Meridian Bioscience Corrects Prior Update Regarding Revogene® SARS-CoV-2 EUA Withdrawal
February 23 2021 - 1:16PM
Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic
testing solutions and life science raw materials, updated its
communication regarding the withdrawal of its application for
Emergency Use Authorization (EUA) with the U.S. Food and Drug
Administration (FDA) for the SARS-CoV-2 molecular diagnostic test
on its Revogene® platform.
In subsequent communication with the FDA
mid-morning on February 23, 2021, the FDA clarified that Meridian
will not be able to distribute its SARS-CoV-2 molecular diagnostic
test on its Revogene® platform until the test receives EUA approval
from the FDA. This corrects the Company’s prior statement that the
Company would resume shipping the Revogene® SARS-CoV-2 test to
customers upon notification of its intent to re-submit an EUA
application.
FORWARD-LOOKING STATEMENTSThe Private Securities
Litigation Reform Act of 1995 provides a safe harbor from civil
litigation for forward-looking statements accompanied by meaningful
cautionary statements. Except for historical information, this
report contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, which may be identified
by words such as “continues”, “estimates”, “anticipates”,
“projects”, “plans”, “seeks”, “may”, “will”, “expects”, “intends”,
“believes”, “signals”, “should”, “can”, “guidance” and similar
expressions or the negative versions thereof and which also may be
identified by their context. All statements that address operating
performance or events or developments that Meridian expects or
anticipates will occur in the future, including, but not limited
to, statements relating to per share diluted net earnings, sales,
product demand, revenue, operating margin, other guidance and the
impact of COVID-19 on its business and prospects, are
forward-looking statements. Such statements, whether expressed or
implied, are based upon current expectations of the Company and
speak only as of the date made. Specifically, Meridian’s
forward-looking statements are, and will be, based on management’s
then-current views and assumptions regarding future events and
operating performance. Meridian assumes no obligation to publicly
update or revise any forward-looking statements even if experience
or future changes make it clear that any projected results
expressed or implied therein will not be realized. These statements
are subject to various risks, uncertainties and other factors that
could cause actual results to differ materially, including, without
limitation, the following: Meridian’s operating results, financial
condition and continued growth depends, in part, on its ability to
introduce into the marketplace enhancements of existing products or
new products that incorporate technological advances, meet customer
requirements and respond to products developed by Meridian’s
competition, its ability to effectively sell such products and its
ability to successfully expand and effectively manage increased
sales and marketing operations. While Meridian has introduced a
number of internally developed products and acquired products,
there can be no assurance that it will be successful in the future
in introducing such products on a timely basis or in protecting its
intellectual property, and unexpected or costly manufacturing costs
associated with its introduction of new products or acquired
products could cause actual results to differ from expectations.
Meridian relies on proprietary, patented and licensed technologies.
As such, the Company’s ability to protect its intellectual property
rights, as well as the potential for intellectual property
litigation, would impact its results. Ongoing consolidations of
reference laboratories and formation of multi-hospital alliances
may cause adverse changes to pricing and distribution. Recessionary
pressures on the economy and the markets in which the Company’s
customers operate, as well as adverse trends in buying patterns
from customers, can change expected results. Costs and difficulties
in complying with laws and regulations, including those
administered by the United States Food and Drug Administration, can
result in unanticipated expenses and delays and interruptions to
the sale of new and existing products, as can the uncertainty of
regulatory approvals and the regulatory process (including the
currently ongoing study and other FDA actions regarding the
Company’s LeadCare products and emergency use authorization
application for the Revogene SARS-CoV-2 test). The international
scope of Meridian’s operations, including changes in the relative
strength or weakness of the U.S. dollar and general economic
conditions in foreign countries, can impact results and make them
difficult to predict. One of Meridian’s growth strategies is the
acquisition of companies and product lines. There can be no
assurance that additional acquisitions will be consummated or that,
if consummated, will be successful and the acquired businesses will
be successfully integrated into Meridian’s operations. There may be
risks that acquisitions may disrupt operations and may pose
potential difficulties in employee retention, and there may be
additional risks with respect to Meridian’s ability to recognize
the benefits of acquisitions, including potential synergies and
cost savings or the failure of acquisitions to achieve their plans
and objectives. Meridian cannot predict the outcome of future
goodwill impairment testing and the impact of possible goodwill
impairments on Meridian’s earnings and financial results. Meridian
cannot predict the possible impact of U.S. health care legislation
enacted in 2010 – the Patient Protection and Affordable Care Act,
as amended by the Health Care and Education Reconciliation Act –
and any modification or repeal of any of the provisions thereof
initiated by Congress or the presidential administration, and any
similar initiatives in other countries on its results of
operations. Efforts to reduce the U.S. federal deficit, breaches of
Meridian’s information technology systems, trade wars, increased
tariffs, and natural disasters and other events could have a
materially adverse effect on Meridian’s results of operations and
revenues. The Company can make no assurances that a material
weakness in its internal control over financial reporting will not
be identified in the future, which if identified and not properly
corrected, could materially adversely affect its operations and
result in material misstatements in its financial statements.
Meridian also is subject to risks and uncertainties related to
disruptions to or reductions in business operations or prospects
due to pandemics, epidemics, widespread health emergencies, or
outbreaks of infectious diseases such as COVID-19. In
addition to the factors described in this paragraph, as well as
those factors identified from time to time in the Company’s filings
with the Securities and Exchange Commission, Part I, Item 1A Risk
Factors of the Company’s most recent Annual Report on
Form 10-K contains a list and description of
uncertainties, risks and other matters that may affect the Company.
Readers should carefully review these forward-looking statements
and risk factors, and not place undue reliance on the Company’s
forward-looking statements.
About Meridian Bioscience,
Inc.Meridian is a fully integrated life science company
that develops, manufactures, markets and distributes a broad range
of innovative diagnostic products. We are dedicated to developing
and delivering better solutions that give answers with speed,
accuracy and simplicity that are redefining the possibilities of
life from discovery to diagnosis. Through discovery and
development, we provide critical life science raw materials used in
immunological and molecular tests for human, animal, plant, and
environmental applications. Through diagnosis, we provide
diagnostic solutions in areas including gastrointestinal and upper
respiratory infections and blood lead level testing. We build
relationships and provide solutions to hospitals, reference
laboratories, research centers, veterinary testing centers,
physician offices, diagnostics manufacturers, and biotech companies
in more than 70 countries around the world.
Meridian’s shares are traded on the NASDAQ
Global Select Market, symbol VIVO. Meridian’s website address is
www.meridianbioscience.com.
Contact:Charlie WoodVice
President – Investor RelationsMeridian Bioscience, Inc.Phone: +1
513.271.3700Email: mbi@meridianbioscience.com
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