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 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 "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: