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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 March 31, 2003

OR

(   ) 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 by checkmark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).   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 May 6, 2003

 
Common Stock, $.01 par value
    37,537,940  

 


 

TriPath Imaging, Inc.

Table of Contents

           
Part I. Financial Information
       
Item 1. Condensed Consolidated Financial Statements (Unaudited)
    2  
 
Condensed consolidated balance sheets As of March 31, 2003 and December 31, 2002
    2  
 
Condensed consolidated statements of operations for the three months ended March 31, 2003 and 2002
    3  
 
Condensed consolidated statements of cash flows For the three months ended March 31, 2003 and 2002
    4  
 
Notes to condensed consolidated financial statements
    5  
Item 2. Management’s Discussion and Analysis of Financial Condition And Results of Operations
    11  
Item 3. Quantitative and Qualitative Disclosures About Market Risk
    20  
Item 4. Controls and Procedures
    21  
Part II. Other Information
       
Item 1. Legal Proceedings
    21  
Item 6. Exhibits and Reports on Form 8-K
    21  
Signatures
    22  
Certifications
    23  
Exhibit Index
    25  

1


 

Part I. FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements:

TriPath Imaging, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands, except share and per share amounts)

                     
        March 31,   December 31,
        2003   2002
       
 
Assets
               
Current assets:
               
 
Cash and cash equivalents
  $ 27,879     $ 32,571  
 
Accounts receivable, net
    10,042       9,370  
 
Inventory, net
    10,286       10,973  
 
Other current assets
    1,437       477  
 
 
   
     
 
   
Total current assets
    49,644       53,391  
Customer use assets, net
    6,894       6,357  
Property and equipment, net
    3,983       4,063  
Other assets
    864       930  
Intangible assets
    9,006       9,210  
 
 
   
     
 
   
Total assets
  $ 70,391     $ 73,951  
 
 
   
     
 
Liabilities and stockholders’ equity
               
Current liabilities:
               
 
Accounts payable
  $ 3,585     $ 2,341  
 
Accrued expenses
    6,423       5,436  
 
Deferred revenue and customer deposits
    1,020       1,103  
 
Deferred research and development funding
    2,066       2,479  
 
Current portion of long-term debt
    355       785  
 
Other current liabilities
          2,410  
 
 
   
     
 
   
Total current liabilities
    13,449       14,554  
Long-term debt, less current portion
    11       13  
Other long-term liabilities
          207  
Stockholders’ equity:
               
 
Common stock, $0.01 par value; 98,000,000 shares authorized; 37,537,940 and 37,454,234 shares issued and outstanding at March 31, 2003 and December 31, 2002, respectively
    375       375  
 
Additional paid-in capital
    283,514       283,396  
 
Deferred compensation
    (72 )     (78 )
 
Accumulated deficit
    (226,832 )     (224,482 )
 
Accumulated other comprehensive loss
    (54 )     (34 )
 
 
   
     
 
   
Total stockholders’ equity
    56,931       59,177  
 
 
   
     
 
   
Total liabilities and stockholders’ equity
  $ 70,391     $ 73,951  
 
 
   
     
 

See accompanying notes to condensed consolidated financial statements

2


 

TriPath Imaging, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)

                   
      Three months ended
      March 31,
     
      2003   2002
     
 
Revenues
  $ 11,147     $ 7,563  
Cost of revenues
    3,878       3,247  
 
   
     
 
 
Gross profit
    7,269       4,316  
Operating expenses:
               
 
Research and development
    1,957       1,920  
 
Regulatory
    1,183       494  
 
Sales and marketing
    4,106       5,476  
 
General and administrative
    2,528       1,890  
 
   
     
 
 
    9,774       9,780  
 
   
     
 
Operating loss
    (2,505 )     (5,464 )
Interest income
    168       344  
Interest expense, including amortization of non-cash debt issuance costs under term loan agreement
    (13 )     (181 )
 
   
     
 
Net loss
  $ (2,350 )   $ (5,301 )
 
   
     
 
Net loss per common share (basic and diluted)
  $ (0.06 )   $ (0.14 )
 
   
     
 
Weighted-average common shares outstanding
    37,509       37,415  
 
   
     
 

See accompanying notes to condensed consolidated financial statements.

3


 

TriPath Imaging, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands, except share and per share amounts)

                   
      Three months ended
      March 31,
     
      2003   2002
     
 
Operating activities
               
Net loss
  $ (2,350 )   $ (5,301 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
 
Depreciation and amortization
    1,067       972  
 
Amortization of non-cash debt issuance costs
          56  
 
Loss on disposal of fixed asset
    9        
 
Amortization of deferred research and development
    (620 )     (620 )
 
Other non-cash items
          324  
Change in operating assets and liabilities:
               
 
Accounts receivable
    (666 )     (64 )
 
Inventory
    (760 )     (650 )
 
Accounts payable and other current liabilities
    (281 )     (1,825 )
 
Other
    (893 )     394  
 
   
     
 
Net cash used in operating activities
    (4,494 )     (6,714 )
Investing activities
               
 
Purchases of property and equipment
    (62 )     (688 )
 
Maturities of short-term investments
          1,000  
 
Other
    196        
 
   
     
 
Net cash provided by investing activities
    134       312  
Financing activities
               
 
Proceeds from short term debt
    318        
 
Proceeds from exercise of stock options
    118       179  
 
Payments on long-term debt and leases
    (750 )     (829 )
 
   
     
 
Net cash used in financing activities
    (314 )     (650 )
Effect of exchange rate changes on cash
    (18 )     2  
 
   
     
 
Net decrease in cash and cash equivalents
    (4,692 )     (7,050 )
Cash and cash equivalents at beginning of period
    32,571       53,477  
 
   
     
 
Cash and cash equivalents at end of period
  $ 27,879     $ 46,427  
 
   
     
 

See accompanying notes to condensed consolidated financial statements

4


 

TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except share and per share amounts)
March 31, 2003

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 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, 2002 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, 2002.

Reclassifications

Certain amounts for the prior period, specifically those attributable to our TriPath Oncology segment (see Note 8) 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 previously reported net loss or stockholders’ equity.

2.   Inventory

Inventory consists of the following:

                 
    March 31,   December 31,
    2003   2002
   
 
Raw materials
  $ 6,772     $ 6,934  
Work-in-process
    1,841       629  
Finished goods
    1,673       3,410  
 
   
     
 
 
  $ 10,286     $ 10,973  
 
   
     
 
Instruments
  $ 8,983     $ 9,761  
Reagents and consumables
    1,303       1,212  
 
   
     
 
 
  $ 10,286     $ 10,973  
 
   
     
 

For the three months ended March 31, 2003 and 2002, reclassifications of $1,445 and $1,124, respectively, occurred between customer-use assets, property and equipment, and inventory.

5


 

TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except share and 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 March 31, 2003, the balance outstanding was $58, 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 January 2003, 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. At March 31, 2003, there was no outstanding balance on the line of credit. 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.

In August 2002, we obtained a $1,500 lease line of credit 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 March 31, 2003, there were $1,224 of assets leased under this lease line.

In April 2003, we obtained a $2,500 lease line of credit from General Electric Capital Corporation. This lease line carries three-year lease terms for items acquired under it. The lease line will be used as an alternative source of capital to secure operating leases for assets, primarily equipment.

6.   Other Liabilities

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

6


 

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

research and development (“R&D”) funding, which will be amortized against such expenses over thirty months on a straight line basis. During the three months ended March 31, 2003, $620 of amortization was recorded against R&D expenses. Included in current liabilities is the unamortized balance of $2,066.

7.   Stock Based Compensation

We account for stock options issued to employees in accordance with APB Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB 25”). Under APB 25, no compensation expense is recognized for stock or stock options issued with an exercise price equivalent to the fair value of our Common Stock. For stock options granted at exercise prices below the deemed fair value, we record deferred compensation expense for the difference between the exercise price of the shares and the deemed fair value. Any resulting deferred compensation expense is amortized ratably over the vesting period of the individual options.

In October 1995, the FASB issued SFAS No. 123, “Accounting for Stock Based Compensation” (“SFAS 123”). For companies that continue to account for stock based compensation arrangements under APB 25, SFAS 123 requires disclosure of the pro forma effect on net income (loss) and earnings (loss) per share as if the fair value based method prescribed by SFAS 123 had been applied.

In December 2002, the FASB issued SFAS No. 148, “Accounting for Stock Based Compensation—Transition and Disclosure—an amendment of FASB Statement No. 123” (“SFAS 148”). This Statement amends FASB Statement No. 123, Accounting for Stock Based Compensation, to provide alternative methods of transition for a voluntary change to the fair value based method of accounting for stock based employee compensation. In addition, this Statement amends the disclosure requirements of Statement 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock based employee compensation and the effect of the method used on reported results (see below).

Had compensation cost for our stock options been determined based on the fair value at the date of grant consistent with the provisions of SFAS 123, with respect to our Equity Incentive Plans and our Employee Stock Purchase Plan, our pro forma net loss and net loss per share would have been as follows:

                   
      Three Months Ended
      March 31,
     
      2003   2002
     
 
Net loss:
               
 
As reported
  $ (2,350 )   $ (5,301 )
 
Pro forma
  $ (3,153 )   $ (6,083 )
Net loss per common share (basic & diluted):
               
 
As reported
  $ (0.06 )   $ (0.14 )
 
Pro forma
  $ (0.08 )   $ (0.16 )

7


 

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

8.   Operations by Industry Segment

Description of Products and Services by Segment

We create solutions that redefine the early detection and clinical management of cancer. Specifically, 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 have developed and marketed an integrated solution for cervical cancer screening and other products that deliver image management, data handling, and prognostic tools for cell diagnosis, cytopathology and histopathology. We have created new opportunities and applications for our proprietary technology by applying recent advances in genomics, biology, and informatics to develop new molecular diagnostic and pharmacogenomic products and services for malignant melanoma and cancers of the cervix, breast, ovary, colon and prostate.

We are organized into two operating units: (1) Commercial Operations, through which we manage the market introduction, sales, service, manufacturing and ongoing development of our products; and (2) TriPath Oncology, our wholly-owned subsidiary through which we manage the development of molecular diagnostic and pharmacogenomic products and services for cancer.

Results by Segment

The results, by segment, for the three months ended March 31, 2003 and 2002, are as follows:

                             
        Three Months Ended March 31, 2003
        Commercial   TriPath        
        Operations   Oncology   Total
       
 
 
Sales
  $ 11,014     $ 133     $ 11,147  
Cost of sales
    3,862       16       3,878  
 
   
     
     
 
 
Gross profit
    7,152       117       7,269  
Operating expenses:
                       
 
Research and development
    517       1,440       1,957  
 
Regulatory
    1,038       145       1,183  
 
Sales and marketing
    3,921       185       4,106  
 
General and administrative
    1,529       999       2,528  
 
   
     
     
 
   
Total operating expenses
    7,005       2,769       9,774  
 
   
     
     
 
 
Operating income / (loss)
  $ 147     $ (2,652 )   $ (2,505 )
 
   
     
     
 

8


 

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

                             
        Three Months Ended March 31, 2002
        Commercial   TriPath        
        Operations   Oncology   Total
       
 
 
Sales
  $ 7,563     $     $ 7,563  
Cost of sales
    3,247             3,247  
 
   
     
     
 
 
Gross profit
    4,316             4,316  
Operating expenses:
                       
 
Research and development
    624       1,296       1,920  
 
Regulatory
    371       123       494  
 
Sales and marketing
    5,299       177       5,476  
 
General and administrative
    1,057       833       1,890  
 
   
     
     
 
   
Total operating expenses
    7,351       2,429       9,780  
 
   
     
     
 
 
Operating loss
  $ (3,035 )   $ (2,429 )   $ (5,464 )
 
   
     
     
 

All sales were generated from external customers. There were no inter-segment revenues. Sales to external customers in the TriPath Oncology segment were $133 during the three months ended March 31, 2003 and were attributable to services sold. Sales to external customers in the Commercial Operations segment for the three months ended March 31, 2003 and 2002 include the following:

                   
      Three Months Ended,
      March 31, 2003   March 31, 2002
     
 
Instruments
  $ 1,077     $ 1,419  
Reagents
    8,372       4,756  
Fee-per-use and other
    1,565       1,388  
 
   
     
 
 
Total sales
  $ 11,014     $ 7,563  
 
   
     
 

At March 31, 2003, we had accounts and notes receivable of $2,036 from a company which disclosed to us its intention to exit the cervical cytology business. The contract we have with this customer was a multi-year agreement that included commitments for reagents and disposables. As we were unable to reach a mutually acceptable settlement under our agreement through negotiations with that company, we filed suit against that company in February 2003 in state court in North Carolina to enforce our rights under the agreement. We believe the defendant company to be credit-worthy and able to satisfy any judgment we may obtain against it. We expect no material adverse financial impact on our results of operations or financial position, although this litigation will result in additional costs to us that we may be unable to recover.

Depreciation and amortization expense for the three months ended March 31, 2003 and 2002 amounted to $1,012, and $960, respectively, for the Commercial Operations segment and $55 and $12, respectively, for the TriPath Oncology segment. The TriPath Oncology segment also amortized $620 of deferred R&D funding against R&D expenses for each of the three-month periods ended March 31, 2003 and 2002.

As of March 31, 2003, the TriPath Oncology segment had total assets of $1,780 and the Commercial Operations segment had total assets of $68,611.

9


 

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

9.   Recently Issued Accounting Standards

In August 2001, the FASB issued SFAS No. 143, “Accounting for Asset Retirement Obligations” (“SFAS 143”). SFAS 143 requires an entity to record a liability for an obligation associated with the retirement of an asset at the time that the liability is incurred by capitalizing the cost as part of the carrying value of the related asset and depreciating it over the remaining useful life of that asset. The standard became effective for us beginning January 1, 2003. The adoption of SFAS 143 had no impact on our results of operations or financial position.

In April 2002, the FASB issued SFAS No. 146, “Accounting for Costs Associated with Exit or Disposal Activities” (“SFAS 146”). SFAS 146 addresses financial accounting and reporting for costs associated with exit or disposal activities and nullifies Emerging Issues Task Force (EITF) Issue No. 94-3,