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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, 2002

OR

[   ]   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
(State or other jurisdiction of
incorporation or organization)
  33-0044608
(I.R.S. Employer
Identification Number)

10210 Genetic Center Drive
San Diego, CA 92121

(Address of principal executive offices)

(858) 410-8000
(Registrant’s Telephone No.)

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 [   ]

As of November 12, 2002, there were 23,799,945 shares of the Registrant’s common stock, par value $0.0001 per share, outstanding.

1


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 (unaudited)
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 4. Submission of Matters to a Vote of Security Holders
Item 5. Other Items
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES
CERTIFICATIONS
EXHIBIT 4.3


Table of Contents

GEN-PROBE INCORPORATED

TABLE OF CONTENTS

         
PART I — FINANCIAL INFORMATION        
Item 1 - Financial Statements:        
Consolidated balance sheets at December 31, 2001 and September 30, 2002 (unaudited)     3  
Consolidated statements of income for the three months ended September 30, 2001 and 2002 (unaudited) and the nine months ended September 30, 2001 and 2002 (unaudited)     4  
Consolidated statements of cash flows for the nine months ended September 30, 2001 and 2002 (unaudited)     5  
Notes to the consolidated financial statements (unaudited)     6  
Item 2 - Management Discussion and Analysis of Financial Condition and Results of Operations     10  
Item 3 - Quantitative and Qualitative Disclosures about Market Risk     21  
Item 4 - Controls and Procedures     21  
PART II — OTHER INFORMATION     22  
Item 1 - Legal Proceedings     22  
Item 4 - Submission of Matters to a Vote of Security Holders     22  
Item 5 - Other Items     23  
Item 6 - Exhibits and Reports on Form 8-K     35  
SIGNATURES     36  
CERTIFICATIONS     36  

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Table of Contents

Item 1. Financial Statements

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

                   
      December 31,   September 30,
      2001   2002
     
 
              (unaudited)
Assets
               
Current assets:
               
 
Cash and cash equivalents
  $ 17,750     $ 91,852  
 
Trade accounts receivable, net of allowance for
doubtful accounts of $824 as of December 31,
2001 and $876 as of September 30, 2002
    11,101       13,648  
 
Accounts receivable — other
    5,129       979  
 
Accounts receivable from related parties
    409        
 
Income taxes receivable
    2,457        
 
Inventories
    11,004       13,016  
 
Deferred income taxes
    3,231       4,827  
 
Prepaid expenses and other current assets
    5,754       5,029  
 
   
     
 
Total current assets
    56,835       129,351  
Property, plant and equipment, net
    60,094       66,881  
Capitalized software
    19,791       22,066  
Other assets
    3,753       2,913  
Purchased intangibles, net
    2,650       2,398  
Goodwill, net of accumulated amortization of $7,677
    17,224       18,621  
 
   
     
 
Total assets
  $ 160,347     $ 242,230  
 
   
     
 
Liabilities and stockholders’ equity
               
Current liabilities:
               
 
Accounts payable
  $ 8,090     $ 7,652  
 
Accounts payable to related parties
          7  
 
Accrued salaries and employee benefits
    7,041       7,350  
 
Other accrued expenses
    4,727       6,622  
 
Deferred revenue
    5,212       2,783  
 
Current portion of long-term debt
    2,000        
 
   
     
 
Total current liabilities
    27,070       24,414  
Long-term debt
    10,000        
Deferred income taxes
    173       648  
Deferred revenue
    7,000       6,500  
Deferred rent
    297       311  
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;
100,000,000 shares authorized,
23,799,945 shares issued and outstanding
    2       2  
 
Additional paid-in capital
    106,103       192,627  
 
Accumulated other comprehensive income
    60       29  
 
Retained earnings
    9,642       17,699  
 
   
     
 
Total stockholders’ equity
    115,807       210,357  
 
   
     
 
Total liabilities and stockholders’ equity
  $ 160,347     $ 242,230  
 
   
     
 

    See accompanying notes.

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Table of Contents

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

                                     
        Three Months Ended   Nine Months Ended
        September 30,   September 30,
       
 
        2001   2002   2001   2002
       
 
 
 
Revenues:
                               
 
Product sales
  $ 24,968     $ 40,919     $ 77,489     $ 97,586  
 
Collaborative research revenue
    6,680       799       14,758       10,876  
 
Royalty and license revenue
    2,894       1,079       4,398       2,969  
 
   
     
     
     
 
Total revenues
    34,542       42,797       96,645       111,431  
Operating expenses:
                               
 
Cost of product sales
    9,588       14,589       28,428       38,475  
 
Research and development
    12,158       9,904       40,549       33,134  
 
Marketing and sales
    4,197       4,298       12,154       12,685  
 
General and administrative
    4,170       5,870       12,433       17,937  
 
Amortization of intangible assets
    237       84       711       252  
 
   
     
     
     
 
Total operating expenses
    30,350       34,745       94,275       102,483  
 
   
     
     
     
 
Income from operations
    4,192       8,052       2,370       8,948  
Other income (expenses)
                               
 
Interest income
    52       285       351       478  
 
Interest expense
    (240 )     (158 )     (776 )     (614 )
 
Other income (expense), net
    9       (402 )     17       3,227  
 
   
     
     
     
 
Total other income (expenses), net
    (179 )     (275 )     (408 )     3,091  
 
   
     
     
     
 
Income before income taxes
    4,013       7,777       1,962       12,039  
Income tax expense (benefit)
    (98 )     2,613       (1,183 )     3,241  
 
   
     
     
     
 
Income before extraordinary loss
    4,111       5,164       3,145       8,798  
 
   
     
     
     
 
Extraordinary loss, net of tax
          741             741  
 
   
     
     
     
 
Net income
  $ 4,111     $ 4,423     $ 3,145     $ 8,057  
 
   
     
     
     
 
Basic and diluted earnings per share:
                               
   
Income before extraordinary loss
  $ 0.17     $ 0.22     $ 0.13     $ 0.37  
   
Extraordinary loss, net of tax
          0.03             0.03  
 
   
     
     
     
 
   
Net income
  $ 0.17     $ 0.19     $ 0.13     $ 0.34  
 
   
     
     
     
 
Weighted average shares outstanding:
                               
 
Basic
    23,800       23,800       23,800       23,800  
 
   
     
     
     
 
 
Diluted
    23,801       23,801       23,801       23,801  
 
   
     
     
     
 

    See accompanying notes.

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Table of Contents

Gen-Probe Incorporated
Consolidated Statements of Cash Flows
(unaudited)
(in thousands)

                       
          Nine Months Ended
          September 30,
         
          2001   2002
         
 
Operating activities
               
Net income
  $ 3,145     $ 8,057  
Adjustments to reconcile net income to net cash provided by operating activities:
               
   
Depreciation and amortization
    12,252       13,153  
   
Loss on disposal of property and equipment
    113       290  
   
Deferred rent payable
    222       14  
   
Deferred revenue
    (2,025 )     (2,929 )
   
Deferred income taxes
    (2,232 )     (1,007 )
   
Changes in assets and liabilities:
               
     
Accounts receivable
    (4,848 )     4,513  
     
Inventories
    992       (2,012 )
     
Prepaid expenses and other current assets
    (2,963 )     725  
     
Accounts payable
    (863 )     (438 )
     
Accrued salaries and employee benefits
    1,515       309  
     
Other accrued expenses
    4,465       1,892  
 
   
     
 
Net cash provided by operating activities
    9,773       22,567  
Investing activities
               
Proceeds from sales and maturities of short-term investments
    6,353        
Purchase of short-term investments
    (2,430 )      
Purchase of property, plant & equipment
    (6,450 )     (9,517 )
Capitalization of software development costs
    (2,492 )     (2,275 )
Capitalization of patent costs
    (681 )     (467 )
Other assets
    (24 )     (84 )
 
   
     
 
Net cash used in investing activities
    (5,724 )     (12,343 )
Financing activities
               
Principal payments on long-term debt
    (2,000 )     (12,000 )
Net capital contribution from merger with Gen-Probe Holding
          75,878  
 
   
     
 
Net cash provided (used) in financing activities
    (2,000 )     63,878  
 
   
     
 
Net increase in cash and cash equivalents
    2,049       74,102  
Cash and cash equivalents at the beginning of the period
    8,641       17,750  
 
   
     
 
Cash and cash equivalents at the end of the period
  $ 10,690     $ 91,852  
 
   
     
 
Supplemental disclosure of cash flow information:
               
Cash paid for:
               
 
Interest
  $ 538     $ 740  
 
   
     
 
 
Income taxes
  $ 105     $ 1,165  
 
   
     
 

    See accompanying notes.

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Table of Contents

Notes to the Consolidated Financial Statements (unaudited)

Note 1 — Basis of Presentation

The accompanying interim financial statements of Gen-Probe Incorporated (“Gen-Probe” or the “Company”) at September 30, 2002, and for the three and nine month periods ended September 30, 2001 and 2002, 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 which may be reported for any other interim period or for the year ending December 31, 2002.

You should also read the financial statements and notes in the Company’s Information Statement, included as Exhibit 99.1 to the Registration Statement on Form 10 filed with the SEC on September 5, 2002, which includes audited financial statements and footnotes for the fiscal years ended December 31, 1999, 2000 and 2001.

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, 2001 and 2002 each included 13 weeks and the nine month periods ended September 30, 2001 and 2002 each included 39 weeks.

Note 3 — Recent Accounting Pronouncements

In June 2001, the FASB issued SFAS No. 141, “Business Combinations,” and SFAS No. 142, “Goodwill and Other Intangible Assets.”

SFAS No. 141 requires that the purchase method of accounting be used for all business combinations initiated after June 30, 2001. Use of the pooling-of-interests method is no longer permitted. SFAS No. 141 also includes guidance on the initial recognition and measurement of goodwill and other intangible assets acquired in a business combination that is completed after June 30, 2001.

SFAS No. 142 no longer permits the amortization of goodwill and indefinite-lived intangible assets. Instead, these assets must be reviewed annually (or more frequently under certain conditions) for impairment in accordance with this statement. This impairment test uses a fair value approach rather than the undiscounted cash flows approach previously required by SFAS No. 121, “Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of.” Intangible assets that do not have indefinite lives will continue to be amortized over their useful lives and reviewed for impairment in accordance with SFAS No. 121. The Company adopted SFAS No. 142 effective January 1, 2002.

With the adoption of SFAS No. 142, the Company will no longer amortize goodwill, which has been estimated to reduce annual amortization expense and increase the Company’s operating income by approximately $612,000. Goodwill and intangibles with indefinite lives will be assigned to reporting units as determined by the Company for purposes of impairment testing and tested using a two-step approach for impairment annually or whenever there is an impairment indicator.

The Company has performed the first of the required impairment tests of goodwill and indefinite lived intangible assets to determine if a transition impairment charge should be recognized under SFAS 142. The Company has determined that there have been no impairments. In the future, the Company will test for impairment at least annually.

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Table of Contents

The following table presents a reconciliation of net income and per share data to what would have been reported had the new rules been in effect during the three month and nine month periods ended September 30, 2001 (in thousands, except per share data):

                                 
    Three Months   Nine Months
    Ended   Ended
    September 30,   September 30,
   
 
    2001   2002   2001   2002
   
 
 
 
Reported net income
  $ 4,111     $ 4,423     $ 3,145     $ 8,057  
Add back goodwill amortization, net of tax
    153             612        
 
   
     
     
     
 
Adjusted net income
  $ 4,264     $ 4,423     $ 3,757     $ 8,057  
 
   
     
     
     
 
Basic and diluted net income per common share:
                               
Reported net income
  $ 0.17     $ 0.19     $ 0.13     $ 0.34  
Goodwill amortization, net of tax
    0.01             0.03        
 
   
     
     
     
 
Adjusted net income
  $ 0.18     $ 0.19     $ 0.16     $ 0.34  
 
   
     
     
     
 

In August 2001, the FASB issued SFAS No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets”, which was adopted by the Company beginning in fiscal 2002. This statement established a number of rules for the recognition, measurement and display of long-lived assets which are impaired and either held for sale or continuing use within the business. In addition, the Statement expanded the definition of a discounted operation to individual reporting units or asset groupings for which identifiable cash flow exists. The adoption of the statement as of January 1, 2002 did not have a significant impact on the Company’s financial statements.

Note 4 — Net Income Per Share

Gen-Probe computes net income per share in accordance with SFAS No. 128, “Earnings Per Share”, and 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 has outstanding for all periods 23,799,945 shares of common stock. 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 basic and diluted shares (in thousands except per share data):

<
                                 
    Three Months   Nine Months
    Ended   Ended
    September 30,   September 30,
   
 
    2001   2002   2001   2002