SUNNYVALE, Calif., Jan. 28 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today reported revenue for the fourth quarter of 2009 of $49.2 million. Net loss was $4.3 million, or $(0.07) per share, which compares to revenue of $37.8 million and a net loss of $6.0 million, or $(0.10) per share, in the fourth quarter of fiscal 2008. Excluding amortization of purchased intangible assets and stock compensation expenses, non-GAAP net income for the fourth quarter of fiscal 2009 was $0.3 million, or $0.01 per share. This compares to a non-GAAP net loss of $2.5 million, or $(0.04) per share, in the fourth quarter of fiscal 2008.

Fiscal 2009 Overview

For the full fiscal year ended December 31, 2009, Cepheid reported revenue of $170.6 million. Net loss for the full year was $22.5 million, or $(0.39) per share, which compares to a net loss of $22.4 million, or $(0.39) per share in 2008. Excluding amortization of purchased intangible assets and stock compensation expenses, non-GAAP net loss for the full year was $5.0 million, or $(0.09) per share. This compares to a non-GAAP net loss of $7.1 million, or $(0.13) per share, for the full year 2008.

"Increasing recognition of the accuracy and ease of use of our GeneXpert® System, coupled with one of the broadest menus of rapid molecular tests available on the market, resulted in year-over-year growth of 28% in our Clinical business," said John Bishop, Cepheid's Chief Executive Officer. "During 2010, we expect our Clinical business will continue to grow rapidly, as we build on our leadership position in molecular diagnostic testing for Healthcare Associated Infections and further extend our women's health test menu and our menu for other critical infectious diseases."

Operational Overview

    --  Fourth quarter of fiscal 2009 Clinical sales of $35.6 million grew 46%
        from $24.4 million in the fourth quarter of 2008, and total fourth
        quarter of fiscal 2009 product sales of $48.2 million grew 34% from the
        same quarter a year ago.  For the full year 2009, total product sales of
        $165.2 million compared to $159.4 million reported for the full year
        2008.  By industry, product sales were, in millions:



                               Three Months Ended     Full Year Ended   
                                   December 31,         December 31,    
                                2009  2008  Change   2009   2008  Change 
                               ----- -----  ------ ------  -----  ------ 
                                                                 
    Clinical Systems           $10.0  $7.8     28%  $26.2  $32.1    -18%
    Clinical Reagents           25.6  16.6     54%   89.7   58.2     54%
                               ----- -----         ------  -----        
        Total Clinical          35.6  24.4     46%  115.9   90.3     28%
    Industrial                   6.1   3.9     58%   19.2   15.4     24%
    Biothreat                    5.1   5.2     -2%   24.8   35.8    -31%
    Partner                      1.4   2.6    -46%    5.3   17.9    -70%
                               ----- -----         ------ ------        
    Total Product Sales        $48.2 $36.1     34% $165.2 $159.4      4%
                               ===== =====         ====== ======

    --  By geography, product sales were, in millions:



                                 Three Months Ended    Full Year Ended   
                                    December 31,         December 31,    
                                 2009  2008  Change   2009   2008  Change 
                                ----- -----  ------ ------ ------  ------ 
    North America                                                
        Clinical                $27.1 $19.0     43%  $88.6  $70.2     26%
        Other                     9.1   9.3     -3%   40.2   55.1    -27%
                                ----- -----         ------ ------        
    Total North America          36.2  28.3     28%  128.8  125.3      3%
                                                                 
    International                                                
        Clinical                  8.5   5.5     55%   27.4   20.0     37%
        Other                     3.5   2.3     54%    9.0   14.1    -36%
                                ----- -----         ------ ------        
    Total International          12.0   7.8     54%   36.4   34.1      7%
                                                                 
                                ----- -----         ------ ------        
    Total Product Sales         $48.2 $36.1     34% $165.2 $159.4      4%
                                ===== =====         ====== ======

    --  During the fourth quarter of fiscal 2009, Cepheid placed a total of 134
        GeneXpert systems and 796 modules.  For the full year 2009, 428
        GeneXpert systems and 2,446 modules were installed.  As of December 31,
        2009, a cumulative total of 1,375 GeneXpert systems and 7,553 modules
        have been placed worldwide.
    --  Cash, cash equivalents, restricted cash and investments, net of the debt
        associated with our Auction Rate Securities, were $46.1 million as of
        December 31, 2009.
    --  DSO improved to 43 days, ahead of the Company's target range.

Business Outlook

For the fiscal year ending December 31, 2010, the Company expects:

    --  Total revenue to be in the range of $195 to $205 million;
    --  Net loss in the range of $(0.35) to $(0.27) per share;
    --  Non-GAAP net income ranging from a loss of $(0.05) to net income of
        $0.02 per share.

Expected non-GAAP net income/loss excludes approximately $16.5 million related to stock compensation expense and approximately $1.5 million related to the amortization of acquired intangibles.

Accessing Cepheid's Fourth Quarter and Full Year 2009 Results Conference Call

The company will host a management presentation at 2:00 p.m. Pacific Time on Thursday, January 28, 2010 to discuss the results. To access the live webcast, please visit Cepheid's website at www.cepheid.com/investors at least 15 minutes before the scheduled start time to download any necessary audio or plug-in software. A replay of the webcast will be available shortly following the call and will remain available for at least 90 days.

Interested participants and investors may also listen to the live teleconference call by dialing 800-299-9086 (domestic) or 617-786-2903 (international), and entering participant code 23247524. A replay will be available for seven days beginning at about 4 p.m. Pacific Time. Access numbers for this replay are 888-286-8010 (domestic) and 617-801-6888 (international), with passcode 33489639.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests for genetic analysis in the clinical, industrial and biothreat markets. The company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The company's easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See www.cepheid.com for more information.

Use of Non-GAAP Measures

The company has supplemented its reported GAAP financial information with non-GAAP measures that do not include employee share-based compensation expense and amortization of purchased intangible assets and restructuring charges. The presentation of this additional information is not meant to be considered in isolation or as a substitute for results prepared in accordance with GAAP. The company's management uses the non-GAAP information internally to evaluate its ongoing business, continuing operational performance and cash requirements, and believes these non-GAAP measures are useful to investors as they provide a basis for evaluating the company's cash requirements and additional insight into the underlying operating results and the company's ongoing performance in the ordinary course of its operations.

These non-GAAP measures may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. The company believes that non-GAAP measures have limitations in that they do not reflect all of the amounts associated with its results of operations as determined in accordance with GAAP and that these measures should only be used to evaluate the company's results of operations in conjunction with the corresponding GAAP measures.

As described above, the company excludes the following items from one or more of its non-GAAP measures when applicable:

Employee stock-based compensation expense. These expenses consist primarily of expenses for employee stock options and employee restricted stock under ASC 718 (formerly SFAS 123(R)). The company excludes employee stock-based compensation expenses from its non-GAAP measures primarily because they are non-cash expenses that the company does not believe are reflective of ongoing operating results. Further, as the company applies ASC 718, it believes that it is useful to investors to understand the impact of the application of ASC 718 on its results of operations.

Amortization of purchased intangible assets. The company incurs amortization of purchased intangible assets in connection with acquisitions. The company excludes these items because these expenses are not reflective of ongoing operating results in the period incurred. These amounts arise from the company's prior acquisitions and have no direct correlation to the operation of the company's business.

Forward-Looking Statements

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 particularly in the clinical market, product pipeline, demand for certain products, future revenues and future net loss. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: our success in increasing direct sales and the effectiveness of new sales personnel; the performance and market acceptance of new products; sufficient customer demand; our ability to develop and complete clinical trials successfully in a timely manner for new products; uncertainties related to the FDA regulatory and European regulatory processes; the level of testing at clinical customer sites; changes in the protocols or levels of testing for Healthcare Associated Infections (HAIs); the company's ability to successfully introduce and sell products in clinical markets other than HAIs; the rate of environmental biothreat testing conducted by the USPS, which will affect the amount of consumable products sold to the USPS; unforeseen development and manufacturing problems; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; lengthy sales cycles in certain markets; the company's reliance on distributors in some regions to market, sell and support its products; the occurrence of unforeseen expenditures, acquisitions or other transactions; the impact of acquisitions; the impact of competitive products and pricing; the company's ability to manage geographically-dispersed operations; and underlying market conditions worldwide, including the uncertain impact of the significant global economic downturn on our business, and that of our customers, potential customers and business partners. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, and its other reports filed with the Securities and Exchange Commission.

All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.



    CONTACTS:
    For Media Inquiries:                For Investor Inquiries:
    --------------------                -----------------------

    Jared Tipton                        Jacquie Ross
    Cepheid Corporate Communications    Cepheid Investor Relations
    Tel: (408) 400 8377                 Tel: (408) 400 8329
    jared.tipton@cepheid.com            investor.relations@cepheid.com




                                FINANCIAL TABLES FOLLOW




                                        CEPHEID

               CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS
                          (in thousands, except per share data)


                                 Three Months Ended          Year Ended
                                    December 31,             December 31,
                                --------------------     ---------------------
                                  2009        2008          2009       2008
                                --------    --------     ---------   ---------

    Revenues:
      System sales              $15,545     $11,058       $42,993     $51,766
      Reagent and
       disposable sales          32,694      25,059       122,192     107,617
                                --------    --------     ---------   ---------
        Total product sales      48,239      36,117       165,185     159,383
      Other revenues                965       1,712         5,442      10,244
                                --------    --------     ---------   ---------
    Total revenues               49,204      37,829       170,627     169,627
                                --------    --------     ---------   ---------
    Costs and operating
     expenses:
      Cost of product
       sales                     27,837      19,729        95,542      89,714
      Collaboration profit
       sharing                    1,653       2,119         8,200      11,089
      Research and
       development                9,916      10,837        39,313      43,310
      Sales and marketing         8,387       7,511        29,156      29,757
      General and
       administrative             5,446       5,079        21,278      20,861
      Gain from legal
       settlement                     -      (1,454)         (243)     (1,454)
      Restructuring charge            -           -           747           -
                                --------    --------     ---------   ---------
        Total costs and
         operating expenses      53,239      43,821       193,993     193,277
                                --------    --------     ---------   ---------
    Loss from operations         (4,035)     (5,992)      (23,366)    (23,650)
    Other income
     (expense), net                (223)       (215)          424         352
                                --------    --------     ---------   ---------
    Loss before income
     tax benefit
     (expense)                   (4,258)     (6,207)      (22,942)    (23,298)
    Income tax benefit
     (expense)                      (24)        161           440         911
                                --------    --------     ---------   ---------
    Net loss                    $(4,282)    $(6,046)     $(22,502)   $(22,387)
                                ========    ========     =========   =========

    Basic and diluted
     net loss per share          $(0.07)     $(0.10)       $(0.39)     $(0.39)
                                ========    ========     =========   =========
    Shares used in
     computing basic and
     diluted net loss
     per share                   58,596      57,648        58,206      57,101
                                ========    ========     =========   =========



                                         CEPHEID

                     CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS
                                      (in thousands)


                                                              
                                                   December 31,   December 31,
                                                       2009           2008
                                                   ------------   ------------
                          ASSETS
    Current assets:
      Cash and cash equivalents                       $35,786        $23,478
      Restricted cash                                       -          1,500
      Short-term investments                           24,931              -
      Accounts receivable, net                         23,014         18,952
      Inventory                                        38,015         33,498
      Prepaid expenses and other current assets         2,421          4,636
                                                     ---------      ---------
    Total current assets                              124,167         82,064
    Property and equipment, net                        24,021         24,109
    Investments                                             -         24,539
    Other non-current assets                              495            920
    Intangible assets                                  30,817         33,791
    Goodwill                                           18,626         18,556
                                                     ---------      ---------
    Total assets                                     $198,126       $183,979
                                                     =========      =========

           LIABILITIES AND SHAREHOLDERS' EQUITY
    Current liabilities:
      Accounts payable                                $21,242        $13,163
      Accrued compensation                              8,869          7,919
      Accrued royalties                                12,929          7,951
      Accrued collaboration profit sharing                826          2,023
      Accrued other liabilities                         1,800          1,324
      Current portion of deferred revenue               2,923          2,834
      Current portion of note payable                     108              -
      Bank borrowing                                   14,618         14,639
                                                     ---------      ---------
    Total current liabilities                          63,315         49,853
    Long-term portion of deferred revenue               2,279          1,753
    Note payable, less current portion                    732              -
    Other liabilities                                   4,234          3,549
                                                     ---------      ---------
    Total liabilities                                  70,560         55,155
                                                     ---------      ---------
    Shareholders' equity:
      Common stock                                    273,052        266,991
      Additional paid-in capital                       56,408         41,619
      Accumulated other comprehensive income (loss)       371            (23)
      Accumulated deficit                            (202,265)      (179,763)
                                                     ---------      ---------
    Total shareholders' equity                        127,566        128,824
                                                     ---------      ---------
    Total liabilities and shareholders' equity       $198,126       $183,979
                                                     =========      =========



                                        CEPHEID

              CONDENSED UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
                                     (in thousands)


                                                          Year Ended
                                                          December 31,
                                                          ------------
                                                      2009            2008
                                                   ---------       ---------
    Cash flows from operating activities:
      Net loss                                     $(22,502)       $(22,387)
      Adjustments to reconcile net loss to net
       cash provided by (used in) operating
       activities:
      Depreciation and amortization                   8,808           7,632
      Amortization of intangible assets               6,823           5,749
      Amortization of prepaid compensation
       expense                                          147             252
      Stock-based compensation related to
       employees and consulting services rendered    15,215          14,064
      Unrealized gain (loss) on auction rate
       securities                                    (6,734)          9,899
      Unrealized gain (loss) on put option            6,143          (9,438)
      Deferred rent                                     (26)            231
      Changes in operating assets and
       liabilities:
        Accounts receivable                          (4,062)          2,495
        Inventory                                    (4,937)         (8,580)
        Prepaid expenses and other current assets     2,059          (2,520)
        Other non-current assets                        425            (676)
        Accounts payable and other current
         liabilities                                 10,753           1,106
        Accrued compensation                            949            (663)
        Deferred revenue                                615          (1,771)
                                                    --------        --------
          Net cash provided by (used in) operating
           activities                                13,676          (4,607)
                                                    --------        --------

    Cash flows from investing activities:
      Capital expenditures                           (8,575)        (14,936)
      Acquisition of leasehold improvements               -             327
      Payments for technology licenses               (1,500)           (418)
      Cost of acquisition, net                         (148)         (1,884)
      Proceeds from sales and maturities of
       marketable securities and short-term
       investments                                      200           2,550
      Proceeds from the sale of fixed assets             20             125
      Transfer to unrestricted cash                   1,500            (983)
                                                    --------        --------
          Net cash used in investing activities      (8,503)        (15,219)
                                                    --------        --------

    Cash flows from financing activities:
      Net proceeds from the issuance of common
       shares and exercise of stock options and
       awards                                         6,061          12,183
      Proceeds from bank borrowing                       20          14,700
      Proceeds from note payable                        849               -
      Principal payments of bank borrowing              (40)            (61)
      Principal payments of notes payable                (9)             (4)
                                                    --------        --------
          Net cash provided by financing
           activities                                 6,881          26,818
                                                    --------        --------

    Effect of exchange rate change on cash              254              10
                                                    --------        --------
    Net increase in cash and cash equivalents        12,308           7,002
    Cash and cash equivalents at beginning of
     period                                          23,478          16,476
                                                    --------        --------
    Cash and cash equivalents at end of period      $35,786         $23,478
                                                    ========        ========



                                       CEPHEID

               RECONCILIATION OF GAAP TO NON-GAAP MEASURES (UNAUDITED)
                      (in thousands, except per share data)


                              Three Months Ended        Year Ended
                                 December 31,           December 31,
                              ------------------     -----------------
                              2009         2008      2009         2008
                            --------     --------  --------    ---------
    Cost of product
     sales                  $27,837      $19,729   $95,542      $89,714
      Stock compensation
       expense                 (682)           -    (2,411)      (1,016)
      Amortization of
       purchased
       intangible assets       (324)        (240)   (1,296)        (963)
                            --------     -------- ---------    ---------
    Non-GAAP measure
     of cost of
     product sales          $26,831      $19,489   $91,835      $87,735

    Gross margin on
     product sales per
     GAAP                        42%          45%       42%          44%
    Gross margin on
     product sales per
     non-GAAP                    44%          46%       44%          45%

    Operating expenses      $23,749      $23,427   $89,747      $93,928
      Stock compensation
       expense               (3,502)      (3,226)  (12,679)     (13,047)
      Amortization of
       purchased
       intangible assets        (83)         (88)     (332)        (222)
                            --------     -------- ---------    ---------
    Non-GAAP measure
     of operating
     expenses               $20,164      $20,113   $76,736      $80,659

    Income (loss) from
     operations             $(4,035)     $(5,992) $(23,366)    $(23,650)
      Restructuring
       charge                     -            -       747            -
      Stock compensation
       expense                4,184        3,226    15,090       14,063
      Amortization of
       purchased
       intangible assets        407          328     1,628        1,185
                            --------     -------- ---------    ---------
    Non-GAAP measure
     of income (loss)
     from operations           $556      $(2,438)  $(5,901)     $(8,402)

    Net income (loss)       $(4,282)     $(6,046) $(22,502)    $(22,387)
      Restructuring
       charge                     -            -       747            -
      Stock compensation
       expense                4,184        3,226    15,090       14,063
      Amortization of
       purchased
       intangible assets        407          328     1,628        1,185
                            --------     -------- ---------    ---------
    Non-GAAP measure
     of net income
     (loss)                    $309      $(2,492)  $(5,037)     $(7,139)

    Basic net income
     (loss) per share        $(0.07)      $(0.10)   $(0.39)      $(0.39)
      Restructuring
       charge                     -            -      0.01            -
      Stock compensation
       expense                 0.07         0.06      0.26         0.25
      Amortization of
       purchased
       intangible assets       0.01            -      0.03         0.01
                            --------     --------  --------    ---------
    Non-GAAP measure
     of net income
     (loss)                   $0.01       $(0.04)   $(0.09)      $(0.13)

    Diluted net income
     (loss) per share        $(0.07)      $(0.10)   $(0.39)      $(0.39)
      Restructuring
       charge                     -            -      0.01            -
      Stock compensation
       expense                 0.07         0.06      0.26         0.25
      Amortization of
       purchased
       intangible assets       0.01            -      0.03         0.01
                            --------     -------- ---------    ---------
    Non-GAAP measure
     of net income
     (loss)                   $0.01       $(0.04)   $(0.09)      $(0.13)

    Shares used in   
     computing basic
     net income (loss)
     per share               58,596       57,648    58,206       57,101
      Incremental shares   
       from the assumed
       conversion of
       dilutive stock   
       options                2,758            -         -            -
                            --------     -------- ---------    ---------
    Shares used in   
     computing diluted   
     net income (loss)
     per share               61,354       57,648    58,206       57,101

SOURCE Cepheid