PARIS, Feb. 9, 2016 /PRNewswire/ -- Sanofi (NYSE:
SNY; EURONEXT: SAN)
|
Q4
2015
|
Change
|
Change
(CER)
|
2015
|
Change
|
Change
(CER)
|
Aggregate Group
sales(1)
|
€9,278m
|
+2.3%
|
-1.6%
|
€37,057m
|
+9.7%
|
+2.2%
|
Business net
income(2)
|
€1,709m
|
-6.5%
|
-13.5%
|
€7,371m
|
+7.7%
|
-0.9%
|
Business
EPS(3)
|
€1.31
|
-5.8%
|
-12.9%
|
€5.64
|
+8.5%
|
0.0%
|
|
(1) Including
Animal Health Business, which is reported on a single line in the
consolidated income statements in accordance with IFRS 5
(Non-current assets held for sale and discontinued operations).
Additionally, Sanofi comments include Animal Health Business for
every income statement line using "Aggregate" wording. (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. (3) (EPS) Earnings Per
Share.
|
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http://www.multivu.com/players/English/7753751-sanofi-2015-annual-results/
Sanofi Chief Executive Officer, Olivier Brandicourt,
commented:
"In 2015, Sanofi made meaningful
progress with key launches, multiple business development
activities and our efforts to simplify the organization. Entering
into exclusive negotiations on a business swap with Boehringer
Ingelheim would bring us leadership in CHC. This is a key first
step in reshaping our portfolio. In 2016, we continue to allocate
resources to our promising late-stage pipeline and the introduction
of innovative medicines, which will position us for accelerated
future growth."
Executing on 2020 strategic roadmap
- Key milestone in reshaping the portfolio with announcement of
exclusive negotiations on business swap
- Significant R&D alliances in oncology and diabetes
- Praluent® launch progressing with significant U.S.
market access for 2016
- Toujeo® available globally in over 20 countries,
reaching sales of €98 million in Q4 2015
Recent achievements in advancing Sanofi's R&D pipeline of
innovative medicines
- Dengvaxia®, the world's first dengue vaccine,
approved in Mexico, Brazil, El
Salvador and the
Philippines
- Biologics License Application for sarilumab accepted for review
by the FDA
- FDA submission for priority review of once-daily combination of
insulin glargine and lixisenatide
Sales growth in Pharmaceuticals, Vaccines and Animal Health
in
2015
- Aggregate Group sales up 2.2% (+9.7% at 2015 exchange
rates) to €37,057 million
- Genzyme continues to be a key driver with sales up 29.5% with
strong momentum in multiple sclerosis
- Vaccines sales were up 7.3% benefiting from double-digit growth
in Emerging Markets
- Diabetes sales decreased 6.8% in line with October guidance,
reflecting lower U.S. sales of Lantus®
- Animal Health demonstrated strong performance with sales up
10.8% driven by NexGard®
- Emerging Markets Aggregate sales increased 7.8%, driven by
strong growth in China, up
19.5%
Solid financial results in 2015 while making significant
investments in new product launches
- Business EPS was €5.64, up 8.5% on a reported basis and stable
at CER
- Free Cash Flow up 12.2% to €8,132 million resulting in net debt
of €7,254 million
- Board proposes dividend of €2.93, the 22nd
consecutive year of dividend growth
2016 financial guidance
- Sanofi expects 2016 Business EPS to be broadly stable at
CER, barring unforeseen major adverse events
R&D Update
Regulatory update
Regulatory updates since the publication of the third quarter
results on October 29, 2015 include
the following:
- In January, Sanofi and Regeneron announced that the U.S. Food
and Drug Administration (FDA) accepted for review the Biologics
License Application (BLA) for sarilumab. Per the
Prescription Drug User Fee Act (PDUFA), the target action date is
Oct. 30, 2016.
- In December, Dengvaxia® was granted
regulatory approval by the regulatory authorities in Brazil, Mexico and the
Philippines.
- In December, the CHMP granted a Positive Opinion recommending
the Marketing Authorization of PR5I, Vaxelis, in EU.
- In December, Sanofi submitted a New Drug Application (NDA) to
the FDA for its investigational fixed-ratio combination of
insulin glargine 100 Units/mL and lixisenatide, which if
approved would be administered as a single daily injection for the
treatment of adults with type 2 diabetes.
At the beginning of February 2016,
the R&D pipeline contained 46 pharmaceutical new molecular
entities (excluding Life Cycle Management) and vaccine candidates
in clinical development of which 14 are in Phase III or have been
submitted to the regulatory authorities for approval.
Collaboration
- In January, Sanofi and Warp Drive Bio, a privately held
biotechnology company using the molecules and mechanisms of nature
to discover and develop transformative medicines, announced that
they have extended and reshaped their existing collaboration
utilizing Warp Drive's proprietary SMART™ (Small
Molecule Assisted Receptor Targeting) and Genome Mining platforms
to discover novel oncology therapeutics and antibiotics.
- In January, Sanofi and Innate Pharma announced that they
have entered into a research collaboration and licensing agreement
to apply Innate Pharma's new proprietary technology to the
development of innovative bispecific antibody formats engaging
natural killer (NK) cells to kill tumor cells through the
activating receptor NKp46.
- In November, Sanofi and Lexicon entered into a
collaboration and license agreement for the development and
commercialization of sotagliflozin, an investigational new oral
dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and
SGLT-2), which could be a potential treatment option for people
with diabetes. The developmental medicine sotagliflozin (LX4211) is
currently being studied in two pivotal Phase III trials in type 1
diabetes, which are expected to report top-line results during the
second half of 2016. Phase III trials in type 2 diabetes are
expected to begin in 2016.
- In November, Sanofi and Hanmi announced a worldwide
license agreement to develop a portfolio of experimental,
long-acting diabetes treatments. Sanofi has obtained an exclusive
worldwide license to develop and commercialize efpeglenatide, a
late-stage long-acting glucagon-like peptide-1 receptor agonist
(GLP1-RA); a weekly insulin and; a fixed-dosed weekly
GLP-1-RA/insulin drug combination.
- Sanofi and BioNTech A.G. announced in November that they
entered into a multiyear exclusive collaboration and license
agreement. This research collaboration between Sanofi and BioNTech
will leverage the scientific expertise of the two organizations to
discover and develop up to five cancer immunotherapies, each
consisting of a mixture of synthetic messenger RNAs (mRNAs).
- In November, Sanofi and AstraZeneca announced a direct
exchange of 210,000 compounds from their respective, proprietary
compound libraries. The exchange represents a novel, open
innovation model of collaboration between two leading
pharmaceutical companies. It will enhance the chemical diversity of
the compound collections of both companies and allow each company
to screen a broader, more diverse chemical space as the starting
point in the search for new, small-molecule medicines.
To access the full press release of the 2015 annual results,
please click here.
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi has core strengths in diabetes
solutions, human vaccines, innovative drugs, consumer healthcare,
emerging markets, animal health and Genzyme. Sanofi is listed
in Paris (EURONEXT: SAN) and in New
York (NYSE: SNY).
Sanofi is the holding company of a consolidated group of
subsidiaries and operates in the United States as Sanofi
US. For more information on Sanofi US, please
visit http://www.sanofi.us and http://www.news.sanofi.us/social-media or
call 1-800-981-2491.
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 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, 2014. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Media Relations:
Mary Kathryn Steel
908-989-0726
USMediaRelations@sanofi.com
Investor Relations:
George Grofik
908-981-5560
IR@sanofi.com
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SOURCE Sanofi