PARIS, July 31, 2017 /PRNewswire/ -- Sanofi (NYSE:
SNY; EURONEXT: SAN)
|
Q2
2017
|
Change
|
Change
at CER
|
Change
at CER/CS(2)
|
H1
2017
|
Change
|
Change
at CER
|
Change
at CER/CS(2)
|
Business net
income(1)
|
€1,696m
|
+1.0%
|
-0.5%
|
-
|
€3,491m
|
+2.6%
|
+0.3%
|
-
|
Business
EPS(1)
|
€1.35
|
+3.1%
|
+1.5%
|
-
|
€2.77
|
+4.9%
|
+2.7%
|
-
|
Second-quarter and first-half 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. Second-quarter and first-half 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
December 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
10 for definitions). The consolidated income statement for
Q2 2017 and H1 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) The closing of the
disposal of Merial in Mexico is
expected in 2017
Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"Sanofi Genzyme, Sanofi Pasteur and Emerging Markets were once
again major contributors to our performance in the quarter. The
continued growth of these businesses, together with disciplined
expense management, enabled us to more than offset the headwinds in
our Diabetes franchise. Consequently, we feel confident in our
full-year outlook and raise our 2017 business EPS guidance. We are
also encouraged by the strong uptake of Dupixent® in the U.S. and
the approval of Kevzara®. The initiation of Phase 3 studies in
additional indications for dupilumab, the Phase 2/3 programs with
the anti PD-1 in multiple cancer indications and fitusiran in
hemophilia were significant R&D milestones in the second
quarter."
Experience the interactive Multichannel News Release
here: https://www.multivu.com/players/English/8093352-sanofi-earnings-results-q2-2017/
Q2 2017 sales growth supported by Specialty Care, Vaccines
and Emerging Markets
- Net sales were €8,663 million, up 6.4% on a reported basis and
5.5% at CER reflecting the change in scope of the CHC and vaccines
Global Business Units (GBUs). At CER and CS, net sales were up
0.6%.
- Sanofi Genzyme GBU grew 14.3% at CER driven primarily by
continued strong sales growth in Multiple Sclerosis; strong U.S.
launch of Dupixent® in atopic dermatitis driven by high
unmet medical need and early market access.
- Sanofi Pasteur GBU grew 19.2% at CER and CS as a result of
strong sales of pediatric combinations and
Menactra®.
- Diabetes and Cardiovascular GBU sales were down 15.0% at CER;
Global Diabetes franchise sales decreased 12.2%.
- CHC GBU sales were stable at CER and CS mainly due to
seasonality in Europe.
- Emerging Markets sales increased 6.6% at CER and CS driven by
robust contribution from China.
2017 business EPS guidance at CER raised on first-half
financial results and disciplined expense management
- Q2 2017 business operating income of €2,299 million, up 4.1% at
CER and constant structure.
- Q2 2017 business EPS grew 1.5% at CER to €1.35 and increased
3.1% on a reported basis.
- Sanofi now expects 2017 business EPS to be broadly stable at
CER, barring unforeseen major adverse events.
- Currency impact on 2017 business EPS is estimated to be
approximately +1% at the average June
2017 exchange rates.
Sustaining innovation in R&D
- Positive CHMP opinion received for Dupixent® in the
EU.
- Kevzara®, an anti IL6 for the treatment of
rheumatoid arthritis, approved in the EU in June.
- Initiation of Phase 3 ATLAS program for fitusiran in patients
with hemophilia.
- Phase 2/3 studies started for SAR439684 (anti PD-1) in Non-Small Cell Lung
Cancer and Basal Cell Carcinoma.
R&D update
Regulatory update
Regulatory updates since the publication of first-quarter
results on April 28, 2017 include the
following:
- The European Commission granted marketing authorization for
Insulin lispro Sanofi® (100 Units/mL) in July for
the treatment of diabetes in adults and children. This followed the
European Medicines Agency's Committee for Medicinal Products for
Human Use (CHMP) positive opinion in May.
- In July, the European Medicines Agency's CHMP adopted a
positive opinion recommending the granting of the marketing
authorization of Dupixent® (dupilumab) for use in
adults with moderate-to-severe atopic dermatitis who are candidates
for systemic therapy.
- In June, the European Commission granted marketing
authorization for Kevzara® (sarilumab) in
combination with methotrexate for the treatment of moderately to
severely active rheumatoid arthritis (RA) in adult patients. In
May, the U.S. Food and Drug Administration (FDA) also approved
Kevzara® for the treatment of adult patients with
moderately to severely active RA.
At the end of July 2017, the
R&D pipeline contained 47 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 June, positive results from two Phase 3b/4 ODYSSEY-DM trials
in patients with diabetes were announced. In the studies,
Praluent® (alirocumab), when administered on top
of maximally tolerated doses of statins, significantly reduced
low-density lipoprotein cholesterol (LDL-C), the primary endpoint
of the ODYSSEY DM-INSULIN study, and was superior to usual care in
reducing non-high-density lipoprotein cholesterol (non-HDL-C), the
primary endpoint of the ODYSSEY DM-DYSLIPIDEMIA study.
- In June, a Phase 3 study evaluating dupilumab in
persistent asthma despite the use of medium to high dose of Inhaled
Corticosteroid and a LABA (Long-Acting Beta Agonist) was initiated
in 6-11 years population. Another Phase 3 evaluating dupilumab in
moderate-to-severe atopic dermatitis in 12-17 years population was
initiated in April.
- In May, a Phase 3 study evaluating SAR439684, a PD-1 inhibitor, in
1st line Non-Small Cell Lung Cancer started.
Phase 2:
- In July, Sanofi and Alnylam announced new positive results from
the ongoing Phase 2 open-label extension (OLE) study with
fitusiran in patients with hemophilia A and B, with or
without inhibitors. These results were presented at the
International Society on Thrombosis and Haemostasis (ISTH) 2017
Congress. The updated clinical results of this study showed that
the safety and tolerability profile of fitusiran remains
encouraging, with no thromboembolic events. Based on these results,
the companies initiated the Phase 3 ATLAS program for fitusiran in
patients with hemophilia A and B with or without inhibitors.
- In July, a Phase 2 study evaluating SAR439684, a PD-1 inhibitor, in advanced
Basal Cell Carcinoma started.
Phase 1:
- SAR439459 (anti-TGF-β)
entered into Phase 1 in monotherapy and combination with
SAR439684 (PD-1 inhibitor) in
patients with advanced solid tumors.
To access the full press release of the 2017 Q2 results,
please click here.
2017 Guidance
Sanofi raises full-year 2017 business EPS guidance to broadly
stable at CER, barring unforeseen major adverse events. The
currency impact on 2017 business EPS is estimated to be
approximately +1% at the average June
2017 exchange rates. As announced in the first quarter 2017
financial results, Sanofi previously expected full-year 2017
business EPS to be stable to -3% at CER, barring unforeseen major
adverse events.
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:
|
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
|
View original
content:http://www.prnewswire.com/news-releases/sanofi-raises-fy-2017-business-eps-guidance-to-broadly-stable-at-cer-300496467.html
SOURCE Sanofi