Cardica Announces Fiscal 2008 Fourth Quarter and Year-End Financial Results

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Tue Aug 5, 2008 4:02pm EDT

- Annual Revenue Increased Over 110% -

REDWOOD CITY, Calif., Aug. 5 /PRNewswire-FirstCall/ -- Cardica, Inc.
(Nasdaq: CRDC) today reported financial results and corporate progress for its
fiscal 2008 fourth quarter and year ended June 30, 2008.
    "Over the course of fiscal 2008, we made excellent commercial and
corporate progress. The clinical adoption of our C-Port systems continued as
we introduced our reloadable C-Port(R) X-CHANGE(TM) system and expanded
applications of our automated anastomosis systems in beating heart and
robot-assisted bypass procedures," said Bernard A. Hausen, M.D., Ph.D.,
president and chief executive officer of Cardica, Inc.  "Subject to receiving
regulatory clearance, we intend to substantially broaden our product portfolio
with the launch of our PAS-Port(R) system and additional devices within the
C-Port product line and to provide a complete suite of automated anastomosis
systems that we believe will continue to help revolutionize revascularization
procedures."
    Recent Highlights and Accomplishments
    Commercial Progress
    --  Trained a total of 318 surgeons on the C-Port(R) Distal Anastomosis
Systems since product introduction, with 38 surgeons trained in the fiscal
2008 fourth quarter;
    --  Increased cumulative worldwide shipments of C-Port systems to nearly
6,000 units, with 1,430 units sold in the fiscal 2008 fourth quarter;
    --  Increased cumulative worldwide shipments of PAS-Port systems to over
8,800 units, with 750 units sold in the fiscal 2008 fourth quarter, with the
vast majority of units deployed in Japan; and
    --  Hosted innovative educational symposia for cardiothoracic and thoracic
surgeons in conjunction with the American Association of Thoracic Surgeons and
the International Society for Minimally Invasive Cardiothoracic Surgery Annual
Meetings.
    Corporate and Pipeline Progress
    --  Submitted 510(k) premarket notification to the U.S. Food and Drug
Administration (FDA) for clearance to market the PAS-Port system in the United
States; and
    --  Presented data showing that the PAS-Port system met its primary
endpoint of non-inferiority to hand-sewn anastomosis in a pivotal, randomized
clinical trial.
    Fiscal 2008 Fourth Quarter Financial Results
    Total product revenue was $1.6 million for the fiscal 2008 fourth quarter
versus $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 for
the same period in fiscal 2007.  Cost of product revenue was $1.4 million for
the fiscal 2008 fourth quarter compared to $0.7 million for the same period in
fiscal 2007.
    Research and development expenses were $2.7 million for the fiscal 2008
fourth quarter compared to $2.1 million for the fiscal 2007 fourth quarter.
Selling, general and administrative expenses for the fiscal 2008 fourth
quarter were $3.7 million compared to $2.4 million for the same period in
fiscal 2007.
    The net loss for the fiscal 2008 fourth quarter was $4.8 million, or $0.31
per share, compared to a net loss of $4.0 million, or $0.34 per share, for the
fiscal 2007 fourth quarter.
    Fiscal Year Ended June 30, 2008 Financial Results
    Total net revenue for the fiscal year ended June 30, 2008 was $7.6
million, compared to $3.5 million for fiscal 2007.  Total operating costs and
expenses for fiscal 2008 were $26.6 million, compared to $19.0 million for
fiscal 2007. The net loss for fiscal 2008 was $18.2 million, or $1.23 per
share, compared to a net loss of $13.6 million, or $1.25 per share, for fiscal
2007.
    Cash, cash equivalents and investments at June 30, 2008 were $23.3
million, compared to $28.3 million at March 31, 2008 and $23.4 million at June
30, 2007.  As of June 30, 2008, common shares outstanding were approximately
15.8 million shares.
    Guidance and Milestones for Fiscal 2009
    Cardica anticipates achieving the following milestones over the course of
fiscal 2009:
    --  Receive clearance from the FDA of the company's 510(k) submission for
the PAS-Port system in the first half of fiscal 2009;
    --  Continue to train 25 to 30 surgeons per quarter on the use and
benefits of the C-Port systems.  In addition, the company expects to commence
training approximately 50 to 60 surgeons per quarter on the use and benefits
of the PAS-Port system, subject to receiving FDA clearance;
    --  Receive CE Mark approval for the C-Port X-CHANGE system in the first
half of fiscal 2009;
    --  Receive clearance to market the C-Port(R) Flex-AV(TM) system, a
modification of the C-Port(R) Flex-A(R) system designed to create an
arteriovenous (AV) fistula for hemodialysis;
    --  Launch the C-Port(R) xV system, a C-Port product line extension
designed to be used with larger vein grafts, in fiscal 2009; and
    --  Achieve additional developmental milestones under two separate
partnerships with Cook Medical.
    Cardica expects to achieve continued sequential product revenue growth
from its currently marketed products.  The magnitude of Cardica's revenue for
2009 is dependent on whether and when FDA clearance for the PAS-Port system is
received.  The company is in the process of working with the FDA to respond to
questions on its 510(k) submission related to the PAS-Port system.  If the
PAS-Port device receives FDA clearance, Cardica expects to launch the product
in the U.S. approximately 60 days after clearance and will provide further
product revenue guidance after the PAS-system Port is introduced in the U.S.
market.
    Collaboration revenue is expected to be between $2 and $3 million in
fiscal year 2009. Cardica anticipates that fiscal 2009 research and
development, sales, general and administrative costs will total between $26
and $28 million, including non-cash stock-based compensation expense of
approximately $2 million.
    Conference Call Details
    To access the live conference call today, Tuesday, August 5 at 4:30 p.m.
Eastern Time via phone, please dial 800-659-2032 from the United States and
Canada or +1-617-614-2712 internationally. The conference ID is 76383319.
Please dial in approximately 10 minutes prior to the start of the call. A
telephone replay will be available beginning approximately one hour after the
call through August 12, 2008 and may be accessed by dialing 888-286-8010 from
the United States and Canada or +1-617-801-6888 internationally. The replay
passcode is 84453290.
    To access the live and subsequently archived webcast of the conference
call, go to the Investor Relations section of Cardica's website at
http://www.cardica.com. Please connect to the website at least 15 minutes
prior to the call to allow for any necessary software downloads.
    About Cardica, Inc.
    Cardica is a leading provider of automated anastomosis systems for
coronary artery bypass graft (CABG) surgery.  By replacing hand-sewn sutures
with easy-to-use automated systems, Cardica's products provide cardiovascular
surgeons with rapid, reliable and consistently reproducible anastomoses, or
connections of blood vessels, often considered the most critical aspect of the
CABG procedure.  Cardica's C-Port(R) Distal Anastomosis Systems are marketed
in Europe and the United States.  The PAS-Port(R) Proximal Anastomosis System
is marketed in Europe and Japan, and Cardica has submitted a 510(k) premarket
notification for clearance to market the PAS-Port system in the United States.
Cardica also is developing additional devices with Cook Medical to facilitate
vascular closure and other surgical procedures.
    Forward-Looking Statements
    This press release contains "forward-looking" statements, including
statements relating to Cardica's intention to broaden its product portfolio,
the matters described under the heading "Guidance and Milestones for Fiscal
2009,"  including the anticipated receipt of FDA clearance of the PAS-Port
system and other products and the timing thereof, expected product revenue
growth, the launch of Cardica's PAS-Port system and other products and the
timing thereof, and all financial guidance for the fiscal year ending June 30,
2009. Any statements contained in this press release that are not historical
facts may be deemed to be forward-looking statements. The words "anticipate,"
"believe," "expect," "intend" and "will" or similar expressions are intended
to identify forward-looking statements. There are a number of important
factors that could cause Cardica's results to differ materially from those
indicated by these forward-looking statements, including risks associated with
market acceptance of Cardica's C- Port systems, manufacturing of the C-Port
systems, Cardica's sales, marketing and distribution strategy and
capabilities, Cardica's ability to obtain regulatory clearance to market the
PAS-Port system and the C-Port Flex-AV system in the United States, the launch
of the C-Port xV system, the timing and success of pre-clinical studies of and
regulatory activities related to the Cook Vascular Access Closure Device and
specialized PFO closure device, as well as other risks detailed from time to
time in Cardica's SEC reports, including its Quarterly Report on Form 10-Q for
the quarter ended March 31, 2008. Cardica expressly disclaims any obligation
or undertaking to release publicly any updates or revisions to any forward-
looking statements contained herein. You are encouraged to read the company's
reports filed with the U.S. Securities and Exchange Commission, available at
http://www.sec.gov.
                        (financial statements follow)



    Cardica, Inc.
    Statements of Operations
    (amounts in thousands except per
    share amounts)                       Three months ended     Year ended
                                              June 30,           June 30,
                                           2008      2007     2008       2007
                                            (unaudited)         (unaudited)

    Revenue
      Product revenue, net                $1,580     $679    $4,934    $2,103
      Development revenue                  1,216      309     2,564     1,370
      Royalty revenue from related-party      19       17        67        56
            Total                          2,815    1,005     7,565     3,529

    Operating costs and expenses
      Cost of product revenue              1,368      726     4,808     2,880
      Research and development             2,664    2,052     8,609     7,014
      Selling, general and
       administrative                      3,722    2,416    13,175     9,057
            Total operating costs and
             expenses                      7,754    5,194    26,592    18,951

    Loss from operations                  (4,939)  (4,189)  (19,027)  (15,422)
    Interest income                          136      202       926     1,113
    Interest expense                         (26)     (26)     (101)     (458)
    Other income (expense)                     2        2         6         2
    Gain on early retirement of notes
     payable to related party                  -        -         -     1,183

    Net loss                             $(4,827) $(4,011) $(18,196) $(13,582)

    Basic and diluted net loss per share  $(0.31)  $(0.34)   $(1.23)   $(1.25)

    Shares used in computing basic and
       diluted net loss per share         15,682   11,826    14,844    10,878



                                          Balance Sheets
                                      (amounts in thousands)
                                        June 30,  June 30,
                                          2008     2007
    Assets                                 (unaudited)
         Cash and investments            $23,265  $23,434
         Other assets                      4,985    3,890
             Total assets                $28,250  $27,324


    Liabilities and stockholders' equity
         Total other current liabilities  $3,348   $2,433
         Deferred revenue                  1,485      882
         Total long-term liabilities       2,000    2,020
         Stockholders' equity             21,417   21,989
             Total liabilities and
              stockholders' equity       $28,250  $27,324

SOURCE  Cardica, Inc.

Bob Newell, Vice President, Finance and Chief Financial Officer of Cardica,
Inc., +1-650-331-7133, investors@cardica.com; or Daryl Messinger of WeissComm
Partners, Inc., +1-415-999-2361, dmessinger@wcpglobal.com
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