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Gen-Probe Reports Financial Results for First Quarter 2009
Date:4/30/2009

-- Company Posts Non-GAAP EPS of $0.51(1), Excluding $0.02 of Expenses Related to Tepnel Acquisition --

-- Product Sales Increase 11%, or 15% on a Constant Currency(2) Basis --

-- Company Generates Total Revenues of $116.2 Million, Operating Cash

Flows of $52.0 Million --

SAN DIEGO, April 30 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) today reported financial results for the first quarter of 2009, including non-GAAP earnings per share (EPS) of $0.51.

"Gen-Probe posted good financial results in the first quarter of 2009, highlighted by a new record in clinical diagnostics product sales, despite significant foreign exchange headwinds," said Henry L. Nordhoff, the Company's chairman and chief executive officer. "In recent weeks, we also completed our Tepnel acquisition and decided to begin a U.S. clinical trial of our PCA3 prostate cancer test, both of which we expect to drive future growth."

As expected, total revenues and net income declined in the first quarter of 2009 compared to the prior year period because the Company recorded $16.4 million of revenue from Bayer in the first quarter of 2008. This non-recurring revenue, which added $0.20 to EPS in the prior year period, represented the third and final payment due to Gen-Probe in connection with the 2006 settlement of the companies' patent infringement litigation.

In the first quarter of 2009, product sales were $112.5 million, compared to $101.5 million in the prior year period, an increase of 11%. Compared to the first quarter of 2008, the stronger U.S. dollar reduced product sales growth by an estimated 4%. Total revenues for the first quarter of 2009 were $116.2 million, compared to $122.6 million in the prior year period, a decrease of 5%. Net income was $27.0 million ($0.51 per share) on a non-GAAP basis in the first quarter of 2009, compared to $31.9 million ($0.58 per share) on a GAAP basis in the prior year period, a decrease of 15% (12% per share). Gen-Probe's non-GAAP results for the first quarter of 2009 exclude $1.6 million ($0.02 per share) of expenses related to the Company's acquisition of Tepnel. Including these expenses, and on a GAAP basis, net income in the first quarter of 2009 was $25.7 million ($0.48 per share).

Detailed Results

Gen-Probe's clinical diagnostics sales in the first quarter of 2009 benefited from continued growth of 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 increased based on market share gains on both the Company's 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 first quarter compared to the prior year period, in line with Gen-Probe's expectations. Clinical diagnostics sales also were negatively affected by the stronger U.S. dollar, which reduced growth by an estimated 2% compared to the prior year period.

In blood screening, product sales in the first quarter of 2009 benefited from $8.2 million of one-time revenue associated with the previously announced renegotiation of the Company's collaboration agreement with Novartis Vaccines and Diagnostics. Novartis markets the collaboration's blood screening products worldwide. This benefit was largely offset, however, by the stronger U.S. dollar, which reduced growth by an estimated $2.9 million, or 6%; by $3.9 million of reduced instrument sales to Novartis due to the timing of orders; and by $1.3 million of lower West Nile virus assay shipments due to ordering patterns.

Product sales were, in millions:

                           Three Months Ended March 31,        Change

                               2009          2008        Reported    Constant
                                                                     Currency
    Clinical
     diagnostics              $59.6         $52.5          14%           16%
    Blood screening           $52.9         $49.0           8%           14%
    Total product sales      $112.5        $101.5          11%           15%


Collaborative research revenues for the first quarter of 2009 were $1.7 million, compared to $2.5 million in the prior year period, a decrease of 32% that resulted primarily from two factors: lower reimbursement from Novartis of shared development expenses in the companies' blood screening collaboration; and the absence of reimbursement from 3M resulting from the termination of the companies' collaboration regarding healthcare-associated infections.

Royalty and license revenues for the first quarter of 2009 were $2.0 million, compared to $18.6 million in the prior year period. As discussed, this significant decrease resulted primarily from $16.4 million of revenue from Bayer that was recorded in the prior year period. This revenue represented the third and final payment due in connection with the 2006 settlement of the companies' patent infringement litigation.

Gross margin on product sales in the first quarter of 2009 was 70.4%, compared to 67.8% in the prior year period. This improvement resulted primarily from the renegotiated blood screening agreement with Novartis, increased sales of APTIMA(R) assays, and lower instrument sales. These benefits were offset in part by the stronger U.S. dollar and by unfavorable manufacturing variances.

Research and development (R&D) expenses in the first quarter of 2009 were $25.0 million, compared to $23.1 million in the prior year period, an increase of 8%. This increase resulted primarily from costs associated with U.S. clinical trials of the investigational APTIMA(R) human papillomavirus (HPV) assay and the development of a fully automated instrument system for low- and mid-volume labs, known as PANTHER.

Marketing and sales expenses in the first quarter of 2009 were $11.1 million, compared to $11.9 million in the prior year period, a decrease of 7% that resulted primarily from the timing of specific studies associated with the Company's ongoing European market development efforts for the APTIMA Combo 2, APTIMA HPV and PROGENSA(TM) PCA3 assays.

General and administrative (G&A) expenses in the first quarter of 2009 were $13.8 million, compared to $11.9 million in the prior year period, an increase of 16% that resulted primarily from $1.6 million of expenses associated with the acquisition of Tepnel. As described above, these transaction-related costs have been excluded from the Company's non-GAAP results for the first quarter. Gen-Probe expects to record additional Tepnel-related charges in the second quarter, which also will be excluded from the Company's non-GAAP results.

Total other income in the first quarter of 2009 was $4.6 million, compared to $5.7 million in the prior year period, a decrease of 19% that resulted primarily from the $1.6 million gain recorded in the first quarter of 2008 related to the Company's sale of its equity investment in Molecular Profiling Institute.

Gen-Probe continues to have a strong balance sheet. As of March 31, 2009, the Company had $652.6 million of cash, cash equivalents and marketable securities, and $170.0 million outstanding under a revolving credit facility. The Company currently pays interest on funds borrowed under the credit facility at a floating rate 0.6 percent above the one-month London Interbank Offered Rate (LIBOR), which was recently 0.5 percent.

In the first quarter of 2009, Gen-Probe generated net cash of $52.0 million from its operating activities, more than double the Company's net income. The Company also repurchased approximately 0.9 million shares of its common stock for $35.6 million during the quarter.

Updated 2009 Financial Guidance

"We are updating our guidance based on our solid first-quarter performance and our Tepnel acquisition," said Herm Rosenman, the Company's senior vice president of finance and chief financial officer. "We continue to expect solid growth from our STD franchise, new products and recently acquired business, although we anticipate that blood screening growth will be pressured by the strong dollar and increasing competitive pressures."

In the table below, Gen-Probe's non-GAAP guidance excludes certain expenses related to the Tepnel acquisition, namely transaction costs and the increase in non-cash depreciation and amortization expense required under the rules of purchase accounting. These expenses are forecast to total between $8 million and $10 million in 2009, equating to between ($0.10) and ($0.13) of EPS on a GAAP basis.

                            Current         Current Guidance    Previous
                            Guidance            (GAAP)          Guidance
                           (non-GAAP)                            (GAAP)*

    Total revenues      $490 to $510         $490 to $510      $460 to $490
                           million             million            million
    Product gross
     margins             68% to 70%          68% to 70%         69% to 72%
    R&D expenses         21% to 23%          21% to 23%         20% to 22%
    Marketing and
     sales expenses      10% to 11%          11% to 12%         10% to 11%
    G&A expenses         10% to 11%          11% to 12%         10% to 11%
    Tax rate             33% to 34%          33% to 34%             34%
    Diluted shares
     outstanding        52 million           52 million         52 to 54
                                                                 million
    EPS               $1.85 to $2.00      $1.72 to $1.90      $1.80 to $2.05


* Did not include revenues or expenses associated with the acquisition of Tepnel.

Recent Events

  • Carl Hull Elected CEO. On March 23, Gen-Probe announced that its board of directors had elected Carl W. Hull the Company's new chief executive officer (CEO), effective May 18, 2009. Mr. Hull, currently the Company's president and chief operating officer, will become CEO following the retirement of current CEO Henry L. Nordhoff. Mr. Hull also is expected to join the Company's board of directors at that time.
  • Tepnel Acquisition Completed. On April 8, Gen-Probe announced that the Company had completed its acquisition of Tepnel Life Sciences plc, a rapidly growing molecular diagnostics and pharmaceutical services company based in the United Kingdom. The acquisition brings Gen-Probe new growth opportunities in transplant diagnostics, genetic testing and pharmaceutical services, and accelerates the Company's European expansion strategy.
  • New Credit Facility. On March 2, Gen-Probe announced it was borrowing $170.0 million under a newly issued credit facility to finance its pending acquisition of Tepnel and for other general corporate purposes, including its existing share repurchase program. The maximum amount that may be borrowed under the facility was increased in April to $250.0 million, under which the Company has borrowed $240.0 million.
  • U.S. Clinical Trial for PCA3. On April 29, Gen-Probe announced that it intends to initiate a U.S. clinical trial for its investigational PCA3 assay. The trial is expected to begin in the third quarter of 2009 and take approximately a year to complete. The Company also announced that it had amended its PCA3 license agreement with DiagnoCure, and will acquire $5 million of newly issued DiagnoCure convertible preferred stock.
  • Victory in HPV Arbitration. On April 1, Gen-Probe announced that the Company, along with its co-respondents F. Hoffmann-La Roche Ltd. and Roche Molecular Systems, Inc., had prevailed in its arbitration with Digene (now Qiagen) concerning the Company's supply and purchase agreement with Roche for HPV products.

Webcast Conference Call

A live webcast of Gen-Probe's first 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 866-454-1437 for domestic callers and 203-369-1239 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 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.

Trademarks

APTIMA, APTIMA COMBO 2, PACE, PROGENSA and TIGRIS 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.

About Non-GAAP Financial Measures

To supplement Gen-Probe's financial results for the first 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, non-GAAP G&A expenses, non-GAAP effective income tax rate, and non-GAAP 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.

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 "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 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 2009 financial targets, (ii) the risk that we may not integrate acquisitions such as Tepnel successfully, (iii) the possibility that the market for the sale of our new products, such as our TIGRIS system, PROCLEIX ULTRIO assay and PROGENSA PCA3 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 industrial collaborations, may not proceed as planned, (v) the risk that products, including the investigational PROGENSA PCA3 assay for which we expect to begin clinical trials shortly, may not be approved by regulatory authorities or 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 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. 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.


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

                                                     March 31,    December 31,
                                                        2009          2008
                                                     (unaudited)
    Assets
    Current assets:
     Cash and cash equivalents                        $286,195      $60,122
     Marketable securities                             366,395      445,056
     Trade accounts receivable, net of allowance
      for doubtful accounts of $600 and $700 at
      March 31, 2009 and December 31, 2008,
      respectively                                      35,206       33,397
     Accounts receivable - other                         1,886        2,900
     Inventories                                        52,175       54,406
     Deferred income tax - short term                    5,965        7,269
     Prepaid income tax                                      -        2,306
     Prepaid expenses                                   14,144       15,094
     Other current assets                                5,699        6,135
    Total current assets                               767,665      626,685

    Marketable securities                               32,677            -
    Property, plant and equipment, net                 142,799      141,922
    Capitalized software, net                           12,780       13,409
    Goodwill                                            18,621       18,621
    Deferred income tax - long term                     12,286       12,286
    Licenses, manufacturing access fees and other
     assets, net                                        56,483       56,608
    Total assets                                    $1,043,311     $869,531

    Liabilities and stockholders' equity
     Current liabilities:
     Accounts payable                                  $15,788      $16,050
     Accrued salaries and employee benefits             19,434       25,093
     Other accrued expenses                              6,239        4,027
     Income tax payable                                  8,491            -
     Short-term borrowings                             170,000            -
     Deferred revenue - short term                       1,592        1,278
    Total current liabilities                          221,544       46,448

    Non-current income tax payable                       4,671        4,773
    Deferred income tax - long term                         54           55
    Deferred revenue - long term                         2,167        2,333
    Deferred compensation plan liabilities               2,244        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, 52,068,633
     and 52,920,971 shares issued and outstanding
     at March 31, 2009 and December 31, 2008,
     respectively                                            5            5
    Additional paid-in capital                         353,304      382,544
    Accumulated other comprehensive income               5,419        3,055
    Retained earnings                                  453,903      428,156
    Total stockholders' equity                         812,631      813,760
    Total liabilities and stockholders' equity      $1,043,311     $869,531


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


                                               Three Months Ended
                                                     March 31,
                                                2009          2008

    Revenues:
     Product sales                          $112,522      $101,507
     Collaborative research revenue            1,675         2,459
     Royalty and license revenue               1,986        18,597
    Total revenues                           116,183       122,563

    Operating expenses:
     Cost of product sales                    33,314        32,636
     Research and development                 24,998        23,066
     Marketing and sales                      11,055        11,908
     General and administrative               13,846        11,937
    Total operating expenses                  83,213        79,547

    Income from operations:                   32,970        43,016
    Other income/(expense)
     Interest income                           4,882         4,207
     Interest expense                           (151)            -
     Other income/(expense)                     (142)        1,473
    Total other income, net                    4,589         5,680
    Income before income tax                  37,559        48,696

    Income tax expense                        11,812        16,751
    Net income                               $25,747       $31,945

    Net income per share:
     Basic                                     $0.49         $0.59
     Diluted                                   $0.48         $0.58

    Weighted average shares outstanding:
     Basic                                    52,407        53,796
     Diluted                                  53,126        55,023


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



                          Three Months Ended             Three Months Ended
                           March 31, 2009                  March 31, 2008
                      Non-      Adjustments  GAAP    Non-   Adjustments  GAAP
                      GAAP                           GAAP
    Revenues:
     Product sales   $112,522  $      -   $112,522  $101,507    $-    $101,507
     Collaborative
      research
       revenue          1,675         -      1,675     2,459     -       2,459
     Royalty and
      license revenue   1,986         -      1,986    18,597     -      18,597
    Total revenues    116,183         -    116,183   122,563     -     122,563

    Operating expenses:
     Cost of product
      sales            33,314         -     33,314    32,636     -      32,636
     Research and
      development      24,998         -     24,998    23,066     -      23,066
     Marketing and
      sales            11,055         -     11,055    11,908     -      11,908
     General and
      administrative   12,244     1,602     13,846    11,937     -      11,937
    Total operating
     expenses          81,611     1,602     83,213    79,547     -      79,547

    Income from
     operations        34,572    (1,602)    32,970    43,016     -      43,016
    Other income/
     (expense)
     Interest income    4,882         -      4,882    4,207      -       4,207
     Interest expense    (151)        -       (151)       -      -           -
     Other income/
     (expense)           (142)        -       (142)   1,473      -       1,473
    Total other income,
     net                4,589         -      4,589    5,680      -       5,680
    Income before
     income tax        39,161    (1,602)    37,559   48,696      -      48,696

    Income tax
     expense           12,187      (375)    11,812   16,751      -      16,751
    Net income       $ 26,974  $ (1,227)  $ 25,747  $31,945     $-    $ 31,945

    Net income
     per share:
      Basic          $   0.51  $  (0.02)  $   0.49  $  0.59     $-    $   0.59
      Diluted        $   0.51  $  (0.02)  $   0.48  $  0.58     $-    $   0.58

    Weighted average
     shares
      outstanding:
      Basic            52,407    52,407     52,407  53,796       -      53,796
      Diluted          53,126    53,126     53,126  55,023       -      55,023

                                   Gen-Probe Incorporated
                       Consolidated Statements of Income - Non-GAAP

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


                                                 Three Months Ended
                                                      March 31,
                                                2009             2008
    Revenues:
     Product sales                           $112,522         $101,507
     Collaborative research revenue             1,675            2,459
     Royalty and license revenue                1,986           18,597
    Total revenues                            116,183          122,563

    Operating expenses:
     Cost of product sales                     33,314           32,636
     Research and development                  24,998           23,066
     Marketing and sales                       11,055           11,908
     General and administrative                12,244           11,937
    Total operating expenses                   81,611           79,547

    Income from operations                     34,572           43,016
    Other income/(expense)
     Interest income                            4,882            4,207
     Interest expense                            (151)               -
     Other income/(expense)                      (142)           1,473
    Total other income, net                     4,589            5,680
    Income before income tax                   39,161           48,696

    Income tax expense                         12,187           16,751
    Net income                               $ 26,974         $ 31,945

    Net income per share:
     Basic                                   $   0.51            $0.59
     Diluted                                 $   0.51            $0.58

    Weighted average shares outstanding:
     Basic                                     52,407           53,796
     Diluted                                   53,126           55,023


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


                                                       Three Months Ended
                                                            March 31,
                                                       2009          2008
    Operating activities:
    Net income                                      $25,747       $31,945
    Adjustments to reconcile net income to net
     cash provided by operating activities:
    Depreciation and amortization                     8,748         8,608
    Amortization of premiums on investments,
     net of accretion of discounts                    1,523         1,735
    Stock-based compensation charges                  5,758         5,192
    Stock-based compensation income tax
     benefits                                           126           369
    Excess tax benefit from stock-based
     compensation                                      (127)         (145)
    Gain on sale of investment in Molecular
     Profiling Institute, Inc.                            -        (1,600)
    Changes in assets and liabilities:
     Trade and other accounts receivable               (784)        3,842
     Inventories                                      2,223        (1,796)
     Prepaid expenses                                   945         3,447
     Other current assets                               436        (1,161)
     Other long term assets                          (1,161)         (743)
     Accounts payable                                  (219)        3,181
     Accrued salaries and employee benefits          (5,657)       (3,069)
     Other accrued expenses                           2,217           965
     Income tax payable                              10,709        15,663
     Deferred revenue                                   147           (45)
     Deferred income tax                              1,305           688
     Deferred rent                                        -           (10)
     Deferred compensation plan liabilities              82           454
    Net cash provided by operating activities        52,018        67,520

    Investing activities:
    Proceeds from sales and maturities of
     marketable securities                           84,008        97,290
    Purchases of marketable securities              (37,124)     (181,546)
    Purchases of property, plant and equipment       (7,525)      (20,033)
    Purchases of intangible assets, including
     licenses and manufacturing access fees            (205)         (194)
    Proceeds from sale of investment in
     Molecular Profiling Institute, Inc.                  -         4,100
    Other assets                                        (13)           75
    Net cash provided by (used in) investing
     activities                                      39,141      (100,308)

    Financing activities:
    Excess tax benefit from stock-based
     compensation                                       127           145
    Repurchase and retirement of restricted
     stock for payment of taxes                         (34)          (41)
    Repurchases of common stock                     (35,627)            -
    Proceeds from issuance of common stock              534         3,027
    Borrowings under credit facility                170,000             -
    Net cash provided by financing activities       135,000         3,131
    Effect of exchange rate changes on cash and
     cash equivalents                                   (86)           (7)
    Net increase (decrease) in cash and cash
     equivalents                                    226,073       (29,664)
    Cash and cash equivalents at the beginning
     of period                                       60,122        75,963
    Cash and cash equivalents at the end of
     period                                        $286,195       $46,299



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

(1) In this press release, all per share amounts are calculated on a fully diluted basis. Non-GAAP EPS excludes $1.6 million ($0.02) of expenses related to the Company's acquisition of Tepnel. Some totals may not foot due to rounding.

(2) In this press release, "constant currency" revenue growth rates assume that average foreign exchange rates in the first quarter of 2009 were equal to those in the first quarter of 2008.


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