxia sales. Third-quarter sales in the Eurasia region increased
32.1% (25.5% at constant structure) to ?303 million supported by strong growth
in Russia and Turkey. During the quarter, sales in Russia were ?158 million up
43.4% and 32.2% at constant structure driven by CHC and Vaccines. In Africa and
the Middle East, sales were ?572 million up 7.8% and 4.0% at constant structure.
In Emerging Markets, at constant structure, year-to-date sales increased 7.4% to
?7,689 million.
Third-quarter sales in Europe were ?2,297 million, up 8.2% or down 1.6% at
constant structure impacted by lower Lovenox sales (down 10.9%), Diabetes sales
(down 3.1%) and Generics sales (down 7.1%) which were not fully offset by the
performance of the Multiple Sclerosis franchise (up 14.3%) and Vaccines (up
9.8%). In Europe, at constant structure, year-to-date sales decreased 0.3% to
?7,058 million.
Sales in Japan increased 6.8% to ?386 million in the third quarter. At constant
structure, sales in Japan were down 12.0% impacted by generic Plavix(®
)competition, lower sales of Aprovel(®) and Vaccines. In Japan, at constant
structure, year-to-date sales decreased 6.7% to ?1,387 million.
R&D update
Consult Appendix 6 for full overview of Sanofi's R&D pipeline
Regulatory update
Regulatory updates since the publication of second-quarter results on July
31, 2017 include the following:
* In September, the European Commission granted marketing authorization for
Dupixent(®) (dupilumab), for use in adults with moderate-to-severe atopic
dermatitis who are candidates for systemic therapy.
* In September, the U.S. Food and Drug Administration (FDA) granted
Breakthrough Therapy designation status to cemiplimab (REGN2810/SAR439684)
for the treatment of adults with metastatic cutaneous squamous cell
carcinoma (CSCC) and adults with locally advanced and unresectable CSCC.
Cemiplimab is an investigational human, monoclonal antibody targeting PD-1,
being jointly developed by Sanofi and Regeneron.
* In September, the FDA granted tentative approval for Admelog(®) (insulin
lispro) 100 Units/mL, a rapid-acting human insulin analog. Sanofi filed a
paragraph IV certification and Eli Lilly did not file a suit against Sanofi
within the 45 days period under Hatch-Waxman Act. Sanofi is currently
working closely with the FDA in order to receive full approval for Admelog
in order to launch in the U.S.
At the end of October 2017, the R&D pipeline contained 44 pharmaceutical new
molecular entities (excluding Life Cycle Management) and vaccine candidates in
clinical development of which 13 are in Phase 3 or have been submitted to the
regulatory authorities for approval.
Portfolio update
Phase 3:
* In October, Sanofi and Regeneron announced that the Phase 3 investigational
study, LIBERTY ASTHMA VENTURE, evaluating dupilumab in adults and
adolescents with severe, steroid-dependent asthma met its primary endpoint
and key secondary endpoints. The study results showed that dupilumab
significantly reduced steroid use, asthma attacks, and improved lung
function.
* In September, Sanofi and Alnylam reported positive topline results from the
APOLLO Phase 3 study of patisiran in hereditary ATTR (hATTR) amyloidosis
patients with polyneuropathy. This study met its primary efficacy endpoint
and all secondary endpoints.
* In September, Sanofi and Regeneron announced positive results of the Phase
3 CAFÉ study for Dupixent(®) in patients with moderate-to-severe atopic
dermatitis who are inadequately controlled with or intolerant to the broad
immunosuppressant drug cyclosporine A (CSA), or when this treatment is
medically inadvisable. The results of this study were presented at the
European Academy of Dermatology and Venerology (EADV) Congress.
* In September, Sanofi and Regeneron announced that the pivotal Phase 3
LIBERTY ASTHMA QUEST study of dupilumab in a broad population of patients
with uncontrolled, persistent asthma met its two primary endpoints.
Dupilumab, when added to standard therapies, reduced severe asthma attacks
(exacerbations) and improved lung function.
* In September, Sanofi alliance partner Alnylam Pharmaceuticals announced that
it had suspended dosing in all ongoing fitusiran studies pending further
review of a safety event (a fatal thrombotic event occurred in a patient
with hemophilia A without inhibitors enrolled in the Phase 2 Open Label
Extension study of fitusiran) and development of a risk mitigation strategy.
Based on overall consideration of fitusiran's benefit-risk profile, Alnylam
aims to resume dosing as soon as it is feasible upon agreement with global
regulatory authorities and with appropriate protocol amendments for enhanced
patient safety monitoring in place.
* SAR341402, a rapid acting insulin, entered into phase 3.
* Cemiplimab, a PD1-inhibitor, entered in phase 3 for second-line treatment of
cervical cancer.
Phase 2:
* In October, positive results from a Phase 2 study of dupilumab in adults
with active moderate-to-severe eosinophilic esophagitis were presented at
the World Congress of Gastroenterology (WCOG). The study showed that
patients who received dupilumab weekly reported a significant improvement in
the ability to swallow versus placebo.
* SAR407899, a Rho kinase inhibitor, entered into phase 2a in microvascular
angina.
* Sanofi decided to stop the development of SAR156597 in Idiopathic Pulmonary
Fibrosis.
Phase 1:
* Sanofi does not intend to continue development with, or seek a license from,
the Walter Reed Army Institute of Research for the Zika vaccine candidate
following BARDA's decision (Biomedical Advanced Research and Development
Authority) to de-scope its contract with Sanofi Pasteur to fund the
manufacture and clinical development of an inactivated Zika vaccine.
2017 third-quarter and first-nine months financial results((9))
Business Net Income((9))
In the third quarter of 2017, Sanofi generated net sales of ?9,053 million, an
increase of 0.3% (up 4.7% at CER). First nine months net sales were ?26,364
million, up 5.7% on a reported basis (up 6.2% at CER).
Third-quarter other revenues increased 27.3% (up 33.3% at CER) to ?340 million
reflecting VaxServe sales contribution of non-Sanofi products of ?268 million
(up 49.5% at CER). First nine months other revenues increased 48.9% (up 49.7% at
CER) to ?859 million reflecting VaxServe sales contribution of ?636 million (up
77.5% at CER).
Third-quarter Gross Profit increased 0.3% to ?6,540 million (up 5.0% at CER). At
CER and CS*, third-quarter Gross Profit increased 0.2%. The gross margin ratio
was stable at 72.2% versus the third quarter of 2016. The positive gross margin
impact of Vaccines, China and Immunology was offset by the negative U.S.
Diabetes net price evolution and currency variations. In the third quarter, the
gross margin ratio of Pharmaceuticals was 72.8%, a decrease of 0.5 percentage
points and the gross margin ratio of Vaccines was 70.3%, an increase of 2.6
percentage points. In the first nine months of 2017, the gross margin ratio
improved by 0.3 percentage points to 71.6% versus the first nine months of
2016. Sanofi expects its gross margin ratio to be between 70% and 71% at CER in
2017.
Research and Development (R&D) expenses increased 9.8% to ?1,341 million (up
12.9% at CER) in the third quarter. At CER and CS*, R&D expenses increased
10.7% reflecting mainly the increased spending on the development programs in
immuno-oncology and sotagliflozin as well as a low base for comparison in the
third quarter of 2016. First-nine months R&D expenses increased 7.3% to ?4,008
million (up 7.3% at CER and up 5.3 % at CER and constant structure).
Third-quarter selling general and administrative expenses (SG&A) were up 1.8% to
?2,314 million (up 5.9% at CER). At CER and CS*, SG&A expenses were down 2.1%
mainly reflecting the increasing effect of cost savings. Despite immunology
launch costs, marketing expenses were slightly down at CER and CS* as a result
of a reduction of Diabetes spending in the U.S. and further cost savings
efforts. In the third quarter, the ratio of SG&A to sales increased 0.4
percentage points to 25.6% compared to the third quarter of 2016. First-nine
months SG&A expenses increased 6.9% to ?7,360 million (up 7.1% at CER and down
0.4% at CER and CS*). In the first nine months of 2017, the ratio of SG&A to
sales increased 0.3 percentage points to 27.9% compared to the same period of
2016.
Third-quarter other current operating income net of expenses was ?16 million
versus -?119 million for the same period of 2016. In the third quarter of 2017,
this line included ?68 million of income related to a capital gain and a
litigation settlement. First nine months other current operating income net of
expenses was ?118 million versus -?49 million in the same period of 2016.
The share of profits from associates was ?40 million in the third quarter versus
?71 million for the same period of 2016. The share of profits from associates
included Sanofi's share in Regeneron profit. In the third quarter of 2016, this
line included the share of profit of Sanofi Pasteur MSD for an amount of ?29
million. In the first nine months, the share of profits from associates was ?121
million versus ?124 million for the same period of 2016.
In the third quarter, non-controlling interests were -?30 million versus -?31
million in the third quarter of 2016. First nine months non-controlling
interests were -?95 million versus -?81 million for the same period of 2016.
(9) See Appendix 3 for 2017 third-quarter and first nine months consolidated
income statement; see Appendix 8 for definitions of financial indicators, and
Appendix 4 for reconciliation of IFRS net income reported to business net
income.
* Adjusted for BI CHC business and termination of SPMSD and others.
Third-quarter business operating income decreased 1.2% to ?2,911million. At CER,
business operating income increased 5.1%. At CER and CS*, business operating
income increased 1.7%. The ratio of business operating income to net sales
decreased 0.4 percentage points to 32.2% versus the same period of 2016. In the
third quarter, the business operating income ratio of Pharmaceuticals was
27.4%, 1.2 percentage points lower and the business operating income ratio of
Vaccines was 51.1%, 0.4 percentage points higher. First-nine months business
operating income increased 6.9% (or up 8.0% at CER) to ?7,652 million. At CER
and CS*, business operating income increased 4.1%. In the first nine months of
2017, the ratio of business operating income to net sales increased 0.3
percentage points to 29.0%.
Net financial expenses were ?77 million in the third quarter versus ?83 million
in the third quarter of 2016. First nine months net financial expenses were ?200
million versus ?274 million in the first nine months of 2016.
Third-quarter (and first nine months) effective tax rate was 24.5% compared to
23.3% in the third quarter of 2016.
Third-quarter business net income((9)) decreased 6.9% to ?2,141 million (down
1.1% at CER). The ratio of business net income to net sales decreased 0.8
percentage points to 23.6% versus the same period of 2016 (excluding Animal
Health business). First nine months business net income decreased 1.2% to ?5,632
million, (down 0.3% at CER). The ratio of business net income to net sales
increased 0.1 percentage points to 21.4% compared to the first nine months of
2016 (excluding Animal Health business).
+------------------------------------------------------------------------------+
|In the third quarter of 2017, business earnings per share((9)) (EPS) decreased|
|4.5% to ?1.71 on a reported basis and increased 1.1% at CER. The average|
|number of shares outstanding was 1,254.3 million in the third quarter of 2017 |
|versus 1,288.5 million in the third quarter of 2016. |
|In the first nine month of 2017, business earnings per share((9)) was ?4.48,|
|up 1.1% on a reported basis and up 2.0% at CER. The average number of shares|
|outstanding was 1,258.3 million in the first nine months of 2017 versus|
|1,287.9 million in the first nine months of 2016. |
+------------------------------------------------------------------------------+
2017 Guidance
Sanofi confirms its full-year 2017 guidance for business EPS((9)) to be broadly
stable at CER, barring unforeseen major adverse events. The currency impact on
2017 business EPS is now estimated to be -1% to -2% if the average September
2017 exchange rates are applied to the fourth quarter of 2017.
Reconciliation of IFRS net income reported to business net income (see Appendix
4)
In the first nine months of 2017, the IFRS net income was ?8,305 million
reflecting the acquisition of BI's CHC business and full consolidation of
Sanofi's European vaccine operations. The main items excluded from the business
net income were:
* A net gain of ?4,484 million resulting from the divestment of the Animal
Health business.
* An amortization charge of ?1,424 million related to fair value remeasurement
on intangible assets of acquired companies (primarily Aventis: ?285 million,
Genzyme: ?658 million and BI CHC business ?188 million) and to acquired
intangible assets (licenses/products: ?105 million). An amortization charge
of ?434 million related to fair value remeasurement on intangible assets of
acquired companies (primarily Aventis: ?81 million, Genzyme: ?200 million
and BI CHC business ?55 million) and to acquired intangible assets
(licenses/products: ?34 million) was recorded in the third quarter. These
items have no cash impact on the Company.
* An impairment of intangible assets of ?31million (of which ?19 million
recorded in the third quarter). This item has no cash impact on the Company.
* A charge of ?174 million (of which ?74 million in the third quarter) mainly
reflecting an increase of Bayer contingent considerations linked to
Lemtrada(®) (charge of ?86 million of which ?2 million in the third quarter
2017) and fair value adjustment of contingent consideration linked to Sanofi
Pasteur MSD termination (?75 million in the third quarter).
* Expenses of ?176 million arising from the impact of the acquisition of BI
CHC business and Sanofi Pasteur MSD termination on inventories.
* Restructuring costs and similar items of ?613 million (of which ?249 million
in the third quarter) mainly related to streamlining initiatives in addition
to the rationalization of the industrial network.
(9) See Appendix 3 for 2017 third-quarter and first nine months consolidated
income statement; see Appendix 8 for definitions of financial indicators, and
Appendix 4 for reconciliation of IFRS net income reported to business net
income.
* A ?909 million tax effect arising from the items listed above, comprising
?467 million of deferred taxes generated by amortization charged against
intangible assets, ?216 million associated with restructuring costs and
similar items, ?56 million associated with the impact of acquisition on
inventories and ?33 million associated with fair value remeasurement of
contingent consideration.
* The third quarter tax effect was ?281 million, including ?134 million of
deferred taxes on amortization charged against intangible assets and ?90
million associated with restructuring costs and similar items (see Appendix
4).
* A tax of ?111 million on dividends paid to shareholders of Sanofi.
On October 6, 2017, the French Constitutional Council (Conseil Constitutionnel)
declared invalid the additional contribution of 3% due on dividends paid in cash
since August 2012. The company will record the impact of this decision and any
additional tax measures in the fourth quarter of 2017.
* An expense of ?41 million net of tax (of which an income of ?2 million in
the third quarter) related to expenses arising from the impact of
acquisitions on associates and joint ventures.
Capital Allocation
In the first nine months of 2017, net cash generated by operating activities was
?4,156 million after capital expenditures of ?1,009 million and an increase in
working capital of ?1,460 million. This net cash flow funded acquisitions and
partnerships net of disposals (?924 million) and restructuring costs and similar
items (?621 million). The swap between BI CHC business and Sanofi Animal Health
business generated a net cash flow of ?4,062 million, partially used to finance
share repurchases (?2,158 million) over the period. Net debt decreased from
?8,206 million at December 31, 2016 to ?6,961 million at the end of September
2017 (amount net of ?9,887 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 regarding the marketing and other potential of the
product, or regarding potential future revenues from the product. 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, unexpected regulatory actions or delays, or
government regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that the product
will be commercially successful, the uncertainties inherent in research and
development, including future clinical data and analysis of existing clinical
data relating to the product, including post marketing, unexpected safety,
quality or manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the ultimate outcome
of such litigation, and volatile economic conditions, as well as those risks
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, 2016. 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: 2017 third-quarter and first nine months net sales by GBU,
franchise, geographic region and product
Appendix 2: 2017 third-quarter and first nine months business net income
statement
Appendix 3: 2017 third-quarter and first nine months consolidated income
statement
Appendix 4: Reconciliation of IFRS net income reported to business net income
Appendix 5: Currency sensitivity
Appendix 6: R&D pipeline
Appendix 7: Expected R&D milestones
Appendix 8: Definitions of non-GAAP financial indicators
Appendix 1: 2017 third-quarter net sales by GBU, franchise, geographic region
and product
+-------------------------------------------------------------------+ +-------------------+
Q3 2017 net| Uni- Rest | Emer- |Total |
sales |Total % CER % re- Eu- % CER ted % CER of % CER | ging % CER |Fran- % CER % re- |
(? million)|GBUs ported rope Sta- the | Mar- |chi- ported|
| tes World | kets | ses |
| | | |
Aubagio | 374 19.3% 14.7% 86 16.0% 274 20.9% 14 8.3%| 8 12.5% | 382 19.2% 14.4%|
| | | |
Lemtrada | 107 3.7% 0.0% 40 10.8% 60 0.0% 7 0.0%| 6 40.0% | 113 5.4% 0.9%|
| | | |
Total MS | 481 15.5% 11.1% 126 14.3% 334 16.5% 21 5.6%| 14 23.1% | 495 15.7% 11.0%|
------------+-------------------- --------------- --------------- --------------+ -------------- +-------------------+
Cerezyme | 119 -3.9% -6.3% 68 0.0% 42 -6.5% 9 -15.4%| 59 14.3% | 178 1.6% -2.7%|
| | | |
Cerdelga | 31 14.3% 10.7% 7 75.0% 23 4.3% 1 0.0%| 0 - | 31 14.3% 10.7%|
| | | |
Myozyme | 166 6.9% 4.4% 88 3.6% 63 8.2% 15 21.4%| 25 0.0% | 191 5.9% 3.2%|
| | | |
Fabrazyme | 158 8.6% 3.9% 40 2.6% 89 9.3% 29 14.8%| 17 -20.8% | 175 4.5% -0.6%|
| | | |
Aldurazyme | 35 2.9% 0.0% 18 0.0% 10 0.0% 7 16.7%| 15 -11.1% | 50 -1.9% -5.7%|
| | | |
Unternehmensinformation / Kurzprofil:
Datum: 02.11.2017 - 07:29 Uhr
Sprache: Deutsch
News-ID 566290
Anzahl Zeichen: 65566
contact information:
Town:
PARIS
Kategorie:
Business News
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