Sanofi delivered solid growth in Q2 2019
PARIS, July 29, 2019 /PRNewswire/ -- Sanofi (NASDAQ: SNY; EURONEXT: SAN)
Q2 2019 Change Change H1 2019 Change Change
at CER at CER
IFRS net
sales
reported
EUR8,628m +5.5% +3.9%
EUR17,019m +5.9% +4.1%
IFRS net
income
reported
-EUR87m -111.4%(2)
EUR1,050m -40.9%
IFRS EPS
reported
-EUR0.07 -111.5%(2)
EUR0.84 -40.8%
---
Business
net
income(1)
EUR1,641m +5.3% +4.9%
EUR3,406m +7.9% +7.0%
Business
EPS(1)
EUR1.31 +4.8% +4.8%
EUR2.73 +7.9% +7.1%
---
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 EUR8,628 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(R).
Vaccines sales increased 24.7% mainly
reflecting the recovery and growth of
Pentaxim(R) 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
EUR1,641 million and 4.9% at CER.
Q2 2019 business EPS(1) up 4.8% at
CER to EUR1.31.
Q2
2019 IFRS EPS was -EUR0.07 (-115.5%)
reflecting a EUR1.8 billion impairment charge
mainly related to Eloctate(R).
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(R) approved for advanced cutaneous
squamous cell carcinoma in the EU.
Dupixent(R) recommended by CHMP
for atopic dermatitis in adolescents.
Dupixent(R) approved in the
U.S. for chronic rhinosinusitis with nasal
polyposis.
FDA
accepted for review MenQuadfi(TM), a
meningococcal vaccine candidate.
---
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(R) 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%."
(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
EUR1.8 billion impairment charge
mainly related to Eloctate
(R)
- 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 EUR5.47.
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(TM)
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(TM)
(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(TM) 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: 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
