SUNNYVALE, Calif., Jan. 30, 2014 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today reported revenue for the fourth quarter of 2013 of $113.3 million. Net loss was $10.3 million, or $(0.15) per share, which compares to revenue of $92.4 million and net income of $5.6 million, or $0.08 per share, in the fourth quarter of 2012. Fourth quarter results for 2013 included a $4.4 million, or $0.06 per share, charge primarily associated with a small, non-core restructuring and impairment of certain assets resulting from a realignment of operations.

Excluding stock compensation expenses, the restructuring expense (which includes an impairment of certain assets), and amortization of acquired purchased intangible assets, non-GAAP net income for the fourth quarter of 2013 was $2.3 million, or $0.03 per share. This compares to a non-GAAP net income of $14.2 million, or $0.20 per share, in the fourth quarter of 2012.

Fiscal 2013 Overview

For the year ended December 31, 2013, Cepheid reported revenue of $401.3 million which compares to revenue of $331.2 million in 2012. Net loss for the year was $18.0 million, or $(0.27) per share, which compares to net loss of $20.0 million, or $(0.30) per share, in 2012 which included a charge of $15.1 million, or $0.23 per share, associated with a litigation settlement.

Excluding stock compensation expenses, the restructuring expense (which includes impairment of certain assets), and amortization of acquired purchased intangible assets, non-GAAP net income for the year was $17.9 million, or $0.26 per share. This compares to a non-GAAP net income of $21.8 million, or $0.31 per share, for the full year 2012, which excluded stock compensation expenses, the amortization of purchased intangible assets, a litigation settlement and a tax benefit related to an intercompany intellectual property transaction.

"Clinical test revenue grew 25% in 2013, with notable strength in our Commercial Clinical Xpert reagents which grew 22%," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "We also placed a record number of GeneXpert systems in 2013, with strength in both our commercial and HBDC businesses, demonstrating the impact of our rapidly expanding Xpert test menu and global sales footprint."

Continued Bishop, "Adoption of our high throughput Infinity system increased with a record 52 shipments in 2013, including 23 in the fourth quarter, further highlighting Cepheid's position as a platform consolidator within the molecular diagnostics market. With a menu of 14 tests and growing, we believe the innovative GeneXpert system is the most compelling choice for labs of all sizes looking to leverage accurate and fast diagnostics without the costs and complexities traditionally associated with molecular technologies."

Operational Overview


    --  Fourth quarter of 2013 total Clinical sales of $101.0 million grew 23%
        from $82.2 million in the fourth quarter of 2012. For the year ended
        December 31, 2013, total Clinical sales of $359.9 million grew 26% from
        $286.3 million in 2012.

    --  By industry, sales were, in millions:


                        Three Months Ended             Full Year Ended
                           December 31,                  December 31,

                         2013      2012    Change       2013       2012 Change
                         ----      ----    ------       ----       ---- ------


    Clinical Systems    $20.2     $13.4           51%  $67.0      $52.8        27%

    Clinical Reagents    80.8      68.8           17%  292.9      233.5        25%
                         ----      ----                -----      -----

        Total Clinical  101.0      82.2           23%  359.9      286.3        26%

    Non-Clinical         12.3      10.2           20%   41.4       44.9        -8%

    Total Sales        $113.3     $92.4           23% $401.3     $331.2        21%
                       ======     =====               ======     ======

    --  By geography, sales were, in millions:


                         Three Months Ended              Full Year Ended
                            December 31,                   December 31,

                          2013      2012    Change        2013       2012 Change
                          ----      ----    ------        ----       ---- ------

    North America

         Clinical        $58.6     $54.3             8% $212.4     $190.0         12%

         Other            11.1       8.8            26%   37.0       38.6         -4%
                          ----       ---                  ----       ----

    Total North America   69.7      63.1            10%  249.4      228.6          9%


    International

         Clinical         42.4      27.8            52%  147.5       96.3         53%

         Other             1.2       1.5           -21%    4.4        6.3        -30%
                           ---       ---                   ---        ---

    Total International   43.6      29.3            49%  151.9      102.6         48%


    Total Sales         $113.3     $92.4            23% $401.3     $331.2         21%
                        ======     =====                ======     ======


    --  Commercial sales, including Clinical and Non-Clinical & Other, were
        $95.5 million in the fourth quarter of 2013 and $335.6 million for the
        full year 2013. Sales to High Burden Developing Countries (HBDC) in the
        fourth quarter of 2013 were $17.8 million and $65.7 million for the full
        year 2013.
    --  During the fourth quarter of 2013, Cepheid placed a record total of 205
        GeneXpert systems in its commercial Clinical business. Additionally,
        Cepheid placed a total of 178 GeneXpert systems as part of its High
        Burden Developing Country (HBDC) program. For the year ended December
        31, 2013, Cepheid placed a total of 619 GeneXpert systems in its
        commercial Clinical business and an additional 1,055 GeneXpert systems
        as part of its HBDC program. As of December 31, 2013, a cumulative total
        of 5,509 GeneXpert systems have been placed worldwide.
    --  GAAP gross margin on sales was 47% and non-GAAP gross margin on sales
        was 50% in the fourth quarter of 2013, which compares to 54% and 56%,
        respectively, in the fourth quarter of 2012. GAAP gross margin on sales
        was 48% and non-GAAP gross margin on sales was 50% for the full year
        2013, which compares to 54% and 55%, respectively, for the full year
        2012.
    --  Cash, cash equivalents and investments were $84.7 million as of December
        31, 2013.
    --  DSO was 42 days.

Business Outlook

For the fiscal year ending December 31, 2014, the Company expects:

-- Total revenue to be in the range of $446 to $461 million; -- Net loss in the range of $(0.26) to $(0.21) per share; -- Non-GAAP net income in the range of $0.24 to $0.29 per share.

Expected non-GAAP net income excludes approximately $33 million related to stock compensation expense and approximately $3 million related to the amortization of purchased intangible assets. The fully diluted share count for the year is expected to be approximately 69 million in the case of a net loss, and approximately 73 million shares in the case of net income.

The following table reconciles net income (loss) per share to the non-GAAP net income per share range:


                                      Guidance
                                     Range for
                                        Year

                                       Ending
                                      December
                                      31, 2014
                                     ---------

                                        Low             High
                                        ---             ----

    Net Income (Loss) Per Share          $(0.26)          $(0.21)

       Stock Compensation Expense         (0.46)           (0.46)

       Amortization of Purchased
        Intangible Assets                 (0.04)           (0.04)

    Non-GAAP Measure of Net
     Income Per Share                     $0.24            $0.29

Accessing Cepheid's Fourth Quarter and Full Year 2013 Results Conference Call

The Company will host a management presentation at 2 p.m. Pacific Time on Thursday, January 30, 2014, to discuss the results. To access the live webcast, please visit Cepheid's website at http://ir.cepheid.com 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.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the Company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the Company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.

Use of Non-GAAP Measures

The Company has supplemented its reported GAAP financial information with non-GAAP measures that do not include employee stock-based compensation expense, amortization of purchased intangible assets, a restructuring in the quarter ended December 31, 2013, a tax benefit related to an intercompany intellectual property transaction in the quarter ended March 31, 2012, and litigation settlement expenses in the quarter ended September 30, 2012. The presentation of this additional information is not meant to be considered in isolation or as a substitute for results prepared in accordance with U.S. 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 U.S. 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 in the period incurred. 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.

Restructuring. The Company excluded a restructuring charge and impairment of certain assets totaling $4.4 million in the fourth quarter of 2013. In connection with the Company's preparation of its annual operating plan, whereby the Company routinely assesses its investments to align its operations with its highest potential opportunities, the Company terminated a small international research team, eliminated a non-GeneXpert clinical product line acquired in a 2007 acquisition, including the impairment of an intangible asset of approximately $1.1 million and the write-down of approximately $0.2 million of inventory, and wrote-off certain manufacturing capital assets totaling approximately $1.3 million that management concluded will not be utilized and therefore have no future realizable value. The Company excluded this item as it believes it was non-recurring in nature, and does not have a direct impact on the operation of the Company's core business.

Tax Benefit Related to Intercompany Intellectual Property (IP) Transaction. The Company excluded a tax benefit related to an intercompany IP transaction from its results for non-GAAP net loss for the quarter ended March 31, 2012. The Company excluded this item as it believes it was non-recurring in nature, and does not have a direct impact on the operation of the Company's core business.

Litigation Settlement Expenses. These expenses consisted primarily of expenses related to the settlement of the Company's litigation with Abaxis. This allocation was determined in accordance with ASC 450, Accounting for Contingencies (formerly SFAS No. 5), and ASC 605-25 (formerly EITF 00-21) using the concepts of fair value based on the past and estimated future revenue streams related to the products covered by the patents previously under dispute. Specifically, the amount recorded in the consolidated income statement as Litigation settlement in the quarter ended September 30, 2012 represented the fair value of the royalty paid on past revenue streams and the residual amount after allocating value to the future revenue streams. The Company excluded this item as it believes it was non-recurring in nature, and does not have a direct impact on the operation of the Company's core 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, future revenues and future net loss/income and profitability, including on a non-GAAP basis, and the breadth and speed of test menu expansion. 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: long sales cycles and variability in systems placements and reagent pull-through in the Company's HBDC program; our success in increasing commercial and HBDC sales and the effectiveness of our sales personnel; the relative mix of commercial and HBDC sales; the performance and market acceptance of new products; sufficient customer demand, customer confidence in product availability and available customer budgets for our customers; our ability to develop new products and complete clinical trials successfully in a timely manner for new products; uncertainties related to the FDA regulatory and international regulatory processes; the level of testing at clinical customer sites, including 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 supply, development and manufacturing problems; our ability to manage our inventory levels; our ability to successfully complete and bring on additional manufacturing lines; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; 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; costs associated with litigation; the impact of competitive products and pricing; the Company's ability to manage geographically-dispersed operations; and underlying market conditions worldwide. 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 Investor Inquiries:

    For Media Inquiries:
    --------------------

                                     Jacquie Ross, CFA

                                      Cepheid Investor
                                      Relations

    Jared Tipton                     Tel: (408) 400 8329

    Cepheid Corporate Communications  investor.relations@cepheid.com

    Tel: (408) 400 8377

    communications@cepheid.com

FINANCIAL TABLES FOLLOW



                                CEPHEID





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


                                       Three Months              Years Ended
                                           Ended                 December 31,
                                       December 31,
                                      -------------                 ------------

                                        2013        2012          2013          2012
                                        ----        ----          ----          ----


    Sales:

    System and
     other sales                     $22,263     $16,876       $76,763       $65,111

    Reagent and
     disposable
     sales                            90,998      75,557       324,529       266,101
                                      ------      ------       -------       -------

    Total sales                      113,261      92,433       401,292       331,212

    Costs and operating expenses:

    Cost of product
     sales                            60,483      42,896       207,933       153,365

    Collaboration
     profit sharing                    2,567       1,416         7,512         7,183

    Research and
     development                      25,340      17,299        80,197        71,673

    Sales and
     marketing                        21,922      16,294        79,941        61,907

    General and
     administrative                   12,854       9,470        41,719        43,298

    Litigation
     Settlement                            -           -             -        15,110

    Total costs and
     operating
     expenses                        123,166      87,375       417,302       352,536
                                     -------      ------       -------       -------

    Income (loss)
     from
     operations                       (9,905)      5,058       (16,010)      (21,324)

    Other income
     (expense), net                     (264)        241          (807)           (4)
                                        ----         ---          ----           ---

    Income (loss)
     before income
     taxes                           (10,169)      5,299       (16,817)      (21,328)

    Benefit from
     (provision
     for) income
     taxes                              (148)        345        (1,148)        1,285

    Net income
     (loss)                         $(10,317)     $5,644      $(17,965)     $(20,043)
                                    ========      ======      ========      ========


    Basic net
     income (loss)
     per share                        $(0.15)      $0.09        $(0.27)       $(0.30)
                                      ======       =====        ======        ======


    Diluted net
     income (loss)
     per share                        $(0.15)      $0.08        $(0.27)       $(0.30)
                                      ======       =====        ======        ======


    Shares used in
     computing
     basic net
     income (loss)
     per share                        68,230      66,370        67,485        65,812
                                      ======      ======        ======        ======


    Shares used in
     computing
     diluted net
     income (loss)
     per share                        68,230      68,787        67,485        65,812
                                      ======      ======        ======        ======


                                               CEPHEID





                           CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS
                                            (in thousands)


                                                 December 31,              December 31,

                                                               2013                      2012
                                                               ----                      ----


                                ASSETS

    Current assets:

    Cash and cash
     equivalents                                            $66,072                   $95,779

    Short-term
     investments                                              8,837                         -

    Accounts
     receivable, net                                         52,202                    43,999

    Inventory                                               103,866                    70,114

    Prepaid expenses
     and other
     current assets                                          13,037                     9,448
                                                             ------                     -----

    Total current
     assets                                                 244,014                   219,340

    Property and
     equipment, net                                          84,886                    54,830

    Investments                                               9,820                         -

    Other non-
     current assets                                             958                       913

    Intangible
     assets, net                                             15,245                    18,767

    Goodwill                                                 39,681                    37,694

    Total assets                                           $394,604                  $331,544
                                                           ========                  ========


                 LIABILITIES AND SHAREHOLDERS' EQUITY

    Current liabilities:

    Accounts payable                                        $52,609                   $33,701

    Accrued
     compensation                                            22,009                    16,540

    Accrued
     royalties                                                5,245                     7,992

    Accrued and
     other
     liabilities                                              7,246                     4,235

    Current portion
     of deferred
     revenue                                                  8,183                     9,599

    Current portion
     of notes
     payable                                                    194                       183
                                                                ---                       ---

    Total current
     liabilities                                             95,486                    72,250

    Long-term
     portion of
     deferred
     revenue                                                  3,424                     1,156

    Notes payable,
     less current
     portion                                                  1,479                     1,685

    Other
     liabilities                                              8,975                     8,911
                                                              -----                     -----

    Total
     liabilities                                            109,364                    84,002
                                                            -------                    ------

    Shareholders' equity:

    Common stock                                            383,379                   355,867

    Additional paid-
     in capital                                             145,900                   117,217

    Accumulated
     other
     comprehensive
     income (loss)                                             (476)                       56

    Accumulated
     deficit                                               (243,563)                 (225,598)
                                                           --------                  --------

    Total
     shareholders'
     equity                                                 285,240                   247,542

    Total
     liabilities and
     shareholders'
     equity                                                $394,604                  $331,544
                                                           ========                  ========



                              CEPHEID





    CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS
                          (in thousands)


                                                          Years Ended
                                                         December 31,
                                                         ------------

                                                         2013           2012
                                                         ----           ----

    Cash flows from operating activities:

    Net loss                                         $(17,965)      $(20,043)

    Adjustments to reconcile net loss to net cash
     provided by operating activities:

    Depreciation and
     amortization of property
     and equipment                                     17,769         13,446

    Amortization of intangible
     assets                                             5,418          4,965

    Impairment of terminated
     patent license, acquired
     intangible assets and
     property and equipment                             2,855          1,399

    Unrealized exchange
     differences                                          419              -

    Stock-based compensation
     related to employees and
     consulting services
     rendered                                          27,635         24,496

    Changes in operating assets and liabilities:

    Accounts receivable                                (6,960)        (6,443)

    Inventory                                         (32,638)        (5,105)

    Prepaid expenses and other
     current assets                                    (5,263)        (2,714)

    Other non-current assets                              150           (172)

    Accounts payable and other
     current liabilities                               17,334         (5,740)

    Accrued compensation                                5,421         (1,736)

    Deferred revenue                                      837            575
                                                          ---            ---

    Net cash provided by
     operating activities                              15,012          2,928


    Cash flows from investing activities:

    Capital expenditures                              (47,526)       (23,150)

    Cash paid for intangible
     asset                                                  -         (2,140)

    Cash paid for technology
     licenses                                          (1,125)             -

    Cost of acquisitions, net                          (3,669)       (24,021)

    Proceeds from maturities and
     sales of marketable
     securities and investments                         3,850              -

    Purchases of marketable
     securities and investments                       (22,511)             -
                                                      -------            ---

    Net cash used in investing
     activities                                       (70,981)       (49,311)


    Cash flows from financing activities:

    Net proceeds from the
     issuance of common shares
     and exercise of stock
     options                                           27,512         27,079

    Proceeds from notes payable                             -            156

    Principal payment of notes
     payable                                             (874)           (72)
                                                         ----            ---

    Net cash provided by
     financing activities                              26,638         27,163


    Effect of exchange rate
     change on cash                                      (376)            (9)
                                                         ----            ---

    Net increase (decrease) in
     cash and cash equivalents                        (29,707)       (19,229)

    Cash and cash equivalents at
     beginning of period                               95,779        115,008

    Cash and cash equivalents at
     end of period                                    $66,072        $95,779
                                                      =======        =======






                                                       CEPHEID





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


                                                                             Three Months Ended         Years Ended

                                                                                December 31,            December 31,
                                                                                ------------            ------------

                                                                                2013            2012      2013          2012
                                                                                ----            ----      ----          ----

    Cost of sales                                           $60,483          $42,896        $207,933  $153,365

      Stock compensation expense                                              (1,084)           (808)   (2,927)       (3,037)

      Restructuring charge including impairment of intangibles                (2,651)         (1,038)   (2,651)       (1,038)

      Amortization of purchased intangible assets                               (345)           (527)   (2,349)       (1,525)
                                                                                ----            ----    ------

    Non-GAAP measure of cost of sales                       $56,403          $40,523        $200,006  $147,765


    Gross margin on sales per GAAP                                                47%             54%       48%           54%

    Gross margin on sales per Non-GAAP                                            50%             56%       50%           55%


    Operating expenses                                      $60,116          $43,063        $201,857  $176,878

      Stock compensation expense                                              (6,534)         (5,756)  (24,708)      (21,415)

      Restructuring charge including impairment of intangibles                (1,783)           (328)   (1,783)         (328)

      Amortization of purchased intangible assets                               (458)           (376)   (1,715)       (1,452)
                                                                                ----            ----    ------        ------

    Non-GAAP measure of operating expenses                  $51,341          $36,603        $173,651  $153,683


    Income (loss) from operations                           $(9,905)          $5,058        $(16,010) $(21,324)

      Stock compensation expense                                               7,618           6,564    27,635        24,452

      Amortization of purchased intangible assets                                803             903     4,064         2,977

      Restructuring charge including impairment of intangibles                 4,434           1,366     4,434         1,366

      Litigation settlement                                       -                -               -    15,110
                                                                ---              ---             ---    ------

    Non-GAAP measure of income from operations               $2,950          $13,891         $20,123   $22,581


    Net income (loss)                                      $(10,317)          $5,644        $(17,965) $(20,043)

      Stock compensation expense                                               7,618           6,564    27,635        24,452

      Amortization of purchased intangible assets                                803             903     4,064         2,977

      Restructuring charge including impairment of intangibles                 4,201           1,093     4,201         1,093

      Litigation settlement                                       -                -               -    15,110

      Tax benefit related to intercompany IP transaction          -                -               -    (1,815)
                                                                ---              ---             ---    ------

    Non-GAAP measure of net income                           $2,305          $14,204         $17,935   $21,774


    Basic net income (loss) per share                        $(0.15)           $0.09          $(0.27)   $(0.30)

      Stock compensation expense                                                0.11            0.09      0.41          0.37

      Amortization of purchased intangible assets                               0.01            0.01      0.06          0.04

      Restructuring charge including impairment of intangibles                  0.06            0.02      0.07          0.02

      Litigation settlement                                       -                -               -      0.23

      Tax benefit related to intercompany IP transaction          -                -               -     (0.03)
                                                                ---              ---             ---     -----

    Non-GAAP measure of net income per share                  $0.03            $0.21           $0.27     $0.33


    Diluted net income (loss) per share                      $(0.15)           $0.08          $(0.27)   $(0.30)

      Stock compensation expense                                                0.11            0.09      0.41          0.35

      Amortization of purchased intangible assets                               0.01            0.01      0.06          0.04

      Restructuring  charge including impairment of intangibles                 0.06            0.02      0.06          0.02

      Litigation settlement                                       -                -               -      0.23

      Tax benefit related to intercompany IP transaction          -                -               -     (0.03)
                                                                ---              ---             ---     -----

    Non-GAAP measure of net income per share                  $0.03            $0.20           $0.26     $0.31


    Shares used in computing basic net income (loss) per share                68,230          66,370    67,485        65,812


    Shares used in computing diluted net income (loss) per share              70,644          69,376    69,928        69,700

SOURCE Cepheid