Sanofi delivers Q1 2015 Business EPS(1) growth of 2.6% at CER(2) and 12.8% on a reported basis
(Thomson Reuters ONE) -
Paris, April 30, 2015
Sanofi delivers Q1 2015 Business EPS((1)) growth of 2.6% at CER((2)) and 12.8%
on a reported basis
Sanofi growth driven by Genzyme and Merial
* Group sales((3)) increased 2.4% (+12.3% on a reported basis) to ?8,810
million
* Slightly lower Diabetes sales (-3.2%) reflects expected pricing impact on
Lantus(®) in the U.S.
* Genzyme delivered 30.9% growth mainly driven by Aubagio(®)
* Animal Health recorded a strong quarter (+13.5%) driven by performance of
NexGard(®)
* Vaccines (-4.6%) declined due to expected delay in Southern Hemisphere
influenza campaign
* Emerging Markets((4)) sales up 7.3%
Solid financial performance
* Business net income((1)) grew 1.6% at CER (up 11.6% on a reported basis) to
?1,726 million despite launch investments and U.S. Lantus(® )pricing impact
* Business EPS((1)) was up 2.6% at CER to ?1.32 and increased 12.8% on a
reported basis
Significant achievements with new product launches
* Toujeo(®) was launched in the U.S. and approved in EU
* Cerdelga(®) approved in Europe and in Japan
* Lemtrada(®) sales benefited from market introduction in the U.S.
* Dengue vaccine rolling submission initiated in 6 endemic countries in Asia
and Latin America
* Results of ELIXA cardiovascular safety with lixisenatide support U.S.
resubmission in Q3 2015
Further progress in R&D
* Phase III study of dupilumab in moderate-to-severe asthma initiated
* Phase IIb of the IL4/IL13 bi-specific mAb in idiopathic pulmonary fibrosis
started
2015 financial guidance
* Sanofi continues to expect 2015 Business EPS((1)) to be stable to slightly
growing versus 2014 at constant average exchange rates, barring major
unforeseen adverse events((5))
* In addition, the positive currency impact on 2015 full-year business EPS is
estimated to be approximately +12%, under the assumption that exchange rates
remain stable in the following three quarters at the average rates of March
2015
Sanofi Chief Executive Officer, Olivier Brandicourt commented:
"Sanofi had a good start to 2015. Our businesses provide a solid foundation
for our new-product cycle. Sanofi's recent launches along with the ongoing
regulatory reviews and planned submissions before year-end will drive future
growth. At this important time for the company, my primary focus will be on
maximizing the value of this innovative product portfolio and further
establishing Sanofi as a leading biopharmaceutical company."
(1) See Appendix 8 for definitions of financial indicators; (2) constant
exchange rates; (3) Growth in net sales is expressed at constant exchange rates
(CER) unless otherwise indicated (see Appendix 8 for a definition); (4) See page
8; (5) 2014 business EPS was ?5.20
Investor Relations: (+) 33 1 53 77 45 45 - E-mail: IR(at)sanofi.com
Media Relations: (+) 33 1 53 77 46 46 - E-mail: MR(at)sanofi.com
Web site: www.sanofi.com Mobile app: SANOFI IR available on the App Store and
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2015 first-quarter figures
Q1 2015 Change Change
(reported) (CER)
Net sales ?8,810 m +12.3% +2.4%
Business net income((1)) ?1,726 m +11.6% +1.6%
Business EPS((1)) ?1.32 +12.8% +2.6%
------------------------------------------------------------
In order to facilitate an understanding of operational performance, Sanofi
comments on the business net income statement. Business net income((1)) is a
non-GAAP financial measure. The consolidated income statement for Q1 2015 is
provided in Appendix 4 and a reconciliation of business net income to
consolidated net income in Appendix 3. Consolidated net income for Q1 2015 was
?1,023 million compared to ?1,084 million for Q1 2014. Consolidated EPS for Q1
2015 was ?0.78 versus ?0.82 for Q1 2014.
2015 first-quarter sales
Unless otherwise indicated, all sales growth figures in this press release are
stated at constant exchange rates((1)).
In the first quarter of 2015, Sanofi generated sales of ?8,810 million, an
increase of 12.3% on a reported basis. Exchange rate movements had a positive
effect of 9.9 percentage points reflecting mainly the weakness of the Euro
against the dollar. Other currencies impacting sales in the first quarter
primarily included the Chinese Yuan on the positive side and the Russian ruble
on the negative side.
? million Q1 2015 Change
net sales (CER)
-----------------------------------------------------
Pharmaceuticals 7,455 +2.2%
Diabetes 1,837 -3.2%
Consumer Healthcare (CHC) 979 +5.3%
Genzyme 821 +30.9%
Generics 478 +10.2%
Oncology 357 -7.3%
Established Rx Products 2,983 -1.5%
Vaccines 697 -4.6%
Animal Health 658 +13.5%
Total net sales 8,810 +2.4%
Pharmaceuticals
Sales for the Pharmaceuticals business increased 2.2% to ?7,455 million in the
first quarter, driven mainly by Genzyme, CHC and established Rx products in
Emerging Markets, which were partially offset by lower sales of Diabetes.
(1) See Appendix 8 for definitions of financial indicators.
Diabetes
? million Q1 2015 Change
net sales (CER)
Lantus(®) 1,584 -5.0%
Amaryl(®) 97 +1.2%
Apidra(®) 91 +10.7%
Insuman(®) 33 +3.1%
BGM (Blood Glucose Monitoring) 16 +0.0%
Lyxumia(®) 8 +60.0%
Toujeo(®) 7 -
Afrezza(®) 1 -
Total Diabetes 1,837 -3.2%
In the first quarter, sales of the Diabetes division decreased 3.2% to ?1,837
million. Sanofi recently managed to secure earlier and broader market access for
Toujeo(®) than expected due to a refined contracting strategy with payers in the
U.S. As a result, Sanofi expects its global diabetes sales performance at
constant exchange rates in the first quarter of 2015 to be indicative of the
full year performance of this division.
Lantus(®) sales were down 5.0% to ?1,584 million over the period reflecting
lower sales in the U.S., which were partially offset by strong growth in
Emerging Markets. In the U.S., sales of Lantus(®) were ?1,007 million, a
decrease of 13.1% due to the expected rebates required to maintain favorable
formulary positions with key payers for contracts that started January 1, 2015.
In Emerging Markets, Lantus(®) sales were strong, up 18.0% to ?276 million,
reflecting solid growth in all regions. In Western Europe, Lantus(®) first-
quarter sales were up 6.3% to ?223 million driven by growth in Germany, Portugal
and Spain.
Toujeo(®), a next-generation basal insulin used to treat adults with type 1 and
type 2 diabetes, was granted approval by the FDA in late February. Full launch
activities in the U.S. market commenced at the end of March and included
Toujeo(® )COACH, a customized patient support program that offers tailored
information and services for patients with diabetes. Sales of the product were
?7 million in the first quarter which primarily reflected wholesaler demand in
advance of the launch.
First-quarter sales of Amaryl(®) were ?97 million, up 1.2% sustained by Emerging
Markets (+12.9% to ?78 million), especially in Latin America and China.
Sales of Apidra(®) increased 10.7% to ?91 million in the first quarter driven by
Emerging Markets (+31.3% to ?22 million). In the U.S. and in Western Europe,
sales were up 3.6% (to ?35 million) and 8.7% (to ?25 million), respectively.
First-quarter sales of Lyxumia(®) were ?8 million. Top-line results from the
Phase IIIb ELIXA cardiovascular outcomes study of Lyxumia(®) were announced in
March and support the planned resubmission of the product in the U.S. in the
third quarter of 2015.
Afrezza(®), a new rapid-acting inhaled insulin therapy (licensing agreement with
MannKind), was launched in the U.S. in February 2015. Sales of the product were
?1 million in the first quarter.
Consumer Healthcare
? million Q1 2015 Change
net sales (CER)
Allegra(®) 142 +16.3%
Doliprane(®) 85 -3.4%
Enterogermina(®) 57 +36.8%
Essentiale(®) 50 -7.6%
Nasacort(®) 42 -16.7%
Maalox(®) 28 +3.7%
Lactacyd(®) 26 -4.0%
Dorflex(®) 23 0.0%
No Spa(®) 22 0.0%
Magne B6(®) 20 +9.1%
Other 484 +6.9%
Total Consumer Healthcare 979 +5.3%
First-quarter sales of Consumer Healthcare products (CHC) were ?979 million, an
increase of 5.3% driven by Allegra(®) and Enterogermina(®). Sales of CHC in
Emerging Markets grew 6.3% to ?455 million over the period led by Eastern
Europe, particularly cough-and-cold products, and Latin America. In the U.S.,
first-quarter sales were up 5.5% to ?259 million driven by Allegra(®) which
benefited from the launch of a new formulation. Sales of Nasacort(®) were ?42
million, a decrease of 16.7% impacted by an unfavorable comparison basis in the
U.S. where the product was launched in the first quarter of 2014. Despite a
price decrease of Doliprane(®) in France in January 2015, CHC sales in Western
Europe increased 0.5% to ?202 million.
Genzyme
? million Q1 2015 Change
net sales (CER)
Cerezyme(®) 189 +4.8%
Myozyme(® )/ Lumizyme(®) 156 +19.0%
Fabrazyme(®) 141 +27.6%
Aldurazyme(®) 48 +9.8%
Cerdelga(®) 10 -
Total Rare Diseases 613 +15.9%
Aubagio(®) 170 +88.5%
Lemtrada(®) 38 -
Total Multiple Sclerosis 208 +118.1%
Total Genzyme 821 +30.9%
First-quarter sales of Genzyme increased 30.9% to ?821 million reflecting the
strong performance of Aubagio(®) and double-digit growth of Rare Diseases
products. Genzyme recorded double-digit sales growth in all territories
including 37.7% to ?357 million in the U.S., 24.2% to ?244 million in Western
Europe, 35.3% to ?145 million in Emerging Markets and 20.7% to ?75 million in
the Rest of the World.
First-quarter sales of Rare Diseases reached ?613 million, an increase of 15.9%.
Sales of the Gaucher franchise grew 10.1% to ?199 million. Sales of Cerezyme(®)
were up 4.8% to ?189 million in the first quarter, led by strong performance in
Emerging Markets (up 16.4% to ?66 million) especially in Latin America.
Cerdelga(®), the only first-line oral therapy for Gaucher disease type 1
patients, was approved by the FDA in August 2014 and recorded sales of ?10
million in the U.S.. The EMA approved Cerdelga(®) for Gaucher disease type 1
patients in January 2015 and the product was launched in its first European
market, Germany, in April. Cerdelga(®) was also approved in Japan at the end of
March.
First-quarter sales of Fabrazyme(®) increased 27.6% to ?141 million driven by
strong growth in the U.S. (up 15.7% to ?71 million), in Emerging Markets (up
157.1% to ?19 million) and in Western Europe, (up 24.0% to ?31million). In
Emerging Markets, sales of the product benefited from a favorable phasing effect
and the addition of new patients in Brazil.
Sales of Myozyme(®)/Lumizyme(®) grew 19.0% to ?156 million in the first quarter,
largely driven by an increase in worldwide diagnosis rates and patient
identification leading to new patient accruals. In the U.S. (up 29.0% to ?48
million) growth was partially due to the conversion of clinical study patients
in 2014. Growth in Emerging Markets (up 36.8% to ?28 million) also benefited
from government ordering patterns in Brazil.
First-quarter sales of Multiple Sclerosis were ?208 million (up 118.1%).
Aubagio(®) continued its success with sales more than doubling to ?170 million
versus ?78 million in the same period of 2014. In the U.S., sales of Aubagio(®)
were ?123 million versus ?59 million in the first quarter of 2014. In Western
Europe, sales were ?36 million (versus ?17 million in the same period of 2014)
reflecting the continued roll out and successful launch in France.
First quarter sales of Lemtrada(®) were ?38 million including ?18 million in
Western Europe and ?16 million in the U.S. where the product was introduced late
last year.
Generics
Sales of Generics increased 10.2% to ?478 million in the first quarter driven by
the performance in Emerging Markets (up 12.7% to ?277 million) led by cough-and-
cold products in Eastern Europe and the performance in Latin America. In the
U.S., sales of generics were up 17.9% to ?41 million due to the growth of the
authorized generics of Lovenox(®) and Taxotere(®). In Western Europe, generics
were down 2.9% to ?138 million. In Rest of the World, sales more than doubled to
?22 million, driven by Allegra(®) generics sales in Japan.
Oncology
? million Q1 2015 Change
net sales (CER)
Jevtana(®) 77 +7.6%
Thymoglobulin(®) 55 -7.7%
Eloxatin(®) 54 +4.3%
Taxotere(®) 53 -31.9%
Mozobil(®) 34 +20.0%
Zaltrap(®) 20 +18.8%
Total Oncology 357 -7.3%
First-quarter sales of Oncology were ?357 million, a decrease of 7.3%, mainly
reflecting lower sales of Taxotere(®).
Sales of Jevtana(®) grew 7.6% to ?77 million in the first quarter, led by the
U.S. (up 15.0% to ?27 million) and Japan where the product was launched in
September 2014.
First-quarter sales of Thymoglobulin(®) were ?55 million, down 7.7%.
First-quarter sales of Taxotere(®) decreased 31.9% (?53 million), mainly due to
generic competition. Over the same period, sales of Eloxatin(® )increased 4.3%
(?54 million) driven by growth in China.
First-quarter sales of Mozobil(®) were ?34 million, up 20.0% driven by growth in
the U.S. (up 15.4% to ?18 million) and Emerging Markets (up 66.7% to ?5
million).
In the first quarter, sales of Zaltrap(®) grew 18.8% to ?20 million, led by
sales in Western Europe (?13 million versus ?7 million in the first quarter of
2014) which offset lower sales in the U.S.
Established Rx Products
? million Q1 2015 Change
net sales (CER)
Plavix(®) 483 -9.4%
Lovenox(®) 438 +1.2%
Renvela(®)/Renagel(®) 226 +13.4%
Aprovel(®)/Avapro(®) 201 +0.0%
Synvisc(® )/Synvisc-One(®) 85 +2.9%
Multaq(®) 83 -4.1%
Allegra(®) 80 -5.0%
Myslee(®)/Ambien(®)/Stilnox(®) 75 -11.5%
Other 1,312 -0.8%
Total Established Rx Products 2,983 -1.5%
Total sales of Established Rx Products were ?2,983 million down 1.5%.
Sales of Plavix(®) were down 9.4% to ?483 million in the first quarter
reflecting lower sales in Western Europe (down 30.6% to ?44 million) due to
generic competition and in Japan (down 12.6% to ?198 million) impacted by an
unfavorable comparison to the previous year resulting from buying patterns in
anticipation of an increase in the consumption tax during the second quarter of
2014. In mid-2015, generic versions of Plavix(®) are anticipated to enter the
market in Japan. In Emerging Markets, sales of Plavix(®) were ?226 million, up
0.5% mainly due to lower sales in the Middle East. In China, sales of the
product increased 4.4% to ?142 million.
First-quarter sales of Lovenox(®) were ?438 million up 1.2%. In Emerging
Markets, sales of the product grew 11.2% (?157 million) led by growth in the
Middle-East and Latin America, which was partially offset by lower sales in the
U.S. (down 31.3% to ?26 million) due to generic competition and stable sales in
Western Europe (?231 million).
Sales of Renvela(®)/Renagel(®) increased 13.4% to ?226 million in the first
quarter, driven by the U.S. (up 19.3% to ?165 million). In the U.S., sales
benefited from reduced competition from Impax which was granted a license to
sell a limited number of bottles of an authorized generic version of Renvela(®)
tablets in the U.S. beginning in April 2014.
In the first quarter, sales of Aprovel(®)/Avapro(®) were stable at ?201 million.
The product recorded strong performance in Emerging Markets (up 18.7% to ?125
million) driven by Latin America and China which was offset by lower sales in
Western Europe (down 33.3% to ?37 million) due to generic competition.
Vaccines
? million Q1 2015 Change
net sales (CER)
Polio/Pertussis/Hib Vaccines 282 +15.6%
(incl. Pentacel(®), Pentaxim(® ), Hexaxim(®)and Imovax(®))
Influenza Vaccines 22 -84.4%
(incl. Vaxigrip(®) and Fluzone(®))
Meningitis/Pneumonia Vaccines 97 +44.6%
(incl. Menactra(®))
Adult Booster Vaccines (incl. Adacel (®)) 95 -1.2%
Travel and Other Endemic Vaccines 82 -1.3%
Other Vaccines 119 +41.4%
Total Vaccines
(consolidated sales) 697 -4.6%
In the first quarter, consolidated sales of Sanofi Pasteur were ?697 million, a
decrease of 4.6% reflecting expected lower influenza vaccines sales due to the
delay of the Southern Hemisphere influenza campaign which impacted the
performance in Emerging Markets (down 19.4% to ?228 million). Excluding
influenza sales, the rest of the portfolio grew 17.2% in the first quarter. In
the U.S., first-quarter sales increased 15.4% to ?395 million driven by the
continued recovery of Pentacel(®), the performance of Menactra(®) and VaxServe
(a Sanofi Pasteur company, U.S. specialty supplier of vaccines).
As the Southern Hemisphere influenza campaign was delayed by two required strain
changes this year, first-quarter sales of Influenza vaccines were ?22 million
versus ?135 million in the first quarter of 2014.
Sales of Polio/Pertussis/Hib vaccines were up 15.6% to ?282 million in the first
quarter. In the U.S., Polio/Pertussis/Hib vaccines sales increased 26.3% to ?118
million, reflecting the continued recovery of Pentacel(®). In Emerging Markets
sales of Polio/Pertussis/Hib vaccines grew 32.2% to ?132 million led by strong
performance of Pentaxim(®) especially in China. In the Rest of the world, first-
quarter sales of Polio/Pertussis/Hib vaccines decreased 43.6% to ?25 million
reflecting lower sales of the Polio vaccine, Imovax(®), and Hib vaccines in
Japan.
In December 2014, Shantha was awarded an order for 37 million doses of
Shan5(TM), its pediatric pentavalent vaccine, to supply global health
organizations in 2015 and 2016. The first 5.3 million doses of Shan5(®),
produced by Shantha, were delivered in March and sales in the first quarter were
?7 million.
First-quarter sales of Menactra(®) grew 50.0% to ?87 million reflecting 62.2%
growth in the U.S. due to favorable CDC order phasing.
Sales of Adult Booster vaccines were down 1.2% to ?95 million in the first
quarter.
First-quarter sales of Travel and Other Endemic vaccines declined 1.3% to ?82
million.
Sales of Sanofi Pasteur MSD (not consolidated), the joint venture with Merck &
Co. in Europe, were ?139 million, (down 11.8% on a reported basis) in the first
quarter due to lower sales of Gardasil(®).
Animal Health
? million Q1 2015 Change
net sales (CER)
Companion Animal 443 +13.1%
Production Animal 215 +14.5%
Total Animal Health 658 +13.5%
of which fipronil products 193 +1.2%
of which Vaccines 186 +11.7%
of which avermectin products 157 +17.5%
----------------------------------------------------
Sales of Animal Health grew 13.5% to ?658 million in the first-quarter
confirming the recovery that started in 2014 and supported by both Companion and
Production Animal segments. In the U.S. and in Emerging Markets, Animal Health
sales grew 15.2% (to ?307 million) and 8.9% (to ?131 million), respectively.
First-quarter sales of the Companion Animals segment were up 13.1% to ?443
million, reflecting the success of NexGard(TM) as well as performance of
Heartgard(®). NexGard(®), Merial's next generation flea and tick product for
dogs, was launched in the U.S. in the first quarter of 2014 and in Europe,
Australia and Japan during 2014 and Brazil in the first quarter of 2015. Sales
of NexGard(®) more than doubled in the first quarter of 2015 compared to the
same period of 2014. The Frontline(®) family of products continued its stable
performance over the period with sales up 1.2%
Sales of the Production Animals segment increased 14.5% to ?215 million in the
first-quarter. The Avian market, impacted last year by Avian influenza mostly in
Asia, recovered in the first quarter while Merial increased its competitive
response particularly in Emerging Markets. The Ruminant business was driven by
the success of LongRange(TM) in the U.S. becoming a leading brand in parasite
control. Sales of Veterinary Public Health products were driven by an outbreak
of Foot-and-Mouth disease in Korea where Merial is a key partner supporting the
management of disease.
Net sales by geographic region
? million Q1 2015 Change
net sales (CER)
United States 2,976 +1.0%
Emerging Markets((a)) 2,859 +7.3%
of which Asia 849 +8.6%
of which Latin America 846 +7.1%
of which Eastern Europe, Russia and Turkey 586 +8.6%
of which Africa and Middle East 530 +2.7%
Western Europe((b)) 2,031 +0.6%
Rest of the world((c)) 944 -3.5%
of which Japan 569 -8.2%
TOTAL 8,810 +2.4%
(a) World less the U.S., Canada, Western Europe, Japan, South Korea, Australia
and New Zealand;
(b) France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium,
Luxembourg, Portugal, Netherlands, Austria, Switzerland, Sweden, Ireland,
Finland, Norway, Iceland, Denmark;
(c) Japan, South Korea, Canada, Australia and New Zealand;
In the U.S., sales were ?2,976 million, up 1.0% in the first quarter. The strong
performance of Genzyme (up 37.7%), Vaccines (up 15.4%), and Animal Health (up
15.2%) were partially offset by lower sales of Lantus(®) (down 13.1%).
First-quarter sales in Emerging Markets increased 7.3% to ?2,859 million.
Pharmaceuticals sales in Emerging Markets increased 10.4% driven by Diabetes (up
18.5%), Genzyme (up 35.3%) and Generics (up 12.7%). Vaccines sales were down
19.4% (?228 million) reflecting the delay of the Southern Hemisphere influenza
campaign. Animal Health recorded good growth (up 8.9% to ?131 million) driven by
Avian products. Sales in China grew 7.7% to ?484 million driven by vaccines,
Lantus(®), Plavix(®), Aprovel(®) and Depakine(®). First-quarter sales in Eastern
Europe, Russia and Turkey were up 8.6% to ?586 million led by good performance
in Turkey, Hungary, Poland and Ukraine. Sales in Russia were ?132 million, up
0.5%. In Africa and Middle-East, sales were ?530 million, up 2.7%. In Latin
America, sales reached ?846 million, up 7.1% reflecting significantly higher
sales in Venezuela that were partially offset by lower sales of vaccines (down
66.9%) in this region. Despite the strong performance of Genzyme (up 64.3%) and
generics (up 9.6%), sales in Brazil decreased 20.9% to ?283 million, impacted by
lower sales of vaccines (down 85.3%). In Venezuela, significantly increased
demand was observed in the first quarter of 2015, due to buying patterns
associated with local market conditions. As a consequence, first-quarter sales
in Venezuela were ?200 million versus ?66 million in the same period of 2014.
Sanofi does not expect this increased demand to be replicated throughout 2015.
This positive impact from Venezuela on Emerging Market sales was partially
offset by low influenza vaccines sales (?20 million in the first quarter of
2015 versus ?105 million in the same period of 2014) due to the delay of the
influenza campaign.
First-quarter sales in Western Europe were ?2,031 million (up 0.6%). The
performance of Genzyme (up 24.2%) and Animal Health (+8.5%) was partially offset
by the impact of generic competition to Aprovel(®) and Plavix(®).
In Japan, sales were ?569 million, a decrease of 8.2% in the first-quarter,
reflecting the impact of generic competition to Taxotere(®), Myslee(®) and
Amaryl(®), lower sales of vaccines and Plavix(®).
R&D update
Consult Appendix 6 for full overview of Sanofi's R&D pipeline
Regulatory update
Regulatory updates since the publication of the 2014 results on February
5, 2015 include the following:
* In April, the FDA granted Fast Track designation to GZ/SAR402671, Genzyme's
oral substrate reduction therapy, for the treatment of Fabry disease.
* In March, Quadracel(®) (Diphtheria, tetanus, pertussis, polio vaccine) was
approved in the U.S. in children 4-6 years of age.
* In March, Cerdelga(®) (eliglustat), an oral treatment for certain adults
living with Gaucher disease type 1, was approved in Japan and in February in
Australia.
* In February, the U.S. Food and Drug Administration (FDA) approved Toujeo(®),
a next generation basal insulin used to treat adults with type 1 and type 2
diabetes. In April, Toujeo(®) was also approved in EU.
At the end of April 2015, the R&D pipeline contained 37 projects (excluding Life
Cycle Management) and vaccine candidates in clinical development of which 12 are
in Phase III or have been submitted to the regulatory authorities for approval.
Portfolio update
Phase III:
* Phase III study of dupilumab in adult patients with uncontrolled moderate-
to-severe asthma was recently initiated.
* In March, top-line results from the Phase IIIb ELIXA cardiovascular outcomes
study, which compared lixisenatide to placebo in a high-risk population of
adults with type 2 diabetes, were announced. The study showed that
lixisenatide was non-inferior, although not superior, to placebo for
cardiovascular safety. Full results from the ELIXA study will be presented
on June 8, 2015, at the American Diabetes Association 75th Scientific
Sessions. The results will also be included in the U.S. New Drug Application
of lixisenatide, which is on track to be resubmitted to the U.S. Food and
Drug Administration in the third quarter of 2015.
* In March, 18-month results from a Phase III trial (ODYSSEY LONG TERM) of
Praluent(®) (alirocumab, in collaboration with Regeneron), an
investigational therapy, involving 2,341 high risk patients with
hypercholesterolemia were published online in The New England Journal of
Medicine. In the ODYSSEY LONG TERM trial, Praluent 150 mg every two weeks
reduced low-density lipoprotein cholesterol (LDL-C) by an additional 62
percent at week 24 when compared to placebo, the primary efficacy endpoint
of the study, with consistent LDL-C lowering maintained over 78 weeks. In a
post hoc analysis using a pre-specified endpoint that included coronary
heart disease death, myocardial infarction, stroke, or unstable angina
requiring hospitalization, a lower rate of adjudicated major adverse cardiac
events was observed in the Praluent(®) group (27 of 1550 patients, 1.7%)
compared with the placebo group (26 of 788 patients, 3.3%; hazard ratio
0.52; 95 percent CI, 0.31 to 0.90; nominal p=0.02).
Phase II:
* Phase IIb development of the IL4/IL13 bi-specific monoclonal antibody,
SAR156597, in Idiopathic pulmonary fibrosis was initiated.
* Sanofi decided to return rights to the anti-CD19 monoclonal antibody
(SAR3419) to ImmunoGen. In addition, the combination of XL765 from Exelixis
with Merck KGaA's pimasertib in Phase II was stopped.
Phase I:
* A myosin inhibitor (partnership with Myokardia), SAR439152, entered Phase I
in hypertrophic cardiomyopathy.
* The HDM2/p53 antagonist, SAR405838, was discontinued in monotherapy as well
as in combination with Merck KGaA's pimasertib. Sanofi also decided not to
pursue the development of SAR252067, an anti-LIGHT monoclonal antibody,
evaluated in Phase I for Crohn's disease. The worldwide rights were returned
to Kyowa Hakko Kirin., Ltd.
* Sanofi decided not to develop further its Phase I project GZ402663 for age-
related macular degeneration
Collaboration
* In February, Sanofi announced that it entered into a research collaboration
and license agreement with Dutch biotech Lead Pharma to discover, develop
and commercialize small-molecule therapies directed against the nuclear
hormone receptors called ROR gamma t to treat a broad range of autoimmune
disorders, including rheumatoid arthritis, psoriasis and inflammatory bowel
disease, which are among the most common.
* In February, Genzyme and Voyager Therapeutics announced a major strategic
collaboration to discover, develop and commercialize novel gene therapies
for severe CNS disorders. The alliance will encompass multiple gene therapy
programs, including programs for Parkinson's disease, Friedreich's ataxia
and Huntington's disease, as well as other CNS disorders.
First-quarter financial results
Business Net Income((1))
In the first quarter of 2015, Sanofi generated net sales of ?8,810 million, an
increase of 12.3% on a reported basis (up 2.4% at constant exchange rates).
Other revenues decreased 3.6% to ?80 million in the first quarter. At constant
exchange rates, other revenues were down 14.5% reflecting lower royalties
received on Enbrel sales in Europe.
First-quarter gross profit increased 12.8% (up 1.8% at constant exchange rates)
to ?6,104 million. The Gross margin ratio improved by 0.3 percentage points to
69.3% versus the first quarter of 2014, reflecting an improvement in industrial
performance and a positive effect from foreign exchange rates which more than
offset the impact from U.S. diabetes and ramp up of biologics.
Research and development expenses were ?1,199 million, up 5.3% in the first
quarter. At constant exchange rates, R&D expenses decreased by 1.8% reflecting
timing of clinical programs in 2015.
First-quarter selling and general expenses (SG&A) increased 17.3% to ?2,438
million. At constant exchange rates, SG&A grew 6.6% reflecting investments in
new launches at Genzyme and U.S. diabetes as well as in Emerging Markets. The
ratio of SG&A to net sales was 1.2 percentage points higher to 27.7% compared
with the first quarter of 2014.
Other current operating income net of expenses was -?67 million in the first
quarter versus -?25 million in the first quarter of 2014. This line in 2015
included a foreign exchange loss of ?66 million booked in connection with our
Venezuelan operations.
The share of profits from associates was ?31 million in the first quarter
(versus ?13 million in the first quarter of 2014) and included Sanofi's share in
Regeneron profit recorded under the equity method since the beginning of April
2014 as well as Sanofi's share of profit in Sanofi Pasteur MSD (the Vaccines
joint venture with Merck & Co. in Europe).
(1) See Appendix 8 for definitions of financial indicators, and Appendix 3 for
reconciliation of business net income to consolidated net income attributable to
equity holders of Sanofi
Non-controlling interests were -?33 million in the first quarter (versus -?35
million in the first quarter of 2014)
Business operating income increased 11.8% to ?2,398 million in the first
quarter. At constant exchange rates, business operating income grew 2.1%. The
ratio of business operating income to net sales was 0.2 percentage points lower
to 27.2% versus the same period of last year, driven by higher SG&A expenses
connected to investment behind launches.
Net financial expenses were ?97 million in the first quarter compared to ?76
million in the first quarter of 2014. This line included capital gains linked to
the sales of some financial investments of ?16 million in the first quarter of
2015 and ?41 million in the first quarter of 2014, respectively.
The first quarter effective tax rate was 25%, which was stable versus the first
quarter of 2014.
First-quarter business net income((1)) grew 11.6% to ?1,726 million. At constant
exchange rates, business net income increased 1.6%. The ratio of business net
income to net sales was 19.6% in the first quarter versus 19.7% in the first
quarter of 2014.
+------------------------------------------------------------------------------+
|In the first quarter of 2015, business earnings per share((1)) (EPS) was |
|?1.32, up 12.8% on a reported basis and up 2.6% at constant exchange rates. |
|The average number of shares outstanding was 1,308.4 million in the first |
|quarter versus 1,319.9 million in the same period in 2014. |
+------------------------------------------------------------------------------+
From business net income to consolidated net income (see Appendix 3)
In the first quarter of 2015, the main reconciling items between business net
income and consolidated net income attributable to equity holders of Sanofi
were:
* A ?618 million amortization charge related to fair value remeasurement on
intangible assets of acquired companies (primarily Aventis: ?178 million,
Genzyme: ?226 million and Merial: ?119 million) and to acquired intangible
assets (licenses/products: ?28 million). These items have no cash impact on
the Group.
* An impairment of intangible assets of ?27 million mainly related to R&D
projects in early stage. This item has no cash impact on the Group.
* An income of ?1 million mainly reflecting a decrease in the fair value of
contingent considerations related to the CVRs (+?23 million) and an increase
of Bayer contingent considerations (-?20 million) linked to Lemtrada(®).
* Restructuring costs of ?353 million mainly related to R&D in France.
* A ?355 million tax effect arising from the items listed above, comprising
?217 million generated by amortization charged against intangible assets,
?121 million associated with restructuring costs, ?10 million associated
with impairment of intangible assets and ?7 million associated with fair
value remeasurement of contingent consideration liabilities (see Appendix
3).
* In "Share of profits/losses from associates", a charge of ?62 million, net
of tax, mainly relating to the share of the fair-value re-measurements on
assets and liabilities as part of the acquisition of associates and to the
share of amortization of intangible assets of joint-ventures. This item has
no cash impact on the Group.
(1) See Appendix 8 for definitions of financial indicators, and Appendix 3 for
reconciliation of business net income to consolidated net income attributable to
equity holders of Sanofi
Capital Allocation
In the first quarter of 2015, net cash generated by operating activities was
?1,247 million after capital expenditures of ?355 million (versus ?279 million
in the first quarter of 2014) driven by investment into new biologics capacities
and after an increase in working capital by ?379 million resulting in particular
from inventory seasonality and the build-up of inventory of products. This net
Cash Flow has contributed to finance a share repurchase (?794 million) partially
offset by proceeds from the issuance of new shares (?247 million), acquisitions
and partnerships net of disposals (?327 million) and restructuring costs (?148
million). Net debt increased from ?7,171 million at December 31, 2014 to ?7,571
million at March 31, 2015 (amount net of ?7,740 million cash and cash
equivalents) and included the translation impact of the debt held in U.S.
dollars which represented ?593 million.
Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, as amended. Forward-looking statements
are statements that are not historical facts. These statements include
projections and estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to future financial
results, events, operations, services, product development and potential, and
statements regarding future performance. Forward-looking statements are
generally identified by the words "expects", "anticipates", "believes",
"intends", "estimates", "plans" and similar expressions. Although Sanofi's
management believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and uncertainties, many
of which are difficult to predict and generally beyond the control of Sanofi,
that could cause actual results and developments to differ materially from those
expressed in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other things, the
uncertainties inherent in research and development, future clinical data and
analysis, including post marketing, decisions by regulatory authorities, such as
the FDA or the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product candidates as well
as their decisions regarding labelling and other matters that could affect the
availability or commercial potential of such product candidates, the absence of
guarantee that the product candidates if approved will be commercially
successful, the future approval and commercial success of therapeutic
alternatives, the Group's ability to benefit from external growth opportunities,
trends in exchange rates and prevailing interest rates, the impact of cost
containment policies and subsequent changes thereto, the average number of
shares outstanding as well as those discussed or identified in the public
filings with the SEC and the AMF made by Sanofi, including those listed under
"Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements"
in Sanofi's annual report on Form 20-F for the year ended December 31, 2014.
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: 2015 first-quarter consolidated net sales by geographic region
and product
Appendix 2: 2015 first-quarter business net income statement
Appendix 3: Reconciliation of business net income to net income attributable
to equity holders of Sanofi
Appendix 4: 2015 first-quarter consolidated income statement
Appendix 5: 2015 currency sensitivity
Appendix 6: R&D pipeline
Appendix 7: Expected R&D milestones in 2015
Appendix 8: Definitions
Appendix 1: 2015 First-quarter consolidated net sales by geographic region and
product
Q1 2015 net Emer- Rest
sales Total % % Western % United % ging % of %
(? million) CER reported Europe CER States CER Markets CER the CER
World
Lantus 1,584 -5.0% 9.4% 223 6.3% 1,007 -13.1% 276 18.0% 78 1.4%
Apidra 91 10.7% 21.3% 25 8.7% 35 3.6% 22 31.3% 9 0.0%
Amaryl 97 1.2% 12.8% 4 -33.3% 1 - 78 12.9% 14 -33.3%
Insuman 33 3.1% 3.1% 18 -14.3% 0 - 14 25.0% 1 -100.0%
Lyxumia 8 60.0% 60.0% 5 66.7% 0 - 2 - 1 -50.0%
Afrezza 1 - - 0 - 1 - 0 - 0 -
Toujeo 7 - - 0 - 7 - 0 - 0 -
Diabetes 1,837 -3.2% 10.5% 290 4.7% 1,051 -12.0% 393 18.5% 103 -6.0%
--------------------------------------- ----------------- ---------------- ---------------- --------------
Taxotere 53 -31.9% -23.2% 2 -50.0% 2 -33.3% 31 -27.8% 18 -34.6%
Jevtana 77 7.6% 16.7% 38 -2.6% 27 15.0% 8 0.0% 4 300.0%
Eloxatine 54 4.3% 17.4% 1 0.0% 1 0.0% 32 8.0% 20 0.0%
Thymoglobulin 55 -7.7% 5.8% 9 0.0% 32 13.0% 9 -41.2% 5 0.0%
Mozobil 34 20.0% 36.0% 10 12.5% 18 15.4% 5 66.7% 1 0.0%
Zaltrap 20 18.8% 25.0% 13 85.7% 6 -37.5% 1 0.0% 0 -
Other Oncology 64 -20.0% -8.6% 14 -12.5% 38 -31.1% 8 -14.3% 4 150.0%
Oncology 357 -7.3% 3.8% 87 2.4% 124 -8.8% 94 -14.6% 52 -5.7%
--------------------------------------- ----------------- ---------------- ---------------- --------------
Aubagio 170 88.5% 117.9% 36 105.9% 123 69.5% 6 400.0% 5 600.0%
Lemtrada 38 580.0% 660.0% 18 260.0% 16 - 2 - 2 -
Cerezyme 189 4.8% 12.5% 61 3.4% 50 -8.9% 66 16.4% 12 11.1%
Cerdelga 10 - - 0 - 10 - 0 - 0 -
Myozyme 156 19.0% 28.9% 69 7.9% 48 29.0% 28 36.8% 11 25.0%
Fabrazyme 141 27.6% 43.9% 31 24.0% 71 15.7% 19 157.1% 20 13.3%
Aldurazyme 48 9.8% 17.1% 17 6.3% 9 14.3% 16 15.4% 6 0.0%
Other Rare
Diseases 69 10.9% 25.5% 12 22.2% 30 21.1% 8 28.6% 19 -10.0%
products
Genzyme 821 30.9% 45.1% 244 24.2% 357 37.7% 145 35.3% 75 20.7%
--------------------------------------- ----------------- ---------------- ---------------- --------------
Plavix 483 -9.4% -0.8% 44 -30.6% 0 - 226 0.5% 213 -12.2%
Lovenox 438 1.2% 5.3% 231 0.0% 26 -31.3% 157 11.2% 24 0.0%
Aprovel 201 0.0% 12.3% 37 -33.3% 3 -25.0% 125 18.7% 36 6.7%
Renagel/ 226 13.4% 31.4% 33 3.1% 165 19.3% 22 0.0% 6 0.0%
Renvela
Allegra 80 -5.0% 0.0% 3 0.0% 0 - 0 - 77 -5.2%
Stilnox 75 -11.5% -3.8% 10 -9.1% 18 -6.3% 16 7.1% 31 -21.6%
Depakine 104 7.6% 13.0% 35 3.0% 0 - 65 10.9% 4 0.0%
Synvisc / 85 2.9% 21.4% 7 16.7% 65 1.9% 10 12.5% 3 -33.3%
Synvisc One
Tritace 75 5.9% 10.3% 30 -6.3% 0 - 44 21.2% 1 -33.3%
Multaq 83 -4.1% 13.7% 10 0.0% 70 -5.0% 3 0.0% 0 0.0%
Lasix 42 11.1% 16.7% 18 -10.0% 1 0.0% 14 8.3% 9 166.7%
Targocid 40 2.7% 8.1% 20 0.0% 0 - 19 13.3% 1 -50.0%
Orudis 50 31.4% 42.9% 4 -20.0% 0 - 45 41.4% 1 0.0%
Cordarone 34 3.1% 6.3% 6 0.0% 0 - 20 11.1% 8 -12.5%
Xatral 25 -4.2% 4.2% 9 -10.0% 0 - 15 0.0% 1 0.0%
Actonel 7 -66.7% -66.7% 1 -75.0% 0 - 4 -50.0% 2 -85.7%
Auvi-Q / 17 40.0% 70.0% 1 0.0% 13 37.5% 0 - 3 100.0%
Allerject
Other
established Rx 918 -3.0% 1.0% 394 -3.9% 81 -33.7% 351 8.7% 92 -5.4%
products
Total
Established Rx 2,983 -1.5% 5.8% 893 -6.3% 442 -5.7% 1,136 9.0% 512 -9.0%
Products
--------------------------------------- ----------------- ---------------- ---------------- --------------
Consumer 979 5.3% 10.6% 202 0.5% 259 5.5% 455 6.3% 63 15.4%
Healthcare
--------------------------------------- ----------------- ---------------- ---------------- --------------
Generics 478 10.2% 13.5% 138 -2.9% 41 17.9% 277 12.7% 22 110.0%
--------------------------------------- ----------------- ---------------- ---------------- --------------
Pharmaceuticals 7,455 2.2% 11.3% 1,854 -0.1% 2,274 -2.8% 2,500 10.4% 827 -3.1%
Polio / 282 15.6% 33.6% 7 16.7% 118 26.3% 132 32.2% 25 -43.6%
Pertussis / HIB
Influenza 22 -84.4% -83.7% 0 - -2 -104.8% 20 -81.9% 4 -66.7%
vaccines
Meningitis / 97 44.6% 73.2% 1 - 74 57.9% 20 26.7% 2 -66.7%
Pneumonia
Adult Booster 95 -1.2% 17.3% 5 -37.5% 73 -6.3% 12 57.1% 5 100.0%
Vaccines
Travel and
other endemic 82 -1.3% 9.3% 8 60.0% 19 0.0% 40 -7.5% 15 -6.7%
vaccines
Other Vaccines 119 41.4% 70.0% 0 -100.0% 113 41.5% 4 200.0% 2 100.0%
Vaccines 697 -4.6% 11.0% 21 0.0% 395 15.4% 228 -19.4% 53 -31.4%
Fipronil 193 1.2% 12.9% 69 9.7% 88 -5.3% 24 4.5% 12 -8.3%
products
Vaccines 186 11.7% 20.8% 42 0.0% 43 2.9% 79 10.3% 22 100.0%
Avermectin 157 17.5% 37.7% 17 6.3% 108 31.3% 11 -9.1% 21 -5.0%
products
Other Animal 122 38.5% 56.4% 28 22.7% 68 36.6% 17 27.3% 9 175.0%
Health
Animal Health 658 13.5% 27.3% 156 8.5% 307 15.2% 131 8.9% 64 32.6%
Total Group 8,810 2.4% 12.3% 2,031 0.6% 2,976 1.0% 2,859 7.3% 944 -3.5%
Appendix 2: Business net income statement
First quarter Group Total Pharmaceuticals Vaccines Animal Health Others
2015
? million Q1 2015 Q1 2014 Change Q1 2015 Q1 2014 Change Q1 2015 Q1 2014 Change Q1 2015 Q1 2014 Change Q1 Q1
2015 2014
Net sales 8,810 7,842 12.3% 7,455 6,697 11.3% 697 628 11.0% 658 517 27.3% - -
Other revenues 80 83 (3.6%) 62 68 (8.8%) 6 7 (14.3%) 12 8 50.0% - -
Cost of sales (2,786) (2,516) 10.7% (2,190) (1,988) 10.2% (376) (350) 7.4% (220) (178) 23.6% - -
As % of net (31.6%) (32.1%) (29.4%) (29.7%) (53.9%) (55.7%) (33.4%) (34.4%)
sales
Gross profit 6,104 5,409 12.8% 5,327 4,777 11.5% 327 285 14.7% 450 347 29.7% - -
As % of net 69.3% 69.0% 71.5% 71.3% 46.9% 45.4% 68.4% 67.1%
sales
Research&
Development (1,199) (1,139) 5.3% (1,039) (995) 4.4% (120) (107) 12.1% (40) (37) 8.1% - -
expenses
As % of net (13.6%) (14.5%) (13.9%) (14.9%) (17.2%) (17.0%) (6.1%) (7.2%)
sales
Selling and
general (2,438) (2,078) 17.3% (2,094) (1,791) 16.9% (156) (129) 20.9% (188) (158) 19.0% - -
expenses
As % of net (27.7%) (26.5%) (28.1%) (26.7%) (22.4%) (20.6%) (28.6%) (30.5%)
sales
Other current
operating (67) (25) (28) (23) 1 (2) - 6 (40) (6)
income/
expenses
Share of
profit/loss of
associates((1)) 31 13 32 8 (1) 5 - - - -
and joint
ventures
Net income
attributable to (33) (35) (33) (35) - - - - - -
non-controlling
interests
Business
operating 2,398 2,145 11.8% 2,165 1,941 11.5% 51 52 (1.9%) 222 158 40.5% (40) (6)
income
As % of net 27.2% 27.4% 29.0% 29.0% 7.3% 8.3% 33.7% 30.6%
sales
Financial
income and (97) (76)
expenses
Income tax (575) (522)
expense
Tax rate((2)) 25.0% 25.0%
Business net 1,726 1,547 11.6%
income
As % of net 19.6% 19.7%
sales
Business
earnings per 1.32 1.17 12.8%
share((3))
(in euros)
(1) Net of tax.
(2) Determined on the basis of Business income before tax, associates and non-
controlling interests.
(3) Based on an average number of shares outstanding of 1,308.4 million in the
first quarter of 2015 and 1,319.9 million in the first quarter of 2014.
Appendix 3: Reconciliation of Business net income to Net income attributable to
equity holders of Sanofi
? million Q1 2015 Q1 Change
2014
Business net income 1,726 1,547 11.6%
Amortization of intangible assets((1)) (618) (677)
Impairment of intangible assets (27) (3)
Fair value remeasurement of contingent 1 (8)
consideration liabilities
Restructuring costs (353) (51)
Other gains and losses, and litigation - 35((2))
Tax effect of items listed above: 355 248
Amortization of intangible assets 217 244
Impairment of intangible assets 10 1
Fair value remeasurement of contingent consideration 7 1
liabilities
Restructuring costs 121 15
Other gains and losses, and litigation - (13)
Share of items listed above attributable to non- 1 1
controlling interests
Restructuring costs of associates and joint ventures, (62) (8)
and expenses arising from the impact of acquisitions on
associates and joint ventures
Net income attributable to equity holders of Sanofi 1,023 1,084 (5.6%)
Consolidated earnings per share((3) )(in euros) 0.78 0.82
(1) Of which related to amortization expense generated by the remeasurement of
intangible assets as part of business combinations: ?590 million in the first
quarter of 2015 and ?657 million in the first quarter of 2014.
(2) In 2014, day one profit on Alnylam shares presented in financial result.
(3) Based on an average number of shares outstanding of 1,308.4 million in the
first quarter of 2015 and 1,319.9 in the first quarter of 2014.
See page 11 for comments on the reconciliation of business net income to
consolidated net income.
Appendix 4: Consolidated income statement
? million Q1 2015 Q1 2014
Net sales 8,810 7,842
Other revenues 80 83
Cost of sales (2,786) (2,516)
Gross profit 6,104 5,409
Research and development expenses (1,199) (1,139)
Selling and general expenses (2,438) (2,078)
Other operating income (30) 10
Other operating expenses (37) (35)
Amortization of intangible assets (618) (677)
Impairment of intangible assets (27) (3)
Fair value remeasurement of contingent consideration 1 (8)
liabilities
Restructuring costs (353) (51)
Operating income 1,403 1,428
Financial expenses (133) (147)
Financial income 36 106
Income before tax and associates and joint ventures 1,306 1,387
Income tax expense (220) (274)
Share of profit/loss of associates and joint ventures (31) 5
Net income 1,055 1,118
Net income attributable to non-controlling interests 32 34
Net income attributable to equity holders of Sanofi 1,023 1,084
Average number of shares outstanding (million) 1,308.4 1,319.9
Earnings per share (in euros) 0.78 0.82
Appendix 5: 2015 currency sensitivity
2015 Business EPS currency sensitivity
Currency Variation Business EPS Sensitivity
U.S. Dollar -0.05 USD/EUR +EUR 0.10
Japanese Yen +5 JPY/EUR -EUR 0.03
Russian Ruble +10 RUB/EUR -EUR 0.06
-----------------------------------------------------------
Currency exposure on Q1 2015
Currency Q1 2015
US $ 34.7%
Euro ? 23.4%
Japanese Yen 6.1%
Brazilian Real 3.1%
Chinese Yuan 5.4%
Russian Ruble 1.5%
British Pound£ 2.1%
Mexican Peso 1.4%
Canadian $ 1.5%
Australian $ 1.4%
Others 19.4%
---------------------------
Currency average rates
Q1 2014 Q1 2015 Change Average March 2015
?/$ 1.37 1.13 -17.7% 1.08
?/Yen 140.76 134.19 -4.7% 130.41
?/Yuan 8.36 7.03 -15.9% 6.76
?/Ruble 48.08 71.09 +47.9% 65.14
------------------------------------------------------------
Appendix 6: R&D Pipeline
Registration
+--------------------------------+----------------------------------------+
| N | |
| Praluent(®) (alirocumab) | Dengue |
| Anti-PCSK9 mAb | Mild-to-severe |
| Hypercholesterolemia, U.S., EU | dengue fever vaccine |
+--------------------------------+----------------------------------------+
| PR5I |
| DTP-HepB-Polio-Hib |
| Pediatric hexavalent vaccine, U.S., EU |
+----------------------------------------+
Phase III
+--------------------------+--------------------------+------------------------+
| LixiLan |N | |
| lixisenatide + insulin |patisiran (ALN-TTR02) | |
| glargine |siRNA inhibitor targeting | Clostridium difficile |
| Fixed-Ratio / Type 2 |TTR | Toxoid vaccine |
| diabetes |Familial amyloid | |
| |polyneuropathy | |
+--------------------------+--------------------------+------------------------+
| |N | |
|N |revusiran (ALN-TTRsc) | Rotavirus |
|Lyxumia(
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