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"Over the course of fiscal 2008, we made excellent commercial andcorporate progress. The clinical adoption of our C-Port systems continued aswe introduced our reloadable C-Port(R) X-CHANGE(TM) system and expandedapplications of our automated anastomosis systems in beating heart androbot-assisted bypass procedures," said Bernard A. Hausen, M.D., Ph.D.,president and chief executive officer of Cardica, Inc. "Subject to receivingregulatory clearance, we intend to substantially broaden our product portfoliowith the launch of our PAS-Port(R) system and additional devices within theC-Port product line and to provide a complete suite of automated anastomosissystems that we believe will continue to help revolutionize revascularizationprocedures."
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Recent Highlights and Accomplishments
Commercial Progress
-- Trained a total of 318 surgeons on the C-Port(R) Distal AnastomosisSystems since product introduction, with 38 surgeons trained in the fiscal2008 fourth quarter;
-- Increased cumulative worldwide shipments of C-Port systems to nearly6,000 units, with 1,430 units sold in the fiscal 2008 fourth quarter;
-- Increased cumulative worldwide shipments of PAS-Port systems to over8,800 units, with 750 units sold in the fiscal 2008 fourth quarter, with thevast majority of units deployed in Japan; and
-- Hosted innovative educational symposia for cardiothoracic and thoracicsurgeons in conjunction with the American Association of Thoracic Surgeons andthe International Society for Minimally Invasive Cardiothoracic Surgery AnnualMeetings.
Corporate and Pipeline Progress
-- Submitted 510(k) premarket notification to the U.S. Food and DrugAdministration (FDA) for clearance to market the PAS-Port system in the UnitedStates; and
-- Presented data showing that the PAS-Port system met its primaryendpoint of non-inferiority to hand-sewn anastomosis in a pivotal, randomizedclinical trial.
Fiscal 2008 Fourth Quarter Financial Results
Total product revenue was $1.6 million for the fiscal 2008 fourth quarterversus $0.7 million for the fiscal 2007 fourth quarter. Total net revenue was$2.8 million for the fiscal 2008 fourth quarter compared to $1.0 million forthe same period in fiscal 2007. Cost of product revenue was $1.4 million forthe fiscal 2008 fourth quarter compared to $0.7 million for the same period infiscal 2007.
Research and development expenses were $2.7 million for the fiscal 2008fourth quarter compared to $2.1 million for the fiscal 2007 fourth quarter.Selling, general and administrative expenses for the fiscal 2008 fourthquarter were $3.7 million compared to $2.4 million for the same period infiscal 2007.
The net loss for the fiscal 2008 fourth quarter was $4.8 million, or $0.31per share, compared to a net loss of $4.0 million, or $0.34 per share, for thefiscal 2007 fourth quarter.
Fiscal Year Ended June 30, 2008 Financial Results
Total net revenue for the fiscal year ended June 30, 2008 was $7.6million, compared to $3.5 million for fiscal 2007. Total operating costs andexpenses for fiscal 2008 were $26.6 million, compared to $19.0 million forfiscal 2007. The net loss for fiscal 2008 was $18.2 million, or $1.23 pershare, compared to a net loss of $13.6 million, or $1.25 per share, for fiscal2007.
Cash, cash equivalents and investments at June 30, 2008 were $23.3million, compared to $28.3 million at March 31, 2008 and $23.4 million at June30, 2007. As of June 30, 2008, common shares outstanding were approximately15.8 million shares.
Guidance and Milestones for Fiscal 2009
Cardica anticipates achieving the following milestones over t
