PARIS, April 28, 2017 /PRNewswire/ -- Sanofi (NYSE:
SNY; EURONEXT: SAN)
|
Q1
2017
|
Change
|
Change at
CER
|
Change at CER
and CS(1)
|
Business net
income(2)
|
€1,795m
|
+4.2%
|
+1.0%
|
-
|
Business
EPS(2)
|
€1.42
|
+6.0%
|
+3.0%
|
-
|
Experience the interactive Multimedia News Release
here: https://www.multivu.com/players/English/8093351-sanofi-earnings-results-q1-2017/
First-quarter 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(3)). 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. The first quarter 2017
income statement also reflects 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 December 2016.
|
(1) CS: constant structure: adjusted for BI CHC business,
termination of SPMSD and others; (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 definitions). The
consolidated income statement for Q1 2017 is provided in Appendix 3
and a reconciliation of IFRS net income reported to business net
income is set forth in Appendix 4; (3) The closing of the disposal
of Merial in Mexico is expected in
2017
Sanofi Chief Executive Officer, Olivier Brandicourt,
commented:
"We have started the year with
robust growth driven by Specialty Care and Vaccines as well as good
performance in Emerging Markets. Our top line in the first quarter
also benefited from the integration of the Boehringer Ingelheim CHC
and European vaccine businesses. At the same time, the simplified
organization continues to contribute to Sanofi's financial
performance. The U.S. launch of Dupixent® for
moderate-to-severe atopic dermatitis marks a key innovation
milestone on our strategic roadmap and lays the foundation for our
new immunology franchise. We are excited to bring this highly
innovative medicine to patients suffering from this devastating
disease."
Q1 2017 sales growth supported by Specialty Care, Vaccines
and Emerging Markets
- Net sales were €8,648 million, up 11.1% on a reported basis and
8.6% at CER reflecting the acquisition of Boehringer Ingelheim's
(BI) CHC business and full consolidation of Sanofi's European
vaccine operations. At constant structure and CER, net sales were
up 3.5%.
- Sanofi Genzyme (Specialty Care) GBU sales increased 15.5% at
CER driven by Multiple Sclerosis products.
- Diabetes and Cardiovascular GBU sales were down 7.7% at CER;
Global Diabetes franchise sales decreased 6.0%.
- Sanofi Pasteur GBU grew 13.2% at CER and constant structure due
to the strong performance of pediatric combinations.
- CHC GBU sales were up 4.7% at CER and constant structure driven
by the performance in Europe.
- Emerging Markets sales increased 8.5% at CER and constant
structure.
Strong financial results and 2017 guidance confirmed
- Business operating income of €2,442 million, up 7.6% at CER and
constant structure.
- Business EPS grew 3.0% at CER to €1.42 and increased 6.0% on a
reported basis.
- Sanofi continues to expect 2017 Business EPS to be stable to
-3% at CER, barring unforeseen major adverse events.
- IFRS net income of €5,701 million (up 424%) included a net gain
of €4,427 million resulting from the divestment of Merial.
Sanofi progresses on its 2020 roadmap
- Integration of Boehringer Ingelheim CHC business on track,
enhancing Sanofi's position in key categories and regions.
- Following the termination of the SPMSD JV, European vaccine
business now fully driven by Sanofi.
- Dupixent®, a breakthrough therapy for
moderate-to-severe atopic dermatitis, now available to adult
patients in the U.S.
- Soliqua™100/33, first once-daily fixed combination of
Lantus® and lixisenatide for type-2 diabetes, launched
in the U.S.
- Kevzara™ BLA for the treatment of rheumatoid arthritis granted
PDUFA date of May 22, 2017.
- FDA approval of Xyzal® Allergy 24H for OTC use and
launch underway ahead of the U.S. spring allergy season.
R&D update
Regulatory update
Regulatory updates since the publication of 2016 full-year
results on February 8, 2017 include
the following:
- In April, the FDA approved a new dosing regimen for
Praluent® of 300 mg administered subcutaneously
once monthly (every 4 weeks).
- In April the European Medicine Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) granted a positive opinion
for the marketing authorization of Kevzara®
(sarilumab), recommending its approval for use in adult patients
with moderately to severely active rheumatoid arthritis.
- In March, the U.S. Food and Drug Administration (FDA) approved
Dupixent® (dupilumab), the first and only
biologic medicine approved for the treatment of adults with
moderate-to-severe atopic dermatitis (AD) whose disease is not
adequately controlled with topical prescription therapies, or when
those therapies are not advisable.
- Following successful conclusion of Le Trait manufacturing site
inspection by FDA, the Kevzara™ (sarilumab) U.S. BLA was
accepted in April for the treatment of rheumatoid arthritis with a
PDUFA date of May 22, 2017.
- At the end of April 2017, the
R&D pipeline contained 46 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 4:
- Top-line results of the ODYSSEY OUTCOMES study on
Praluent® are now expected to be reported in the
first quarter of 2018 based on communications from the independent
DSMB (Data and Safety Monitoring Board). Recruitment for this
18,600-patient cardiovascular outcomes trial was completed in
November 2015 and the scheduled
two-year follow-up of patients is underway.
Phase 3:
- The results of the CAFÉ study evaluating dupilumab in
cyclosporine-resistant patients in moderate-to-severe atopic
dermatitis were positive and demonstrated an acceptable safety
profile. These results will be submitted to the EMA and presented
at a scientific Congress.
- In March, detailed results from the one-year Phase 3 CHRONOS
study were presented at the Annual Meeting of the American Academy
of Dermatology (AAD). In this study, patients receiving
Dupixent® with topical corticosteroids (TCS)
achieved significantly improved measures of overall disease
severity compared to TCS alone in adults with uncontrolled
moderate-to-severe AD with a safety profile consistent with
previous studies.
Phase 2:
- SP0232 / MEDI8897 (partnership with MedImmune), a
monoclonal antibody, entered the portfolio in Phase 2 for the
prevention of lower respiratory tract illness in infants caused by
respiratory syncytial virus.
- SAR566658, a
maytansin-loaded anti-CA6 monoclonal antibody, entered into Phase 2
for the treatment of triple negative breast cancer.
- A Phase 2 study was initiated to evaluate isatuximab in
acute lymphoblastic leukemia.
Phase 1:
- SAR440181 / MYK491
(collaboration with MyoKardia), for the treatment of dilated
cardiomyopathy (DCM1 myosin activation), entered Phase 1.
To access the full press release of the 2017 Q1 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 March
2017 exchange rates to the rest of the year, 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, 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