PARIS, Nov. 2, 2017 /PRNewswire/ -- Sanofi (NYSE: SNY;
EURONEXT: SAN)
|
Q3
2017
|
Change
|
Change
at CER
|
Change
at CER/CS(3)
|
9M
2017
|
Change
|
Change
at CER
|
Change
at CER/CS(3)
|
IFRS net sales
reported
|
€9,053m
|
+0.3%
|
+4.7%
|
-0.2%
|
€26,364m
|
+5.7%
|
+6.2%
|
+1.2%
|
IFRS net income
reported
|
€1,567m
|
-6.4%
|
-
|
-
|
€8,305m
|
+111.9%
|
-
|
-
|
IFRS EPS
reported
|
€1.25
|
-3.8%
|
-
|
-
|
€6.60
|
+117.1%
|
-
|
-
|
Third-quarter and first nine months 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(4)). 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. Third-quarter and first nine months 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.
(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 8
for definitions). The consolidated income statement for Q3 2017 and
9M 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) changes in net sales are expressed at constant exchange rates
(CER) unless otherwise indicated (see Appendix 8); (3) CS: constant
structure: adjusted for BI CHC business, termination of SPMSD and
others; (4) The closing of the disposal of Merial in Mexico is expected in 2017; (5) See definition
page 8; (6) 2016 Business EPS was €5.68; (7) Collaboration with
Regeneron.
Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8093353-sanofi-earnings-results-q3-2017/
Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"The strong launch of Dupixent® in the U.S., the
continued double-digit growth of our Multiple Sclerosis franchise
and the performance of our pediatric vaccines were important
drivers in the quarter. These positive dynamics, accompanied by
robust growth in Emerging Markets and disciplined expense
management, offset the decline of our Diabetes franchise. We are
pleased by the progress in R&D demonstrated by the positive
phase 3 topline results in asthma for Dupixent® and the
recent advances of cemiplimab, our anti PD-1, in oncology."
Q3 2017 sales performance supported by Sanofi Genzyme, Sanofi
Pasteur and Emerging Markets
- Net sales were €9,053 million, up 0.3% on a reported basis and
4.7%(2) at CER reflecting the change in scope of the CHC
and Vaccines Global Business Units (GBUs). At CER and
CS(3), net sales were stable (-0.2%).
- Sanofi Genzyme grew 13.9% at CER due to the strong U.S. launch
of Dupixent® and good growth in Multiple
Sclerosis.
- Sanofi Pasteur grew 7.2% at CER and CS largely driven by
pediatric combinations and booster vaccines.
- CHC sales were up 1.0% at CER and CS impacted by increased
competition in developed markets.
- Diabetes and Cardiovascular sales declined 14.8% at CER. Given
increased visibility on sales performance, Sanofi refines its
global Diabetes franchise outlook to -6% to -8% CAGR over 2015-2018
at CER.
- Emerging Markets(5) sales increased 7.3% at CER and
CS driven by strong contributions from China and Russia.
Q3 2017 business EPS consistent with the full-year
guidance
- Q3 2017 business operating income of €2,911 million, up 5.1% at
CER and +1.7% at CS.
- Q3 2017 business EPS(1) grew 1.1% at CER to €1.71
and decreased 4.5% on a reported basis.
- Sanofi continues to expect 2017 business EPS(1) to
be broadly stable(6) at CER, barring unforeseen major
adverse events.
- Currency impact on 2017 business EPS is estimated to be -1% to
-2% at the average September 2017
exchange rates.
Sustaining Innovation in R&D
- Dupixent® approved in the EU in moderate to severe
atopic dermatitis.
- Positive topline results of the Phase 3 QUEST and VENTURE
studies confirmed the safety and efficacy profile of dupilumab in
asthma; U.S. filing in persistent uncontrolled asthma expected to
take place in Q4.
- In immuno-oncology, FDA granted Breakthrough Therapy
designation status to cemiplimab(7) (anti PD-1).
R&D update
Regulatory update
Regulatory updates since the publication of second-quarter
results on July 31, 2017 include the
following:
- In September, the European Commission granted marketing
authorization for Dupixent® (dupilumab), for use
in adults with moderate-to-severe atopic dermatitis who are
candidates for systemic therapy.
- In September, the U.S. Food and Drug Administration (FDA)
granted Breakthrough Therapy designation status to
cemiplimab (REGN2810/SAR439684) for the treatment of adults with
metastatic cutaneous squamous cell carcinoma (CSCC) and adults with
locally advanced and unresectable CSCC. Cemiplimab is an
investigational human, monoclonal antibody targeting PD-1, being
jointly developed by Sanofi and Regeneron.
- In September, the FDA granted tentative approval for
Admelog® (insulin lispro) 100 Units/mL, a rapid-acting
human insulin analog. Sanofi filed a paragraph IV certification and
Eli Lilly did not file a suit against Sanofi within the 45 days
period under Hatch-Waxman Act. Sanofi is currently working closely
with the FDA in order to receive full approval for Admelog in order
to launch in the U.S.
At the end of October 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:
- In October, Sanofi and Regeneron announced that the Phase 3
investigational study, LIBERTY ASTHMA VENTURE, evaluating
dupilumab in adults and adolescents with severe,
steroid-dependent asthma met its primary endpoint and key secondary
endpoints. The study results showed that dupilumab significantly
reduced steroid use, asthma attacks, and improved lung
function.
- In September, Sanofi and Alnylam reported positive topline
results from the APOLLO Phase 3 study of patisiran in
hereditary ATTR (hATTR) amyloidosis patients with polyneuropathy.
This study met its primary efficacy endpoint and all secondary
endpoints.
- In September, Sanofi and Regeneron announced positive results
of the Phase 3 CAFÉ study for Dupixent® in
patients with moderate-to-severe atopic dermatitis who are
inadequately controlled with or intolerant to the broad
immunosuppressant drug cyclosporine A (CSA), or when this treatment
is medically inadvisable. The results of this study were presented
at the European Academy of Dermatology and Venerology (EADV)
Congress.
- In September, Sanofi and Regeneron announced that the pivotal
Phase 3 LIBERTY ASTHMA QUEST study of dupilumab in a broad
population of patients with uncontrolled, persistent asthma met its
two primary endpoints. Dupilumab, when added to standard therapies,
reduced severe asthma attacks (exacerbations) and improved lung
function.
- In September, Sanofi alliance partner Alnylam Pharmaceuticals
announced that it had suspended dosing in all ongoing
fitusiran studies pending further review of a safety event
(a fatal thrombotic event occurred in a patient with hemophilia A
without inhibitors enrolled in the Phase 2 Open Label Extension
study of fitusiran) and development of a risk mitigation strategy.
Based on overall consideration of fitusiran's benefit-risk profile,
Alnylam aims to resume dosing as soon as it is feasible upon
agreement with global regulatory authorities and with appropriate
protocol amendments for enhanced patient safety monitoring in
place.
- SAR341402, a rapid acting
insulin, entered into phase 3.
- Cemiplimab, a PD1-inhibitor, entered in phase 3 for
second-line treatment of cervical cancer.
Phase 2:
- In October, positive results from a Phase 2 study of
dupilumab in adults with active moderate-to-severe
eosinophilic esophagitis were presented at the World Congress of
Gastroenterology (WCOG). The study showed that patients who
received dupilumab weekly reported a significant improvement in the
ability to swallow versus placebo.
- SAR407899, a Rho kinase
inhibitor, entered into phase 2a in microvascular angina.
- Sanofi decided to stop the development of SAR156597 in Idiopathic Pulmonary Fibrosis.
Phase 1:
- Sanofi does not intend to continue development with, or seek a
license from, the Walter Reed Army Institute of Research for the
Zika vaccine candidate following BARDA's decision (Biomedical
Advanced Research and Development Authority) to de-scope its
contract with Sanofi Pasteur to fund the manufacture and clinical
development of an inactivated Zika vaccine.
To access the full press release of the 2017 Q3 results,
please click here.
2017 Guidance
Sanofi confirms its full-year 2017 guidance for business
EPS(9) to be broadly stable at CER, barring unforeseen
major adverse events. The currency impact on 2017 business EPS is
now estimated to be -1% to -2% if the average September 2017 exchange rates are applied to the
fourth quarter of 2017.
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 regarding the marketing and other potential of the
product, or regarding potential future revenues from the product.
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, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, and volatile economic
conditions, as well as those risks 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:
|
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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SOURCE Sanofi