CINCINNATI--(BUSINESS WIRE)--
Meridian Bioscience, Inc. (NASDAQ: VIVO) today provided the financial
community with guidance regarding the Company’s fiscal 2013 sales and
earnings estimates. Based on the Company’s business planning and
budgeting activities for the fiscal year ending September 30, 2013,
management expects net sales to be in the range of $190 to $195 million
and per share diluted earnings to be between $0.86 and $0.91. The per
share estimates assume an increase in average shares outstanding from
approximately 41.6 million at fiscal 2012 year end to 41.8 million at
fiscal 2013 year end. Net earnings are expected to increase between 8%
and 14% from fiscal 2012 to fiscal 2013 excluding reorganization costs
in 2012. This includes the $0.03 charge to earnings for the Medical
Device Tax effective January 1, 2013 and the $0.03 charge to earnings
representing the incremental cost of clinical trials for an important
new illumigene® product over and above the cost
of clinical trials for past illumigene products. The sales
and earnings guidance provided in this press release is from expected
internal growth and does not include the impact of any additional
acquisitions the Company might complete during fiscal 2013.
On July 26, 2012, management revised guidance downward for fiscal 2012
and reaffirms that guidance of per share diluted earnings of between
$0.78 - $0.81 on net sales of $171 million to $175 million.
John A. Kraeutler, Chief Executive Officer, stated, “Our expectations
for fiscal year 2013 are realistic and are based, in part, upon where
the Company expects its results to be for fiscal 2012, ending September
30. Revenue increases using the mid-point of guidance are 11%, and are
expected to be driven primarily by contributions from our illumigene
molecular technology platform, organic growth coming from our Bioline
Life Science unit, continued expansion of our managed care collaborative
efforts that are designed to motivate physicians to test patients for H.
pylori and, consistent growth from converting labs to testing with
our rapid foodborne products. Beginning on January 1, 2013, the Medical
Device Tax, part of the Affordable Care Act legislation, becomes
effective. The majority of our US diagnostics revenue will be taxed at
2.3% resulting in a charge of over $2 million.
“Specifically, with regard to illumigene revenues, our
guidance includes tests for C. difficile disease, tests for Group
B strep and tests for illumigene Group A strep which is
expected to be FDA cleared for U.S. marketing around the start of the
new fiscal year. illumigene Mycoplasma and illumigene
Pertussis revenues are not included as these products are not expected
to be available for sale until late in the first half of fiscal 2013.
“Our new product pipeline is robust and we plan to introduce two
additional new illumigene tests later in fiscal 2013.
These tests are in the category of common sexually transmitted diseases
and they have large market potential. In addition, we expect to launch a
rapid immunoassay that will be useful in the diagnosis of sepsis and, we
plan to debut a device that greatly simplifies DNA extraction from human
specimens. The illumigene tests in development offer
significant opportunity however; we expect that clinical trial costs
will be sizeable. We have allocated an incremental $2+ million for these
trials and that expense is reflected in the guidance calculation. New
revenues related to this incremental R&D investment will be realized in
late fiscal 2013 or early 2014. The reduction in earnings from this
incremental expense, along with the charge due to the Medical Device
Tax, is expected to be $0.06.”
William J. Motto, Executive Chairman, commented, “We believe the
guidance provided in this press release is realistic. During fiscal
2013, we will continue to introduce new products, including those for
our illumigene molecular-based platform, maintain a strong
balance sheet, continue to pay liberal cash dividends, and focus on cost
efficiencies throughout the organization. As usual, we will actively
look for accretive acquisition opportunities that fit well with our
expanding business.”
FORWARD LOOKING STATEMENTS
The 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
"estimates", "anticipates", "projects", "plans", "seeks", "may", "will",
"expects", "intends", "believes", "should" and similar expressions or
the negative versions thereof and which also may be identified by their
context. Such statements, whether expressed or implied, are based upon
current expectations of the Company and speak only as of the date made.
The Company 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 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. While Meridian has introduced a number of internally
developed products, there can be no assurance that it will be successful
in the future in introducing such products on a timely basis. Meridian
relies on proprietary, patented and licensed technologies, and 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 our 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. 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
main 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. The
Company cannot predict the possible impact of recently-enacted United
States healthcare legislation and any similar initiatives in other
countries on its results of operations. In addition to the factors
described in this paragraph, Part I, Item 1A Risk Factors of our Form
10-K contains a list and description of uncertainties, risks and other
matters that may affect the Company.
Meridian is a fully integrated life science company that manufactures,
markets and distributes a broad range of innovative diagnostic test
kits, purified reagents and related products and offers
biopharmaceutical enabling technologies. Utilizing a variety of methods,
these products and diagnostic tests provide accuracy, simplicity and
speed in the early diagnosis and treatment of common medical conditions,
such as gastrointestinal, viral and respiratory infections. Meridian’s
diagnostic products are used outside of the human body and require
little or no special equipment. The Company's products are designed to
enhance patient well-being while reducing the total outcome costs of
healthcare. Meridian has strong market positions in the areas of
gastrointestinal and upper respiratory infections, serology,
parasitology and fungal disease diagnosis. In addition, Meridian is a
supplier of rare reagents, specialty biologicals and related
technologies used by biopharmaceutical companies engaged in research for
new drugs and vaccines. The Company markets its products and
technologies to hospitals, reference laboratories, research centers,
diagnostics manufacturers and biotech companies in more than 60
countries around the world. The Company’s shares are traded through
NASDAQ’s Global Select Market, symbol VIVO. Meridian's website address
is www.meridianbioscience.com.
Meridian Bioscience, Inc.
John A. Kraeutler, Chief Executive
Officer, 513-271-3700
Source: Meridian Bioscience, Inc.
