PARIS, April 29, 2016 /PRNewswire/ -- Sanofi (NYSE:
SNY; EURONEXT: SAN)
Experience the interactive Multimedia News Release here:
http://www.multivu.com/players/English/7788751-sanofi-earnings-results-q1-2016/
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Q1
2016
|
Change
|
Change
(CER)
|
Aggregate Group
sales(1)
|
€8,543m
|
-1.9%
|
+0.7%
|
Business net
income(2)
|
€1,722m
|
-0.2%
|
+3.5%
|
Business
EPS(3)
|
€1.34
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+1.5%
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+5.3%
|
(1) Including Animal Health Business (see Appendix 8 for
definition of Aggregate Group sales) 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 (see Appendix 8 for
definition). The consolidated income statement for Q1 2016 is
provided in Appendix 4 and a reconciliation of business net income
to IFRS net income reported in Appendix 3; (3) (EPS) Earnings Per
Share.
Sanofi Chief Executive Officer, Olivier Brandicourt,
commented:
"I am pleased with the solid
performance of the Group in the first quarter driven by Sanofi
Genzyme, Sanofi Pasteur and Merial as well as our growth in
Emerging Markets. At the same time, we have made significant
progress with two major late-stage pipeline assets, dupilumab and
sarilumab, highlighting the potential of our emerging immunology
franchise. As we enter the second quarter, we remain focused on the
execution of our strategic priorities and confirm our financial
outlook of broadly stable Business EPS at CER for the full
year."
Solid financial results and 2016 Guidance confirmed
- Aggregate Group sales increased by 0.7% (-1.9% at 2016 exchange
rates) to €8,543 million (with VaxServe sales of non-Group products
of €83 million now reported in Other revenues). Excluding
Venezuela, Aggregate Group sales
grew 3.0%
- Business EPS was up 5.3% at CER to €1.34 and increased 1.5% on
a reported basis
- Sanofi continues to expect 2016 Business EPS to be broadly
stable at CER, barring unforeseen major adverse events
Sales performance led by Sanofi Genzyme and Emerging
Markets
- Sanofi Genzyme Global Business Unit (GBU) sales increased
20.5%, driven by the MS franchise
- Strong growth of Sanofi Pasteur GBU with sales of €625m, up
+8.2%, despite expected lower sales of Pentacel® due to
supply constraints in the U.S.
- Diabetes and Cardiovascular GBU performance reached €1,499
million, down 5.8%. On a worldwide basis, including Emerging
Markets, Diabetes franchise sales declined 4.5%
- General Medicines & Emerging Markets GBU sales of €4,490
million, -4.3%, or stable excluding Venezuela
- Total Emerging Markets sales were €2,373 million, an increase
of 13.1% excluding Venezuela
Advancing the next wave of innovation
- Dupilumab is the first systemic therapy to show positive Phase
III results in moderate-to-severe atopic dermatitis, representing a
promising new class of immunotherapies
- Sarilumab demonstrated superiority vs. adalimumab in a Phase
III monotherapy study in rheumatoid arthritis
- The WHO Strategic Advisory Group of Experts on Immunization
recommended the use of Dengvaxia® in endemic countries.
The first public dengue immunization program started in
the Philippines in April
R&D Update
Regulatory update
Regulatory updates since the publication of the fourth quarter
results on February 9, 2016 include
the following:
- In February, the U.S. Food and Drug Administration (FDA)
accepted the New Drug Application (NDA) for the investigational
fixed-ratio combination of basal insulin glargine and
GLP-1 receptor agonist lixisenatide for the treatment of adults
with type 2 diabetes. The FDA decision is anticipated in
August 2016. In March, the FDA
announced that on May 25, 2016, the
Endocrinologic and Metabolic Drugs Advisory Committee will review
the NDA for the investigational fixed-ratio combination of basal
insulin glargine and lixisenatide and investigational lixisenatide.
In Europe, Sanofi submitted the
dossier of this fixed-ratio combination to health authorities in
March.
- In February, the new hexavalent pediatric vaccine, PR5i
(DTP-HepB-Polio-Hib), was granted a Marketing Authorization in
EU.
At the end of April 2016, the
R&D pipeline contained 46 pharmaceutical new molecular entities
(excluding Life Cycle Management) and vaccine candidates in
clinical development of which 15 are in Phase III or have been
submitted to the regulatory authorities for approval.
Portfolio update
Phase III:
- The Data Monitoring Committee (DMC) of the ODYSSEY OUTCOMES
study for Praluent® has completed the first
interim analysis based on unblinded study data. In addition to the
review of the safety data, the DMC performed a futility assessment
and recommended the study continue with no changes. Sanofi remains
blinded to the actual results of this analysis. The second interim
analysis for futility and overwhelming efficacy potentially could
occur in the second half of 2016 when 75% of the targeted number of
primary events have occurred
- In March, Sanofi and Regeneron announced positive topline
results from the Phase III ODYSSEY ESCAPE trial evaluating
Praluent® (alirocumab) Injection in patients with
an inherited form of high cholesterol known as heterozygous
familial hypercholesterolemia, whose cholesterol levels required
chronic, weekly or bi-weekly apheresis therapy.
- In March, Sanofi and Regeneron announced that a Phase III
monotherapy study, SARIL-RA-MONARCH, met its primary endpoint
demonstrating that sarilumab was superior to adalimumab
(marketed by AbbVie as Humira®) in improving signs and
symptoms in patients with active rheumatoid arthritis at Week
24.
- In April, Sanofi and Regeneron announced positive topline
results from two placebo-controlled Phase 3 studies known as
LIBERTY AD SOLO 1 and SOLO 2, evaluating investigational
dupilumab in adult patients with inadequately controlled
moderate-to-severe atopic dermatitis. In the studies, treatment
with dupilumab as monotherapy significantly improved measures of
overall disease severity, skin clearing, itching, quality of life,
and mental health.
- The second generation meningococcal ACYW conjugate vaccine,
Men Quad TT, with a broader age indication (from infants to
the elderly) entered into Phase III.
Phase II:
- In March, data from a Phase I/II clinical study, NEO1,
evaluating the investigational novel enzyme replacement therapy
neoGAA in 24 patients with late-onset Pompe disease were
presented at WORLD Symposium 2016. The safety and efficacy data
from this study support further development of the therapy. Sanofi
plans to begin enrolling patients in a pivotal Phase 3 trial for
neoGAA in Q2 2016.
- SAR422459, ABC4A gene
therapy, entered in Phase IIa in Stargardt Disease, a rare eye
disease.
To access the full press release of the 2016 Q1 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, 2015. 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:
|
Investor
Relations:
|
Anna
Robinson
|
George
Grofik
|
908-989-0726
|
908-981-5560
|
Email:
USMediaRelations@sanofi.com
|
Email:
IR@sanofi.com
|
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SOURCE Sanofi