Cepheid's product development programs continue to be on track. As expected, the Company filed a 510(k) with the FDA for the Xpert MRSA/SA -- SSTI (Skin and Soft Tissue Infection) product in March and expects to submit a 510(k) for the Xpert MRSA/SA -- BC (Blood Culture) product during the current quarter. The development of the GeneXpert Infinity-48 is on track with shipment expected to begin in December of this year. A functional prototype of the GeneXpert Infinity-48 is expected to be unveiled at the American Association of Clinical Chemistry (AACC) meeting in July.
Business Outlook
For fiscal year 2008, the Company is raising its previously provided
revenue guidance:
-- Total revenue is expected to be in the range of $183 million to
$190 million.
o Product sales are expected to be in the range of $176 million to
$181 million.
o Xpert MRSA test sales are expected to be in the range of
$52 million to $55 million.
-- GAAP net loss for 2008 is expected to be in the range of $10 million to
$12 million, or $(.18) to $(.21) per share.
-- Non-GAAP net income is expected to be in the range of $3 million to
$5 million, or $.05 to $.08 income per fully-diluted share. Non-GAAP
net income excludes approximately $14 million related to stock
compensation expense and $1 million related to the amortization of
acquired intangibles.
Safe Harbor Statement
This press release contains forward-looking statements that are not
purely historical regarding Cepheid's or its management's intentions,
beliefs, expectations and strategies for the future, including those
relating to potential growth in clinical products sales, future product
releases, future regulatory clearance of products, other future development
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