TIDM0RB9
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company
specializing in treatments for respiratory allergies, today
provided an update on its business performance and refined its 2018
business outlook. The revised outlook reflects a solid start to the
year with company-wide operational efficiency improvements; market
share gains across the portfolio and geographies; and improved
clarity on market access in Europe.
"Our performance during the first months of 2018 confirm the
strength of Stallergenes Greer's business fundamentals. We have
continued the momentum from 2017 and, we are executing on our
commercial priorities," said Fereydoun Firouz, Chairman and Chief
Executive Officer. "With increased profitability, we can now
confidently focus on our future, by sustaining our investments in
both innovation and the upgrades of our manufacturing sites and
quality systems."
Performance through the first months of 2018 was driven by
several factors:
-- Operational Efficiency: The company was able to effectively manage its
expenses through a series of efficiency measures that resulted
in
earlier than expected cost savings. As the year progresses,
the
company will continue its commitment to operational efficiency
while
investing in manufacturing upgrades and innovation, including
the
completion of the phase III trial for the company's House Dust
Mite
tablet candidate, STAGR320.
-- Commercial Excellence in Europe and International: Strong sales and
marketing execution in Europe and International have continued
to
result in market share gains, especially in France, Italy and
Eastern
Europe. Staloral has consistently outpaced competition and
Oralair has
continued to gain shares in key markets. Data from the
BREATH
real-world evidence program presented last week at the
European
Academy of Allergy and Clinical Immunology Congress continue
to
strengthen the value proposition of these products.
-- Leadership in North America: Stallergenes Greer continues to lead the
core bulk allergen business in the U.S. and Canada. While the
U.S.
grass tablet market has declined versus 2017, the recalibration
of the
commercial strategy has improved the profitability of the
Oralair
franchise and the company is building a sustainable platform
to
capture future growth in the tablet market.
-- Market access in Europe: The recent clarification of the reimbursement
framework in France for Named Patient Products and the
confirmation of
the increase of governmental funding for Oralair in Italy
have
provided clarity and therefore better predictability into the
business.
Investments in Quality and Technical Operations Continue
On the manufacturing front, Stallergenes Greer has made major
investments in the quality systems and modernization of the
manufacturing sites in Antony and Amilly, France and in Lenoir, in
the U.S. In addition, the company increased the manufacturing and
supply of sublingual products to meet market demand and partially
offset the temporary shortage of injectable products in the
European and International markets.
The company has continued to progress through its remediation
plan in Antony, following the injunction received on 4 January 2018
from the French National Agency for Medicines and Health Products
Safety (ANSM). Several actions are underway and the company is
committed to addressing all the observations of the agency and
strengthening its quality culture across the organization. For
example, significant renovation work is underway and extensive
training has been completed for the employees working on aseptic
operations, traceability of pharmaceutical operations and
deviations.
As part of the proceedings related to the injunction, the
company received notification of potential financial penalties in
the event of non-compliance with the agreed timelines. Stallergenes
Greer is engaging with the ANSM regarding this notification and it
would be premature to make any conclusion about the outcome. If
sanction applied, the penalties are expected to be EUR1 million or
less.
2018 Revised Financial Perspectives
With the current performance and clarity of market access in
Europe, the company now expects 2018 net sales to be in the range
of EUR270 million to EUR280 million and EBITDA to be in the range
of EUR40 million to EUR50 million. This is updated from the outlook
provided on 22 March 2018. At that time, the company expected
mid-single digit revenue growth and EBITDA to be higher than 2017's
EBITDA of EUR21.9 million.
The financial data that support the statements presented in this
press release are the company's current and best estimates and have
not been audited or reviewed by the statutory auditors. The company
will provide an update to the market during its earnings call on 30
August 2018.
ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global
healthcare company specializing in the diagnosis and treatment of
allergies through the development and commercialization of allergy
immunotherapy products and services. Stallergenes Greer plc is the
parent company of GREER Laboratories, Inc. (whose registered office
is in the US) and Stallergenes SAS (whose registered office is in
France).
TRADING INFORMATIONName: Stallergenes GreerISIN: GB00BZ21RF93 1
- Ticker: STAGRICB Classification: 4577LEI:
213800CYVZA7GJQEME86Market: Euronext Paris regulated market
Additional information is available at
http://www.stallergenesgreer.com.
This document (including information incorporated by reference
in this document), oral statements made and other information
published by the Company contain statements that are or may be
forward-looking with respect to the financial condition and/or
results of operations and businesses of the Company. These
statements can be identified by the use of forward-looking
terminology such as "believe," "expects," "project," "estimated,"
"forecast," "should," "plan," "may" or the negative of any of
these, or other variations thereof, or comparable terminology
indicating expectations or beliefs concerning future events. These
forward-looking statements include risk and uncertainty because
they relate to events and depend on circumstances that will occur
in the future. Without being exhaustive, such factors include
economic situations and business conditions, including legal and
product evaluation issues, fluctuations in currencies and demand,
and changes in competitive factors. These and other factors are
more fully described in the Company's 2017 annual report published
on 16 April 2018 on the Company's website
www.stallergenesgreer.com. Actual results may differ from those set
forth in the forward-looking statements, due to various factors.
Save as required by applicable law, neither the Company nor any
other person assumes any obligation to update these forward-looking
statements or to notify any person of any such update.
Stallergenes Greer plcCommunications and Investor
RelationsNatacha Gassenbach, +1 (617) 225
8013natacha.gassenbach@stallergenesgreer.comorMedia Relations
AgencyHavas - Paris (Europe)Samuel Rousseau, +33 (0) 6 51 03 51
43samuel.rousseau@havas.com
View source version on businesswire.com:
https://www.businesswire.com/news/home/20180606006455/en/
This information is provided by Business Wire
(END) Dow Jones Newswires
June 07, 2018 02:00 ET (06:00 GMT)
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