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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

x   Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
    For the quarterly period ended September 30, 2003

OR

o   Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Commission File Number 0-21872

GEN-PROBE INCORPORATED


(Exact name of registrant as specified in its charter)
     
Delaware   33-0044608

 
(State or other jurisdiction of   (I.R.S. Employer
incorporation or organization)   Identification Number)

10210 Genetic Center Drive
San Diego, CA 92121-4362


(Address of principal executive offices)

(858) 410-8000


(Registrant’s telephone number, including area code)

     Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

     Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

     As of November 7, 2003, there were 48,574,823 shares of the registrant’s common stock, par value $0.0001 per share, outstanding.

 


TABLE OF CONTENTS

Item 1. Financial Statements
Consolidated Balance Sheets
Consolidated Statements of Income
Consolidated Statements of Cash Flows
Notes to the Consolidated Financial Statements
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Item 4. Controls and Procedures
PART II — OTHER INFORMATION
Item 1. Legal Proceedings
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES
EXHIBIT 31.1
EXHIBIT 31.2
EXHIBIT 32.1
EXHIBIT 32.2


Table of Contents

GEN-PROBE INCORPORATED

TABLE OF CONTENTS

     
PART I — FINANCIAL INFORMATION    
Item 1 - Financial Statements:    
Consolidated balance sheets at December 31, 2002 and September 30, 2003 (unaudited)   3
Consolidated statements of income for the three months ended September 30, 2002 and 2003 (unaudited) and the nine months ended September 30, 2002 and 2003 (unaudited)
  4
Consolidated statements of cash flows for the nine months ended September 30, 2002 and 2003 (unaudited)
  5
Notes to the consolidated financial statements (unaudited)   6
Item 2 - Management’s Discussion and Analysis of Financial Condition and Results of Operations   10
Item 3 - Quantitative and Qualitative Disclosures about Market Risk   35
Item 4 - Controls and Procedures   35
PART II — OTHER INFORMATION   35
Item 1 - Legal Proceedings   35
Item 6 - Exhibits and Reports on Form 8-K   36
SIGNATURES   37

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Item 1. Financial Statements

Gen-Probe Incorporated

Consolidated Balance Sheets
(in thousands,
except share and per share data)
                   
      December 31,   September 30,
      2002   2003
     
 
              (unaudited)
Assets
               
Current assets:
               
 
Cash and cash equivalents
  $ 43,118     $ 37,697  
 
Short-term investments
    64,842       103,027  
 
Trade accounts receivable, net of allowance for doubtful accounts of $787 as of December 31, 2002 and $719 as of September 30, 2003
    11,891       14,421  
 
Accounts receivable — other
    1,024       2,406  
 
Inventories
    12,928       14,999  
 
Deferred income taxes
    7,178       8,893  
 
Prepaid expenses and other current assets
    5,114       8,868  
 
   
     
 
Total current assets
    146,095       190,311  
Property, plant and equipment, net
    65,870       65,662  
Capitalized software
    22,802       24,355  
Goodwill
    18,621       18,621  
Other assets
    4,769       4,396  
 
   
     
 
Total assets
  $ 258,157     $ 303,345  
 
 
   
     
 
Liabilities and stockholders’ equity
               
Current liabilities:
               
 
Accounts payable
  $ 8,148     $ 8,750  
 
Accrued salaries and employee benefits
    8,961       9,920  
 
Other accrued expenses
    6,598       7,823  
 
Deferred revenue
    7,100       8,081  
 
   
     
 
 
Total current liabilities
    30,807       34,574  
 
Deferred income taxes
    5,112       7,311  
 
Deferred revenue
    6,333       5,833  
 
Deferred rent
    327       326  
 
Minority interest
          1,552  
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, 47,599,890 and 48,526,008 shares issued and outstanding at December 31, 2002 and September 30, 2003, respectively
    5       5  
 
Additional paid-in capital
    192,624       204,972  
 
Accumulated other comprehensive income
    300       470  
 
Retained earnings
    22,649       48,302  
 
   
     
 
Total stockholders’ equity
    215,578       253,749  
 
   
     
 
Total liabilities and stockholders’ equity
  $ 258,157     $ 303,345  
 
 
   
     
 

Note: The Balance Sheet at December 31, 2002 has been derived from the audited financial statements as of that date.

See accompanying notes.

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Table of Contents

Gen-Probe Incorporated

Consolidated Statements of Income
(in thousands, except per share data)
(unaudited)
                                   
      Three Months Ended   Nine Months Ended
      September 30,   September 30,
     
 
      2002   2003   2002   2003
     
 
 
 
Revenues:
                               
 
Product sales
  $ 40,919     $ 47,927     $ 97,586     $ 137,846  
 
Collaborative research revenue
    799       3,737       10,876       9,474  
 
Royalty and license revenue
    1,079       617       2,969       1,811  
 
   
     
     
     
 
Total revenues
    42,797       52,281       111,431       149,131  
Operating expenses:
                               
 
Cost of product sales
    14,723       10,828       38,940       34,802  
 
Research and development
    10,145       16,837       33,971       44,324  
 
Marketing and sales
    4,366       5,943       12,926       16,490  
 
General and administrative
    5,427       5,740       16,394       15,757  
 
Amortization of intangible assets
    84       84       252       252  
 
 
   
     
     
     
 
Total operating expenses
    34,745       39,432       102,483       111,625  
 
   
     
     
     
 
Income from operations
    8,052       12,849       8,948       37,506  
Other income (expense)
                               
 
Interest income
    285       564       478       1,447  
 
Interest expense
    (1,393 )     (14 )     (1,849 )     (57 )
 
Other income (expense), net
    (402 )     55       3,227       121  
 
 
   
     
     
     
 
Total other income (expense)
    (1,510 )     605       1,856       1,511  
 
   
     
     
     
 
Income before income taxes
    6,542       13,454       10,804       39,017  
Income tax expense
    2,119       4,604       2,747       13,364  
 
   
     
     
     
 
Net income
  $ 4,423     $ 8,850     $ 8,057     $ 25,653  
 
 
   
     
     
     
 
Net income per share:
                               
 
Basic
  $ 0.09     $ 0.18     $ 0.17     $ 0.54  
 
 
   
     
     
     
 
 
Diluted
  $ 0.09     $ 0.18     $ 0.17     $ 0.52  
 
 
   
     
     
     
 
Weighted average shares outstanding:
                               
 
Basic
    47,600       47,987       47,600       47,745  
 
   
     
     
     
 
 
Diluted
    47,602       50,393       47,602       49,159  
 
   
     
     
     
 

See accompanying notes.

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Gen-Probe Incorporated

Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
                       
          Nine Months Ended
          September 30,
         
          2002   2003
         
 
Operating activities
               
Net income
  $ 8,057     $ 25,653  
Adjustments to reconcile net income to net cash provided by operating activities:
               
   
Depreciation and amortization
    13,153       11,780  
   
Loss on disposal of property and equipment
    290       75  
   
Deferred rent
    14       (1 )
   
Deferred revenue
    (2,929 )     481  
   
Deferred income taxes
    (1,007 )     148  
   
Changes in assets and liabilities:
               
     
Accounts receivable
    4,513       (2,151 )
     
Inventories
    (2,012 )     (2,020 )
     
Prepaid expenses and other current assets
    725       (3,259 )
     
Accounts payable
    (438 )     (448 )
     
Accrued salaries and employee benefits
    309       959  
     
Other accrued expenses
    1,892       1,029  
 
   
     
 
Net cash provided by operating activities
    22,567       32,246  
Investing activities
               
Proceeds from sales and maturities of short-term investments
          30,456  
Purchases of short-term investments
          (64,033 )
Purchases of property, plant & equipment
    (9,517 )     (8,363 )
Cash paid for acquisition of Molecular Light Technology Limited, net of cash acquired
          (5,941 )
Capitalization of software development costs
    (2,275 )     (1,553 )
Capitalization of patent costs
    (467 )     (466 )
Other assets
    (84 )     (115 )
 
   
     
 
Net cash used in investing activities
    (12,343 )     (50,015 )
Financing activities
               
Principal payment on long term debt
    (12,000 )      
Net capital contribution from merger with Gen-Probe Holding
    75,878        
Proceeds from issuance of common stock
          12,348  
 
   
     
 
Net cash provided by financing activities
    63,878       12,348  
Net increase (decrease) in cash and cash equivalents
    74,102       (5,421 )
Cash and cash equivalents at the beginning of the period
    17,750       43,118  
 
   
     
 
Cash and cash equivalents at the end of the period
  $ 91,852     $ 37,697  
 
   
     
 
Supplemental disclosure of cash flow information:
               
Cash paid for:
               
 
Interest
  $ 740     $ 44  
 
   
     
 
 
Income taxes
  $ 1,165     $ 10,983  
 
   
     
 

See accompanying notes.

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Notes to the Consolidated Financial Statements (unaudited)

Note 1 — Basis of Presentation

     The accompanying interim consolidated financial statements of Gen-Probe Incorporated (“Gen-Probe” or the “Company”) at September 30, 2003, and for the three and nine month periods ended September 30, 2002 and 2003, are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In management’s opinion, the unaudited financial statements include all adjustments, consisting only of normal recurring accruals, necessary to state fairly the financial information therein, in accordance with generally accepted accounting principles. Interim results are not necessarily indicative of the results that may be reported for any other interim period or for the year ending December 31, 2003.

     These unaudited consolidated financial statements and footnotes thereto should be read in conjunction with the audited financial statements and footnotes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2002.

     On September 5, 2003, the Company’s Board of Directors authorized a two-for-one stock split implemented as a 100% stock dividend, effective September 30, 2003 for holders of record as of September 16, 2003. All prior share and per share amounts in this Quarterly Report on Form 10-Q have been restated to reflect the stock split.

Note 2 — Reporting Periods

     The Company operates and reports on fiscal periods ending on the Friday closest to the end of the month except for year-end, which closes December 31. For ease of presentation, the quarterly reporting periods are deemed to end on March 31, June 30 and September 30. The three month periods ended September 30, 2002 and 2003 each included 13 weeks and the nine month periods ended September 30, 2002 and 2003 each included 39 weeks.

Note 3 — Recent Accounting Pronouncements

     In November 2002, the Emerging Issues Task Force (“EITF”) reached consensus on Issue No. 00-21, “Accounting for Revenue Arrangements with Multiple Deliverables.” This consensus requires that revenue arrangements with multiple deliverables be divided into separate units of accounting if the deliverables in the arrangement meet specific criteria. In addition, arrangement consideration must be allocated among the separate units of accounting based on their relative fair values, with certain limitations. The Company adopted the provisions of this consensus for revenue arrangements entered into after July 1, 2003. The adoption of this accounting pronouncement did not have a material impact on the Company’s consolidated financial position or results of operations.

     In 2002, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (“SFAS”) No. 145, “Rescission of SFAS Nos. 4, 44 and 64, Amendment of SFAS No. 13 and Technical Correction as of April 2002.” This statement rescinds SFAS No. 4, “Reporting Gains and Losses from Extinguishment of Debt,” and an amendment of that statement, SFAS No. 64, “Extinguishments of Debt Made to Satisfy Sinking-Fund Requirements.” The Company adopted this statement in 2003 and reclassified the prepayment premium and the deferred financing fees associated with the early pay-off of debt recorded in the third quarter of 2002, from an extraordinary loss, net of tax benefit, to interest expense on the statement of income. The tax benefit has been reflected as a component of income tax expense. The reported net income did not change.

     In December 2002, the FASB issued SFAS No. 148, “Accounting for Stock-Based Compensation, Transition and Disclosure — an amendment of FASB Statement No. 123.” This statement amends SFAS No. 123 “Accounting for Stock Based Compensation” to provide alternative methods of voluntarily transitioning to the fair value based method of accounting for stock-based employee compensation. SFAS No. 148 also amends the disclosure requirements of SFAS No. 123 to require disclosure of the method used to account for stock-based employee compensation and the effect of the method on reported results in both annual and interim financial statements. The Company has chosen not to adopt fair value accounting for employee stock options under SFAS No. 123 and SFAS No. 148, but will continue to disclose the required pro forma information in the notes to the consolidated financial statements.

     Pro forma information regarding net income is required to be disclosed in interim financial statements by SFAS No. 148, and has been determined as if the Company had accounted for its employee stock options and employee stock purchase plan under the fair value method of SFAS No. 123. The fair value for these options was estimated at the dates of grant using the minimum value option pricing model through September 16, 2002 and the Black-Scholes pricing model for all option grants made subsequent to that date.

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Table of Contents

     Had compensation expense for stock options granted been determined based on the fair value of the options at the date of grant, accounting consistent with SFAS No. 123, the Company’s net income and net income per share would have been as follows (in thousands, except per share data):

                                     
        Three Months   Nine Months
        Ended September 30,   Ended September 30,
        2002   2003   2002   2003
       
 
 
 
Net income:
                               
 
As reported
  $ 4,423     $ 8,850     $ 8,057     $ 25,653  
 
Total stock-based employee compensation expense determined under fair value based method for all awards, net of related tax effects
    (175 )     (946 )     (621 )     (1,414 )
 
   
     
     
     
 
Pro forma net income
  $ 4,248     $ 7,904     $ 7,436     $ 24,239  
 
 
   
     
     
     
 
Net income per share:
                               
 
As reported:
                               
   
Basic
  $ 0.09     $ 0.18     $ 0.17     $ 0.54  
   
Diluted
  $ 0.09     $ 0.18     $ 0.17     $ 0.52  
 
Pro forma:
                               
   
Basic
  $ 0.09     $ 0.16     $ 0.16     $ 0.51  
   
Diluted
  $ 0.09     $ 0.16     $ 0.16     $ 0.49  

     The pro forma effects on net income for the three and nine month periods ended September 30, 2002 and 2003 are not likely to be representative of the effects on reported net income in future periods. In management’s opinion, existing stock option valuation models do not provide a reliable single measure of the fair value of employee stock options that have vesting provisions and are not transferable. In addition, option valuation models require the input of highly subjective assumptions, and changes in such subjective assumptions can materially affect the fair value estimate of employee stock options.

Note 4 — Net Income Per Share

     Gen-Probe computes net income per share in accordance with SFAS No. 128, “Earnings Per Share,” and the Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin (“SAB”) No. 98. Under the provisions of SFAS No. 128, basic net income per share is computed by dividing the net income for the period by the weighted average number of common shares outstanding during the period. Diluted net income per share is computed by dividing the net income for the period by the weighted average number of common and common equivalent shares outstanding during the period.

     Under the provisions of SAB No. 98, common shares issued for nominal consideration, if any, would be included in the per share calculations as if they were outstanding for all periods presented. No common shares have been issued for nominal consideration. The Company had 47,599,890 shares of common stock outstanding as of September 30, 2002 and 48,526,008 shares of common stock outstanding as of September 30, 2003. The Company considers common equivalent shares from the exercise of stock options in the instance where the shares are dilutive to net income of the Company by application of the treasury stock method.

     The following table sets forth the computation of net income per share (in thousands, except per share amounts):

                                   
      Three Months   Nine Months
      Ended   Ended
      September 30,   September 30,
     
 
      2002   2003   2002   2003
     
 
 
 
Net income
  $ 4,423     $ 8,850     $ 8,057     $ 25,653