PARIS, Feb. 7, 2018 /PRNewswire/ -- Sanofi (NYSE:
SNY; EURONEXT: SAN)
|
Q4
2017
|
Change
|
Change
at CER
|
Change
at CER/CS(2)
|
2017
|
Change
|
Change
at CER
|
Change
at CER/CS(2)
|
IFRS net sales
reported
|
€8,691m
|
-2.0%
|
+4.1%
|
-1.6%
|
€35,055m
|
+3.6%
|
+5.6%
|
+0.5%
|
IFRS net income
reported
|
€129m
|
-83.7%
|
-
|
-
|
€8,434m
|
+79.1%
|
-
|
-
|
IFRS EPS
reported
|
€0.10
|
-83.9%
|
-
|
-
|
€6.71
|
+83.3%
|
-
|
-
|
Business net
income(1)
|
€1,332m
|
-17.1%
|
-10.8%
|
-
|
€6,964m
|
-4.7%
|
-2.6%
|
-
|
Business
EPS(1)
|
€1.06
|
-15.2%
|
-8.8%
|
-
|
€5.54
|
-2.5%
|
-0.4%
|
-
|
Fourth-quarter and
2017 accounts reflect the acquisition of the former Boehringer
Ingelheim Consumer Healthcare (CHC) business and the disposal of
the Animal Health business (completed on January 1, 2017). In
accordance with IFRS 5 (Non-Current Assets Held for Sale and
Discontinued Operations), Animal Health results in 2016 and gain on
disposal in 2017 are reported separately. Fourth-quarter and 2017
income statements also reflect the consolidation of European
operations related to Sanofi vaccine portfolio, following the
termination of the Sanofi Pasteur MSD joint venture (SPMSD JV) with
Merck at the end of 2016.
|
Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8268451-sanofi-2017-annual-results/
(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
10 for definitions). The consolidated income statement for Q4 2017
and 2017 is provided in Appendix 3 and a reconciliation of IFRS net
income reported to business net income is set forth in Appendix 4;
(2) CS: constant structure: adjusted for BI CHC business,
termination of SPMSD and others; (3) changes in net sales are
expressed at constant exchange rates (CER) unless otherwise
indicated (see Appendix 10); (4) based on current
understanding of the US tax reform; (5) Subject to the
completion of the acquisition; (6) 2017 business EPS was
€5.54
Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"In 2017, we continued to execute on our strategic goals with
the strong launch of Dupixent®, the positive pivotal data for
cemiplimab and for dupilumab in asthma. At the same time, we
managed the challenges in U.S. diabetes as well as the impact from
sevelamer generics and Dengvaxia®. Recently, we announced a series
of strategic steps - we are obtaining the global rights to
fitusiran and plan to acquire Bioverativ and Ablynx - which will
establish Sanofi as a new global leader in rare blood disorders.
Additionally, these actions will further strengthen our pipeline
and provide us with the powerful new Nanobody® technology platform.
Overall, after a period of significant reshaping since 2015, we are
positioned to drive growth in 2018."
Q4 2017 sales reflect strong Dupixent®
launch offset by anticipated declines in U.S. diabetes and
Renagel®
- Net sales were €8,691 million, down 2.0% on a reported basis
and up 4.1%(3) at CER. At CER/CS(3), net
sales were down 1.6%.
- Strong Sanofi Genzyme sales growth (up 16.8%) driven by
contribution from new immunology franchise.
- Sanofi Pasteur sales increased 1.2% at CER/CS impacted by order
phasing effects and Dengvaxia®.
- CHC sales grew 2.5% at CER/CS.
- Diabetes and Cardiovascular GBU sales down 19.1%.
- Emerging Markets sales increased 2.1% at CER/CS, driven by
Pharmaceuticals which increased 4.0% at CER/CS.
Sanofi Genzyme, Sanofi Pasteur and Emerging Markets sales
growth more than offset Diabetes sales decline in 2017
- Net sales in 2017 were €35,055 million, up 3.6% on a reported
basis and 5.6%(2) at CER. Net sales were up 0.5% at
CER/CS.
- Sanofi Genzyme grew 15.1% to €5,674 million while Sanofi
Pasteur increased 8.3% (at CER/CS) to €5,101 million.
- Emerging Markets sales were up 6.0% at CER/CS supported by
strong performance in China (up
15.1% at CER/CS).
- Diabetes and Cardiovascular GBU sales declined 14.3% to €5,400
million.
Sanofi meets its full-year 2017 business EPS guidance
- Q4 2017 business EPS(1) decreased 8.8% at CER to
€1.06, including financial impact from Dengvaxia®
(-€0.10).
- 2017 business EPS(1) of €5.54 (-0.4% at CER) and
IFRS EPS of €6.71 (+83.3% on a reported basis).
- Net debt was €5,229 million at the end of 2017, a decrease from
€8,206 million at the end of 2016.
- Board proposes dividend of €3.03, an increase of 2.4%.
- 2017 business net income (BNI) effective tax rate unaffected by
the U.S. tax reform. In 2018, Sanofi expects the BNI effective tax
rate to be around 22% primarily as a result of U.S. tax
reform(4).
Sanofi progresses on its strategic priorities
- Sanofi to acquire Bioverativ(5) for $11.6 billion to expand in specialty care and
strengthen its leadership in rare diseases.
- Sanofi to acquire Ablynx(5) for €3.9 billion to
strengthen its R&D strategy with innovative
Nanobody® technology platform.
- Agreement signed with Regeneron to accelerate and expand
investments for the development of cemiplimab and dupilumab.
- FDA supplemental BLA submission for dupilumab in uncontrolled
persistent asthma for adults and adolescents.
2018 financial outlook
- Sanofi expects 2018 business EPS(1) to grow between
2% and 5%(6) at CER, including the anticipated
contribution from the recently announced acquisitions, barring
unforeseen major adverse events. Applying the average December 2017 exchange rates, the currency impact
on 2018 business EPS is estimated to be -3% to -4%.
R&D update
Sanofi presented its R&D strategy and innovative pipeline on
December 13, 2017 which are
summarized in the following press release:
http://mediaroom.sanofi.com/sanofi-presents-rd-strategy-and-innovative-pipeline/
Regulatory update
Regulatory updates since December 13,
2017 include the following:
- In January, the Ministry of Health, Labor and Welfare (MHLW) in
Japan granted marketing and
manufacturing authorization for Dupixent® for the
treatment of atopic dermatitis in adults not adequately controlled
with existing therapies.
- In December, a marketing authorization application for
patisiran (partnership with Alnylam), an investigational
RNAi therapeutic targeting transthyretin for the treatment of
adults with hereditary transthyretin-mediated amyloidosis, was
submitted by Alnylam to the European Medicines Agency (EMA).
- In December a supplemental biologics license application for
dupilumab (partnership with Regeneron) was submitted to the
U.S. Food and Drug Administration (FDA) for uncontrolled,
persistent asthma for patients aged 12 and over.
At the beginning of February 2018,
the R&D pipeline contained 70 projects including 36 new
molecular entities and novel vaccines in clinical development. 25
projects are in Phase 3 or have been submitted to the regulatory
authorities for approval.
Portfolio update
Phase 3:
- At the end of 2017, the phase 3 program evaluating
efpeglenatide (partnership with Hanmi), a weekly GLP-1
agonist, in type 2 diabetes was initiated.
- In December 2017, the FDA lifted
the hold on clinical studies with fitusiran (an
investigational RNAi therapeutic targeting antithrombin for the
treatment of patients with hemophilia A and B; partnership with
Alnylam), including the Phase 2 open-label extension (OLE) study
and the ATLAS Phase 3 program.
Phase 1:
- In November 2017, Sanofi
announced that Principia will grant Sanofi an exclusive, worldwide
license to develop and commercialize SAR442168/PRN2246. This is a low dose
covalent BTK inhibitor which crosses the blood brain barrier.
Recently a Phase 1 clinical trial in healthy volunteers was
initiated in multiple sclerosis.
Alliances/Collaboration
- In January, 2018, Sanofi and Regeneron announced that they will
accelerate and expand investment for the clinical development of
the PD-1 (programmed cell death protein 1) antibody
cemiplimab in oncology and dupilumab in Type 2
allergic diseases.
- In January, 2018, Sanofi and Alnylam announced a strategic
restructuring of their RNAi therapeutics alliance to streamline and
optimize development and commercialization of certain products for
the treatment of rare genetic diseases. Specifically:
-
- Sanofi will obtain global development and commercialization
rights to fitusiran, an investigational RNAi therapeutic,
currently in development for the treatment of people with
hemophilia A and B.
- Alnylam will obtain global development and commercialization
rights to its investigational RNAi therapeutics programs for the
treatment of ATTR amyloidosis, including patisiran and
ALN-TTRsc02.
- Sanofi recently signed a clinical collaboration agreement with
Roche to explore the role of atezolizumab in combination with
isatuximab in certain solid tumors, reflecting scientific evidence
that checkpoint inhibition by CD38 may reverse resistance to
PD-L1.
To access the full press release of the 2017 Q4 results,
please click here.
2018 Guidance
Sanofi expects 2018 Business EPS to grow between 2% and 5% at
CER, including the anticipated contribution from the recently
announced acquisitions, barring unforeseen major adverse events.
Applying the average December 2017
exchange rates, the currency impact on 2018 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, to
complete related transactions 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,
2016. 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:
Ashleigh Koss
908-981-8745
Email: Ashleigh.koss@sanofi.com
Investor Relations:
George Grofik
+33 (0)1 53 77 45 45
Email: IR@sanofi.com
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SOURCE Sanofi