PARIS, July 30, 2015 /PRNewswire/ -- Sanofi (NYSE: SNY;
EURONEXT: SAN)
|
Q2
2015
|
Change
(reported)
|
Change
(CER)
|
|
|
|
|
Net sales
|
€9,378m
|
+16.1%
|
+4.9%
|
|
|
|
|
Business net
income(1)
|
€1,840m
|
+19.7%
|
+4.2%
|
|
|
|
|
Business
EPS(2)
|
€1.41
|
+20.5%
|
+5.1%
|
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.
(2)(EPS) Earnings Per Share
Experience the interactive Multimedia News Release here:
http://www.multivu.com/players/English/7569551-sanofi-results-q2-2015/
Sanofi Chief Executive Officer, Olivier Brandicourt commented:
"In the
second quarter, Sanofi delivered solid growth on both the top and
bottom lines that was consistent with our expectations. We continue
to execute on multiple product launches and are excited about the
recent approval of Praluent®. We are also investing in
our commercial infrastructure, biologic capabilities and R&D
programs including in immuno-oncology. Recently, we announced a new
organizational structure which will be implemented beginning in
January 2016 and will simplify and
focus Sanofi to optimize future growth."
Sales growth broad based across geographies and
businesses
- Group sales increased 4.9% (+16.1% on a reported basis) to
€9,378 million
- Slightly lower Diabetes sales (-3.8%) consistent with previous
quarter and significant U.S. market access already granted for
Toujeo®
- Genzyme delivered 26.6% growth; rare disease products increased
9.1% and the Multiple Sclerosis franchise sales more than
doubled
- Animal Health recorded another strong quarter (+14.2%) driven
by NexGard®
- Vaccines sales grew 8.6% led by influenza and booster
vaccines
- Emerging Markets sales increased 7.5%
Strong financial performance
- Business net income grew 4.2% at CER (+19.7% on a reported
basis) to €1,840 million
- Business EPS increased 5.1% at CER to €1.41 and grew 20.5% on a
reported basis
Significant progress in advancing innovative products
- Praluent® approved on July
24, in the U.S. and recommended for approval in the EU
- Positive Phase III topline results announced for LixiLan in
diabetes in July and sarilumab in rheumatoid arthritis in May
- Phase IIIb ELIXA study results demonstrated cardiovascular
safety of lixisenatide supporting the U.S. regulatory filing
- Olipudase alfa for Niemann-Pick type B advanced to Phase II and
Breakthrough Therapy designation granted by FDA
New strategic collaboration with Regeneron in
immuno-oncology
- Collaboration includes a PD-1 inhibitor in Phase I and other
immuno-oncology antibodies currently in Preclinical development,
including LAG3, GITR and PD-L1
R&D Update
Regulatory updates since the publication of the first quarter
results on April 30, 2015 include the
following:
- In late July, a New Drug Application (NDA) for
lixisenatide, a once-daily GLP-1 analogue, was submitted to
the U.S. Food and Drug Administration (FDA) for the treatment of
Diabetes.
- In July, the U.S. FDA approved Praluent®
(alirocumab, collaboration with Regeneron), the first FDA-approved
treatment in a new class of drugs known as PCSK9 inhibitors.
Praluent® is indicated as an adjunct to diet and
maximally tolerated statin therapy for the treatment of adults with
heterozygous familial hypercholesterolemia or clinical
atherosclerotic cardiovascular disease, who require additional
lowering of low-density lipoprotein (LDL) cholesterol. In parallel,
the CHMP also issued an opinion recommending the approval of
Praluent® in EU in July. The final EMA decision is
expected in late September.
- In July, the Ministry of Health, Labor and Welfare (MHLW) in
Japan granted a marketing
authorization for Lantus® XR (known as
Toujeo® in the U.S. and Europe), a next-generation basal insulin for
the treatment of type 1 and type 2 diabetes.
Toujeo® was also approved in Canada in May and Australia in June.
- In June, the FDA granted Breakthrough Therapy designation to
olipudase alfa. This enzyme replacement therapy is being
investigated by Genzyme for the treatment of patients with
Niemann-Pick disease Type B.
At the end of July 2015, the
R&D pipeline contained 36 pharmaceutical new molecular entities
(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.
2015 Guidance
- The performance of the second quarter is in line with the full
year guidance announced on February 5,
2015. Sanofi expects 2015 Business EPS(2) to be
stable to slightly growing versus 2014 at constant average exchange
rates, barring major unforeseen adverse events.
- In addition, the positive currency impact on 2015 full-year
business EPS is estimated to be approximately +10%, under the
assumption that exchange rates remain stable in the following two
quarters at the average rates of June
2015.
To access the full press release of the Q2 2015 results,
please click here.
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.
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 or call 1-800-981-2491.
Media Relations:
908-989-0726
Email: USMediaRelations@Sanofi.com
Investor Relations:
908-981-5560
Email: IR@sanofi.com
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SOURCE Sanofi