Gen-Probe Reports Strong Financial Results for Third Quarter 2006
  • Company Reports GAAP EPS of $0.28
  • Product Sales Establish New Quarterly Record of $83.5 Million, Up 21% From Prior Year
  • Total Revenues Also Increase 21%, to a New Quarterly Record of $92.2 Million

SAN DIEGO, Nov. 1 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) today reported strong financial results for the third quarter and nine months ended September 30, 2006, including new quarterly records for product sales and total revenues.

On a GAAP basis, net income for the third quarter of 2006 was $15.1 million ($0.28 per share), compared to net income of $16.4 million ($0.31 per share) in the prior year period. GAAP earnings in the third quarter of 2006 include expenses related to share-based compensation under SFAS No. 123(R), which reduced after-tax earnings by $4.0 million ($0.08 per share). Adjusting only for these expenses, net income for the third quarter of 2006 was $19.2 million ($0.36 per share) on a non-GAAP basis, an increase of 16% per share compared to the prior year period.

Throughout this press release, all per share amounts are calculated on a fully diluted basis, and no adjustments have been made to GAAP results except those related to implementing SFAS No. 123(R). Gen-Probe believes these non-GAAP financial measures help investors compare current results to those in prior periods. See the section below entitled "About Non-GAAP Financial Measures."

Product sales for the third quarter of 2006 were a record $83.5 million, compared to $68.9 million in the prior year period, an increase of 21%. Total revenues for the third quarter of 2006 were a record $92.2 million, compared to $76.3 million in the prior year period, an increase of 21%.

On a GAAP basis, net income for the first nine months of 2006 was $43.3 million ($0.82 per share), compared to net income of $43.3 million ($0.83 per share), in the prior year period. GAAP earnings in the first nine months of 2006 include expenses related to share-based compensation under SFAS No. 123(R), which reduced after-tax earnings by $10.4 million ($0.19 per share). On a non-GAAP basis, net income for the first nine months of 2006 was $53.7 million ($1.01 per share), an increase of 22% per share compared to the prior year period.

Product sales in the first nine months of 2006 were $239.8 million, compared to $193.7 million in the prior year period, an increase of 24%. Total revenues in the first nine months of 2006 were $263.7 million, compared to $218.0 million in the prior year period, an increase of 21%.

"Gen-Probe once again posted strong financial results in the third quarter of 2006, as both clinical diagnostics and blood screening sales grew by more than 20% compared to the prior year," said Henry L. Nordhoff, the Company's chairman, president and chief executive officer. "In addition, we secured several new product approvals that we believe will solidify our market leadership positions and generate future growth."

Detailed Results

Gen-Probe's clinical diagnostics sales in the third quarter of 2006 were led by the APTIMA Combo 2(R) assay, an amplified nucleic acid test (NAT) for simultaneously detecting Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). Sales of this assay continued to grow strongly, driven by market share gains on both the semi-automated instrument platform and on the high-throughput, fully automated TIGRIS(R) system. Revenue from the PACE(R) product line, the Company's non-amplified tests for the same microorganisms, declined in the third quarter compared to the prior year period, in line with Gen-Probe's expectations.

In blood screening, product sales benefited primarily from continued international expansion, and from higher pricing associated with commercial sales of the PROCLEIX(R) WNV (West Nile virus) assay in the United States. Gen-Probe's blood screening products are marketed worldwide by Chiron, a business unit of Novartis Vaccines and Diagnostics. Sales of TIGRIS(R) instruments and spare parts to Chiron totaled $2.0 million in the third quarter, compared to $3.5 million in the prior year period, a decrease that was in line with Gen-Probe's expectations.

    Product sales were, in millions:



                     Three Months Ended Sept. 30,  Nine Months Ended Sept. 30,
                       2006     2005   Increase    2006     2005   Increase
    Clinical
     diagnostics      $43.3    $36.0      20%     $125.8   $104.3      21%
    Blood screening   $40.2    $32.9      22%     $114.0    $89.4      28%
    Total product
     sales            $83.5    $68.9      21%     $239.8   $193.7      24%


Collaborative research revenues for the third quarter of 2006 were $1.5 million, compared to $6.3 million in the prior year period. For the first nine months of 2006, collaborative research revenues were $14.7 million, compared to $19.4 million in the prior year period. In both the third quarter and first nine months of 2006, collaborative research revenues decreased primarily due to the elimination of "cost recovery" revenue that Gen-Probe had been receiving for investigational use of the PROCLEIX WNV assay. In the third quarter of 2006, the Company began recording in product sales all revenues associated with the PROCLEIX WNV assay, which was approved for use on Gen-Probe's enhanced semi-automated instrument system (eSAS) in December of 2005.

Royalty and license revenues for the third quarter of 2006 were $7.3 million, compared to $1.0 million in the prior year period. For the first nine months of 2006, royalty and license revenues were $9.2 million, compared to $5.0 million in the prior year period. In both the third quarter and first nine months of 2006, royalty and license revenues increased primarily due to $5.0 million of revenue associated with the settlement of Gen-Probe's patent infringement lawsuits against Bayer. In addition, Gen-Probe earned $1.0 million of license revenue in the third quarter of 2006 under the Company's 2004 agreement with Tosoh. This payment was contingent upon a favorable outcome for Gen-Probe in its legal disputes with Bayer.

On a GAAP basis, gross margin on product sales was 71.5% in the third quarter of 2006, compared to 69.0% in the prior year period. The increase in gross margin percentage resulted primarily from higher pricing associated with commercial sales of the PROCLEIX WNV assay in the United States, and from lower sales of TIGRIS instruments and spare parts for blood screening to Chiron. Under Gen-Probe's contract with Chiron, these sales are made approximately at cost. These improvements in gross margin percentage were partially offset by SFAS No. 123(R), which added $0.7 million to cost of goods sold. The amount of share-based compensation expense included in cost of goods sold is expected to increase in the fourth quarter of 2006 as the related inventory is sold. On a non-GAAP basis, gross margin on product sales was 72.4% in the third quarter of 2006.

On a GAAP basis, gross margin on product sales was 68.8% for the first nine months of 2006, compared to 70.4% in the prior year period. This decrease resulted primarily from SFAS No. 123(R), which added $1.4 million to cost of goods sold, from additional scrap expense incurred in the second quarter of 2006, and from low-margin sales of TIGRIS instruments and spare parts for blood screening to Chiron. On a non-GAAP basis, gross margin on product sales was 69.4% in the first nine months of 2006.

On a GAAP basis, research and development (R&D) expenses were $24.2 million in the third quarter of 2006, compared to $17.5 million in the prior year period, an increase of 38%. This increase resulted primarily from SFAS No. 123(R), which added $2.0 million to R&D expenses, and from the timing of the Company's development program for human papillomavirus (HPV). On a non-GAAP basis, R&D expenses were $22.2 million in the third quarter of 2006, an increase of 27% compared to the prior year period.

On a GAAP basis, R&D expenses for the first nine months of 2006 were $63.8 million, compared to $53.6 million in the prior year period, an increase of 19%. This increase resulted primarily from the factors described above, including SFAS No. 123(R), which added $5.7 million to R&D expenses. On a non-GAAP basis, R&D expenses were $58.1 million in the first nine months of 2006, an increase of 8% compared to the prior year period.

On a GAAP basis, marketing and sales expenses were $9.5 million in the third quarter of 2006, compared to $7.6 million in the prior year period, an increase of 25%. This increase resulted primarily from SFAS No. 123(R), which added $0.9 million to marketing and sales expenses, from higher commissions associated with increased sales of clinical diagnostics products, and from increased headcount. On a non-GAAP basis, marketing and sales expenses were $8.7 million in the third quarter of 2006, an increase of 14% compared to the prior year period.

On a GAAP basis, marketing and sales expenses were $27.5 million for the first nine months of 2006, compared to $22.4 million in the prior year period, an increase of 23%. This increase resulted primarily from SFAS No. 123(R), which added $2.3 million to marketing and sales expenses, and from the other factors described above. On a non-GAAP basis, marketing and sales expenses were $25.2 million in the first nine months of 2006, an increase of 13% compared to the prior year period.

On a GAAP basis, general and administrative (G&A) expenses were $12.7 million in the third quarter of 2006, compared to $7.8 million in the prior year period, an increase of 63%. This increase resulted primarily from $2.0 million of incremental legal expenses that Gen-Probe paid its outside litigation counsel in connection with the Company's settlement of its disputes with Bayer, and from SFAS No. 123(R), which added $2.7 million to G&A expenses. On a non-GAAP basis, G&A expenses were $10.0 million in the third quarter of 2006, an increase of 28% compared to the prior year period.

On a GAAP basis, G&A expenses for the first nine months of 2006 were $34.1 million, compared to $22.8 million in the prior year period, an increase of 50%. This increase resulted primarily from SFAS No. 123(R), which added $6.8 million to G&A expenses, and from the additional legal expenses described above. On a non-GAAP basis, G&A expenses were $27.3 million in the first nine months of 2006, an increase of 20% compared to the prior year period.

Gen-Probe continues to have a strong balance sheet. As of September 30, 2006, the Company had $271.5 million of cash, cash equivalents and short-term investments, and no debt. In the first nine months of 2006, Gen-Probe generated net cash of $72.0 million from its operating activities, including $33.8 million in the third quarter of 2006.

Updated 2006 Financial Guidance

"Based on our strong performance in the third quarter, we are increasing our full-year 2006 revenue guidance and raising the low end of our EPS guidance," said Herm Rosenman, the Company's vice president of finance and chief financial officer.

Gen-Probe's non-GAAP 2006 guidance for gross margins, R&D expenses, marketing and sales expenses, G&A expenses, effective income tax rate and EPS is computed without the effect of SFAS No. 123(R) and is reconciled to the corresponding GAAP measure in the bullets and table below and discussed in the section titled "About Non-GAAP Financial Measures."

The following table describes Gen-Probe's updated guidance for the full year 2006, on both a GAAP and a non-GAAP basis. The percentages shown are of total revenues.



                           GAAP       Estimated Effects of       Non-GAAP
                         Guidance     SFAS No. 123(R) (a)        Guidance

    Total Revenues  $349 - $352 million       None         $349 - $352 million

    Product Gross
     Margin             Approx. 69%       Less than 1%         69% to 70%

    R&D Expenses        24% to 25%         Approx. 2%          22% to 23%

    Marketing and
     Sales Expenses     10% to 11%         Approx. 1%           9% to 10%

    G&A Expenses        12% to 13%         Approx. 2%          10% to 11%

    Effective Income
     Tax Rate           Approx. 37%       Less than 1%         Approx. 37%

    Diluted EPS       $1.09 to $1.12     $0.27 to $0.28      $1.37 to $1.39

    (a) These estimated effects reconcile the Company's 2006 GAAP financial
        guidance ranges to the Company's non-GAAP financial guidance ranges.
        The reconciling item represents the estimated impact of SFAS
        No. 123(R), which includes non-cash stock compensation awards,
        including stock options and employee stock purchase plan shares.


About Non-GAAP Financial Measures

To supplement Gen-Probe's financial results for the third quarter and first nine months of 2006 and its 2006 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, non-GAAP product gross margin, non-GAAP R&D expenses, non-GAAP marketing and sales expenses, non-GAAP G&A expenses, non-GAAP effective income tax rate, and non-GAAP diluted EPS. Gen-Probe's management does not itself, 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.

Recent Events

* FDA License for PROCLEIX ULTRIO Assay. On October 4, Gen-Probe announced that the U.S. Food and Drug Administration (FDA) had granted marketing approval for the PROCLEIX ULTRIO assay to run on the eSAS. The assay was approved to screen donated blood, plasma, organs and tissue for HIV-1 and hepatitis C virus (HCV) in individual blood donations or in pools of up to 16 blood samples, and to detect the presence of hepatitis B virus (HBV). However, the initial pivotal study for the assay was not designed to, and did not, demonstrate yield, defined as HBV-infected blood donations that are negative based on serology tests. Based on discussions with the FDA, Gen-Probe and Chiron plan to initiate a post-marketing study in early 2007 to demonstrate HBV yield and gain a donor-screening claim for HBV.

* Response to TIGRIS/WNV Questions. On September 20, Gen-Probe announced that it had submitted responses to the FDA's questions on the Company's regulatory application to run the previously approved PROCLEIX WNV assay on the investigational TIGRIS system.

* APTIMA(R) Qualitative Viral Assays. On October 5, Gen-Probe announced that the FDA had granted marketing approval for the APTIMA HIV-1 RNA qualitative assay. The assay may be used as an aid in the diagnosis of acute and primary HIV-1 infection, and to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive (positive) for HIV-1 antibodies. The assay is the first FDA-approved qualitative nucleic acid test for these intended uses. Gen-Probe expects to launch the assay this month in conjunction with the APTIMA HCV RNA qualitative assay.

* Additional TIGRIS Menu. On October 18, Gen-Probe announced that the FDA had granted marketing clearance to run the Company's standalone APTIMA assays for CT and GC on the TIGRIS system. And on August 22, the Company announced that the FDA had granted marketing clearance to use the APTIMA Combo 2 assay to test two additional kinds of patient samples on the TIGRIS system. These samples are liquid Pap specimens collected in the PreservCyt(R) solution and processed with Cytyc's ThinPrep(R) 2000 system, and clinician- and patient-collected vaginal swab specimens.

* New TIGRIS Patent. On October 16, Gen-Probe announced that it had been issued U.S. Patent No. 7,118,892, which extends the Company's intellectual property estate relating to integrated instrument systems for nucleic acid testing.

* Stronger Corporate Governance Practices. On October 2, Gen-Probe announced that as part of its ongoing efforts to strengthen its corporate governance practices, the Company's board of directors had approved the termination of its shareholder rights plan, or "poison pill," and instituted a stock ownership policy for officers and directors.

Webcast Conference Call<

A live webcast of Gen-Probe's third quarter 2006 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) 365-4158 for domestic callers and (203) 369-0225 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 nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has more than 20 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 900 people. For more information, go to www.gen-probe.com.

Trademarks

TIGRIS, APTIMA, APTIMA COMBO 2 and PACE are trademarks of Gen-Probe Incorporated. ULTRIO and PROCLEIX are trademarks of Chiron, a business unit of Novartis Vaccines and Diagnostics. All other trademarks are the property of their owners.

Caution Regarding Forward-Looking Statements

Any statements in this press release about our expectations, beliefs, plans, objectives, assumptions or future events or performance, including those under the heading "Updated 2006 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 milestone payments, growth opportunities, and plans and objectives 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 2006 growth, revenue, earnings or other financial targets, (ii) the risk that we may not earn or receive milestone payments from our collaborators, including Novartis, (iii) the possibility that the market for the sale of our new products, such as our TIGRIS system, APTIMA Combo 2 assay and PROCLEIX ULTRIO assay, may not develop as expected, (iv) the enhancement of existing products and the development of new products, including products, if any, to be developed under our recent industrial collaborations, may not proceed as planned, (v) the risk that products including our PROCLEIX ULTRIO assay, TIGRIS instrument for blood screening, or PROCLEIX WNV assay on the TIGRIS instrument may not be approved by regulatory authorities or commercially available in the time frame we anticipate, or at all, (vi) we may not be able to compete effectively, (vii) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, (viii) we are dependent on Novartis, Bayer and other third parties for the distribution of some of our products, (ix) we are dependent 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 of our products, (xi) changes in government regulation affecting our diagnostic products could harm our sales and increase our development costs, (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. The foregoing list sets forth 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.




                            Gen-Probe Incorporated
                      Consolidated Balance Sheets - GAAP

               (In thousands, except share and per share data)

                                                  September 30,   December 31,
                                                      2006           2005
                                                   (Unaudited)
    Assets
    Current assets:
      Cash and cash equivalents                      $62,066        $32,328
      Short-term investments                         209,454        187,960
      Trade accounts receivable, net of allowance
       for doubtful accounts of $670 and $790 at
       September 30, 2006 and December 31, 2005,
       respectively                                   24,303         31,930
      Accounts receivable - other                      2,171          1,924
      Inventories                                     44,524         36,342
      Deferred income taxes                           10,030         10,389
      Prepaid expenses                                11,450         10,768
      Other current assets                             4,977          4,184
    Total current assets                             368,975        315,825

    Property, plant and equipment, net               130,289        105,190
    Capitalized software                              19,066         20,952
    Goodwill                                          18,621         18,621
    License, manufacturing access fees and
     other assets                                     56,074         49,648
    Total assets                                    $593,025       $510,236

    Liabilities and stockholders' equity
    Current liabilities:
      Accounts payable                               $10,948        $14,029
      Accrued salaries and employee benefits          18,324         14,910
      Other accrued expenses                           3,955          3,264
      Income tax payable                               7,582         13,192
      Deferred revenue                                 4,296          7,771
    Total current liabilities                         45,105         53,166

    Deferred income taxes                              5,425          5,124
    Deferred revenue                                   3,833          4,333
    Deferred rent                                        153            240

    Commitments and contingencies

    Stockholders' equity:
    Preferred stock, $.0001 par value per share;
     20,000,000 shares authorized, none issued
     and outstanding                                      --             --
    Common stock, $.0001 par value per share;
     200,000,000 shares authorized, 52,051,761
     and 51,137,541 shares issued and outstanding
     at September 30, 2006 and December 31, 2005,
     respectively                                          5              5
    Additional paid-in capital                       322,302        281,907
    Deferred compensation                                 --         (5,951)
    Accumulated other comprehensive income (loss)        281         (1,231)
    Retained earnings                                215,921        172,643
    Total stockholders' equity                       538,509        447,373
    Total liabilities and stockholders' equity      $593,025       $510,236



                              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,
                                        2006      2005      2006      2005

    Revenues:
      Product sales                   $83,470   $68,941   $239,811   $193,651
      Collaborative research revenue    1,470     6,336     14,743     19,358
      Royalty and license revenue       7,287       994      9,151      4,984
    Total revenues                     92,227    76,271    263,705    217,993

    Operating expenses:
      Cost of product sales            23,801    21,399     74,715     57,247
      Research and development         24,178    17,506     63,833     53,597
      Marketing and sales               9,526     7,555     27,533     22,365
      General and administrative       12,748     7,822     34,104     22,793
    Total operating expenses           70,253    54,282    200,185    156,002

    Income from operations             21,974    21,989     63,520     61,991
    Total other income, net             1,921     1,318      5,081      3,400
    Income before income taxes         23,895    23,307     68,601     65,391

    Income tax expense                  8,779     6,890     25,323     22,057
    Net income                        $15,116   $16,417    $43,278    $43,334

    Net income per share:
      Basic                             $0.29     $0.32      $0.84      $0.86
      Diluted                           $0.28     $0.31      $0.82      $0.83

    Weighted average shares
     outstanding:
      Basic                            51,638    50,726     51,407     50,518
      Diluted                          53,180    52,464     53,001     52,381



                            Gen-Probe Incorporated
                   Consolidated Statements of Income - GAAP

                    (In thousands, except per share data)
                                 (Unaudited)

                                                    Three Months Ended
                                                    September 30, 2006
                                           Non-GAAP     Adjustments     GAAP
    Revenues:
      Product sales                         $83,470         $--       $83,470
      Collaborative research revenue          1,470          --         1,470
      Royalty and license revenue             7,287          --         7,287
    Total revenues                           92,227          --        92,227

    Operating expenses:
      Cost of product sales                  23,058         743 a      23,801
      Research and development               22,154       2,024 a      24,178
      Marketing and sales                     8,663         863 a       9,526
      General and administrative              9,999       2,749 a      12,748
    Total operating expenses                 63,874       6,379        70,253

    Income from operations                   28,353      (6,379)       21,974
    Total other income, net                   1,921          --         1,921
    Income before income taxes               30,274      (6,379)       23,895

    Income tax expense                       11,110      (2,331)a       8,779
    Net income                              $19,164     $(4,048)      $15,116

    Net income per share:

    Diluted earnings per share:
      Basic                                   $0.37      $(0.08)        $0.29
      Diluted                                 $0.36      $(0.08)        $0.28

    Weighted average shares outstanding:
      Basic                                  51,638          --        51,638
      Diluted                                53,309        (129)b      53,180


                                                    Three Months Ended
                                                    September 30, 2005
                                           Non-GAAP     Adjustments     GAAP
    Revenues:
      Product sales                         $68,941         $--      $68,941
      Collaborative research revenue          6,336          --        6,336
      Royalty and license revenue               994          --          994
    Total revenues                           76,271          --       76,271

    Operating expenses:
      Cost of product sales                  21,399          --       21,399
      Research and development               17,506          --       17,506
      Marketing and sales                     7,555          --        7,555
      General and administrative              7,822          --        7,822
    Total operating expenses                 54,282          --       54,282

    Income from operations                   21,989          --       21,989
    Total other income, net                    1,318         --        1,318
    Income before income taxes                23,307         --       23,307

    Income tax expense                         6,890         --        6,890
    Net income                               $16,417        $--      $16,417

    Net income per share:

    Diluted earnings per share:
      Basic                                    $0.32        $--        $0.32
      Diluted                                  $0.31        $--        $0.31

    Weighted average shares outstanding:
      Basic                                   50,726         --       50,726
      Diluted                                 52,464         --       52,464


    (a) Adjustments to exclude the impact of stock option and ESPP expense in
        accordance with SFAS No.123(R).  Net income for the three months ended
        September 30, 2006 included stock-based compensation expense that
        Gen-Probe recorded as a result of the adoption of SFAS No. 123(R) on
        January 1, 2006.  For the three months ended September 30, 2006, this
        expense totaled $6,379,000 before income taxes (after deducting
        $287,000 of net capitalization to inventory on the Company's balance
        sheet) and $4,048,000 net of income taxes for the period.  The Company
        did not record this stock-based compensation expense for the three
        months ended September 30, 2005. As previously disclosed in the notes
        to the financial statements for the three months ended September 30,
        2005, net income including pro forma stock-based compensation expense
        for this period was $12,578,000.

    (b) The shares adjustment for dilutive securities includes stock awards
        outstanding calculated under the treasury stock method that are not
        included in the GAAP diluted calculation as their effect would be
        anti-dilutive.



                            Gen-Probe Incorporated
                      Consolidated Statements of Income

                    (In thousands, except per share data)
                                 (Unaudited)

                                                    Nine Months Ended
                                                    September 30, 2006
                                           Non-GAAP     Adjustments     GAAP
    Revenues:
      Product sales                       $239,811        $--      $239,811
      Collaborative research revenue        14,743         --        14,743
      Royalty and license revenue            9,151         --         9,151
    Total revenues                         263,705         --       263,705

    Operating expenses:
      Cost of product sales                 73,349      1,366 a      74,715
      Research and development              58,135      5,698 a      63,833
      Marketing and sales                   25,198      2,335 a      27,533
      General and administrative            27,349      6,755 a      34,104
    Total operating expenses               184,031     16,154       200,185

    Income from operations                  79,674    (16,154)       63,520
    Total other income, net                  5,081         --         5,081

    Income before income taxes              84,755    (16,154)       68,601

    Income tax expense                      31,105     (5,782)a      25,323
    Net income                             $53,650   $(10,372)      $43,278

    Net income per share:

    Diluted earnings per share:
      Basic                                  $1.04     $(0.20)        $0.84
      Diluted                                $1.01     $(0.19)        $0.82

    Weighted average shares outstanding:
      Basic                                 51,407         --        51,407
      Diluted                               53,180       (179)b      53,001


                                                    Nine Months Ended
                                                    September 30, 2005
                                           Non-GAAP     Adjustments     GAAP
    Revenues:
      Product sales                       $193,651        $--      $193,651
      Collaborative research revenue        19,358         --        19,358
      Royalty and license revenue            4,984         --         4,984
    Total revenues                         217,993         --       217,993

    Operating expenses:
      Cost of product sales                 57,247         --        57,247
      Research and development              53,597         --        53,597
      Marketing and sales                   22,365         --        22,365
      General and administrative            22,793         --        22,793
    Total operating expenses               156,002         --       156,002

    Income from operations                  61,991         --        61,991
    Total other income, net                  3,400         --         3,400
    Income before income taxes              65,391         --        65,391

    Income tax expense                      22,057         --        22,057
    Net income                             $43,334        $--       $43,334

    Net income per share:

    Diluted earnings per share:
      Basic                                  $0.86        $--         $0.86
      Diluted                                $0.83        $--         $0.83

    Weighted average shares outstanding:
      Basic                                 50,518         --        50,518
      Diluted                               52,381         --        52,381


    (a) Adjustments to exclude the impact of stock option and ESPP expense in
        accordance with SFAS No.123(R).  Net income for the nine months ended
        September 30, 2006 included stock-based compensation expense that Gen-
        Probe recorded as a result of the adoption of SFAS No. 123(R) on
        January 1, 2006. For the nine months ended September 30, 2006, this
        expense totaled $16,154,000 before income taxes (after deducting
        $1,159,000 that has been capitalized to inventory on the Company's
        balance sheet) and $10,372,000 net of income taxes for the period. The
        Company did not record this stock-based compensation expense for the
        nine months ended September 30, 2005.  As previously disclosed in the
        notes to the financial statements for the six months ended
        September 30, 2005, net income including pro forma stock-based
        compensation expense for this period was $31,863,000.

    (b) The shares adjustment for dilutive securities includes stock awards
        outstanding calculated under the treasury stock method that are not
        included in the GAAP diluted calculation as their effect would be
        anti-dilutive.



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

                                                        Nine Months Ended
                                                           September 30,
                                                        2006           2005
    Operating activities
    Net income                                        $43,278        $43,334
    Adjustments to reconcile net income to net
     cash provided by operating activities:
      Depreciation and amortization                    19,752         16,694
      Stock-based compensation charges - restricted
       stock                                            1,601            445
      Stock-based compensation charges - all other     16,154             --
      Stock option income tax benefits                    111          6,948
      Excess tax benefit from employee stock options   (8,232)            --
      Loss on disposal of property and equipment            4            262
      Changes in assets and liabilities:
        Accounts receivable                             7,550         (5,562)
        Inventories                                    (6,830)        (6,809)
        Prepaid expenses                                 (682)        (3,760)
        Other assets                                     (798)        (2,033)
        Accounts payable                               (3,103)         5,525
        Accrued salaries and employee benefits          3,414          4,767
        Other accrued expenses                            624         (1,169)
        Income tax payable                              2,615          6,467
        Deferred revenue                               (3,975)         5,253
        Deferred income taxes                             645         (2,134)
        Deferred rent                                     (87)           (47)
    Net cash provided by operating activities          72,041         68,181

    Investing activities
    Proceeds from sales and maturities of
     short-term investments                            83,641         98,693
    Purchases of short-term investments              (104,163)      (105,672)
    Cash paid for acquisition of minority
     interest in Molecular Light Technology Limited        --         (1,539)
    Purchases of property, plant and equipment        (40,126)       (29,894)
    Capitalization of intangible assets, including
     license and manufacturing access fees             (2,245)       (22,450)
    Cash paid for investment in Qualigen               (6,993)            --
    Other assets                                         (223)          (821)
    Net cash used in investing activities             (70,109)       (61,683)

    Financing activities
    Excess tax benefit from employee stock options      8,232             --
    Proceeds from issuance of common stock             19,089         13,963
    Net cash provided by financing activities          27,321         13,963
    Effect of exchange rate changes on cash and
     cash equivalents                                     485           (369)
    Net increase in cash and cash equivalents          29,738         20,092
    Cash and cash equivalents at the beginning of
     period                                            32,328         25,498
    Cash and cash equivalents at the end of period    $62,066        $45,590

CONTACT:
Michael Watts
Sr. Director, Investor Relations and Corporate Communications
Gen-Probe Incorporated
+1-858-410-8673


Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121

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