PARIS, April 26, 2019 /PRNewswire/ -- Sanofi (NASDAQ:
SNY; EURONEXT: SAN)
|
Q1
2019
|
Change
|
Change
at CER
|
IFRS net sales
reported
|
€8,391m
|
+6.2%
|
+4.2%
|
IFRS net income
reported
|
€1,137m
|
+11.9%
|
-
|
IFRS EPS
reported
|
€0.91
|
+12.3%
|
-
|
Business net
income(1)
|
€1,765m
|
+10.5%
|
+9.0%
|
Business
EPS(1)
|
€1.42
|
+10.9%
|
+9.4%
|
Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8530051-sanofi-earnings-results-q1-2019/
First-quarter sales(2) growth driven by Specialty
Care, Vaccines and strong contribution from Emerging
Markets
- Net sales were €8,391 million, an increase of 6.2% on a
reported basis, 4.2%(2) at CER and 3.8% at
CER/CS(3).
- Sanofi Genzyme GBU sales were up 30.8% (16.0% at
CER/CS(3)), driven by Dupixent® and
consolidation of Bioverativ.
- Vaccines sales up 20.1%, reflecting the recovery and growth of
Pentaxim® in China and
Menactra® strength in Emerging Markets.
- CHC sales up 0.6%, as Emerging Markets growth more than offset
lower sales in mature markets and non-core divestments.
- Primary care GBU sales were down 17.0% (-11.8% at CER/CS)
impacted by lower diabetes sales and divestiture of EU
generics.
- Emerging Markets sales(4) grew strongly (up 13.6%)
across all regions, primarily driven by China.
Q1 2019 business EPS(1) growth reflected sales
performance, favorable product mix and cost discipline
- Q1 2019 business net income increased 10.5% to €1,765 million
and 9.0% at CER.
- Business EPS(1) in the first quarter was up 9.4% at
CER to €1.42.
- IFRS EPS was €0.91 (up 12.3%).
Full-year 2019 business EPS(1) guidance
confirmed
- Sanofi continues to expect 2019 business EPS(1) to
grow between 3% and 5% at CER(5) barring unforeseen
major adverse events. Applying the average April 2019 exchange rates, the currency impact on
2019 business EPS is estimated to be around 2%.
Key regulatory milestones achieved in R&D
- Dupixent® approved in the U.S. for atopic dermatitis
in adolescent patients.
- FDA granted Priority Review in the U.S. for
Dupixent® in adults with chronic rhinosinusitis with
nasal polyps.
- CHMP recommended approval of Dupixent® in EU for
severe asthma in adults and adolescents.
- Praluent® label extension approved by EMA to include
reduction of the risk of cardiovascular events in eligible
patients.
- Libtayo® approved in Canada for cutaneous squamous cell
carcinoma.
- CHMP recommended approval in EU and U.S. FDA issued a
CRL(6).regarding ZynquistaTM for type 1
diabetic adult patients.
Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"I am pleased with the strong start in 2019 as we sustained our
new growth phase and delivered business EPS growth of 9.4%. We
executed on key launches in Specialty Care led by the impressive
uptake of Dupixent® in atopic dermatitis and asthma and
also delivered strong growth in Vaccines. At the same time, our new
GBU structure enabled us to optimize our growth opportunity in
China & Emerging Markets and
to adapt to the pressures in Primary Care. Based on our performance
in the first quarter, we remain confident in the growth outlook for
our business over the rest of the year despite challenging industry
dynamics."
(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 Q1 2019 is
provided in Appendix 3 and a reconciliation of reported IFRS net
income 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) Constant
Structure: Adjusted for Bioverativ acquisition and divestment of
European Generics business; (4) See definition page 8; (5) 2018
business EPS was €5.47; (6) Complete Response Letter.
R&D update
Consult Appendix 6 for full overview of Sanofi's R&D
pipeline
Regulatory update
Regulatory updates since February 7,
2019 include the following:
- In March, the European Medicines Agency's Committee for
Medicinal Products for Human Use (CHMP) adopted a positive opinion
for ZynquistaTM (sotagliflozin, developed by
Sanofi and Lexicon), a dual SGLT1 and SGLT2 inhibitor, recommending
its approval in the European Union for the treatment of adults with
type 1 diabetes. In March, the U.S. Food and Drug Administration
(FDA) issued a Complete Response Letter regarding the New Drug
Application for Zynquista™ for the treatment of adults with
type 1 diabetes in combination with insulin.
- In March, Praluent® (collaboration with
Regeneron) was approved in the European Union to reduce the risk of
cardiovascular events in patients with established cardiovascular
disease
- In March, the U.S. FDA approved Dupixent®
(collaboration with Regeneron) for adolescent patients 12 to 17
years of age with moderate-to-severe atopic dermatitis whose
disease is not adequately controlled with topical prescription
therapies, or when those therapies are not advisable.
- In March, the U.S. FDA accepted for Priority Review the
supplemental Biologics License Application (sBLA) for
Dupixent® as an add-on maintenance treatment for
adults with inadequately-controlled severe chronic rhinosinusitis
with nasal polyps (CRSwNP). The target action date for the FDA
decision is June 26, 2019.
- In March, the European Medicines Agency's CHMP adopted a
positive opinion for Dupixent®, recommending its
approval in the European Union for use in adults and adolescents
(12 years and older) as add-on maintenance treatment for severe
asthma with type 2 inflammation characterized by raised blood
eosinophils and/or raised FeNO who are inadequately controlled with
high dose inhaled corticosteroid plus another medicinal product for
maintenance treatment.
- In the first quarter, the U.S. FDA accepted for review a
supplemental Biologic License Application (sBLA) for
Fluzone® HD QIV.
At the end of April 2019, the
R&D pipeline contained 84 projects including 32 new molecular
entities in clinical development. 35 projects are in phase 3 or
have been submitted to the regulatory authorities for approval.
Portfolio update
Phase 3:
- In February, positive results from two phase 3 trials
evaluating Dupixent® in patients with recurring
severe CRSwNP were presented at the 2019 Annual Meeting of the
American Academy of Allergy, Asthma & Immunology.
Phase 2:
- A phase 2b/3 study evaluating
Dupixent® in Chronic Obstructive Pulmonary
Disease (COPD) is in the process of being initiated.
- A phase 2b study evaluating
SAR442168, a BTK inhibitor
(collaboration with Principia), in multiple sclerosis was
initiated.
- A phase 2 study evaluating isatuximab in combination
with chemotherapy in pediatric patients with relapsed refractory
acute lymphoblastic leukemia or acute myeloid leukemia was
initiated.
Phase 1:
- SAR441169, a RORC (ROR
gamma T) antagonist entered phase 1 for the treatment of
psoriasis.
Collaboration
In April, Sanofi and Alnylam agreed to conclude the research and
option phase of the companies' 2014 RNAi therapeutics alliance in
rare genetic diseases. The material collaboration terms for
patisiran, vutrisiran (ALN-TTRsc02) and fitusiran, as previously
announced, will continue unchanged. As part of this agreement,
Alnylam will advance an additional investigational asset in an
undisclosed rare genetic disease through the end of IND-enabling
studies. Sanofi will be responsible for any potential further
development or commercialization of such asset. In addition,
Alnylam and Sanofi have agreed to amend certain terms of the
companies' equity agreement, with Sanofi obtaining a release of its
lock-up of Alnylam stock holdings, subject to certain trading
restrictions, among other provisions.
To access the full press release of the 2019 Q1 results, please
click here.
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,
2018. 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