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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

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from ____ to ____

Commission file number 0-22885

TRIPATH IMAGING, INC.


(Exact name of registrant as specified in its charter)
     
Delaware   56-1995728

 
(State or other jurisdiction of incorporation or organization)   (IRS Employer Identification No.)
     
780 Plantation Drive, Burlington, North Carolina   27215

 
(Address of principal executive offices)   (Zip Code)

(336) 222-9707


(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 the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

         
Class   Outstanding at November 4, 2002

 
Common Stock, $.01 par value     37,480,297  

 


 

TriPath Imaging, Inc.

Table of Contents

     
    Page
   
Part I. Financial Information    
 
Item 1. Condensed Consolidated Financial Statements (Unaudited)   2
 
Condensed consolidated balance sheets As of September 30, 2002 and December 31, 2001.
  2
 
Condensed consolidated statements of operations for the three months and nine months ended September 30, 2002 and 2001.
  3
 
Condensed consolidated statements of cash flows For the nine months ended September 30, 2002 and 2001.
  4
 
Notes to unaudited condensed consolidated financial statements
  5
 
Item 2. Management’s Discussion and Analysis of Financial Condition And Results of Operations   10
 
Item 3. Quantitative and Qualitative Disclosures About Market Risk   23
 
Item 4. Controls and Procedures   23
 
 
Part II. Other Information    
 
Item 1. Legal Proceedings   23
 
Item 6. Exhibits and Reports on Form 8-K   24
 
Signatures   25
 
Certifications   26

1


 

Part I. FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements:

TriPath Imaging, Inc.

Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands, except share amounts)
                     
        September 30,   December 31,
        2002   2001
       
 
Assets
               
Current assets:
               
 
Cash and cash equivalents
  $ 35,598     $ 53,477  
 
Short-term investments
          2,499  
 
Accounts receivable, net
    9,186       9,581  
 
Inventory, net
    11,209       10,718  
 
Other current assets
    842       1,079  
 
   
     
 
   
Total current assets
    56,835       77,354  
 
Customer-use assets, net
    6,357       6,089  
Property and equipment, net
    4,276       2,362  
Other assets
    2,218       916  
Intangible assets
    9,414       10,027  
 
   
     
 
   
Total assets
  $ 79,100     $ 96,748  
 
   
     
 
Liabilities and stockholders’ equity
               
Current liabilities:
               
 
Accounts payable
  $ 3,924     $ 4,411  
 
Accrued expenses
    4,555       4,116  
 
Deferred revenue and customer deposits
    1,068       730  
 
Deferred research and development funding
    2,479       2,479  
 
Current portion of long-term debt
    1,522       2,720  
 
Other current liabilities
    2,475        
 
   
     
 
   
Total current liabilities
    16,023       14,456  
 
Long-term debt, less current portion
    17       790  
Other long-term liabilities
    826       4,210  
 
Stockholders’ equity:
               
 
Common stock, $0.01 par value; 98,000,000 shares authorized; 37,479,595 and 37,304,738 shares issued and outstanding at September 30, 2002 and December 31, 2001, respectively
    375       373  
 
Additional paid-in capital
    283,430       283,396  
 
Accumulated other comprehensive loss
    (31 )     (59 )
 
Deferred compensation
    (123 )      
 
Accumulated deficit
    (221,417 )     (206,418 )
   
Total stockholders’ equity
    62,234       77,292  
 
   
     
 
   
Total liabilities and stockholders’ equity
  $ 79,100     $ 96,748  
 
   
     
 

See accompanying notes to condensed consolidated financial statements

2


 

TriPath Imaging, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)
(In thousands, except per share amounts)
                                   
      Three months ended   Nine months ended
      September 30,   September 30,
     
 
      2002   2001   2002   2001
     
 
 
 
Sales
  $ 9,826     $ 5,250     $ 26,521     $ 20,690  
Cost of sales
    3,886       2,248       10,925       10,000  
 
   
     
     
     
 
 
Gross profit
    5,940       3,002       15,596       10,690  
 
Operating expenses:
                               
 
Research and development
    2,073       1,880       6,334       5,304  
 
Regulatory
    1,000       517       2,092       1,542  
 
Sales and marketing
    4,741       5,120       15,490       12,314  
 
General and administrative
    2,474       3,127       7,027       7,004  
 
    10,288       10,644       30,943       26,164  
 
   
     
     
     
 
Operating loss
    (4,348 )     (7,642 )     (15,347 )     (15,474 )
Interest income
    191       650       804       1,962  
Interest expense, including amortization of non-cash debt issuance costs under term loan agreement
    (123 )     (502 )     (456 )     (1,345 )
 
   
     
     
     
 
Net loss
  $ (4,280 )   $ (7,494 )   $ (14,999 )   $ (14,857 )
 
   
     
     
     
 
 
Net loss per common share (basic and diluted)
  $ (0.11 )   $ (0.21 )   $ (0.40 )   $ (0.43 )
 
   
     
     
     
 
 
Weighted-average common shares outstanding
    37,480       36,141       37,433       34,861  
 
   
     
     
     
 

See accompanying notes to condensed consolidated financial statements.

3


 

TriPath Imaging, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)
(In thousands, except per share amounts)
                   
      Nine months ended
      September 30,
     
      2002   2001
     
 
Operating activities
               
Net loss
  $ (14,999 )   $ (14,857 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
 
Depreciation and amortization
    2,861       3,276  
 
Non-cash interest expense
    169       670  
 
Gain on disposal of fixed asset
    (5 )     (9 )
 
Amortization of deferred research and development
    (1,859 )     (413 )
 
Other non-cash items
    950       1,276  
Change in operating assets and liabilities:
               
 
Accounts and notes receivable
    (875 )     1,481  
 
Inventory
    (2,420 )     (1,255 )
 
Accounts payable and other current liabilities
    (65 )     (2,213 )
 
Other
    554       (542 )
 
   
     
 
Net cash used in operating activities
    (15,689 )     (12,586 )
 
Investing activities
               
 
Purchases of property and equipment
    (2,460 )     (521 )
 
Disposals of property and equipment
    5       9  
 
Maturities of short-term investments
    2,499        
 
Other
          136  
 
   
     
 
Net cash provided by (used in) investing activities
    44       (376 )
 
Financing activities
               
 
Proceeds from issuance of stock
          17,806  
 
Proceeds from exercise of stock options
    234       776  
 
Payments on long-term debt
    (2,489 )     (2,475 )
 
Outside funding of research and development
          6,198  
 
Other
          (29 )
 
   
     
 
Net cash (used in) provided by financing activities
    (2,255 )     22,276  
 
Effect of exchange rate changes on cash
    21       (64 )
 
   
     
 
Net (decrease) increase in cash and cash equivalents
    (17,879 )     9,250  
Cash and cash equivalents at beginning of period
    53,477       54,340  
 
   
     
 
Cash and cash equivalents at end of period
  $ 35,598     $ 63,590  
 
   
     
 

See accompanying notes to condensed consolidated financial statements

4


 

TriPath Imaging, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)
(In thousands, except per share amounts)
September 30, 2002

1. Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared by TriPath Imaging, Inc. in accordance with generally accepted accounting principles for interim financial information and applicable Securities and Exchange Commission regulations for interim financial information. These financial statements do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. The balance sheet at December 31, 2001 has been derived from the audited financial statements at that date, but does not include all the information and footnotes required by generally accepted accounting principles for complete financial statements. The accompanying unaudited condensed consolidated financial statements reflect all adjustments (consisting of normal, recurring accruals) which, in the opinion of management, are necessary for a fair presentation of the results for the interim periods presented. The results of operations for such periods are not necessarily indicative of the results expected for the full year or for any future periods. The accompanying condensed consolidated financial statements and related notes should be read in conjunction with our audited consolidated financial statements and notes included in our Annual Report on Form 10-K (File No. 0-22885) for the year ended December 31, 2001.

Reclassifications

Certain amounts, specifically those attributable to our TriPath Oncology segment (see Note 7) and to our accounting for health care costs, in the accompanying condensed consolidated financial statements have been reclassified to more accurately reflect research and development and general and administrative expenses. These reclassifications had no effect on current, or previously, reported net loss or stockholders’ equity.

2. Inventory

Inventory consists of the following:

                 
    September 30,   December 31,
    2002   2001
   
 
Raw materials
  $ 8,102     $ 7,442  
Work-in-process
    432       275  
Finished goods
    2,675       3,001  
 
   
     
 
 
  $ 11,209     $ 10,718  
 
   
     
 
Instruments
  $ 9,886     $ 9,628  
Reagents and consumables
    1,323       1,090  
 
   
     
 
 
  $ 11,209     $ 10,718  
 
   
     
 

For the three months ended September 30, 2002 and 2001, reclassifications of $150 and $296, respectively, occurred between customer-use assets, property and equipment, and inventory. For the nine months ended September 30, 2002 and 2001, such reclassifications were $1,712 and $1,418, respectively.

5


 

Tripath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except per share amounts)

3. Net Loss Per Share of Common Stock

Per share information is based upon the weighted-average number of shares of common stock outstanding during the period. We incurred losses during all periods presented. As a result, options and warrants were not used to compute diluted loss per share since the effect would be anti-dilutive. Accordingly, there is no difference between basic and diluted loss per share in the periods presented.

4. Long-Term Debt

Included in current and long-term debt are the remaining outstanding balances on a $7,000 subordinated term loan, which we obtained from a syndicate of lenders in February 2000 to finance operations. As of September 30, 2002, the balance outstanding was $1,458, all classified as current. The loan, which is collateralized by substantially all of our assets, accrues interest at a rate equal to the U.S. Treasury Note plus 8%. Accrued interest was due monthly for the first six months of each draw, at which time the outstanding principal balance became payable over a thirty-month term. In connection with this term loan, we issued to the lenders warrants to purchase 223,253 shares of our common stock. Using a Black-Scholes pricing model, the warrants were valued upon issuance at $675, which represented non-cash debt issuance costs. These warrants, which expire in 2007, were recorded as additional paid-in capital and the resulting debt issuance costs are being amortized on a straight-line basis to interest expense over the three-year term of the loan. These warrants have a weighted average exercise price of $4.70 and were exercisable upon issuance.

5. Line of Credit

In February 2000, we obtained a $5,000 working capital facility with Silicon Valley Bank. The outstanding balance is limited to an amount equal to 80% of eligible accounts receivable. The line commitment was renewed for an additional one-year term in January 2002. At September 30, 2002, there was no outstanding balance on the line of credit. In August 2002, a letter of credit for $1,500 was issued against this line to secure operating lease financing in connection with certain facility related capital expenditures. The line bears interest at the bank’s prime rate plus 1/2% and is collateralized by substantially all of our assets. The line of credit carries customary covenants, including the maintenance of a minimum modified quick ratio, minimum tangible net worth and other requirements.

During August 2002, we obtained a $1,500 lease line of credit (“lease line”) from Bank of America. This lease line is secured by a letter of credit against our line of credit with Silicon Valley Bank discussed above. This lease line carries three-year lease terms for items acquired under it and financing charges based on three-year constant Treasury Maturities. The lease line will be used as an alternative source of capital to secure operating leases for assets, primarily equipment. As of September 30, 2002, there were $301 of assets leased under this lease line.

6. Other Liabilities

We have recorded a short-term contingent liability of $2,475 in accordance with the provisions of Financial Accounting Standards Board (“FASB”) Statement of Financial Accounting Standards (“SFAS”) No. 5, “Accounting for Contingencies,” on the basis that the likelihood of a future event occurring is probable and reasonably estimable. This contingency relates to our obligation to pay a third party, who received 180,000 shares of our common stock in January 2001 under a settlement agreement, an amount in cash equal to the difference between the market price of our common stock on a specified date in January 2003 and a predetermined target price. The aggregate amount of such obligation will in no event

6


 

TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except per share amounts)

exceed $2,880. An amount of $1,525, attributable to this contingent liability, was accrued under other long-term liabilities at December 31, 2001.

We entered into a series of agreements with Becton, Dickinson and Company (“BD”) on July 31, 2001, to develop and commercialize molecular diagnostics and pharmacogenomic tests for cancer as part of the ongoing strategic alliance between BD and Millennium Pharmaceuticals, Inc. (“Millennium”). We have accounted for the transaction in accordance with the provisions of SFAS No. 68, “Research and Development Arrangements.” In connection with the transaction, we recorded $6,198 in deferred research and development (“R&D”) funding, which will be amortized against such expenses over thirty months on a straight line basis. During the three and nine months ended September 30, 2002, $620 and $1,859, respectively, of amortization was recorded against R&D expenses. Included in current and other long-term liabilities are the unamortized balances of $2,479 and $826, respectively.

7. Operations by Industry Segment

Description of Products and Services by Segment

We develop, manufacture, market and sell proprietary products for cancer detection, diagnosis, staging, and treatment selection. We are using our proprietary technologies and know-how to create an array of products designed to improve the clinical management of cancer. We currently operate in two business segments: Commercial Operations, which centers its efforts on cervical cancer screening, and TriPath Oncology, which is focused on the development of molecular diagnostic and pharmacogenomic tests for malignant melanoma and cancers of the cervix, breast, ovary, colon, and prostate.

Results by Segment

TriPath Oncology began operations on July 31, 2001. The results, by segment, for the three and nine months ended September 30, 2002 and 2001, are as follows:

                             
        Three Months Ended September 30, 2002
       
        Commercial   TriPath        
        Operations   Oncology   Total
       
 
 
Sales
  $ 9,826     $     $ 9,826  
Cost of sales
    3,886             3,886  
 
   
     
     
 
 
Gross profit
    5,940             5,940  
Operating expenses:
                       
 
Research and development
    491       1,582       2,073  
 
Regulatory
    871       129       1,000  
 
Sales and marketing
    4,521       220       4,741  
 
General and administrative
    1,490       984       2,474  
 
   
     
     
 
   
Total operating expenses
    7,373       2,915       10,288  
 
   
     
     
 
 
Operating loss
  $ (1,433 )   $ (2,915 )   $ (4,348 )
 
   
     
     
 

7


 

TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except per share amounts)

Results by Segments, continued

                             
        Three Months Ended September 30, 2001
       
        Commercial   TriPath        
        Operations   Oncology   Total
       
 
 
Sales
  $ 5,250     $     $ 5,250  
Cost of sales
    2,248             2,248  
 
   
     
     
 
 
Gross profit
    3,002             3,002  
Operating expenses:
                       
 
Research and development
    1,135       745       1,880  
 
Regulatory
    517             517  
 
Sales and marketing
    5,120             5,120  
 
General and administrative
    2,484       643       3,127  
 
   
     
     
 
   
Total operating expenses
    9,256       1,388       10,644  
 
   
     
     
 
 
Operating loss
  $ (6,254 )   $ (1,388 )   $ (7,642 )