PARIS,
July 29, 2019 /PRNewswire/ -- Sanofi
(NASDAQ: SNY; EURONEXT: SAN)
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Q2 2019
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Change
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Change
at CER
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H1 2019
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Change
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Change
at CER
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IFRS net sales
reported
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€8,628m
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+5.5%
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+3.9%
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€17,019m
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+5.9%
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+4.1%
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IFRS net income
reported
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-€87m
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-111.4%(2)
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-
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€1,050m
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-40.9%
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-
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IFRS EPS
reported
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-€0.07
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-111.5%(2)
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-
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€0.84
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-40.8%
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-
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Business net
income(1)
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€1,641m
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+5.3%
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+4.9%
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€3,406m
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+7.9%
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+7.0%
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Business
EPS(1)
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€1.31
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+4.8%
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+4.8%
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€2.73
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+7.9%
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+7.1%
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Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8581551-sanofi-earnings-results-q2-2019/
Second-quarter 2019 sales growth(3) driven
by Sanofi Genzyme, Sanofi Pasteur and Emerging
Markets
- Net sales were
€8,628 million, up 5.5% on a reported basis, up 3.9%(3)
at CER and up 5.8% at CER/CS(4).
- Sanofi Genzyme
sales up 21.8% due to strong launch performance of
Dupixent®.
- Vaccines sales
increased 24.7% mainly reflecting the recovery and growth of
Pentaxim® in China and low basis for
comparison.
- CHC sales up 1.1%,
as U.S. growth more than offset lower sales in Europe impacted by
non-strategic brand divestments.
- Primary Care GBU
sales declined 10.4% at CER/CS mainly as a result of lower Diabetes
sales.
- Emerging Markets
sales(5) grew double-digits (up 10.0%) supported by
higher Vaccines and Rare Disease sales.
2019 business EPS guidance revised
upward
- Q2 2019 business
net income increased 5.3% to €1,641 million and 4.9% at
CER.
- Q2 2019 business
EPS(1) up 4.8% at CER to €1.31.
- Q2 2019 IFRS EPS
was -€0.07 (-115.5%) reflecting a €1.8 billion impairment charge
mainly related to Eloctate®.
- Business
EPS(1) in 2019 is now expected to grow approximately 5%
at CER(6) barring unforeseen major adverse events.
Applying the average July 2019 exchange rates, the currency impact
on 2019 business EPS is estimated to be between 1% and
2%.
Key regulatory milestones achieved in
R&D
- Isatuximab accepted
for review by the FDA and EMA for approval in relapsed/refractory
multiple myeloma.
- Libtayo®
approved for advanced cutaneous squamous cell carcinoma in the
EU.
- Dupixent® recommended by CHMP for atopic
dermatitis in adolescents.
- Dupixent® approved in the U.S. for chronic
rhinosinusitis with nasal polyposis.
- FDA accepted for
review MenQuadfi™, a meningococcal vaccine candidate.
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Sanofi Chief Executive Officer, Olivier Brandicourt,
commented:
"Sanofi continued its growth phase with a solid
business performance in the second quarter, led by the strong
launch of Dupixent® driven by the accelerated uptake in
atopic dermatitis and asthma in the U.S. Specialty Care and
Vaccines were significant contributors across all geographies. Our
increased focus in R&D delivered important results with several
positive data read-outs and the achievement of regulatory
milestones. We are confident in the growth outlook for the year.
Consequently, we have revised upward our guidance for full-year
business EPS growth to approximately 5%."
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(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 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) including a €1.8 billion impairment charge mainly related to
Eloctate ®
– see page 12; (3) Changes in net
sales are expressed at constant exchange rates (CER) unless
otherwise indicated (see Appendix 10); (4) Constant Structure:
Adjusted for divestment of European Generics business and sales of
Bioverativ products to SOBI; (5) See definition page 9; (6) 2018
business EPS was €5.47.
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R&D update
Consult Appendix 6 for full overview of Sanofi's R&D
pipeline
Regulatory update
Regulatory updates since April 26,
2019 include the following:
- In July, the U.S. Food and Drug Administration (FDA)
accepted for review the Biologics License Application (BLA) for
isatuximab for the treatment of patients with
relapsed/refractory multiple myeloma (RRMM). The target action date
for the FDA decision is April 30,
2020.
- In June, Libtayo® (cemiplimab,
collaboration with Regeneron) was approved in the European Union
(EU) for the treatment of adults with metastatic or locally
advanced cutaneous squamous cell carcinoma (CSCC) who are not
candidates for curative surgery or curative radiation.
- In June, the European Medicines Agency's (EMA) Committee
for Medicinal Products for Human Use (CHMP) adopted a positive
opinion for Dupixent® (dupilumab, collaboration
with Regeneron) recommending extending its approval in the EU to
include adolescents 12 to 17 years of age with moderate-to-severe
atopic dermatitis who are candidates for systemic
therapy.
- The FDA accepted for review the BLA for Sanofi's
MenQuadfi™ Meningococcal Polysaccharide Tetanus Toxoid
Conjugate Vaccine candidate to help prevent meningococcal
meningitis. The target action date for the FDA decision is
April 25, 2020.
- In June, the FDA approved Dupixent® for
the treatment of chronic rhinosinusitis with nasal polyposis
(CRSwNP) in adults whose disease is not adequately
controlled.
- In May, the European Commission approved
Dupixent® for use in adults and adolescents 12
years and older as an add-on maintenance treatment for severe
asthma with type 2 inflammation characterized by raised blood
eosinophils and/or raised fractional exhaled nitric oxide (FeNO),
who are inadequately controlled with high dose inhaled
corticosteroid (ICS) plus another medicinal product for maintenance
treatment.
- In May, SAR341402 (insulin
aspart), a rapid acting insulin, was submitted to the EMA for the
treatment of Type I and II diabetes.
- In April, the FDA approved Praluent®
(collaboration with Regeneron) to reduce the risk of heart attack,
stroke, and unstable angina requiring hospitalization in adults
with established cardiovascular disease.
At the end of July 2019, the
R&D pipeline contained 83 projects, including 34 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:
- Topline results from three Phase 3 trials of
Zynquista™ (sotagliflozin) in adults with type 2 diabetes
from the InSynchrony clinical program were announced on
July 26. Given the primary endpoint
results of blood sugar control (HbA1c) reduction in the SOTA-CKD3
and SOTA-CKD4 studies, Sanofi provided notice to Lexicon that it is
terminating the collaboration to develop, manufacture, and
commercialize Zynquista™ in all ongoing global type 1 and type 2
diabetes programs. At this time, the ongoing Phase 3 clinical
trials will continue and there will be no immediate changes. Sanofi
has expressed willingness to work with Lexicon to ensure a smooth
transition of the studies. Sanofi remains committed to working and
supporting the investigators and patients enrolled in the studies
while next steps are discussed with Lexicon.
- Results from a phase 3 study evaluating
Soliqua®/Suliqua® (insulin
glargine 100 Units/mL and lixisenatide) in adults with type 2
diabetes inadequately controlled by GLP-1 receptor agonist (GLP-1
RA) treatments were presented at the American Diabetes Association
(ADA) Scientific Sessions in June. The study met the primary
objective by demonstrating a statistically superior reduction of
average blood sugar level (HbA1c) after 26 weeks, compared with
continuing GLP-1 RA treatment.
- Pivotal phase 3 ICARIA-MM trial results were presented at
the 2019 American Society of Clinical Oncology (ASCO) Annual
Meeting in June and demonstrated that isatuximab added to
pomalidomide and dexamethasone (isatuximab combination therapy)
showed statistically significant improvements compared to
pomalidomide and dexamethasone (pom-dex) alone in patients with
relapsed/refractory multiple myeloma (RRMM).
- A phase 3 study evaluating cemiplimab, a PD-1
inhibitor, in adjuvant treatment for Cutaneous Squamous Cell
Carcinoma (CSCC) started.
- Dupilumab , moved into phase 3 in
Chronic Obstructive Pulmonary Disease (COPD).
- Fitusiran , a siRNA inhibitor
targeting AT3, entered phase 3 for pediatric
hemophilia.
- Nirsevimab (
SP0232, collaboration with Medimmune), a monoclonal
antibody, entered phase 3 for respiratory syncytial virus
(RSV)
Phase 2:
- SAR440340/REGN3500
(collaboration with Regeneron), an investigational IL-33
antibody, met the primary endpoint of improvement in loss of asthma
control when comparing monotherapy to placebo in a phase 2
proof-of-concept trial The trial also met a key secondary endpoint,
demonstrating SAR440340 monotherapy
significantly improved lung function compared to placebo. Patients
treated with Dupixent® monotherapy did numerically
better than SAR440340 across all
endpoints, although the trial was not powered to show differences
between active treatment arms. The combination of SAR440340 and Dupixent® did not
demonstrate increased benefit compared to Dupixent®
monotherapy in this trial.
Phase 1:
- A phase 1 trial evaluating SAR441255, a trigonal GLP1R/GIPR/GCGR agonist
was initiated.
- SAR441236
, a tri-specific neutralizing anti-HIV mAb, entered into
phase 1.
An additional seven research projects have been
discontinued to enhance the company's focus on delivering first and
best in class medicines
Collaboration
In June, Sanofi and Google announced that they will
establish a new virtual Innovation Lab with the ambition to
transform how future medicines and health services are delivered by
tapping into the power of emerging data technologies. The
collaboration aims to change how Sanofi develops new treatments and
will focus on three key objectives: to better understand patients
and diseases, to increase Sanofi's operational efficiency, and to
improve the experience of Sanofi's patients and
customers.
To access the full press release of the 2019 Q2 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:
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Investor Relations:
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Ashleigh
Koss
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George
Grofik
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908-981-8745
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+33 (0)1 53 77 45
45
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Email: Ashleigh.koss@sanofi.com
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Email: IR@sanofi.com
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content:http://www.prnewswire.com/news-releases/sanofi-delivered-solid-growth-in-q2-2019-300892206.html
SOURCE Sanofi