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8-K - FORM 8-K - GEN PROBE INCa59361e8vk.htm
Exhibit 99.1
(Gen-Probe logo)
Contact:
Michael Watts
Vice president, investor relations and
corporate communications
858-410-8673
For Immediate Release
Gen-Probe Reports Financial Results for the First Quarter of 2011
— Company Posts Non-GAAP EPS of $0.54, 13% Higher than in the Prior Year Period,
and GAAP EPS of $0.48 —
— Record Total Revenues of $143.0 Million Driven by Acquisition of GTI,
Growth in PRODESSE and APTIMA Franchises —
SAN DIEGO, CA, April 28, 2011 — Gen-Probe Incorporated (NASDAQ: GPRO) today reported financial results for the first quarter of 2011, highlighted by record total revenues of $143.0 million and non-GAAP earnings per share (EPS) of $0.54, 13% higher than in the prior year period.
“Gen-Probe posted solid financial results in the first quarter of 2011, including all-time highs in product sales and total revenues, based on the acquisition of GTI and good growth from our PRODESSE influenza and APTIMA women’s health products,” said Carl Hull, the Company’s president and chief executive officer. “In addition, all our major pipeline initiatives remain on track, with an important new product cycle just beginning.”
Key financial results for the first quarter of 2011 were ($ in millions, except EPS):
                                                 
    Non-GAAP   GAAP
    2011   2010   Change   2011   2010   Change
     
Product sales
  $ 138.1     $ 130.6       +6 %   $ 138.1     $ 130.6       +6 %
Total revenues
  $ 143.0     $ 135.4       +6 %   $ 143.0     $ 135.4       +6 %
Operating profit
  $ 38.9     $ 33.7       +15 %   $ 34.7     $ 31.4       +11 %
Net income
  $ 26.6     $ 24.0       +11 %   $ 23.3     $ 24.2       -4 %
EPS
  $ 0.54     $ 0.48       +13 %   $ 0.48     $ 0.48       0 %
Revenue Detail
Clinical diagnostics product sales established a new record in the first quarter of 2011. Growth of 15% was driven by sales of GTI products, which were not part of Gen-Probe in the prior year period, by the PRODESSE influenza franchise, and by the APTIMA Combo 2® assay for detecting Chlamydia and gonorrhea. Foreign currency fluctuations had a minimal effect on clinical diagnostics sales compared to the prior year period.
In blood screening, sales declined compared to the first quarter of 2010, as expected, due mainly to lower sales of instruments to Novartis, the Company’s blood screening collaborator. Foreign currency fluctuations reduced blood screening sales by an estimated $0.3 million, or less than 1%, compared to the prior year period.

 


 

Sales of research products and services in the first quarter of 2011 were $3.1 million, down 24% compared to the prior year period due to continued weakness in pharmaceutical outsourcing.
First quarter product sales were ($ in millions):
                                 
    Three Months Ended March 31,   Change
            As   Constant
    2011   2010   Reported   Currency
     
Clinical Diagnostics
  $ 88.3     $ 76.9       +15 %     +15 %
Blood Screening
  $ 46.7     $ 49.6       -6 %     -5 %
Research Products and Services
  $ 3.1     $ 4.1       -24 %     -25 %
 
Total Product Sales
  $ 138.1     $ 130.6       +6 %     +6 %
Collaborative research revenues in the first quarter of 2011 were $3.6 million, compared to $3.3 million in the prior year period, an increase of 9% that resulted primarily from increased funding from Novartis associated with the development of the fully automated PANTHER™ instrument and the PROCLEIX® ULTRIO® Plus assay for the blood screening market.
Royalty and license revenues in the first quarter of 2011 were $1.4 million, compared to $1.6 million in the prior year period, a decrease of 13% that resulted from the combined effect of several small items.
GAAP Income Statement Details
Gross margin on product sales was 69.6% in the first quarter of 2011, compared to 67.3% in the prior year period. This increase resulted mainly from a favorable product sales mix, namely higher sales of PRODESSE and APTIMA products, and lower sales of instrumentation.
Acquisition-related amortization expenses were $2.8 million in the first quarter of 2011, compared to $2.2 million in the prior year period, an increase of 27% that resulted mainly from the acquisition of GTI in December of 2010.
Research and development (R&D) expenses were $29.0 million in the first quarter of 2011, compared to $29.7 million in the prior year period, a decrease of 2% that resulted primarily from lower clinical trial expenses.
Marketing and sales expenses were $16.5 million in the first quarter of 2011, compared to $14.8 million in the prior year period, an increase of 12% that resulted primarily from the addition of GTI’s cost structure, and European sales force expansion and market development efforts.
General and administrative (G&A) expenses were $18.2 million in the first quarter of 2011, compared to $14.7 million in the prior year period, an increase of 24% that resulted primarily from the addition of GTI’s cost structure and costs associated with the Company’s patent infringement litigation against Becton, Dickinson.
Total other income was $0.4 million in the first quarter of 2011, compared to $4.9 million in the prior year period. This significant decrease resulted primarily from the absence of a non-cash gain related to a change in the fair value of contingent consideration, lower net realized gains on sales of marketable securities, lower yields on the Company’s municipal bond portfolio, and lower investment balances due to cash used for share repurchases and the acquisition of GTI.
Income tax expense was $11.8 million in the first quarter of 2011, corresponding to a tax rate of 34%.

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Non-GAAP Income Statement Details
Excluding $0.1 million of acquisition-related depreciation expense, gross margin on product sales was 69.7% in the first quarter of 2011, compared to 67.4% in the prior year period.
Excluding transaction-related and restructuring costs, G&A expenses were $16.8 million in the first quarter of 2011, compared to $14.7 million in the prior year period.
Total other income was $0.4 million in the first quarter of 2011, compared to $3.2 million in the prior year period. The prior year amount excludes the non-cash gain related to a change in the fair value of contingent consideration.
Income tax expense was $12.8 million in the first quarter of 2011, corresponding to a tax rate of 32%.
Cash Flows and Balance Sheet
In the first quarter of 2011, Gen-Probe generated net cash of $40.1 million from operating activities, substantially higher than GAAP net income of $23.3 million. The Company spent $10.8 million on property, plant and equipment in the quarter, leading to free cash flow of $29.3 million. The Company repurchased approximately 756,000 shares of its stock in the first quarter for $48.0 million.
Gen-Probe continues to have a strong balance sheet. As of March 31, 2011, the Company had $491.3 million of cash, cash equivalents and marketable securities, and $250 million of short-term debt. The Company pays interest on this debt at a rate 0.6% above the one-month London Interbank Offered Rate (LIBOR), which was recently below 0.3%.
2011 Financial Guidance
Gen-Probe is reiterating its 2011 financial guidance, which was introduced on February 15.
“We continue to anticipate that 2011 will be a good year financially for Gen-Probe,” said Herm Rosenman, the Company’s senior vice president, finance, and chief financial officer. “We forecast continued, high-single-digit growth in product sales. We also expect improving gross and operating margins to drive solid earnings growth, despite increased legal expenses and substantially lower non-operating income.”
Gen-Probe’s 2011 financial guidance is provided in the table below:
         
    Non-GAAP   GAAP
 
Total revenues
  $570 to $595 million   $570 to $595 million
Product gross margins
  68% to 69.5%   68% to 69.5%
Acquisition-related amortization and other transaction expense
  N/A   $13 to 14 million
Operating margin
  27% to 29%   25% to 27%
Tax rate
  32% to 33%   32% to 33%
Diluted shares
  48 to 49 million   48 to 49 million
EPS
  $2.28 to $2.40   $2.06 to $2.20

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Webcast Conference Call
A live webcast of Gen-Probe’s first quarter 2011 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. Call 800-839-5573 (domestic) or 402-220-2075 (international).
About Gen-Probe
Gen-Probe is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility. Gen-Probe is headquartered in San Diego and employs approximately 1,400 people. For more information, go to www.gen-probe.com.
About Non-GAAP Financial Measures
Gen-Probe’s management believes that 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. To supplement the Company’s financial results for the first quarter of 2011 and its 2011 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 gross margin, non-GAAP marketing and sales expenses, non-GAAP G&A expenses, non-GAAP operating margin, non-GAAP income tax rate, and non-GAAP 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 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. Further, our reconciliations of non-GAAP to GAAP operating results, which are included on the attached tables, are presented in the format of consolidated statements of income solely to assist a reader in understanding the impact of the various adjustments to our GAAP operating results, individually and in the aggregate, and are not intended to place any undue prominence on our non-GAAP operating results.
Trademarks
APTIMA, APTIMA COMBO 2, TIGRIS and PANTHER are trademarks of Gen-Probe. All other trademarks are the property of their owners.

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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 “2011 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, the development and commercialization of new products, 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 2011 financial targets, (ii) the risk that we may not integrate acquisitions, such as Tepnel, Prodesse and GTI, successfully, (iii) the possibility that the market for the sale of our new products, such as our PANTHER instrument system and PROGENSA PCA3, APTIMA HPV and APTIMA trichomonas 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 investigational products, including those now 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 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.
# # #

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Gen-Probe Incorporated
Consolidated Balance Sheets — GAAP

(In thousands, except share and per share data)
                 
    March 31,     December 31,  
    2011     2010  
    (Unaudited)        
Assets
               
Current assets:
               
Cash and cash equivalents
  $ 93,563     $ 59,690  
Marketable securities
    177,908       170,648  
Trade accounts receivable, net of allowance for doubtful accounts of $405 and $355 at March 31, 2011 and December 31, 2010, respectively
    59,633       54,739  
Accounts receivable — other
    3,548       5,493  
Inventories
    65,180       66,416  
Deferred income tax
    13,774       13,634  
Prepaid income tax
    26       2,993  
Prepaid expenses
    13,837       11,672  
Other current assets
    5,698       5,148  
 
           
Total current assets
    433,167       390,433  
Marketable securities, net of current portion
    219,808       259,317  
Property, plant and equipment, net
    163,538       160,863  
Capitalized software, net
    14,014       13,981  
Patents, net
    12,327       12,450  
Goodwill
    150,639       150,308  
Purchased intangibles, net
    118,338       120,270  
License, manufacturing access fees and other assets, net
    62,427       60,175  
 
           
Total assets
  $ 1,174,258     $ 1,167,797  
 
           
 
               
Liabilities and stockholders’ equity
               
Current liabilities:
               
Accounts payable
  $ 11,471     $ 14,614  
Accrued salaries and employee benefits
    19,066       26,825  
Other accrued expenses
    16,768       13,935  
Income tax payable
    7,649       634  
Short-term borrowings
    250,000       240,000  
Deferred income tax
    91        
Deferred revenue
    1,460       1,166  
 
           
Total current liabilities
    306,505       297,174  
Non-current income tax payable
    8,864       8,315  
Deferred income tax
    27,308       29,775  
Deferred revenue, net of current portion
    2,318       2,500  
Other long-term liabilities
    7,149       6,654  
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, 47,663,833 and 47,966,156 shares issued and outstanding at March 31, 2011 and December 31, 2010, respectively
    5       5  
Additional paid-in capital
    172,133       195,820  
Accumulated other comprehensive (loss) income
    (177 )     678  
Retained earnings
    650,153       626,876  
 
           
Total stockholders’ equity
    822,114       823,379  
 
           
Total liabilities and stockholders’ equity
  $ 1,174,258     $ 1,167,797  
 
           

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Gen-Probe Incorporated
Consolidated Statements of Income — GAAP

(In thousands, except per share data)
(Unaudited)
                 
    Three Months Ended  
    March 31,  
    2011     2010  
Revenues:
               
Product sales
  $ 138,112     $ 130,569  
Collaborative research revenue
    3,568       3,264  
Royalty and license revenue
    1,358       1,586  
 
           
Total revenues
    143,038       135,419  
Operating expenses:
               
Cost of product sales (excluding acquisition-related intangible amortization)
    41,943       42,661  
Acquisition-related intangible amortization
    2,805       2,216  
Research and development
    28,963       29,681  
Marketing and sales
    16,522       14,781  
General and administrative
    18,153       14,679  
 
           
Total operating expenses
    108,386       104,018  
 
           
Income from operations
    34,652       31,401  
Other income (expense):
               
Investment and interest income
    735       3,898  
Interest expense
    (503 )     (546 )
Gain on contingent consideration
          1,745  
Other income (expense), net
    177       (159 )
 
           
Total other income, net
    409       4,938  
 
           
Income before income tax
    35,061       36,339  
Income tax expense
    11,784       12,146  
 
           
Net income
  $ 23,277     $ 24,193  
 
           
Net income per share:
               
Basic
  $ 0.49     $ 0.49  
 
           
Diluted
  $ 0.48     $ 0.48  
 
           
 
               
Weighted average shares outstanding:
               
Basic
    47,861       49,233  
 
           
Diluted
    49,004       49,739  
 
           

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

(In thousands, except per share data)
(Unaudited)
                                                 
    Three Months Ended     Three Months Ended  
    March 31, 2011     March 31, 2010  
    Non-GAAP     Adjustments     GAAP     Non-GAAP     Adjustments     GAAP  
Revenues:
                                               
Product sales
  $ 138,112     $     $ 138,112     $ 130,569     $     $ 130,569  
Collaborative research revenue
    3,568             3,568       3,264             3,264  
Royalty and license revenue
    1,358             1,358       1,586             1,586  
         
Total revenues
    143,038             143,038       135,419             135,419  
Operating expenses:
                                               
Cost of product sales (excluding acquisition-related intangible amortization)
    41,852       91       41,943       42,570       91       42,661  
Acquisition-related intangible amortization
          2,805       2,805             2,216       2,216  
Research and development
    28,963             28,963       29,681             29,681  
Marketing and sales
    16,522             16,522       14,781             14,781  
General and administrative
    16,800       1,353       18,153       14,652       27       14,679  
         
Total operating expenses
    104,137       4,249       108,386       101,684       2,334       104,018  
         
Income from operations
    38,901       (4,249 )     34,652       33,735       (2,334 )     31,401  
Other income (expense):
                                               
Investment and interest income
    735             735       3,898             3,898  
Interest expense
    (503 )           (503 )     (546 )           (546 )
Gain on contingent consideration
                            1,745       1,745  
Other income (expense), net
    177             177       (159 )           (159 )
         
Total other income, net
    409             409       3,193       1,745       4,938  
         
Income before income tax
    39,310       (4,249 )     35,061       36,928       (589 )     36,339  
Income tax expense
    12,756       (972 )     11,784       12,957       (811 )     12,146  
         
Net income
  $ 26,554     $ (3,277 )   $ 23,277     $ 23,971     $ 222     $ 24,193  
         
Net income per share:
                                               
Basic
  $ 0.55     $ (0.06 )   $ 0.49     $ 0.49     $     $ 0.49  
         
Diluted
  $ 0.54     $ (0.06 )   $ 0.48     $ 0.48     $     $ 0.48  
         
Weighted average shares outstanding:
                                               
Basic
    47,861             47,861       49,233             49,233  
         
Diluted
    49,004             49,004       49,739             49,739  
         

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Gen-Probe Incorporated
Consolidated Statements of Cash Flows — GAAP

(In thousands)
(Unaudited)
                 
    Three Months Ended  
    March 31,  
    2011     2010  
Operating activities:
               
Net income
  $ 23,277     $ 24,193  
Adjustments to reconcile net income to net cash provided by operating activities:
               
Depreciation and amortization
    11,345       11,308  
Amortization of premiums on investments, net of accretion of discounts
    2,673       2,216  
Stock-based compensation
    6,036       5,902  
Excess tax benefit from employee stock-based compensation
    (1,425 )     (1,596 )
Deferred revenue
    97       (833 )
Deferred income tax
    (615 )     (1,360 )
Gain on contingent consideration
          (1,745 )
Loss on disposal of property and equipment
    24       47  
Changes in assets and liabilities:
               
Trade and other accounts receivable
    (2,816 )     7,696  
Inventories
    3,420       1,110  
Prepaid expenses
    (2,116 )     (2,200 )
Other current assets
    (536 )     (95 )
Other long-term assets
    (132 )     (257 )
Accounts payable
    (3,196 )     (8,065 )
Accrued salaries and employee benefits
    (7,847 )     (5,256 )
Other accrued expenses
    (40 )     (1,630 )
Income tax payable
    11,500       11,827  
Other long-term liabilities
    456       (575 )
 
           
Net cash provided by operating activities
    40,105       40,687  
 
           
 
               
Investing activities:
               
Proceeds from sales and maturities of marketable securities
    30,460       139,425  
Purchases of marketable securities
    (5,731 )     (71,390 )
Purchases of property, plant and equipment
    (10,762 )     (7,828 )
Purchases of capitalized software
    (780 )     (1,089 )
Purchases of intangible assets, including licenses and manufacturing access fees
    (923 )     (722 )
Other
    501       (310 )
 
           
Net cash provided by investing activities
    12,765       58,086  
 
           
 
               
Financing activities:
               
Repurchase and retirement of common stock
    (47,972 )     (10,961 )
Proceeds from issuance of common stock and employee stock purchase plan
    17,390       16,912  
Repurchase and retirement of restricted stock for payment of taxes
    (358 )     (39 )
Excess tax benefit from employee stock-based compensation
    1,425       1,596  
Borrowings, net
    10,000        
 
           
Net cash (used in) provided by financing activities
    (19,515 )     7,508  
 
           
Effect of exchange rate changes on cash and cash equivalents
    518       (1,620 )
 
           
Net increase in cash and cash equivalents
    33,873       104,661  
Cash and cash equivalents at the beginning of period
    59,690       82,616  
 
           
Cash and cash equivalents at the end of period
  $ 93,563     $ 187,277  
 
           

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