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Gen-Probe Reports Financial Results for Third Quarter 2009

October 29, 2009

-- Operating Activities Generate $31.9 Million of Cash in Quarter --

SAN DIEGO, Calif., Oct. 29 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) today reported financial results for the third quarter of 2009, with record product sales and total revenues driving non-GAAP earnings per share (EPS) of $0.47.

"Gen-Probe posted very good financial results in the third quarter of 2009, driven by strong growth in our base STD testing business and revenue from our recent Tepnel acquisition," said Carl Hull, the Company's president and chief executive officer. "We also advanced several strategic priorities by acquiring the infectious disease company Prodesse, spinning off our industrial testing business, and initiating two pivotal clinical studies in oncology and women's health."

Comparisons to the third quarter of 2008 were negatively affected by a one-time, $10.0 million milestone payment in the prior year period, as described below.

In the third quarter of 2009, product sales were $119.0 million, compared to $108.3 million in the prior year period, an increase of 10%. Compared to the third quarter of 2008, the stronger US dollar reduced product sales growth by an estimated $2.5 million, or 2%(2). Total revenues for the third quarter of 2009 were $122.7 million, compared to $121.2 million in the prior year period, an increase of 1%.

Net income was $23.8 million ($0.47 per share) on a non-GAAP basis in the third quarter of 2009, compared to $29.1 million ($0.52 per share) in the prior year period, a decrease of 18% (10% per share). Including $1.6 million of after-tax expenses ($0.03 per share) related to the Company's acquisitions of Tepnel and Prodesse and the industrial spin-off, net income in the third quarter of 2009 was $22.2 million ($0.44 per share) on a GAAP basis.

For the first nine months of 2009, product sales were $348.3 million, compared to $323.5 million in the prior year period, an increase of 8%. Compared to the first nine months of 2008, the stronger US dollar reduced product sales growth by an estimated $11.1 million, or 3%. Total revenues for the first nine months of 2009 were $359.4 million, compared to $363.6 million in the prior year period, a decrease of 1%.

Net income was $74.0 million ($1.43 per share) on a non-GAAP basis in the first nine months of 2009, compared to $85.8 million ($1.55 per share) in the prior year period, a decrease of 14% (8% per share). Including $6.3 million of after-tax expenses ($0.12 per share) related to the Company's acquisitions of Tepnel and Prodesse and the industrial spin-off, net income in the first nine months of 2009 was $67.8 million ($1.31 per share) on a GAAP basis.

As previously disclosed, Gen-Probe's total revenues, net income and EPS in the first nine months of 2008 benefited from a number of non-recurring items. The two most significant benefits were:

    --  $16.4 million of royalty and license revenue ($0.20 of EPS), which was
        recorded in the first quarter of 2008 based on the settlement of patent
        infringement litigation against Bayer (now Siemens Healthcare
        Diagnostics).

    --  $10.0 million of collaborative research revenue ($0.12 of EPS), which
        was recorded from the Company's commercial partner, Novartis
        Diagnostics, in the third quarter of 2008 based on the full approval by
        the US Food and Drug Administration (FDA) of the PROCLEIX® ULTRIO®
        assay on the TIGRIS® system.

By comparison, the Company's product sales, total revenues, net income and EPS in the first nine months of 2009 benefited from $8.2 million of one-time revenue ($0.10 of EPS) recorded in the first quarter associated with the previously announced renegotiation of the Company's collaboration agreement with Novartis Diagnostics.

Detailed Results

Gen-Probe's clinical diagnostics sales of $69.6 million in the third quarter of 2009 benefited from revenue associated with Tepnel's transplant diagnostics and genetic testing products, and continued strong growth of the APTIMA Combo 2® assay, an amplified nucleic acid test (NAT) for simultaneously detecting Chlamydia trachomatis and Neisseria gonorrhoeae. Clinical diagnostics sales were negatively affected by the stronger US dollar, which reduced growth by an estimated $0.8 million, or more than 1%, compared to the prior year period.

In blood screening, product sales of $45.4 million in the third quarter of 2009 were negatively affected by $7.9 million of lower product shipments to Novartis. This reduction, which was expected, resulted primarily from: lower US shipments of the PROCLEIX HIV-1/HCV assay as customers began to adopt the PROCLEIX ULTRIO assay; lower US shipments of the PROCLEIX ULTRIO assay due to the post-marketing study in the prior year period; and lower West Nile virus assay shipments due to previously discussed ordering patterns. Blood screening sales growth also was negatively affected by the stronger US dollar, which reduced growth by an estimated $1.7 million, or 3%. "As we forecast three months ago, blood screening sales in the third quarter continued to be affected by negative ordering patterns that outweighed a 1% increase in underlying donations tested," Mr. Hull said.

Sales of research products and services in the third quarter of 2009 were $3.9 million. These sales, resulting from the Tepnel acquisition, were not included in Gen-Probe's prior year results.

Third quarter product sales were, in millions:


                                      Three Months
                                     Ended Sept. 30,             Change
                                     ---------------      --------------------
                                                            As        Constant
                                     2009       2008      Reported    Currency
                                     ----       ----      --------    --------
    Clinical
     Diagnostics                     $69.6      $55.5        25%          27%
    Blood Screening                  $45.4      $52.7       -14%         -11%
    Research Products and Services    $3.9        N/A       N/A          N/A
                                      ----        ---       ---          ---
    Total Product Sales             $119.0     $108.3        10%          12%

Product sales in the first nine months of 2009 were, in millions:


                                       Nine Months
                                     Ended Sept. 30,             Change
                                     ---------------      --------------------
                                                             As       Constant
                                     2009       2008      Reported    Currency
                                     ----       ----      --------    --------
    Clinical Diagnostics            $196.6     $165.2        19%          21%
    Blood Screening                 $144.1     $158.2        -9%          -4%
    Research Products and Services    $7.6        N/A       N/A          N/A
                                      ----        ---       ---          ---
    Total Product Sales             $348.3     $323.5         8%          11%

Collaborative research revenues in the third quarter of 2009 were $2.0 million, compared to $11.3 million in the prior year period. As discussed above, this significant decrease resulted primarily from a $10.0 million milestone the Company earned from Novartis in the prior year period based on the full FDA approval of the PROCLEIX ULTRIO assay on the TIGRIS system. For the first nine months of 2009, collaborative research revenues were $5.9 million, compared to $18.5 million in the prior year period.

Royalty and license revenues for the third quarter of 2009 were $1.8 million, compared to $1.6 million in the prior year period, an increase of 13%. For the first nine months of 2009, royalty and license revenues were $5.3 million, compared to $21.6 million in the prior year period. As discussed above, this significant decrease resulted primarily from $16.4 million of revenue that was recorded in the first quarter of 2008 associated with the settlement of Gen-Probe's patent infringement litigation against Bayer.

Gross margin on product sales in the third quarter of 2009 was 69.5% on a non-GAAP basis that excludes $0.1 million of acquisition-related depreciation expense, compared to 71.7% in the prior year period. This decrease resulted primarily from the stronger US dollar, the addition of Tepnel's generally lower-margin revenues, and lower sales of blood screening products. For the first nine months of 2009, gross margin on product sales was 69.1% on a non-GAAP basis that excludes $0.2 million of acquisition-related depreciation expense, compared to 70.4% in the prior year period. On a GAAP basis, gross margin on product sales was 69.4% in the third quarter of 2009, and 69.0% for the first nine months of the year.

Acquisition-related intangible amortization expenses were $1.1 million in the third quarter of 2009 and $2.3 million in the first nine months of the year, compared to $0 in the comparable prior year periods.

Research and development (R&D) expenses in the third quarter of 2009 were $27.5 million, compared to $24.5 million in the prior year period, an increase of 12% that resulted primarily from expenses associated with clinical trials of the Company's HPV, PCA3 and trichomonas assays, and from the addition of Tepnel's R&D activities. For the first nine months of 2009, R&D expenses were $78.5 million, compared to $76.9 million in the prior year period, an increase of 2%.

Marketing and sales expenses in the third quarter of 2009 were $13.5 million, compared to $10.7 million in the prior year period, an increase of 26% that resulted primarily from the addition of Tepnel's cost structure, and European sales force expansion and market development efforts. For the first nine months of 2009, marketing and sales expenses were $38.5 million, compared to $34.1 million in the prior year period, an increase of 13%.

General and administrative (G&A) expenses in the third quarter of 2009 were $14.2 million on a non-GAAP basis that excludes $1.1 million of transaction-related expense, compared to $12.9 million in the prior year period. This increase of 10% resulted primarily from the addition of Tepnel's cost structure. For the first nine months of 2009, G&A expenses were $41.0 million on a non-GAAP basis that excludes $5.9 million of transaction-related expense, compared to $38.5 million in the prior year period, an increase of 6%. On a GAAP basis, G&A expenses were $15.2 million in the third quarter of 2009, up 18% compared to the prior year period, and $46.9 million for the first nine months of the year, up 22% compared to the prior year period.

Total other income in the third quarter of 2009 was $4.3 million, compared to $2.2 million in the prior year period, an increase of 95% that resulted primarily from a $1.6 million impairment charge in the prior year period associated with the Company's equity investment in Qualigen, Inc. For the first nine months of 2009, total other income was $17.4 million, compared to $11.6 million in the prior year period, an increase of 50% that resulted primarily from investment gains realized from selling portions of the Company's municipal bond portfolio.

In the third quarter of 2009, Gen-Probe generated net cash of $31.9 million from its operating activities, substantially higher than GAAP net income of $22.2 million. The Company spent $7.6 million on property, plant and equipment in the quarter.

In the third quarter of 2009, the Company repurchased approximately 1.8 million shares of its stock for $69.3 million, completing the share repurchase program announced in August of 2008. Throughout the program, the Company repurchased approximately 6.0 million shares of its common stock for $249.8 million.

Gen-Probe continues to have a strong balance sheet. As of September 30, 2009, the Company had $517.9 million of cash, cash equivalents and short-term investments, and $240.8 million of short-term debt. The Company currently pays interest on substantially all of this debt at a rate 0.6 percent above the one-month London Interbank Offered Rate (LIBOR), which was recently below 0.3 percent. In October, Gen-Probe paid approximately $60.0 million to complete its acquisition of Prodesse.

Updated 2009 Financial Guidance

In the table below, Gen-Probe's non-GAAP guidance excludes certain expenses related to the Tepnel and Prodesse acquisitions, and the spin-off of the Company's industrial testing business.


                      Current       Previous       Current         Previous
                      Guidance      Guidance       Guidance        Guidance
                     (non-GAAP)    (non-GAAP)       (GAAP)          (GAAP)
    Total revenues  $493 to $500  $490 to $503  $493 to $500     $490 to $503
                       million       million       million          million
    Product gross
     margins            ~ 69%      68% to 69%      ~ 69%          68% to 69%
    Acquisition-
     related
     intangibles
     amortization        N/A           N/A      $3-4 million     $3-4 million
    R&D expenses        ~ 22%         ~ 22%        ~ 22%            ~ 22%
    Marketing and
     sales
     expenses           ~ 11%       10% to 11%     ~ 11%          10% to 11%
    G&A expenses        ~ 11%       10% to 11%   12% to 13%       11% to 12%
    Tax rate            ~ 34%         ~ 34%        ~ 34%            ~ 34%
    Diluted shares ~ 51.5 million  ~ 52 million  ~ 51.5 million ~ 52 million
    EPS            $1.90 to $1.93 $1.85 to $1.95 $1.77 to $1.79 $1.73 to $1.85

Recent Events

    --  Prodesse Acquisition.  On October 22, the Company announced that it had
        completed its acquisition of Prodesse, Inc., a leader in molecular
        testing for influenza and other infectious diseases, for approximately
        $60.0 million in cash.  Gen-Probe's purchase price could increase to up
        to $85.0 million if Prodesse achieves certain financial and regulatory
        milestones in 2010 and 2011.
    --  EUA for ProFlu-ST(TM).  Earlier today, Gen-Probe announced that the FDA
        had granted an EUA (emergency use authorization) for Prodesse's test,
        ProFlu-ST(TM), to be used in CLIA high complexity laboratories for the
        diagnosis of 2009 H1N1 influenza virus infection, aided by an algorithm
        that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3
        virus results, from a single sample in individuals who are diagnosed
        with influenza A by currently available FDA-cleared or authorized
        devices.
    --  Industrial Spin-Off.  On September 14, Gen-Probe announced that it was
        spinning off its industrial testing assets into a new, independent
        company focused on developing rapid, highly accurate molecular assays
        for biopharmaceutical production, water and food safety testing, and
        other applications.  Gen-Probe owns 19.9% of the new company, Roka
        Bioscience, Inc.
    --  Prostate Cancer Clinical Trial.  On August 27, the Company announced
        that it had begun a clinical trial intended to secure US regulatory
        approval of its PROGENSA® PCA3 assay, a new molecular test that may
        help determine the need for a repeat prostate biopsy.
    --  Trichomonas Clinical Trial.  On August 17, Gen-Probe announced that it
        had begun a clinical trial intended to secure US regulatory approval of
        its APTIMA® assay for Trichomonas vaginalis on the fully automated
        TIGRIS® system.  Trichomonas is a common, sexually transmitted
        parasite.
    --  Qiagen Arbitration.  In April, Gen-Probe announced that the Company and
        Roche had prevailed in the arbitration with Digene (now Qiagen)
        concerning the Company's supply and purchase agreement with Roche for
        HPV products.  In August, the arbitrators issued their final award,
        which granted Gen-Probe's motion to recover attorneys' fees and costs in
        the amount of $3.0 million from Digene.  Gen-Probe has filed a petition
        to confirm the arbitration award in the US District Court for the
        Southern District of New York, and Digene has filed a petition to vacate
        or modify the award.  A hearing on the petitions is set for December.
    --  Patent Litigation.  On October 21, Gen-Probe disclosed that it had filed
        a complaint for patent infringement against Becton, Dickinson and
        Company in the US District Court for the Southern District of
        California.  The complaint alleges that Becton Dickinson's Viper(TM)
        XTR(TM) testing system and associated consumables infringe eight of the
        Company's US patents.  The complaint seeks monetary damages and
        injunctive relief.

    --  R&D Re-Organization.  In October, the Company re-organized its R&D
        organization into several cross-functional project teams to increase
        alignment with corporate strategy, better integrate research activities
        into product development, accommodate new areas of therapeutic focus,
        and ultimately increase development efficiency and speed to market.

Webcast Conference Call

A live webcast of Gen-Probe's third quarter 2009 conference call for investors can be accessed at http://www.gen-probe.com beginning at 4:30 p.m. Eastern Time today. The webcast will be archived for at least 90 days. A telephone replay of the call also will be available for approximately 24 hours. The replay number is 866-360-7718 for domestic callers and 203-369-0170 for international callers.

About Gen-Probe

Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective NATs used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has more than 25 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,200 people. For more information, go to www.gen-probe.com.

About Non-GAAP Financial Measures

To supplement Gen-Probe's financial results for the third quarter of 2009 and its updated 2009 financial guidance, in each case presented in accordance with GAAP, Gen-Probe uses the following financial measures defined as non-GAAP by the SEC: non-GAAP net income, gross margin, G&A expenses, income tax rate, and EPS. Gen-Probe's management does not, nor does it suggest that investors should, consider such non-GAAP financial measures in isolation from, or as a substitute for, financial information prepared and presented in accordance with GAAP. Gen-Probe's management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company's performance by excluding certain expenses that may not be indicative of core business results. Gen-Probe believes that both management and investors benefit from referring to these non-GAAP financial measures in assessing Gen-Probe's performance and when planning, forecasting and analyzing future periods. These non-GAAP financial measures also facilitate management's internal comparisons to Gen-Probe's historical performance and our competitors' operating results. Gen-Probe believes these non-GAAP financial measures are useful to investors in allowing for greater transparency with respect to supplemental information used by management in its financial and operational decision making.

Trademarks

APTIMA, APTIMA COMBO 2 and TIGRIS are trademarks of Gen-Probe. PROCLEIX and ULTRIO are trademarks of Novartis. All other trademarks are the property of their owners.

Caution Regarding Forward-Looking Statements

Any statements in this news release about our expectations, beliefs, plans, objectives, assumptions or future events or performance, including those under the heading "Updated 2009 Financial Guidance," are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning Gen-Probe's financial condition, possible or expected results of operations, regulatory approvals, future milestones, growth opportunities, and plans of management are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied. Some of these risks, uncertainties and assumptions include but are not limited to: (i) the risk that we may not achieve our expected 2009 financial targets, (ii) the risk that we may not integrate acquisitions, such as Tepnel and Prodesse, successfully, (iii) the possibility that the market for the sale of our new products, such as our PROGENSA PCA3 and APTIMA HPV assays, may not develop as expected, (iv) the enhancement of existing products and the development of new products may not proceed as planned, (v) the risk that products, including the investigational PROGENSA PCA3 and APTIMA HPV and trichomonas assays in US clinical trials, may not be approved by regulatory authorities or become commercially available in the time frame we anticipate, or at all, (vi) the risk that we may not be able to compete effectively, (vii) the risk that we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, (viii) our dependence on Novartis, Siemens (as assignee of Bayer) and other third parties for the distribution of some of our products, (ix) our dependence on a small number of customers, contract manufacturers and single source suppliers of raw materials, (x) changes in third-party reimbursement policies regarding our products could adversely affect sales, (xi) changes in government regulation or tax policy affecting our diagnostic products could harm our sales, increase our development costs or increase our taxes, (xii) the risk that our intellectual property may be infringed by third parties or invalidated, and (xiii) our involvement in patent and other intellectual property and commercial litigation could be expensive and could divert management's attention. This list includes some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties we face and a discussion of our financial statements and footnotes, see documents we file with the SEC, including our most recent annual report on Form 10-K and all subsequent periodic reports. We assume no obligation and expressly disclaim any duty to update forward-looking statements to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.

----------------

(1) In this press release, all per share amounts are calculated on a fully diluted basis. Non-GAAP EPS for the third quarter of 2009 excludes $1.6 million of after-tax expenses ($0.03 per share) related to the Company's acquisitions of Tepnel and Prodesse, and the spin-off of industrial testing assets to Roka BioScience. Some totals may not foot due to rounding.

(2) In this press release, all estimates of "constant currency" growth exclude foreign currency fluctuations associated with acquired Tepnel revenues, since Tepnel was not part of Gen-Probe in the prior year period.


    Contact:

    Michael Watts
    Vice president, investor relations and corporate communications
    858-410-8673


                              Gen-Probe Incorporated
                        Consolidated Balance Sheets - GAAP
                 (In thousands, except share and per share data)

                                                   September 30,  December 31,
                                                       2009           2008
                                                       ----           ----
                                                   (unaudited)
    Assets
    Current assets:
       Cash and cash equivalents, including
        restricted cash of $18 and $0 at
        September 30, 2009 and December 31,
        2008, respectively                             $156,739      $60,122
       Marketable securities                            361,203      371,276
       Trade accounts receivable, net of
        allowance for doubtful accounts of $740
        and $700 at September 30, 2009 and
        December 31, 2008, respectively                  44,629       33,397
       Accounts receivable - other                        3,185        2,900
       Inventories                                       58,432       54,406
       Deferred income tax                                8,827        7,269
       Prepaid income tax                                 8,809        2,306
       Prepaid expenses                                  17,956       15,094
       Other current assets                               4,443        6,135
                                                          -----        -----
    Total current assets                                664,223      552,905

    Marketable securities, net of current portion         6,677       73,780
    Property, plant and equipment, net                  153,594      141,922
    Capitalized software, net                            12,496       13,409
    Goodwill                                             91,114       18,621
    Deferred income tax, net of current portion          12,193       12,286
    Purchased intangibles, net                           56,097          298
    Licenses, manufacturing access fees and
     other assets, net                                   63,255       56,310
                                                         ------       ------
    Total assets                                     $1,059,649     $869,531
                                                     ==========     ========

    Liabilities and stockholders' equity
    Current liabilities:
      Accounts payable                                  $18,035      $16,050
      Accrued salaries and employee benefits             27,815       25,093
      Other accrued expenses                             11,194        4,027
      Income tax payable                                    853            -
      Short-term borrowings                             240,841            -
      Deferred income tax                                 1,355            -
      Deferred revenue                                    2,238        1,278
                                                          -----        -----
    Total current liabilities                           302,331       46,448

    Non-current income tax payable                        5,401        4,773
    Deferred income tax, net of current portion          14,387           55
    Deferred revenue, net of current portion              2,249        2,333
    Other long-term liabilities                           3,357        2,162

    Commitments and contingencies

    Stockholders' equity:
       Preferred stock, $0.0001 par value per
        share, 20,000,000 shares authorized,
        none issued and outstanding                           -            -
       Common stock, $0.0001 par value per
        share; 200,000,000 shares authorized,
        48,925,449 and 52,920,971 shares issued
        and outstanding at September 30, 2009
        and December 31, 2008, respectively                   5            5
       Additional paid-in capital                       231,838      382,544
       Accumulated other comprehensive income             4,167        3,055
       Retained earnings                                495,914      428,156
                                                        -------      -------
    Total stockholders' equity                          731,924      813,760
                                                        -------      -------
    Total liabilities and stockholders' equity       $1,059,649     $869,531
                                                     ==========     ========


                             Gen-Probe Incorporated
                    Consolidated Statements of Income - GAAP
                      (In thousands, except per share data)
                                    (Unaudited)

                                 Three Months Ended       Nine Months Ended
                                    September 30,           September 30,
                                 ------------------      ------------------
                                 2009          2008      2009          2008
                                 ----          ----      ----          ----
    Revenues:
      Product sales            $118,951      $108,253  $348,289      $323,461
      Collaborative research
       revenue                    2,000        11,343     5,862        18,453
      Royalty and license
       revenue                    1,753         1,581     5,281        21,640
                                  -----         -----     -----        ------
    Total revenues              122,704       121,177   359,432       363,554

    Operating expenses:
      Cost of product sales
       (excluding
       acquisition-related
       intangibles
       amortization)             36,345        30,681   107,939        95,827
      Acquisition-related
       intangibles amortization   1,136             -     2,250             -
      Research and development   27,475        24,507    78,542        76,941
      Marketing and sales        13,477        10,709    38,547        34,070
      General and
       administrative            15,234        12,908    46,903        38,516
                                 ------        ------    ------        ------
    Total operating expenses     93,667        78,805   274,181       245,354
                                 ------        ------   -------       -------
    Income from operations       29,037        42,372    85,251       118,200

    Investment and interest
     income                       4,676         4,167    19,680        12,274
    Interest expense               (588)           (1)   (1,465)           (3)
    Other income/(expense)          210        (1,929)     (827)         (647)
                                    ---        ------      ----          ----
    Total other income, net       4,298         2,237    17,388        11,624
                                  -----         -----    ------        ------
    Income before income tax     33,335        44,609   102,639       129,824

    Income tax expense           11,139        15,531    34,881        44,010
                                 ------        ------    ------        ------
    Net income                  $22,196       $29,078   $67,758       $85,814
                                =======       =======   =======       =======

    Net income per share:
      Basic                       $0.45         $0.53     $1.33         $1.58
                                  =====         =====     =====         =====
      Diluted                     $0.44         $0.52     $1.31         $1.55
                                  =====         =====     =====         =====

    Weighted average shares
     outstanding:
      Basic                      49,614        54,363    51,133        54,174
                                 ======        ======    ======        ======
      Diluted                    50,136        55,552    51,767        55,357
                                 ======        ======    ======        ======

                              Gen-Probe Incorporated
                   Consolidated Statements of Income - Non-GAAP
                       (In thousands, except per share data)
                                    (Unaudited)

                                                     Three Months Ended
                                                     September 30, 2009
                                               ----------------------------
                                               Non-GAAP  Adjustments   GAAP
                                               --------  -----------   ----
    Revenues:
      Product sales                            $118,951         $-   $118,951
      Collaborative research revenue              2,000          -      2,000
      Royalty and license revenue                 1,753          -      1,753
                                                  -----        ---      -----
    Total revenues                              122,704          -    122,704

    Operating expenses:
      Cost of product sales (excluding
      acquisition-related intangibles
      amortization)                              36,252         93     36,345
      Acquisition-related intangibles
       amortization                                   -      1,136      1,136
      Research and development                   27,475          -     27,475
      Marketing and sales                        13,477          -     13,477
      General and administrative                 14,155      1,079     15,234
                                                 ------      -----     ------
    Total operating expenses                     91,359      2,308     93,667
                                                 ------      -----     ------
    Income from operations                       31,345     (2,308)    29,037

    Investment and interest income                4,676          -      4,676
    Interest expense                               (588)         -       (588)
    Other income/(expense)                          210          -        210
                                                    ---        ---        ---
    Total other income, net                       4,298          -      4,298
                                                  -----        ---      -----
    Income before income tax                     35,643     (2,308)    33,335

    Income tax expense                           11,864       (725)    11,139
                                                 ------       ----     ------
    Net income                                  $23,779    $(1,583)   $22,196
                                                =======    =======    =======

    Net income per share:
      Basic                                       $0.48     $(0.03)     $0.45
                                                  =====     ======      =====
      Diluted                                     $0.47     $(0.03)     $0.44
                                                  =====     ======      =====

    Weighted average shares outstanding:
      Basic                                      49,614          -     49,614
                                                 ======        ===     ======
      Diluted                                    50,136          -     50,136
                                                 ======        ===     ======


                              Gen-Probe Incorporated
                   Consolidated Statements of Income - Non-GAAP
                       (In thousands, except per share data)
                                   (Unaudited)

                                                     Nine Months Ended
                                                    September 30, 2009
                                               ----------------------------
                                               Non-GAAP  Adjustments   GAAP
                                               --------  -----------   ----
    Revenues:
      Product sales                            $348,289          $-  $348,289
      Collaborative research revenue              5,862           -     5,862
      Royalty and license revenue                 5,281           -     5,281
                                                  -----         ---     -----
    Total revenues                              359,432           -   359,432

    Operating expenses:
      Cost of product sales (excluding
      acquisition-related intangibles
      amortization)                             107,756         183   107,939
      Acquisition-related intangibles
       amortization                                   -       2,250     2,250
      Research and development                   78,542           -    78,542
      Marketing and sales                        38,547           -    38,547
      General and administrative                 41,018       5,885    46,903
                                                 ------       -----    ------
    Total operating expenses                    265,863       8,318   274,181
                                                -------       -----   -------
    Income from operations                       93,569      (8,318)   85,251

    Investment and interest income               19,680           -    19,680
    Interest expense                             (1,465)          -    (1,465)
    Other income/(expense)                         (827)          -      (827)
                                                   ----         ---      ----
    Total other income, net                      17,388           -    17,388
                                                 ------         ---    ------
    Income before income tax                    110,957      (8,318)  102,639

    Income tax expense                           36,934      (2,053)   34,881
                                                 ------      ------    ------
    Net income                                  $74,023     $(6,265)  $67,758
                                                =======     =======   =======

    Net income per share:
      Basic                                       $1.45      $(0.12)    $1.33
                                                  =====      ======     =====
      Diluted                                     $1.43      $(0.12)    $1.31
                                                  =====      ======     =====

    Weighted average shares outstanding:
      Basic                                      51,133           -    51,133
                                                 ======         ===    ======
      Diluted                                    51,767           -    51,767
                                                 ======         ===    ======

                              Gen-Probe Incorporated
                   Consolidated Statements of Cash Flows - GAAP
                                  (In thousands)
                                   (Unaudited)

                                                          Nine Months Ended
                                                             September 30,
                                                          ------------------
                                                          2009          2008
                                                          ----          ----
    Operating activities:
    Net income                                          $67,758       $85,814
      Adjustments to reconcile net income to net cash
       provided by operating activities:
      Depreciation and amortization                      29,468        26,217
      Amortization of premiums on investments, net of
       accretion of discounts                             4,050         5,118
      Stock-based compensation                           17,743        15,012
      Stock-based compensation income tax benefits        1,937         3,025
      Excess tax benefit from stock-based compensation   (1,186)       (2,510)
      Deferred revenue                                     (249)       (3,399)
      Deferred income tax                                (1,318)         (961)
      Gain on sale of investment in MPI                       -        (1,600)
      Impairment of intangible assets                         -         5,086
      Loss on disposal of property and equipment             82            38
      Changes in assets and liabilities:
        Trade and other accounts receivable              (4,379)       11,403
        Inventories                                       2,325        (4,270)
        Prepaid expenses                                 (1,675)        7,060
        Other current assets                              2,156        (2,255)
        Goodwill                                            856             -
        Other long-term assets                           (3,608)         (510)
        Accounts payable                                 (2,985)        7,381
        Accrued salaries and employee benefits                1         4,922
        Other accrued expenses                            1,672            96
        Income tax payable                               (6,655)        2,926
        Other long-term liabilities                         733           426
                                                            ---           ---
    Net cash provided by operating activities           106,726       159,019
                                                        -------       -------

    Investing activities:
    Proceeds from sales and maturities of marketable
     securities                                         410,700        94,103
    Purchases of marketable securities                 (338,976)     (225,290)
    Purchases of property, plant and equipment          (22,284)      (30,530)
    Capitalization of software development costs           (576)            -
    Purchases of intangible assets, including licenses
     and manufacturing access fees                         (918)       (1,868)
    Net cash paid for business combinations            (123,713)            -
    Cash paid for investment in DiagnoCure and related
     license fees                                        (5,500)            -
    Proceeds from sale of investment in MPI                   -         4,100
    Cash paid for Roche manufacturing access fees             -       (10,000)
    Other assets                                           (175)           10
                                                           ----           ---
    Net cash used in investing activities               (81,442)     (169,475)
                                                        -------      --------

    Financing activities:
    Excess tax benefit from stock-based compensation      1,186         2,510
    Repurchase and retirement of restricted stock for
     payment of taxes                                      (923)       (1,309)
    Repurchase and retirement of common stock          (174,847)       (9,992)
    Proceeds from issuance of common stock                5,961        17,848
    Short-term borrowings, net                          238,450             -
                                                        -------           ---
    Net cash provided by financing activities            69,827         9,057
                                                         ------         -----
    Effect of exchange rate changes on cash and cash
     equivalents                                          1,506          (198)
                                                          -----          ----
    Net increase (decrease) in cash and cash
     equivalents                                         96,617        (1,597)
    Cash and cash equivalents at the beginning of
     period                                              60,122        75,963
                                                         ------        ------
    Cash and cash equivalents at the end of period     $156,739       $74,366
                                                       ========       =======

SOURCE Gen-Probe Incorporated

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