PARIS, Feb. 8, 2017 /PRNewswire/ -- Sanofi (NYSE:
SNY; EURONEXT: SAN)
|
Q4
2016
|
Change
|
Change
(CER)
|
2016
|
Change
|
Change
(CER)
|
Business net
income(1)
|
€1,606m
|
-6.0%
|
-2.9%
|
€7,308m
|
-0.9%
|
+2.5%
|
Business
EPS(2)
|
€1.25
|
-4.6%
|
-1.5%
|
€5.68
|
+0.7%
|
+4.1%
|
(1) 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
11 for definitions). The consolidated income statement for
Q4 2016 and 2016 is provided in Appendix 4 and a reconciliation of
business net income to IFRS net income reported is set forth in
Appendix 3; (2) (EPS) Earnings Per Share
Following the announcement of exclusive negotiations with
Boehringer Ingelheim and as per the IFRS 5 presentation requirement
for discontinued operations, net income for Sanofi's Animal Health
business (Merial) was reported on a separate line ("Net income from
the held for exchange Animal Health Business") in the Consolidated
Income Statement for 2016 and the prior year. In the first three
quarters of 2016, Sanofi comments included Merial for every income
statement line using the term "Aggregate". Sanofi neither presents
"Aggregate" figures nor reports Animal Health business as an
operating segment in Q4 2016 and in 2016 as a result of the closing
early in 2017 of the swap of the Animal Health/CHC business with
Boehringer Ingelheim. 2016 net sales including Animal Health were
€36,529 million of which €9,466 million in the fourth quarter of
2016.
Experience the interactive Multimedia News Release here:
https://www.multivu.com/players/English/7788755-sanofi-2016-annual-results/
Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"2016
was a busy year for Sanofi as we progressed on our 2020 strategic
roadmap. We successfully closed the Boehringer Ingelheim asset
swap, lifting us into a leadership position in Consumer Healthcare.
Our streamlined organization started to deliver and supported a
stronger financial performance than initially anticipated. At the
same time, we completed the filing of our breakthrough innovation
Dupixent® for the first indication, atopic
dermatitis, in the U.S and Europe.
Separately, we recently advanced five new molecules into
registrational studies."
All Global Business Units delivered positive sales
performance in the fourth quarter of 2016
- Net sales were €8,867 million, up 3.3% on a reported basis (up
3.4% at CER).
- Sanofi Genzyme (Specialty Care) GBU increased 12.6% driven by
multiple sclerosis products.
- Sanofi Pasteur GBU grew 3.7% due to strong pediatric
combination franchise sales.
- Diabetes and Cardiovascular GBU sales were up 3.8%. Global
diabetes franchise sales increased 1.9%.
2016 sales supported by Specialty Care and Vaccines
- Net sales in 2016 were €33,821 million, down 0.7% on a reported
basis and up 1.2% at CER.
- Sanofi Genzyme GBU sales reached €5,019 million, up 17.3% while
Sanofi Pasteur sales grew 8.8% to €4,577 million.
- Emerging Markets sales increased 2.4% to €9,593 million (up
7.0% excluding Venezuela).
Solid financial results in 2016 despite launch investments,
supported by cost savings
- 2016 Business EPS of €5.68 (+4.1% at CER) and IFRS EPS of €3.66
(+11.6% on a reported basis).
- Q4 2016 Business EPS was €1.25, down -1.5% at CER impacted by
an unfavorable tax rate comparison.
- Q4 2016 Business operating income grew 3.7% at CER
- Board proposes dividend of €2.96, the 23rd
consecutive annual increase.
Sanofi progresses on its strategic priorities
- Closing of the Boehringer Ingelheim (BI) business swap elevates
Sanofi into a global leadership position in CHC.
- Sanofi Pasteur and MSD end joint vaccines business to pursue
their European vaccine strategies independently.
- Soliqua™ 100/33 launched in the U.S. and Suliqua™ approved in
EU for type-2 diabetic patients.
- Kevzara™ (sarilumab) in rheumatoid arthritis approved in
Canada and U.S. resubmission
planned in Q1 2017.
- 5 NMEs started registrational studies in 2016: isatuximab,
PD-1, sotagliflozin, olipudase alfa and NeoGAA.
R&D update
Regulatory update
Regulatory updates since the publication of the third quarter
results on October 28, 2016 include
the following:
- In January 2017, Kevzara™
(sarilumab) was approved in Canada
for the treatment of moderate to severe rheumatoid arthritis in
adults.
On October 28, 2016, the U.S. Food
and Drug Administration (FDA) issued a Complete Response Letter
(CRL) regarding the Biologics License Applications (BLA) for
sarilumab for the treatment of adult patients with moderately to
severely active rheumatoid arthritis. The CRL refers to certain
deficiencies identified during a routine good manufacturing
practice inspection of the Sanofi Le Trait facility where sarilumab
is filled and finished, one of the last steps in the manufacturing
process. Satisfactory resolution of these deficiencies is required
before the BLA can be approved. Based on review of Sanofi's
responses to the FDA 483 letters as well as proposed corrective
actions, the FDA has classified the Le Trait 'fill and finish'
facility as "acceptable". Sanofi plans the re-submission of
sarilumab U.S. BLA in the first quarter of 2017 subject to
successful FDA pre-approval inspection of Le Trait.
- In December 2016, the European
Medicines Agency accepted for review the Marketing Authorization
Application for Dupixent® (dupilumab) for the
treatment of adults with moderate-to-severe atopic dermatitis (AD)
who are candidates for systemic therapy.
- In November 2016, the FDA
approved once-daily Soliqua™ 100/33 (insulin glargine 100
Units/mL & lixisenatide 33 mcg/mL injection) for the treatment
of adults with type 2 diabetes inadequately controlled on basal
insulin (less than 60 Units daily) or lixisenatide. In January 2017, the European Commission also
approved Suliqua™ in combination with metformin for the
treatment of adults with type 2 diabetes to improve glycemic
control when this has not been provided by metformin alone or
metformin combined with another oral glucose lowering medicinal
product or with basal insulin.
At the beginning of February 2017,
the R&D pipeline contained 44 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 3:
- Sotagliflozin, an oral SGLT-1&2 inhibitor, entered
into Phase 3 in type 2 diabetes.
- The Phase 3 program evaluating dupilumab, an anti-IL4Rα
monoclonal antibody, in nasal polyposis was initiated.
- GZ402666 (also referred as neoGAA) entered into Phase 3
for the treatment of Pompe Disease.
- Isatuximab, an anti-CD38 naked monoclonal antibody,
entered Phase 3 development for the treatment of relapsed
refractory multiple myeloma.
- In November, Sanofi and Regeneron announced that the ongoing
Praluent® ODYSSEY OUTCOMES trial will continue as
planned, based on the recommendation of an independent Data
Monitoring Committee (DMC) after a second pre-specified interim
analysis was conducted.
- In November, the results of SARIL-RA-MONARCH, a Phase 3 study,
demonstrated the superiority of investigational sarilumab
monotherapy versus adalimumab (marketed by AbbVie as
Humira®) monotherapy in improving the clinical signs and
symptoms in adults with active rheumatoid arthritis. The data were
presented at the American College of Rheumatology 2016 Annual
Meeting. Top-line results had been announced in March 2016.
Phase 2:
- SAR439152, a myosin
inhibitor, moved into Phase 2 for the treatment of Hypertrophic
cardiomyopathy.
- SAR425899, a GLP-1 / GCGR
agonist, entered into Phase 2 in type 2 diabetes.
- SAR566658, a
maytansin-loaded anti-CA6 monoclonal antibody, moved into Phase 2
for the treatment of solid tumors.
- Shan6, a pediatric hexavalent vaccine from Shantha,
entered Phase 2.
- A vaccine entered Phase 2 against HIV infection for at
risk population.
Phase 1:
- SAR439794, a TLR4 agonist
immunomodulator, entered Phase 1 for the treatment of peanut
allergy.
- An inactivated Zika vaccine entered Phase 1.
- Respiratory Syncytial Virus vaccine for infants entered
Phase 1.
Collaboration
On December 28th, 2016,
Hanmi and Sanofi entered into an amendment to their initial
license agreement executed for the development of a portfolio of
long-acting diabetes treatments. Sanofi returned to Hanmi the
rights related to the weekly long-acting insulin to primarily focus
on development of the weekly GLP-1 (efpeglenatide). Hanmi will take
the development lead on the weekly insulin and will assume
responsibility for the development of the long-acting weekly
efpeglenatide/insulin drug combination for a certain period of
time, after which Sanofi will re-assume responsibility for
development.
To access the full press release of the 2016 annual results,
please click here.
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 December
2016 exchange rates, the currency impact on 2017 Business
EPS is estimated to be +3% to +4%.
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, 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:
|
Ashleigh
Koss
|
George
Grofik
|
908-981-8745
|
+33 (0) 1 53 77 45
45
|
Email:
Ashleigh.koss@sanofi.com
|
Email:
IR@sanofi.com
|
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visit:http://www.prnewswire.com/news-releases/sanofi-delivers-2016-sales-and-business-eps-growth-at-cer-300404158.html
SOURCE Sanofi