Sanofi Delivers Robust Q1 2017 Financial Results
(Thomson Reuters ONE) -
Paris, April 28, 2017
Sanofi Delivers Robust Q1 2017 Financial Results
Q1 2017 Change Change at CER Change at CER and CS((1))
IFRS net sales reported ?8,648m +11.1% +8.6% +3.5%
IFRS net income reported ?5,701m +424.5% - -
IFRS EPS reported ?4.52 +438.1% - -
--------------------------------------------------------------------------------
Business net income((2)) ?1,795m +4.2% +1.0% -
Business EPS((2)) ?1.42 +6.0% +3.0% -
--------------------------------------------------------------------------------
First-quarter 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((3))). 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. The first
quarter 2017 income statement also reflects 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 December
2016.
+------------------------------------------------------------------------------+
|Q1 2017 sales growth supported by Specialty Care, Vaccines and Emerging |
|Markets |
| * Net sales were ?8,648 million, up 11.1% on a reported basis and 8.6%((4)) |
| at CER reflecting the acquisition of Boehringer Ingelheim's (BI) CHC |
| business and full consolidation of Sanofi's European vaccine operations. |
| At constant structure and CER, net sales were up 3.5%. |
| * Sanofi Genzyme (Specialty Care) GBU sales increased 15.5% at CER driven by|
| Multiple Sclerosis products. |
| * Diabetes and Cardiovascular GBU sales were down 7.7% at CER; Global |
| Diabetes franchise sales decreased 6.0%. |
| * Sanofi Pasteur GBU grew 13.2% at CER and constant structure due to the |
| strong performance of pediatric combinations. |
| * CHC GBU sales were up 4.7% at CER and constant structure driven by the |
| performance in Europe. |
| * Emerging Markets((5)) sales increased 8.5% at CER and constant structure. |
| |
|Strong financial results and 2017 guidance confirmed |
| * Business operating income of ?2,442 million, up 7.6% at CER and constant |
| structure. |
| * Business EPS((2)) grew 3.0% at CER to ?1.42 and increased 6.0% on a |
| reported basis. |
| * Sanofi continues to expect 2017 Business EPS((2)) to be stable to -3%((6))|
| at CER, barring unforeseen major adverse events. |
| * IFRS net income of ?5,701 million (up 424%) included a net gain of ?4,427 |
| million resulting from the divestment of Merial. |
| |
|Sanofi progresses on its 2020 roadmap |
| * Integration of Boehringer Ingelheim CHC business on track, enhancing |
| Sanofi's position in key categories and regions. |
| * Following the termination of the SPMSD JV, European vaccine business now |
| fully driven by Sanofi. |
| * Dupixent(®), a breakthrough therapy for moderate-to-severe atopic |
| dermatitis, now available to adult patients in the U.S. |
| * Soliqua(TM)100/33, first once-daily fixed combination of Lantus(®) and |
| lixisenatide for type-2 diabetes, launched in the U.S. |
| * Kevzara(TM) BLA for the treatment of rheumatoid arthritis granted PDUFA |
| date of May 22, 2017. |
| * FDA approval of Xyzal(®) Allergy 24H for OTC use and launch underway ahead|
| of the U.S. spring allergy season. |
+------------------------------------------------------------------------------+
Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"We have started the year with robust growth driven by Specialty Care and
Vaccines as well as good performance in Emerging Markets. Our top line in the
first quarter also benefited from the integration of the Boehringer Ingelheim
CHC and European vaccine businesses. At the same time, the simplified
organization continues to contribute to Sanofi's financial performance. The U.S.
launch of Dupixent(®) for moderate-to-severe atopic dermatitis marks a key
innovation milestone on our strategic roadmap and lays the foundation for our
new immunology franchise. We are excited to bring this highly innovative
medicine to patients suffering from this devastating disease".
(1) CS: constant structure: adjusted for BI CHC business, termination of SPMSD
and others; (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 8 for definitions). The
consolidated income statement for Q1 2017 is provided in Appendix 3 and a
reconciliation of IFRS net income reported to business net income is set forth
in Appendix 4; (3) The closing of the disposal of Merial in Mexico is expected
in 2017; (4) changes in net sales are expressed at constant exchange rates (CER)
unless otherwise indicated (see Appendix 8); (5) See page 7; (6) 2016 Business
EPS was ?5.68
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 first-quarter Sanofi sales
Unless otherwise indicated, all percentage changes in sales in this press
release are stated at CER((7)).
In the first quarter of 2017, Company sales were ?8,648 million, up 11.1% on a
reported basis. Exchange rate movements had a favorable effect of 2.5 percentage
points reflecting mainly the positive evolution of the U.S. dollar, Brazilian
Real and Japanese Yen which more than offset the negative impact from the
Egyptian Pound, Turkish Lira and British Pound. Company sales benefited from the
acquisition of BI's CHC business and full consolidation of Sanofi's European
vaccines operations leading to an increase of 8.6% at CER. At CER and constant
structure, Company sales were up 3.5%.
Global Business Units
The table below presents sales by Global Business Unit (GBU) and reflects the
organization of Sanofi which became effective as of January 1, 2016. This
structure drives deeper specialization, simplifies reporting and provides clear
focus on growth drivers. Please note that in Emerging Markets, Specialty Care
and Diabetes and Cardiovascular sales are included in the General Medicines and
Emerging Markets GBU.
Net Sales by GBU Q1 2017 Change Change
(? million) (CER) at CER/CS*
Sanofi Genzyme (Specialty Care)((a)) 1,379 +15.5% +15.5%
Diabetes and Cardiovascular((a)) 1,419 -7.7% -7.7%
General Medicines & Emerging Markets((b)) 3,725 +2.2% +2.1%
Consumer Healthcare (CHC) 1,341 +42.7% +4.7%
Total Pharmaceuticals 7,864 +7.4% +2.6%
Sanofi Pasteur (Vaccines) 784 +22.2 +13.2%
Total Company sales 8,648 +8.6% +3.5%
(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 table below presents first quarter 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 Q1 2017 (CER) at Markets at Markets at
(? million) CER/CS* CER/CS* CER/CS*
--------------------------------- ------------------
Specialty Care 1,620 +15.6% +15.6% 1,379 +15.5% 241 +16.3%
Diabetes and 1,795 -4.0% -4.0% 1,419 -7.7% 376 +12.3%
Cardiovascular
Established Rx 2,640 +0.6% +0.3% 1,634 -4.1% 1,006 +8.3%
Products
Consumer 1,341 +42.7% +4.7% 937 +6.1% 404 +1.3%
Healthcare (CHC)
Generics 468 -2.0% -1.7% 268 -5.0% 200 +3.4%
Vaccines 784 +22.2% +13.2% 468 +14.6% 316 +11.1%
Total net sales 8,648 +8.6% +3.5% 6,105 +1.6% 2,543 +8.5%
*CS : constant structure
Pharmaceuticals
First-quarter Pharmaceuticals sales increased 7.4% to ?7,864 million. At
constant structure, Pharmaceuticals sales were up 2.6% driven by Multiple
Sclerosis, CHC, Rare Disease, Oncology and Cardiovascular franchises.
(7) See Appendix 8 for definitions of financial indicators.
Rare Disease franchise
Net sales (? million) Q1 2017 Change
(CER)
Myozyme(® )/ Lumizyme(®) 190 +12.7%
Cerezyme(®) 176 -4.9%
Fabrazyme(®) 177 +15.4%
Aldurazyme(®) 52 +8.3%
Cerdelga(®) 31 +30.4%
Others 86 +3.8%
Total Rare Diseases 712 +7.6%
In the first quarter, Rare Disease sales increased 7.6% to ?712 million driven
by the accrual of patients worldwide. Rare Disease sales grew at double digits
in the U.S. and Emerging Markets, up 12.2% and 11.1%, respectively.
In the first quarter, Gaucher (Cerezyme(®) and Cerdelga(®)) sales decreased
1.0% to ?207 million, due to lower Cerezyme(®) sales in Emerging Markets (down
10.7% to ?50 million) mostly driven by ordering patterns in Latin America.
Cerdelga(®) sales increased 30.4% to ?31 million of which ?25 million were
generated in the U.S. (up 26.3%).
First-quarter Fabrazyme(®) sales were up 15.4% to ?177 million, reflecting a
continued accrual of new Fabry patients.
Myozyme(®)/Lumizyme(®) sales increased 12.7% to ?190 million in the first
quarter, mainly due to new patient accruals and increased worldwide diagnosis of
Pompe disease.
Multiple Sclerosis franchise
Net sales (? million) Q1 2017 Change
(CER)
Aubagio(®) 371 +29.7%
Lemtrada(®) 125 +40.9%
Total Multiple Sclerosis 496 +32.4%
First-quarter Multiple Sclerosis (MS) sales increased 32.4% to ?496 million,
reflecting strong Aubagio(®) and Lemtrada(®) performance in the U.S. and Europe.
In the first quarter, Aubagio(® )sales increased 29.7% to ?371 million driven by
the U.S. (up 33.0% to ?259 million) and Europe (up 23.0% to ?91 million). In the
U.S., Aubagio(®) has achieved market share of 9.0% (source IMS TRX-Q1 2017) and
is now the most "switched to" disease modifying therapy in the U.S. (source IMS
NPA Market Dynamics).
First-quarter Lemtrada(®) sales increased 40.9% to ?125 million, including ?67
million in the U.S. (up 39.1%) and ?45 million in Europe (up 31.4%).
Oncology franchise
Net sales (? million) Q1 2017 Change
(CER)
Jevtana(®) 97 +5.6%
Thymoglobulin(®) 72 +7.7%
Taxotere(®) 47 +2.2%
Eloxatin(®) 45 +7.1%
Mozobil(®) 40 +11.4%
Zaltrap(®) 16 -5.9%
Others 95 +46.0%
Total Oncology 412 +12.8%
First-quarter Oncology sales increased 12.8% to ?412 million driven mainly by
Jevtana(®) and boosted by a U.S. government order for Leukine(®). Jevtana(®
)sales were up 5.6% to ?97 million in the first quarter led by Europe (up 5.7%
to ?37 million) and Japan. In the first quarter, Thymoglobulin(®) sales
increased 7.7% to ?72 million supported by the U.S. (up 8.1% to ?41 million).
Eloxatin(®) sales increased 7.1% to ?45 million in the first quarter supported
by China (Emerging Markets sales were up 27.6% to ?37 million) which offset
generic competition in Canada. First-quarter Taxotere(®) sales increased 2.2%
(to ?47 million) driven by Emerging Markets (up 23.3% to ?37) which offset
continued generic competition in Japan.
Diabetes franchise
Net sales (? million) Q1 2017 Change
(CER)
Lantus(®) 1,226 -14.1%
Toujeo(®) 192 +78.6%
Total glargine 1,418 -7.7%
Apidra(®) 98 +14.1%
Amaryl(®) 89 +5.7%
Insuman(®) 27 -15.6%
BGM (Blood Glucose Monitoring) 17 -
Lyxumia(®) 7 -22.2%
Soliqua(®) 4 -
Total Diabetes 1,663 -6.0%
In the first quarter, Diabetes sales decreased 6.0% to ?1,663 million, including
lower Lantus(®) sales in the U.S. First-quarter U.S. Diabetes sales were down
14.7% to ?839 million. Sales in Emerging Markets increased 12.1% to ?373
million. Sales in Europe were ?326 million, a decrease of 3.0%.
In the first quarter, Sanofi glargine (Lantus(®) and Toujeo(®)) sales decreased
7.7% to ?1,418 million. In the U.S., Sanofi glargine sales of ?805 million were
down 15.5% and reflected the impact of the exclusion from various CVS commercial
formularies. The U.S. Diabetes sales decline is expected to accelerate over the
remainder of the year primarily due to the United Health formulary exclusion
which started April 1, 2017 as well as an incremental impact from the CVS
formulary exclusion. In Europe, Sanofi glargine sales decreased 3.1% to ?245
million due to biosimilar competition in several European markets.
Over the quarter, Lantus(®) sales were ?1,226 million down 14.1%. In the U.S.,
Lantus(®) sales decreased 20.9% to ?690 million mainly reflecting lower average
net price and patients switching to Toujeo(®) as well as the aforementioned
impact of formulary exclusions. In Europe, first-quarter Lantus(®) sales were
?199 million (down 14.8%) due to biosimilar competition and patients switching
to Toujeo(®). In Emerging Markets, sales were up 9.6% to ?253 million.
First-quarter Toujeo(®) sales were ?192 million (up 78.6%) of which ?115 million
(up 42.3%) were recorded in the U.S. and ?46 million in Europe.
Amaryl(®) sales were ?89 million, up 5.7% in the first quarter, of which ?73
million were generated in Emerging Markets (up 8.5%).
First-quarter Apidra(®) sales increased 14.1% to ?98 million, reflecting double
digit growth in the U.S. (up 12.0% to ?29 million), Europe (up 12.9% to ?35
million), and Emerging Markets (up 20.0% to ?24 million).
Since January 2017, Soliqua(TM) 100/33 (insulin glargine 100 Units/mL &
lixisenatide 33 mcg/mL injection; lixisenatide was in-licensed from Zealand
Pharma) has been available in the U.S. Soliqua(TM) sales were ?4 million in the
first quarter.
Cardiovascular franchise
First-quarter Praluent(®) sales (collaboration with Regeneron) were ?34 million
of which ?24 million was in the U.S. and ?8 million in Europe. This reflected
significant payer utilization management restrictions in the U.S. and limited
market access in Europe.
In January 2017, the U.S. District Court for the District of Delaware issued an
injunction that required Sanofi and Regeneron to stop marketing, selling and
manufacturing Praluent(®) in the U.S. starting from February 21, 2017. However,
on February 8, 2017, the Court of Appeals for the Federal Circuit stayed
(suspended) the permanent injunction for Praluent(®) pending the companies'
appeal. As a result, Sanofi and Regeneron will continue marketing, selling and
manufacturing Praluent(®) in the U.S. during the appeal process. The Court of
Appeals is scheduled to hear oral arguments on June 6, 2017.
First-quarter Multaq(®) sales were ?98 million, up 10.5% reflecting 9.6% growth
(to ?83 million) in the U.S.
Established Rx Products
Net sales (? million) Q1 2017 Change
(CER)
Lovenox(®) 415 +2.2%
Plavix(®) 380 -1.8%
Renvela(®)/Renagel(®) 246 +2.1%
Aprovel(®)/Avapro(®) 193 +13.0%
Synvisc(® )/Synvisc-One(®) 90 -1.1%
Myslee(®)/Ambien(®)/Stilnox(®) 73 -1.4%
Allegra(®) 68 -13.3%
Other 1,175 -0.2%
Total Established Rx Products 2,640 +0.6%
---------------------------------------------------
In the first quarter, Established Rx Products sales increased 0.6% to ?2,640
million, reflecting strong performance in Emerging Markets (up 8.2% to ?1,006
million) which offset the impact of generic competition to Plavix(®) in Japan.
In the U.S., Established Rx Products sales decreased 4.9% (to ?365 million). In
Europe, Established Rx Products sales decreased 2.1% to ?907 million.
Lovenox(® )sales increased 2.2% to ?415 million in the first quarter, driven by
strong performance in Emerging Markets (up 14.3% to ?120 million), which offset
lower sales in Europe (down 1.5% to ?257 million).
In the first quarter, Plavix(® )sales were down 1.8% to ?380 million due to
generic competition in Japan that started in June 2015 (sales in Japan were down
33.7% to ?64 million). In Emerging Markets, Plavix sales increased 10.8% to ?262
million sustained by the performance in China.
First-quarter Renvela(®)/Renagel(® )sales increased 2.1% to ?246 million. In the
U.S. where Sanofi expects generic competition before the end of 2017, first-
quarter sales were up 3.1% to ?207 million. In Europe, Renvela(®)/Renagel(®
)sales were down 13.6% to ?18 million due to generic competition.
Aprovel(®)/Avapro(®) sales were up 13.0% (to ?193 million) driven by product
sales to our partner in Japan and sales in China.
Consumer Healthcare
CHC sales by geography and category are provided in Appendix 1.
Net sales (? million) Q1 2017 Change Change
(CER) at CER/CS*
Allergy Cough & Cold 414 +58.7% +12.6%
of which Allegra(®) 145 -0.7% -
of which Mucosolvan(®) 35 na na
Pain 324 +45.1% +10.2%
of which Doliprane(®) 83 +7.8% -
of which Buscopan(®) 42 na na
Digestive 229 +55.6% -8.3%
of which Dulcolax(®) 47 na na
of which Enterogermina(®) 47 +9.5% -
of which Essentiale(®) 35 -17.9% -
of which Zantac(®) 27 na na
Nutritionals 164 +36.3% -1.3%
of which Pharmaton(®) 17 na na
Other 210 +11.0% +3.1%
of which Gold Bond(®) 50 +2.1% -
Total Consumer Healthcare 1,341 +42.7% +4.7%
*CS : constant structure
In the first quarter, Consumer Healthcare (CHC) sales increased 42.7% to ?1,341
million reflecting the closing of the acquisition of Boehringer Ingelheim CHC
business on January 1(st), 2017 and the transfer of some Sanofi products to the
new Chinese joint-venture between Sanofi and China Resources Sanjiu (CR999). At
constant structure, Sanofi CHC sales increased 4.7% in the first quarter mainly
driven by the strong performance in Europe.
In Europe, CHC sales were up 68.2% to ?406 million. At constant structure, sales
were up 10.0%, due to an early cough and cold season. Over the period double-
digit growth at constant structure was achieved by the Allergy Cough and Cold
category (up 21.6%, driven by Mucosolvan(®), Bisolvon(®) and Allegra(®)) and the
pain category (up 15.7% driven by Buscopan(®) and Doliprane(®)).
In the U.S., first quarter CHC sales increased 18.7% to ?348 million. At
constant structure, CHC sales were up 2.4% driven by the launch of Xyzal(®)
Allergy 24HR (sales of ?43 million) which was approved in February as an over-
the-counter treatment for the relief of symptoms associated with seasonal and
year-round allergies. In the first quarter, the performance at constant
structure of the Allergy, Cough and Cold (up 12.9%, driven by Xyzal(®) launch)
and Pain categories (up 16.7%) were partially offset by lower sales of the
Digestive category (down 19.2%, impacted by lower sales of Dulcolax(®) and
Zantac(®)).
In Emerging Markets, first-quarter CHC sales increased 20.9% to ?404 million. At
constant structure, CHC sales were up 1.3% reflecting lower sales in Russia
which continued to be impacted by the economic environment. In Emerging Markets,
the strong performance at constant structure of the Allergy Cough and Cold
category (up 14.1%) was partially offset by lower sales of the Digestive
category due to Essentiale(®).
In the rest of the world, CHC sales were up 151.5% to ?183 million. At constant
structure, CHC sales were up 4.9% mainly driven by the Nutritionals and Pain
categories.
Generics
In the first quarter, Generics sales decreased 2.0% to ?468 million reflecting
lower sales in Europe (down 3.4% to ?198 million), and a 2.8% increase in
Emerging Markets (to ?200 million).
As announced in our 2020 strategic roadmap, Sanofi has carefully reviewed all
options for our Generics business in Europe and made the definitive decision to
initiate a carve-out process expected to be completed by the end of 2018.
Importantly, Sanofi confirms its commitment to Generics in other parts of the
world with a greater focus on the Emerging Markets.
Vaccines
Net sales (? million) Q1 2017 Change Change
(CER) at CER/CS*
Polio/Pertussis/Hib vaccines 432 +46.2% +38.0%
(incl. Pentacel(®), Pentaxim(® )and Imovax(®))
Influenza vaccines 38 +85.0% +85.0%
(incl. Vaxigrip(®) and Fluzone(®))
Adult Booster vaccines (incl. Adacel (®)) 79 -5.0% -23.2%
Meningitis/Pneumonia vaccines 95 -24.6% -24.6%
(incl. Menactra(®))
Travel and other endemic vaccines 106 +25.3% +8.3%
Dengvaxia(®) 17 -5.3% -5.3%
Other vaccines 17 +23.1% +14.3%
Total Vaccines (consolidated sales) 784 +22.2% +13.2%
*CS : constant structure
First quarter consolidated Vaccines sales were up 22.2% to ?784 million and
reflected the termination of the Sanofi Pasteur MSD joint-venture in Europe from
December 31, 2016. At constant structure, sales were up 13.2% mainly driven by
the Polio/Pertussis/Hib (PPH) franchise. In the U.S., sales were up 13.5% to
?287 million. In Emerging Markets, sales grew 11.5% to ?316 million. In Europe,
sales were up 110.4% to ?100 million reflecting the termination of SPMSD JV. At
constant structure, European sales were up 4.1%.
In the first quarter, Polio/Pertussis/Hib vaccines sales increased 46.2% to ?432
million. At constant structure, PPH sales grew 38.0% reflecting supply recovery
of Pentacel(®) and CDC order phasing in the U.S. (U.S. Pentacel(®) sales: ?89
million versus ?21 million in the first quarter of 2016), and increased release
of Pentaxim(®) batches in China.
Influenza vaccines sales were up 85.0% to ?38 million boosted by supply to
Butantan in Brazil in the first quarter.
First-quarter Adult Booster vaccines sales were ?79 million, down 5.0%, or down
23.2% at constant structure impacted by Repevax(®) supply disruption in Europe.
First quarter Dengvaxia(® )sales were ?17 million mainly reflecting the sales of
the third dose for the public immunization program implemented in the
Philippines at the beginning of 2016.
First-quarter Menactra(®) sales were down 21.6% to ?90 million mainly due to the
U.S. CDC ordering pattern in the previous year.
First-quarter Travel and other endemic vaccines sales were ?106 million up
25.3% and up 8.3% at constant structure.
Company sales by geographic region
Sanofi sales (? million) Q1 2017 Change Change
(CER) (CER/CS)
United States 2,764 +3.0% +1.2%
Emerging Markets((a)) 2,543 +11.3% +8.5%
of which Latin America 676 +18.6% +12.0%
of which Asia (including South Asia((b))) 983 +13.4% +12.4%
of which Africa, Middle East 546 +1.6% -0.7%
of which Eurasia((c)) 298 +14.3% +9.9%
Europe((d)) 2,411 +10.4% +1.8%
Rest of the World((e)) 930 +14.9% +2.2%
of which Japan 529 +19.9% -0.6%
Total Sanofi sales 8,648 +8.6% +3.5%
*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
First-quarter sales in the U.S. were ?2,764 million, an increase of 3.0% or
1.2% at constant structure driven mainly by the Multiple Sclerosis franchise (up
34.2%), Vaccines (up 13.5%), Oncology (up 23.1%), Rare Diseases (up 12.2%) and
Cardiovascular (up 25.6%) which offset lower sales of Diabetes (down 14.7%).
First-quarter sales in Emerging Markets were ?2,543 million, up 11.3% or 8.5% at
constant structure driven by Established Rx products (up 8.3% at constant
structure), Diabetes (up 12.1%), Vaccines (up 11.5%), Oncology (up 22.6%) and
Rare Disease (up 11.1%). In Asia, first quarter sales were up 13.4% (up 12.4% at
constant structure) to ?983 million reflecting strong performance in China (up
17.0% at constant structure to ?597 million), driven by Pharmaceuticals and also
by the end of the vaccines market disruption. In Latin America, first quarter
sales increased 18.6% (up 12.0% at constant structure) to ?676 million sustained
by Brazil. First-quarter sales in Brazil increased 24.5% at constant structure
to ?320 million supported by performance of Established Rx Products, Vaccines,
generics and CHC. First-quarter sales in the Eurasia region increased 14.3%
(9.9% at constant structure) to ?298 million supported by strong growth in
Turkey. Over the quarter, sales in Russia were ?147 million up 0.9% and down
4.3% at constant structure impacted by local economic conditions. In Africa and
the Middle East, sales were ?546 million up 1.6% or down 0.7% at constant
structure reflecting lower sales in Middle East due to phasing of vaccines
supply and a modest growth in Africa.
First-quarter sales in Europe were ?2,411 million, up 10.4% or 1.8% at constant
structure, mainly driven by the performance of the Multiple Sclerosis franchise
(up 25.7%) and CHC (up 10.0% at constant structure) which offset lower sales in
Diabetes (down 3.0%) and Established Rx Products (down 3.1% at constant
structure).
Sales in Japan increased 19.9% to ?529 million in the first quarter. At constant
structure, sales in Japan were down 0.6% impacted by generic Plavix(®
)competition which was partially offset by strong growth of vaccines sales.
R&D update
Consult Appendix 6 for full overview of Sanofi's R&D pipeline
Regulatory update
Regulatory updates since the publication of 2016 full-year results on February
8, 2017 include the following:
* In April, the FDA approved a new dosing regimen for Praluent(®) of 300 mg
administered subcutaneously once monthly (every 4 weeks).
* In April the European Medicine Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) granted a positive opinion for the marketing
authorization of Kevzara(®) (sarilumab), recommending its approval for use
in adult patients with moderately to severely active rheumatoid arthritis.
* In March, the U.S. Food and Drug Administration (FDA) approved Dupixent(®)
(dupilumab), the first and only biologic medicine approved for the treatment
of adults with moderate-to-severe atopic dermatitis (AD) whose disease is
not adequately controlled with topical prescription therapies, or when those
therapies are not advisable.
* Following successful conclusion of Le Trait manufacturing site inspection by
FDA, the Kevzara(TM) (sarilumab) U.S. BLA was accepted in April for the
treatment of rheumatoid arthritis with a PDUFA date of May 22, 2017.
At the end of April 2017, the R&D pipeline contained 46 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 4:
* Top-line results of the ODYSSEY OUTCOMES study on Praluent(®) are now
expected to be reported in the first quarter of 2018 based on communications
from the independent DSMB (Data and Safety Monitoring Board). Recruitment
for this 18,600-patient cardiovascular outcomes trial was completed in
November 2015 and the scheduled two-year follow-up of patients is underway.
Phase 3:
* The results of the CAFÉ study evaluating dupilumab in cyclosporine-resistant
patients in moderate-to-severe atopic dermatitis were positive and
demonstrated an acceptable safety profile. These results will be submitted
to the EMA and presented at a scientific Congress.
* In March, detailed results from the one-year Phase 3 CHRONOS study were
presented at the Annual Meeting of the American Academy of Dermatology
(AAD). In this study, patients receiving Dupixent(®) with topical
corticosteroids (TCS) achieved significantly improved measures of overall
disease severity compared to TCS alone in adults with uncontrolled moderate-
to-severe AD with a safety profile consistent with previous studies.
Phase 2:
* SP0232 / MEDI8897 (partnership with MedImmune), a monoclonal antibody,
entered the portfolio in Phase 2 for the prevention of lower respiratory
tract illness in infants caused by respiratory syncytial virus.
* SAR566658, a maytansin-loaded anti-CA6 monoclonal antibody, entered into
Phase 2 for the treatment of triple negative breast cancer.
* A Phase 2 study was initiated to evaluate isatuximab in acute lymphoblastic
leukemia.
Phase 1:
* SAR440181 / MYK491 (collaboration with MyoKardia), for the treatment of
dilated cardiomyopathy (DCM1 myosin activation), entered Phase 1.
2017 first-quarter financial results((8))
Business Net Income((8))
In the first quarter of 2017, Sanofi generated sales of ?8,648 million, an
increase of 11.1% (up 8.6% at CER).
First-quarter other revenues increased 71.7% (up 66.9% at CER) to ?249 million
including VaxServe sales of non-Sanofi products of ?173 million (versus ?83
million in the first quarter of 2016).
First-quarter Gross Profit increased 13.1% to ?6,200 million (up 10.6% at CER).
At CER and constant structure*, Gross Profit increased 5.4%. The gross margin
ratio improved by 1.3 percentage points to 71.7% versus the first quarter of
2016, mainly reflecting the positive impact of the growing Multiple Sclerosis
business, a favorable product and geographical mix in our Established Rx Product
franchise, as well as industrial productivity improvements. These impacts more
than offset the negative U.S. Diabetes net price evolution. In the first
quarter, the gross margin ratio of Pharmaceuticals was 73.1%, an improvement of
1.6 percentage points and the gross margin ratio of Vaccines decreased 0.6
percentage points to 58.0%. Sanofi expects its gross margin ratio to be
approximately 70% at CER in 2017.
Research and Development expenses increased 6.0% to ?1,309 million (up 4.0% at
CER) in the first quarter. At CER and constant structure*, R&D expenses were up
2.1% reflecting the increased spending on our development programs in oncology
(isatixumab, PD-1) and sotagliflozin.
First-quarter selling general and administrative expenses (SG&A) were up 12.0%
to ?2,478 million (up 9.5% at CER).
At CER and constant structure*, SG&A was up 1.5% mainly reflecting launch costs
for Dupixent(®), Kevzara(TM) and Xyzal(®), commercial and marketing investments
behind key Emerging countries and our Europe Vaccines business, as well as one-
time costs associated with the integration of Boehringer Ingelheim CHC business.
On the other hand, our Diabetes sales and marketing spending in the U.S. was
adapted to the new competitive environment.
First-quarter other current operating income net of expenses was ?34 million
versus ?93 million for the same period of 2016. In the first quarter of 2016,
this line included an arbitration award of ?192 million to Sanofi and also a
foreign exchange loss related to Venezuela (?92 million).
The share of profits from associates was ?30 million in the first quarter versus
?23 million for the same period of 2016. The share of profits from associates
included Sanofi's share in Regeneron profit.
In the first quarter, non-controlling interests were -?35 million versus -?27
million in the first quarter of 2016.
First-quarter business operating income increased 15.0% to ?2,442 million. At
CER, business operating income increased 11.7%. At CER and constant structure*,
business operating income increased 7.6%. The ratio of business operating income
to net sales increased 0.9 percentage point to 28.2% versus the same period of
2016. In the first quarter, the business operating income ratio of
Pharmaceuticals was 30.1%, 1.4 percentage points higher and the business
operating income ratio of Vaccines increased 0.7 percentage points to 13.5%.
Net financial expenses were ?63 million in the first quarter versus ?117 million
in the first quarter of 2016, reflecting mainly a lower cost of net debt.
First-quarter effective tax rate was 24.5% compared with 22.6% in the first
quarter of 2016.
First-quarter business net income((8)) increased 4.2% to ?1,795 million (up
1.0% at CER). The ratio of business net income to net sales increased 0.9
percentage points to 20.8% versus the same period of 2016 (excluding Animal
Health business).
+------------------------------------------------------------------------------+
|In the first quarter of 2017, business earnings per share((8)) (EPS) increased|
|6.0% to ?1.42 on a reported basis and 3.0% at CER. The average number of|
|shares outstanding was 1,262.4 million in the first quarter of 2017 versus|
|1,288.4 million in the first quarter of 2016. |
+------------------------------------------------------------------------------+
(8) See Appendix 3 for 2017 first-quarter 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
2017 guidance
Sanofi expects 2017 Business EPS to be stable to -3% at CER, barring unforeseen
major adverse events, consistent with its previously announced Strategic Roadmap
guidance for the 2016-17 period. Applying the average March 2017 exchange rates
to the rest of the year, the currency impact on 2017 Business EPS is estimated
to be +3% to +4%.
Reconciliation of IFRS net income reported to business net income (see Appendix
4)
In the first quarter of 2017, the IFRS net income was ?5,701 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 ?4,427 million resulting from the divestment of the Animal
Health business (subject to post-closing adjustment).
* A ?503 million amortization charge related to fair value remeasurement on
intangible assets of acquired companies (primarily Aventis: ?104 million,
Genzyme: ?231 million and BI CHC business ?66 million) and to acquired
intangible assets (licenses/products: ?37 million). These items have no cash
impact on the Company.
* A charge of ?36 million mainly reflecting an increase of Bayer contingent
considerations linked to Lemtrada(®) (charge of ?21 million) and CVR fair
value adjustment (charge of ?16 million).
* Expenses of ?88 million arising from the impact of the acquisition of BI CHC
business and the termination of SPMSD joint venture on inventories.
* Restructuring costs and similar items of ?119 million mainly related to the
organizational transformation program at the industrial level in Europe and
North America.
* A ?248 million tax effect arising from the items listed above, comprising
?182 million of deferred taxes generated by amortization charged against
intangible assets, ?43 million associated with restructuring costs and
similar items, ?28 million associated with the impact of acquisition on
inventories and ?6 million associated with fair value remeasurement of
contingent consideration liabilities.
* An expense of ?24 million net of tax related to restructuring costs of
associates and joint-ventures, and expenses arising from the impact of
acquisitions on associates and joint-ventures.
Capital Allocation
In the first quarter of 2017, net cash generated by operating activities was
?954 million after capital expenditures of ?382 million and an increase in
working capital of ?766 million. This net cash flow largely funded acquisitions
and partnerships net of disposals (?222 million) and restructuring costs and
similar items (?211 million). The swap between BI CHC business and Sanofi Animal
Health business generated a net cash flow of ?5,288 million (pre-tax amount as
tax payments on the gain are expected in the next quarters), partially used to
finance share repurchases (?1,289 million) over the quarter. As a consequence,
net debt decreased from ?8,206 million at December 31, 2016 to ?3,685 million at
March 31, 2017 (amount net of ?14,924 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, 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 first-quarter net sales by GBU, franchise, geographic region
and product
Appendix 2: 2017 first-quarter Business net income statement
Appendix 3: 2017 first-quarter 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 first-quarter net sales by GBU, franchise, geographic region
and product
+------------------------------------------------------------+ +--------------------+
| Rest | Emer- | |
Q1 2017 |Total % % re- Eu- % United % of % | ging |Total % % re- |
(? million) |GBUs CER ported rope CER States CER the CER | Mar- % CER |Fran- CER ported|
| Wo- | kets |chises |
| rld | | |
| | | |
Aubagio | 363 30.1% 33.5% 91 23.0% 259 33.0% 13 30.0%| 8 14.3% | 371 29.7% 33.0%|
| | | |
Lemtrada | 120 41.2% 41.2% 45 31.4% 67 39.1% 8 150.0%| 5 33.3% | 125 40.9% 42.0%|
| | | |
Total MS | 483 32.8% 35.3% 136 25.7% 326 34.2% 21 64.3%| 13 20.0% | 496 32.4% 35.1%|
--------------------+------------------------------------------------------------+ -------------- +--------------------+
Cerezyme | 126 -2.4% 0.0% 68 -2.8% 46 0.0% 12 -9.1%| 50 -10.7% | 176 -4.9% -3.3%|
| | | |
Cerdelga | 31 30.4% 34.8% 5 66.7% 25 26.3% 1 0.0%| 0 - | 31 30.4% 34.8%|
| | | |
Myozyme | 163 11.0% 11.6% 82 5.1% 67 18.2% 14 16.7%| 27 25.0% | 190 12.7% 14.5%|
| | | |
Fabrazyme | 158 12.3% 14.5% 40 8.1% 93 13.9% 25 13.6%| 19 54.5% | 177 15.4% 18.8%|
| | | |
Aldurazyme | 35 0.0% 0.0% 19 0.0% 11 0.0% 5 0.0%| 17 30.8% | 52 8.3% 8.3%|
| | | |
Total Rare | 589 6.9% 9.5% 231 2.6% 274 12.2% 84 2.7%| 123 11.1% | 712 7.6% 10.2%|
Disease | | | |
--------------------+------------------------------------------------------------+ -------------- +--------------------+
Taxotere | 10 -37.5% -37.5% 1 0.0% 1 0.0% 8 -42.9%| 37 23.3% | 47 2.2% 2.2%|
| | | |
Jevtana | 89 4.8% 6.0% 37 5.7% 40 2.6% 12 9.1%| 8 16.7% | 97 5.6% 7.8%|
| | | |
Eloxatine | 8 -38.5% -38.5% 2 100.0% 0 - 6 -50.0%| 37 27.6% | 45 7.1% 7.1%|
| | | |
Thymoglobulin | 57 7.8% 11.8% 10 11.1% 41 8.1% 6 0.0%| 15 7.1% | 72 7.7% 10.8%|
| | | |
Mozobil | 38 12.1% 15.2% 11 10.0% 25 14.3% 2 0.0%| 2 0.0% | 40 11.4% 14.3%|
| | | |
Zaltrap | 15 -6.3% -6.3% 13 8.3% 2 -50.0% 0 -| 1 0.0% | 16 -5.9% -5.9%|
| | | |
Total Onco- | 307 9.9% 12.0% 88 8.6% 181 23.1% 38 -26.0%| 105 22.6% | 412 12.8% 15.1%|
logy | | | |
--------------------+------------------------------------------------------------+ -------------- +--------------------+
Sanofi Genzyme | | |
(Spe- |1,379 15.5% 18.0% 455 9.8% 781 23.1% 143 -1.5%| 241 16.3% | 1,620 15.6% 18.2%
cialty Care) | | |
| | | |
Lantus | 973 -18.8% -16.6% 199 -14.8% 690 -20.9% 84 -9.1%| 253 9.6% | 1,226 -14.1% -12.1%|
| | | |
Toujeo | 176 66.0% 70.9% 46 142.1% 115 42.3% 15 133.3%| 16 - | 192 78.6% 86.4%|
| | | |
Apidra | 74 12.3% 13.8% 35 12.9% 29 12.0% 10 11.1%| 24 20.0% | 98 14.1% 15.3%|
| | | |
Amaryl | 16 -5.9% -5.9% 5 -37.5% 1 -100.0% 10 37.5%| 73 8.5% | 89 5.7% 1.1%|
| | | |
Insuman | 21 -4.8% 0.0% 20 -4.8% 1 0.0% 0 0.0%| 6 -36.4% | 27 -15.6% -15.6%|
| | | |
Total Diabetes |1,290 -10.3% -8.1% 326 -3.0% 839 -14.7% 125 5.2%| 373 12.1% | 1,663 -6.0% -4.1%|
--------------------+------------------------------------------------------------+ -------------- +--------------------+
Multaq | 96 10.7% 14.3% 11 0.0% 83 9.6% 2 -| 2 0.0% | 98 10.5% 14.0%|
| | | |
Praluent | 33 166.7% 175.0% 8 200.0% 24 155.6% 1 -| 1 - | 34 175.0% 183.3%|
| | | |
Total Cardio- | 129 30.2% 34.4% 19 42.9% 107 25.6% 3 -| 3 50.0% | 132 30.6% 34.7%|
vascular | | | |
--------------------+------------------------------------------------------------+ -------------- +--------------------+
Diabetes & | | |
Cardio- |1,419 -7.7% -5.3% 345 -1.1% 946 -11.5% 128 7.0%| 376 12.3% | 1,795 -4.0% -2.0%
vascular | | |
| +--------------+ | |
Plavix | 380 -1.8% -2.1% 39 -7.1% 0 -100.0% 79 -27.9% 262 10.8%| | 380 -1.8% -2.1%|
| | | |
Lovenox | 415 2.2% 2.7% 257 -1.5% 15 -6.7% 23 -4.5% 120 14.3%| | 415 2.2% 2.7%|
| | | |
Renagel / | 246 2.1% 5.1% 18 -13.6% 207 3.1% 9 0.0% 12 20.0%| | 246 2.1% 5.1%|
Renvela | | | |
| | | |
Aprovel | 193 13.0% 14.2% 31 -6.1% 3 -25.0% 45 61.5% 114 8.5%| | 193 13.0% 14.2%|
| | | |
Allegra | 68 -13.3% -9.3% 2 50.0% 0 - 66 -15.1% 0 -| | 68 -13.3% -9.3%|
| | | |
Myslee / | | | |
Ambien / | 73 -1.4% 4.3% 10 -9.1% 15 0.0% 29 -10.0% 19 21.4%| | 73 -1.4% 4.3%|
Stilnox | | | |
| | | |
Synvisc / | | | |
Synvisc | 90 -1.1% 2.3% 8 0.0% 67 -4.5% 4 150.0% 11 -9.1%| | 90 -1.1% 2.3%|
One | | | |
| | | |
Depakine | 112 9.8% 9.8% 40 2.5% 0 - 4 -25.0% 68 17.2%| | 112 9.8% 9.8%|
| | | |
Tritace | 62 3.2% 0.0% 39 -2.5% 0 - 1 - 22 4.5%| | 62 3.2% 0.0%|
| | | |
Lasix | 35 2.9% 2.9% 18 -5.3% 0 - 2 -50.0% 15 23.1%| | 35 2.9% 2.9%|
| | | |
Targocid | 37 0.0% 0.0% 19 -5.0% 0 - 1 -50.0% 17 13.3%| | 37 0.0% 0.0%|
| | | |
Other Rx Drugs | 929 -1.6% 0.1% 426 -1.4% 58 -24.3% 99 3.3% 346 1.8%| | 929 -1.6% 0.1%|
| | | |
Total Estab- | | | |
lished Rx |2,640 0.6% 1.9% 907 -2.1% 365 -4.9% 362 -6.3% 1,006 8.2%| | 2,640 0.6% 1.9%|
Products | | | |
--------------------+------------------------------------------------------------- -------------+ +--------------------+
Generics | 468 -2.0% 2.0% 198 -3.4% 37 -28.6% 33 26.9% 200 2.8%| | 468 -2.0% 2.0%|
--------------------+------------------------------------------------------------- -------------+ +--------------------+
Total Emerging | | | |
Markets | 241 16.3% 19.3% 241 16.3%| | |
Specialty Care | | | |
--------------------+------------------------------------------------------------- -------------+ +--------------------+
Total Emerging | | | |
Markets Dia- | 376 12.3% 12.9% 376 12.3%| | |
betes & Cardio- | | | |
vascular | | | |
--------------------+------------------------------------------------------------- -------------+ +--------------------+
General Medicines |3,725 2.2% 3.9% 1,105 -2.4% 402 -7.6% 395 -4.1% 1,823 9.5%| | 3,108 0.2% 1.9%|
& Emerging Markets | | | |
| | | |
Allergy, Cough & | 414 58.7% 63.0% 107 197.2% 154 12.9% 62 176.2% 91 36.9%| | 414 58.7% 63.0%|
Cold | | | |
| | | |
Pain | 324 45.1% 50.7% 139 47.4% 44 16.7% 29 600.0% 112 27.5%| | 324 45.1% 50.7%|
| | | |
Digestive | 229 55.6% 61.3% 85 59.3% 44 500.0% 12 450.0% 88 3.8%| | 229 55.6% 61.3%|
| | | |
Nutritionals | 164 36.3% 45.1% 33 17.9% 1 0.0% 63 65.7% 67 26.5%| | 164 36.3% 45.1%|
| | | |
Consumer |1,341 42.7% 48.2% 406 68.2% 348 18.7% 183 151.5% 404 20.9%| | 1,341 42.7% 48.2%|
Healthcare | | | |
| | | |
| | | |
|
Unternehmensinformation / Kurzprofil:
Datum: 28.04.2017 - 07:30 Uhr
Sprache: Deutsch
News-ID 538987
Anzahl Zeichen: 65567
contact information:
Town:
PARIS
Kategorie:
Business News
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"Sanofi Delivers Robust Q1 2017 Financial Results"
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